From owner-sci-resources@net.bio.net Mon May 01 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-95-012 - V24(15) 04/28/95 Date: 2 May 1995 09:53:33 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 552 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3o5o2d$gmg@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA95012 CA-95-012 P1O1 *************************************** INVESTIGATOR GRANTS FOR CLINICAL CANCER THERAPY RESEARCH NIH GUIDE, Volume 24, Number 15, April 28, 1995 RFA: CA-95-012 P.T. 34; K.W. 0715035, 0745070 National Cancer Institute Letter of Intent Receipt Date: September 1, 1995 Application Receipt Date: October 20, 1995 PURPOSE The Cancer Therapy Evaluation Program (CTEP) and the Biological Response Modifiers Program (BRMP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI) invites research grant applications for the conduct of therapeutic clinical trials research employing new agents, concepts, or strategies for the treatment of cancer. This initiative is aimed at encouraging new clinical investigators who have not previously had independent grant funding to submit research applications in this area of research. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Investigator Grants for Clinical Cancer Therapy Research, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. An important principle to remember is that the more extensive the prior independent research experiences, regardless of funding sources, the greater likelihood there will be diminished priority for award. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01) as its funding mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed four years. The direct cost for the four year period may not exceed $500,000. The direct cost in any budget period may not exceed $150,000. The anticipated award date is July 1996. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is contingent upon the continuing availability of funds for this purpose. This RFA is a one-time solicitation for new applications for award in FY 96. NCI encourages investigators who responded to the previous solicitation (RFA CA-94-014) to resubmit. The NCI has plans to re- issue this RFA for funding in 1997. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Approximately $2,000,000 in total costs per year for each of four years will be committed to fund applications submitted in response to this RFA. It is anticipated that ten new individual awards will be made. RESEARCH OBJECTIVES Background In the past year, a number of groups have expressed concern over the declining number of clinical investigators entering and remaining in academic research. Clinical investigators are a critical component in translating new therapeutic agents and modalities from the laboratory into the clinic. They must maintain a broad perspective and knowledge concerning clinical and basic sciences, while developing new cancer therapies that are hypothesis driven. They are highly interactive with basic and clinical researchers in related disciplines. This translational clinician is considered distinct >From the clinician who also has a PhD or equivalent training and concentrates on basic research or the clinician who participates in cancer research solely by entering patients on clinical trials. The Clinical Investigations Task Force of the National Cancer Advisory Board and a sub-committee of the American Association of Clinical Oncology (ASCO) have both been addressing the problem of the decreasing number of academic clinical investigators. One of the problems identified is the lack of suitable mechanisms for the training and funding of clinical oriented investigators involved in translating basic research into new cancer treatments. The traditional grants mechanisms (R01, R29) are under-utilized and often do not fit the needs of young clinical investigators for the support of clinical trials research. The R29 grant mechanism requires the investigator to devote at least 50 percent effort to a five year project and the yearly budget is limited to approximately $70,000. Most clinicians have major clinical and teaching responsibilities and it is impossible to support both the clinical and laboratory components needed within the budget limitations of an R29 grant. New clinical investigators often do not have the publication or research track record to be competitive for R01 grant support. Thus, very few clinical trial research applications are submitted by new clinical investigators. DCT would like to reverse this trend and encourage new clinical investigators, who have not previously received R01 or R29 grant support, to submit grant applications for the conduct of translational clinical trials research. Project Description The Cancer Therapy Evaluations Program and the Biological Response Modifiers Program encourage qualified clinical investigators to develop R01 grant applications for the conduct of cancer clinical trials research on new therapeutic agents and modalities. Grant applications must include clinical trials involving human subjects and designed to ultimately improve cancer survival. The clinical trials must have a strong rationale and be based upon preclinical data, preferably generated by the applicant or collaborators, that support the underlying hypotheses. New clinical therapeutic trials employing drugs (including differentiating agents), biologics (including cytokines, antibodies), vaccine strategies, radiation, or surgery whether used as a single agent/modality or in combination are appropriate. Investigators are urged especially to address the more difficult therapeutic challenges, including the most common malignancies (e.g., breast, ovarian, prostrate, lung). Laboratory studies to monitor patients or to study the mechanism of antitumor effect and resistance should be included. The laboratory studies should be in support of the clinical trial, such that their conduct leads to a greater understanding of the relationship of the therapy and biological changes in the patient or the mechanism of action of an anti-tumor response. Laboratory studies would include pharmacokinetic studies of cytotoxic, immune-modulating, differentiation-inducing, and/or targeted therapeutic agents or relevant pharmacodynamic correlative studies. Measurement of particular biological responses would also be desirable particularly when this information would be relevant to the interpretation of the success or failure of the therapy in individual patients on the clinical trial. It is expected that a significant level of effort, at least 25 percent, will be committed to the research project by the Principle Investigator. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator must be included with the application. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 4928 of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by September 1, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is be sent to: Ms. Diane Bronzert Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 APPLICATION PROCEDURES The research grant application form PHS 398, (rev. 9/91) is to be used in applying for this RFA. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the NCI program staff listed under INQUIRIES. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 Bethesda, MD 20852 (for express mail) Applications must be received by October 20, 1995. If an application is received after that date, it will be returned. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. B. Special Instructions for the Completion of the PHS 398 Application NIH has recently been designated a "re-invention laboratory" by the Public Health Service. One component of our efforts to streamline NIH operations is to simplify the grant application and review process. Therefore, an experiment is being conducted to determine ways to reduce the administrative burden in applying for an NIH grant without compromising those elements needed by the initial scientific peer review group to assess the scientific merit of the application and the reasonableness of the proposed budget. In responding to the RFA, the following are specific instructions for sections of the PHS 398 application form (rev. 9/91) that should be completed differently from usual. Some sections are modified and others in the application do not need to be completed for the submission of the application but WILL be requested if your application receives a priority score in the fundable range. For all other items in the application, follow the usual instructions on pages 9-32 of the PHS 398 booklet. FACE PAGE (Form AA) - The title and number of the RFA must be typed in line 2a. Failure to do so could result in delayed processing of your application such that it may not reach the review committee in time for review. Item 10, INVENTIONS AND PATENTS - Do not complete. See Specific Instructions - Appendix for Instructions. FORM DD - PAGE 4 - DETAILED BUDGET PAGE FOR INITIAL BUDGET PERIOD Enter direct costs only for the following: o Personnel, Patient Care Costs, Alterations-Renovations - Complete these sections as instructed in the PHS 398 booklet. o Consultant Costs - Itemize only if proposed consultant costs exceed $10,000 or if a consultant is identified as key personnel. o Equipment - Itemize only individual equipment items in excess of $10,000. o Supplies - Itemize (a) all animal costs and (b) any individual supply item which costs more than $10,000. If animals are involved, state their unit purchase and care costs. Enter total animal costs and supply costs on separate lines. o Travel and Other Expenses - Itemize any expense category that exceeds $5,000. Form EE - Page 5 - BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD - Do not complete this page. Unless you are requesting unusual increases or decreases in future years, they will be automatically escalated on the direct costs proposed for the first year (minus one time costs for equipment) by four percent. Form FF - Page 6 - BIOGRAPHICAL SKETCH - For each KEY person only, provide a two-page biographical sketch. Name, Position Title, Education - Complete these sections as instructed in the PHS 398 booklet. Research and Professional Experience - Identify your research background and experience relevant to the research proposed. Specifically, provide: o A list of previous research positions that are felt to be of significance or relevance for the review of the proposed research; o Complete references, titles, and authors on all peer-reviewed publications representative of your research career or pertinent to the research proposed; o The title and funding source of all active research grants or contracts on which you are principal investigator, co-investigator, or project leader. Indicate current percent effort for each award. o The title and length of service on any peer review group, council, or program advisory committee. Form GG - Page 7 - OTHER SUPPORT - Do not complete. Updated information will be requested by NCI staff from only those applicants being considered for funding. Form HH - Page 8 - RESOURCES AND ENVIRONMENT - Complete this section as requested in the PHS 398 form. SPECIFIC INSTRUCTIONS - RESEARCH PLAN (Booklet Pages 19-24) - Applications in response to this RFA should be concise and shorter than regular grant applications. Items 1-4 may not exceed 20 pages in total. Item 1 - Specific Aims - In one page or less, list in priority order, the broad, long-range objectives. Describe concisely and realistically the hypothesis to be tested and what the specific research described in this application is intended to accomplish. Item 2 - Background and Significance - In two to three pages, use this section to describe (a) how the proposed research will contribute to meeting the goals and objectives of the RFA; and, (b) explain the rationale for the selection of the general methods and approaches proposed to accomplish your specific aims. Items 3-4 - Progress Report/Preliminary Studies, Research Design and Methods - In seventeen pages or less, complete as instructed on pages 20-21 of the PHS 398 booklet with the modification that the clinical protocol(s) and up to six publications, manuscripts submitted or accepted for publication, patents, or invention reports can be included in the Appendix (see below). Investigator may use this section to address the following: o preliminary studies pertinent to the application; o rationale and hypothesis for the clinical trial and laboratory studies. o general methods that will be utilized; provide specific details for those techniques which are unique or where a significant departure from a generally accepted technique is important for reviewers to know; o outcome measures that will be used to assess the success or failure of each set of experiments (include statistical analyses for laboratory and clinical studies); o plans for the rigorous data management and verification of research data; o potential pitfalls in the experimental design and alternative studies that will be done if the proposed experiments fail. Items 5-6 - Human Subjects, Vertebrate Animals - Complete as described on pages 22-23. State clearly the plans for early detection of and protection against adverse effects on human subjects. Documentation for the composition of the proposed study population in terms of gender and racial/ethnic group together with a rationale for its choice must be included in the Human Subjects section. Item 7 - Consultants/Collaborators - Biographical sketches should conform to the brief format described previously for Form FF. Item 8 - Consortium, Contractual Arrangements - In one page or less, provide a brief explanation of the programmatic fiscal and administrative arrangements made with collaborating organizations. Item 9 - Literature Cited - In five pages or less, give full literature citations including the title of the article. SPECIFIC INSTRUCTIONS - APPENDIX (Page 24) - Up to ten publications, manuscripts submitted or accepted for publication, patents, and invention reports may be provided. Clinical protocol(s) must be included in this section. Other than this change, complete as instructed. Questions regarding these instructions may be directed to the program staff listed under INQUIRIES. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) for completeness and by the NCI for responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the Request for Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. The review group will assess the scientific merit of the studies using the following review criteria: 1. Importance, timeliness, and clinical merit of the clinical trials. 2. Quality of data supporting the proposed clinical trial. 3. Scientific and technical merit of the proposed laboratory studies. 4. Relevance of the proposed laboratory studies to the clinical trials. 5. Research training and clinical qualifications of the Principal Investigator and staff in the area of the proposed research. 6. Availability and quality of the resources necessary to perform research. 7. Quality of data verification and management plans and statistical analysis. The initial review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each approved application. They will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA Applications considered by the National Cancer Advisory Board will be considered for award based upon (a) scientific and technical merit; (b) availability of funds; and (c) programmatic priorities. Preference will also be given to clinical investigators who are new to this research area. Letter of Intent Receipt Date: September 1, 1995 Application Receipt Date: October 20, 1995 Review by National Cancer Advisory Board: May 1996 Anticipated Award Date: July 1996 INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not specific proposed research would be responsive are strongly encouraged. The program staff welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding general programmatic issues and chemotherapy agents to: Ms. Diane Bronzert Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 6130 Executive Boulevard MSC 7432 Bethesda, MD 20892-7432 Telephone: (301) 496-8866 FAX: (301) 480-4663 Email: BRONZERD@DCT.NCI.NIH.GOV Direct inquiries regarding programmatic issues using biologics to: Dr. Toby Hecht Division of Cancer Treatment National Cancer Institute FCRDC 1052, Room 247 Bethesda, MD 20892 Telephone: (301) 846-1098 FAX: (301) 846-5429 Email: HECHT@NCIFCRF.GOV Direct inquiries regarding fiscal matters to: Ms. Eileen M. Natoli Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, ext. 256 FAX: (301) 496-8601 Email: NATOLIE@GAB.NCI.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.395, Cancer Treatment Research. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended, Public Law 99-158, 42 USC 241 and 285) and administered under HHS grants policies. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Mon May 01 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA MH-95-003 - V24(15) 04/28/95 Date: 2 May 1995 09:53:42 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 433 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3o5o2m$gn4@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA MH95003 MH-95-003 P1O1 *************************************** ROLE OF THE BLOOD BRAIN BARRIER IN HIV NEUROPATHOGENESIS NIH GUIDE, Volume 24, Number 15, April 28, 1995 RFA: MH-95-003 P.T. 34; K.W. 0715008, 1002030 National Institute of Mental Health National Institute of Neurological Disorders and Stroke Letter of Intent Receipt Date: May 22, 1995 Application Receipt Date: June 27, 1995 PURPOSE The Office on AIDS, National Institute of Mental Health (NIMH), supports investigations directed at developing effective strategies to prevent or reduce behaviors that place individuals at risk for HIV infection and fosters research to enhance the understanding of the profound impact of the Human Immunodeficiency Virus (HIV) infection on the central nervous system (CNS). In addition, the National Institute of Neurological Disorders and Stroke (NINDS) supports research on neurological aspects of HIV infection (neuro-AIDS) in adults and children. The principal objective of this Request for Applications (RFA) is to stimulate research on the role of the blood brain barrier (BBB) in the neuropathogenesis of HIV infection and disease progression. The results of these investigations are expected to constitute preliminary data for proposals to block HIV entry into the CNS, and prevent the detrimental effects of the virus on the CNS. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Role of the Blood Brain Barrier in HIV Neuropathogenesis, is related to the priority areas of HIV infection of the nervous system and mental health and disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone (202) 783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The mechanisms available for support of this RFA are the National Institutes of Health (NIH) research project grant (R01), FIRST (R29) award, small grant award (R03-NIMH only), and the investigator-initiated interactive research project grant. Responsibility for the planning, direction, and execution of the proposed research project will be solely that of the applicant. The anticipated award date is September 1995. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will also vary. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE In fiscal year 1995, a total of $1.5 million contributed equally by NIMH and NINDS has been set aside for this RFA for about six to ten awards. Support may be requested for a period of up to five years. Foreign applicants may request no more than three years of support. RESEARCH OBJECTIVES Background The CNS appears to be a prime target of HIV. Investigators have shown that the CNS becomes infected with HIV early during the disease course. Neurobehavioral and neurologic changes occur in the majority of HIV-1 infected individuals. Autopsies have shown evidence of CNS cell damage in 80 to 90 percent of people who die with AIDS. The exact mechanism by which HIV enters the CNS, whether as a free virus and/or via infected cells (e.g., monocyte/macrophages) remains unknown. This RFA is intended to focus attention on investigating the role of the blood-brain barrier (BBB) in HIV neuropathogenesis, with the objective of generating information that will lead to development of therapeutic interventions to prevent the infection and the devastating effects of the virus on the CNS. The blood-brain barrier is an intricate cellular system composed of vascular endothelial cells and perivascular astrocytes that restrict the passage of molecules between the blood stream and the brain parenchyma. The function of this microvascular system is to ensure the proper maintenance of the neuronal microenvironment. This function is accomplished by employing selective transport mechanisms and utilizing tight junctions between neighboring cells to restrict passage of materials. Investigations have detected abnormalities in the human BBB in association with HIV infection. Significantly higher than normal levels of serum proteins (fibrinogen and IgG) were detected in the postmortem brain tissue of HIV-infected individuals as compared to matched seronegative controls. The diffuse leakage into the brain parenchyma, distinct from focal breakdown associated with tissue necrosis, was taken to signify abnormal vascular permeability. Studies have also described similar findings in the post-mortem brain tissue from individuals with AIDS dementia. These observations suggest that abnormal permeability of the BBB is associated with HIV infection. However, the exact role the perturbation of the BBB plays in HIV neuropathogenesis and in disease progression is unclear. For example, one would like to know whether the perturbation of the BBB precedes or succeeds the entry of HIV into the parenchyma. In addition to the brain parenchyma, cerebrospinal fluid (CSF) constitutes the second compartment of the CNS. Investigations have demonstrated that the CSF contains HIV-infected immunocytes throughout the course of the disease. How this and other reported changes in the CSF relate to alterations in the brain parenchyma and vice versa, is poorly understood. It is important that this relationship be defined because the CSF is the only CNS compartment accessible to sampling during life. It can be accessed during the disease progression to facilitate diagnosis, to yield information on the time-course of the CNS disease, and to deliver therapeutic agents. CSF communicates with the blood via the choroid plexus, which shows evidence of HIV infection. Thus, mechanisms underlying communication between the CNS, the CSF, and blood must be better understood to prevent HIV trafficking between these compartments. Areas of Interest The following are examples of research topics pertinent to this RFA to be investigated in humans and/or animal models. This list is not intended to be comprehensive, nor are the examples meant to be exclusive. Researchers responding to this RFA need not limit themselves to these topics; however, a clear linkage of the proposed study to the potential design of therapeutic interventions is desirable. o Define the mechanism(s) by which HIV virions enter, exit, and spread through the CNS. o Identify, characterize, and monitor changes in the BBB associated with HIV infection and disease progression. o Determine whether or not progressive immunodeficiency, caused by HIV, results in changes in the BBB and/or normal trafficking of immunocytes, particularly monocytes. o Determine whether or not HIV infection of circulating monocytes increases the probability of their entry into the CNS. o Identify changes in normal trafficking of immunocytes through the CNS (the brain parenchyma and the CSF) which occur as a result of HIV infection. o Identify and characterize viral-specific and nonspecific mechanisms underlying the perturbation of the BBB occurring during HIV neuropathogenesis. o Characterize potential adverse effects of HIV infection on the development of the BBB. o Develop and characterize in vivo models relevant to this RFA. o Determine changes in the selective passage of substances across the BBB that occur as a result of HIV infection. o Determine whether or not HIV-infected cells traffic from CNS compartments back into circulation. o Characterize functional changes of the choroid plexus associated with HIV infection. o Test neutralization of immunocyte chemoattractants and blocking of cell adhesion molecules (known to facilitate immunocyte trafficking), as means of blocking HIV entry into the CNS. o Determine the impact of current and potential CNS antiretroviral, psychopharmacologic, and other medications on the integrity of the BBB in HIV infection. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by May 22, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the applicatio may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows Institute staff to estimate the potential review workload and avoid conflicts of interest in the review. The letter of intent is to be addressed to Dr. Walter L. Goldschmidts or Dr. A.P. Kerza-Kwiatecki at the addresses listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title, "Role of Blood Brain Barrier in HIV Neuropathogenesis" (MH-95-003) must be typed on line 2a of the face page of the application form and the YES box must be marked. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC Program Director or Principal Investigator could be included with the application. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for courier or express service) At the time of submitssion, two additional copies of the application must be sent to Dr. Walter L. Goldschmidts or Dr. A.P. Kerza-Kwiatecki at the addresses listed under INQUIRIES. Applications must be received by June 27, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit in accordance with the review criteria stated below, by an appropriate peer review group convened by the NIMH/NINDS. As part of the initial merit review, all applications will receive a written critique and undergo a streamlined (triage) review process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second review by the national advisory council, where applicable. Review Criteria Criteria for scientific/technical merit review of applications are the following: o significance and originality of proposed research from a scientific or technical standpoint; o qualifications and experience of the Principal Investigator and the staff in areas specifically related to the questions under investigation; o adequacy of the conceptual and technical framework for the research, including evidence of familiarity with relevant research literature and proposed techniques; o access to appropriate study population(s), specimens, and equipment; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated; o adequacy of the existing and proposed facilities and resources; o adequacy of the data analysis plan; o appropriateness of the proposed budget, staffing plan, and time frame in relation to the proposed project. The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment. AWARD CRITERIA The following criteria will be considered in making funding decision: o scientific merit as determined during the peer review process o availability of funds INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Walter L. Goldschmidts, Ph.D. Office on AIDS National Institute of Mental Health Parklawn Building, Room 10-75 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-7281 FAX: (301) 443-9719 Email: wgoldsch@aoamh2.ssw.dhhs.gov A.P. Kerza-Kwiatecki, Ph.D. Division of Demyelination, Atrophic, and Dementing Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 804 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-1431 FAX: (301) 402-2060 Email: ak45w@nih.gov Ljubisa Vitkovic, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health Parklawn Building, Room 11C-06 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-5288 FAX: (301) 443-4822 Email: lv5g@nih.gov General information on the NIMH AIDS Programs may be obtained from: Ellen Stover, Ph.D. Director, Office on AIDS National Institute of Mental Health Parklawn Building, Room 10-75 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-7281 FAX: (301) 443-9719 Email: estover@aoamh2.ssw.dhhs.gov Direct inquiries regarding fiscal matters to: Ms. Diana S. Trunnell Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-14 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3065 FAX: (301) 443-6885 Email: dt21a@nih.gov Ms. Dianna Jessee Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-9231 FAX: (301) 402-0219 Email: dj35j@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance 93.242, Mental Health Research Grants, and 93,853 and 93,854 Neurological Disorders Grants. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and to promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon May 01 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 15, pt. 2of3, 28 April 1995 Date: 2 May 1995 09:53:18 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1499 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3o5o1u$glp@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950428 V24N15 P2O3 ************************************ year of support beginning in fiscal year 1996. A total of seven to nine awards are anticipated, pending receipt of applications of sufficient scientific merit and the availability of funds for this purpose. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Etiology and Pathogenesis of Temporomandibular Disorders, is related to the priority area of oral health and the cross-cutting issue of women's health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Governing Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations,, and award criteria for this solicitation may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher@nih.gov), and by mail and email from the program contact listed below. Patricia S. Bryant, PhD Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN 18A 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2095 FAX: (301) 480-8318 Email: BryantP@de45.nidr.nih.gov $$R6 END ************************************************************ $$P1 BEGIN PA-95-049 FULL-TEXT ************************************** MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA AVAILABLE: PA-95-049 P.T. 34; K.W. 0710030 National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute on Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Environmental Health Sciences National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Center for Human Genome Research National Center for Research Resources Application Receipt Dates: February 1, June 1, and October 1 PURPOSE The Mentored Research Scientist Development Award (MRSDA) (K01) is for research scientists who need an additional period of sponsored research experience as a way to gain expertise in a research area new to the candidate or in an area which would demonstrably enhance the candidate's scientific career. It is expected that following this experience, the candidate will be able to pursue an independent and productive research career. The Mentored Research Scientist Development Award (K01) provides an intensive, supervised career development experience in one of the biomedical, behavioral, or clinical sciences. The proposed experience should be in a research area new to the applicant and/or one in which an additional supervised research experience will demonstrably enhance the candidate's scientific career. The experiences should permit the application of novel or highly promising interdisciplinary approaches to particular research problems. Candidates must justify the need for a three, four, or five year period of mentored research experience and must be able to provide a convincing case that the proposed period of support will substantially enhance his/her career and/or will allow the pursuit of a novel or promising approach to a particular research problem. Candidates who have interrupted their careers because of illness or pressing family care commitments may apply if they can clearly demonstrate the potential for productive independent research and the need for an additional period of mentored research experience in order to accomplish an effective scientific reentry. Similarly, faculty members at institutions with a substantial minority enrollment, who wish to enhance their research skills through a supervised research experience at a nearby research center, may also apply, if they agree to remain at their parent institution after completion of the award. The MRSDA replaces four existing NIH career development mechanisms, including the Research Scientist Development Award (K01), the Minority School Faculty Development Award (K14), the Research Career Reentry Program (K17), and the Scientist Development Award (K21). Individuals who were eligible to apply for any one of these awards are now eligible to apply for a K01 award. Therefore, this Program Announcement (PA) supersedes all previous K01, K14, K17, and K21 program announcements. The NIH will no longer accept competing applications for the old K01, K14, K17, and K21 awards. Existing policies and provisions will remain in effect for current K01, K14, K17, and K21 recipients until completion of the non-competing years of their three to five year career development program. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Mentored Research Scientist Development Award, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contacts listed below. Dr. Robin A. Barr Office of Extramural Affairs National Institute on Aging Gateway Building, Room 2C218, MSC 9205 7201 Wisconsin Avenue Bethesda, MD 20892-9205 Telephone: (301) 496-9322 FAX: (301) 402-9245 Email: Barr@nihniagw.bitnet Dr. Ernestine D. Vanderveen, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 Email: tvanderv@willco.niaaa.nih.gov Ms. Frances Cotter Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1207 FAX: (301) 443-8744 Email: fcotter@willco.niaaa.nih.gov Dr. Mary C. Dufour Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 514 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4897 FAX: (301) 443-8614 Email: m.dufour@willco.niaaa.nih.gov Richard Lymn, Ph.D. Extramural Programs National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-49E 45 Center Drive, MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-5128 FAX: (301) 480-4543 Email: rl28b@nih.gov The NICHD will accept applications for the K01 under Clinical Rehabilitation Investigator Development Award (CRIDA), but will limit eligibility to candidates who have both clinical training in the rehabilitation related professions (e.g., P.T., O.T., R.N.) and possess doctoral level degrees (e.g., Ph.D., D.Eng., D.Ed.). Individuals supported under CRIDA must be committed to developing careers as independent investigators in medical rehabilitation. Danuta Krotoski, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Building 61E, Room 2A03 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 FAX: (301) 402-0832 Email: krotoskd@hd01.nichd.nih.gov Dr. Lester Gorelic Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 643 Bethesda, MD 20892 Telephone: (301) 496-7344 FAX: (301) 402-4551 Email: gorelicl@dea.nci.nih.gov (This award is reserved exclusively for minority faculty development) Dr. Michael Galvin Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 Research Triangle Park, NC 27709 Telephone: (919) 541-7825 FAX: (919) 541-2843 Email: galvin@niehs.nih.gov National Heart, Lung, and Blood Institute (The NHLBI does not accept applications for the Mentored Research Scientist Award (K01). It does, however, periodically issue Request for Applications (RFA) for the Minority School Faculty Development Award (K01) and the Research Development Award for Minority Faculty (K01) in the NIH Guide for Grants and Contracts.) Dr. Bettie Graham National Center for Human Genome Research Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: bg30t@nih.gov George T. Niederehe, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-3264 FAX: (301) 594-6784 Email: gniedere@aoamh4.ssw.dhhs.gov Kenneth G. Lutterman, Ph.D. Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10-95 Rockville, MD 20857 Telephone: (301) 443-3373 FAX: (301) 443-4045 Email: klutterm@nih.gov Henry Khachaturian, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health 5600 Fishers Lane, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-8033 FAX: (301) 443-1731 Email: hkhach@helix.nih.gov Leonard Mitnick, Ph.D. Office of AIDS Programs National Institute of Mental Health 5600 Fishers Lane, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-9719 FAX: (301) 443-9719 Email: lmitnick@aoamh2.ssw.dhhs.gov Mr. Edward Donohue Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1016A Bethesda, MD 20892 Telephone: (301) 496-4188 FAX: (301) 402-4370 Email: ed25b@nih.gov Dr. Mary Lucas Leveck Acute and Chronic Illness Branch National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-5963 FAX: (301) 480-8260 Email: mleveck@ep.ninr.nih.gov Leo A. Whitehair, D.V.M, Ph.D. Comparative Medicine Program National Center for Research Resources Westwood Building, Room 857 Bethesda, MD 20892 Telephone: (301) 435-0746 FAX: (301) 480-3660 Email: leow@ep.ncrr.nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-95-050 FULL-TEXT ************************************** INDEPENDENT SCIENTIST AWARD NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA AVAILABLE: PA-95-050 P.T. 34; K.W. 0710030 National Institute on Aging National Institute of Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute Of Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Health and Human Development National Institute of Deafness and Other Communication Disorders National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Heart, Lung, and Blood Institute National Institute of Mental Health Application Receipt Dates: February 1, June 1, and October 1 PURPOSE The Independent Scientist Award (ISA) (K02) provides support for newly independent scientists who can demonstrate the need for a period of intensive research focus as a means of enhancing their research careers. This award is intended to foster the development of outstanding scientists and enable them to expand their potential to make significant contributions to their field of research. This award replaces two existing career development awards including the Research Scientist Development Award (K02) and the Research Career Development Award (K04). Individuals who were eligible to apply for either of these awards are now directed to apply for a K02 award. Therefore, this Program Announcement (PA) supersedes all previous K02 and K04 program announcements. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Independent Scientist Award, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Dr. Robin A. Barr Office of Extramural Affairs National Institute on Aging Gateway Building, Room 2C218, MSC 9205 7201 Wisconsin Avenue Bethesda, MD 20892-9205 Telephone: (301) 496-9322 FAX: (301) 402-9245 Email: Barr@nihniagw.bitnet Dr. Ernestine D. Vanderveen, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 Email: tvanderv@willco.niaaa.nih.gov Ms. Frances Cotter Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1207 FAX: (301) 443-8744 Email: fcotter@willco.niaaa.nih.gov Dr. Mary C. Dufour Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 514 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4897 FAX: (301) 443-8614 Email: m.dufour@willco.niaaa.nih.gov Dr. Milton Hernandez Office of Scientific Training and Manpower Development National Institute of Allergy and Infectious Diseases Solar Building, Room 3C21 Bethesda, MD 20892 Telephone: (301) 496-7291 FAX: (301) 402-0369 Email: mh35c@nih.gov Richard Lymn, Ph.D. Extramural Programs National Institute on Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-49E 45 Center Drive, MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-5128 FAX: (301) 480-4543 Email: rl28b@nih.gov Hildegard Topper Special Assistant to the Deputy Director National Institute of Child Health and Human Development Building 31, Room 2A-03 Bethesda, MD 20892 Telephone: (301) 496-0104 FAX: (301) 402-1104 Email: topperh@hd03.nichd.nih.gov Daniel Sklare, Ph.D. National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400B-13 Bethesda, MD 20892 Telephone: (301) 496-1804 FAX: (301) 402-6251 Email: Daniel_Sklare@nih.gov Dr. James A. Lipton Special Assistant for Training and Career Development National Institute of Dental Research Natcher Building, Room 4AN.18J Bethesda, MD 20892 Telephone: (301) 594-2618 FAX: (301) 480-8319 Email: liptonj@de45.nidr.nih.gov Ronald Margolis, Ph.D. Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 5AN-12J MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8819 FAX: (301) 480-3503 Email: margolis@ep.niddk.nih.gov Charles Rodgers, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AS-19J MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: rodgersc@ep.niddk.nih.gov Timothy P. Condon, Ph.D. OSPEL/SPAB National Institute on Drug Abuse Parklawn Building, Room 10A-55 Telephone: (301) 443-6072 FAX: (301) 443-6277 Email: tc52x@nih.gov Charles W. Sharp, Ph.D. Division of Basic Research National Institute on Drug Abuse Parklawn Building, Room 10A-31 Telephone: (301) 443-1887 FAX: (301) 594-6043 Email: cs107m@nih.gov Arthur Horton, Ed.D. Division of Clinical Research National Institute on Drug Abuse Parklawn Building, Room 10A-30 Telephone: (301) 443-4060 FAX: (301) 443-2317 Email: ah61x@nih.gov Ann Blanken Division of Epidemiology and Prevention Research National Institute on Drug Abuse Parklawn Building, Room 9A-55 Telephone: (301) 443-6543 FAX: (301) 443-9847 Email: ab108v@nih.gov Jamie Biswas, Ph.D. Medications Development Division National Institute on Drug Abuse Parklawn Building, Room 11A-55 Telephone: (301) 443-5280 FAX: (301) 443-2599 Email: jb168r@nih.gov Dr. Michael Galvin Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 Research Triangle Park, NC 27709 Telephone: (919) 541-7825 FAX: (919) 541-2843 Email: galvin@niehs.nih.gov Thomas Blaszkowski, Ph.D. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute Federal Building, Room 208A 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-1841 FAX: (301) 480-1455 Email: tb33i@nih.gov Michael Commarato, Ph.D. Division of Heart and Vascular diseases National Heart, Lung, and Blood Institute Federal Building, Room 3C04 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-1724 FAX: (301) 402-2043 Email: mc63a@nih.gov Joyce Creamer Division of Blood diseases and Resources National Heart, Lung, and Blood Institute Federal Building, Room 5C02 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-8388 FAX: (301) 480-0867 Email: jc85n@nih.gov James Kiley, Ph.D. National Center for Sleep Disorders Research National Heart, Lung, and Blood Institute Building 31, Room 4A11 Bethesda, MD 20892 Telephone: (301) 496-7443 FAX: (301) 496-7508 Email: jk52a@nih.gov Mary Reilly Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640 5333 Westbard Avenue Bethesda, MD 20892 Telephone: (301) 594-7466 FAX: (301) 594-7487 Email: mr50w@nih.gov George T. Niederehe, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-3264 FAX: (301) 594-6784 Email: gniedere@aoamh4.ssw.dhhs.gov Kenneth G. Lutterman, Ph.D. Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10-95 Rockville, MD 20857 Telephone: (301) 443-3373 FAX: (301) 443-4045 Email: klutterm@aoamh2.ssw.dhhs.gov Henry Khachaturian, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health 5600 Fishers Lane, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-8033 FAX: (301) 443-1731 Email: hkhach@helix.nih.gov Leonard Mitnick, Ph.D. Office of AIDS Programs National Institute of Mental Health 5600 Fishers Lane, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-9719 FAX: (301) 443-9719 Email: lmitnick@aoamh2.ssw.dhhs.gov $$P2 END ************************************************************ $$P3 BEGIN PA-95-051 FULL-TEXT ************************************** SENIOR SCIENTIST AWARD NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA AVAILABLE: PA-95-051 P.T. 34; K.W. 0710030 National Institute on Alcoholism and Alcohol Abuse National Institute on Drug Abuse National Institute of Mental Health Application Receipt Dates: February 1, June 1, and October 1 PURPOSE The Senior Scientist Award (K05) provides stability of support to outstanding scientists who have demonstrated a sustained, high level of productivity and whose expertise, research accomplishments, and contributions to the field have been and will continue to be critical to the mission of the particular NIH center or institute. The award provides salary support for award periods of five years as a means of enhancing the individual recipient's skills and dedication to his/her area of research. The Senior Scientist Award (K05) permits NIH institutes and centers to identify and support exceptionally talented investigators who are well established in their field of research. Since not all of the NIH institutes and centers support this award, potential applicants should contact the appropriate NIH program staff listed under INQUIRIES prior to preparing an application. The NIH recently reviewed the career awards (K-series) used to develop the research capabilities of clinicians and other scientists needed to carry out the nation's research mission in the biomedical and behavioral sciences. This evaluation resulted in several changes: (1) the total number of K mechanisms were reduced from 19 to six; (2) the review criteria were refined to clarify the career development goals of the K award; and (3) K award applications will be assigned to initial review groups managed by the prospective funding institute or center to which the application has been assigned. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Senior Scientist Award, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Dr. Ernestine D. Vanderveen, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 Email: tvanderv@willco.niaaa.nih.gov Ms. Frances Cotter Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1207 FAX: (301) 443-8744 Email: fcotter@willco.niaaa.nih.gov Dr. Mary C. Dufour Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 514 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4897 FAX: (301) 443-8614 Email: m.dufour@willco.niaaa.nih.gov Timothy P. Condon, Ph.D. Office of Science Policy, Education, and Legislation National Institute on Drug Abuse Parklawn Building, Room 10A-55 Rockville, MD 20857 Telephone: (301) 443-6072 FAX: (301) 443-6277 Email: tc52x@nih.gov Charles W. Sharp, Ph.D. Division of Basic Research National Institute on Drug Abuse Parklawn Building, Room 10A-31 Rockville, MD 20857 Telephone: (301) 443-1887 FAX: (301) 594-6043 Email: cs107m@nih.gov Arthur Horton, Ed.D. Division of Clinical Research National Institute on Drug Abuse Parklawn Building, Room 10A-30 Rockville, MD 20857 Telephone: (301) 443-4060 FAX: (301) 443-2317 Email: ah61x@nih.gov Ann Blanken Division of Epidemiology and Prevention Research National Institute on Drug Abuse Parklawn Building, Room 9A-55 Rockville, MD 20857 Telephone: (301) 443-6543 FAX: (301) 443-9847 Email: ab108v@nih.gov Jamie Biswas, Ph.D. Medications Development Division National Institute on Drug Abuse Parklawn Building, Room 11A-55 Rockville, MD 20857 Telephone: (301) 443-5280 FAX: (301) 443-2599 Email: jb168r@nih.gov George T. Niederehe, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-3264 FAX: (301) 594-6784 Email: gniedere@aoamh4.ssw.dhhs.gov Kenneth G. Lutterman, Ph.D. Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10-95 Rockville, MD 20857 Telephone: (301) 443-3373 FAX: (301) 443-4045 Email: klutterm@nih.gov Henry Khachaturian, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health 5600 Fishers Lane, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-8033 FAX: (301) 443-1731 Email: hkhach@helix.nih.gov Leonard Mitnick, Ph.D. Office of AIDS Programs National Institute of Mental Health 5600 Fishers Lane, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-9719 FAX: (301) 443-9719 Email: lmitnick@aoamh2.ssw.dhhs.gov $$P3 END ************************************************************ $$P4 BEGIN PA-95-052 FULL-TEXT ************************************** ACADEMIC CAREER AWARD NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA AVAILABLE: PA-95-052 P.T. 34; K.W. 0710030 National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Environmental Health Sciences National Institute of Mental Health Application Receipt Dates: February 1, June 1, and October 1 PURPOSE The Academic Career Award (K07) is used by the NIH Institutes and Centers to support individuals interested in introducing or improving curriculum in a particular scientific field as a means of enhancing the educational or research capacity at the grantee institution. Since not all of the NIH Institutes and Centers offer this award, potential applicants should contact the appropriate NIH program staff listed under INQUIRIES, prior to preparing an application. This Academic Career Award (K07) supports two types of activities: Development. The K07 provides support for more junior candidates who are interested in developing an academic and research expertise in a particular field, as a way to increase the overall pool of individuals capable of research or teaching in the identified area. During the period of the award, the candidate will become a successful academician in the chosen area. Teaching, curriculum building, research, and leadership skills are to be learned during the tenure of the award. For junior candidates, a mentor is required. Leadership. The K07 also supports more senior individuals with acknowledged scientific expertise and leadership skills who are interested in improving the curricula and enhancing the research capacity within an academic institution. It is expected that support under this award will increase the visibility and the overall research support or academic capacity for the given field of research within the academic medical/health and research community. Not all of the NIH awarding components support the K07 or both components of this award. For example, the National Institute of Mental Health does not support the leadership component of this award. Applicants are strongly encouraged to contact the prospective NIH awarding component prior to preparing an application. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Academic Career Award, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Dr. Robin A. Barr Office of Extramural Affairs National Institute on Aging Gateway Building, Room 2C218, MSC 9205 7201 Wisconsin Avenue Bethesda, MD 20892-9205 Telephone: (301) 496-9322 FAX: (301) 402-9245 Email: Barr@nihniagw.bitnet Dr. Ernestine D. Vanderveen, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 Email: tvanderv@willco.niaaa.nih.gov Ms. Frances Cotter Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1207 FAX: (301) 443-8744 Email: fcotter@willco.niaaa.nih.gov Dr. Mary C. Dufour Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 514 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4897 FAX: (301) 443-8614 Email: m.dufour@willco.niaaa.nih.gov Richard Lymn, Ph.D. Extramural Programs National Institute on Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-49E MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-5128 FAX: (301) 480-4543 Email: rl28b@nih.gov Dr. John Schneider or Dr. Andrew Vargosko Division of Cancer Biology, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892 Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: schneidj@dcbdcep.nci.nih.gov Email: vargoska@dcbdcep.nci.nih.gov Dr. Annette Kirshner Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-03 Research Triangle Park, NC 27709 Telephone: (919) 541-0488 FAX: (919) 541-2843 Email: kirshner@niehs.nih.gov National Heart, Lung, and Blood Institute (The NHLBI does not accept applications for the Academic Career Award on a regular basis. It does, however, issue Requests for Applications (RFAs) using this award as programmatic needs arise.) George T. Niederehe, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-3264 FAX: (301) 594-6784 Email: gniedere@aoamh4.ssw.dhhs.gov $$P4 END ************************************************************ $$P5 BEGIN PA-95-053 FULL-TEXT ************************************** MENTORED CLINICAL SCIENTIST DEVELOPMENT AWARD NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA AVAILABLE: PA-95-053 P.T. 34; K.W. 0710030, 0785035 National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke Application Receipt Dates: February 1, June 1, and October 1 PURPOSE The purpose of the Mentored Clinical Scientist Development Award (MCSDA) (K08) is to support the development of outstanding clinician research scientists. This mechanism provides specialized study for clinically trained professionals who are committed to a career in research and have the potential to develop into independent investigators. The award supports a three, four, or five year period of supervised research experience that may integrate didactic studies with laboratory or clinically-based research. The proposed research should have both intrinsic research importance and be a suitable vehicle for learning the methodology, theories, and conceptualizations necessary for a well trained independent researcher. Because of the focus on progression to independence, the prospective candidate should propose a period of study and development consistent with this goal and his or her previous research and clinical experience. For example, a candidate with limited experience in a given field of research may find a phased developmental program lasting for five years that includes a designated period of didactic training and supervised research experience the most efficient means of attaining independence. A candidate with substantial previous research experience may require a shorter award period appropriate for the transition to independence. The entire program should be comparable in scope and rigor to meeting the requirements for an advanced research degree. This award replaces the Clinical Investigator Award (K08), the Physician Scientist Award (K11), the Dentist Scientist Award (K15), and the Scientist Development Award for Clinicians (K20). Individuals who were eligible to apply for one of these awards are now directed to apply for an MCSDA. Therefore, this program Announcement supersedes all previous K08, K11, K15 and K20 program announcements and competing applications for these awards will no longer be accepted. Existing policies and provisions will remain in effect for current K08, K11, K15 and K20 recipients until completion of the non-competing years of their career development program. The NIH institutes and centers implement this award in different ways to accommodate the career needs of researchers in fields within their missions. For example the National Institute of Dental Research (NIDR) requires that, in most situations, candidates must pursue a program that includes didactic and supervised basic or behavioral science research experiences which result in the Ph.D. degree. The NIDR may, under specific circumstances, provide support under this program for the development of advanced clinical knowledge and skills in either a recognized clinical specialty or equivalent dental clinical discipline. Therefore, the prospective candidate must have a D.D.S. or an equivalent degree but need not have started postgraduate training, such as in a clinical specialty or general practice dental residency. However, preference will be given to applicants with advanced training in general or specialty practice. Dentists without advanced clinical knowledge and skills are eligible for the MCSDA but are encouraged to seek appointments to the Mentored Clinical Scientist Development Program Award (K12). All applicants are strongly encouraged to contact the prospective awarding component to discuss issues of eligibility and the specific provisions of this award. The NIH recently reviewed its career awards (K) used to develop the research capabilities of clinicians and other scientists needed to carry out the nation's research mission in the biomedical and behavioral sciences. This evaluation resulted in several changes: (1) the total number of K mechanisms were reduced from 19 to six; (2) the review criteria were refined to clarify the career development goals of the K award; and (3) K award applications will be assigned to initial review groups managed by the prospective funding institute or center to which the application has been assigned. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Mentored Clinical Scientist Development Award, is related to the priority area of human resource development. Potential candidates may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Dr. Robin A. Barr Office of Extramural Affairs National Institute on Aging 7201 Wisconsin Avenue, Room 2C218, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9322 FAX: (301) 402-9245 Email: Barr@nihniagw.bitnet Dr. Ernestine D. Vanderveen, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 Email: tvanderv@willco.niaaa.nih.gov Ms. Frances Cotter Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1207 FAX: (301) 443-8744 Email: fcotter@willco.niaaa.nih.gov Dr. Mary C. Dufour Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 514 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4897 FAX: (301) 443-8614 Email: m.dufour@willco.niaaa.nih.gov Dr. Milton Hernandez Office of Scientific Training and Manpower Development National Institute of Allergy and Infectious Diseases Solar Building, Room 3C21 Bethesda, MD 20892 Telephone: (301) 496-7291 FAX: (301) 402-0369 Email: mh35c@nih.gov Richard Lymn, Ph.D. Extramural Programs National Institute on Arthritis and Musculoskeletal and Skin Diseases 45 Center Drive, Room 5AS-49E MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-5128 FAX: (301) 480-4543 Email: rl28b@nih.gov Dr. John Schneider or Dr. Andrew Vargosko Division of Cancer Biology, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892 Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: schneidj@dcbdcep.nci.nih.gov or vargoska@dcbdcep.nci.nih.gov Hildegard Topper Special Assistant to the Deputy Director National Institute of Child Health and Human Development Building 31, Room 2A-03 Bethesda, MD 20892 Telephone: (301) 496-0104 FAX: (301) 402-1104 Email: topperh@hd03.nichd.nih.gov Daniel Sklare, Ph.D. National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400B-13 Bethesda, MD 20892 Telephone: (301) 496-1804 FAX: (301) 402-6251 Email: Daniel_Sklare@nih.gov Dr. James A. Lipton Special Assistant for Training and Career Development National Institute of Dental Research Natcher Building, Room 4AN.18J Bethesda, MD 20892 Telephone: (301) 594-2618 FAX: (301) 480-8319 Email: liptonj@de45.nidr.nih.gov Ronald Margolis, Ph.D. Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 5AN-12J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8819 FAX: (301) 480-3503 Email: margolis@ep.niddk.nih.gov Charles Rodgers, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-19J MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: rodgersc@ep.niddk.nih.gov Judith Podskalny, Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN-12E, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8876 FAX: (301) 480-8300 Email: podskalnyj@ep.niddk.nih.gov Timothy P. Condon, Ph.D. Office of Science Policy, Education, and Legislation National Institute on Drug Abuse Parklawn Building, Room 10A-55 Rockville, MD 20857 Telephone: (301) 443-6072 FAX: (301) 443-6277 Email: tc52x@nih.gov Charles W. Sharp, Ph.D. Division of Basic Research National Institute on Drug Abuse Parklawn Building, Room 10A-31 Rockville, MD 20857 Telephone: (301) 443-1887 FAX: (301) 594-6043 Email: cs107m@nih.gov Arthur Horton, Ed.D. Division of Clinical Research National Institute on Drug Abuse Parklawn Building, Room 10A-30 Rockville, MD 20857 Telephone: (301) 443-4060 FAX: (301) 443-2317 Email: ah61x@nih.gov Ann Blanken Division of Epidemiology and Prevention Research National Institute on Drug Abuse Parklawn Building, Room 9A-55 Rockville, MD 20857 Telephone: (301) 443-6543 FAX: (301) 443-9847 Email: ab108v@nih.gov Jamie Biswas, Ph.D. Medications Development Division National Institute on Drug Abuse Parklawn Building, Room 11A-55 Rockville, MD 20857 Telephone: (301) 443-5280 FAX: (301) 443-2599 Email: jb168r@nih.gov Dr. Michael Galvin Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 Research Triangle Park, NC 27709 Telephone: (919) 541-7825 FAX: (919) 541-2843 Email: galvin@niehs.nih.gov Dr. Maria Giovanni National Eye Institute Building 31, Room 6A48 Bethesda, MD 20892 Telephone: (301) 496-0484 FAX: (301) 402-0528 Email: mg37u@nih.gov Thomas Blaszkowski, Ph.D. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute Federal Building, Room 208A Bethesda, MD 20892 Telephone: (301) 496-1841 FAX: (301) 480-1455 Email: tb33i@nih.gov Michael Commarato, Ph.D. Division of Heart and Vascular diseases National Heart, Lung, and Blood Institute 7550 Wisconsin Avenue, Room 3C04 Bethesda, MD 20892 Telephone: (301) 496-1724 FAX: (301) 402-2043 Email: mc63a@nih.gov Joyce Creamer Division of Blood diseases and Resources National Heart, Lung, and Blood Institute 7550 Wisconsin Avenue, Room 5C02 Bethesda, MD 20892 Telephone: (301) 496-8388 FAX: (301) 480-0867 Email: jc85n@nih.gov James Kiley, Ph.D. National Center for Sleep Disorders Research National Heart, Lung, and Blood Institute Building 31, Room 4A11 Bethesda, MD 20892 Telephone: (301) 496-7443 FAX: (301) 496-7508 Email: jk52a@nih.gov Mary Reilly Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640 Bethesda, MD 20892 Telephone: (301) 594-7466 FAX: (301) 594-7487 Email: mr50w@nih.gov George T. Niederehe, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-3264 FAX: (301) 594-6784 Email: gniedere@aoamh4.ssw.dhhs.gov Kenneth G. Lutterman, Ph.D. Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10-95 Rockville, MD 20857 Telephone: (301) 443-3373 FAX: (301) 443-4045 Email: klutterm@nih.gov Henry Khachaturian, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health 5600 Fishers Lane, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-8033 Email: hkhach@helix.nih.gov Leonard Mitnick, Ph.D. Office of AIDS Programs National Institute of Mental Health 5600 Fishers Lane, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-9719 Email: lmitnick@aoamh2.ssw.dhhs.gov Mr. Edward Donohue Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1016A Bethesda, MD 20892 Telephone: (301) 496-4188 Email: ed25b@nih.gov $$P5 END ************************************************************ $$P6 BEGIN PA-95-054 FULL-TEXT ************************************** MENTORED CLINICAL SCIENTIST DEVELOPMENT PROGRAM AWARD NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA AVAILABLE: PA-95-054 P.T. 34; K.W. 0710030, 0785035 National Institute on Aging National Institute of Dental Research Application Receipt Dates: February 1, June 1, and October 1 PURPOSE The Mentored Clinical Scientist Development Program Award (MCSDPA) (K12) is an award to an educational institution to support career development experiences for clinicians leading to research independence. Under this award, newly-trained clinicians are to be selected and appointed to this program award by the grantee institution. In other respects, the research experience of the candidates selected for support under this award should resemble those supported by the individual Mentored Clinical Scientist Development Award. Applications for this award should propose a research plan that has both intrinsic research importance and will also serve as a suitable vehicle for learning the methodology, theories, and conceptualizations necessary for a well trained independent researcher. The program should be designed to accommodate appointees with varying levels of experiences. For example, a prospective candidate with limited experience in a given field of research may find it appropriate to engage in a structured, phased developmental program, including a designated period of didactic training followed by a period of supervised research experience. The entire program should be comparable in scope and rigor to meeting the requirements for an advanced research degree. The NIH institutes and centers have modified this award to accommodate the career pathways of researchers in fields related to their missions. For example, the National Institute of Dental Research (NIDR) requires that all candidates must pursue a program that includes didactic and supervised basic or behavioral research experiences that result in the Ph.D. degree. The NIDR provides support under this program for the development of advanced clinical knowledge and skills in either a recognized clinical specialty or equivalent dental clinical discipline. Therefore, the prospective candidate must have a D.D.S. or an equivalent degree but need not have started postgraduate training, such as in a clinical specialty. Dentists who already posses advanced clinical knowledge and skills are eligible for the MCSDPA under special circumstances, but are encouraged to seek appointments to the Mentored Clinical Scientist Development Award (K08). All applicants and potential appointees are strongly advised to contact the prospective NIH awarding component for information about eligibility and the specific provisions of this award. This award replaces two comparable NIH career development program awards for clinicians. These are the Physician Scientist Program Award (K12) and the Dentist Scientist Program Award (K16). Institutions and departments that were eligible to apply for either of these program awards are now eligible to apply for the MCSDPA award. Therefore, this program announcement supersedes all previous K12 and K16 program announcements. The NIH will no longer accept competing applications for the old K12 and K16 awards. The new MCSDPA has been modified to incorporate the features of these career development programs. Existing policies and provisions will remain in effect for current K12 and K16 awards until completion of their non-competing years. The NIH recently reviewed its career awards (K-series) used to develop the research capabilities of clinicians and other scientists needed to carry out the nation's research mission in the biomedical and behavioral sciences. This evaluation resulted in several changes: (1) the total number of K mechanisms were reduced from 19 to six; (2) the review criteria were refined to clarify the career development goals of the K award; and (3) K award applications will be assigned to initial review groups managed by the prospective funding institute or center to which the application has been assigned. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Mentored Clinical Scientist Development Program Award, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Dr. Robin A. Barr Office of Extramural Affairs National Institute on Aging 7201 Wisconsin Avenue, Room 2C218, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9322 Email: Barr@nihniagw.bitnet Dr. James A. Lipton Special Assistant for Training and Career Development National Institute of Dental Research Natcher Building, Room 4AN.18J Bethesda, MD 20892 Telephone: (301) 594-2618 Email: liptonj@de45.nidr.nih.gov $$P6 END ************************************************************ $$P7 BEGIN PA-95-055 FULL-TEXT ************************************** RESEARCH ON COMORBID MENTAL AND DRUG ABUSE DISORDERS NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA AVAILABLE: PA-95-055 P.T. 34; K.W. 0715129, 0404009, 0755030, 0715008, 0745027 National Institute on Drug Abuse National Institute of Mental Health PURPOSE The purpose of this program announcement is to encourage research on comorbid mental and drug abuse disorders. One aim of this research program is to explore and identify etiological and neurobiological factors that are associated with the co-occurrence of drug abuse/addiction and mental disorders. A second aim is to develop new treatment and prevention interventions for the population afflicted with these disorders. A third aim is to develop effective strategies and procedures for managing the impact of HIV/AIDS on individuals with comorbid mental and addictive disorders and the impact of comorbid mental and addictive disorders on persons with HIV/AIDS. A fourth aim is to assess existing drug abuse and mental health treatment interventions and services for persons with mental and addictive disorders. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement, Research on Comorbid Mental and Drug Abuse Disorders, is primarily related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contacts listed below. Arthur MacNeill Horton, Jr., Ed.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-46 Rockville, MD 20857 Telephone: (301) 443-6697 Email: ah61x@nih.gov Kathryn M. Magruder, M.P.H., Ph.D. Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10C-06 Rockville, MD 20857 Telephone: (301) 443-3364 Email: kmagrude@aoamh2.ssw.dhhs.gov $$P7 END ************************************************************ $$P8 BEGIN PA-95-056 FULL-TEXT ************************************** BIOBEHAVIORAL PAIN RESEARCH NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA AVAILABLE: PA-95-056 From owner-sci-resources@net.bio.net Mon May 01 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 15, pt. 1of3, 28 April 1995 Date: 2 May 1995 09:53:08 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1499 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3o5o1k$glc@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950428 V24N15 P1O3 ************************************ X-comment: RFAS described: MH-95-003, CA-95-012, DE-95-002, PA-95-049, PA-95- 050, PA-95-051, PA-95-052, PA-95-053, PA-95-054, P A-95-055, PA-95-056 NIH GUIDE - Vol. 24, No. 15 - April 28, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** REVISION OF NIH CAREER DEVELOPMENT GRANT MECHANISMS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** FY 95 FUNDING MECHANISMS FOR THE NATIONAL ACTION PLAN ON BREAST CANCER National Cancer Institute INDEX: CANCER $$INDEX N3 ********************************************************** COMMONLY ASKED QUESTIONS ABOUT EQUIPMENT UNDER GRANTS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N4 ********************************************************** GUIDELINES ON INCLUSION OF WOMEN, MINORITIES, AND PERSONS WITH DISABILITIES IN NIH SPONSORED AND/OR SUPPORTED INTRAMURAL AND EXTRAMURAL SCIENTIFIC MEETINGS AND CONFERENCES National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** CENTRAL IMMUNOLOGY LABORATORY FOR AIDS VACCINE CLINICAL TRIALS (RFP NIH-NIAID-DAIDS-96-14) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R2 ********************************************************** SYNTHESIS OF BULK CHEMICALS AND DRUGS FOR PRECLINICAL AND CLINICAL STUDIES (RFP NCI-CM-57238-30) National Cancer Institute INDEX: CANCER $$INDEX R3 ********************************************************** PREPARATION OF GONADAL CELLS AND CELL FRACTIONS (RFP NICHD-IRP-95-15) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R4 06/27/95 ************************************************* ROLE OF THE BLOOD BRAIN BARRIER IN HIV NEUROPATHOGENESIS (RFA MH-95-003) National Institute of Mental Health National Institute of Neurological Disorders and Stroke INDEX: MENTAL HEALTH; NEUROLOGICAL DISORDERS, STROKE $$INDEX R5 10/20/95 ************************************************* INVESTIGATOR GRANTS FOR CLINICAL CANCER THERAPY RESEARCH (RFA CA-95-012) National Cancer Institute INDEX: CANCER $$INDEX R6 10/24/95 ************************************************* ETIOLOGY AND PATHOGENESIS OF TEMPOROMANDIBULAR DISORDERS (RFA DE-95-002) National Institute of Dental Research Office of Research on Women's Health INDEX: DENTAL RESEARCH; WOMEN'S HEALTH $$INDEX P1 ********************************************************** MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD (PA-95-049) National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Environmental Health Sciences National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Center for Human Genome Research National Center for Research Resources INDEX: AGING; ALCOHOL ABUSE, ALCOHOLISM; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; CANCER; ENVIRONMENTAL HEALTH SCIENCES; MENTAL HEALTH; NEUROLOGICAL DISORDERS, STROKE; NURSING; HUMAN GENOME; RESEARCH RESOURCES $$INDEX P2 ********************************************************** INDEPENDENT SCIENTIST AWARD (PA-95-050) National Institute on Aging National Institute of Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Heart, Lung, and Blood Institute National Institute of Mental Health INDEX: AGING; ALCOHOL ABUSE, ALCOHOLISM; ALLERGY, INFECTIOUS DISEASES; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT; DEAFNESS, OTHER COMMUNICATION DISORDERS; DENTAL RESEARCH; DIABETES, DIGESTIVE, KIDNEY DISEASES; DRUG ABUSE; ENVIRONMENTAL HEALTH SCIENCES; HEART, LUNG, BLOOD; MENTAL HEALTH $$INDEX P3 ********************************************************** SENIOR SCIENTIST AWARD (PA-95-051) National Institute on Alcohol Abuse and Alcoholism National Institute on Drug Abuse National Institute of Mental Health INDEX: ALCOHOL ABUSE, ALCOHOLISM; DRUG ABUSE; MENTAL HEALTH $$INDEX P4 ********************************************************** ACADEMIC CAREER AWARD (PA-95-052) National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Environmental Health Sciences National Institute of Mental Health INDEX: AGING; ALCOHOL ABUSE, ALCOHOLISM; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; CANCER; ENVIRONMENTAL HEALTH SCIENCES; MENTAL HEALTH $$INDEX P5 ********************************************************** MENTORED CLINICAL SCIENTIST DEVELOPMENT AWARD (PA-95-053) National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke INDEX: AGING; ALCOHOL ABUSE, ALCOHOLISM; ALLERGY, INFECTIOUS DISEASES; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; CANCER; CHILD HEALTH, HUMAN DEVELOPMENT; DEAFNESS, OTHER COMMUNICATION DISORDERS; DENTAL RESEARCH; DIABETES, DIGESTIVE, KIDNEY DISEASES; DRUG ABUSE; ENVIRONMENTAL HEALTH SCIENCES; EYE; HEART, LUNG, BLOOD; MENTAL HEALTH; NEUROLOGICAL DISORDERS, STROKE $$INDEX P6 ********************************************************** MENTORED CLINICAL SCIENTIST DEVELOPMENT PROGRAM AWARD (PA-95-054) National Institute on Aging National Institute of Dental Research INDEX: AGING; DENTAL RESEARCH $$INDEX P7 ********************************************************** RESEARCH ON COMORBID MENTAL AND DRUG ABUSE DISORDERS (PA-95-055) National Institute on Drug Abuse National Institute of Mental Health INDEX: DRUG ABUSE; MENTAL HEALTH $$INDEX P8 ********************************************************** BIOBEHAVIORAL PAIN RESEARCH (PA-95-056) National Institute of Nursing Research National Institute of Dental Research National Institute on Aging National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Drug Abuse National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke Office of Alternative Medicine INDEX: NURSING; DENTAL RESEARCH; AGING; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; CANCER; CHILD HEALTH, HUMAN DEVELOPMENT; DRUG ABUSE; HEART, LUNG, BLOOD; MENTAL HEALTH; NEUROLOGICAL DISORDERS, STROKE; ALTERNATIVE MEDICINE THIS PUBLICATION IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE USING A PERSONAL COMPUTER (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/594- 7270 FOR DETAILS. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTING EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** REVISION OF NIH CAREER DEVELOPMENT GRANT MECHANISMS NIH GUIDE, Volume 24, Number 15, April 28, 1995 P.T. 34; K.W. 1014006 National Institutes of Health The program announcements that follow in this edition of the NIH Guide for Grants and Contracts describe the six new career development grant mechanisms (K-series) that replace the 14 previous awards. The new grant mechanisms have been developed to streamline the system of career awards. They do not change the instructions for preparing career award applications as described in the Research Career Development Awards section of the Public Health Service (PHS) Grant Application Form (Form PHS 398) nor do they appreciably change the eligibility of individuals for career award support. They do, however, simplify the career grant options so that prospective applicants can more easily understand how these awards mesh with their own career goals and can be used to enhance the development of their research skills. The new awards are organized by career level, the type of previous training, and whether a mentor is required. For example, the Mentored Clinical Scientists Development Award (K08) provides support for individuals with health-professional degrees who require an intensive, supervised research experience that will lead to independence as a researcher. This award replaces four awards with comparable provisions: the Clinical Investigator Award (K08), the Physician Scientist Award (K11), the Dental Scientist Award (K15), and the Scientist Development Award for Clinicians (K20). The program announcement for the Mentored Clinical Scientist Development Award (K08) will provide applicants with general information about application characteristics and review criteria that are common across most of the NIH Institutes and Centers (ICs). Prospective applicants are advised, however, that some of the new awards are not supported by all of the ICs, some of the ICs selectively encourage career development in specific fields or for individuals with previous training in specialized areas, and some of the ICs offer different award provisions such as salary and research expenses. In some cases, an IC will issue a separate program announcement (PA) or request for applications (RFA) to describe the specific provisions or intent of their award. Accordingly, applicants are strongly encouraged to examine the list of participating NIH institutes and centers for each program announcement and to make contact with one of the individuals listed at under the INQUIRIES section of each program announcement, prior to developing an application. The new awards are organized as follows: o MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD (K01)--an award to provide research scientists with an additional period of sponsored research experience as a way to gain expertise in a research area new to the applicant or in an area which would demonstrably enhance the applicant's scientific career. This award is generally reserved for individuals interested in switching to a new research field, for individuals who have interrupted their career because of illness or pressing family care responsibilities, or for faculty at minority institutions who wish to enhance their capacity for independent research. This proposed mechanism replaces the K01, K14, K17 and K21 mechanisms. o INDEPENDENT SCIENTIST AWARD (K02)--an award to support recently independent scientists with outstanding potential to become future leaders in biomedical, behavioral or clinical sciences. This proposed mechanism replaces the K02 and the K04 mechanisms. o SENIOR SCIENTIST AWARD (K05)--an award to support senior scientists who are recognized leaders in the field. This mechanism is the same as the K05 mechanism. o ACADEMIC CAREER AWARD (K07)--an award to support individuals who wish to develop expertise in a specific academic area or to support acknowledged experts to develop curricula and research capacity within an academic institution. This mechanism is the same as the current K07. o MENTORED CLINICAL SCIENTIST DEVELOPMENT AWARD (K08)--an individual award for clinicians who need an intensive period of mentored research experience. This proposed mechanism replaces the K08, K11, K15 and K20 mechanisms. o MENTORED CLINICAL SCIENTIST DEVELOPMENT PROGRAM AWARD (K12)--the program variant of the K08. This award replaces the K12 and K16 mechanisms. As mentioned above, not all of the NIH ICs participate in a regular basis in each of these awards. The following is a listing of the currently participating ICs: o MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD (K01) -- National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute on Arthritis and Musculoskeletal and Skin Diseases, National Cancer Institute, National Institute of Environmental Health Sciences, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Institute of Nursing Research, National Center for Human Genome Research, National Center for Research Resources o INDEPENDENT SCIENTIST AWARD (K02) -- National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute of Allergy and Infectious Diseases, National Institute on Arthritis and Musculoskeletal and Skin Diseases, National Institute of Child Health and Human Development, National Institute of Deafness and Other Communication Disorders, National Institute of Dental Research, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute on Drug Abuse, National Institute of Environmental Health Sciences, National Heart, Lung, and Blood Institute, National Institute of Mental Health o SENIOR SCIENTIST AWARD (K05) -- National Institute on Alcoholism and Alcohol Abuse, National Institute on Drug Abuse, National Institute of Mental Health o ACADEMIC CAREER AWARD (K07) -- National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute on Arthritis and Musculoskeletal and Skin Diseases, National Cancer Institute, National Institute of Environmental Health Sciences, National Institute of Mental Health o MENTORED CLINICAL SCIENTIST DEVELOPMENT AWARD (K08) -- National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute of Allergy and Infectious Diseases, National Institute on Arthritis and Musculoskeletal and Skin Diseases, National Cancer Institute, National Institute of Child Health and Human Development, National Institute on Deafness and Other Communication Disorders, National Institute of Dental Research, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute on Drug Abuse, National Institute of Environmental Health Sciences, National Eye Institute, National Heart, Lung, and Blood Institute, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke o MENTORED CLINICAL SCIENTIST DEVELOPMENT PROGRAM AWARD (K12) -- National Institute on Aging, National Institute of Dental Research Applicants should direct inquiries to one of the Institute or Center contacts listed in the program announcement for each specific career award. If you need additional information about the policies and procedures related to career awards or you need assistance in identifying an appropriate contact, you may wish to write or call: Dr. Walter Schaffer Research Training and Special Program Office National Institutes of Health Building 31, Room 5B44 Bethesda, MD 20892 Telephone: (301) 496-9743 FAX: (301) 496-0166 Email: ws11q@nih.gov $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** FY 95 FUNDING MECHANISMS FOR THE NATIONAL ACTION PLAN ON BREAST CANCER NIH GUIDE, Volume 24, Number 15, April 28, 1995 P.T. 34; K.W. 1014006, 0715036 National Cancer Institute PROGRAM GOALS AND SCOPE The National Action Plan on Breast Cancer (NAPBC) is a major public/private partnership created to eradicate the epidemic of breast cancer. The implementation of the Plan is coordinated by the Public Health Service's (PHS) Office on Women's Health. Several mechanisms (listed below) have been established for funding of projects that directly address the six high priority areas identified by the Plan. The six priority areas include: information dissemination, national biological resource banks, consumer involvement, breast cancer etiology, clinical trials accessibility, and issues related to breast cancer susceptibility genes. A description of the priority areas for the Innovative Small Grants and Omnibus PHS Administrative Supplements appears in the NIH Guide to Grants and Contracts noted below. INNOVATIVE SMALL GRANTS The NAPBC announced on April 7, 1995 (NIH Guide for Grants and Contracts, Volume 24, Number 13), an innovative small grants (R03) solicitation that will be administered by the PHS Office on Women's Health and funded through the National Cancer Institute (NCI). This initiative will fund grants up to $50,000 a year direct costs for up to two years. The goal of this initiative is to provide support for novel, creative pilot research and outreach projects that, if successful, will yield exceptionally important new information on breast cancer. A second goal is to support developmental, exploratory, or pilot projects that could serve as the basis for well-defined future research and outreach project applications in the area of breast cancer. The applications will be evaluated for scientific and technical merit by National Institutes of Health peer review group(s). The applications will be evaluated for relevance to the priority areas identified by Working Groups of the Plan. Applications must be submitted to the Division of Research Grants, NIH, by June 14, 1995. ADMINISTRATIVE SUPPLEMENTS TO EXISTING FEDERAL GRANTS o Public Health Service Grants -- The NAPBC announced on April 14, 1995 (NIH Guide for Grants and Contracts, Volume 24, Number 14), an Omnibus PHS Administrative Supplements solicitation for administrative supplements to existing PHS grants for up to $100,000 for one year. This omnibus administrative supplement program will be administered by the PHS Office on Women's Health and funded through the NCI. Any currently funded PHS grant relevant to breast cancer that addresses one or more of the six priority areas is eligible for an administrative supplement under this announcement. It is especially important to note that all requests for supplements MUST be within the scope of the parent grant. The parent grant can deal with breast cancer, other cancers, other diseases, or any of the above six priority areas. The program director for each grant must be contacted for questions about the consistency of the proposed supplemental project's aims with the parent project. Further, the parent grant must have a minimum of one year remaining (end date no sooner than September 30, 1996) in the project from the time the supplement is awarded. A copy of the official initial peer review comments for the grant (e.g., summary statement or the equivalent) must be submitted. For grants sponsored by agencies outside of the National Institutes of Health, the funds will be transferred to those agencies via interagency agreements. The receiving agency must obligate funds before the end of the fiscal year in accordance with that agency's operating policies and procedures. Contracts are not eligible for this supplement program. The supplements will be subject to restrictions outlined in the solicitation. Applications must be submitted to the PHS Office on Women's Health by June 14, 1995. o Grants from Other Federal Agencies -- The NAPBC also solicits with this notice requests for administrative supplements for up to $100,000 for one year to existing grants from Federal agencies outside the PHS. This administrative supplement program will be administered by the PHS Office on Women's Health and funded through the NCI. Any currently funded Federal grant relevant to breast cancer that addresses one or more of the six priority areas is eligible for an administrative supplement under this announcement. It is especially important to note that all requests for supplements MUST be within the scope of the parent grant. The parent grant can deal with breast cancer, other cancers, other diseases, or any of the above six priority areas. The program director for each grant must be contacted for questions on the consistency of the proposed supplemental project's aims with the parent project. Further, the parent grant must have a minimum of one year remaining (end date no sooner than September 30, 1996) in the project from the time the supplement is awarded. A copy of the official initial peer review comments for the grant (e.g., summary statement or the equivalent) must be submitted. The funds will be transferred to those agencies via interagency agreements. The receiving agency must obligate funds before the end of the fiscal year in accordance with the agency's operating policies and procedures. Contracts are not eligible for this supplement program. Instructions for applicants can be obtained >From the PHS Office on Women's Health. Applications must be submitted to the PHS Office on Women's Health by June 14, 1995. INTRAMURAL FEDERAL PROJECTS o Public Health Service Projects -- The NAPBC solicits with this notice requests for administrative supplements to existing intramural Federal projects and contracts supported by PHS-based agencies. This mechanism will fund supplements for up to $100,000 a year total costs for one year to PHS projects. This administrative supplement program will be administered by the PHS Office on Women's Health and funded through the NCI. Any existing PHS intramural project or contract that has relevance to breast cancer that addresses one or more of the six priority areas is eligible for an administrative supplement under this announcement. It is especially important to note that all requests for supplements MUST be within the scope of the parent project. The parent project can deal with breast cancer, other cancers, other diseases, or any of the above six priority areas. For projects in agencies outside of the National Institutes of Health, the funds will be transferred to those agencies via interagency agreements. The receiving agency must obligate funds before the end of the fiscal year in accordance with the agency's operating policies and procedures. Instructions for applicants can be obtained from the PHS Office on Women's Health. Applications must be submitted to PHS Office on Women's Health by June 14, 1995. o Projects in Other Federal Agencies -- The NAPBC solicits with this notice requests for administrative supplements to existing intramural Federal projects and contracts supported by Federal agencies outside of the PHS. This mechanism will fund supplements for up to $100,000 a year total costs for one year. This administrative supplement program will be administered by the PHS Office on Women's Health and funded through the NCI. Any existing PHS intramural project or contract that has relevance to breast cancer that addresses one or more of the six priority areas is eligible for an administrative supplement under this announcement. It is especially important to note that all requests for supplements MUST be within the scope of the parent project. The parent project can deal with breast cancer, other cancers, other diseases, or any of the above six priority areas. For projects in agencies outside of the National Institutes of Health, the funds will be transferred to those agencies via interagency agreements. The receiving agency must obligate funds before the end of the fiscal year in accordance with the agency's operating policies and procedures. Instructions for applicants can be obtained from the PHS Office on Women's Health. Applications must be submitted to PHS Office on Women's Health by June 14, 1995. SUPPORT OF PEER-REVIEWED, UNFUNDED GRANT APPLICATIONS o Public Health Service Grants -- The NAPBC solicits with this notice requests for the funding of grant applications addressing the six priority areas that have been peer-reviewed and recommended for funding between September 30, 1994, and September 30, 1995, but not awarded due to lack of sufficient funds. The initial awarding of funds cannot exceed one year. Additional funding for up to two years may be considered. Applications eligible for this mechanism should be brought to the attention of the Plan. Principal investigators who believe that their unfunded grant applications are eligible for this program should contact the PHS Office on Women's Health and their PHS program administrator. A copy of the original grant application and a copy of the official initial peer review comments for the application (e.g., summary statement or the equivalent) must be submitted to the Plan. Program administrators who identify eligible grant applications must obtain written permission from the principal investigator to submit official initial peer review comments for the application (e.g., summary statement or the equivalent) and a copy of the original grant application for funding consideration to the Plan. For selected grant applications submitted to PHS agencies outside of the National Institutes of Health, the funds will be transferred to those agencies via interagency agreements. Funds must be obligated before the end of the fiscal year. The application with a copy of the original grant application and the summary statement of review must be submitted to the PHS Office on Women's Health by June 14, 1995. o Grant Applications Submitted to Other Federal Agencies -- The NAPBC solicits with this notice requests for the funding of grant applications addressing the six priority areas that have been peer reviewed and recommended for funding between September 30, 1994, and September 30, 1995, but not awarded due to lack of sufficient funds. The initial awarding of funds cannot exceed one year. Additional funding for up to two years may be considered. Grant applications eligible for this mechanism should be brought to the attention of the Plan. Principal investigators who believe that their unfunded grant applications are eligible for this program should contact the PHS Office on Women's Health and their program administrator. A copy of the original grant application and a copy of the official initial peer review comments for the grant (e.g., summary statement or the equivalent) must be submitted to the Plan. Program administrators who identify eligible grant applications must obtain written permission from the principal investigator to submit official initial peer review comments for the grant (e.g., summary statement or the equivalent) and a copy of the original grant application for funding consideration to the Plan. If selected for support, the funds will be transferred to those agencies via interagency agreements. Funds must be obligated before the end of the fiscal year. The application with a copy of the original grant application and the summary statement of review must be submitted to the PHS Office on Women's Health by June 14, 1995. INQUIRIES For more information on the National Action Plan on Breast Cancer FY95 funding programs, contact: Susan J. Blumenthal, M.D., M.P.A. Deputy Assistant Secretary for Health (Women's Health) Co-Chair, The National Action Plan on Breast Cancer ATTN: Suzanne G. Haynes, Ph.D. (etiology; consumer involvement) Cheryl Marks, Ph.D. (clinical trials; information dissemination) Debbie Saslow, Ph.D. (breast cancer susceptibility genes; tissue banks) Diane K. Wagener, Ph.D. (general information) PHS Office on Women's Health Hubert Humphrey Building, Room 730-B 200 Independence Avenue, S.W. Washington, DC 20201 Telephone: (202) 401-9587 or (202) 690-7650 FAX: (202) 401-9590 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** COMMONLY ASKED QUESTIONS ABOUT EQUIPMENT UNDER GRANTS NIH GUIDE, Volume 24, Number 15, April 28, 1995 P.T. 34; K.W. 1014006, 0735000 National Institutes of Health The National Institutes of Health (NIH) Grants Policy Office and awarding institutes and centers frequently receive questions from research administrators and investigators regarding equipment purchased with Public Health Service (PHS) research grant funds. To assist recipients of PHS research grants, NIH staff have developed the following questions and answers regarding equipment. The information below does not represent new policy or a revision to policy. Rather, it is a summary of current regulations and policies pertaining to grant equipment. The answers provided are based on the assumption that there are no special requirements in the program legislation or regulations or special terms and conditions of award that would supersede the regulations and policies cited below. Appropriate citations to policy or regulation appear within or following each answer. The HHS regulations on the Administration of Grants appear in the Code of Federal Regulations (CFR) at 45 CFR 74 and 45 CFR 92. Part 74 is applicable to all recipients except those covered by Part 92, which governs awards to state and local governments. The regulations at Part 74 were recently revised to implement the revision to OMB Circular A-110, and were published in the Federal Register on August 25, 1994 (Vol. 59, No. 164). The PHS Grants Policy Statement (GPS) was revised effective April 1, 1994, and an addendum was effective February 15, 1995. A single copy of each was mailed to all current PHS grantee organizations, which may photocopy the documents as needed. NIH grantees that did not receive a copy may contact the NIH Division of Research Grants, Office of Grants Information, on 301/594-7248 to request a single copy. In addition, the GPS is available on the NIH Gopher. The NIH Gopher contains information about NIH, including the NIH Guide for Grants and Contracts, and has text-searching capabilities. It is possible to ~tunnel~ to the NIH Gopher (gopher.nih.gov) if you have access to a system with Gopher. Local computer support should be consulted for additional information or assistance If you have additional questions that cannot be answered by the sponsored research office at your organization, you should contact the grants management specialist identified on your PHS Notice of Grant Award. WHAT IS THE DEFINITION OF EQUIPMENT? The definition for equipment, as stated in 45 CFR Parts 74 and 92, is an article of tangible nonexpendable personal property having a useful life of more than one year and an acquisition cost of $5,000 or more per unit. However, consistent with recipient organizational policy, lower limits may be established. Grantees may implement the new definition (provided they do so consistently on an organization-wide basis) even though the definition in the cost principles may not yet correspond. (45 CFR Part 74.2 and 74.34) DOES THE $5,000 THRESHOLD (UNDER THE REVISED 45 CFR PART 74) ONLY APPLY TO EQUIPMENT PURCHASED AFTER THE EFFECTIVE DATE OF THE REVISION? No. If grantees elect to implement the revised definition, it should be applied to all grantee equipment. Grantees are not required to track equipment under two different definitions. DOES EQUIPMENT PURCHASED UNDER A GRANT BELONG TO THE PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR? PHS research grants are made to an organization on behalf of the Principal Investigator (PI) or Program Director. Title to equipment acquired with HHS funds vests in the organization receiving financial assistance directly from an HHS awarding agency to carry out a project or program, subject to certain restrictions described at 45 CFR Part 74.34 (see next question). Whereas in the past, title to equipment, property, and supplies purchased under a research grant to a for-profit organization vested in the Federal Government, the revised HHS regulations now permit for-profit grantees to retain title. (45 CFR Part 74.34) CAN HHS REQUIRE THE TRANSFER OF EQUIPMENT FROM THE GRANTEE TO ANOTHER PARTY? Yes, HHS has the right to require equipment (including title) purchased with grant funds to be transferred to the Federal Government or to an eligible third party named by the HHS awarding office, under the conditions specified in 45 CFR Part 74.34(h). Although it is seldom necessary to do so, this right may be invoked in cases where a grant is transferring to a new organization and the equipment purchased with grant funds is needed to continue the research at the new grantee organization. (45 CFR Part 74.34; GPS, p. 8-13) DOES THE GRANTEE ORGANIZATION HAVE AN OBLIGATION TO THE GOVERNMENT FOR EQUIPMENT AFTER A GRANT HAS ENDED? Non-profit institutions of higher education and nonprofit organizations whose primary purpose is the conduct of scientific research (hereinafter referred to as exempt grantees) hold title and are exempted from further obligation to the Federal Government for equipment acquired under a PHS grant for support of basic or applied scientific research (except for the HHS right to require transfer as described above). Nonexempt grantees (hospitals, for-profit organizations, and non-profit organizations whose primary purpose is other than scientific research) hold title and must follow the requirements described in 45 CFR Part 74.34 and the PHS Grants Policy Statement, pp. 8-10 through 8-14. WHEN IS PHS PRIOR APPROVAL REQUIRED TO PURCHASE EQUIPMENT? Prior approval for the purchase of equipment is required if it will represent a change of scope for the project. If the purchase will require significant rebudgeting (see GPS p. 8-1), the grantee organization is required to consult with the grants management office for a decision as to whether the rebudgeting constitutes a change of scope. In addition, the purchase of equipment exceeding $25,000 (per unit), when not included in the originally approved budget, requires prior approval from PHS, unless the grant was awarded under the Federal Demonstration Project or Expanded Authority terms and conditions. (GPS, p. 8-4) (Note: equipment costing in excess of $25,000 requires prior approval regardless of the amount of PHS funds to be applied toward the purchase, e.g., even if only $5,000 of grants funds will be used toward the purchase of equipment costing $25,001). IS PHS PRIOR APPROVAL REQUIRED IN ORDER TO REBUDGET FUNDS FOR THE PURCHASE OF GENERAL PURPOSE EQUIPMENT? PHS no longer differentiates between general purpose and special purpose equipment. Thus, other than as described above for equipment in excess of $25,000 or a change of scope, PHS prior approval is not required. However, the expenditure must be reasonable and necessary for the conduct of the grant activities, as well as allowable and allocable as a direct cost to the grant. IS PHS PRIOR APPROVAL REQUIRED TO PURCHASE EQUIPMENT IN THE FINAL SIX MONTHS OF THE PROJECT PERIOD? No. PHS eliminated this prior approval requirement with the revised PHS Grants Policy Statement effective October 1, 1990. Nonetheless, all charges to a grant project, particularly in the final months of the project period, must be allowable and allocable as a direct cost to the grant, and be reasonable and necessary for the conduct of grant activities. Equipment may not be purchased simply to use an unobligated balance remaining at the end of the project. WHAT HAPPENS TO EQUIPMENT WHEN THE PI MOVES TO ANOTHER ORGANIZATION? The grantee organization is the legal entity to which a grant is awarded. When the PI moves to another organization, the following options apply in the order listed. (45 CFR Part 74.34 and GPS, p. 8- 13) (1) The grantee organization may request continuation of the project under the direction of an alternate PI. If the alternate PI is approved by PHS, the grant will continue and thus title to the equipment purchased under the grant will remain with the original grantee organization. (2) The organization may relinquish its interests and rights in the grant to the PI's new organization. If the new organization is approved by the PHS awarding component to continue the grant activity, then the grant will be awarded and any equipment purchased with grant funds and still needed for the grant project would be expected to transfer to the new grantee organization, which would assume title. If the original grantee does not voluntarily agree to relinquish equipment with the grant, HHS may require transfer of the equipment as specified in 45 CFR Part 74.34(h). (3) If an alternate PI is not accepted by the PHS awarding component (or no alternate is nominated), and the original grantee refuses to relinquish its rights in the grant to the new organization (or if the new organization is not accepted by the PHS awarding component to continue the research), then the grant will be terminated. Title to equipment will remain with the original grantee organization, subject to disposition or use as described below. The PI's new organization may submit a new application through the regular NIH peer review process to request support for the research. It is important to reiterate that a change of grantee may not take place where it will involve the transfer of a grant to or between foreign institutions or international organizations. (GPS, p. 8-3) WHAT EQUIPMENT MAY BE CHARGED AS AN ALTERATION AND RENOVATION (A&R) EXPENSE? Fixed equipment, such as casework, a fume hood, a large autoclave, or biological safety cabinet, is an allowable A&R charge. Furnishings and movable equipment are not allowable as A&R costs. Additional information on alteration and renovation costs can be found in the PHS Grants Policy Statement on pp. 7-2 and 7-3. UNDER CONFERENCE GRANTS (R13 OR U13), MAY GRANT FUNDS BE USED FOR THE RENTAL OF EQUIPMENT? Grant funds may be used for the rental of necessary equipment under a conference grant. Funds may not be used for the purchase of equipment. (GPS, p. A7-2) MAY GRANTEES USE EQUIPMENT ACQUIRED WITH HHS FUNDS TO PROVIDE SERVICES TO NON-FEDERAL ORGANIZATIONS? Yes. However, nonexempt grantees are specifically prohibited from doing so for a fee that is less than private companies charge for equivalent services, unless specifically authorized by Federal statute, for so long as the Federal Government retains an interest in the equipment. For both exempt and nonexempt grantees, user charges will accrue as program income and must be reported on the Financial Status Report (SF 269). (45 CFR Part 74.34(b)(1) and 74.24) ARE DEPRECIATION OR USE CHARGES ON EQUIPMENT AN ALLOWABLE COST ON A GRANT? Depreciation or use charges on equipment are an allowable cost, but not normally allocable as a direct cost to a grant. Such charges are usually included in the organization's indirect cost base for determination of its indirect cost rate. Depreciation or use charges on equipment acquired under a federally supported project are unallowable. (GPS, p. 7-6) ARE COSTS OF INSURING EQUIPMENT PURCHASED WITH PROJECT FUNDS AN ALLOWABLE EXPENSE? Normally these costs are included in the organization's indirect cost base, but may be allocable as a direct cost if this manner of charging is the normal organizational policy, consistently applied regardless of the source of funds. (GPS, p. 7- 8) WHAT SHOULD A GRANTEE DO IF A PIECE OF EQUIPMENT IS LOST, DAMAGED, OR STOLEN? The grantee is responsible for maintaining an internal control system to insure adequate safeguards to prevent loss, damage, or theft of equipment purchased with PHS grant funds. If such a system does not exist or is lacking in any way, the grantee must implement any necessary corrective actions. For non-exempt grantees, if damage, loss, or theft occurs despite the fact that the recipient has the required control system in place, there will be no obligation to PHS for the equipment, unless the recipient receives compensation for the damage, loss, or theft from insurance or some other source. If the grantee is compensated for the damage, loss, or theft, but does not replace the equipment for use on the grant, the rules regarding sale of equipment apply (45 CFR Part 74.34(g)). HOW MAY EQUIPMENT BE USED AFTER THE END OF A GRANT? Exempt grantees hold title and are exempted from further obligation to the Federal Government for equipment acquired under a PHS grant for support of basic or applied scientific research, except for the HHS right to require transfer as described above. Nonexempt grantees hold title and shall use the equipment in the project or program for which it was acquired as long as needed, whether or not the project or program continues to be supported by Federal funds, and shall not encumber the property without approval of the HHS awarding agency. When no longer needed for the original project or program, the recipient shall use the equipment in connection with its other federally sponsored activities, if any, in the following order of priority: (1) Program, projects or activities sponsored by the HHS awarding agency; (2) Program projects or activities sponsored by other HHS awarding agencies; (3) Program, projects or activities sponsored by other Federal agencies. If the grantee no longer needs the equipment for the above purposes, the grantee may retain the equipment for other uses, provided that compensation is made to the original HHS awarding agency or its successor. If the recipient has no further need for the equipment, it shall request disposition instructions from the HHS awarding agency. See 45 CFR Part 74.34(g) for additional information. $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** GUIDELINES ON INCLUSION OF WOMEN, MINORITIES, AND PERSONS WITH DISABILITIES IN NIH SPONSORED AND/OR SUPPORTED INTRAMURAL AND EXTRAMURAL SCIENTIFIC MEETINGS AND CONFERENCES NIH GUIDE, Volume 24, Number 15, April 28, 1995 P.T. 34; K.W. 1014006 National Institutes of Health Effective date: March 31, 1995 INTRODUCTION The National Institutes of Health (NIH) recognizes the value of supporting scientific meetings relevant to its health and scientific mission. In addition, NIH affirms that the value of scientific meetings is enhanced by including participants from all segments of the scientific population and, when appropriate, members of the lay community, in both the planning and conduct of such meetings. Further, the NIH Revitalization Act (P.L. 103-43, Section 206), which adds section 402(b) to the Public Health Service Act, requires NIH to "in conducting and supporting programs for research, research training, recruitment, and other activities, provide for an increase in the number of women and individuals from disadvantaged backgrounds (including racial and ethnic minorities) in the fields of biomedical and behavioral research." In addition, Section 504 of the Rehabilitation Act and the Americans with Disabilities Act require reasonable accommodations to be provided to individuals with disabilities. POLICY It is the NIH policy that organizers of scientific meetings should make a concerted effort to achieve appropriate representation of women, racial/ethnic minorities and persons with disabilities, and other individuals who have been traditionally underrepresented in science, in all NIH sponsored and/or supported scientific meetings. In addition, organizers who name NIH as a sponsor or use NIH facilities must make a concerted effort to achieve appropriate representation in compliance with this policy. "Appropriate" means representation based on the availability of scientists from these groups known to be working in a particular field of biomedical or behavioral research. The plans to seek appropriate representation should be specified during selection of organizing committees, speakers, and other invited participants, such as session chairs and panel discussants. In addition, efforts should be made to encourage attendance by women, minorities and persons with disabilities at all NIH sponsored and/or supported scientific meetings as a means of increasing their participation in the particular scientific field. The plans to seek appropriate representation will be included as an evaluation criterion during review of the requests for funding for these meetings. This policy shall apply to all domestic or international scientific meetings sponsored by and/or receiving support from the NIH. "Scientific meetings" include all meetings, conferences, workshops, symposia, seminar series, and lectures that involve organizing/planning committees, expenditure of funds, invited participants, or are nationally or internationally advertised. Such meetings may be initiated by the NIH's institute, center or division (ICD) extramural and intramural programs or by contracts, or may be investigator-initiated requests for grants or cooperative agreements. Reasonable efforts should be made, as well, to fulfill the goal of this policy for single seminars sponsored by NIH laboratories or extramural programs. All NIH sponsored and/or supported conferences must be held at accessible sites, as outlined by section 504 of the Rehabilitation Act of 1973 and, as applicable, the Americans with Disabilities Act of 1990. Conference registration materials should provide a question that will allow participants with disabilities to voluntarily identify any special needs, so that conference organizers can make plans to accommodate these needs. When making awards for grants, cooperative agreements, or contracts for scientific meetings, NIH will work with applicants as necessary to assist them to comply with this policy. NIH's extramural and intramural staff who initiate scientific meetings must comply with this policy. It is the responsibility of the ICD Directors to implement this policy. The NIH Director will assure that all extramural and intramural programs comply with this policy. NOTE: NIH adopts the Office of Management and Budget definitions provided in Directive Number 15 for racial and ethnic categories for the purposes of this policy: American Indian or Alaskan Native; Asian or Pacific Islander; Black (not of Hispanic origin); Hispanic; and White(not of Hispanic origin). Whites are defined as the majority group; the remaining categories comprise the racial/ethnic minorities. The classification of an individual is by self- identification. A person with a disability means any person who (a) has a physical or mental impairment which substantially limits one or more of such person's major life activities; (b) has a record of such an impairment; or (c) is regarded as having such an impairment, as described under section 504 of the Rehabilitation Act of 1973 and the Americans with Disabilities Act of 1990. Scientific societies and organizations may facilitate this process by making relevant information voluntarily provided by their membership available to members planning such scientific meetings. INQUIRIES For additional information about these guidelines contact the following staff person in the appropriate awarding component: Dr. Miriam Kelty Office of Extramural Affairs National Institute on Aging Gateway Building, Room 2C218F Bethesda, MD 20892 Telephone: (301) 496-9322 Email: mk46u@nih.gov Dr. Kenneth Warren Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 409 Rockville, MD 20892 Telephone: (301) 443-4375 Email: kwarren@willco.niaaa.nih.gov Dr. John McGowan Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C07 Bethesda, MD 20892 Telephone: (301) 496-7291 Email: jm80c@nih.gov Dr. Stephen Gordon Extramural Programs National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 45/5AS25U Bethesda, MD 20892 Telephone: (301) 594-4977 Email: gordons@ep.niams.nih.gov Dr. Yvonne Maddox Deputy Director National Institute of Child Health and Human Development Building 31, Room 2A03 Bethesda, MD 20892 Telephone: (301) 496-1848 Email: ym5n@nih.gov Dr. Earleen Elkins Division of Extramural Activities National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, EPS-400C Rockville, MD 20892 Telephone: (301) 496-8693 Email: ee19u@nih.gov Dr. Lois K. Cohen Extramural Program National Institute of Dental Research Natcher Building 45, Room 4AN18E Bethesda, MD 20892 Telephone: (301) 594-7710 Dr. Walter Stolz Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building 45, Room 6AS25C Bethesda, MD 20892 Telephone: (301) 594-8834 Email: stolzw.niddk@dvsgate.niddk.nih.gov Ms. Eleanor Friedenberg Office of Extramural Program Review National Institute on Drug Abuse Parklawn Building, Room 10-42 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-2755 Email: ef27d@nih.gov Dr. Anne Sassaman Division of Extramural Research and Training National Institute of Environmental Health Sciences Building 3, Room 301A P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-7723 Email: as56j@nih.gov Dr. Sue Shafer Division of Extramural Activities National Institute of General Medical Sciences Natcher Building 45, 2AN32D Bethesda, MD 20892 Telephone: (301) 594-4499 Email: ss78v@nih.gov Dr. Hugh Stamper Division of Extramural Activities National Institute of Mental Health Parklawn Building, Room 9-105 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3367 Email: hs19s@nih.gov Dr. Constance Atwell Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1016 Bethesda, MD 20892 Telephone: (301) 496-9248 Email: ca23c@nih.gov Dr. Teresa Radebaugh Extramural Programs National Institute of Nursing Research Natcher Building 45, Room 3AN32D Bethesda, MD 20892 Telephone: (301) 594-5968 Email: tradebaugh@ep.ninr.nih.gov Dr. Marvin Kalt Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 600C Bethesda, MD 20892 Telephone: (301) 496-5147 Email: kaltm@dea.nci.nih.gov Dr. Ralph Helmsen Research Training and Resources Officer National Eye Institute Executive Plaza South, Room 350 Bethesda, MD 20892 Telephone: (301) 496-5301 Email: rjh@eps.nei.nih.gov Dr. Ronald Geller Division of Extramural Affairs National Heart, Lung, and Blood Institute Rockledge 2, Room 7100 Bethesda, MD 20892 Telephone: (301) 435-0260 Email: rg33k@nih.gov Dr. Milton Corn Division of Extramural Programs National Library of Medicine Building 38A, Room 5N503 Bethesda, MD 20892 Telephone: (301) 496-4621 Email: mc105x@nih.gov Dr. Louise Ramm Deputy Director for Extramural Research Resources National Center for Research Resources One Rockledge Centre, Room 5158, MSC 7965 Bethesda, MD 20892 Telephone: (301) 435-0879 Email: louiser@ep.ncrr.nih.gov Dr. Mark Guyer Assistant Director for Program Coordination National Center for Human Genome Research Building 38A, Room 605 Bethesda, MD 20892 Telephone: (301) 496-0844 Email: mg25m@nih.gov Dr. Kenneth Bridbord Chief, International Studies Branch Fogarty International Center Building 31, Room B2C39 Bethesda, MD 20892 Telephone: (301) 496-2516 Email: kb16r@nih.gov $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NIH-NIAID-DAIDS-96-14 ************************************ CENTRAL IMMUNOLOGY LABORATORY FOR AIDS VACCINE CLINICAL TRIALS NIH GUIDE, Volume 24, Number 15, April 28, 1995 RFP AVAILABLE: NIH-NIAID-DAIDS-96-14 P.T. 34; K.W. 0710070, 0755015, 0715008, 0740075 National Institute of Allergy and Infectious Diseases The Clinical Development Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases, NIH has a requirement to provide for the centralized performance of immunological assays to evaluate HIV-specific humoral and cellular immune responses in support of Phase I and II clinical trials of candidate AIDS vaccines. The purpose of this contract is to support the NIAID in its mission to stimulate research towards discovery and testing of prototype vaccines for the acquired immunodeficiency syndrome (AIDS). It is anticipated that one cost-reimbursement, completion type contract will be awarded for a period of seven years. The electronic version of RFP NIH-NIAID-DAIDS-96-14 will be available on or about April 26, 1995 through the NIH Gopher and Internet using the following electronic mail addresses and instructions: 1. To access the NIH Gopher: Point your gopher client to GOPHER@NIH.GOV PORT 70 (you should now be in the NIH Gopher). Select "Grant and Research Information," then select "R&D Request for Proposals (RFP)." 2. To access the NIH Grant Line (Internet): Configure your terminal emulator as: 1200 or 2400 baud, even parity, 7 data bits, 1 stop bit, Half Duplex. Using the procedure specified in your communication software, dial 301-402-2221. When you get a response indicating that you have been connected, then type ,GEN1 (the comma is mandatory) and press ENTER; you will be prompted by the NIH system for "INITIALS?." Type BB5 and press ENTER. You will then be prompted for "Account?." Type CCS2 and press ENTER. Note that the RFP for this procurement has been revised to include only the Work Statement, deliverable and reporting requirements, special requirements and mandatory qualification, if any, the Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Following proposal submission and the initial review process, offerors comprising the competitive range will be requested to provide additional documentation to the Contracting Officer. Responses to this RFP will be due on July 7, 1995. Any responsible offeror may submit a proposal which will be considered by the Government. This advertisement does not commit the Government to award a contract. INQUIRIES Direct inquiries to: Cyndie Cotter Contracts Management Branch National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3C07 Rockville, MD 20852 Telephone: (301) 402-0641 FAX: (301) 402-0972 Email: cc41w@nih.gov $$R1 END ************************************************************ $$R2 BEGIN NCI-CM-57238-30 ****************************************** SYNTHESIS OF BULK CHEMICALS AND DRUGS FOR PRECLINICAL AND CLINICAL STUDIES NIH GUIDE, Volume 24, Number 15, April 28, 1995 RFP AVAILABLE: NCI-CM-57238-30 P.T. 34; K.W. 1003006, 1003012, 0740020 National Cancer Institute The Pharmaceutical Resources Branch (PRB), Developmental Therapeutics Program (DTP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI) at the National Institutes of Health (NIH) anticipates making award(s) of cost-reimbursement, incrementally funded contracts, for a base period of three years, with two one year option years, beginning on or about April 1, 1996. The objective of this project is the preparation of chemicals and bulk drugs needed by the program for preclinical and clinical studies. This contract will provide and operate a materials preparation laboratory for the synthesis of varying amounts of materials, not readily available from other sources in the quantity and/or quality needed by the NCI. The scale of the work to be performed under this solicitation requires a functional large-scale facility with at least one (20-100 gallons) glass-lined reactor, and several glass reaction vessels (50 and 100 litres), with the necessary supporting equipment and laboratories. The project may be proposed on two levels. Level I offerors shall provide 2.75 to 3 technical staff years, per year, with completion and deliveries of the targets of 8 to 12 assignments, excluding reports. Level ii offerors shall provide 5.5 to 6 technical staff years, per year, with completion and deliveries of the targets of 15 to 25 assignments, excluding reports. The proposed principal investigator should be trained in organic or medicinal chemistry, preferably at the Ph.D. level, from an accredited university or possess equivalent experience, and have extensive experience in the conception and execution of chemical syntheses, scaleups and synthetic process development. The offeror must be registered with the Food and Drug Administration (FDA) as a manufacturer of bulk drugs. Facilities shall meet FDA standards in accordance with the current good manufacturing practices (GMP), as well as be in compliance with all OSHA, DOT, and EPA regulations, and those of similar state and local agencies. Non-compliance of the above requirements shall render the proposal technically unacceptable, without the consideration of award. The standard industrial classification (sic) code is 8731. Offerors who qualify as a small business are encouraged to submit proposals. The facilities of foreign offerors must conform to all the standards of their equivalent national, state and local regulatory agencies. This is a recompetition of a group of contracts and clinical studies. The Request for Proposal (RFP) will be available on or about May 29, 1995. INQUIRIES A copy of the RFP may be obtained by written request to: Elsa B. Carlton Research Contracts Branch National Cancer Institute Executive Plaza South, Room 603 6120 Executive Boulevard MSC 7220 Bethesda MD 20892-7220 $$R2 END ************************************************************ $$R3 BEGIN NICHD-IRP-95-15 ****************************************** PREPARATION OF GONADAL CELLS AND CELL FRACTIONS NIH GUIDE, Volume 24, Number 15, April 28, 1995 RFP AVAILABLE: NICHD-IRP-95-15 P.T. 34; K.W. 0780005, 0780015 National Institute of Child Health and Human Development The Endocrinology and Reproduction Research Branch, Intramural Research program, National Institute of Child Health and Human Development, is seeking organizations with the capability to provide freshly prepared and purified rat Leydig cells from rat testis. This program also requires the provision of short-term Leydig cell cultures from adult rats, long-term cultures from rat fetal testes, Nb2 lymphoma cells, and of established mouse tumor Leydig cell lines. In addition, it requires the preparation of cell fractions and of well-characterized gonadotropin and prolactin receptor preparations >From luteinized rat ovaries, testes and SF9 cells overexpressing the LH receptor. The successful contractor must have the capability of delivering the viable and hormone-responsive Leydig cell preparations before 8:00 a.m. within one hour of completion of the preparation procedure three times a week to the National Institutes of Health, Bethesda, Maryland. This announcement is a new solicitation, but not a new project. The issuance of this Request for Proposals (RFP) will be on or about April 28, 1995, and proposals are due by 4:00 p.m. (local time), June 30, 1995. INQUIRIES All requests must cite RFP number NICHD-IRP-95-15. All sources who consider themselves qualified are encouraged to submit a proposal. This advertisement does not commit the Government to make an award. Those organizations interested in responding must request the full- text version of the RFP, in writing, from: Mrs. Lynn Salo Contracts Management Branch National Institute of Child Health and Human Development Executive Building, Room 7A07 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-4611 FAX: (301) 402-3676 $$R3 END ************************************************************ $$R4 BEGIN MH-95-003 FULL-TEXT ************************************** ROLE OF THE BLOOD BRAIN BARRIER IN HIV NEUROPATHOGENESIS NIH GUIDE, Volume 24, Number 15, April 28, 1995 RFA AVAILABLE: MH-95-003 P.T. 34; K.W. 0715008, 1002030 National Institute of Mental Health National Institute of Neurological Disorders and Stroke Letter of Intent Receipt Date: May 22, 1995 Application Receipt Date: June 27, 1995 PURPOSE The Office on AIDS, National Institute of Mental Health (NIMH), supports investigations directed at developing effective strategies to prevent or reduce behaviors that place individuals at risk for HIV infection and fosters research to enhance the understanding of the profound impact of the Human Immunodeficiency Virus (HIV) infection on the central nervous system (CNS). In addition, the National Institute of Neurological Disorders and Stroke (NINDS) supports research on neurological aspects of HIV infection (neuro-AIDS) in adults and children. The principal objective of this Request for Applications (RFA) is to stimulate research on the role of the blood brain barrier (BBB) in the neuropathogenesis of HIV infection and disease progression. The results of these investigations are expected to constitute preliminary data for proposals to block HIV entry into the CNS, and prevent the detrimental effects of the virus on the CNS. The mechanisms available for support of this RFA are the National Institutes of Health (NIH) research project grant (R01), First Independent Research Support and Transition (FIRST) award (R29), small grant award (R03-NIMH only), and the investigator-initiated interactive research project grant (IRPG). In FY 1995, a total of $1.5 million contributed equally by NIMH and NINDS has been set-aside for this RFA to fund about six to ten awards. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Role of the Blood Brain Barrier in HIV Neuropathogenesis, is related to the priority areas of HIV infection of the nervous system and mental health and disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 telephone (202) 783-3238. INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Walter L. Goldschmidts, Ph.D. Office on AIDS National Institute of Mental Health Parklawn Building, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-7281 FAX: (301) 443-9719 Email: goldsch@aoamh2.ssw.dhhs.gov $$R4 END ************************************************************ $$R5 BEGIN CA-95-012 FULL-TEXT ************************************** INVESTIGATOR GRANTS FOR CLINICAL CANCER THERAPY RESEARCH NIH GUIDE, Volume 24, Number 15, April 28, 1995 RFA AVAILABLE: CA-95-012 P.T. 34; K.W. 0715035, 0745070 National Cancer Institute Letter of Intent Receipt Date: September 1, 1995 Application Receipt Date: October 20, 1995 PURPOSE The Cancer Therapy Evaluation Program (CTEP) and the Biological Response Modifiers Program (BRMP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI) invites research grant applications to conduct therapeutic clinical trials research employing new agents, concepts, or strategies for the treatment of cancer. This initiative is aimed at encouraging new clinical investigators who have not previously had independent grant funding to submit research applications in this area of research. Approximately $2,000,000 in total costs per year for four years will be committed to fund applications submitted in response to this RFA. It is anticipated that ten new individual awards will be made. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Investigator Grants for Clinical Cancer Therapy Research, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Ms. Diane Bronzert Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 Email: BRONZERD@DCT.NCI.NIH.GOV $$R5 END ************************************************************ $$R6 BEGIN DE-95-002 FULL-TEXT ************************************** ETIOLOGY AND PATHOGENESIS OF TEMPOROMANDIBULAR DISORDERS NIH GUIDE, Volume 24, Number 15, April 28, 1995 RFA AVAILABLE: DE-95-002 P.T. 34; K.W. 0715148, 0765033, 0755030, 0705050 National Institute of Dental Research Office of Research on Women's Health Letter of Intent Receipt Date: September 1, 1995 Application Receipt Date: October 24, 1995 PURPOSE The National Institute of Dental Research (NIDR) and the Office of Research on Women's Health (ORWH) invite applications to support research clarifying the etiology and pathogenesis of disorders producing persisting pain or dysfunction within the temporomandibular joint or masticatory muscles (temporomandibular disorders or TMDs). Research also may include the development of appropriate models to study normal function and pathological changes in the masticatory muscles and temporomandibular joint (TMJ) and to clarify biobehavioral processes influencing muscle or joint function or pathology. Studies that elucidate mechanisms underlying the higher prevalence of these disorders in women are also encouraged. Projects funded under this initiative will utilize the individual investigator-initiated research project grant (R01) or the First Independent Research Support and Transition (FIRST) (R29) award support mechanisms. It is anticipated that $1,770,000 will be available for the first From owner-sci-resources@net.bio.net Mon May 01 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 30 April 1995 Date: 1 May 1995 19:06:33 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 114 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3o4439$5j6@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: News Title: NSF-MCI - BACKGROUND INFORMATION ON THE INTERNET/NSFNET File size (bytes): STIS Filename: nsfmci.txt Document Type: Press Release Title: MIGRATION PATTERNS OF FISH File size (bytes): RECORDED IN THEIR OTOLITHS (EARSTONES) STIS Filename: pr9528.txt (NSF) Title: DISCOVERY OF ANCIENT TOOLS SHEDS NEW LIGHT ON ORIGINS OF MODERN HUMANS File size (bytes): STIS Filename: pr9529.txt Document Type: Program Guideline Title: NSF 95-77 Partnership in Engineering Research Centers File size (bytes): 42427 STIS Filename: nsf9577.txt Document Type: Report Title: NSF 95-69 Disseminating Innovation in Undergraduate Education Proceedings Document File size (bytes): STIS Filename: nsf9569.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Dir of Awards Title: NSF 95-73 Teacher Preparation and NSF Collarboratives for Excellence in Teacher Preparation File size (bytes): FY 93 and 94 Awards STIS Filename: nsf9573.txt (NSF) Document Type: News Title: MPSLECT -- "Have Laser -- Will Travel" File size (bytes): 1530 STIS Filename: mpslect.txt Document Type: Phone Book Title: NSF Alpha Telephone File size (bytes): 100164 STIS Filename: phnalpha.txt Title: NSF Organizational Directory File size (bytes): 99061 STIS Filename: phnorg.txt Document Type: Program Guideline Title: NSF 95-77 Partnership in Engineering Research Centers File size (bytes): 42427 STIS Filename: nsf9577.txt Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 46689 STIS Filename: sesvac.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve sesvac.txt, the text of your message should be as follows: get sesvac.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve sesvac.txt, you would enter: ftp> get sesvac.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Mon May 01 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 15, pt. 3of3, 28 April 1995 Date: 2 May 1995 09:53:26 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 64 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3o5o26$gm4@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950428 V24N15 P3O3 ************************************ P.T. 34; K.W. 0414015, 0715150, 0414000, 1002019, 1002030, 0785050 National Institute of Nursing Research National Institute of Dental Research National Institute on Aging National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Drug Abuse National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke Office of Alternative Medicine PURPOSE The purpose of this biobehavioral pain research program announcement is to inform the scientific community of the interests of the various institutes at the National Institutes of Health (NIH) and to stimulate and foster a wide range of basic and clinical studies on pain as it relates to the missions of these Institutes. Applications using the R01 and R29 mechanisms, as well as the R03 mechanism by some institutes, are encouraged to study individual differences in pain responses that may be due to factors such as genetic differences, endocrine activity, neural activity, immune function, psychological state, disability state, age, gender, and cultural background. Research is also needed in areas such as understanding the neuroanatomical pathways and the neurophysiological mechanisms in pain. The pain experience needs to be examined at all levels of research including the gene, molecule, cell, organ, and individual with the goal of developing biobehavioral interventions to manage or prevent pain. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Biobehavioral Pain Research, is related to the priority areas of chronic disabling conditions, cancer, and clinical prevention services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Dr. Mary Lucas Leveck National Institute of Nursing Research Natcher Building, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-5963 Email: mleveck@ep.ninr.nih.gov $$P8 END ************************************************************ From owner-sci-resources@net.bio.net Mon May 01 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DE-95-002 - V24(15) 04/28/95 Date: 2 May 1995 09:53:50 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 414 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3o5o2u$gng@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DE95002 DE-95-002 P1O1 *************************************** ETIOLOGY AND PATHOGENESIS OF TEMPOROMANDIBULAR DISORDERS NIH GUIDE, Volume 24, Number 15, April 28, 1995 RFA: DE-95-002 P.T. 34; K.W. 0715148, 0765033, 0755030, 0705050 National Institute of Dental Research Office of Research on Women's Health Letter of Intent Receipt Date: September 1, 1995 Application Receipt Date: October 24, 1995 PURPOSE The National Institute of Dental Research (NIDR) and the Office of Research on Women's Health (ORWH) invite applications to support research clarifying the etiology and pathogenesis of disorders producing persisting pain or dysfunction within the temporomandibular joint or masticatory muscles (temporomandibular disorders or TMDs). Research also may include the development of appropriate models to study normal function and pathological changes in the masticatory muscles and temporomandibular joint (TMJ) and to clarify biobehavioral processes influencing muscle or joint function or pathology. Studies that elucidate mechanisms underlying the higher prevalence of these disorders in women are also encouraged. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Etiology and Pathogenesis of Temporomandibular Disorders, is related to the priority area of oral health and the cross-cutting issue of women's health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Governing Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible to apply for First Independent Research Support and Transition (FIRST) (R29) awards. Applications >From minority individuals and women are encouraged. MECHANISM OF SUPPORT The mechanisms of support utilized will be the individual research project grant (R01) and the FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five years. It is anticipated that most R01 applicants will request no more than three years of support. This RFA is a one-time solicitation for applications for new and competing renewal awards. Future competitive renewal applications will compete with all investigator-initiated applications and will be reviewed according to customary referral and review procedures. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for all awards under this RFA will be $1,770,000. The NIDR and the ORWH plan to fund a total of approximately seven to nine grants in FY 1996. This level of support assumes receipt of a sufficient number of applications of high scientific merit. Applications may not request more than four percent annual increases for inflation over subsequent years. Although this program is provided for in the financial plans of the NIDR and the ORWH, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and the availability of funds. RESEARCH OBJECTIVES Background The principal signs and symptoms of the TMDs are pain in the jaw region, including pain and tenderness in the masticatory muscles and/or the temporomandibular joints, sometimes combined with limitations or disturbance of mandibular movements (e.g., jaw "locking," restricted jaw opening, or chewing problems). Such signs and symptoms often occur in the context of etiologically distinct disorders, adding complexity to differential diagnosis. Some of the TMDs appear to arise directly from degenerative or inflammatory changes within the TMJ. Others appear to reflect increased vulnerability to injury or disruptions of reparative processes following macro- or micro-trauma within the TMJ or masticatory muscles. Abnormalities in muscle function or structure also may contribute to the persistent muscle fatigue and soreness commonly reported. Behavioral factors also appear to contribute to the onset or exacerbation of symptoms for some patients with TMDs. However, the dearth of rigorous basic science studies which focus on the biological bases for the TMDs prompts the emphasis seen in this RFA on biological aspects of etiology and pathogenesis. The signs or symptoms associated with the TMDs are relatively common. A recent meta-analysis indicated that an average of 30 percent of subjects studied in 23 predominantly European prevalence studies reported such signs or symptoms. Using narrower criteria for TMD- related pain, investigators evaluating a large sample of adults enrolled in a U.S. health maintenance organization (HMO) concluded that persisting or recurrent jaw pain affects more than 10 percent of adults at any one time and one in three adults at some time over their life span. Studies also suggest that the TMDs can lead to significant disruptions in functional activities such as chewing or speaking, can impair social and personal functioning, and diminish overall quality of life. Aggressive treatment approaches to the TMDs, including surgical reconstruction particularly with the use of alloplastic implants, have resulted in severe disability. A preponderance of females have been noted in most studies of patients seeking care for the TMDs. Initially, this was thought to reflect gender-related differences in health care seeking behaviors or differences in tolerance for pain and other physical symptoms. However, several recent epidemiological studies indicate overall associations between female gender and vulnerability to joint and muscle disorders. Such findings suggest the need to evaluate how hormonal or other gender-related factors influence the development of disorders, such as the TMDs, involving joints and muscles. Although there is not universal agreement on a classification schema for the TMDs, many U.S. clinical scientists have begun using a set of research diagnostic criteria that categorizes clinical TMD conditions within three broad clusters (i.e., muscle diagnoses; disc displacements; and joint disorders consisting of arthralgia, osteoarthritis of the TMJ, and osteoarthrosis of the TMJ) and additionally categorizes each patient according to levels of pain- related disability and psychosocial characteristics. Two NIH-sponsored meetings held during 1994 summarized available scientific information on the TMDs and identified promising research directions. Both the International Workshop on the TMDs and Related Pain Conditions and the Workshop on TMJ Alloplastic Implants and Local/Systemic Response, were sponsored by the NIDR, with co- sponsorship from the National Institute of Arthritis and Musculoskeletal Disorders (NIAMS), the NIH's Office of Research on Women's Health (ORWH), the Agency for Health Care Policy and Research (AHCPR), and the Food and Drug Administration (FDA). At both meetings participants recommended a major expansion of research to clarify the etiology and pathogenesis of these conditions. Topics included in this RFA reflect key recommendations relevant to etiology/pathogenesis emerging from these workshops. Scope of Research Sought Basic science and clinical research studies are sought that will contribute to the understanding of biological processes underlying various TMDs. Studies of both normal and pathological conditions in the masticatory muscles and the TMJ fall within the scope of this RFA, as do studies of biobehavioral processes directly influencing muscle or joint function or pathology. Examples of some pertinent areas and research topics are listed below. This list is intended to be illustrative, not exhaustive. Topics are not presented in any particular priority order: o Determine the molecular and cellular composition of normal and abnormal tissues of the TMJ, masticatory muscles and ligaments, identifying molecular mechanisms involved in the synthesis, maintenance, and degradation of these tissues. o Characterize neural plasticity at the molecular, cellular, and physiological level in response to injuries involving the TMJ and masticatory muscles (including the introduction of artificial materials or devices). o Define central nociceptive pathways activated in response to injury of the TMJ, masticatory muscles, or other orofacial tissues and characterize modulatory processes influencing such activation. o In relationship to alloplastic implant materials used in TMJ repair, identify how cellular, humoral, genetic, and neuroendocrine/hormonal factors are associated with individual differences in biological response and identify methods to modulate adverse biological responses. o Determine the mediators and inhibitors of inflammation in the TMJ or masticatory muscles, and the mechanisms regulating their release and action. o Determine the role of jaw movement and function in the maintenance of the molecular, cellular, and morphological integrity of the TMJ. o Develop biological markers for diseases affecting the TMJ or masticatory muscles. o Conduct studies to clarify relationships between fibromyalgia and temporomandibular myofascial pain, to determine the natural course of disc displacement and osteoarthritis, or to clarify the biological effects of TMJ disc displacement on surrounding tissues. o Identify and characterize gender-related biological factors that may predispose women to develop TMDs or related orofacial pain conditions. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens previous policies (Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The current policy contains some new provisions that are substantially different from the 1990 policies. Investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. LETTER OF INTENT Prospective applicants are asked to submit, by September 1, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA to which the application responds. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains will assist in planning for the timely review of applications. Receipt of such letters will allow NIDR staff to estimate the potential review workload and make review plans that will avoid possible conflict of interest. The NIDR staff will provide no response to letters of intent. The letter of intent is to be addressed to Dr. Patricia Bryant at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91), available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants (DRG), National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248). Applications for the FIRST (R29) Award must include at least three sealed letters of reference attached to the face page of the original application. FIRST (R29) Award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The RFA label available in the PHS 398 application kit must be affixed to the bottom of the face page of the original and the original must be placed on top of the entire package. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, in order to identify the application as a response to this RFA, the RFA title "ETIOLOGY AND PATHOGENESIS OF TEMPOROMANDIBULAR DISORDERS" and number "DE-95-002" must be typed in item 2a of the face page of the application form and the YES box must be checked. Specific attention should be given to efforts to contain costs and ensure cost-competitive implementation of the project's research goals. Investigators also are encouraged to examine the potential for securing supplementary funds for the project from non-NIDR sources, such as not-for-profit and for-profit organizations. If additional financial support from non-NIDR sources is planned to complement or expand the research proposed for support by the NIDR, the applicant should explain how such activities will further the goals of the project and make it more cost-effective. Awardees will be expected to update this information on an annual basis. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health 6705 Rockledge Drive, Suite 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express or courier service) At the time of submission, two additional copies of the application must also be sent to: Dr. H. George Hausch Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-44F 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Applications must be received by October 24, 1995. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Division of Research Grants and responsiveness by the NIDR. Incomplete and/or unresponsive applications will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by a special emphasis panel convened by the Scientific Review Branch, NIDR, solely to review these applications, utilizing the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and assigned a priority score. Applications deemed non-competitive will be withdrawn from further consideration; the principal investigator/program director and the official signing for the applicant organization will be notified of this action, after the initial review. Factors to be considered in the evaluation of the scientific merit of applications will be similar to those used in the review of traditional research project grant applications and will include: the novelty, originality, and feasibility of the approach; the training, experience, and research competence of the investigator(s); the adequacy of experimental design; the accessibility and appropriateness of study populations, study and facilities. Secondary review of the applications will be conducted by the National Advisory Dental Research Council. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program balance and priorities, and the availability of funds. Applicants also should be aware that the total cost of the research proposed will be considered by NIDR and ORWH staff and the National Advisory Dental Research Council in making funding recommendations. In circumstances in which applications have similar scientific merit, but vary in cost- competitiveness, the NIDR and ORWH are likely to select the more cost-competitive application for funding. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Patricia S. Bryant, Ph. D. Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN 18A 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2095 FAX: (301) 480-8318 Email: BryantP@de45.NIDR.NIH.GOV Direct inquiries regarding grants management issues to: Ms. Theresa Ringler Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AS-55 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 Schedule Letter of Intent Receipt Date: September 1, 1995 Application Receipt Date: October 24, 1995 Scientific Review Date: January 1996 Advisory Council Date: June 1996 Earliest Award Date: September 1996 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Mon May 01 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-050 - V24(15) 04/28/95 Date: 2 May 1995 09:54:03 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 715 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3o5o3b$go2@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95050 PA-95-050 P1O1 *************************************** INDEPENDENT SCIENTIST AWARD NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA NUMBER: PA-95-050 P.T. 34; K.W. 0710030 National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Heart, Lung, and Blood Institute National Institute of Mental Health Application Receipt Dates: February 1, June 1, and October 1 PURPOSE The Independent Scientist Award (ISA) (K02) provides support for newly independent scientists who can demonstrate the need for a period of intensive research focus as a means of enhancing their research careers. This award is intended to foster the development of outstanding scientists and enable them to expand their potential to make significant contributions to their field of research. This award replaces two existing career development awards, the Research Scientist Development Award (K02) and the Research Career Development Award (K04). Individuals who were eligible to apply for either of these awards are now directed to apply for a K02 award. Therefore, this Program Announcement (PA) supersedes all previous K02 and K04 program announcements. The NIH recently reviewed its career awards (K-series) used to develop the research capabilities of clinicians and other scientists needed to carry out the nation's research mission in the biomedical and behavioral sciences. This evaluation resulted in several changes: (1) the total number of K mechanisms were reduced from 19 to six; (2) the review criteria were refined to clarify the career development goals of the K award; and (3) K award applications will be assigned to initial review groups managed by the prospective funding institute or center to which the application has been assigned. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Independent Scientist Award, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS The candidate must have a doctoral degree and peer-reviewed, independent, research support at the time the award is made. The candidate must also be willing to spend a minimum of 75 percent effort conducting research and research career development during the period of the award. In addition, the candidate must demonstrate that the requested period of research focus will foster his/her career as highly productive scientist in the indicated field of research. Scientists whose work is primarily theoretical may apply for this award in the absence of external research grant support. Applications may be submitted on behalf of candidates by domestic, non-Federal organizations, public or private, such as medical, dental, or nursing schools or other institutions of higher education. Minorities and women are encouraged to apply. Candidates must be U.S. citizens or noncitizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Noncitizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states, but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. MECHANISM OF SUPPORT Awards in response to this program announcement will use the K02 mechanism. Planning, direction, and execution of the program will be the responsibility of the candidate. However, the institution must demonstrate a commitment to the candidate and the candidate's goals for career development. The project period for the K02 award is five years. Awards may be renewed once at the discretion of the NIH awarding unit. Not all of the NIH awarding components allow renewal of this award. Prospective candidates are advised to discuss this issue withe the appropriate contact listed under INQUIRIES. RESEARCH OBJECTIVES A. Environment: The institution should have a demonstrated commitment to research and a commitment to the continuing development of the candidate as an independent scientist. The institution must provide assurance that the candidate is an integral part of its research and academic program. B. Program: The award provides five consecutive, 12 month appointments. At least 75 percent of the recipient's full-time professional effort must be devoted to the program and the remainder devoted to other research-related and/or teaching pursuits consistent with the objectives of the award. C. Allowable Costs: 1. Salary: The NIH will provide salary and fringe benefits for the K recipient. The salary limits are not uniform throughout the NIH and are determined independently by each component of the NIH. Therefore, prospective candidates should contact the NIH component to which the application is targeted to ascertain the maximum contribution to the candidate's salary. The institution may supplement the NIH contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case, may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the ISA. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary requested must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. 2. Research Development Support: It is expected that candidates for a K02 award will have research support at the time of the award. However, there are some research specialties in which only minimal research support is needed, i.e., theoreticians and computer scientists. In such cases, incidental research expenses may be provided at the discretion of the individual institute or center. Candidates may request funds to offset the cost of tuition, fees, and books related to career development. Applicants should request additional information from the relevant NIH institute or center listed under INQUIRIES. 3. Ancillary Personnel Support: Salary for secretarial, technical, and/or administrative assistance, etc., is not allowed. 4. Indirect costs: Indirect costs will be reimbursed at eight percent of modified total direct costs, or at the actual indirect cost rate, whichever is less. D. Evaluation: In carrying out its stewardship of human resource related programs, the NIH, at some point in the future, may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified, that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. E. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution. The funds may be used for health-related research purposes. The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Usually, funds budgeted in and institute-supported research or training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. An institute will give consideration to approval for use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of an NIH career award must receive prior written approval of the institute awarding component. F. Special Leave: Leave to another institution, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NIH funding component is required. To obtain prior approval, the award recipient must submit a letter to the NIH describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH funding component and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Parental leave will be granted consistent with the policies of the NIH and the grantee institution. G. Termination or Change of Institution: When a grantee institution plans to terminate an award, the NIH funding component must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. If the individual is moving to another eligible institution, career award support may be continued provided: A new career award application is submitted by the new institution; The period of support requested is no more than the time remaining within the existing award period; and The new application is submitted far enough in advance of the requested effective date to allow the necessary time for review. The funding component may require a new review by an initial review group and/or the appropriate national advisory council or board. Alternatively, review may be carried out by staff within the NIH funding component depending upon the circumstances. The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipient in writing of this determination, the reasons therefor, the effective date, and the right to appeal the decision. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES This is a generic program announcement for the NIH Independent Scientist Award (ISA). Since some of the NIH institutes and centers may not participate in this program or may have different award provisions, it is strongly recommended that prospective applicants contact the staff person in the relevant institute or center listed under "INQUIRIES" early in the planning phase of application preparation. Such contact will help ensure that applications are responsive to the career development goals of individual institutes and centers. Applications are to be submitted on form PHS 398 (rev. 9/91) and will be accepted on or before the receipt deadlines indicated in the application kit (February 1, June 1 and October 1). Forms are available at most institutional offices of sponsored research and >From the Office of Grants Information, Division of Research Grants, NIH, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The application must address the following issues: Candidate o Describe the candidate's commitment to a career in biomedical or behavioral research o Document the candidate's success as an independent investigator and his/her potential to make future contributions to the chosen field of research. o Describe immediate and long-term career objectives. Explain how this award will contribute to these goals. o Describe how the Independent Scientist Award will further the candidate's research career and ultimate impact on science. Career Development Plan o Describe the career development plan, incorporating consideration of the candidate's goals and prior experience. o The candidate must describe plans to participate in courses related to instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction as well as the amount and nature of the candidate's participation. No award will be made if an application lacks this component; Research Plan o Describe the research plan as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/ Preliminary Studies, Research Design and Methods. Environment and Institutional Commitment o The application must contain evidence of the applicant institution's commitment to the career enhancement of the candidate. Indicate the types of facilities, supplies, equipment, and human resources that will be made available to the applicant. Provide assurance that the candidate will be able to devote 75 percent of his/her full-time professional effort to research related activities. Budget o Budget requests must be provided according to the instructions in form PHS 398. The request for tuition and fees, books, travel, etc., must be justified and specified by category. To identify the application as a response to this program announcement, check "yes" on item 2a of page 1 of the application and enter "PA-95-050, Independent Scientist Award" and the name of the NIH institute or center that you would like your application to be assigned for funding. Submit a signed, typewritten original of the application with Checklist, and five signed photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the Division of Research Grants and responsiveness to the program announcement by the appropriate institute or center staff. Incomplete or nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by he appropriate national advisory council or board. The following review criteria will be applied: Candidate o Capacity to carry out independent research; o Potential to become an outstanding scientist who will make significant contributions to the field; o Past and present research productivity as evidenced by contributions to the scientific literature, and success in obtaining independent funding; o Ability to conceptualize and organize a long-term research approach; and o Level of training, experience, and competence commensurate with the purposes of the award. Career Development Plan o Likelihood that the award will contribute substantially to the continued scientific development and productivity of the candidate; o The extent to which the award will enable a candidate to devote full time to research and related duties by release from teaching, administration, clinical work, and other responsibilities; o Consistency of the career development plan with the candidate's career goals; and o Collaboration with other active investigators and opportunities for professional growth. Research Plan o Quality of research plan and significance for contributing to the scientific literature; o Scientific and technical merit of the proposed research plan; and o adequancy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. Environment and Institutional Commitment o Institutional commitment to the development of the candidate as an independent scientist and assurances that the institution intends the candidate to be an integral part of its research and academic program; and o Strength of the institution's commitment to scientific research. Budget o Justification of budget requests in relation to career development goals and research aims and plans. AWARD CRITERIA The institute or center will notify the applicant of the board or council's action shortly after its meeting. Funding decisions will be made based on the recommendations of the initial review group and council/board, the need for research personnel in specific program areas, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this PA are encouraged especially during the planning phase of the application. Below is a listing of each institute's or center's program or grants management contacts. Dr. Robin A. Barr Office of Extramural Affairs National Institute on Aging Gateway Building, Room 2C218, MSC 9205 7201 Wisconsin Avenue Bethesda, MD 20892-9205 Telephone: (301) 496-9322 FAX: (301) 402-9245 Email: Barr@nihniagw.bitnet Dr. Ernestine D. Vanderveen, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 Email: tvanderv@willco.niaaa.nih.gov Ms. Frances Cotter Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1207 FAX: (301) 443-8744 Email: fcotter@willco.niaaa.nih.gov Dr. Mary C. Dufour Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 514 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4897 FAX: (301) 443-8614 Email: m.dufour@willco.niaaa.nih.gov Dr. Milton Hernandez Office of Scientific Training and Manpower Development National Institute of Allergy and Infectious Diseases Solar Building, Room 3C21 Bethesda, MD 20892 Telephone: (301) 496-7291 FAX: (301) 402-0369 Email: mh35c@nih.gov Richard Lymn, Ph.D. Extramural Programs National Institute on Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-49E 45 Center Drive, MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-5128 FAX: (301) 480-4543 Email: rl28b@nih.gov Hildegard Topper Special Assistant to the Deputy Director National Institute of Child Health and Human Development Building 31, Room 2A-03 Bethesda, MD 20892 Telephone: (301) 496-0104 FAX: (301) 402-1104 Email: topperh@hd03.nichd.nih.gov Daniel Sklare, Ph.D. National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400B-13 Bethesda, MD 20892 Telephone: (301) 496-1804 FAX: (301) 402-6251 Email: Daniel_Sklare@nih.gov Dr. James A. Lipton Special Assistant for Training and Career Development National Institute of Dental Research Natcher Building, Room 4AN.18J Bethesda, MD 20892 Telephone: (301) 594-2618 FAX: (301) 480-8319 Email: liptonj@de45.nidr.nih.gov Ronald Margolis, Ph.D. Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 5AN-12J MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8819 FAX: (301) 480-3503 Email: margolis@ep.niddk.nih.gov Charles Rodgers, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AS-19J MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: rodgersc@ep.niddk.nih.gov Timothy P. Condon, Ph.D. OSPEL/SPAB National Institute on Drug Abuse Parklawn Building, Room 10A-55 Telephone: (301) 443-6072 FAX: (301) 443-6277 Email: tc52x@nih.gov Charles W. Sharp, Ph.D. Division of Basic Research National Institute on Drug Abuse Parklawn Building, Room 10A-31 Telephone: (301) 443-1887 FAX: (301) 594-6043 Email: cs107m@nih.gov Arthur Horton, Ed.D. Division of Clinical Research National Institute on Drug Abuse Parklawn Building, Room 10A-30 Telephone: (301) 443-4060 FAX: (301) 443-2317 Email: ah61x@nih.gov Ann Blanken Division of Epidemiology and Prevention Research National Institute on Drug Abuse Parklawn Building, Room 9A-55 Telephone: (301) 443-6543 FAX: (301) 443-9847 Email: ab108v@nih.gov Jamie Biswas, Ph.D. Medications Development Division National Institute on Drug Abuse Parklawn Building, Room 11A-55 Telephone: (301) 443-5280 FAX: (301) 443-2599 Email: jb168r@nih.gov Dr. Michael Galvin Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 Research Triangle Park, NC 27709 Telephone: (919) 541-7825 FAX: (919) 541-2843 Email: galvin@niehs.nih.gov Thomas Blaszkowski, Ph.D. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute Federal Building, Room 208A 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-1841 FAX: (301) 480-1455 Email: tb33i@nih.gov Michael Commarato, Ph.D. Division of Heart and Vascular diseases National Heart, Lung, and Blood Institute Federal Building, Room 3C04 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-1724 FAX: (301) 402-2043 Email: mc63a@nih.gov Joyce Creamer Division of Blood diseases and Resources National Heart, Lung, and Blood Institute Federal Building, Room 5C02 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-8388 FAX: (301) 480-0867 Email: jc85n@nih.gov James Kiley, Ph.D. National Center for Sleep Disorders Research National Heart, Lung, and Blood Institute Building 31, Room 4A11 Bethesda, MD 20892 Telephone: (301) 496-7443 FAX: (301) 496-7508 Email: jk52a@nih.gov Mary Reilly Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640 5333 Westbard Avenue Bethesda, MD 20892 Telephone: (301) 594-7466 FAX: (301) 594-7487 Email: mr50w@nih.gov George T. Niederehe, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-3264 FAX: (301) 594-6784 Email: gniedere@aoamh4.ssw.dhhs.gov Kenneth G. Lutterman, Ph.D. Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10-95 Rockville, MD 20857 Telephone: (301) 443-3373 FAX: (301) 443-4045 Email: klutterm@aoamh2.ssw.dhhs.gov Henry Khachaturian, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health 5600 Fishers Lane, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-8033 FAX: (301) 443-1731 Email: hkhach@helix.nih.gov Leonard Mitnick, Ph.D. Office of AIDS Programs National Institute of Mental Health 5600 Fishers Lane, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-9719 FAX: (301) 443-9719 Email: lmitnick@aoamh2.ssw.dhhs.gov AUTHORITY AND REGULATIONS The Independent Scientist Awards are made under the authority of Title III, Section 301 of the Public Health Service (PHS) Act as amended (Public Law 78-410, as amended, 42 USC 241). The Code of Federal Regulations, Title 42 Part 52, and Title 45 part 74, are applicable to this program. This program is described in the Catalog of Federal Domestic Assistance No. 93.121. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Mon May 01 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-053 - V24(15) 04/28/95 Date: 2 May 1995 09:55:07 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 859 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3o5o5b$grl@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95053 PA-95-053 P1O1 *************************************** MENTORED CLINICAL SCIENTIST DEVELOPMENT AWARD NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA NUMBER: PA-95-053 P.T. 34; K.W. 0710030, 0785035 National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke Application Receipt Dates: February 1, June 1, and October 1 PURPOSE The purpose of the Mentored Clinical Scientist Development Award MCSDA is to support the development of outstanding clinician research scientists. This mechanism provides specialized study for clinically trained professionals who are committed to a career in research and have the potential to develop into independent investigators. The award supports a three, four, or five year period of supervised research experience that may integrate didactic studies with laboratory or clinically-based research. The proposed research should have both intrinsic research importance and be a suitable vehicle for learning the methodology, theories, and conceptualizations necessary for a well trained independent researcher. Because of the focus on progression to independence, the prospective candidate should propose a period of study and development consistent with this goal and his or her previous research and clinical experience. For example, a candidate with limited experience in a given field of research may find a phased developmental program lasting for five years which includes a designated period of didactic training and supervised research experience the most efficient means of attaining independence. A candidate with substantial previous research experience may require a shorter award period appropriate for the transition to independence. The entire program should be comparable in scope and rigor to meeting the requirements for an advanced research degree. This award replaces the Clinical Investigator Award (K08), the Physician Scientist Award (K11), the Dentist Scientist Award (K15), and the Scientist Development Award for Clinicians (K20). Individuals who were eligible to apply for one of these awards are now directed to apply for an MCSDA. Therefore, this program announcement supersedes all previous K08, K11, K15 and K20 program announcements and competing applications for these awards will no longer be accepted. Existing policies and provisions will remain in effect for current K08, K11, K15 and K20 recipients until completion of the non-competing years of their career development program. The NIH institutes and centers implement this award in different ways to accomodate the career needs of researchers in fields within their missions. For example the National Institute of Dental Research (NIDR) requires that, in most situations, candidates must pursue a program that includes didactic and supervised basic or behavioral science research experiences that result in the Ph.D. degree. The NIDR may, under specific circumstances, provide support under this program for the development of advanced clinical knowledge and skills in either a recognized clinical specialty or equivalent dental clinical discipline. Therefore, the prospective candidate must have a D.D.S. or an equivalent degree but need not have started postgraduate training, such as in a clinical specialty or general practice dental residency. However, preference will be given to applicants with advanced training in general or specialty practice. Dentists without advanced clinical knowledge and skills are eligible for the MCSDA but are encouraged to seek appointments to the Mentored Clinical Scientist Development Program Award (K12). All applicants are strongly encouraged to contact the prospective awarding component to discuss issues of eligibility and the specific provisions of this award. The NIH recently reviewed its career awards (K) used to develop the research capabilities of clinicians and other scientists needed to carry out the nation's research mission in the biomedical and behavioral sciences. This evaluation resulted in several changes: (1) the total number of K mechanisms were reduced from 19 to six; (2) the review criteria were refined to clarify the career development goals of the K award; and (3) K award applications will be assigned to initial review groups managed by the prospective funding institute or center to which the application has been assigned. HEALTHY PEOPLE 2000 The Public Health Service is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Mentored Clinical Scientist Development Award, is related to the priority area of human resource development. Potential candidates may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS The candidate must have a clinical degree or its equivalent, must have initiated postgraduate clinical training, must identify a mentor with extensive research experience, and must be willing to spend a minimum of 75 percent of full-time professional effort conducting research and research career development. Applications may be submitted, on behalf of candidates, by domestic, non-Federal organizations, public or private, such as medical, dental, or nursing schools or other institutions of higher education. Minorities and women are encouraged to apply. Candidates must be U.S. citizens or noncitizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Noncitizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. Former principal investigators on NIH research project (R01), FIRST Awards (R29), sub-projects of program project (P01) or center grants (P50), or the equivalent, are not eligible. A candidate for the MCSDA may not concurrently apply for any other PHS award that duplicates the provisions of this award nor have another application pending award. MCSDA recipients are encouraged to apply for independent research grant support during the period of this award. MECHANISM OF SUPPORT Awards in response to this program announcement will use the K08 mechanism. Planning, direction, and execution of the program will be the responsibility of the candidate and her/his mentor on behalf of the applicant institution. The project period may be for three, four or five years and will depend upon the number of years of prior research experience, the need for additional experiences to achieve independence, and the policy of each particular institute or center. Awards are not renewable. RESEARCH OBJECTIVES A. Environment: The institution must have a well-established research and clinical career development programs and qualified faculty in clinical and basic research to serve as mentors. The institution must be able to demonstrate a commitment to the development of the candidate as a productive, independent investigator. And, the candidate, mentor and institution must be able to describe a multi- disciplinary career development program that will maximize the use of relevant research and educational resources. B. Program: The award provides three to five consecutive 12 month appointments. At least 75 percent of the recipient's full-time professional effort must be devoted to the program and the remainder devoted to other clinical and teaching pursuits consonant with the objectives of the award. The basic science component must develop knowledge and research skills in scientific areas relevant to the career goals of the candidate. C. Mentor(s): The recipient must receive appropriate mentoring throughout the three to five year program. Where feasible, women and minority mentors should be involved as role models. D. Allowable Costs: 1. Salary: The NIH will provide salary and fringe benefits for the K recipient. The salary limits are not uniform throughout the NIH and are determined independently by each component of the NIH. Therefore, prospective candidates should contact the NIH component to which the application is targeted to ascertain the maximum contribution to the candidate's salary. The institution may supplement the NIH contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case, may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the MCSDA. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary requested must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. 2. Research Development Support: Most awarding components at the NIH will provide up to $20,000 per year is allowed for the following expenses: (a) tuition, fees, and books related to career development; (b) research expenses, such as supplies, equipment and technical personnel; (c) travel to research meetings or training; (d) statistical services including personnel and computer time. The amount of research development support is not uniform across all awarding components. Prospective candidates should contact the NIH component to which the application is targeted to ascertain the maximum amounts available. The National Institute of Dental Research and the National Heart, Lung, and Blood INstitute will provide up to $15,000 for research development support. The National Institute of Mental Health will provide up to $50,000 for research development support. 3. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed. 4. Indirect costs: Indirect costs will be reimbursed at 8 percent of modified total direct costs, or at the actual indirect cost rate, whichever is less. E. Evaluation: In carrying out its stewardship of human resource related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified, that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. F. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution. The funds may be used for health-related research purposes. The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component. G. Special Leave: Leave to another institution, including a foreign laboratory, may be permitted if directly related to the purpose of the award.nly local, institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NIH funding component is required. To obtain prior approval, the award recipient must submit a letter to the NIH describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH funding component and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Parental leave will be granted consistent with the policies of the NIH and the grantee institution. H. Termination or Change of Institution: When a grantee institution plans to terminate an award, the NIH funding component must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. If the individual is moving to another eligible institution, career award support may be continued provided: A new career award application is submitted by the new institution; The period of support requested is no more than the time remaining within the existing award period; and The new application is submitted far enough in advance of the requested effective date to allow the necessary time for review. The funding component may require a review by an initial review group and/or the appropriate National Advisory Council or Board. Alternatively, review may be carried out by staff within the NIH funding component depending upon the circumstances. The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipient in writing of this determination, the reasons therefor, the effective date, and the right to appeal the decision. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES This is a generic program announcement for the MCSDA. Therefore, all candidates are strongly encouraged to contact the staff person in the relevant institute or center listed under INQUIRIES. Such contact should occur early in the planning phase of application preparation. Such contact will help ensure that applications are responsive to the career development goals and policies of the individual institute or center. Applications are to be submitted on form PHS 398 (rev. 9/91) and will be accepted on or before the receipt deadlines indicated in the application kit (February 1, June 1 and October 1). Forms are available at most institutional offices of sponsored research and >From the Office of Grants Information, Division of Research Grants, NIH, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The application must address the following issues: Candidate o Describe the candidate's commitment to a career in biomedical or behavioral research o Establish the candidate's potential to develop into an independent investigator. o Describe immediate and long-term career objectives, explaining how the award will contribute to their attainment. o Letters of recommendation. Three sealed letters of recommendation addressing the candidate's potential for a research career must be included as part of the application. Career Development Plan o Describe the career development plan incorporating consideration of the candidate's goals and prior experience. It should describe a systematic plan to obtain the necessary basic biomedical or behavioral science background and research experience to launch an independent research career. More junior candidates with little previous research experience may require a phased developmental period in which the first year(s) of the award are largely of a didactic nature followed by a period of intense, supervised research experience. Candidates with more experience at the time of application may need a shorter developmental period and may already have an adequate basic science background. In any case, the career development plan must be tailored to the needs of the candidate and the ultimate goal of independence as a researcher. o Candidates seeking support from NIDR should also include a description of their plan to obtain the necessary clinical training o Candidates must describe plans to receive Instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction. No award will be made if an application lacks this component. Research Plan o Describe the research plan and the use of a basic or clinical science approach to a biomedical or behavioral problem. The research plan must be described as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/ Preliminary Studies, Research Design and Methods. The candidate should consult with the mentor regarding the development of this section. Mentor's Statement o The application must include information on the mentor(s) including information on research qualifications and previous experience as a research supervisor. The applications must also include information to describe the nature and extent of supervision that will occur during the proposed award period. Environment and Institutional Commitment o The sponsoring institution must document a strong, well- established research program related to the candidate's area of interest including a high-quality research environment with staff capable of productive collaboration with the candidate. The sponsoring institution also must provide a statement of commitment to the candidate's development into a productive, independent investigator. Budget o Budget requests must be provided according to the instructions in form PHS 398. The request for tuition and fees, books, travel, research development support, etc., must be justified and specified by category. To identify the application as a response to this program announcement, check "YES" on item 2a of page 1 of the application and enter "PA-95-053, Mentored Clinical Scientist Development Award" and the name of the NIH institute or center that you would like your application to be assigned for funding. Submit a signed, typewritten original of the application with Checklist, and five signed photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the Division of Research Grants and for responsiveness to this program announcement by the appropriate institute or center staff. Incomplete or nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by he appropriate national advisory council or board. The following review criteria will be applied: Candidate o Quality of the candidate's academic and clinical record, o Potential to develop as an independent researcher; o Commitment to a research career; and o Likelihood that the plan will contribute substantially to the achievement of scientific independence. Career Development Plan o Likelihood that the career development plan will contribute substantially to the scientific development of the candidate; o Appropriateness of the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence; o Consistency of the career development plan with the candidate's career goals; and o Quality of the proposed training in responsible conduct of research. Research Plan Reviewers recognize that an individual with limited research experience is less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator. Although it is understood that K08 applications do not require the level of detail necessary in regular research grant proposals, a fundamentally sound research plan must be provided. In general, less detail is expected with regard to research planned for the later years of the award, but the application should outline the general goals for these years. o Appropriateness of the research plan to the stage of research development and as a vehicle for developing the research skills as described in the career development plan; o Scientific and technical merit of the research question, design and methodology; o Relevance of the proposed research to the candidate's career objectives; and o Adequacy of the plan's attention to gender and minority issues. Mentor o Appropriateness of mentor's research qualifications in the area of this application; o Quality and extent of mentor's proposed role in providing guidance and advice to the candidate; o Previous experience in fostering the development of researchers; and o History of research productivity and support. Environment and Institutional Commitment o Applicant institution's commitment to the scientific development of the candidate and assurances that the institution intends the candidate to be an integral part of its research program; o Adequacy of research facilities and training opportunities; o Quality and relevance of the environment for scientific and professional development of the candidate; and o Applicant institution's commitment to an appropriate balance of research and clinical responsibilities. Budget o Justification of the requested budget in relation to career development goals and research aims. AWARD CRITERIA The institute or center will notify the applicant of the board or council's action shortly after its meeting. Funding decisions will be made based on the recommendations of the initial review group and council/board, the need for research personnel in specific program areas, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this program announcement are strongly encouraged especially during the planning phase of the application. Below is a listing of each institute's or center's program or grants management contacts. Dr. Robin A. Barr Office of Extramural Affairs National Institute on Aging 7201 Wisconsin Avenue, Room 2C218, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9322 FAX: (301) 402-9245 Email: Barr@nihniagw.bitnet Dr. Ernestine D. Vanderveen, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 Email: tvanderv@willco.niaaa.nih.gov Ms. Frances Cotter Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1207 FAX: (301) 443-8744 Email: fcotter@willco.niaaa.nih.gov Dr. Mary C. Dufour Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 514 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4897 FAX: (301) 443-8614 Email: m.dufour@willco.niaaa.nih.gov Dr. Milton Hernandez Office of Scientific Training and Manpower Development National Institute of Allergy and Infectious Diseases Solar Building, Room 3C21 Bethesda, MD 20892 Telephone: (301) 496-7291 FAX: (301) 402-0369 Email: mh35c@nih.gov Richard Lymn, Ph.D. Extramural Programs National Institute on Arthritis and Musculoskeletal and Skin Diseases 45 Center Drive, Room 5AS-49E MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-5128 FAX: (301) 480-4543 Email: rl28b@nih.gov Dr. John Schneider or Dr. Andrew Vargosko Division of Cancer Biology, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892 Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: schneidj@dcbdcep.nci.nih.gov or vargoska@dcbdcep.nci.nih.gov Hildegard Topper Special Assistant to the Deputy Director National Institute of Child Health and Human Development Building 31, Room 2A-03 Bethesda, MD 20892 Telephone: (301) 496-0104 FAX: (301) 402-1104 Email: topperh@hd03.nichd.nih.gov Daniel Sklare, Ph.D. National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400B-13 Bethesda, MD 20892 Telephone: (301) 496-1804 FAX: (301) 402-6251 Email: Daniel_Sklare@nih.gov Dr. James A. Lipton Special Assistant for Training and Career Development National Institute of Dental Research Natcher Building, Room 4AN.18J Bethesda, MD 20892 Telephone: (301) 594-2618 FAX: (301) 480-8319 Email: liptonj@de45.nidr.nih.gov Ronald Margolis, Ph.D. Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 5AN-12J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8819 FAX: (301) 480-3503 Email: margolis@ep.niddk.nih.gov Charles Rodgers, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-19J MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: rodgersc@ep.niddk.nih.gov Judith Podskalny, Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN-12E, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8876 FAX: (301) 480-8300 Email: podskalnyj@ep.niddk.nih.gov Timothy P. Condon, Ph.D. Office of Science Policy, Education, and Legislation National Institute on Drug Abuse Parklawn Building, Room 10A-55 Rockville, MD 20857 Telephone: (301) 443-6072 FAX: (301) 443-6277 Email: tc52x@nih.gov Charles W. Sharp, Ph.D. Division of Basic Research National Institute on Drug Abuse Parklawn Building, Room 10A-31 Rockville, MD 20857 Telephone: (301) 443-1887 FAX: (301) 594-6043 Email: cs107m@nih.gov Arthur Horton, Ed.D. Division of Clinical Research National Institute on Drug Abuse Parklawn Building, Room 10A-30 Rockville, MD 20857 Telephone: (301) 443-4060 FAX: (301) 443-2317 Email: ah61x@nih.gov Ann Blanken Division of Epidemiology and Prevention Research National Institute on Drug Abuse Parklawn Building, Room 9A-55 Rockville, MD 20857 Telephone: (301) 443-6543 FAX: (301) 443-9847 Email: ab108v@nih.gov Jamie Biswas, Ph.D. Medications Development Division National Institute on Drug Abuse Parklawn Building, Room 11A-55 Rockville, MD 20857 Telephone: (301) 443-5280 FAX: (301) 443-2599 Email: jb168r@nih.gov Dr. Michael Galvin Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 Research Triangle Park, NC 27709 Telephone: (919) 541-7825 FAX: (919) 541-2843 Email: galvin@niehs.nih.gov Dr. Maria Giovanni National Eye Institute Building 31, Room 6A48 Bethesda, MD 20892 Telephone: (301) 496-0484 FAX: (301) 402-0528 Email: mg37u@nih.gov Thomas Blaszkowski, Ph.D. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute Federal Building, Room 208A Bethesda, MD 20892 Telephone: (301) 496-1841 FAX: (301) 480-1455 Email: tb33i@nih.gov Michael Commarato, Ph.D. Division of Heart and Vascular diseases National Heart, Lung, and Blood Institute 7550 Wisconsin Avenue, Room 3C04 Bethesda, MD 20892 Telephone: (301) 496-1724 FAX: (301) 402-2043 Email: mc63a@nih.gov Joyce Creamer Division of Blood diseases and Resources National Heart, Lung, and Blood Institute 7550 Wisconsin Avenue, Room 5C02 Bethesda, MD 20892 Telephone: (301) 496-8388 FAX: (301) 480-0867 Email: jc85n@nih.gov James Kiley, Ph.D. National Center for Sleep Disorders Research National Heart, Lung, and Blood Institute Building 31, Room 4A11 Bethesda, MD 20892 Telephone: (301) 496-7443 FAX: (301) 496-7508 Email: jk52a@nih.gov Mary Reilly Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640 Bethesda, MD 20892 Telephone: (301) 594-7466 FAX: (301) 594-7487 Email: mr50w@nih.gov George T. Niederehe, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-3264 FAX: (301) 594-6784 Email: gniedere@aoamh4.ssw.dhhs.gov Kenneth G. Lutterman, Ph.D. Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10-95 Rockville, MD 20857 Telephone: (301) 443-3373 FAX: (301) 443-4045 Email: klutterm@nih.gov Henry Khachaturian, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health 5600 Fishers Lane, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-8033 Email: hkhach@helix.nih.gov Leonard Mitnick, Ph.D. Office of AIDS Programs National Institute of Mental Health 5600 Fishers Lane, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-9719 Email: lmitnick@aoamh2.ssw.dhhs.gov Mr. Edward Donohue Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1016A Bethesda, MD 20892 Telephone: (301) 496-4188 Email: ed25b@nih.gov AUTHORITY AND REGULATIONS The Mentored Clinical Scientist Development Awards are made under the authority of Title III, Section 301 of the Public Health Service (PHS) Act as amended (Public Law 78-410, as amended, 42 USC 241). The Code of Federal Regulations, Title 42 Part 52, and Title 45 part 74, are applicable to this program. This program is described in the Catalog of Federal Domestic Assistance No. 93.121. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Mon May 01 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-054 - V24(15) 04/28/95 Date: 2 May 1995 09:54:58 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 595 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3o5o52$gr7@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95054 PA-95-054 P1O1 *************************************** MENTORED CLINICAL SCIENTIST DEVELOPMENT PROGRAM AWARD NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA NUMBER: PA-95-054 P.T. 34; K.W. 0710030, 0785035 National Institute on Aging National Institute of Dental Research Application Receipt Dates: February 1, June 1, and October 1 PURPOSE The Mentored Clinical Scientist Development Program Award (MCSDPA) is an award to an educational institution to support career development experiences for clinicians leading to research independence. Under this award, newly-trained clinicians are to be selected and appointed to this program award by the grantee institution. In other respects, the research experience of the candidates selected for support under this award should resemble those supported by the individual Mentored Clinical Scientist Development Award. Applications for this award should propose a research plan which has both intrinsic research importance and will also serve as a suitable vehicle for learning the methodology, theories, and conceptualizations necessary for a well trained independent researcher. The program should be designed to accommodate appointees with varying levels of experiences. For example, a prospective candidate with limited experience in a given field of research may find it appropriate to engage in a structured, phased developmental program, including a designated period of didactic training followed by a period of supervised research experience. The entire program should be comparable in scope and rigor to meeting the requirements for an advanced research degree. The NIH institutes and centers have modified this award to accommodate the career pathways of researchers in fields related to their missions. For example, the National Institute of Dental Research (NIDR) requires that all candidates must pursue a program that includes didactic and supervised basic or behavioral research experiences which result in the Ph.D. degree. The NIDR provides support under this program for the development of advanced clinical knowledge and skills in either a recognized clinical specialty or equivalent dental clinical discipline. Therefore, the prospective candidate must have a D.D.S. or an equivalent degree but need not have started postgraduate training, such as in a clinical specialty. Dentists who already posses advanced clinical knowledge and skills are eligible for the MCSDPA under special circumstances, but are encouraged to seek appointments to the Mentored Clinical Scientist Development Award (K08). All applicants and potential appointees are strongly advised to contact the prospective NIH awarding component for information about eligibility and the specific provisions of this award. This award replaces two comparable NIH career development program awards for clinicians. These are the Physician Scientist Program Award (K12) and the Dentist Scientist Program Award (K16). Institutions and departments that were eligible to apply for either of these program awards are now eligible to apply for the MCSDPA award. Therefore, this Program Announcement (PA) supersedes all previous K12 and K16 program announcements. The NIH will no longer accept competing applications for the old K12 and K16 awards. The new MCSDPA has been modified to incorporate the features of these career development programs. Existing policies and provisions will remain in effect for current K12 and K16 awards until completion of their non-competing years. The NIH recently reviewed its career awards (K) used to develop the research capabilities of clinicians and other scientists needed to carry out the nation's research mission in the biomedical and behavioral sciences. This evaluation resulted in several changes: (1) the total number of K mechanisms were reduced from 19 to six; (2) the review criteria were refined to clarify the career development goals of the K award; and (3) K award applications will be assigned to initial review groups managed by the prospective funding institute or center to which the application has been assigned. HEALTHY PEOPLE 2000 The Public Health Service is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Mentored Clinical Scientist Development Program Award, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications will be accepted from departments or divisions from domestic, non-Federal organizations, such as medical, dental or nursing schools, or from comparable institutions of higher education that have strong, well-established research and training programs. The applicant institution must have adequate numbers of highly trained faculty in clinical and basic sciences who have the interest and capability to provide guidance to clinically-trained individuals in the development of research independence. The environment should be one which will stimulate and increase the interactions between basic scientists and clinical investigators. Institutions with a MCSPDA may recruit and select candidates into their programs on a local basis rather than submitting a separate application on behalf of each prospective candidate. In all aspects, the program awards are intended to provide support for the development of clinical scientists in the same manner and under the same conditions as the individual Mentored Clinical Scientist Development Award (K08). Therefore, candidates for support under this program award must have a clinical degree or its equivalent, must have initiated internship and residency training (or its equivalent), and must be provided with a mentor(s) who has extensive research experience and a record of providing the type of training required under this award. The candidate also must be willing to spend a minimum of 75 percent of full-time professional effort conducting research, career development, and/or research related activities. Minorities and women are encouraged to apply. Candidates appointed under this program award must be U.S. citizens or noncitizen nationals, or have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Noncitizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states, but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. Candidates who are or have been former principal investigators on NIH research projects (R01), FIRST Awards (R29), sub-projects of program project (P01) or center grants (P50), or the equivalent, are not eligible for appointment under this program. Candidates may not concurrently hold any other PHS award that duplicates the provisions of this award. MCSDPA candidates are encouraged to apply for independent research grant support during the period of support under this award. MECHANISM OF SUPPORT Awards in response to this PA will use the K12 mechanism. The program award provides five years of support and is renewable. Appointees may receive three to five years of support depending upon the number of years of prior research experience, the need for additional experiences to achieve independence, and the policy of the NIH awarding unit. Planning, direction, and execution of the program will be the responsibility of the appointee and her/his mentor and consistent with the goals of the program award. RESEARCH OBJECTIVES A. Environment: The institution must have well-established research and clinical career development program and qualified faculty in clinical and basic research to serve as mentors. The appointee, mentor and institution must develop innovative multi-disciplinary programs to maximize the available research and educational resources. B. Program Director: The proposed Program Director should possess the scientific expertise, leadership and administrative capabilities required to coordinate and supervise an interdisciplinary research and development program of this scope. The Director should also be experienced in the design and management of programs for developing investigators, and should be able to demonstrate a superior record of preparation of clinicians for independent research. In addition, a committee with representatives from the appropriate basic and clinical science departments should be established to advise the Program Director. C. Mentors: Each candidate appointed on the program award must have a primary sponsor who is recognized as an accomplished investigator and is actively involved in basic or clinical research and who has a successful record of providing the type of training required under this award. An assigned mentor will provide guidance for the development of each candidate assigned to the program. The mentor must be committed to continue this involvement throughout the appointee's total period of development under the award. D. Program: The program award provides five years of renewable support. The award is intended to support candidates who receive three to five years support consisting of consecutive 12 month appointments. The support is often divided into two distinct phases- -a basic science component and an intensive research experience under the general guidance of a qualified mentor. The basic science component must develop knowledge and research skills in scientific areas relevant to the career development goals of the candidate and must include relevant didactic and laboratory experiences. In all cases, the types of developmental experiences provided should be consistent with the candidate's prior experience and needs. At least 75 percent of the recipient's full-time professional effort must be devoted to the program and the remainder devoted to developing other clinical and teaching pursuits consonant with the objectives of the award. E. Allowable Costs: 1. Salary: The NIH will provide salary and fringe benefits for the candidate only. The salary limits on career awards are not uniform throughout the NIH and are determined independently by each component of the NIH. Therefore, prospective applicants should contact the component to which the application is targeted to ascertain the salary cap for appointees under the MCSDPA. No compensation is provided for the program director or the mentors. The institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case, may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the MCSDA. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary requested for each candidate must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. 2. Research Development Support: Each appointee will be allowed up to $20,000 per year for the following expenses: (a) tuition, fees, and books related to career development; (b) research expenses, such as supplies, equipment and technical personnel; (c) travel to research meetings or training; (d) statistical services including personnel and computer time. The NIDR will provide up to $15,000 for research development support for each candidate. 3. Indirect costs: Indirect costs will be reimbursed at 8 percent of modified total direct costs, or at the actual indirect cost rate, whichever is less. F. Evaluation: In carrying out its stewardship of human resource related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified, that candidates may be contacted after the completion of their career development experiences for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. G. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the candidate. Such fees must be assigned to the grantee institution for disposition by any of the following methods: The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution. The funds may be used for health-related research purposes. The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Usually, funds budgeted in and institute-supported research or training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. An institute will give consideration to approval for use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of an NIH career award must receive prior written approval of the institute awarding component. H. Special Leave: Candidates appointed to this program career award may engage in research experiences at another institution, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of the NIH funding component is required. To obtain prior approval, the program director must submit a letter to the NIH describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH funding component and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Parental leave will be granted consistent with the policies of the NIH and the grantee institution. The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipient in writing of this determination, the reasons therefor, the effective date, and the right to appeal the decision. A final progress report, invention statement, and Financial Status Report are required upon termination or relinquishment of an award. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES This is a generic program announcement for the NIH MCSDPA. Therefore, it is strongly recommended that prospective applicants contact the staff person in the relevant institute or center listed under "INQUIRIES" early in the planning phase of application preparation. Such contact will help ensure that applications are responsive to the career development goals of individual institutes and centers. It should be noted that not all NIH institutes and centers use the MCSDPA as a means of recruiting clinicians into research. Applications are to be submitted on form PHS 398 (rev. 9/91) and will be accepted on or before the receipt deadlines indicated in the application kit (February 1, June 1 and October 1). Forms are available at most institutional offices of sponsored research and >From the Office of Grants Information, Division of Research Grants, NIH, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The application must address the following issues: (1) Provide information establishing the commitment of the applicant institution, the program director, and the faculty mentors to providing developmental experiences that lead to independence in biomedical, behavioral, or clinical research. (2) Summarize the immediate and long-term career objectives of the program, explaining how the program and the MCSDPA will contribute to their attainment. (3) Describe the career development plans for prospective candidates. Considering the program goals and the likely goals of prospective candidates, describe a plan to provide the necessary basic science background and research experiences considering the expected range of prior research training in the applicant pool. For example, candidates with little previous research experience may require a phased developmental period in which the first year or two of support under this program award are comprised largely of didactic training in the basic sciences. For these candidates, a second phase would be an intensive, supervised research experience to complete the five year developmental program. More experienced candidates may benefit >From moving immediately to a mentored research environment and a shorter period of support under this program award. The application should contain a description of how the career development plan will be tailored to the needs of the prospective candidates. (4) Describe the pool of potential candidates including information about the types of prior clinical and research training. Also, describe how the appointments will be made to the MCSDPA. Describe the composition of the selection committee and the criteria to be used for selection. Describe plans to recruit candidates from racial or ethnic groups that are currently underrepresented in biomedical, behavioral, or clinical sciences. (5) Describe to the extent possible the types of research experiences available to the candidates. The research experiences may include either basic or clinical science approaches to biomedical or behavioral problems. Provide examples of potential experiences using the format described in form PHS 398, including Specific Aims, Background and Significance, Progress Report/ Preliminary Studies, Research Design and Methods. (6) Instructions in the responsible conduct of research. Applications must include plans for instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency and duration of instruction; and the amount and nature of faculty participation. No award will be made if an application lacks this component. (7) Renewal applications must include a detailed account of the career outcomes of all candidates supported by this grant including positions held, research involvement, publications, and other evidence that this program award is meeting the objectives of the NIH awarding component Budget requests must be provided according to the instructions in form PHS 398. The request for tuition and fees, books, travel, research development expenses, etc., must be justified and specified by category. To identify the application as a response to this PA, check "YES" on item 2a of page 1 of the application and enter PA-95-054, Mentored Clinical Scientist Development Program Award" and the name of the NIH institute or center that you would like your application to be assigned. Submit a signed, typewritten original of the application with Checklist, and five signed photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the Division of Research Grants and responsiveness to the PA by the appropriate institute or center staff. Incomplete or nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by he appropriate national advisory council or board. The following review criteria will be applied: Program Director o The program director's experience in managing career development programs and success in preparing clinician investigators for independent research careers; Candidate(s) o Availability of high quality potential candidates, o Plans for recruiting and selecting candidates (including minorities and women); and o Plan to identify candidates with a commitment to research and the potential to develop as an independent researcher; o For renewal applications, the career success of candidates that have terminated support under this award within the past 10 years. Career Development Plan o Likelihood that the career development plan will contribute substantially to the scientific development of the candidates; o Appropriateness of the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence for the prospective candidates; o Consistency of the career development plan with prospective candidate's career goals; and o Quality of the training in the responsible conduct of research. Research Plan o Usefulness of the research plans as a vehicle for developing the research skills as described in the career development plan; o Scientific and technical merit of the research questions, design and methodology; o Relevance of the proposed research to the career objectives of the potential candidate(s); and o Adequacy of the plan's attention to gender and minority issues. Mentor o Appropriateness of the faculty mentors research qualifications in the area of this application; o Quality and extent of the mentors proposed role in providing guidance and advice to candidates; o Previous experience of the mentors in fostering the development of researchers; and Environment o Applicant institution's commitment to the scientific development of the candidate(s) and assurances that the institution intends the program and the supported candidate(s) to be an integral part of its research program; o Adequacy of research facilities and training opportunities; o Quality of the environment for scientific and professional development; and o Applicant institution's commitment to the appropriate balance of research and clinical responsibilities. Budget o Justification of budget requests in relation to career development goals and research aims. AWARD CRITERIA The institute or center will notify the applicant of the board or council's action shortly after its meeting. Funding decisions will be made based on the recommendations of the initial review group and council/board, the need for research personnel in specific program areas, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this program announcement are encouraged especially during the planning phase of the application. Below is a listing of NIH contacts for this career development award: Dr. Robin A. Barr Office of Extramural Affairs National Institute on Aging 7201 Wisconsin Avenue, Room 2C218, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9322 Email: Barr@nihniagw.bitnet Dr. James A. Lipton Special Assistant for Training and Career Development National Institute of Dental Research Natcher Building, Room 4AN.18J Bethesda, MD 20892 Telephone: (301) 594-2618 Email: liptonj@de45.nidr.nih.gov Ms. Theresa Ringler Grants Management Office National Institute of Dental Research Natcher Building, Room 4AS-55 Bethesda, MD 20892 Telephone: (301) 594-4800 FAX: (301) 480-8301 AUTHORITY AND REGULATIONS The Mentored Clinical Scientist Development Program Awards are made under the authority of Title III, Section 301 of the Public Health Service (PHS) Act as amended (Public Law 78-410, as amended, 42 USC 241). The Code of Federal Regulations, Title 42 Part 52, and Title 45 part 74, are applicable to this program. This program is described in the Catalog of Federal Domestic Assistance No. 93.121. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Mon May 01 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-056 - V24(15) 04/28/95 Date: 2 May 1995 09:54:47 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 604 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3o5o4n$gqp@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95056 PA-95-056 P1O1 *************************************** BIOBEHAVIORAL PAIN RESEARCH NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA NUMBER: PA-95-056 P.T. 34; K.W. 0414015, 0715150, 0414000, 1002019, 1002030, 0785050 National Institute of Nursing Research National Institute of Dental Research National Institute on Aging National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Drug Abuse National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke Office of Alternative Medicine PURPOSE The purpose of this biobehavioral pain research program announcement is to inform the scientific community of the interests of the various institutes at the National Institutes of Health (NIH) and to stimulate and foster a wide range of basic and clinical studies on pain as they relate to the missions of these Institutes. Applications are encouraged to study individual differences in pain responses which may be due to factors such as genetic differences, endocrine activity, neural activity, immune function, psychological state, disability state, age, gender, and cultural background. Research is also needed in areas such as understanding the neuroanatomical pathways and the neurophysiological mechanisms in pain. The pain experience needs to be examined at all levels of research including the gene, molecule, cell, organ, and individual with the goal of developing biobehavioral interventions to manage or prevent pain. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, "Biobehavioral Pain Research," is related to the priority areas of chronic disabling conditions, cancer, and clinical prevention services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017- 001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) awards (R29). MECHANISM OF SUPPORT The mechanisms of support will be the research project grant (R01) and the FIRST award (R29). Additionally, some institutes will use the small research grant (R03) mechanism; applicants are advised to contact the program official listed under INQUIRIES for information. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994). RESEARCH OBJECTIVES Pain is a critical national health problem. It is the most common reason for medical appointments, nearly 40 million visits annually, and costs this country over $100 billion each year in health care and lost productivity. Pain has a profound effect on the quality of human life. In addition to possible deleterious effects on immune function, pain can cause disruptions in sleep, eating, mobility, and overall functional status. In the hospitalized patient, pain may be associated with increased length of stay, longer recovery time, and poorer patient outcomes, all of which have health care quality and cost implications. Progress is being made in understanding the neuroanatomical pathways and the neurophysiological and neurochemical mechanisms involved in pain. However, understanding the subjective pain experience in individuals presents unique scientific challenges. Even though the basic physiology may be similar, people react in very different ways, perhaps due to genetic differences, endocrine activity, neural activity, immune function, stress, psychological state, age, gender, and cultural background. Thus, the pain experience needs to be examined at all levels of basic and clinical research, including the gene, molecule, cell, organ, and individual, with the goal of developing biobehavioral interventions to manage or prevent pain. In order to develop a research agenda, ten NIH institutes sponsored a workshop, "Biobehavioral Pain Research: A Multi-Institute Assessment of Cross-Cutting Issues and Research Needs," in January 1994. This meeting, under the aegis of the NIH Health and Behavior Coordinating Committee, resulted in the identification of research needs from a broad spectrum of the scientific community expert in pain research. The following pain research areas cut across Institutes and programs and should not be viewed as restricted to only one specific Institute. Current NIH referral guidelines will be used to assign grant applications to the most appropriate NIH Institute based on the scientific focus of the application. The following topics and study areas are not intended to be comprehensive or exclusive: Understanding Critical Interfaces Between Biology and Behavior o Explore the neural basis of pain perception and discover targets in the signal transduction pathways that may be the most effective points for interventions in the control of pain across the lifespan. o Examine the neuroendocrine and immunological correlates of pain. o Investigate both pharmacological and behavioral interventions to prevent pain. o Refine neuroimaging algorithms for the study of structural and functional correlates of pain perception. o Conduct animal and human studies on the temporal patterning of pain. o Explore the basic developmental aspects of pain processing, including an integration of psychological, neurochemical, and molecular approaches which could impact the treatment of pain across the life span. o Identify genes relevant to pain and pain inhibitory mechanisms. o Examine the role of placebo effect in pain treatment. Pain, Suffering, and Emotion o Explore basic mechanisms of the conscious perception of pain and the affective responses to pain. o Examine the relative importance of biological, socioenvironmental, and psychological variables in explaining variations in pain- expressive behaviors. o Clarify the relationship between depression and chronic pain by elucidating the biological factors, characteristics of the pain (e.g., location, quality, timing), environmental circumstances, and personal characteristics that are predictive of this relationship. o Elucidate emotions and emotional disturbances, in addition to depression, (e.g., anger, fear, anxiety) which are associated with acute and chronic pain conditions, and determine how these emotions modify the experience of pain. Pain and Behavior o Explore the sensory, cognitive, and affective aspects of acute and chronic pain across the lifespan. o Elucidate the interaction of biological markers, central nervous system mechanisms, and drug and behavioral interventions. o Determine the relative contributions of biological, psychological, behavioral, and environmental predictors of the course of pain, pain dysfunction, and response to treatment for pain. o Examine addiction risk in patients taking controlled drugs for pain; the role of tolerance, addiction and dependence in the consumption of these drugs; and implications of long-term use in noncancer disease states. o Develop and refine biobehavioral techniques for optimizing adherence to pain management. Behavior-Related Interventions o Evaluate research strategies to integrate medical, nursing, dental, neurological, pharmacological, and behavioral treatments for pain problems. Compare the relative effectiveness of each mode of treatment, and combined treatments, and their potentiating effects on multiple outcomes, such as pain, physical functioning, psychological functioning, health care utilization, and costs. o Conduct research on the mechanisms and process variables that are responsible for the efficacy of behavioral interventions. This research includes studies to understand better the effect of patients' expectations and beliefs, psychophysiological states (e.g., anxiety, relaxation, stress), adherence, and specific cognitive (e.g., imagery) and social (e.g., support) components in behavioral interventions. o Determine which behavioral treatments are most effective for specific subgroups of patients differentiated by factors such as age, gender, race, ethnic group, level of dysfunction, or psychosocial characteristics. o Conduct clinical trials of cognitive/behavioral pain control methods and combinations of medical, pharmacological, and cognitive/behavioral pain control methods. o Compare the costs of various types of interventions for pain, including economic analyses of pain, pain dysfunction, and pain treatments with different and combined biomedical and biopsychosocial models of treatment. o Investigate the effectiveness and appropriate targeting of alternative treatments (e.g., hypnosis, massage, spinal manipulations, acupuncture) using randomized, controlled trials of these treatments in association with conventional medical approaches. o Assess methods for primary, secondary, and tertiary prevention of pain. o Establish dose-response curves for biobehavioral interventions. o Test interventions to improve health care practice in such areas as pain assessment, analgesic management, pain prevention, and rehabilitation. Commonalities and Differences in Pain Expression, Experience, and Treatment o Study cognitive factors in the experience of pain, disability, and pain behaviors across disorders, including such factors as self- efficacy, perceived control, and pain beliefs. o Establish the factors that prevent a person with acute pain from developing a chronic pain problem and a chronic pain- related disability. Areas to assess include patient biological/organic, psychosocial, and socioeconomic characteristics, interactions of the patient with health care providers, family and social supports, and workplace factors. o Refine existing techniques for measuring pain and develop new techniques that are disease- and outcome-specific for different populations. o Determine the supraspinal mechanisms of pain modulation, determine the effects of specific pain treatments on these central nervous system processes, and apply new findings on CNS plasticity to the understanding of pain. o Examine the interrelationships between pain and other symptoms and comorbidities (e.g., fatigue, sleep alterations, nausea, vomiting, anxiety, mood disorders, physical deconditioning, stress). Pain in Special Populations o Test culturally sensitive approaches to pain assessment and management, including translation of the instruments into foreign languages and validation as needed. o Investigate biobehavioral pain treatments for special populations including infants, children, elderly, cognitively impaired, ethnic minority groups, substance abusers with pain disorders, and individuals with disabilities. o Determine effective biobehavioral interventions for HIV- and AIDS- related pain, as well as the pain prevalence, scope, and severity of patients who are HIV-infected. Explore alterations in nociceptive mechanisms and pain perception in patients with HIV. o Investigate the roles of sleep and circadian variation in the precipitation and modulation of pain in populations who have special rest - activity needs such as infants, children, elderly, pregnant women, night-shift workers. This research could include studies of the effect of pain and its pharmacological treatment on sleep and daytime alertness, as well as the effects of disturbed sleep on pain and pain perception. Studies of seasonal and other variations are also appropriate. o Test and evaluate pharmacotherapies and behavioral treatments in patients with current and past histories of addiction, including infants born to drug-, alcohol-, and tobacco-dependent mothers, and HIV-infected persons. o Investigate the effectiveness of biobehavioral pain management in terminally ill and dying patients. o Study the interrelationship of Axis II, as well as Axis I, psychiatric disorders (e.g., borderline personality, histrionic, antisocial) and chronic pain, and relate these findings to pharmacological and behavioral therapies. o Determine gender-related differences in the pain experience, such as whether the experience of clinical chronic pain varies during the menstrual cycle and, if so, the hormonal, immunological, neuronal, and psychological correlates of this variability. o Investigate biobehavioral approaches to managing pain associated with acute and chronic illness such as arthritis, cancer, diabetes, sickle cell disease, low back pain, headaches, temporomandibular disorders, and other orofacial pain conditions. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. After May 8, 1995, the telephone number will be (301) 435-0715 and the address will be as below. The title and number of the program announcement must be typed in Section 2a on the face page of the application. Applications for the FIRST award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST award (R29) applications submitted without the required number reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit, in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by he appropriate national advisory council or board. Review Criteria o scientific, technical, or clinical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that institute/center (IC). The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Mary Lucas Leveck National Institute of Nursing Research Natcher Building, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-5963 Email: mleveck@ep.ninr.nih.gov Dr. Patricia Bryant Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-24K Bethesda, MD 20892-6402 Telephone: (301) 594-2095 Email: BryantP@DE45.nidr.nih.gov Dr. Andrew Monjan Neuroscience and Neuropsychology of Aging Program National Institute on Aging Gateway Building, Suite 3C307 Bethesda, MD 20892 Telephone: (301) 496-9350 Email: monjana@gw.nia.nih.gov Dr. Julia B. Freeman Extramural Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-19F Bethesda, MD 20892-6500 Telephone: (301) 594-5052 Email: freemanj@ep.niams.nih.gov Dr. Claudette Varricchio Community Oncology and Rehabilitation Branch National Cancer Institute Executive Plaza North, Suite 300 Bethesda, MD 20892 Telephone: (301) 496-8541 Email: varriccc@dcpcepn.nci.nih.gov Dr. Louis Quatrano National Center for Medical Rehabilitation Research National Institute on Child Health and Human Development Building 61E, Room 2A03 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 Email: quatranl@hd01.nichd.nih.gov Dr. Joseph Frascella Behavioral Neurobiology Research Branch National Institute on Drug Abuse Parklawn Building, Room Number 10A-19 Rockville, MD 20857 Telephone: (301) 443-4877 Email: jf80t@nih.gov Dr. Peter G. Kaufmann Behavioral Medicine Research Group National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7936 Bethesda, MD 20892-7936 Telephone: (301) 435-0404 Email: pvk@cu.nih.gov Dr. Fred Altman Basic Prevention and Behavioral Medicine Research Branch National Institute of Mental Health Parklawn Building, Room Number 10-104 Bethesda, MD 20892 Telephone: (301) 443-4337 Fax: (301) 443-4045 Email: hfb@cu.nih.gov Dr. Cheryl A. Kitt Division of Demyelinating, Atrophic and Dementing Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 802 Bethesda, MD 20892 Telephone: (301) 496-1431 Email: kittc%nindsfed%nih@fedtcp.ninds.nih.gov Dr. John Spencer Office of Alternative Medicine Executive Plaza South, Suite 450 Bethesda, MD 20892-9904 Telephone: (301) 402-4333 Email: spencerj@odeps.nih.gov Direct inquiries regarding fiscal matters to: Sally A. Nichols Grants Management Officer National Institute of Nursing Research Natcher Building, Room 3AN-32 Bethesda, MD 20892-6301 Telephone: (301) 594-6869 Email: snichols@ep.ninr.nih.gov Theresa Ringler Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AS-55 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 Email: Rubenstein@DE45.nidr.nih.gov Joanne Colbert Grants Management Office National Institute on Aging Gateway Building, Suite 2N212 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 Email: colbertj@gw.nia.nih.gov Mary Graham Grants Management Officer National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS.19A Bethesda, MD 20892-6500 Telephone: (301) 594-3504 Email: grahamm@ep.niams.nih.gov Bob Hawkins Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-7800 Email: Hawkinsr@gab.nci.nih.gov Mary Ellen Colvin Grants Management Specialist National Institute of Child Health and Human Development Building 61, Room 8A17G Bethesda, MD 20892-7510 Telephone: (301) 496-1303 Email: colvinm@hd01.nichd.nih.gov Gary Fleming Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: gfleming@aoada.ssw.dhhs.gov Jane Davis Grants Management Officer National Heart, Lung, and Blood Institute Rockledge Two, Room 7174 Bethesda, MD 20892-7926 Telephone: (301) 435-0166 Email: janedavis:nhlbi-wb-1:nih Diana Trunnell Grants Management Officer National Institute of Mental Health Parklawn Building, Room 7C08 Bethesda, MD 20892 Telephone: (301) 443-3065 Email: dt21a@nih.gov Karen D. Shields Grants Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 Bethesda, MD 20892 Telephone: (301) 496-9231 Email: Karen_Shields%NINDSFED%NIH@fedtcp.ninds.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Mon May 01 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-051 - V24(15) 04/28/95 Date: 2 May 1995 09:54:39 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 591 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3o5o4f$gqa@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95051 PA-95-051 P1O1 *************************************** SENIOR SCIENTIST AWARD NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA NUMBER: PA-95-051 P.T. 34; K.W. 0710030 National Institute on Alcoholism and Alcohol Abuse National Institute on Drug Abuse National Institute of Mental Health Receipt Dates: February 1, June 1, and October 1 PURPOSE The Senior Scientist Award (K05) provides stability of support to outstanding scientists who have demonstrated a sustained, high level of productivity and whose expertise, research accomplishments, and contributions to the field have been and will continue to be critical to the mission of the particular NIH center or institute. The award provides salary support for award periods of five years as a means of enhancing the individual recipient's skills and dedication to his/her area of research. The Senior Scientist Award (K05) permits NIH institutes and centers to identify and support exceptionally talented investigators who are well established in their field of research. Since not all of the NIH centers and institutes support this award, potential applicants should contact the appropriate NIH program staff listed under INQUIRIES, prior to preparing an application. The NIH recently reviewed its career awards (K) used to develop the research capabilities of clinicians and other scientists needed to carry out the nation's research mission in the biomedical and behavioral sciences. This evaluation resulted in several changes: (1) the total number of K mechanisms were reduced from 19 to six; (2) the review criteria were refined to clarify the career development goals of the K award; and (3) K award applications will be assigned to initial review groups managed by the prospective funding institute or center to which the application has been assigned. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Senior Scientist Award, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS The candidate must be a senior scientist and a recognized leader in the field with a distinguished record of original contributions; must have long-term support from a funding institute or center; and must have peer-reviewed grant support at the time of the award. Scientists whose work is primarily theoretical may, depending on the policy of the institute or center, apply for this award in the absence of research grant support. Applications may be submitted on behalf of candidates by domestic, non-Federal organizations, public or private, such as medical, dental, or nursing schools or other institutions of higher education. Minorities and women are encouraged to apply. Candidates must be U.S. citizens or noncitizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Noncitizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. MECHANISM OF SUPPORT Awards in response to this PA will use the K05 mechanism. Planning, direction, and execution of the program will be the responsibility of the candidate. The institution must demonstrate a commitment to the candidate and the candidate's goals for continued career development. The project period for the K05 award is five years. Awards are renewable at the discretion of the NIH awarding unit. RESEARCH OBJECTIVES A. Environment: The institution must have a demonstrated commitment to the continued support and development of the candidate. The institution must also provide assurance that the candidate will continue to be an integral part of its research and academic programs. B. Program: The award provides five consecutive 12 month appointments. At least 75 percent of the recipient's full-time professional effort must be devoted to the program and the remainder devoted to other research-related and/or teaching pursuits consonant with the objectives of the award. C. Allowable Costs: 1. Salary: The NIH will provide salary and fringe benefits for the K recipient. The salary limits are not uniform throughout the NIH and are determined independently by each component of the NIH. Therefore, prospective candidates should contact the NIH component to which the application is targeted to ascertain the maximum contribution to the candidate's salary. The institution may supplement the NIH contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case, may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the Senior Scientist Award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary requested must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institutions from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. 2. Research Development Support: It is expected that candidates for a K05 award will have research support at the time of the award. However, there are some research specialties in which only minimal research support is needed, i.e., theoreticians and computer scientists. In such cases, incidental research expenses may be provided at the discretion of the individual institute or center. Candidates may request funds to offset the cost of tuition, fees, and books related to career development. Applicants should contact the relevant NIH institute or center program staff for additional information. 3. Ancillary Personnel Support: Salary for secretarial, technical, and/or administrative assistance, etc., is not allowed. 4. Indirect costs: Indirect costs will be reimbursed at eight percent of modified total direct costs, or at the actual indirect cost rate, whichever is less. F. Evaluation: In carrying out its stewardship of human resource related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified, that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. G. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution. The funds may be used for health-related research purposes. The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks must be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Usually, funds budgeted in an NIH supported research or training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The funding component will give consideration to approval for use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the funding component. H. Special Leave: Leave to another institution, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NIH funding component is required. To obtain prior approval, the award recipient must submit a letter to the NIH describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH funding component and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Parental leave will be granted consistent with the policies of the NIH and the grantee institution. I. Termination or Change of Institution: When a grantee institution plans to terminate an award, the NIH funding component must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. If the individual is moving to another eligible institution, career award support may be continued provided: A new career award application is submitted by the new institution; The period of support requested is no more than the time remaining within the existing award period; and The new application is submitted far enough in advance of the requested effective date to allow the necessary time for review. The funding component may require a new review by an initial review group and/or the appropriate national advisory council or board. Alternatively, review may be carried out by staff within the NIH funding component depending upon the circumstances. The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipient in writing of this determination, the reasons therefor, the effective date, and the right to appeal the decision. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES This is a generic program announcement for the NIH Senior Scientist Award (SSA). Since not all NIH institutes and centers support the SSA and the features of the award may vary, prospective applicants are strongly advised to contact the staff person in the relevant institute or center listed under "INQUIRIES" early in the planning phase of application preparation. Such contact will help ensure that applications are responsive to the career development goals of individual institutes and centers. Applications are to be submitted on form PHS 398 (rev. 9/91) and will be accepted on or before the receipt deadlines indicated in the application kit (February 1, June 1 and October 1). Forms are available at most institutional offices of sponsored research and >From the Office of Grants Information, Division of Research Grants, NIH, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248. Applicants are strongly advised to follow the instructions in the form PHS 398. The narrative for this award should be divided into three sections: (1) Candidate, (2) Career and Research Plan; and (3) Institutional Environment. (1) Candidate: Include information on background, training and experience. In addition to completing the biographical sketch requested in the application kit, the candidate should provide an overview of the clinical and/or research experience to date, including a list of scientific accomplishments and the record of research funding. Candidates should also describe their current involvement in science education including training/mentoring future researchers and other activities that could be considered science advocacy, scientific integrity training, or education. Finally, there should be a summary of future career goals, a statement of short-term and long-term research goals, and a statement of how the award will benefit the candidate by release from duties unrelated to research. (2) The candidate must provide evidence of a continuing and productive commitment to a research career that is relevant to the mission of the funding institute or center by submitting a statement of research career interests and a three-part plan: (a) a description of specific activities that will sustain the candidate's outstanding performance and the capacity to address relevant research problems; (b) a description of the research that the candidate proposes to pursue during the period of support, including fully developed, high- quality career and research plans that demonstrate a commitment to the research goals of the awarding institute. Provide plans for obtaining research support for such activities. (c) a description of science education activities in which the applicant intends to participate. Candidates are expected to engage in mentoring and where possible, other science education activities that will enhance training or public understanding of science. (3) The awardee institution must document a strong, well-established research program related to the candidate's area of research interest including a high-quality research environment with staff capable of productive collaboration with the candidate. The sponsoring institution also must provide a statement of commitment to the candidate's research career. Specifically, evidence must be provided to assure the applicant is on a full-time faculty appointment and that the appointment is not contingent upon receipt of this award and to ensure the feasibility of the proposed research plan, including availability of and access to clinical populations, laboratory space, and other resources. The sponsoring institutions should also describe actions it will take to ensure that the candidate will be able to devote at least 75 percent of his/her full-time professional effort to research. A description of the department's overall research program and details of relevant research are required. The department chairperson or research director is to submit information on the institution's research programs; plans for development of these programs; and specific plans for the candidate. The institution should provide plans for use of any institutional funds that will be released as a result of the award. It is expected that such funds will revert to the individual recipient's department and will be used in a manner which will further the spirit of the award. Budget requests must be provided according to the instructions in form PHS 398. The request for tuition and fees, books, travel, etc., must be justified and specified by category. To identify the application as a response to this PA, check "YES" on item 2a of page 1 of the application and enter "PA-95-051, Senior Scientist Award" and the name of the NIH institute or center that you would like your application to be assigned. Submit a signed, typewritten original of the application with Checklist, and five signed photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the Division of Research Grants and responsiveness to the PA by the appropriate institute or center staff. Incomplete or nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by he appropriate national advisory council or board. The following review criteria will be applied: Candidate o The extent to which the award will enable the candidate to devote full-time to research and research-related activities and will permit release from teaching, administrative, clinical, and other non- research related responsibilities; o A consistent record of outstanding research productivity including program research funding and record of publication of scientific reports, including publication of influential research papers or seminal theoretical papers; o Likelihood of continuing and significant contributions to scientific knowledge; o Recognition as a leading senior scientist as judged by peers; o Leadership of a productive research program; and o Ability to develop and maintain an environment for training high- quality investigators. Career Development and Research Plan o Long-term substantive plan for future research; o Consistency of the career development plans with the candidates' career goals; and o Quality of plans for mentoring and science education activities. o Scientific and technical merit of the research plan; o Significance of the research plan and the probability of significant contributions to scientific knowledge; o adequancy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. Institutional Environment and Commitment to the Candidate o Adequacy of facilities and general environment to conduct the research program; o Availability of collaborative opportunities with other investigators; o Reputation of the applicant institution and the candidate's department as a center of active, high-quality research; and o Institutional support of the candidate's commitment to research and research training. AWARD CRITERIA The institute or center will notify the applicant of the board or council's action shortly after its meeting. Funding decisions will be made based on the recommendations of the initial review group and council/board, the need for research personnel in specific program areas, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this PA are encouraged especially during the planning phase of the application. Below is a listing of each institution's or center's program and grants management contacts. Dr. Ernestine D. Vanderveen, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 Email: tvanderv@willco.niaaa.nih.gov Ms. Frances Cotter Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1207 FAX: (301) 443-8744 Email: fcotter@willco.niaaa.nih.gov Dr. Mary C. Dufour Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 514 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4897 FAX: (301) 443-8614 Email: m.dufour@willco.niaaa.nih.gov Timothy P. Condon, Ph.D. Office of Science Policy, Education, and Legislation National Institute on Drug Abuse Parklawn Building, Room 10A-55 Rockville, MD 20857 Telephone: (301) 443-6072 FAX: (301) 443-6277 Email: tc52x@nih.gov Charles W. Sharp, Ph.D. Division of Basic Research National Institute on Drug Abuse Parklawn Building, Room 10A-31 Rockville, MD 20857 Telephone: (301) 443-1887 FAX: (301) 594-6043 Email: cs107m@nih.gov Arthur Horton, Ed.D. Division of Clinical Research National Institute on Drug Abuse Parklawn Building, Room 10A-30 Rockville, MD 20857 Telephone: (301) 443-4060 FAX: (301) 443-2317 Email: ah61x@nih.gov Ann Blanken Division of Epidemiology and Prevention Research National Institute on Drug Abuse Parklawn Building, Room 9A-55 Rockville, MD 20857 Telephone: (301) 443-6543 FAX: (301) 443-9847 Email: ab108v@nih.gov Jamie Biswas, Ph.D. Medications Development Division National Institute on Drug Abuse Parklawn Building, Room 11A-55 Rockville, MD 20857 Telephone: (301) 443-5280 FAX: (301) 443-2599 Email: jb168r@nih.gov George T. Niederehe, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-3264 FAX: (301) 594-6784 Email: gniedere@aoamh4.ssw.dhhs.gov Kenneth G. Lutterman, Ph.D. Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10-95 Rockville, MD 20857 Telephone: (301) 443-3373 FAX: (301) 443-4045 Email: klutterm@nih.gov Henry Khachaturian, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health 5600 Fishers Lane, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-8033 FAX: (301) 443-1731 Email: hkhach@helix.nih.gov Leonard Mitnick, Ph.D. Office of AIDS Programs National Institute of Mental Health 5600 Fishers Lane, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-9719 FAX: (301) 443-9719 Email: lmitnick@aoamh2.ssw.dhhs.gov AUTHORITY AND REGULATIONS The Senior Scientist Awards are made under the authority of Title III, Section 301 of the Public Health Service (PHS) Act as amended (Public Law 78-410, as amended, 42 USC 241). The Code of Federal Regulations, Title 42 Part 52, and Title 45 part 74, are applicable to this program. This program is described in the Catalog of Federal Domestic Assistance No. 93.121. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Mon May 01 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-055 - V24(15) 04/28/95 Date: 2 May 1995 09:54:30 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 468 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3o5o46$gpt@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95055 PA-95-055 P1O1 *************************************** RESEARCH ON COMORBID MENTAL AND DRUG ABUSE DISORDERS NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA NUMBER: PA-95-055 P.T. 34; K.W. 0715129, 0404009, 0755030, 0715008, 0745027 National Institute on Drug Abuse National Institute of Mental Health PURPOSE The purpose of this program announcement is to encourage research on comorbid mental and drug abuse disorders. One aim of this research program is to explore and identify etiological and neurobiological factors that are associated with the co-occurrence of drug abuse/addiction and mental disorders. A second aim is to develop new treatment and prevention interventions for the population afflicted with these disorders. A third aim is to develop effective strategies and procedures for managing the impact of HIV/AIDS on individuals with comorbid mental and addictive disorders and the impact of comorbid mental and addictive disorders on persons with HIV/AIDS. A fourth aim is to assess existing drug abuse and mental health treatment interventions and services for persons with mental and addictive disorders. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement, Research on Comorbid Mental and Drug Abuse Disorders, is primarily related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal Government. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as principal investigators. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) award. MECHANISM OF SUPPORT The mechanisms available for support of this program announcement are the regular research project grant (R01), the small grant (R03), the FIRST award (R29), and the clinical cooperative grant (R10). Because the nature and scope of the research proposed in response to this program announcement may vary, it is anticipated that the size of an award will vary also. RESEARCH OBJECTIVES Background Research has suggested that comorbidity of drug addiction with mental disorders may have prognostic value and important implications for the prevention and treatment of drug dependence. Drugs of abuse and addiction may precipitate or exacerbate mental disorders; self- medication for mental disorders may result in drug abuse or addiction. The forms of comorbidity may be influenced by the class of drug abused, the duration of drug use, individual sensitivity to drug effects and whether the drug effects are acute, or due to withdrawal or residual conditions. Knowledge of comorbid disorders is important because it can enable prevention and treatment services to be appropriately configured and designed for clinical populations. The etiology of drug abuse and addiction has been shown to be complex and multifactorial and influenced by environmental and constitutional factors. Increased knowledge of factors influencing drug abuse/addiction and comorbid mental conditions will be helpful for patient-treatment matching and maximizing the effectiveness of available treatment interventions and services. The importance of a greater focus upon comorbid mental and addictive disorders is underscored by research studies that suggest there is a greatly increased risk for substance use disorder for individuals with various mental disorders compared to those without. Programs that focus on drug abuse and dependence and programs that focus on mental disorders tend not to be integrated with one another and, in general, tend not to make HIV-related issues a primary focus. Psychiatric symptoms and drug use are associated with increased HIV risk behaviors. This is true in both treatment populations and out- of-treatment populations. Clinical studies suggest that people who have a history of comorbid mental and addictive disorders, when treated for drug addiction, tend to relapse at a greater rate than those without a history of mental disorder. Interventions for the mental disorder appear to reduce the relapse rate of these individuals. These findings suggest that treatment of a comorbid mental condition may prove to be crucial to effective drug abuse treatment in populations with concurrent mental and addictive disorders. It is worth noting that AIDS is a major co-occurring condition among drug users in the USA. Injection drug users are the second largest group of persons with AIDS in this country. Male injection drug users who also have sex with men are an important subgroup of injectors with AIDS, accounting for approximately 20 percent of these cases. Also, the majority of cases of AIDS attributed to heterosexual transmission, were sexual partners of drug users. Moreover, more than 50 percent of children with AIDS were the offspring of mothers who either abused drugs or were sexual partners of persons who did. Clearly, drug abuse treatment programs and HIV/AIDS treatment facilities need to treat both drug dependence and AIDS-related complications, including resulting mental health conditions such as depressive and anxiety disorders. Research is encouraged on HIV/AIDS disease issues, including transmission, disease progression, risk-behavior change and treatment, in drug abusing populations with comorbid mental disorders. A number of studies show that psychiatric comorbidity, including both diagnosable conditions and subsyndromal levels of psychiatric symptomatology, is associated with difficulties in retention in drug abuse treatment and that non-entry to or drop- out >From treatment is associated with higher levels of risk behavior and higher HIV seroconversion rates. Other studies suggest lower levels of adherence to medical regimens and risk reduction recommendations among drug abusers with comorbid mental disorders. Moreover, studies suggest increased rates of depression in HIV seropositive drug abusing populations that appear to be directly associated with stage of HIV disease. In this context, the interaction of HIV issues with comorbid mental conditions in drug abusing populations requires further exploration in terms of (1) describing the changes in risk for morbidity and mortality related to these comorbid mental conditions and (2) elucidating the mechanisms underlying the effects of these comorbidities on risk, with the objective of designing effective prevention and treatment strategies. Description of Program Studies under this program announcement may focus on the etiology, prevention, treatment, and neurobiology of comorbid mental and addictive disorders. Neurobiological studies may involve neuroimaging (e.g., MRI, CT, PET, SPECT, and EEG). Treatment research studies may focus on the development, piloting and efficacy testing of therapeutic interventions. Prevention studies may focus upon testing theory-based preventive interventions focused on reducing the risk of onset and progression of comorbid conditions prior to clinical diagnosis. Services research studies are also appropriate under this program announcement, and may involve analyses of existing treatment data bases, collection of new data, including effectiveness studies of strategies for improving services to comorbid populations. Studies may be based in a variety of public and private settings (e.g., hospitals, residential programs, outpatient programs, community based programs, primary care settings, correctional settings) and may involve a variety of treatment or non-treatment populations. The use of multiple outcome domains (e.g., work performance) as criterion variables is encouraged. Subpopulations of children, adolescents, women, minorities, persons in correctional and parole settings, homeless persons with serious mental illnesses and drug abuse/addictive disorders, and the elderly experiencing comorbid mental and addictive disorders are of particular interest. Examples of Research Topics Research topics might include, but are not limited to, the following: Studies involving neuroimaging of individuals with comorbid mental and addictive disorders to expose evolving neural substrates of behavior. Studies of drug induced neuropsychological deficits in comorbid mental and addictive disordered populations. Assessment of these deficits and their relationship to therapeutic efficacy may be also studied. Studies of etiological and neurobiological factors that underlie the co-occurrence of drug abuse/addiction and mental disorders. Cohort studies of high risk groups ( e.g., children in high drug abuse areas, children of drug abusers, children of individuals with mental disorders, elderly or homeless persons with serious mental illnesses and drug abuse/addictive disorders) to assess potential risk factors for the co-occurrence of drug abuse/addiction and mental disorders. In addition, data on patterns of symptoms, levels of impairments, help-seeking behaviors, and treatment history are needed. Pharmacological interventions alone and in combination with behavioral approaches may be examined. Protocols may be developed for detoxification, maintenance, and relapse prevention for specific drugs of abuse when other comorbid conditions are present. Drug- medication, medication-medication, and medication-disease interactions may be examined when pharmacotherapy is prescribed for one or both of the addictive or mental disorders, as well as HIV/AIDS. Behavioral therapies (e.g., cognitive therapy, psychotherapy, family therapy, counseling, motivational interventions) to treat clients diagnosed with a drug use disorder plus one or more other co- occurring mental disorder may be developed and piloted. Fully developed therapies may be tested for efficacy. Behavioral interventions may also be developed, piloted and tested to prevent comorbid conditions prior to clinical diagnosis. Approaches to minimize the harm associated with drug addiction and comorbid mental disorders, including both pharmacological and behavioral interventions, may be developed and piloted and tested for efficacy. The developmental stage of the child or adolescent with or at risk for comorbid mental and addictive disorders is an important prevention and treatment consideration. The development, piloting, and efficacy testing of preventive interventions and treatment protocols specifically designed for children and adolescents at particular developmental stages is needed. Studies involving course and temporal relationships of illness as individuals move from having a single disorder to comorbid disorders. Such studies can be clinical or epidemiological in design. The effect of treatment can be used to observe change in course, severity and impairment among the multiple disorders studied. Specific financing and reimbursement policies, and cost- and utilization-management strategies, and effects of resource/funding limitations on aspects of prevention and treatment service delivery and subsequent outcomes for populations afflicted with comorbid mental and addictive disorders may be studied. Also of interest are questions regarding the effect of service delivery system variables (e.g. organizational structure and environment, management and treatment practices and philosophy, staffing patterns, and clinical training and expertise of drug abuse and mental health providers) on treatment outcome in these populations. Studies assessing the prevention and treatment needs in this population and the relationship of need to demand, access, and service utilization. In addition, studies to test assessment strategies and interventions to overcome barriers to access to and utilization of services. Integration of models for delivery of drug abuse and mental health services for clients with a drug use disorder and a comorbid mental disorder warrant further study. Innovative approaches to prevention, outreach, client assessment, case management, assertive community treatment, managed care, family treatment and systems-of-referral among available service providers may be studied with the aim of increasing enrollment in and decreasing early withdrawal from treatment. A particular area of interest is the development of appropriate referral systems between drug abuse/addiction and mental health providers. Therapeutic environments such as psychiatric outpatient, inpatient, short-and long-term residential programs, as well as hospitals, primary care clinics, social service agencies, and correctional facilities may be evaluated for their effectiveness for clients with specific comorbid conditions. Impact of comorbid mental and addictive disorders on HIV/AIDS requires research to address linkage of services, continuity of care, service utilization management, matching services to client needs, financing/cost constraints, and cost effectiveness and cost-benefits. In addition, studies of the effects of disconnections of services between mental health and drug abuse populations and also, drug abuse populations and homeless programs are of interest. Development of AIDS prevention/intervention techniques that maximize adherence to risk reduction and prophylactic regimens across changes in cognitive, emotional, and physical state related to drug abuse, fluctuating psychiatric status and HIV disease stage. These could include the development of intervention approaches to change behaviors of persons seen in primary care, drug abuse treatment or mental health settings, or through community outreach. In addition, studies that examine the role of cognitive dysfunction and poor psychosocial functioning on the development of drug abuse, mental disorders and HIV infection are of interest. Genetic epidemiologic research is needed to examine rates of mental and drug abuse/addiction disorders in families to assess whether comorbidity is attributable to a causal mechanism between the co- occurring mental and drug abuse/addictive disorders or if each disorder is a manifestation of similar underlying factors (genetic, environmental, or a combination). Case-control studies of biological, familial, or psychological factors that distinguish those with both mental and drug abuse/addictive disorders, those with either disorder alone, and those with neither disorder. Research into the development of statistical methods for the analysis of the transmission of co-occurring mental and drug abuse/addictive disorders. Development of clinical instruments to conduct broad-based behavioral/environmental assessments of risk for HIV and associated illnesses, e.g., tuberculosis, in comorbid mental disordered populations of drug abusers. In addition, clinical instruments should be developed using novel dimensional, non-DSM IV, assessments as well as brief methods of identification and assessment for field trials. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and >From the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The title and number of the program announcement must be typed in Item 2a of face page of the application. FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST (R29) award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express or courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications that are complete and responsive to the program announcement will be reviewed for scientific and technical merit by a peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under receive, will be discussed, assigned a priority score and receive a second level review by the appropriate national advisory council. R03 applications do not receive a second-level review. Review Criteria o scientific, technical, or clinical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequancy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animals subjects, and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Arthur MacNeill Horton, Jr., Ed.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-46 Rockville, MD 20857 Telephone: (301) 443-6697 Email: ah61x@nih.gov Kathryn M. Magruder, M.P.H., Ph.D. Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10C-06 Rockville, MD 20857 Telephone: (301) 443-3364 Email: kmagrude@aoamh2.ssw.dhhs.gov Direct inquires regarding fiscal issues to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: gf6s@nih.gov Bruce Ringler Grants Management Branch National Institute of Mental health 5600 Fishers Lane, Room 7C-15 Rockville, MD 20857 Telephone: (301) 443-2065 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of Section 301 of the Public Health Service Act (42 USC 241) and administered under PHS policies and Federal Regulations at Title 42 CFR 52 "Grants for Research Projects," Title 45 CFR Part 74 and 92, "Administration of Grants" and 45 CFR Part 46, "Protection of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Sections of the Code of Federal Regulations are available in booklet form from the U.S. Government Printing Office. Grants must be administered in accordance with the PHS Grants Policy Statement, (rev. 10/90), which may be available from your office of sponsored research. From owner-sci-resources@net.bio.net Mon May 01 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-052 - V24(15) 04/28/95 Date: 2 May 1995 09:54:23 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 607 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3o5o3v$gpe@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95052 PA-95-052 P1O1 *************************************** ACADEMIC CAREER AWARD NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA NUMBER: PA-95-052 P.T. 34; K.W. 0710030 National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Environmental Health Sciences National Institute of Mental Health Application Receipt Dates: February 1, June 1, and October 1 PURPOSE The Academic Career Award (K07) is used by the NIH Institutes and Centers to support individuals interested in introducing or improving curriculum in a particular scientific field as a means of enhancing the educational or research capacity at the grantee institution. Since not all of the NIH Institutes and Centers offer this award, potential applicants should contact the appropriate NIH program staff listed at the end of this program announcement, prior to preparing an application. This Academic Career Award (K07) supports two types of activities: Development. The K07 provides support for more junior candidates who are interested in developing an academic and research expertise in a particular field, as a way to increase the overall pool of individuals capable of research or teaching in the identified area. During the period of the award, the candidate will become a successful academician in the chosen area. Teaching, curriculum building, research, and leadership skills are to be learned during the tenure of the award. For junior candidates, a mentor is required. Leadership. The K07 also supports more senior individuals with acknowledged scientific expertise and leadership skills who are interested in improving the curricula and enhancing the research capacity within an academic institution. It is expected that support under this award will increase the visibility and the overall research support or academic capacity for the given field of research within the academic medical/health and research community. Not all of the NIH awarding components support the K07 or both componets of this award. For example, the National Institute of Mental Health does not support the leadership component of this award. Applicants are strongly encouraged to contact the prospective NIH awarding component prior to preparing an application. The NIH recently reviewed its career awards (K-series) used to develop the research capabilities of clinicians and other scientists needed to carry out the nation's research mission in the biomedical and behavioral sciences. This evaluation resulted in several changes: (1) the total number of K mechanisms were reduced from 19 to six; (2) the review criteria were refined to clarify the career development goals of the K award; and (3) K award applications will be assigned to initial review groups managed by the prospective funding institute or center to which the application has been assigned. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Academic Career Award, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Candidates for this award must have a clinical or research doctoral degree. Candidates for the development award must demonstrate the potential to develop into an excellent academician, in the fields of interest to the NIH awarding institute or center. Candidates must be able to identify a mentor who is an expert in the research field of interest and has a record of providing the type of supervision required by this award. Candidates must also be able to devote at least 75 percent of full-time professional effort to the research and developmental programs required for academic development. Candidates for the leadership award must have sufficient clinical training, research, or teaching experience in the academic area of interest to the NIH to implement a program of curriculum development within the applicant institution; must have an academic appointment at a level sufficient to enable her/him to exert an influence on the coordination of research, teaching, and clinical practice in an emerging field; and must be in a position to devote at least 25 percent effort to the program, a portion of which may include research. Applications may be submitted, on behalf of candidates, by domestic, non-Federal organizations, public or private, such as medical, dental, or nursing schools or other institutions of higher education. Minorities and women are encouraged to apply. Candidates must be U.S. citizens or noncitizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Noncitizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. MECHANISM OF SUPPORT Awards in response to this PA will use the K07 mechanism. Planning, direction, and execution of the program will be the responsibility of the candidate. However, the institution must demonstrate a commitment to the candidate and the candidate's goals for career development. The project period is five years for the development award and two to five years for the leadership award. Awards are renewable at the discretion of the NIH awarding unit. RESEARCH OBJECTIVES A. Environment: The institution must be able to demonstrate a commitment to research in the area of interest to the NIH and must remain committed to the career development of the candidate. The institution must provide assurance that the candidate is an integral part of its research and academic programs. B. Program: The award supports up to five consecutive 12 month appointments for the duration of the grant. For the development award, applicants are expected to commit at least 75 percent of full- time professional effort to the career development program. The remainder may be devoted to other research-related and/or teaching pursuits consonant with the objectives of the award. For the leadership award, applicants are expected to commit at least 25 percent effort. C. Mentor: For the development award, the recipient must receive appropriate mentoring throughout the award. Where feasible, women and minority mentors should be involved as role models. D. Allowable Costs 1. Salary: The NIH will provide salary and fringe benefits for the K recipient. The salary limits are not uniform throughout the NIH and are determined independently by each component of the NIH. Therefore, prospective candidates should contact the NIH component to which the application is targeted to ascertain the maximum contribution to the candidate's salary. The institution may supplement the NIH contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case, may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the Academic Award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary requested must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. 2. Research Support: Research expenses and career development costs may be provided at the discretion of the NIH institute or center. Applicants should contact the relevant NIH institute or center program staff for additional information. 3. Ancillary Personnel Support: Salary for mentors or for secretarial, technical, and/or administrative assistance, etc., is not allowed. 4. Indirect costs: Indirect costs will be reimbursed at 8 percent of modified total direct costs, or at the actual indirect cost rate, whichever is less. E. Evaluation: In carrying out its stewardship of human resource related programs the NIH may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified, that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. F. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution. The funds may be used for health-related research purposes. The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component. G. Special Leave: Leave to another institution, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NIH funding component is required. To obtain prior approval, the award recipient must submit a letter to the NIH describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH funding component and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Parental leave will be granted consistent with the policies of the NIH and the grantee institution. H. Termination or Change of Institution: When a grantee institution plans to terminate an award, the NIH funding component must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. If the individual is moving to another eligible institution, career award support may be continued provided: A new career award application is submitted by the new institution; The period of support requested is no more than the time remaining within the existing award period; and The new application is submitted far enough in advance of the requested effective date to allow the necessary time for review. The funding component may require a new review by an initial review group and/or the appropriate National Advisory Council or Board. Alternatively, review may be carried out by staff within the NIH funding component depending upon the circumstances. The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipient in writing of this determination, the reasons therefor, the effective date, and the right to appeal the decision. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES This is a generic program announcement for the NIH Academic Career Award (K07). It is strongly recommended that prospective applicants contact the staff person in the relevant institute or center listed under INQUIRIES early in the planning phase of application preparation to discuss research areas of interest and award provisions, which differ across NIH funding components. Such contact will help ensure that applications are responsive to the career development goals of individual institutes and centers. Applications are to be submitted on form PHS 398 (rev. 9/91) and will be accepted on or before the receipt deadlines indicated in the application kit (February 1, June 1 and October 1). Forms are available at most institutional offices of sponsored research and >From the Office of Grants Information, Division of Research Grants, NIH, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248. Applicants are strongly advised to follow the instructions in the PHS form 398. The application should include: Candidate o Describe the candidate's commitment to an academic research career in the area of interest to the NIH. o Provide evidence that the candidate has the capacity to provide leadership as a teacher or researcher. o Describe the immediate and long-term career objectives and how those objectives will meet the needs for expansion or enhancement of the academic or research capacity in a field of research of interest to the NIH funding component. o Letters of recommendation. Candidates for the development Academic Award must provide three sealed letters of recommendation addressing the applicant's potential for a research career must be included as part of the application. Career Development Plan o Describe the career development plan incorporating consideration of the candidate's goals and prior experience. Describe the plan to obtain the necessary research and pedagogical experience to facilitate further development as an academician. The career development plan must be tailored to the career goals of the candidate and the intent of the award. o Candidates for the development award must describe plans to receive instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction as well as the amount and nature of faculty participation. Candidates at the leadership stage must include information about his/her participation in courses designed to provide instruction in the responsible conduct of research. Research Plan o Describe the research plan. The applicant should describe the research plan necessary to initiate academic and research development in the area of interest to the NIH funding component. The plan should be described as outlined in form PHS 398, Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. Candidates for the development award should coordinate the development of the research plan with their prospective mentor. Environment and Institutional Commitment o The institution must provide evidence of commitment and support for the proposed experience. There must be evidence of support for the candidate and his/her career development plan and for the further enhancement of the academic area of interest to the NIH funding component. Mentor's Statement o Candidates for the development Academic Award must include information on the mentor(s) including his/her research qualifications and previous experience as a research supervisor. The application must also include information describing the nature and extent of supervision that will occur during the proposed award period. Budget o Budget requests must be provided according to the instructions in form PHS 398. The request for tuition and fees, books, travel, etc., must be justified and specified by category. To identify the application as a response to this PA, check "YES" on item 2a of page 1 of the application and enter "PA-95-052, Academic Career Award" and the name of the NIH institute or center that you would like the application to be assigned. Submit a signed, typewritten original of the application with Checklist, and five signed photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the Division of Research Grants and responsiveness to the PA by the appropriate institute or center staff. Incomplete or nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by he appropriate national advisory council or board. The following review criteria will be applied: Candidate o Evidence of excellence in academic, research, and (where appropriate) clinical activities; o Potential to become an outstanding investigator, teacher, resource person, and leader in research, educational and (where appropriate) clinical programs related to the mission of the NIH award component; o Potential to become or to continue as an independent researcher; o Quality and breadth of prior scientific training and experience; and o Degree and extent of previous research support and publications considering academic level of candidate. Career Development Plan o Quality and feasibility of the candidate's career development plan, including, in broad terms, plans after termination of award. O Quality of the proposed plan to enhance pedagogical and leadership skills. Research Plan o Quality and feasibility of research and teaching plan; o Relationship of the research plan to the career development goals and the candidate's previous experience; and o adequancy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. Environment o Commitment of the institution to strengthening research and education activities in the area of interest to the NIH institute or center; o Merit of the institution plan to strengthen research and training activities beyond the current status of activities and capacities; and o Scope and nature of collaboration among participating schools and departments. Mentor o For the development academic award, the mentor's prior experience and record in fostering academic growth and productivity. Budget o Justification of budget requests in relation to career development goals and research aims and plans; AWARD CRITERIA The institute or center will notify the applicant of the board or council's action shortly after its meeting. Funding decisions will be made based on the recommendations of the initial review group and council/board, the need for research personnel in specific program areas, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this PA are encouraged especially during the planning phase of the application. Below is a listing of each institute's or center's program or grants management contacts. Dr. Robin A. Barr Office of Extramural Affairs National Institute on Aging Gateway Building, Room 2C218, MSC 9205 7201 Wisconsin Avenue Bethesda, MD 20892-9205 Telephone: (301) 496-9322 FAX: (301) 402-9245 Email: Barr@nihniagw.bitnet Dr. Ernestine D. Vanderveen, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 Email: tvanderv@willco.niaaa.nih.gov Ms. Frances Cotter Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1207 FAX: (301) 443-8744 Email: fcotter@willco.niaaa.nih.gov Dr. Mary C. Dufour Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 514 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4897 FAX: (301) 443-8614 Email: m.dufour@willco.niaaa.nih.gov Richard Lymn, Ph.D. Extramural Programs National Institute on Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-49E MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-5128 FAX: (301) 480-4543 Email: rl28b@nih.gov Dr. John Schneider or Dr. Andrew Vargosko Division of Cancer Biology, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892 Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: schneidj@dcbdcep.nci.nih.gov Email: vargoska@dcbdcep.nci.nih.gov Dr. Annette Kirshner Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-03 Research Triangle Park, NC 27709 Telephone: (919) 541-0488 FAX: (919) 541-2843 Email: kirshner@niehs.nih.gov National Heart, Lung, and Blood Institute (The NHLBI does not accept applications for the Academic Career Award on a regular basis. It does, however, issue Requests for Applications (RFAs) using this award as programmatic needs arise.) George T. Niederehe, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-3264 FAX: (301) 594-6784 Email: gniedere@aoamh4.ssw.dhhs.gov AUTHORITY AND REGULATIONS The Academic Career Awards are made under the authority of Title III, Section 301 of the Public Health Service (PHS) Act as amended (Public Law 78-410, as amended, 42 USC 241). The Code of Federal Regulations, Title 42 Part 52, and Title 45 part 74, are applicable to this program. This program is described in the Catalog of Federal Domestic Assistance No. 93.121. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Mon May 01 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-049 - V24(15) 04/28/95 Date: 2 May 1995 09:54:14 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 738 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3o5o3m$gor@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95049 PA-95-049 P1O1 *************************************** MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA NUMBER: PA-95-049 P.T. 34; K.W. 0710030 National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Environmental Health Sciences National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Center for Human Genome Research National Center for Research Resources Application Receipt Dates: February 1, June 1, and October 1 PURPOSE The Mentored Research Scientist Development Award (MRSDA) is for research scientists who need an additional period of sponsored research experience as a way to gain expertise in a research area new to the candidate or in an area that would demonstrably enhance the candidate's scientific career. It is expected that following this experience, the candidate will be able to pursue an independent and productive research career. The Mentored Research Scientist Development Award (K01) provides an intensive, supervised career development experience in one of the biomedical, behavioral, or clinical sciences. The proposed experience should be in a research area new to the applicant and/or one in which an additional supervised research experience will demonstrably enhance the candidate's scientific career. The experiences should permit the application of novel or highly promising interdisciplinary approaches to particular research problems. Candidates must justify the need for a three, four, or five year period of mentored research experience and must be able to provide a convincing case that the proposed period of support will substantially enhance his/her career and/or will allow the pursuit of a novel or promising approach to a particular research problem. Candidates who have interrupted their careers because of illness or pressing family care commitments may apply if they can clearly demonstrate the potential for productive independent research and the need for an additional period of mentored research experience in order to accomplish an effective scientific reentry. Similarly, faculty members at institutions with a substantial minority enrollment, who wish to enhance their research skills through a supervised research experience at a nearby research center, may also apply, if they agree to remain at their parent institution after completion of the award. The MRSDA replaces four existing NIH career development mechanisms, including the Research Scientist Development Award (K01), the Minority School Faculty Development Award (K14), the Research Career Reentry Program (K17), and the Scientist Development Award (K21). Individuals who were eligible to apply for any one of these awards are now eligible to apply for a K01 award. Therefore, this Program Announcement (PA) supersedes all previous K01, K14, K17, and K21 program announcements. The NIH will no longer accept competing applications for the old K01, K14, K17, and K21 awards. Existing policies and provisions will remain in effect for current K01, K14, K17, and K21 recipients until completion of the non-competing years of their three to five year career development program. Funding institutes and centers may, from time to time, issue PAs or requests for applications (RFAs) that modify the ELIGIBILITY REQUIREMENTS or MECHANISM OF SUPPORT sections of this program announcement in order to meet special program needs such as soliciting applications from specially targeted groups of investigators. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Mentored Research Scientist Development Award, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS In general, the candidate must have a research or a health- professional doctorate or its equivalent, and must have demonstrated the capacity or potential for highly productive independent research in the period after the doctorate. Applicants for the K01 from the National Center for Human Genome Research, however, may be non- biologists without a doctoral degree such as computer scientists, physicists, mathematicians, and chemists. All applicants are encouraged to contact the prospective NIH awarding component regarding their eligibility for the K01. The candidate must identify a mentor with extensive research experience, and must be willing to spend a minimum of 75 percent of full-time professional effort conducting research and research career development activities for the period of the award. Applications may be submitted on behalf of candidates by domestic, non-Federal organizations, public or private, such as medical, dental, or nursing schools or other institutions of higher education. Minorities and women are encouraged to apply. Candidates must be U.S. citizens or noncitizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Noncitizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states, but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. Candidates may have been principal investigators on PHS research grants and may have been supported by a research career award in the past, provided the proposed research experience is a fundamentally new field of study or there has be a significant hiatus in their research career because of family or other personal obligations. Current principal investigators on PHS research grants are not eligible. MECHANISM OF SUPPORT Awards in response to this PA will use the K01 mechanism. Planning, direction, and execution of the program will be the responsibility of the candidate and her/his mentor on behalf of the applicant institution. The project period may be for three, four, or five years and will depend upon the number of years of prior research experience, the need for additional experiences to achieve independence, and the policy of each particular institute or center. Awards are not renewable. RESEARCH OBJECTIVES A. Environment: The institution must have a well-established research and/or clinical career development program(s) and qualified faculty to serve as mentors. The institution must be able to demonstrate a commitment to the development of the candidate as a productive, independent investigator. And, the candidate, mentor and institution must be able to describe a multi- disciplinary career development program that will maximize the use of relevant research and educational resources. B. Program: The award provides three to five consecutive 12 month appointments. At least 75 percent of the recipient's full-time professional effort must be devoted to the program and the remainder devoted to other research-related and/or teaching pursuits consistent with the objectives of the award. The candidate must develop knowledge in the basic sciences and research skills relevant to his or her career goals. The candidate may find it appropriate to include relevant didactic and laboratory or field research experiences. C. Mentor(s): The recipient must receive appropriate mentoring throughout the three to five year program. Where feasible, women and minority mentors should be involved as role models. D. Allowable Costs: 1. Salary: The NIH will provide salary and fringe benefits for the K award recipient. The salary limits are not uniform throughout the NIH and are determined independently by each component of the NIH. Therefore, prospective candidates should contact the NIH component to which the application is targeted to ascertain the maximum contribution to the candidate's salary. The institution may supplement the NIH contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case, may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the MRSDA. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary requested must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. 2. Research Development Support: Most awarding components of the NIH will provide up to $20,000 per year for the following expenses: (a) tuition, fees, and books related to career development; (b) research expenses, such as supplies, equipment, and technical personnel; (c) travel to research meetings or training; (d) statistical services including personnel and computer time. The National Institute of Mental Health will provide up to $50,000 for research development support. 3. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed. 4. Indirect costs: Indirect costs will be reimbursed at eight percent of modified total direct costs, or at the actual indirect cost rate, whichever is less. F. Evaluation: In carrying out its stewardship of human resource related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. G. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution. The funds may be used for health-related research purposes. The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks must be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component. H. Special Leave: Leave to another institution, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of the NIH funding component is required. To obtain prior approval, the award recipient must submit a letter to the NIH describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH funding component and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Parental leave will be granted consistent with the policies of the NIH and the grantee institution. I. Termination or Change of Institution: When a grantee institution plans to terminate an award, the NIH funding component must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. If the individual is moving to another eligible institution, career award support may be continued provided: A new career award application is submitted by the new institution; The period of support requested is no more than the time remaining within the existing award period; and The new application is submitted far enough in advance of the requested effective date to allow the necessary time for review. The funding component may require a review by an initial review group and/or the appropriate National Advisory Council or Board. Alternatively, review may be carried out by staff within the NIH funding component, depending upon the circumstances. The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipient in writing of this determination, the reasons therefor, the effective date, and the right to appeal the decision. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES This is a generic program announcement for the MRSDA. Because some of the NIH institutes and centers may not participate in this program or may have different award provisions, it is strongly recommended that prospective applicants contact the staff person in the relevant institute or center listed under INQUIRIES early in the planning phase of application preparation. Such contact will help ensure that applications are responsive to the career development goals and policies of the NIH institute or center. Applications are to be submitted on form PHS 398 (rev. 9/91) and will be accepted on or before the receipt deadlines indicated in the application kit (February 1, June 1 and October 1). Forms are available at most institutional offices of sponsored research and >From the Office of Grants Information, Division of Research Grants, NIH, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The application must address the following issues: Candidate o Establish the candidate's commitment to a career in biomedical or behavioral research o Establish the candidate's potential to develop into a successful independent investigator. o Summarize the candidate's immediate and long-term career objectives, explaining how the award will contribute to their attainment. o Letters of recommendation. Three sealed letters of recommendation addressing the candidate's potential for a research career must be included as part of the application Career Development Plan o Describe the career development plan, incorporating consideration of the candidate's goals and prior experience. It should describe a systematic plan to obtain the necessary basic biomedical or behavioral science background and research experience to launch or reinitiate an independent research career. o Candidates must describe plans to receive instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction as well as the amount and nature of faculty participation. No award will be made if an application lacks this component. Research Plan o Describe the research plan and the use of a basic or clinical approach to a biomedical or behavioral problem. The candidate and mentor together must describe the research plan as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. Mentor's Statement o The application must include information on the mentor(s) including information on research qualifications and previous experience as a research supervisor. The application must also include information that describes the nature and extent of supervision that will occur during the proposed award period. Environment and Institutional Commitment o The sponsoring institution must document a strong, well- established research program related to the candidate's area of interest including a high-quality research environment with staff capable of productive collaboration with the candidate. The sponsoring institution also must provide a statement of commitment to the candidate's development into a productive, independent investigator. Budget o Budget requests must be provided according to the instructions in form PHS 398. The request for tuition and fees, books, travel, etc., must be justified and specified by category. To identify the application as a response to this PA, check "YES" on item 2a of page 1 of the application and enter "PA-95-049, Mentored Research Scientist Development Award" and the name of the NIH institute or center that you would like the application to be assigned for funding. Submit a signed, typewritten original of the application with Checklist, and five signed photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the Division of Research Grants and responsiveness to the PA by the appropriate institute or center staff. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by he appropriate national advisory council or board. The following review criteria will be applied: Candidate o Commitment to an independent research career; o Potential to develop (or evidence of the capacity to develop) as an independent investigator; o Quality and breadth of prior scientific training and experience, including, where appropriate, the record of previous research support and publications. Career Development Plan o Likelihood that the plan will contribute substantially to the scientific development of the candidate and the achievement of scientific independence; o Appropriateness of the research plan to the career goals of the candidate; o Appropriateness of the plan to update conceptual and theoretical knowledge, and the proposed award duration; o Consistency of the career development plan with the candidate's prior research and academic experience and the stated career goals; o Clarity of the goals and scope of the plan and the need for the proposed research experience; and o Quality of the proposed training in the responsible conduct of research. Research Plan All candidates for this award will have had previous research experience and in some cases will have been Principal Investigators in other scientific fields. A sound research plan that is consistent with the career development plan and the candidate's level of research development must be provided. o Usefulness of the research plan as a vehicle for enhancing existing research skills as described in the career development plan; o Scientific and technical merit of the research question, design and methodology, judged in the context of the candidate's previous training and experience; o Relevance of the proposed research to the candidate's career objectives; and o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. Mentor o Appropriateness of mentor's research qualifications in the area of this application; o Quality and commitment of the mentor to supervising and guiding the candidate throughout the award period; o Previous experience in fostering the development of researchers; and o History of research productivity and support. Institutional Environment and Commitment o Applicant institution's commitment to the scientific development of the candidate and assurances that the institution intends the candidate to be an integral part of its research program; o Adequacy of research facilities and training opportunities; o Quality of environment for scientific and professional development; and o Applicant institution's willingness to develop an appropriate mix of research, teaching and administrative responsibilities for the candidate. Budget o Justification of budget requests in relation to career development goals and research aims and plans. AWARD CRITERIA The NIH institute or center will notify the applicant of the national advisory board or council's action shortly after its meeting. Funding decisions will be made based on the recommendations of the initial review group and council/board, the need for research personnel in specific program areas, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this PA are encouraged, especially during the planning phase of the application. Below is a listing of each institute's or center's program or grants management contacts. Dr. Robin A. Barr Office of Extramural Affairs National Institute on Aging Gateway Building, Room 2C218, MSC 9205 7201 Wisconsin Avenue Bethesda, MD 20892-9205 Telephone: (301) 496-9322 FAX: (301) 402-9245 Email: Barr@nihniagw.bitnet Dr. Ernestine D. Vanderveen, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 Email: tvanderv@willco.niaaa.nih.gov Ms. Frances Cotter Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1207 FAX: (301) 443-8744 Email: fcotter@willco.niaaa.nih.gov Dr. Mary C. Dufour Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 514 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4897 FAX: (301) 443-8614 Email: m.dufour@willco.niaaa.nih.gov Richard Lymn, Ph.D. Extramural Programs National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-49E 45 Center Drive, MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-5128 FAX: (301) 480-4543 Email: rl28b@nih.gov The NICHD will accept applications for the K01 under Clinical Rehabilitation Investigator Development Award (CRIDA), but will limit eligibility to candidates who have both clinical training in the rehabilitation related professions (e.g., P.T., O.T., R.N.) and possess doctoral level degrees (e.g., Ph.D., D.Eng., D.Ed.). Individuals supported under CRIDA must be committed to developing careers as independent investigators in medical rehabilitation. Danuta Krotoski, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Building 61E, Room 2A03 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 FAX: (301) 402-0832 Email: krotoskd@hd01.nichd.nih.gov Dr. Lester Gorelic Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 643 Bethesda, MD 20892 Telephone: (301) 496-7344 FAX: (301) 402-4551 Email: gorelicl@dea.nci.nih.gov (This award is reserved exclusively for minority faculty development) Dr. Michael Galvin Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 Research Triangle Park, NC 27709 Telephone: (919) 541-7825 FAX: (919) 541-2843 Email: galvin@niehs.nih.gov National Heart, Lung, and Blood Institute (The NHLBI does not accept applications for the Mentored Research Scientist Award (K01). It does, however, periodically issue Request for Applications (RFA) for the Minority School Faculty Development Award (K01) and the Research Development Award for Minority Faculty (K01) in the NIH Guide for Grants and Contracts.) Dr. Bettie Graham National Center for Human Genome Research Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: bg30t@nih.gov George T. Niederehe, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-3264 FAX: (301) 594-6784 Email: gniedere@aoamh4.ssw.dhhs.gov Kenneth G. Lutterman, Ph.D. Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10-95 Rockville, MD 20857 Telephone: (301) 443-3373 FAX: (301) 443-4045 Email: klutterm@nih.gov Henry Khachaturian, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health 5600 Fishers Lane, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-8033 FAX: (301) 443-1731 Email: hkhach@helix.nih.gov Leonard Mitnick, Ph.D. Office of AIDS Programs National Institute of Mental Health 5600 Fishers Lane, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-9719 FAX: (301) 443-9719 Email: lmitnick@aoamh2.ssw.dhhs.gov Mr. Edward Donohue Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1016A Bethesda, MD 20892 Telephone: (301) 496-4188 FAX: (301) 402-4370 Email: ed25b@nih.gov Dr. Mary Lucas Leveck Acute and Chronic Illness Branch National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-5963 FAX: (301) 480-8260 Email: mleveck@ep.ninr.nih.gov Leo A. Whitehair, D.V.M, Ph.D. Comparative Medicine Program National Center for Research Resources Westwood Building, Room 857 Bethesda, MD 20892 Telephone: (301) 435-0746 FAX: (301) 480-3660 Email: leow@ep.ncrr.nih.gov AUTHORITY AND REGULATIONS The Mentored Research Scientist Development Awards are made under the authority of Title III, Section 301 of the Public Health Service (PHS) Act as amended (Public Law 78-410, as amended, 42 USC 241). The Code of Federal Regulations, Title 42 Part 52, and Title 45 part 74, are applicable to this program. This program is described in the Catalog of Federal Domestic Assistance No. 93.121. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Fri May 05 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 16, pt. 1of1, 5 May 1995 Date: 5 May 1995 18:29:27 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 609 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3oejdn$mg@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950505 V24N16 P1O1 ************************************ X-comment: RFAs described: DA-95-004, PA-95-057, PAR-95-058, PA-95-059 NIH GUIDE - Vol. 24, No. 16 - May 5, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** PUBLIC FORUM ON TUITION POLICY National Institutes of Health INDEX: NATIONAL INSTITUTE OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** STATISTICAL AND CLINICAL COORDINATING CENTER FOR THE CLINICAL NETWORK FOR CONTRACEPTIVE RESEARCH (RFP NICHD-CD-95-03) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R2 07/21/95 ************************************************* COOPERATIVE DRUG ABUSE TREATMENT OUTCOME STUDY (RFA DA-95-004) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P1 ********************************************************** HIV RISK BEHAVIORS, DETERMINANTS, AND CONSEQUENCES (PA-95-057) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P2 ********************************************************** MINORITY RESEARCH INFRASTRUCTURE SUPPORT PROGRAM (PAR-95-058) National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX P3 ********************************************************** LOCAL POPULATION/AREA EPIDEMIOLOGIC RESEARCH ON DRUG ABUSE (PA-95- 059) National Institute on Drug Abuse INDEX: DRUG ABUSE THIS PUBLICATION IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE USING A PERSONAL COMPUTER (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/594- 7270 FOR DETAILS. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTING EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. THE DIVISION OF RESEARCH GRANTS (DRG) IS MOVING TO A NEW LOCATION. EFFECTIVE MAY 8, 1995, ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** PUBLIC FORUM ON TUITION POLICY NIH GUIDE, Volume 24, Number 15, April 28, 1995 P.T. National Institutes of Health The following Notice of Invitation from the Chair of the Task Force on Tuition Reimbursement has been sent to program directors of all National Research Service Award (NRSA) Research Training Grants, business officials and administrative officials at institutions with NRSA Research Training Grants, and relevant professional societies. All interested parties are invited to participate in the Public Forum on NRSA Tuition Reimbursements as indicated in the letter. NOTICE OF INVITATION April 24, 1995 To: All Parties Interested in a Public Forum on NRSA Tuition Reimbursements at the National Institutes of Health From: Chairman, Task Force on Tuition Reimbursement Re: Public Forum on Tuition Policy Under a relatively fixed budget, it has been very difficult for the NIH to continue its policy of paying the full costs of tuition, fees, and health insurance (hereafter called tuition) for predoctoral trainees supported by National Research Service Award (NRSA) institutional research training grants. At the current time, tuition accounts for about half of the cost of supporting a predoctoral trainee, and costs the NIH more than $70 million out of a total NIH NRSA predoctoral training budget of $155 million. At some institutions, graduate tuition costs exceed $25,000 per year. As a cost saving measure, the NIH froze tuition in 1989 for all ICs (Institutes and Centers). After fiscal year 1989, some Institutes returned to a full reimbursement policy while others kept tuition reimbursements frozen. As a consequence, there is considerable disparity in tuition policies across the NIH ICs. Although the NIH has made several attempts to develop a uniform tuition policy, none has been endorsed by the academic community, and none has been adopted as formal policy by the NIH. In an attempt to resolve this issue, a Task Force has been assembled to consider the tuition reimbursement policy on NRSA institutional research training awards. The Task Force will officiate at a one-day public meeting, to which all interested parties are invited. Immediately following the Public Forum, the Task Force will prepare a summation of the testimony from the Public Forum, and the members will develop recommendations for a uniform NRSA tuition policy. PUBLIC FORUM ON TUITION REIMBURSEMENT The Public Forum will be convened on June 5, 1995, in the Natcher Conference Center, 45 Center Drive, National Institutes of Health campus, Bethesda, Maryland. The one-day meeting will begin at 8:30 am and conclude at approximately 5:30 p.m. During the Public Forum, individuals will provide brief testimony on tuition reimbursement concerns and issues at the invitation of the Task Force. There will be opportunities for other audience members to offer comments during periods of "Open Discussion" scheduled throughout the day. We would like to invite all interested parties to submit a two page response, no later than May 25, to the questions below. Individuals interested in responding should mail their responses to the address shown below, or FAX (301-480-8256) their responses to Dr. Ernest Marquez by May 25, 1995. The Task Force will review the responses and select the individuals who will be invited to address the Task Force at its June 5 Public Forum. Be assured that the Task Force will review all responses generated by this solicitation: 1. Should there be a uniform policy for tuition reimbursement on all NRSA institutional training grants made by the NIH? 2. What is the relationship of tuition to the overall cost of training a predoctoral student at your institution, i.e., What specific costs are covered by tuition? a. Is the tuition charged for graduate students the same as that for undergraduate students? b. Is the tuition charged the same amount for each year of graduate school, i.e., during course work and full-time research? 3. Assuming an NIH policy to pay less than the full cost of tuition, which of the following reimbursement proposals would you prefer for your institution, and why? a. The NIH would pay a fixed percentage of published tuition charges for all predoctoral trainees regardless of the actual cost. b. The NIH would pay a fixed tuition amount for all predoctoral trainees regardless of actual cost (The NSF model). c. The NIH would pay a fixed amount of tuition for all trainees in public institutions and a higher, but fixed amount of tuition for all trainees in private institutions. The amounts would be based on average tuition costs for public institutions and for private institutions, and in no case would NIH pay more than 100% of tuition costs. This is sometimes called the Capped Two-Tiered Cost of Education Allowance. d. The NIH would pay 100 percent of tuition costs below $6,000 and lesser amounts of any costs above this amount in what is sometimes called a Marginal Rate Model. For example, one model proposes the following reimbursement rates: 1) If tuition costs are 0-$6000, 100% of this amount is paid 2) If tuition costs are $6000-10,000, the amount paid would be $6,000 plus 65% of the amount over $6,000 3) If tuition costs are $10,000-14,000, the amount paid would be $8,600 plus 45% of the amount over $10,000 4) If tuition costs are $14,000-18,000, the amount paid would be $10,400 plus 30% of the amount over $14,000 5) If tuition costs are in excess of $18,000, the amount paid would be $11,600 plus 20% of the amount over $18,000 e. None of the above four models necessarily involves a direct relationship between the tuition payment and the quality of training. Can you suggest a workable algorithm which would include quality of education as one of the determining factors in the tuition reimbursement? 4. Assuming constant federal dollars for training, what do you see as a proper balance between number of trainees and tuition reimbursements? Would you favor paying full tuition even at the expense of training positions? What is a rational way to achieve this balance? If you have further questions about the Public Forum, please telephone Dr. Ernest Marquez at (301) 594-5965 or E-Mail at emarquez@ep.ninr.nih.gov. We hope that you will take the opportunity to assist in our effort to gather the views of people interested in the tuition reimbursement policies of the NIH by sending us a letter no later than May 25 to: Task Force on Tuition Reimbursement c/o Dr. Ernest Marquez National Institutes of Health National Institute of Nursing Research Building 45, Room 3AN-12E 45 Center Drive MSC 6302 Bethesda, MD 20892-6302 We know you share our interest in providing an equitable and fair discussion on the issue of tuition reimbursement by the National Institutes of Health. Sincerely, \s\ Dr. Paul Anderson Chairman, Task Force on Tuition Reimbursement TASK FORCE ROSTER Dr. Paul S. Anderson (Chair) E.I. Dupont-Merck Pharmaceuticals Co. Wilmington, DE 19880-0353 Dr. Robert Birgeneau Dean of Science Massachusetts Institute of Technology Cambridge, MA 02139 Dr. Gail Cassell University of Alabama at Birmingham UAB Station Birmingham, AL 35294 Dr. Carl Frieden Washington University School of Medicine St Louis, MO 63110 Dr. Manual Navia Vertex Pharmaceuticals Cambridge, MA 02139 Dr. Baldomero Olivera University of Utah Dept of Biology Salt Lake City, UT 84112 Dr. John Perkins Dean University of Texas SW Med CTR/Dallas Dallas, TX 75235 Dr. William Reznikoff University of Wisconsin 420 Henry Mall Madison, WI 53706 Dr. Robert Simoni Stanford University Dept of Biological Sciences Stanford, CA 94305-5020 Dr. Jeanne Sinkford, DDS Director, Office of Women and Minority Affairs American Association of Dental Schools Dean Emeritus, Howard University College of Dentistry Washington, DC 20036-2212 Dr. James Staros Professor and Chair Department of Molecular Biology Vanderbilt University College of Arts and Sciences Nashville, TN 37232-0146 Dr. Palmer Taylor Department of Pharmacology School of Medicine University of California San Diego La Jolla, CA 92093-0636 $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NICHD-CD-95-03 ******************************************* STATISTICAL AND CLINICAL COORDINATING CENTER FOR THE CLINICAL NETWORK FOR CONTRACEPTIVE RESEARCH NIH GUIDE, Volume 24, Number 16, May 5, 1995 RFP AVAILABLE: NICHD-CD-95-03 P.T. National Institute of Child Health and Human Development The Contraceptive Development Branch and the Contraceptive and Reproductive Evaluation Branch of the Center for Population Research of the National Institute of Child Health and Human Development (NICHD) is seeking an organization to support a network of clinical sites conducting contraceptive clinical trials necessary for FDA approval of new contraceptive drugs and devices and further evaluation of existing drugs and devices. The statistical and clinical coordinating center will provide the statistical, protocol development, clinical monitoring, data management and data analysis support for the coordination of this multicenter clinical trials network. The NICHD anticipates initiating evaluation of as many as seven spermicides, four male condoms, three female devices, and two other contraceptive drugs between 1995 and 1999. All responsible sources may submit an offer that will be considered by the agency. It is anticipated that one cost reimbursement, incrementally funded term form contract will be awarded under the RFP for a period of five years, beginning October 1, 1995. This RFP is a new competition. This announcement is not a request for proposals (RFP). RFP NICHD-CD-95-03 will be issued on or about April 27, 1995. Proposals will be due approximately 60 days thereafter. The Standard Industrial Code assigned to this acquisition is 7379 and the size is $18 million. INQUIRIES The proposed contract is 100 percent set-aside for small business concerns. Copies of the RFP may be obtained by sending a written or FAX request to: Paul J. Duska Contracts Management Branch National Institute of Child Health and Human Development Executive Building, Suite 7A-07 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 FAX: (301) 402-3676 $$R1 END ************************************************************ $$R2 BEGIN DA-95-004 FULL-TEXT ************************************** COOPERATIVE DRUG ABUSE TREATMENT OUTCOME STUDY NIH GUIDE, Volume 24, Number 16, May 5, 1995 RFA AVAILABLE: DA-95-004 P.T. National Institute on Drug Abuse Letter of Intent Receipt Date: June 23, 1995 Application Receipt Date: July 21, 1995 PURPOSE The purpose of this Request for Applications (RFA) is to support a cooperative agreement (U01) to study drug abuse treatment in typical, stable programs. Investigators may propose research based on or incorporating existing data sets to which they have access. Under the cooperative agreement, the National Institute on Drug Abuse (NIDA) will also make available data collected under NIDA contracts (the "DATOS family of studies") for further collaborative analyses. Cooperative agreement investigators will also design and conduct follow-up studies of drug abuse treatment clients that were interviewed in the DATOS family of studies. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Cooperative Drug Abuse Treatment Outcome Study, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (date line 301-402-2221) and the NIH Gopher (gopher.gov.nih), and email from the program contact listed below. Services Research Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-30 Rockville, MD 20857 Telephone: (301) 443-4060 Email: FTIMS@AOADA.SSW.DHHS.GOV $$R2 END ************************************************************ $$P1 BEGIN PA-95-057 FULL-TEXT ************************************** HIV RISK BEHAVIORS, DETERMINANTS, AND CONSEQUENCES NIH GUIDE, Volume 24, Number 16, May 5, 1995 PA AVAILABLE: PA-95-057 P.T. National Institute on Drug Abuse PURPOSE The purpose of this program announcement is to stimulate research on the social and other environmental factors that influence the drug injecting and sexual HIV risk behaviors of drug users and their sexual partners. Behaviors do not occur independent of, but are shaped by, the social and physical environment, as well as the individual's psychological and physiological status. By understanding how characteristics of the environment act and interact with each other, and with other characteristics of the individual, more effective HIV prevention strategies can be developed. Important aspects of this concept involve improving knowledge of factors that determine the temporal variability in risk behaviors, i.e., why risk behaviors occur at some times and not at others, and of factors underlying behaviors that protect against HIV transmission. Populations of interest include injecting drug users (IDUs), sexual partners of IDUs, and non-injecting drug users whose HIV risk behaviors may be related to their drug use. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, HIV Risk Behaviors, Determinants, and Consequences, is related to the priority area of reducing HIV transmission. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202 783-3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Richard H. Needle, Ph.D., M.P.H. Community Research Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-30 Rockville, MD 20857 Telephone: (301) 443-6720 Email: rn28e@nih.gov $$P1 END ************************************************************ $$P2 BEGIN PAR-95-058 FULL-TEXT ************************************* MINORITY RESEARCH INFRASTRUCTURE SUPPORT PROGRAM NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA AVAILABLE: PAR-95-058 P.T. 34, FF; K.W. 0710030, 0715095 National Institute of Mental Health PURPOSE The Minority Research Infrastructure Support Program (M-RISP) has been established by the National Institute of Mental Health (NIMH) in response to recommendations made by scientists from predominantly minority academic institutions to build mental health research programs in these settings. The purpose of M-RISP is to increase the capacity of minority institutions and their faculty to conduct rigorous mental health-relevant research. The intent of the research infrastructure program is to strengthen the research environments of minority institutions through grant support to develop and/or expand existing capacities for conducting behavioral and neuroscience research in all fields related to mental health. Minority students will benefit from participation in projects as research assistants and will be encouraged to pursue careers in fields related to mental health. To facilitate the goals of assisting institutions increase their capacity to conduct mental health research, the M-RISP program provides support for two types of core activities: (1) Institutional research development support, to strengthen the institutional infrastructure and enhance the capability of individual faculty members to undertake mental health-related research; and (2) Individual investigator research support, for developing research scientists to conduct small grant research activities that can lead to successful applications for funding under regular research grant mechanisms. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Minority Research Infrastructure Support Program, is related to the priority area of mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The PA, which describes the institutional developmental and individual investigator research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and email from the program contact listed below. Rodney R. Cocking, Ph.D. Office for Special Populations National Institute of Mental Health Parklawn Building, Room 17C-14 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3641 FAX: (301) 443-8552 Email: RC4@CU.nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-95-059 FULL-TEXT ************************************** LOCAL POPULATION/AREA EPIDEMIOLOGIC RESEARCH ON DRUG ABUSE NIH GUIDE, Volume 24, Number 16, May 5, 1995 PA AVAILABLE: PA-95-059 P.T. National Institute on Drug Abuse PURPOSE The purpose of this program announcement is to encourage research on the local population/area epidemiology of drug abuse and its correlates and consequences. Research support mechanisms include research project grants (R01), small grants (R03), and First Independent Research and Transition (FIRST) (R29) awards. Small grants provide research support of up to $50,000 per year in direct costs plus appropriate indirect costs for up to two years FIRST (R29) awards provide support for five years and up to $350,000 in direct costs over the entire project period. HEALTH PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000,: a PHS-led national activity for setting priority areas. This program announcement, Local Population/Area Epidemiologic Research on Drug Abuse, is primarily related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0, or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Peter Hartsock, Dr. P.H. Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-53 Rockville, MD 20857 Telephone: (301) 443-6720 Email: ph45z@nih.gov $$P3 END ************************************************************ From owner-sci-resources@net.bio.net Fri May 05 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-059 - V24(16) 05/05/95 Date: 5 May 1995 18:30:02 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 431 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3oejeq$nh@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95059 PA-95-059 P1O1 *************************************** LOCAL POPULATION/AREA EPIDEMIOLOGIC RESEARCH ON DRUG ABUSE NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA NUMBER: PA-95-059 P.T. National Institute on Drug Abuse PURPOSE The purpose of this program announcement is to encourage research on the local population/area epidemiology of drug abuse and its correlates and consequences. HEALTH PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Local Population/Area Epidemiologic Research on Drug Abuse, is primarily related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT Research support mechanisms include research project grants (R01), small grants (R03), and First Independent Research and Transition (FIRST) (R29) awards. Because the nature and scope of the research proposed in response to this program announcement may vary, it is anticipated that the size of an award will vary also. Small grants provide research support of up to $50,000 per year in direct costs plus appropriate indirect costs for up to two years. FIRST awards provide support for five years and up to $350,000 in direct costs over the entire project period. RESEARCH OBJECTIVES Background Many national-level drug abuse epidemiologic studies have been conducted to date, but at present, compelling public health needs have mandated the development of a coordinated program of research on the local-level population/area epidemiology of drug abuse and its correlates and consequences. Epidemiology, which is the study of disease/health problems within and across populations and across time, is both a method and a perspective that seeks to elucidate factors associated with the causes of the disease/health problems as well as with the progression of these problems and the variance in their clinical manifestation. These factors and their relationships form "webs of causation," which need to be scrutinized through a mix of epidemiologic research approaches. In this respect, the need for epidemiologic studies of local populations to determine underlying connections between drug abuse, infectious diseases, and violence and accidents was recognized at the recent (Nov 1994) White House Conference on Health, Safety, and Food. Various forms of local-level drug abuse epidemiologic research have been undertaken in the past but rarely in a manner that coordinated both quantitative (e.g., probability-based surveys) and qualitative (e.g., "trained observational") approaches so as to maximize both their unique contributions and their complementary/combined or synergistic potential. This program announcement encourages such coordination. Additionally, while the major focus of this program announcement is on local drug abuse epidemiology, attention is encouraged on closer coordination of epidemiology with, thus helping to guide, prevention planning. Such coordination has not been undertaken on a wide scale and particularly with applicability for meeting local-level public health needs. Local-level applications of epidemiology together with prevention will help to meet national-level public health needs. "Local" in this case refers to the state level down to the community level. Community can be defined in census tract, mental health catchment area and other geographic terms, as well as by demographic terms, including cultural/racial groupings in defined local areas (e.g., Hispanic or African American clusters in cities) and in undefined geographic areas (e.g., Native Alaskan communities). Community can also include groups designated by sexual orientation (e.g., gays) in local geographic settings and also by numerous other definitions. Other terms for community include but are not limited to "street-level," and "neighborhood." The direction towards local population/area research, coupled with better coordinated quantitative and qualitative research approaches and with epidemiology more closely allied with and helping to direct the dispersal of prevention resources, is important now as never before, especially considering the public health prominence of drug abuse and related correlates and consequences such as AIDS. This direction is also important because, in an era of both pressing public health needs and major budget constraints, resource distribution needs to be guided more efficiently. Investigators are encouraged to build on existing locally-based initiatives such as the Community Epidemiology Work Group (CEWG) sites, Drug Use Forecasting (DUF) sites, Center for Substance Abuse Prevention (CSAP)-funded Community Coalitions, and AIDS outreach community systems. Program Description Two areas of research are sought through this program announcement. These areas include methodological and content research as applied to the local population/area epidemiology of drug abuse and its associated problems. Examples of the research areas to be addressed are provided below. Research Areas: Methodology and Content Applications are encouraged that focus on methodological research dealing with improving our means (e.g., cross-sectional versus longitudinal survey approaches) for determining the epidemiology of local-level drug abuse and related problems. Applications are also encouraged that concern "content" or the determination of specific epidemiologic patterns of local drug abuse and associated problems (e.g., transitions from non-injecting to injecting drug use and vice versa among African Americans, Hispanics, and whites in designated inner city areas; implications for the spread of HIV or violence and crime). The areas of methodology and content are not meant to be mutually exclusive, however, and creative applications are encouraged that address in a coordinated manner the need for better information in both areas. Additionally, methodological and/or content studies are encouraged that strengthen bridge-building and coordination between local population/area epidemiology and prevention. Such enhanced coordination, particularly in light of special public health problems such as drug abuse's high association with AIDS and violence, is of great importance. Researchers are thus encouraged to test new methods or new combinations of methods that meet the need for greater understanding the epidemiology of these problems and their interrelationships at the local level and with attention paid to how epidemiology may guide prevention. The following are intended as examples of areas of research interest: Methodology o Refine and strengthen the procedures and parameters for both determining and predicting local population/area drug abuse epidemiology. o Refine our understanding of the strengths and weaknesses of quantitative and qualitative research methodologies. a. Clarify the appropriateness and applications of quantitative methods to provide accurate incidence, prevalence, trend, and predictive estimates of local population/area drug abuse and its correlates and consequences. b. Clarify the appropriateness and applications of qualitative methods, both to provide 1. an in-depth knowledge of behavior (e.g., quantitative surveys have looked at needle sharing behavior among drug users but apparently have ignored and/or been unable to obtain information on needle sharing between drug users and their sexual partners; this is the kind of difficult-to-obtain information necessary for understanding local drug use patterns that can be provided through qualitative methods); and 2. a critical bridgehead into local populations/areas that can then be exploited by quantitative methods (e.g., the original NIDA-supported R01 AIDS outreach research that combined qualitative and quantitative methods to develop epidemiologically-targeted and assessed prevention). o Issues of research design, dealing with cross-sectional versus longitudinal approaches for local-level drug abuse epidemiologic research should be explored. o In both quantitative and qualitative research methodologies, issues of precision, reliability, and validity of measures (e.g., self-report) should be explored. o In methodological research on both quantitative and qualitative approaches, special emphasis should be placed on how to accurately determine race, gender, socio-economic status, community, culture, and other social and structural variables associated singly or in combination (e.g., "webs of causation") with the epidemiology of drug abuse and its correlates and consequences at the local level. Special research emphasis should be placed on women, minorities, and youth. o The use of alternative/complementary measures (e.g., "molecular epidemiology": polymerase chain reaction (PCR), which enables us to determine needle sharing behavior and HIV status independent of, and confirmatory to, self report) and their application to local drug abuse epidemiology should be explored. o Methodological studies are needed that investigate both separate use and integration of such various data elements as a. indicator data, including: data from direct measurement (e.g., blood and urine samples, psychological exams), data from indirect measurement (e.g., "ecological" indicators--census and vital statistics data) b. observational data (e.g., ethnographic studies) c. survey data d. modeling data, which can integrate indicator, observational, and survey data. o Methodological studies should be conducted to develop instruments that are comparable between areas and between populations. Geographic and demographic comparability is essential for the efficacious and equitable allocation (i.e., targeting) of prevention resources to local areas and populations. o Methodological studies should be conducted to specifically address the issue of human subjects protection. This is no small issue but, indeed, grows bigger as the defined area and/or population grow smaller. Drug abuse, itself, and related problems such as AIDS carry serious social stigma. The more delimited the geographic area and/or demographic group, the greater risk of serious leaks of personal information and compromise of human subjects protection agreements. Such leaks can happen directly, as in the case of an acquaintance of a drug user seeing them go into a test site. Leaks can happen indirectly, as in the case of rural drug abuse and AIDS in a southern state, where, because of the public publication of vital statistics data, direct pin-pointing of HIV positive drug users in small communities was undertaken by non-public health persons. Content o Describe incidence, prevalence, trends and predictions of drug abuse patterns and related problems (e.g., HIV, crime, violence) and associated high-risk behavior (e.g., needle sharing, sex for crack), in local populations and areas. o Explore different forms of local drug use (e.g., non-injecting, injecting) and the dynamics contributing to the prevalence of one form versus the other, the transition/evolution from one form to another, and the cessation of drug use (e.g., through death, treatment, prevention, "natural recovery"). Special emphasis should be placed on determining not only risk factors for various forms of drug use but protective factors as well. o Identify situational factors (e.g., shooting galleries, crack houses, economically depressed areas, prisons, migrant camps) that contribute to varying patterns of local drug use and associated problems. o Delineate the role of social and structural factors (e.g., community, culture, socio-economic status, race, gender), separately or in combination (e.g., "webs of causation") in the epidemiology of local drug use and its correlates and consequences. o Specify the role of cognitive processes (e.g., decision making) in local drug use and associated risk taking. o Identify the role of economic forces (e.g., "supply" and "demand"), and social and political forces (e.g., strong grass roots and governmental opposition to the drug trade and drug use) in local drug use epidemiology. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard receipt dates indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained >From the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, telephone 301/594-7248. The title and number of the program announcement must be typed in Section 2a on the face page of the application. FIRST applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710* Bethesda, MD 20817 (for express/overnight delivery service) REVIEW CONSIDERATIONS Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Small grants (R03) do not receive a second level review. Review Criteria o Scientific or technical significance and originality of the proposed research; o Appropriateness and adequacy of the research approach and methodology proposed to carry out the research; o Qualifications and research experience of the Principal Investigator and staff; o Availability of resources necessary to the research; o Appropriateness of the proposed budget and duration in relation to the proposed research; and o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, and safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the NIDA. The following will be considered in making funding decisions: quality of the proposed project as determined by the peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries on the scientific and programmatic aspects to: Peter Hartsock, Dr.P.H. Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-53 Rockville, MD 20857 Telephone: (301) 443-6720 Email: ph45z@nih.gov Direct inquiries regarding fiscal matters related to drug abuse relevant studies to: Dr. Gary Fleming Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-6710 Email: gfleming@aoada2.ssw.dhhs.gov AUTHORITIES AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistant No. 93.279. Awards are made under authorization of the Public Health Service Act, Section 301, and administered under PHS policies and Federal Regulations at 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Grants must be administered in accordance with the Public Health Service Grants Policy Statement (DHHS Publication No. (OASH) 82-50-000 GPO 0017-020-0090-1 (rev. 4/94). The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Fri May 05 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-95-058 - V24(16) 05/05/95 Date: 5 May 1995 18:29:46 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 475 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3oejea$n3@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAR95058 PAR-95-058 P1O1 ************************************* MINORITY RESEARCH INFRASTRUCTURE SUPPORT PROGRAM NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA NUMBER: PAR-95-058 P.T. 34, FF; K.W. 0710030, 0715095 National Institute of Mental Health PURPOSE The Minority Research Infrastructure Support Program (M-RISP) has been established by the National Institute of Mental Health (NIMH) in response to recommendations made by scientists from predominantly minority academic institutions to build mental health research programs in these settings. This program announcement supersedes the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) Minority Institutions Research Development Program (MIRDP) program announcement, dated April 1989. The purpose of M-RISP is to increase the capacity of minority institutions and their faculty to conduct rigorous mental health-relevant research. The intent of the research infrastructure program is to strengthen the research environments of minority institutions through grant support to develop and/or expand existing capacities for conducting behavioral and neuroscience research in all fields related to mental health. Minority students will benefit from participation in projects as research assistants and will be encouraged to pursue careers in fields related to mental health. To facilitate the goals of assisting institutions increase their capacity to conduct mental health research, the M-RISP program provides support for two types of core activities: (1) Institutional research development support, to strengthen the institutional infrastructure and enhance the capability of individual faculty members to undertake mental health-related research; and (2) Individual investigator research support, for developing research scientists to conduct small grant research activities that can lead to successful applications for funding under regular research grant mechanisms. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Minority Research Infrastructure Support Program, is related to the priority area of mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications for M-RISP may be submitted by domestic public and private universities, four-year colleges, non-profit and for-profit domestic organizations such as hospitals, laboratories, units of public agencies of State or local governments, eligible agencies of the Federal government, or other institutions conducting research in mental health related fields. The applicant must indicate which of the following eligibility conditions applies to the institution: o An academic institution with at least 55 percent minority (Black, Hispanic, American Indian or Alaskan Native, Asian or Pacific Islander) student enrollment. o An institution with more than 30 percent minority student enrollment in each of the past three years that can provide evidence of efforts to recruit members of ethnic or racial groups into scientific careers. Additionally, the institution should show evidence of demonstrated commitment to minority faculty recruitment and development in expenditure of resources, as well as documented institutional need for support in its research development program. Potential applicants who intend to apply under this eligibility criterion are advised to consult with NIMH staff (as listed under Inquiries) before submitting an application. o An Indian tribe may apply in conjunction with one or more institutions of higher learning that offer undergraduate and graduate degrees in mental health-related fields. Such applicants must have a recognized governing body and perform substantial governmental functions, or qualify as an Alaska Regional Corporation (ARC) as defined in the Alaska Native Claims Settlement Act (43 U.S.C. 1601 et seq.). Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Grants awarded under the M-RISP program will use the resource-related research projects mechanism (R24) of the National Institutes of Health (NIH). This mechanism is used to support research projects that enhance capabilities to contribute to extramural research of the Public Health Service (PHS). Grants funded under M-RISP are awarded directly to the applicant institution and are nontransferable. Allowable Costs Each application should include proposals related to both core elements (Institutional Research Development Support and Individual Investigator Research Projects) and indicate how the infrastructure support will enhance the individual research projects. In some cases, the application may also request support for Research Assistantships for students to work with faculty members who have research funding through another mechanism of support. Institutions are encouraged to use funds under M-RISP to increase availability of Research Assistants on these projects, not to be used to replace any Research Assistant positions supported by other Federal or non-Federal awards. The NIMH recognizes that different types of institutions will require different types of research infrastructure development activities and initiatives, depending upon particular needs and circumstances. Accordingly, this announcement provides general rather than specific guidance as to the types of development activities appropriate under M-RISP. Support may be requested for, but is not limited to, the following: o Partial salary support for persons engaged in the project o Research training for junior investigators o Scientific and statistical consultation, including expenses incurred by a scientific advisory committee o Biostatistical and data management services o Research technicians and assistants o Research instruments o Small, project-specific equipment o Pilot and feasibility studies o Research subject costs o Data acquisition costs FUNDS AVAILABLE The average M-RISP grant is $300,000 per year plus negotiated indirect costs. The infrastructure core component of most M-RISP grants averages $50,000 per year, direct costs. Individual Investigator projects average $50,000 per year, direct costs. Support is limited to three years for the first-time application. The core, infrastructure component of an M-RISP grant is renewable for intervals of up to five years. Competitive renewals are permitted so long as new Individual Investigators of subprojects are supported by the program. Individual Investigators who participate in subprojects on the M-RISP grant should not expect more than a total of six years of support through the M-RISP program. RESEARCH OBJECTIVES Background M-RISP is designed to enable predominantly minority institutions with small research programs in mental health to develop into significantly stronger research settings. It is part of an integrated NIMH approach to developing a broader national infrastructure for mental health research that includes NIMH support for clinical and services research centers, minority research centers, rural mental health research centers, social work research development centers, research infrastructure support programs, and M-RISP. Together, these programs provide a continuum of research infrastructure support for institutions. To facilitate these goals, M-RISP provides support for two types of primary activities: Institutional Research Development Support M-RISP provides support to strengthen the institutional infrastructure so as to enhance the capability of individual faculty members to undertake mental health research. Requests may be made for infrastructure enhancements such as laboratory development, including limited support for equipment, support of collaborative linkages with senior scientists in other institutions, and provision of resources for data management and statistical analyses. For individual faculty development, support may be requested for such activities as enrolling in advanced seminars in scientific techniques, and for pilot work to serve as a basis for the development of individual research projects. Individual Investigator Research Projects. In addition to capacity development support, an M-RISP grant provides support for at least two initial or developmental research subprojects from at least two or more faculty members who serve as Individual Investigators of these subprojects. The intent of this component of M-RISP is to support research activities that will lead to successful applications for funding under the usual investigator-initiated grants programs of NIMH. Individual Investigator projects should be designed to take advantage of the infrastructure development being supported by the program. In addition to these two main elements in M-RISP, an optional component is also available for faculty members who have obtained research funding for mental health research through other sources of funds. Research Assistantships for Associate Investigator Projects. Investigators under this program are research project directors whose funding for the research project has been obtained from other sources (including Federal, State, local, and/or private support). In such cases, additional funds may be requested through M-RISP to support minority undergraduate or graduate students to serve as research assistants on the funded research projects. Application Characteristics An M-RISP application must present a plan that (1) assesses current institutional and faculty capacity to conduct mental health-related research; (2) identifies unmet needs; and (3) describes activities that will be undertaken to develop and strengthen the institutional research infrastructure. The plan should include both an institutional research development program and two or more individual investigator projects. The plan should cover a period of three years (up to five years for competitive renewals) and indicate how the capacity to conduct mental health research will be improved significantly in this time period. The application should contain the following: Institutional Research Development Plan o Specific aims o Summary of relevant ongoing mental health research o Assessment of institutional capacity to conduct state-of- the art research on mental health issues; identification of gaps which M-RISP is intended to fill o Design and procedures to be used to accomplish the specific aims of the research infrastructure development plan over the time period of the proposed project (3 years for new applications; up to 5 years for competitive renewal applications), including plans for administrative structure, recruitment and retention of persons skilled in mental health research, staff training and mentoring, statistical and other consultation and data management, and collaboration with other institutions o Description of equipment, space, and other facility resources available to support the development plan and extent to which enhancement of these resources is needed o Description of institutional financial commitment to support the proposed minority mental health research infrastructure development o Brief descriptions (1 page each) of individual research studies that will be undertaken as part of infrastructure development, including plans for data collection and analysis The research plan section of the application is limited to 25 pages. Individual Investigator Research Projects o Linkages to overall institutional capacity development plan o Specific aims o Background and significance o Progress report/preliminary studies o Literature review o Research plan, including experimental design and methods o Protection of human subjects, where applicable o Protection of vertebrate animals, if applicable o Consultants and collaborators o Consortium/contractual arrangements o Detailed budgets for each project The research plans for the Individual Investigator Research Projects are limited to 25 pages each. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Applications will be accepted annually on the single receipt date of June 1 and reviewed on the following schedules: Application Receipt Date: June 1 Initial Review Group: Oct/Nov Council Meeting: Jan/Feb Earliest Start Date: April 1 Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The title and number of the program announcement must be typed in Section 2a on the face page of the application: NIMH MINORITY RESEARCH INFRASTRUCTURE SUPPORT PROGRAM. Applicants should specify in Item 2b that the R24 mechanism is being used. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040-MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for courier/overnight mail service) REVIEW CONSIDERATIONS Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIMH in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second-level review by the National Advisory Mental Health Council. Review Criteria Institutional Research Development Plan o significance of overall project to the goals of this program announcement o appropriateness of the institutional research development plan for applicant institution and extent to which this plan will build on current institutional support for mental health research and significantly augment and improve the support for research o quality of the institutional research development plan, including plans for enhancing institutional capacity and individual faculty research development plans and the degree to which the parts enhance one another in achieving overall objectives o probability that proposal can be implemented successfully, and the likelihood that it will result in competitive research proposals from individual faculty members o experience and appropriateness of the Program Director o evidence of institutional support and commitment to the proposed program Individual Investigator Research Projects o significance and originality of proposed research and potential for publication o adequacy of literature review and justification of the proposed theoretical framework o appropriateness and scientific quality of the experimental approach and methodology proposed to carry out the research, including appropriateness of control or comparison groups, plans for recruitment and retention of subjects, use of consultants, and provisions for other scientifically necessary linkages o qualifications and research experience of the Individual Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research o for competitive renewals, progress report and publications associated with prior funding period o availability of the resources necessary to perform the research, including access to research subjects o appropriateness of the proposed budget and duration in relation to the proposed research o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research o contribution of Associate Investigator Projects to overall objectives of institutional infrastructure plan and benefits to students participating on the associated projects The initial review group will also examine the provisions for the protection of human and animal subjects. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to NIMH. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. Priority will be given to those institutions or departments with no other support for infrastructure. SPECIAL REQUIREMENTS Grant funds may be used for expenses clearly related to infrastructure development and necessary to conduct research projects, including both direct costs which can be specifically identified with the project and allowable indirect costs for the institution. Funds may not be used to establish, add a component to, or operate a treatment, rehabilitation, or prevention intervention service program. Support for research related treatment, rehabilitation, or prevention services and programs may be requested only for costs required by the research. These costs must be justified in terms of research objectives, methods, and designs which promise to yield generalizable knowledge and/or make a significant contribution to theoretical concepts. When independent research funds become available to support Individual Investigator Research Projects, the proposed reallocation of existing funds will be discussed with appropriate Institute staff on a case by case basis. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Rodney R. Cocking, Ph.D. Office for Special Populations National Institute of Mental Health Parklawn Building, Room 17C-14 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3641 FAX: (301) 443-8552 Email: RC4@CU.nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-3065 Email: DT21A@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994). The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and to promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. From owner-sci-resources@net.bio.net Fri May 05 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-057 - V24(16) 05/05/95 Date: 5 May 1995 18:29:38 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 360 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3oeje2$mo@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95057 PA-95-057 P1O1 *************************************** HIV RISK BEHAVIORS, DETERMINANTS AND CONSEQUENCES NIH GUIDE, Volume 24, Number 16, May 5, 1995 PA NUMBER: PA-95-057 P.T. National Institute on Drug Abuse PURPOSE The purpose of this program announcement is to stimulate research on the social and other environmental factors that influence the drug injecting and sexual HIV risk behaviors of drug users and their sexual partners. Behaviors do not occur independent of, but are shaped by, the social and physical environment, as well as the individual's psychological and physiological status. By understanding how characteristics of the environment act and interact with each other, and with other characteristics of the individual, more effective HIV prevention strategies can be developed. Important aspects of this concept involve improving knowledge of factors that determine the temporal variability in risk behaviors, i.e., why risk behaviors occur at some times and not at others, and of factors underlying behaviors that protect against HIV transmission. Populations of interest include injecting drug users (IDUs), sexual partners of IDUs, and non-injecting drug users whose HIV risk behaviors may be related to their drug use. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, HIV Risk Behaviors, Determinants, and Consequences, is related to the priority area of reducing HIV transmission. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202 783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT Research support mechanisms include traditional research project grants (R01), small grants (R03), and FIRST (R29) awards. Submissions as Investigator-Initiated Interactive Research Project Grants (IRPG) may be made. For information on the IRPG mechanism, see NIH Guide for Grants and Contracts, Vol. 23, No. 28, July 29, 1994. Because the nature and scope of the research proposed in response to this program announcement may vary, it is anticipated that the size of an award will also vary. Traditional research project grants (R01) provide support for up to five years. Small grants (R03) provide research support of up to $50,000 per year in direct costs plus appropriate indirect costs for up to two years. FIRST (R29) awards provide support for five years and up to $350,000 in direct costs over the entire project period. RESEARCH OBJECTIVES Background and Significance Injection drug use and sexual activity with injecting drug users are increasingly important modes of HIV transmission in the United States. Of 396,015 adult cases of AIDS reported to the CDC through June 1994, 31 percent were injecting drug users and 3.5 percent were sexual contacts of IDUs. Of reported cases of AIDS among women in the U.S., 48 percent were attributable to injection drug use and 20 percent were attributable to heterosexual contact with a male IDU, making these the first and second highest exposure categories, respectively, in women. Thirty eight percent of the 5,734 pediatric AIDS cases were in children of mothers who injected drugs; 17 percent were in children of mothers who were sex partners of IDUs. Non-injecting drug use has also been associated with increased HIV risk, (e.g., in homosexual and bisexual men, in sexual exchanges for "crack" cocaine). Of particular concern is that the proportion of cases related to drug abuse has steadily increased over the last decade. Among drug users and their sexual partners, considerable variability exists in the extent of HIV risk behaviors, not only among different individuals, but also for each person over time and from one situation to another. Factors that influence involvement in risky behaviors are not well understood. Research has focused primarily on specific risk behaviors and on the individual "at risk." Relatively little attention has been given to the contextual, situational, or temporal variability in these behaviors. Of special interest is the episodic nature of HIV risk-taking behaviors and the factors that account for change and/or stability of such behaviors. Research on situational and other environmental factors that influence decisions to engage in behaviors known to transmit HIV are needed to enhance the development of effective strategies to prevent infection with HIV. Program Objectives The primary goal of this program announcement is to improve the knowledge base on social and other environmental factors influencing drug-related HIV risk behaviors. Studies should be focused on hypothesis generation and testing in order to discover and clarify determinants of HIV-related risk behaviors. Study designs should result in data on antecedents and consequences of behavior that initiate, increase, maintain, or diminish risk behaviors. Variables may be selected from one or several domains of social, cultural, economic, psychological, environmental, or physiological factors. Applications using the dyad or social network within which risk behaviors occur as the unit of study are encouraged. Studies are also encouraged that will enhance understanding of why some individuals engage in certain types of risk behaviors that others encountering many of the same influences do not. While intervention studies are not the focus of this program announcement, it is intended that the knowledge gained from studies supported will identify factors amenable to intervention. Thus, research under this program announcement should be applicable to public health interventions and intervention research. The developmental phases of risk behaviors also need to be studied to determine when transitions occur and when would be the best opportunities for intervention and change. For example, we need to improve understanding of the impact of social and cultural factors on the development of drug injection and drug-use related sexual behaviors, identification of competing needs and choices that are involved in situations in which risky behaviors occur, assessment of the impact of factors such as perceptions of HIV prevalence and community (social network) drug use patterns, and delineation of relationships between developmental processes and risk, (e.g., adolescent's establishment of independence from family). Other examples of areas of interest include, but are not limited to: a. Initiation of drug injection, including factors influencing the transition from non-injecting to injecting use, e.g., assessment of the roles of social networks, peer influence, and community influences. b. Continuation of injecting drug use with particular examination of injection patterns associated with use of specific drugs or drug combinations, sharing of needles and other paraphernalia, sexual risk, gender roles, and choice of location for drug use. c. Physiologic effects of drugs (e.g., withdrawal, impaired learning or reasoning while abusing drugs) and their interaction with psychological, social, and environmental factors in determining the natural history of drug use and HIV risk behaviors. d. Factors affecting decisions to use risk reduction strategies, such as bleach disinfection, refraining from sharing, discontinuing injection, or participation in needle exchange programs; factors related to relapse from these risk reduction strategies to behavior with increased risk levels. e. Sexual risk behaviors associated with drug use, such as the mechanisms by which "crack" cocaine use, methamphetamine use, or specific aspects of drug use among homosexual or bisexual men, adolescents, women, and other under-studied groups contribute to risk. f. Aspects of the social dyad, social networks, peer influences, peer group composition, and beliefs about gender roles that may contribute to sexual risk taking in conjunction with or separate from drug use. g. Environmental and community-level structural factors that may be associated with level of HIV risk, including factors such as the prevalence of drug use in a region or community, population trends, economic resources available to a community, access to sterile syringes, the presence of institutions that support family cohesion, etc. Regional or community-level interpersonal factors could also be studied, e.g., neighborhood cohesion, overlap of various social networks, communication styles, police-resident interactions, attitudes towards drug and alcohol users in the community, etc. h. Specification of factors that influence drug using and sexual behaviors in HIV seropositive drug abusers. i. Studies that specifically focus on understanding individuals who have avoided or reduced risk, despite the influence of factors normally associated with high levels of risk. Such studies should clarify protective factors, whether they be interpersonal, environmental, or intrapersonal. j. Studies of the relationship between the natural history of HIV infection and transmission risk and behaviors. k. Studies of the impact of cognitive and/or neurologic impairment that results from drug use as well as HIV infection on the decision-making processes involved in avoiding or engaging in risk behaviors. l. Studies on the time course of the multilevel processes (physiological, psychological, social, and environmental) that determine particular risk behaviors on the part of individuals. Such studies may involve naturalistic methodologies such as case histories, diary keeping, and the like. m. Studies to develop new or adapt existing methodologies to improve validity and reliability of measures, and to strengthen research designs and data analytic capabilities. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard AIDS receipt dates indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grant Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, telephone 301/435-0714. The title and number of this program announcement must be typed in Item 2a on the face page of the application. FIRST award applicants must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Small grants do not receive a second-level review. Review Criteria o Scientific, technical, or medical significance and originality of the proposed research; o Appropriateness and adequacy of the research approach and methodology proposed to carry our the research; o Qualifications and research experience of the principal investigators; o Availability of resources necessary to the research; o Appropriateness of the proposed budget and duration in relation to the proposed research; and o Adequacy of the plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. The initial review group will also examine the provisions for the protection of human and animal subjects, and safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the Institute. The following will be considered in making funding decisions: quality of the proposed project as determined by the peer review, availability of funds, and program priority. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Richard H. Needle, Ph.D., M.P.H. Community Research Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-30 Rockville, MD 20857 Telephone: (301) 443-6720 Email: rn28e@nih.gov Direct inquiries regarding fiscal matters to: Dr. Gary Fleming Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: gfleming@aoada2.ssw.dhhs.gov AUTHORITIES AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279 and 93.242. Awards are made under authorization of the Public Health Service Act, Section 301, and administered under PHS policies and Federal Regulations at 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Grants must be administered in accordance with the Public Health Service Grants Policy Statement (DHHS Publication No. (OASH) 82-50-000 GPO 0017-020-0090-1 (rev. 4/94). The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Fri May 05 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DA-95-004 - V24(16) 05/05/95 Date: 5 May 1995 18:30:12 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 954 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3oejf4$o2@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DA95004 DA-95-004 P1O1 *************************************** COOPERATIVE DRUG ABUSE TREATMENT OUTCOME STUDY NIH GUIDE, Volume 24, Number 16, May 5, 1995 RFA: DA-95-004 P.T. National Institute on Drug Abuse Letter of Intent Receipt Date: June 23, 1995 Application Receipt Date: July 21, 1995 PURPOSE The purpose of this Request for Applications (RFA) is to support a cooperative agreement to study drug abuse treatment in typical, stable programs. Investigators may propose research based on or incorporating existing data sets to which they have access. Under the cooperative agreement, the National Institute on Drug Abuse (NIDA) will also make available data collected under NIDA contracts (the "DATOS family of studies") for further collaborative analyses. Cooperative agreement investigators will also design and conduct follow-up studies of drug abuse treatment clients that were interviewed in the DATOS family of studies. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Cooperative Drug Abuse Treatment Outcome Study, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U01), an "assistance" mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, primary responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award." The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is September 30, 1995. Because the nature and scope of the research proposed in response to this RFA may vary, the size of an award will also vary. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the Institute, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. At this time NIDA anticipates that there will be a renewed competition after five years. If NIDA does not continue the program, awardees may submit grant applications through the usual investigator-initiated grants program. FUNDS AVAILABLE It is anticipated that approximately $1.3 million will be available to support the first year of the Cooperative Drug Abuse Treatment Outcome Study. It is anticipated that one award for the Coordinating Center will be made and two awards for Field Research Collaborative Centers will be made. The budget for the Coordinating Center is expected to be approximately one-third of the total in the first years but to increase proportionally, commensurate with follow-up fieldwork expenses, in the third through fifth years. RESEARCH OBJECTIVES Background The effectiveness of publicly-funded drug abuse treatment in treating heroin and opioid addiction was established by studies such as the Drug Abuse Reporting Program (DARP) and the Treatment Outcome Prospective Study (TOPS), which were conducted on cohorts entering treatment in 1969-73 and 1979-81, respectively. Since TOPS, patterns of drug use and the characteristics of clients presenting for drug treatment have changed, and major changes have taken place in the drug treatment system itself. These changes include the appearance of HIV/AIDS in drug abuse treatment populations, transmitted through injection drug use and drug-related sexual behavior; and the entry of new populations of drug users into treatment following the emergence of cocaine as a primary drug of abuse. At the treatment program/system level, changes include decreased levels of funding, the emergence of private third-party payors for drug abuse treatment, the significant development of a new modality (short-term inpatient care), and the evolution of existing treatment modalities related to funding changes and changes in patterns of drug use. Because of changes in treatment programs and practices, in client characteristics, and in drug use patterns, too little is currently known about the effectiveness of drug abuse treatment delivered in typical programs in the community despite a continuing need to understand what bearing these factors have on treatment outcomes. Furthermore, there are important research questions that could not be addressed in DARP or TOPS that may be examined with more recent data, such as the role of psychopathology in treatment outcomes. A broad range of important drug abuse treatment and health services research questions may be addressed through analyses of existing data, including data from investigator-initiated research and data >From previous large-scale research and evaluation studies, such as TOPS. Under the cooperative agreement, NIDA will also make available three current databases it has developed under contract. These databases were created under the DATOS, DATOS-Adolescent, and CTOS research, and are described briefly below. Cooperative agreement investigators are encouraged to capitalize on NIDA's investment in these studies by using data from the DATOS family of studies to conduct intensive collaborative analyses. DATOS family of studies. In 1989, NIDA initiated a series of studies whose goals, broadly, were to investigate drug abuse treatment in typical, stable programs in order to characterize treatment as it is usually delivered and its effectiveness for current treatment populations and drug abuse patterns; to investigate the role of client and program characteristics in determining outcomes; and to investigate the relation between impairment and outcomes during and after treatment. The DATOS family of studies includes the Drug Abuse Treatment Outcome Study (DATOS), the Drug Abuse Treatment Outcome Study of Adolescents (DATOS-Adolescent), and the Cocaine Treatment Outcome Study (CTOS). Each of these studies was developed and carried out under separate NIDA contracts with the Research Triangle Institute (RTI). The DATOS studies provide rich databases with potential to address important questions in treatment outcome and health services research. Data were collected in a number of domains, including demographics, alcohol and drug use, physical and mental health, income, illegal involvement, employment, cognitive functioning, motivation and readiness, HIV/AIDS risk behavior, and treatment process and outcomes. In each study, the data sets that were acquired were deliberately designed to contain far more research potential than can be realized under the existing contract procurements. Refer to Table 1, "Points of Interview in DATOS During and After Treatment," which is available from the program staff listed under INQUIRIES. For purposes of developing an informed application, DATOS, DATOS- Adolescent, and CTOS research design and instrumentation packages are available by written request from the Services Research Branch, at the address listed under INQUIRIES. DATOS. The Drug Abuse Treatment Outcome Study is a longitudinal prospective study of adults entering drug abuse treatment programs in 1991-1993. Drug abuse treatment programs were purposely chosen to represent drug abuse treatment delivered in typical stable programs. Program-level and client-level data were obtained. Under DATOS, intake data were collected on 10,000 adults in 99 drug abuse treatment programs in 11 cities. Data were collected at 1 and 3 months during treatment and at 12 months after treatment. The study obtained data on clients in four types of treatment programs, including methadone maintenance, short-term residential (hospital inpatient, chemical dependency), long-term residential (therapeutic community), and outpatient drug-free treatment. The 12-month follow-up sample of 4,500 was drawn from 85 programs. The follow-up is stratified on treatment modality, drug pattern, impairment level, and length of time in treatment. The major goal of DATOS is to evaluate treatment effectiveness. As part of this, secondary goals are to describe current drug abuse treatment populations in terms of demographic characteristics, psychological variables, sociocultural variables, treatment history, tenure, and during-treatment behaviors; to characterize existing modalities and interventions of treatment; to determine the relation between psychological impairment and treatment outcomes; and to determine the relationship between treatment outcomes and important client, program, and treatment factors. DATOS-Adolescent. The Drug Abuse Treatment Outcome Study of Adolescents is a longitudinal prospective study of drug abuse treatment effectiveness in the adolescent population based on a sample of outpatient and residential drug abuse treatment programs for adolescents. The methodology, research design, instrumentation, and objectives of DATOS-Adolescent are designed to parallel DATOS where possible. DATOS-Adolescent began in 1991 and is still underway. Under DATOS- Adolescent, intake and follow-up data will be collected from approximately 1,500 collateral or family members and 3,000 adolescents in approximately 35 public and private drug abuse programs in 8 to 10 cities from mid-1993 through early 1995. CTOS. The Cocaine Treatment Outcome Study is an accelerated, 2-year retrospective study of 772 clients from 23 DATOS program sites in seven cities (Chicago, Miami, Minneapolis, New York, Pittsburgh, Portland, and New Orleans), based on clinical records and a 12-month follow-up interview. The follow-up interview is identical to that used in DATOS, and baseline data were obtained retrospectively (at follow-up) to supplement clinical records. The goal of the study is to rapidly acquire more knowledge about outcomes for clients admitted to treatment with a primary diagnosis of cocaine dependence. Program Objectives This cooperative study has two objectives. The first objective is to conduct studies to learn more about treatment received in typical community-based drug abuse treatment programs, particularly with regard to questions of treatment effectiveness and outcomes, as well as other questions related to health services, such as access to and utilization of treatment services, and cost-effectiveness of treatment. Studies may be carried out using data from the public domain or data from other research and evaluation studies. It is expected that databases from the DATOS family of studies will constitute significant resources in meeting this objective. The second objective is to carry out long-term follow-ups of drug abuse treatment clients in the DATOS family of studies. This includes: a 36-month follow-up of adults in DATOS to assess drug use patterns and outcomes in the three years after treatment, investigate factors predictive of relapse, and identify patterns of health service utilization over time; and a 24-month follow-up of adolescents and their family members or collaterals in DATOS- Adolescent. Program Components This study will involve the cooperation of investigators from a Coordinating Center, Field Research Collaborative Centers, and the NIDA Services Research Branch, Division of Clinical and Services Research, in conducting treatment and health services research studies. Under the cooperative agreement, it is anticipated that one Coordinating Center and two Field Research Collaborative Centers will be supported. Separate applications are being solicited for a Coordinating Center and for Field Research Collaborative Centers to participate in this collaborative study. If an institution chooses to apply for multiple awards, there should be no overlap in research and support personnel. Coordinating Center The Coordinating Center has two unique functions. The first involves coordinating cross-site cooperative study project initiatives. The second involves follow-up data collection activities. Coordination of cross-site activities The Coordinating Center will be responsible for all executive secretariat functions, including organization of Steering Committee meetings and teleconferences, developing steering committee agendas, taking minutes of sessions, photocopying and distributing materials prior to steering committee sessions, and preparation of reports from the Steering Committee to the NIDA Project Officer (who will not be a NIDA Collaborating Scientist). The meeting agenda topics may include development of research issues, planning of collaborative arrangements, planning of studies and analyses on defined topics, discussion of strategies to facilitate expeditious dissemination of cooperative agreement research findings, progress reports, and reports of scientific findings. The Coordinating Center will function as a repository for data to be analyzed under this cooperative agreement (as permitted by the data owners), including data from the DATOS family of studies. The Coordinating Center will provide documented copies of data sets used in the cooperative agreement, technical assistance, and programming support related to data management to other cooperative agreement investigators. Follow-up data collection Not only are data collected in the DATOS family of studies a valuable resource; they also represent a potential for further long-term studies of factors that influence the outcomes of individuals treated for drug abuse. Follow-up studies may permit investigation of long-term impacts of changes in drug abuse treatment access, utilization, and effectiveness; long-term outcomes for those who entered drug treatment but dropped out prior to engaging in treatment, including their prior and subsequent treatment history and investigation of spontaneous remission of drug abuse without effective treatment; research on sub-groups of particular interest, such as sub-groups defined by psychopathology, or individuals abstinent after one treatment contrasted with continuing drug users; or patterns of drug abuse, service utilization, and outcomes over time. Because of the opportunities represented by the DATOS samples and the valuable expertise that can be provided by the cooperative agreement investigators, follow-up studies of subjects in the DATOS family of studies will be carried out under the cooperative agreement. Investigators from the Coordinating Center and the Field Research Collaborative Centers will collaborate on the research design and development of instrumentation for the follow-up studies. The Coordinating Center will provide fieldwork and administrative management of the follow-up data collection efforts. In conducting the follow-ups, comparability of essential data elements with data collected under NIDA contract for the 12-month follow-ups will be maintained. However, some data elements may be deleted, or it may be desirable to augment data previously collected. The cooperative agreement investigators should be prepared to review and alter instrumentation based on analyses of data and needs of the field. The Coordinating Center will insure that procedures for collecting follow-up data are uniform so that no problems arise with comparability across sites or across interviewed samples. The Coordinating Center will link follow-up data with existing data on DATOS and DATOS-Adolescent subjects. Under contract requirements for DATOS and DATOS-Adolescent, locator information has been retained, with appropriate protection of client confidentiality, to enable long-term follow-ups of individuals in the DATOS and DATOS-Adolescent samples. DATOS follow-up. It is planned that the Coordinating Center will carry out a 36-month follow-up of individuals who were in the DATOS 12-month follow-up sample. The DATOS 12-month follow-up sample frame consists of 4,500 clients from 85 drug abuse treatment programs. Coordinating Center applicants should budget to follow up 3,500 individuals. DATOS programs are in 11 cities--Chicago, Houston, Miami, Minneapolis, New Orleans, New York, Newark, Pittsburgh, Phoenix, Portland, and San Jose. The follow-up will involve developing and field-testing the follow-up interview; hiring and training field interviewers to conduct the follow-up interview; reproducing the 36-month follow-up questionnaire; conducting data entry, editing, and analysis of data; monitoring the quality of the follow-up data; and reporting to NIDA and the Steering Committee on the progress of the follow-up. DATOS-Adolescent follow-up. DATOS-Adolescent is the first longitudinal study of adolescents treated in typical community-based programs. As such, it presents a unique opportunity to follow a cohort of adolescents into adulthood to investigate long-term drug-using behavior and health service utilization patterns of clients admitted to drug treatment at an early age. In addition to the 36-month follow-up of adults in DATOS, applicants for the Coordinating Center should anticipate conducting a 24-month follow-up study of 3,000 adolescents and 1,500 collaterals in the third and fourth years of the cooperative agreement. Field Research Collaborative Centers The Field Research Collaborative Centers will collaborate with each other, with the Coordinating Center, and with NIDA investigators on drug abuse treatment studies using existing data sets to which they have access or data from the DATOS family of studies. Field Research Collaborative Centers will also carry out analyses using follow-up data collected under the cooperative study as these data become available. Applicants for Field Research Collaborative Centers should have expertise in large-scale multi-site services research in order to identify important research issues and carry out appropriate studies. Each Field Research Collaborative Center will have a strong research focus on particular areas relevant to drug abuse treatment evaluation research and health services research areas. In making an award, consideration will be given to Field Research Collaborative Centers that are complementary rather than overlapping in their areas of interest. Areas of research emphasis for a Field Research Collaborative Center might include: o Research on the relationships between client, program, and treatment factors, and treatment effectiveness. o Research on the impact of psychopathology, cognitive functioning, physical health, and other co-morbid conditions on outcomes during and after treatment. Conceptualization and development of a multidimensional index of impairment. o Investigation of models of drug abuse treatment in current practice, based on treatment structure and process variables, conceptualization of stage of recovery/readiness for treatment, or continuity of care models. Research to update treatment typologies. o Program-level health services research, including impact of various financing and reimbursement strategies on access, utilization, and outcomes; cost effectiveness of treatment; impact of health service delivery factors on drug abuse treatment outcomes; changes in drug abuse treatment and treatment outcomes over time. All research and analyses will be reviewed and approved by the Steering Committee, and the Steering Committee may negotiate collaborative study plans after award so that individual cooperative agreement components focus on complementary, non-duplicative research studies. Field Research Collaborative Center applicants should propose studies to investigate well-conceptualized research questions. The intent of this cooperative agreement is to advance scientific knowledge about the effectiveness of drug abuse treatment as it is typically practiced by conducting analyses addressing a wide range of questions of scientific and policy relevance. While not exhaustive, the following general areas may serve as points of departure for cooperative agreement studies: o Drug use prior to, during, and after treatment. o Prevalence of multiple impairments in the population entering drug abuse treatment, and relation to outcomes. o Changes in mental health indicators during treatment. The role of psychological factors in drug abuse treatment. o Factors related to treatment retention. o Comparison of services and process in different types of treatment. o Comparison of problem areas (e.g., Addiction Severity Index problem domains) before and after treatment. o Comparative costs and benefits of drug abuse treatment, by modality. o Impact of legal involvement on treatment entry, retention, and outcomes. o Effectiveness of interventions to reduce HIV/AIDS risk behaviors during and after treatment. Collaborative analyses of follow-up data. The conceptualization of addiction as a recurrent disorder marked by cycles of drug use, abstinence, and relapse raises new questions on the design, delivery, and utilization of health services. Research is needed to examine the long-term outcomes of drug abuse treatment in sub-groups defined by gender, race/ethnicity, age, and psychological functioning. Although not an exhaustive list, follow-up research may include: o The long-term impact of changes in drug abuse treatment access, utilization, a