From owner-sci-resources@net.bio.net Tue Sep 06 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 4 September 1994 Date: 6 Sep 1994 17:38:43 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 82 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <34j22j$vb@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: Letter Title: LCIS9401 DEFINING ALL-OPTICAL NETWORKS File size (bytes): 117847 STIS Filename: lcis9401 Title: LENG9401 NATIONAL SBIR/FEDERAL HIGH TECH CONFERENCES FOCUS ON SBIR PROGRAM, COMMERCIALIZING R&D, AND NEW PROGRAM OPPORTUNITIES File size (bytes): 3048 STIS Filename: leng9401 Document Type: Program Guideline Title: NSF 94-119 Mathematical Sciences Postdoctoral Research Fellowships File size (bytes): 41126 STIS Filename: nsf94119 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Program Guideline Title: NSF93-151--Postdoctoral Research Fellowships in Molecular Evolution File size (bytes): 367 STIS Filename: nsf93151 Also available: nsf93151.doc Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 53872 STIS Filename: sesvac ------------------------------------------------------------------------ ** 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, the text of your message should be as follows: get sesvac Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve sesvac, you would enter: ftp> get sesvac 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 Sep 12 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 12 September 1994 Date: 12 Sep 1994 18:38:17 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 91 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <352vq9$pf5@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: Recruit Title: Biologist (Science Assistant) File size (bytes): 3718 STIS Filename: vex9441 Title: Biologist (Science Assistant) File size (bytes): 3676 STIS Filename: vex9442 Title: Physicist/Chemist/Materials Scientist (Program Director) File size (bytes): 5150 STIS Filename: vex9443 Title: Systems Accountant (Special Assistant) File size (bytes): 5169 STIS Filename: vgs94116 Title: Computer Specialist File size (bytes): 5396 STIS Filename: vgs94117 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Program Guideline Title: NSF93-151--Postdoctoral Research Fellowships in Molecular Evolution File size (bytes): 32395 STIS Filename: nsf93151 Also available: nsf93151.doc Title: NSF 94-114 Postdoctoral Fellowships in Biosciences Related to the Environment File size (bytes): 26732 STIS Filename: nsf94114 Also available: nsf94114.doc Title: NSF 94-114 Postdoctoral Fellowships in Biosciences Related to the Environment File size (bytes): 26732 STIS Filename: nsf94114 Also available: nsf94114.doc ------------------------------------------------------------------------ ** 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 nsf94114, the text of your message should be as follows: get nsf94114 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf94114, you would enter: ftp> get nsf94114 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 Thu Sep 15 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-94-029 - V23(33) 09/16/94 Date: 15 Sep 1994 23:47:44 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 444 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <35bf2g$qnq@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AI94029 AI-94-029 P1O1 *************************************** PEDIATRIC AIDS: FACTORS IN TRANSMISSION AND PATHOGENESIS NIH GUIDE, Volume 23, Number 32, August 26, 1994 RFA: AI-94-029 P.T. 34, AA; K.W. 0715008, 0765033 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: November 15, 1994 Application Receipt Date: February 16, 1995 PURPOSE The Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for research designed to study transmission and pathogenesis of HIV-1 in infants and children. Applications are sought for laboratory studies that elucidate: (1) the timing and mechanism of transmission of HIV from mother to infant or (2) factors that determine whether infected children become long-term asymptomatic survivors or suffer from rapidly progressive disease. The NIAID seeks applications for research studies that utilize advances in virology, immunology, and genetics to address these questions. Of special interest are those basic research studies that hold promise for development of clinical strategies to prevent mother-to-infant transmission of HIV-1 or to treat perinatally infected children to prolong and improve the quality of their lives. For applications proposing use of clinical specimens, documented access to an adequate number of samples to address the study hypotheses will be required. 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), Pediatric AIDS: Factors in Transmission and Pathogenesis is related to the priority areas of: HIV infection, immunization and infectious diseases, and maternal and infant health. 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 202-782-3238). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private institutions, 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 will be the individual research project grant (R01) and the FIRST (R29) award. Multidisciplinary approaches that involve collaborative efforts among investigators in the fields of basic immunology, molecular biology, genetics, virology, and infectious disease are strongly encouraged. The total project period for an application submitted in response to this RFA may not exceed five years. This RFA is a one-time solicitation for applications for new and competing renewal awards. Future competing 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 made under this RFA will be $2,000,000. In Fiscal Year 1995, the NIAID plans to fund approximately 12 R01s/R29s. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Applications may not request more than four percent annual inflationary increases for future years. The usual PHS policies governing grants administration and management will apply. Although this program is provided for in the financial plans of the NIAID, 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 availability of funds. RESEARCH OBJECTIVES Background Mother to infant transmission of HIV continues to be one of the fastest growing aspects in the worldwide pandemic of AIDS. The World Health Organization has estimated that over 10 million children worldwide will be infected by the year 2000. In the United States, the Centers for Disease Control and Prevention estimate that 10,000 children are currently infected with HIV, and approximately 6000 infants are born annually to HIV-infected women in the U.S. The recent success in the AIDS Clinical Trials Group (ACTG) protocol 076 suggests that prevention strategies in the perinatal period may be highly efficient at decreasing mother to infant HIV-1 transmission. The ACTG 076 study indicated that women with greater than 200 CD4 cells x 106 /cc3 who initiate treatment with zidovudine (ZDV) during pregnancy can prevent transmission of HIV to their infants in about two-thirds of the cases. However, this study did not address the effectiveness of ZDV in women with less than 200 CD4 counts or who may be infected with ZDV-resistant variants. Unfortunately, other studies have indicated that women with lower CD4 counts may have an even higher likelihood of transmitting HIV to their infants. The recently initiated trial (ACTG 185) comparing HIV Immune Globulin (HIVIG) with IVIG placebo, both combined with ZDV, will include women with a wider range of CD4 counts and prior anti-retroviral therapy, but results of that trial will not be available for four to five years. In 1991, the NIAID funded a series of grants focused on two areas of basic research in Pediatric AIDS -- early diagnosis of HIV infection and studies to investigate factors involved in mother to infant transmission of HIV. These grants focused primarily on immunological and virological factors influencing mother to infant transmission and have led to many of the concepts about the mode and timing of perinatal HIV transmission. The objectives of this RFA are: to encourage coordinated basic research on the immunology, host genetics, and virology associated with perinatal HIV-1 transmission, its timing and mode, and to identify factors that appear to delay progressive manifestations of pediatric HIV-1 infection. Scope of Research Sought in this RFA The NIAID wishes to support continued research in Pediatric AIDS in the following targeted areas. o Studies attempting to define the timing of perinatal transmission relative to HIV-1 viral load and disease progression. o Coordinated studies of immunological, virological and host genetic factors that might influence perinatal HIV-1 transmission. o Studies that evaluate viral pathogenesis with a specific focus on infection of cell subsets in fetuses, neonates and young infants. o Studies that investigate oral or mucosal surfaces either as the exposure route for infants or as a source of perinatal infection by AIDS viruses. o Studies that evaluate the immunology, physiology, genetics and virology of children with long-term survival of HIV infection. These are examples of appropriate studies; other studies addressing risk for or timing of transmission of HIV-1 from mother to infant, or disease progression in the infant may be proposed. Advances in quantitative HIV culture techniques, polymerase chain reaction (PCR) detection of HIV, detection of immune complex-dissociated HIV-1 p24 antigen, and detection of HIV- specific IgA have enabled clinical research teams to rapidly and accurately identify HIV-infected children within the first several months of life. It now appears that, in the absence of breastfeeding, about half of the infants infected with HIV at or before birth can be identified at the time of birth, whereas HIV is not detected in the remaining children until one to twelve weeks after birth. These and other findings have suggested that there may be at least two modes of perinatal HIV infection and that the timing of infection (in utero versus intrapartum) may greatly affect viral load and disease progression in the infant. Stratification of data based on the time of initial detection of HIV-1 may be useful in studies of perinatal or postnatal (breastfeeding) infection. Several other issues regarding perinatal HIV transmission and pediatric AIDS have received only limited attention. Although early detection of HIV infection is possible, information about immunological and virological factors that influence perinatal transmission is still fragmentary and studies that have coordinately evaluated both immunological factors and viral factors are limited in scope. Although it is widely believed that genetic factors may play a role in susceptibility to or severity of HIV infection, only a few studies have evaluated genetic factors related to perinatal HIV transmission along with either virological or immunological parameters. Thus, studies of the host (mother and child) genetics and immune responses coordinated with HIV virology will be considered responsive to this RFA. Fetuses, neonates, and young infants may become infected by entry of the virus into their blood (across the placenta) or by exposure of mucosal surfaces to HIV-infected blood, cervical secretions, or milk. Certain viral characteristics may facilitate infection of infants by one or both of these routes. Non-syncytium inducing (NSI) variants of HIV that can replicate well in macrophages and monocytes appear to be the predominant type of HIV that has been obtained from infants in several small studies. Macrophage-tropic and/or cytopathic HIV variants might have a selective advantage in transmission, pathogenesis or evasion of immune defenses. Studies that address these topics with respect to perinatal infection will be considered responsive to this RFA. Some recent data suggest that intrapartum transmission of HIV may occur by the oral/mucosal route. Studies that coordinate virological and immunological studies of mucosal surfaces in HIV-infected infants and/or women during different stages of pregnancy are of utmost importance to resolve issues of intrapartum transmission. Studies to evaluate the specificity, function and timing of pediatric IgA responses to HIV might shed light on the route and mode of exposure in infants that become infected with HIV. Highly focused animal studies to address oral transmission and potential intervention strategies will be considered responsive to this RFA. Finally, a number of children that have become infected with HIV have led disease-free lives for more that seven years with relatively little impact upon their CD4 cell number, immune system or health. Intensified studies on immunology, physiology, genetics and virology in these children might shed light on the factors that allow successful control of HIV infection and progression to AIDS. Clinical samples, if required, may be drawn from clinical trials or ongoing natural history studies. This solicitation is not intended for direct conduct of clinical trials, patient care, or maintenance of natural history cohorts. Availability of adequate numbers of clinical samples or animal resources to address the study hypotheses MUST BE documented in the application. STUDY POPULATIONS 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 as a separate Part VIII in the Federal Register of March 28, 1994 (59 FR 14508-14513). This was also reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Vol. 23, No. 11. Investigators may obtain copies from these sources, from program staff or from Dr. Fast or Dr. Mathieson (listed in INQUIRIES below) who may also provide additional relevant information concerning the policy. Note: Studies of mother-to-infant transmission may, by their nature, include women but not men as study subjects. The gender of their infants will be unknown to the investigator in studies beginning during pregnancy. If the population of HIV-infected women available for study is limited to, or primarily composed of, one racial or ethnic group, investigators should explain the circumstances in the application and address potential ways to overcome this limitation. LETTER OF INTENT Prospective applicants are asked to submit, by November 15, 1994, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, and the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the standard research grant application form PHS 398 (rev. 9/91). For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number and the words "PEDIATRIC AIDS: FACTORS IN TRANSMISSION & PATHOGENESIS" must be typed in. Application forms may be obtained from the institution's office for sponsored research or its equivalent and 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. It is highly recommended that the Program Officers in the Vaccine Research and Development Branch be contacted in the early stages of preparation of the application. (See program contact in INQUIRIES below.) Applications must be received by February 16, 1995. Applications that are not received by the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 09/91) application kit, will be judged non-responsive and will be returned to the applicant. The RFA label available in the application form PHS 398 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. FIRST (R29) applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been 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. Submit a signed, typewritten original of the application including the checklist, three signed, exact, single-sided photocopies, and one copy of any appendix material, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional exact copies of the grant application and five sets of any appendix material must be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness to the RFA by NIAID staff. Incomplete applications will be returned to the applicant without further consideration. If NIAID staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to this RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID. As part of the initial merit review, a process (triage) may be used by the initial review group in which the applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to this RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. The factors to be considered in the evaluation of scientific merit of each application will be those used in the review of traditional research project grant applications, including: the novelty, originality, and feasibility of the approach; the training, experience, and research competence of the investigator(s); the adequacy of the experimental design; and the adequacy and suitability of the facilities. The initial review group will also be instructed to provide an assessment of the extent to which the proposed research that might advance the fields of research specifically targeted by this RFA. While the following review factors do not usually influence the priority score, they are nonetheless carefully considered by the initial review group: the appropriateness of the requested budget to the work proposed; the adequacy of protection of human subjects and/or animals in research; and the adherence, whenever appropriate, to NIH guidelines concerning adequate representation of women and minorities in clinical research. Any documented concerns expressed by the initial review group about any of these factors on a given application may influence the recommendation of the Advisory Council concerning funding of that application. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program priorities, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Potential applicants are welcome to seek clarification of any issues or questions. Direct inquiries regarding programmatic issues to: Bonnie J. Mathieson, Ph.D. or Patricia E. Fast, M.D., Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2B06 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8200 FAX: (301) 402-1506 or (301) 480-5703 Direct inquiries regarding review issues; address the letter of intent to; and mail two copies of the application and five sets of appendices to: Dianne Tingley, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C16 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-0818 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Ms. Carol Alderson Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B27 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7075 FAX: (301) 480-3780 Schedule Letter of Intent Receipt Date: November 15, 1994 Application Receipt Date: February 16, 1995 Scientific Review Date: June/July 1995 Advisory Council Date: September 1995 Earliest Award Date: September 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.856 Microbiology and Infectious Diseases Research and 93.855 Immunology, Allergy and Transplantation Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. 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 Thu Sep 15 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-95-001 - V23(33) 09/16/94 Date: 15 Sep 1994 23:47:49 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 519 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <35bf2l$qoe@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL95001 HL-95-001 P1O1 *************************************** GENE-NUTRIENT INTERACTIONS IN THE PATHOGENESIS OF CONGENITAL HEART DEFECTS NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFA: HL-95-001 P.T. National Heart, Lung and Blood Institute Letter of Intent Receipt Date: December 16, 1994 Application Receipt Date: April 21, 1995 PURPOSE The Division of Heart and Vascular Diseases invites applications to conduct research into the relationship between genes and nutrients in the etiology and prevention of Congenital Cardiovascular Malformations (CCVM). One goal is to foster basic research into the effects of nutrients on embryologic and fetal development of the cardiovascular system. Approaches may include cell and organ culture, the generation of genetically altered animal models and the use of molecular biology and molecular genetics to elucidate the mechanisms underlying those effects. A second goal is to encourage small epidemiologic investigations into the role of nutrients in the pathogenesis of human CCVM. 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), Gene-Nutrient Interactions in the Pathogenesis of Congenital Heart Defects, is related to the priority areas of maternal and infant health, infant mortality and nutrition. 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 or local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Awards in connection with this RFA will be made to foreign institutions only for research of very unusual merit, need and promise and in accordance with PHS policy governing such awards. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01). 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 the present RFA may not exceed five years. 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. Since a variety of approaches would represent valid responses to this RFA, it is anticipated that there will be a range of costs among individual grants awarded. FUNDS AVAILABLE The total funds available for the first year of this program (direct plus indirect costs) are $2.00M. Funding is expected to begin in September 1995. It is anticipated that no more than eight grants will be awarded under this program. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plan of the NHLBI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Administrative adjustments in project period and/or amount of support may be required at the time of the award. In order to more evenly distribute administrative workload and reduce the number of awards with July 1 or September 30 start dates, the NHLBI will award ten months of time and money for the first competing budget period of this project. This action results in a project period of 58 months. Investigators should plan their research projects and budgets within these timeframes. RESEARCH OBJECTIVES Disciplines and Expertise Expertise appropriate for investigators includes but is not restricted to: developmental biology, human or animal genetics, molecular biology, epidemiology, experimental nutrition, human nutrition and dietetics, biochemistry, and biostatistics. Background Congenital cardiovascular malformations (CCVM) present our society with an enormous burden of grief and expense. About eight percent of all deaths during the first year of life are due to CCVM. Each year approximately 30,000 babies are born with CCVM, of whom 2,900 will die before their first birthday. Birth defects comprise the largest component of infant mortality in the United States and 42 percent of deaths due to birth defects are caused by CCVM. All U.S. population groups are afflicted by these relatively high rates. For example, although much of the 2.5 fold elevation in infant mortality of African American infants is due to prematurity and Respiratory Distress Syndrome, these infants experience excessive deaths from CCVM as well. Many of the children with CCVM who survive infancy go on to suffer sustained disease. After asthma and mental retardation, CCVM represent the most frequent cause of serious chronic childhood morbidity, being more common than cystic fibrosis and hemophilia. CCVM in older children and adolescents are accompanied by chronic use of medications, multiple medical procedures, hospitalizations, and often, repeated open heart operations requiring cardiopulmonary bypass. Not surprisingly, these children are likely to suffer impaired physical and social development. Furthermore, deaths due to CCVM occur throughout childhood, adolescence and young adulthood. Three thousand six hundred children under age 15 die annually from CCVM; 700 of these are more than 1 year old. In 1992, nearly $500 million was spent to cover the costs of 44,000 hospitalizations of children under age 15 with CCVM. The societal costs of serious CCVM are unknown, but are certainly very high, considering the loss of productive years of life, the burden on caregivers, and the magnitude of medical expenses. For many years the etiology of CCVM was thought to be multifactorial, involving a complex interaction of the feto-placento-maternal unit and teratogens. Genes were thought to play only a small role, in part because few children with CCVM lived long enough to reproduce; this hampered detection of the genetic nature of many of these defects. After a decade of focused research, much of which was funded by NHLBI, there are new insights into the pathogenesis of CCVM. It now appears that many if not most CCVM are caused by gene mutations. A genetic etiology is now either strongly suspected or confirmed for at least eight different structural cardiovascular malformations. One of these, supravalvular aortic stenosis, is now known to be caused by a mutation in the elastin gene. It is possible that the abnormal genotype causing as many as half of these eight CCVM may be identified relatively soon. Given the unsatisfactory nature of current treatments for many CCVM, it seems prudent to consider strategies for prevention. Other than genetic counseling and avoidance of pregnancy, there are no interventions available to reduce the frequency of offspring with congenital heart disease. Recent findings in the pathogenesis and prevention of neural tube defects, however, support the concept that risk of other birth defects, including CCVM, may in some cases be related to maternal nutrient intake. This concept is buttressed by the results of clinical trials that have focused on the role of folate in the prevention of neural tube defects. Approximately half of all NTD, whether among the general population or among high risk mothers who have already borne a child with an NTD, may be prevented by daily supplementation of the maternal diet with 4 mg of folate interaction between the genetic background of the mother or fetus and the increased need for folate or other nutrients but the relative importance of such interactions in the causation of most cases of NTD is unknown. Recent genetic research on NTD has associated the location of different NTDs (ranging from anencephaly to sacral meningocele) with a variety of specific maternal exposures such as hyperthermia or low folate intake. NTDs are, by definition, the result of failure of early morphogenetic processes. The mechanisms underlying neural tube closure have been studied in considerable detail. There appear to be five different "zippers" that span the length of the neural tube and function to close it during development. These zippers are presumably under the control of one or more genes, mutations in which would cause an NTD in the region of that zipper. Proper function of two of these zippers appears to be sensitive to folate deficiency. These preliminary findings in the pathogenesis of NTD support the concept that risk of other types of birth defects may also be affected by maternal nutrient intake. Progress being made in elucidating gene-nutrient interactions in organs other than heart lends credence to the possibility that such connections could be made for CCVM. For example, Vitamin C has been shown to be required growth, malformations mirroring part of the CRBP I expression pattern during development. CRABP I transcripts, on the other hand, are found in tissues which are separate and distinct from those expressing CRBP I. Saturation of the cytoplasmic pool of CRABP I with large doses of exogenous RA could be expected to cause homeobox or other genes to be turned on inappropriately. This may be part of the mechanism by which one metabolite of vitamin A, isotretoin, consumed in the first trimester of pregnancy, produces conotruncal malformations in the human embryo. Not all of the malformations that may be secondary to gene-nutrient interactions are necessarily the result of inadequate or excessive maternal nutrient intake. Rather, mutated genes may interact with normal nutrient intake to produce an abnormal phenotype. This concept is well illustrated by the Pallid (pa) mouse mutant. When fed a normal diet, mice homozygous for the pa allele produce offspring which are ataxic due to failure of otolith formation. When these same genotypically mutant mice are fed supraphysiologic supplements of the trace element manganese, their pups are phenotypically normal, showing no signs of ataxia. Moreover, genotypically normal rats fed a diet deficient in manganese produce offspring with the Pallid phenotype of ataxia and absent otolith formation. The manganese deficient phenotype has also been reported in chick, mouse and guinea pig and appears to result from depressed mucopolysaccharide synthesis. According to Hurley, "Manipulation of a single agent (the nutrient manganese) could, through deprivation, alter the expression of the wild type gene to produce a phenocopy of the mutant. On the other hand, administration of large amounts of the agent (the nutrient manganese) altered the expression of the mutant allele to produce the normal phenotype." In this light, it is useful to consider the following paradigm (modified from Hurley): LEVEL OF NUTRIENT INTAKE Mutant Genotype ---------------------> Mutant Phenotype Normal Genotype ---------------------> Normal Phenotype Mutant Genotype ---------------------> Normal Phenotype Normal Genotype ---------------------> Mutant Phenotype Areas of Research Two general areas of research are appropriate for this RFA, namely molecular/genetic studies of cardiovascular morphogenesis in animal models and small epidemiologic investigations of the role of nutrients in the pathogenesis of human CCVM. It is anticipated that both approaches will yield much needed information on measures that eventually may prevent some cases of CCVM in humans. Successful applications will have hypotheses to direct the course of the research. The molecular/genetic research will test hypotheses regarding potential mechanisms by which a nutritional deficiency or toxicity may produce malformations comparable to human CCVM. Given the existing body of literature on Vitamin A/beta-carotene, studies involving retinoid related genes must address the mechanisms by which decreased RA affects normal morphogenesis of the cardiovascular system. Far less information is available regarding the role of other nutrients in organogenesis. Hence, research on the role of vitamins and trace elements in the pathogenesis of CCVM may be more broadly applied. The use of well-defined animal models, whether naturally occurring or transgenic, is encouraged. Researchers may propose to study gene-nutrient interactions in 'normal' animals fed a nutrient-deficient diet. Investigators also may wish to propose targeted interventions that may correct the abnormal phenotype of an animal model of inherited CCVM. Research resources, such as Keeshond Beagles, which suffer form conotruncal defects, or Yucatan miniature swine, which have a high frequency of ventricular septal defects, may be considered. Similar investigations in humans would be premature and are not appropriate for this RFA. Large new epidemiologic studies are not likely to be feasible with the budgets allotted for grants awarded under this RFA; 'add-on' projects may be proposed, however, to take advantage of existing or planned research programs. Studies that propose to make use of already existing epidemiologic data bases or cohorts with well-defined nutrient intake and pregnancy outcomes are acceptable. However, diagnosis of CCVM in children involved in studies must be performed by a pediatric cardiologist, using appropriate techniques such as echocardiography or angiography to avoid errors due to mis-diagnosis. The following examples of potential studies are given for illustrative purposes only. Investigators are urged to use their own knowledge of the field in preparing their grant applications. o small epidemiologic studies of cases of specific CCVMs for which maternal diets are well-defined o nutritional investigations in animal strains with known predispositions toward specific defects o studies of the role of nutrients in gene expression during cardiovascular development o studies elucidating the role of nutrients in the proliferation and differentiation of progenitor cells o Tissue culture studies of nutrient requirements for synthesis of the cardiac extracellular matrix o elucidation of the role of nutrients in the migration of cells and formation of tissues Exclusions Clinical intervention trials and treatment studies in humans will not be considered responsive to this RFA. Large epidemiologic studies and multiproject studies similar to program project applications will not be accepted. STUDY POPULATIONS 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 December 16, 1994, 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 that it contains is helpful in planning for the review of applications. It allows NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. C. James Scheirer at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application for 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 may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 240, Bethesda, MD 20892, telephone 301/594-7248. The RFA label available in the PHS 398 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, to identify the application as a response to this RFA, Check "YES", enter the title "Gene-Nutrient Interactions in the Pathogenesis of Congenital Heart Defects", and the RFA number HL-95-001 on line 2a of the face page of the application. Send or deliver 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 Westwood Building, Room 240 Bethesda, MD 20892** Send two additional copies of the application to Dr. Scheirer at the address listed under INQUIRIES. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants, otherwise the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. 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. Applications must be received by April 21, 1995. If an application is received after that date, it will be returned to the applicant. 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 Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is either late or not responsive to the RFA, NHLBI staff will 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 RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NHLBI in accordance with 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 be assigned a priority score. Applications determined to be non- competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the National Heart, Lung, Blood Advisory Council. Review criteria for this RFA are generally the same as those for unsolicited research grant applications. o the novelty, originality and feasibility of the approach and the adequacy of the experimental design o the competence of the principal investigator and collaborators to accomplish the proposed research, and the commitment and time they will devote to the project o the suitability of the facilities to perform the proposed research, including laboratories, instrumentation and data management systems o the appropriateness of the requested budget and duration for the proposed research o adequate plans for interaction and communication of information and concepts among investigators involved in collaborative studies AWARD CRITERIA Awards made under this RFA to foreign institutions will be made only for research of very unusual merit, need and promise, and in accordance with Public Health Service policy governing such awards. Upon initiation of the program, the Division of Heart and Vascular Diseases will sponsor periodic meetings to encourage exchange of information among investigators who participate in this program and stimulate collaboration. Applicants should request additional travel funds for a one-day meeting each year, most likely to be held in Bethesda, Maryland. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. Applications must fulfill all the eligibility criteria to be considered for funding. The most important criterion in selecting awardees will be the scientific merit as reflected in the priority score. However, factors such as program balance and available funds may enter into selection from among meritorious applications. Timetable Letter of Intent Receipt Date: December 16, 1994 Application Receipt Date: April 21, 1995 Review by NHLBAC: September 1995 Anticipated Award Date: September 1995 INQUIRIES Written and telephone inquiries are encouraged. We welcome the opportunity to clarify any issues or questions from potential applicants. Inquiries regarding programmatic issues may be directed to: Dr. Abby G. Ershow Lipid Metabolism-Atherogenesis Branch National Heart, Lung, and Blood Institute Federal Building, Room 401 7550 Wisconsin Avenue MSC 9050 Bethesda, MD 20892-9050 Telephone: (301) 496-1681 FAX: (301) 496-9882 Dr. Constance Weinstein Cardiac Diseases Branch National Heart, Lung and Blood Institute Federal Building, Room 3C06 7550 Wisconsin Avenue MSC 9050 Bethesda, MD 20892-9050 Telephone: (301) 496-1081 FAX: (301) 480-6282 Direct inquiries regarding review and application procedures, address the leter of intent to, and mail two copies of the application to: Dr. C. James Scheirer Division of Extramural Affairs National, Heart, Lung, and Blood Institute Westwood Building, Room 548B Bethesda, MD 20892 Telephone: (301) 594-7478 FAX: (301) 594-7407 Inquiries regarding fiscal and administrative matters may be directed to: Mr. William Darby Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A11 Bethesda, MD 20892 Telephone: (301) 594-7458 FAX: (301) 594-7492 AUTHORITY AND REGULATIONS The programs of the Division of Heart and Vascular Diseases, National Heart, Lung, and Blood Institute, are identified in the Catalog of Federal Domestic Assistance No, 93.837. Awards will be made under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under specifically 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372, or to Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. 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 Thu Sep 15 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 33, pt. 1of3, 16 September 1994 Date: 15 Sep 1994 23:47:01 -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: <35bf15$qi7@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940916 V23N33 P1O3 ************************************ X-comment: RFAS described: AG-95-001, RR-94-005, HL-95-002, CA-94-030, AI-94- 029, CA-94-031, HL-95-001, HD-95-003 NIH GUIDE - Vol. 23, No. 33 - September 16, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** IMPLEMENTATION OF MODIFICATIONS OF THE NIH GUIDE National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** THE HUMAN BRAIN PROJECT: PHASE I FEASIBILITY STUDIES (PA-93-068) National Institute of Mental Health National Institute on Drug Abuse National Institute on Aging National Institute on Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Library of Medicine Fogarty International Center National Institute of Dental Research National Heart, Lung, and Blood Institute National Institute on Alcohol Abuse and Alcoholism National Science Foundation Office of Naval Research National Aeronautics and Space Administration Department of Energy INDEX: MENTAL HEALTH; DRUG ABUSE; AGING; CHILD HEALTH, HUMAN DEVELOPMENT; DEAFNESS, OTHER COMMUNICATIONS DISORDERS; NATIONAL LIBRARY OF MEDICINE; FOGARTY INTERNATIONAL CENTER; DENTAL RESEARCH; HEART, LUNG, BLOOD; ALCOHOL ABUSE, ALCOHOLISM; NATIONAL SCIENCE FOUNDATION; NAVAL RESEARCH; AERONAUTICS AND SPACE ADMINISTRATION; ENERGY NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** STUDIES TO EVALUATE THE TOXIC AND CARCINOGENIC POTENTIAL OF SELECTED CHEMICALS IN LABORATORY ANIMALS VIA INHALATION (RFP NIH-ES-94-46) National Institute of Environmental Health Sciences INDEX: ENVIRONMENTAL HEALTH SCIENCES $$INDEX R2 ********************************************************** ENHANCING RECOVERY IN CORONARY HEART DISEASE (ENRICHD) PATIENTS - CLINICAL UNITS (RFP NHLBI-HC-94-28) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R3 ********************************************************** SMALL ANIMAL MODELS OF LENTIVIRUS INFECTION FOR EVALUATING HIV THERAPEUTICS (RFP NIH-NIAID-DAIDS-95-17) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R4 ********************************************************** CLINICAL CENTERS FOR ETIOLOGY OF SARCOIDOSIS: A CASE CONTROL STUDY (RFP NHLBI-HR-94-21) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R5 ********************************************************** IN VITRO TEST SYSTEMS FOR EVALUATING CHEMOTHERAPIES AGAINST HIV (RFP NIH-NIAID-DAIDS-95-19) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R6 12/09/94 ************************************************* MINORITY DISSERTATION RESEARCH GRANTS IN AGING (RFA AG-95-001) National Institute on Aging INDEX: AGING $$INDEX R7 12/09/94 ************************************************* BIOENGINEERING FOR DISEASE PREVENTION AND CONTROL (RFA RR-94-005) National Center for Research Resources The Whitaker Foundation INDEX: RESEARCH RESOURCES; THE WHITAKER FOUNDATION $$INDEX R8 01/19/95 ************************************************* MECHANISMS OF POST BONE MARROW TRANSPLANTATION LUNG INJURY (RFA HL-95-002) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R9 01/20/95 ************************************************* SMALL GRANTS FOR HISTORICALLY BLACK COLLEGES AND UNIVERSITIES (RFA CA-94-030) National Cancer Institute INDEX: CANCER $$INDEX R10 02/16/95 ************************************************ PEDIATRIC AIDS: FACTORS IN TRANSMISSION AND PATHOGENESIS (RFA AI-94-029) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R11 02/21/95 ************************************************ SPECIALIZED PROGRAMS OF RESEARCH EXCELLENCE IN PROSTATE CANCER (RFA CA-94-031) National Cancer Institute INDEX: CANCER $$INDEX R12 04/21/95 ************************************************ GENE-NUTRIENT INTERACTIONS IN THE PATHOGENESIS OF CONGENITAL HEART DEFECTS (RFA HL-95-001) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R13 05/18/95 ************************************************ SPECIALIZED RESEARCH CENTER PROGRAMS OR CENTER CORE GRANTS TO SUPPORT RESEARCH IN REPRODUCTION (RFA HD-95-003) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** RESEARCH ON EFFECTIVENESS OF CHILDREN'S MENTAL HEALTH SERVICES (PA-94- 094) National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX P2 ********************************************************** DRUG DISCOVERY FOR OPPORTUNISTIC INFECTIONS ASSOCIATED WITH AIDS (PA- 94-095) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** IMPLEMENTATION OF MODIFICATIONS OF THE NIH GUIDE NIH GUIDE, Volume 23, Number 33, September 16, 1994 P.T. 16; K.W. 1004017, 1014002 National Institutes of Health The next issue of the NIH Guide (Vol. 23, No. 34, September 23, 1994) will comply with the revised policies for format and distribution. The printed edition will include Notices of Availability of Program Announcements (PAs), Requests for Applications (RFAs), and Requests for Proposals (RFPs) and policy notices. The full text of the PAs and RFAs is available online on several platforms as described below, and may be obtained electronically by sending a request via email to NIH program staff identified under the INQUIRIES section of each PA and RFA. 1. Electronic Subscriptions to the NIH Guide The NIHGDE-L list is open for subscriptions from individuals. To minimize the possibility of errors, it is best for each person to subscribe him/herself to the list. Subscribing and unsubscribing to/from a list is done via e-mail. BITNET users should send mail to LISTSERV@JHUVM, and Internet users to LISTSERV@JHUVM.HCF.JHU.EDU. To subscribe to the E-Guide list, the text of the mail should be: SUBSCRIBE NIHGDE-L First-name Last-name The First & Last names should be in upper & lower case; e.g.: SUBSCRIBE NIHGDE-L Bill Jones This will register the e-mail address from which the mail was sent for E-Guide distribution. If you wish to have the E-Guide sent to an address from which mail cannot be sent (e.g., an internal distribution list), send mail to WKJ@NIHCU (BITNET) or WKJ@CU.NIH.GOV (Internet). To remove yourself from this list, send mail to LISTSERV@JHUVM (or LISTSERV@JHUVM.HCF.JHU.EDU) containing as the text: UNSUBSCRIBE NIHGDE-L 2. Table of Contents Some users who subscribed to the NIHGDE-L list had problems with the volume of mail that was received each week. They would prefer to see a table of contents, and access the NIH Guide files via Gopher when necessary. For that purpose, the NIHTOC-L list has been established at the NIH. It will contain only the table of contents for each week's NIH Guide. It is an open list that one can subscribe to by sending mail to LISTSERV@NIHLIST or LISTSERV@LIST.NIH.GOV (Internet). The mail should contain as text: SUBSCRIBE NIHTOC-L First-name Last-name If you do subscribe to the NIHTOC-L list and are already subscribed to the NIHGDE-L list, you will probably want to UNSUBSCRIBE from that list. 3. NIH Grant Line Bulletin Board The NIH Grant Line includes information about NIH extramural programs, including the NIH Guide for Grants and Contracts. A new feature on the NIH Grant Line allows the rapid transmission of files via Bitnet or Internet to a Bitnet or Internet address instead of downloading via a modem. To access the NIH Grant Line, the terminal emulator must be configured as follows: 1200 or 2400 baud, even parity, 7 data bits, 1 stop bit, half duplex. Using the procedure specified in the communication software, dial 1-301-402-2221. When a response indicates that a connection has been made, type ,GEN1 (the comma is mandatory) and press ENTER; the NIH system will prompt for INITIALS?. Type BB5 and press ENTER. A prompt will ask for ACCOUNT? Type CCS2 and press ENTER. Messages and a menu will be displayed that allow one to read Bulletins and download Files. Back issues of the NIH Guide are found in different Directories. GUIDE90 has issues going back to July 6, 1990; GUIDE91, GUIDE92, and GUIDE93 have all issues for each year. Type F (for FILES) to access any of the files that are arranged into directories. To get an overview of the kinds of information available, type D (for Directory). Access to NIH Grant Line via the Internet To access the NIH Grant Line in an interactive Internet session, Telnet to WYLBUR.CU.NIH.GOV and, when a message has been received that the connection is open, type VT100. At the INITIALS? prompt, type BB5 and at the ACCOUNT? prompt, type CCS2. This puts the user into the NIH Grant Line. 4. NIH Gopher The NIH Gopher contains information about the NIH, including the NIH Guide for Grants and Contracts, and has text searching capability. One can tunnel to the NIH Gopher at gopher.nih.gov, if one has access to a system with a Gopher client. Local computer support staff should be consulted for additional information. INQUIRIES Myra Brockett, Program Analyst Institutional Affairs Office National Institutes of Health Telephone: (301) 496-5366 email: q2c@cu.nih.gov $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** THE HUMAN BRAIN PROJECT: PHASE I FEASIBILITY STUDIES NIH GUIDE, Volume 23, Number 33, September 16, 1994 PA NUMBER: PA-93-068 P.T. 34; K.W. 0705010, 1002030, 1004017 National Institute of Mental Health National Institute on Drug Abuse National Institute on Aging National Institute on Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Library of Medicine Fogarty International Center National Institute of Dental Research National Heart, Lung, and Blood Institute National Institute on Alcohol Abuse and Alcoholism National Science Foundation Office of Naval Research National Aeronautics and Space Administration Department of Energy For those intending to apply for grants under the Human Brain Project, this addendum is meant to supplement the program announcement PA- 93-068; NIH Guide, Vol. 22, No. 13, April 2, 1993, which is still in effect and must be consulted in conjunction with this addendum. The Human Brain Project is a broadly based Federal research initiative, supported in a coordinated fashion by 14 Federal organizations across five Federal agencies. The general purpose of this initiative is to encourage and support investigator-initiated, basic and clinical neuroscience and behavioral research and development of computer-based resources that could be used to facilitate research on the brain and its functions. Particular emphasis is placed on research and development of tools and approaches to store and manipulate information about the brain and behavior, as well as electronic network technologies which will give scientists access to the stored information and the ability to integrate and synthesize information. The network tools will also provide electronic channels of communication and collaboration to geographically distant laboratories. These capabilities and approaches are referred to here as informatics and include areas such as computer science, mathematics, statistics, and engineering. The combination of brain and behavioral research with informatics research constitutes the developing field of neuroinformatics. To optimize their utility to brain and behavioral researchers, these technologies and approaches will be developed in the context of specific, ongoing, research on the brain and its functions. Thus, all applications need to have an informatics science research component as well as a research component related to the brain and/or behavior. It is, therefore, expected that each application will include a multidisciplinary research team. Application components related to ethical, legal, and social issues pertinent to this initiative are encouraged. Also encouraged are components of applications that are designed to reach out to the public, academic, and/or commercial sectors and educate them about the opportunities that are presented by research and development of neuroinformatics. Participation in an Annual Spring Meeting held in the Washington, DC area is encouraged. In applications for the R01 mechanism, funds to support travel to this meeting should be included in the budget for the principal investigator and up to one additional key member of the research team. In applications for the P20 mechanism, funds to support travel to this meeting should be included in the budget for the principal investigator (the director of the grant), the director of each subproject, and up to one additional key member from the P20 research team. All applications for these feasibility research grants should include a detailed, year-by-year timetable of specific goals. Applications should: o Contain both a brain and/or behavioral research component AND an informatics research component that are well integrated and which promise to move both fields forward o Include a specific plan to monitor progress and evaluate tools and approaches being developed Dates for the submission and resubmission of Phase I Human Brain Project applications and review cycles are as follows: Letter of Intent Receipt Date: July 1 Application Receipt Date: October 15 Administrative Review: October Scientific Review: February/March Advisory Council Review: May/June Earliest Start Date: July It should be noted that there is no additional receipt date for resubmitted applications or for competitive continuations (i.e., renewals). All applications, initial submissions, resubmissions, and competitive continuations will be received only once a year, October 15. Applicants may apply for Interactive Research Project Grants (IRPGs) in addition to the R01 and P20 mechanisms. The IRPG allows for formal interactions between and among research efforts that are funded independently. The IRPG encourages collaborative relationships that do not require extensive, shared, physical resources. A minimum of two independent investigators may submit concurrent, collaborative, cross-referenced individual R01/R29 applications. The proposed projects must not be dependent on each other to the extent that one could not be accomplished in the absence of the other. Applications may be from one or more institutions. Applications will be reviewed independently for scientific merit. Applications judged to have significant and substantial scientific merit will be considered for funding both as independent awards and in the context of the proposed IRPG collaboration. Those interested in applying for an IRPG should consult Program Announcement PA-94-086, NIH Guide, Vol. 23, Number 28, July 29, 1994. Grantees will be encouraged to take steps to perfect copyright protection of software produced as a result of Human Brain Project funding. These should include prominent notification in the software and its documentation that the software is copyrighted. Notification could consist of the following: "c Copyright [year] by [your name, the names of you and your colleagues, or the name of your institution] with funding from the Human Brain Project." This notification will identify the source of the software and help ensure that the software can be shared freely while protecting any commercial rights in it. In addition, grantees will be required to agree that they will provide the primary funding organization, upon its request and at a reasonable cost, a copy of any software produced under Human Brain Project funding, with the understanding that the Federal organizations directly involved with the Human Brain Project will have the right to use such software for internal research and archival purposes only and will not permit its distribution beyond those organizations. INQUIRIES Women, minorities, and those with disabilities are especially encouraged to apply. Potential applicants are strongly encouraged to contact the Agency or Institute representative to discuss their plans prior to preparing an application. The names of the representatives from each of the participating Agencies, Institutes, and Center may be obtained from: Michael F. Huerta, Ph.D. National Institute of Mental Health 5600 Fishers Lane, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-5625 FAX: (301) 443-1731 E-mail (internet): HMI@CU.NIH.GOV $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NIH-ES-94-46 ********************************************* STUDIES TO EVALUATE THE TOXIC AND CARCINOGENIC POTENTIAL OF SELECTED CHEMICALS IN LABORATORY ANIMALS VIA INHALATION NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFP AVAILABLE: NIH-ES-94-46 P.T. National Institute of Environmental Health Sciences The purpose of this contract is to evaluate the toxic and carcinogenic potential of selected chemicals of interest. Exposure to these test chemicals is via inhalation. This project includes two year studies of vanadium pentoxide and napthalene, prechronic and two year studies of propylene glycol mono-t-butyl ether, decalin and tetralin. The base contract award shall include work activities associated with the development of generation and monitoring methods, as well as health and safety concerns along with 14-day studies of decalin, propylene glycol mono-t-butyl ether, and tetralin. The Government may, pending the availability of funds, exercise options for: a 14-day study of vanadium pentoxide; a 54-day study of naphthalene; 90-day studies of decalin, propylene glycol mono-t-butyl ether, and tetralin; two year studies of vanadium pentoxide, napthalene, decalin, propylene glycol mono-t-butyl ether, and tetralin; and a special 90-day study of vanadium pentoxide. These studies shall be conducted according to the Specifications for the Conduct of Studies to Evaluate the Toxic and Carcinogenic Potential of Chemical, Biological and Physical Agents in Laboratory Animals for the National toxicology Program" dated August 1992, with subsequent revisions. Award of one cost-reimbursement, completion type contract with an estimated period of performance for the base contract of approximately eight months on an open competition basis is contemplated as a result of this solicitation. Exercise of all options under this solicitation could result in a multi-year cost reimbursement type contract with a total term of four years five months. INQUIRIES Interested organizations should request either a streamlined or full RFP package. If no selection is made, a streamlined version of the RFP will be provided, which includes only the Statement of Work, deliverables and reporting requirements, special requirements and mandatory qualifications (if any), and technical evaluation criteria. After examination of these documents, any organization interested in responding to this RFP must request the entire RFP in writing or by telephone (919) 541-0416 or by telefax request (919) 541-2712. All responsible sources may submit a proposal that will be considered by the Agency. Expected release date of the RFP is September 19, 1994 with proposals due November 3, 1994. Requests must reference RFP No. NIH-ES-94-46 and are to be forwarded to: Marilyn B. Whaley Contracts and Procurement Management Branch, OM National Institute of Environmental Health Sciences 79 T.W. Alexander Drive, 4401 Building P.O. Box 12874 Research Triangle Park, NC 27709 $$R1 END ************************************************************ $$R2 BEGIN NHLBI-HC-94-28 ******************************************* ENHANCING RECOVERY IN CORONARY HEART DISEASE (ENRICHD) PATIENTS - CLINICAL UNITS NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFP AVAILABLE: NHLBI-HC-94-28 P.T. National Heart, Lung, and Blood Institute The National Heart, Lung, and Blood Institute (NHLBI) is soliciting proposals from organizations/institutions to serve as clinic units in a multicenter trial to determine the effects of psychosocial interventions on morbidity and mortality in coronary heart disease (CHD) patients. The primary objective of this multicenter trial is to evaluate the effects of psychosocial interventions on the cardiac-related morbidity and mortality of MI patients at high psychosocial risk. High psychosocial risk is defined as the presence of depression and/or social isolation. The study design will compare a psychosocial intervention group, in which patients are provided with social support and psychological treatment designed to decrease social isolation and depression, with a health education control and a standard medical care group, using a combined endpoint of CHD death plus reinfarction. Secondary endpoints include health-related quality of life; adherence to medications and health-promoting behaviors; and ischemic events, measured by ambulatory electrocardiogram and exercise tolerance testing. To accomplish its objective, this program proposes to award approximately eight clinical units for patient accession, intervention, and data collection. It is anticipated that a total of 3,000 patients, or approximately 375 patients shall be enrolled per clinical unit. The period of performance is anticipated for six years beginning in August 1995. The Request for Proposal (RFP) NHLBI-HC-94-28 is available and proposals are due November 18, 1994. Offerors other than continental North American institutions will not be considered based on the need for scientifically comparable data. INQUIRIES All requests for this solicitation must be submitted in writing; oral requests must be confirmed either in writing or by FAX. Written requests must include three self-addressed mailing labels, cite RFP NHLBI-HC-94-28, and be sent to: Cheryl A. Jennings Division of Extramural Affairs National Heart, Lung, and Blood Institute 7550 Wisconsin Avenue, Room 3C16 Bethesda, MD 20892 $$R2 END ************************************************************ $$R3 BEGIN NIH-NIAID-DAIDS-95-17 ************************************ SMALL ANIMAL MODELS OF LENTIVIRUS INFECTION FOR EVALUATING HIV THERAPEUTICS NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFP AVAILABLE: NIH-NIAID-DAIDS-95-17 P.T. National Institute of Allergy and Infectious Diseases The Developmental Therapeutics Branch, Basic Research and Development Program, Division of AIDS, NIAID, NIH, has a requirement for the evaluation of antiviral therapies/strategies for HIV-1/AIDS in established small animal models of lentivirus infection. These capabilities will be used by the Division of AIDS, NIAID, it its effort to develop antiviral therapies/strategies for human subjects infected with HIV-1. Evaluation encompasses in vitro and in vivo determinations of efficacy and toxicity, and when needed, limited pharmacokinetics for in vivo studies. Further characterization and modification of the proposed animal model, or development of other models may be required. Therapies to be tested, alone and in combination, include antiviral agents (drugs and biologics), gene-based and other novel strategies. Examples of lentivirus models considered at this time to be appropriate for this RFP include HIV-1 in immunocompromised mice constituted with human cells or tissues and feline immunodeficiency virus in cats; nonhuman primate models are excluded from the competition. This announcement is for the recompetition of several current animal model contracts. The RFP is now available and proposals will be due by COB on or about November 30, 1994. It is anticipated that two level- of-effort, cost-reimbursement type contracts will be awarded and that the period of performance for each contract will be four years (estimated start date August 1, 1995). The Government reserves the right to make only one award per animal model and to limit the number of awards based on the merit of the technical proposals received. It is estimated that the Contractor will expend 340 percent effort per year in accomplishment of the Government's objectives for this requirement. INQUIRIES A short-form version of the RFP will be available, for informational purposes, which includes only the background information, the full Statement of Work, and Evaluation Criteria. There is sufficient information in this document to enable prospective offerors to determine if they have the expertise/capability to meet the Government's requirements. A full-text version will also be available, which includes all the necessary information, business forms, etc., in order to submit a proposal. There are a limited number of full-text versions available. Therefore, request the short-form RFP first, then the full-text version only if you are going to submit a proposal. All requests must be in writing. Specify if you are requesting the short- version or full-text version of the RFP. FAX requests are acceptable, but written requests containing two self-addressed mailing labels are preferred. Requests for the RFP must be directed to: Mr. Bruce E. Anderson Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-8371 FAX: (301) 402-0972 $$R3 END ************************************************************ $$R4 BEGIN NHLBI-HR-94-21 ******************************************* CLINICAL CENTERS FOR ETIOLOGY OF SARCOIDOSIS: A CASE CONTROL STUDY NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFP AVAILABLE: NHLBI-HR-94-21 P.T. National Heart, Lung, and Blood Institute The overall objective of this program is to support a six year multi-center case-control study on the potential etiologic factors for sarcoidosis. The program will be conducted in three Phases. Phase I (12 Months) will involve protocol development. Phase II (48 Months) will involve recruitment and follow-up. Phase III will involve data analysis and publication preparation. This program will consists of a clinical coordinating center and up to twelve clinical centers. The clinical centers will recruit 840 sarcoidosis patients and 1680 control subjects for study over a four year period. The cases will also be followed to gain information on the natural history of this disease including risk factors for progression of disease. The protocol to be developed during Phase I (12 Months) will include a comprehensive clinical characterization of each participant and determination of markers of immune responsiveness. Each clinical center will: (1) participate in a cooperative effort with other study investigators to develop and pretest data reporting forms; (2) establish and train staff to conduct the study; (3) enroll, interview, and examine 70 patients (age 21 years or older) with sarcoidosis and, enroll, interview and collect a blood specimen from 140 matched control subjects over a four year period; (4) shall have a patient population composition that will enable the investigators to address factors of gender and ethnicity that are hypothesized to play a role in the susceptibility to and expression of sarcoidosis; (5) document the diagnosis of sarcoidosis in recruited cases by standard clinical criteria, including histologic evidence of non-caseating granulomatous inflammation and exclusion of other diseases; (6) perform follow-up assessment on the patients; (7) assess progression of disease and use of medical care resources; (8) collect data and forward the data to the Clinical Coordinating Center; (9) participate in the biological banking system as managed by the Clinical Coordinating Center in collaboration with the NHLBI-supported repository; (10) work with other study investigators in the preparation and writing of reports and manuscripts for publication; (11) interact with the Clinical Coordinating Center to provide data and related information necessary for data analysis, and (12) work with other study investigators in the preparation and writing of reports and manuscripts for publication. This announcement is for clinical centers only. A separate Request for Proposals (RFP) for the clinical coordinating center will be released in the near future. This is not a request for proposals. It is anticipated that RFP NHLBI- HR-94-21 will be available on or about September 15, 1994, with proposals due on or about November 30, 1994. It is to be noted that award of a contract for this study shall be made only to offerors who are located in the United States of America. INQUIRIES Copies of the RFP may be obtained by submitting a written request along with three self-addressed mailing labels to: Joanne C. Deshler Contracts Operations Branch National Heart, Lung, and Blood Institute Westwood Building, Room 654 5333 Westbard Avenue Bethesda, MD 20892 $$R4 END ************************************************************ $$R5 BEGIN NIH-NIAID-DAIDS-95-19 ************************************ IN VITRO TEST SYSTEMS FOR EVALUATING CHEMOTHERAPIES AGAINST HIV NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFP AVAILABLE: NIH-NIAID-DAIDS-95-19 P.T. National Institute of Allergy and Infectious Diseases The Developmental Therapeutics Branch, Basic Research and Development Program, Division of AIDS of the National Institute of Allergy and Infectious Diseases (NIAID), NIH has a requirement for in vitro test systems to evaluate chemotherapies against HIV. The Contractor will be required to do the following with compounds provided by the Government: evaluate potential therapeutic agents in cell-based in vitro assays for anti-HIV efficacy and cytotoxicity; analyze the data generated in antiviral and cytotoxicity assays; and provide an assessment of the experimental data. The RFP contains mandatory qualification criteria that excludes pharmaceutical companies from participating as an offeror or subcontractor. A pharmaceutical company is defined as an organization which sells drugs or other therapeutic agents for profit. This announcement is a recompetition for two current contracts (Emory University N01-AI-05078 and IIT Research Institute N01-AI-05077). It is anticipated that there will be two awards. The issuance of the RFP will be on or about September 16, 1994 and proposals will be due by COB on or about December 9, 1994. It is anticipated that two level-of- effort type cost-reimbursement contracts will be awarded and that the period of performance for this contract will be five years. The approximate start date of the contract will be on or about July 9, 1995. INQUIRIES A short-form version of the RFP will be available, for informational purposes, which includes only the background information, the full Statement of Work, and Evaluation Criteria. There is sufficient information in this document to enable prospective offerors to determine if they have the expertise/capability to meet the Government's requirements. A full-text version will also be available, which includes all the necessary information, business forms, etc., in order to submit a proposal. Request the short-form RFP first, then the full-text version of the RFP. FAX requests are acceptable, but written requests containing two self-addressed mailing labels are preferred. Requests for the RFP are to be directed to: Mr. Ross Kelley Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 6003 Executive Boulevard, MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 402-2234 FAX: (301) 402-0972) This advertisement does not commit the Government to award a contract. No collect calls will be accepted. $$R5 END ************************************************************ $$R6 BEGIN AG-95-001 FULL-TEXT ************************************** MINORITY DISSERTATION RESEARCH GRANTS IN AGING NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFA AVAILABLE: AG-95-001 P.T. 34, FF National Institute on Aging Application Receipt Date: December 9, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE Small grants to support doctoral dissertation research will be available for minority doctoral candidates intending to study problems in aging. 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, Minority Dissertation Research Grants in Aging, is related to several priority areas applicable to aging. Potential candidates for the grants 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 Individuals eligible to apply are minority students who belong to a particular racial or ethnic group. In awarding these grants the National Institute on Aging (NIA) will give priority to African Americans, Hispanic Americans, Native Americans and Pacific Islanders or other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research. The student must intend to conduct dissertation research on aging. The doctoral candidate must have a dissertation topic approved by the named committee. This information must be verified in a letter of certification from the thesis chairperson and submitted with the grant application (see APPLICATION PROCEDURES). The applicant institution must be domestic and must administer the grant on behalf of the proposed investigator. The candidate for dissertation research grant support must be a citizen, or noncitizen national, of the United States or have been lawfully admitted for permanent residence. The performance site may be foreign or domestic. MECHANISM OF SUPPORT The mechanism of support is the NIH small grant (R03). Grants may be made for up to two years. Grants to support dissertation research will provide no more than $30,000 in total direct costs, and no more than $25,000 in direct costs in any one year. FUNDS AVAILABLE The NIA anticipates funding approximately 20 grants with a total cost of up to $600,000. SPECIAL REQUIREMENTS The doctoral candidate must be the designated Principal Investigator on the grant. The principal investigator's salary may not exceed $12,000 per twelve months. For other special requirements, see the RFA. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. APPLICATION PROCEDURES Applications are to be prepared on the grant application form PHS 398 (rev. 9/91). The application form is 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 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 and number (Minority Dissertation Research Grants in Aging, AG-95-001) must be typed on line 2a of the face page of the application form and the YES box must be marked. Applications must be received by December 9, 1994. The investigator must submit the original and five copies of the completed application and letters of support. The original and three of these copies must be submitted directly to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Two additional copies of the application must be sent to: Chief, S.R.O. National Institute on Aging Gateway Building, Suite 2C212 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 ATTN: Minority Dissertation REVIEW CONSIDERATIONS Dissertation research grants are competitive. Review will be conducted by a special committee convened by the NIA for this purpose. AWARD CRITERIA The anticipated date of award is May 1995. Final funding decisions are based on the recommendations of the reviewers, the relevance of the project to NIA priorities, and the availability of funds. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. direct requests for the RFA and inquiries regarding programmatic issues to: Dr. Robin A. Barr Office of Extramural Affairs National Institute on Aging 7201 Wisconsin Avenue, Suite 2C218 MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9322 Direct inquiries relating to fiscal matters to: Mr. Joseph Ellis National Institute on Aging Gateway Building, Suite 2N212 7201 Wisconsin Avenue MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.366. Awards are made under authorization of the Public Health Service Act Title IV, Part A (Public Law 79-410, as amended by Public Law 99-158, 42 DSC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. The requirements of Executive Order 12372, "Intergovernmental Review of Federal Programs," are not applicable to NIA research grant programs. $$R6 END ************************************************************ $$R7 BEGIN RR-94-005 FULL-TEXT ************************************** BIOENGINEERING FOR DISEASE PREVENTION AND CONTROL NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFA AVAILABLE: RR-94-005 P.T. 34; K.W. 0706000, 0745027, 0795003 National Center for Research Resources The Whitaker Foundation Application Receipt Date: December 9, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE NIH CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Center for Research Resources (NCRR) and The Whitaker Foundation invite investigator-initiated research project grant applications for the research and development of devices, instruments, and methodologies for the prevention and control of disease and disabling conditions, and the reduction of health care costs and risks. This solicitation is limited to novel, cost-effective bioengineering approaches in the following areas: (1) microsensors, (2) physiological monitoring, and (3) drug delivery systems. The Whitaker Foundation (Whitaker) is a private, non-profit foundation that encourages and supports biomedical engineering research and training. 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, Bioengineering for Disease Prevention and Control, is related to the priority area of disease prevention. 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, public and private, non-profit and for-profit organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT The mechanism of NCRR support for this program will be the individual research project grant (R01) and the total project period may not exceed four years (three years for foreign applicants). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The NCRR and Whitaker plan to make several awards each in Fiscal Year 1995. The earliest possible award date is July 1, 1995. Because the nature and scope of the research proposed in response to this RFA will vary, it is anticipated that the size of an award will vary also. 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 The NCRR and Whitaker anticipate making a total of six to eight awards for project periods of up to four years and anticipate that each will set-aside $1 million for the initial funding period. Funding in response to this RFA is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCRR, the award of research grants pursuant to this RFA by NCRR is contingent on the availability of funds appropriated for Fiscal Year 1995. RESEARCH OBJECTIVES Background The recent explosion of new knowledge in both the physical and biological sciences offers unprecedented opportunities to develop devices, sensors, instruments, and novel methods for use in basic research and clinical care. Many of these technologies, if used appropriately, also should reduce health care costs. The overall goal of this program, jointly announced and sponsored by the NCRR and Whitaker, is to stimulate the development of new or improved technologies that (1) have the potential to prevent or detect disease and/or disabling conditions in the early stages, when often they can be most efficiently and effectively treated; (2) will reduce the length of hospital stay or eliminate the need for in-patient care altogether; (3) will transfer health care procedures from the hospital to the home or an ambulatory environment; and (4) will provide acute and/or rehabilitation therapy based upon the specific physiological or functional need of the patient. Objectives and Scope The objective of this program is to stimulate technological research and development of novel, cost effective bioengineering approaches to the prevention, treatment, or rehabilitation of disease or disabling conditions. Applications need to be based on sound scientific, engineering, and medical rationale. There must be a clearly identified target patient population to which the research is addressed. Since work in technological innovation typically involves many disciplines (e.g., physics, chemistry, biology, engineering), applicants should consider using appropriate multidisciplinary teams in many cases. Research supported under this program is restricted to the following areas: o Microsensors. The emphasis is on devices that are non- invasive, minimally invasive, miniature, stable, and durable. o Physiological monitoring. The emphasis is on innovative detection and accurate readout. The monitoring must be a cost effective alternative to current practices. o Drug delivery systems. The emphasis is on automating the delivery of the accurate amount of medication when needed by the patient. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). These forms 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 240, Bethesda, MD 20892, telephone (301) 594-7248. Applications must be received by December 9, 1994. Any application received after this date will be considered ineligible for this special solicitation and will be returned to the applicant without review. Applicants are requested to submit a brief letter with their application, co-signed by the institutional official, authorizing that the application and summary statement be made available to Whitaker. The absence of this authorization letter will preclude the possibility of funding by Whitaker. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by NCRR. Incomplete applications will be returned to the applicant without further consideration. If NCRR staff find that the application is not responsive to this RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCRR in accordance with the peer 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 this RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator and the official signing for the applicant organization will be promptly notified. The complete review criteria are included in the RFA. A second level of review will be provided by the National Advisory Research Resources Council (NARRC), whose review may be based on policy considerations as well as scientific merit. Only applications recommended by NARRC may be considered for funding by the NCRR. Grants made by Whitaker need to be approved by its Foundation Governing Committee. AWARD CRITERIA The earliest anticipated award date is July 1, 1995. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: Richard DuBois, Ph.D Biomedical Research Technology Program National Center for Research Resources 5333 Westbard Avenue, Room 8A-15 Bethesda, MD 20892 Telephone: (301) 594-7934 Peter Katona, Sc.D. Biomedical Engineering Programs The Whitaker Foundation 901 15th Street, N.W. Washington, DC 20005 Telephone: (202) 408-1505 Direct inquiries regarding fiscal matters to: Mr. Paul Karadbil Office of Grants and Contracts Management National Center for Research Resources 5333 Westbard Avenue, Room 849 Bethesda, MD 20892 Telephone: (301) 594-7955 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.371, Biomedical Research Technology. Awards will be made under authorization of the Public Health Service Act, Title III, Part A (Public Law 78-410, as amended, 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R7 END ************************************************************ $$R8 BEGIN HL-95-002 FULL-TEXT ************************************** MECHANISMS OF POST BONE MARROW TRANSPLANTATION LUNG INJURY NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFA AVAILABLE: HL-95-002 P.T. National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 1, 1994 Application Receipt Date: January 19, 1995 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Heart, Lung, and Blood Institute (NHLBI) invites research grant applications to support research on immunological, cellular, and molecular mechanisms of post bone marrow transplantation lung injury. The primary objectives of this special grant program are to determine the etiology and to understand the cellular and molecular mechanisms involved in the pathogenesis of idiopathic pneumonia syndrome (IPS) that frequently follows bone marrow transplantation. 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, Mechanisms of Post Bone Marrow Transplantation Lung Injury, is related to the priority areas of immunization and infectious diseases and cancer. 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 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. Applications from minority individuals, women, and new investigators are encouraged. MECHANISM OF SUPPORT This program sill be awarded using an incremental funding method that is being tested by the NIH. Refer to the special instructions and the application procedures section in the RFA. Funds must be requested in increments of $50,000 each (direct costs), or applications will be returned. This RFA solicits applications for the National Institutes of Health (NIH) individual research project grant (R01) support mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. It is anticipated that support for this program will begin in August 1995. Up to four years of support may be requested for these R01s. For this RFA, funds must be requested in $50,000 direct cost increments and a maximum of four increments ($200,000 direct costs) per year may be requested. Only limited budget information will be required and any budget adjustments made by the Initial Review Group will be in increments of $50,000. Instructions for completing the Biographical Sketch have also been modified. In addition, Other Support information and the application Checklist page will be requested by NHLBI staff upon consideration for an award. The APPLICATION PROCEDURES section of the RFA provides specific details of modifications to standard application instructions. 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. The National Institute of Allergy and Infectious Diseases (NIAID) also has interest in the immunological/inflammatory/ infectious aspects of post bone marrow transplant injury. Therefore, applications that are of mutual interest are likely to be given a secondary assignment to the NIAID in accordance with the NIH referral guidelines. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the entire program is $1.5 million. It is anticipated that no more than eight awards will be issued under this program. Since a variety of approaches would represent valid responses to this RFA, it is anticipated that there will be a range of costs among individual grants awarded. Although this program is provided for in the financial plans of the NHLBI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funds will be awarded in lump sum direct cost amounts in increments of $50,000, less any overlap or other necessary administrative adjustments. Indirect costs will be awarded based on the negotiated rate at the time of each award. RESEARCH OBJECTIVES Bone marrow transplantation offers potentially curative treatment for a growing number of patients with a variety of diseases. However, in spite of encouraging developments, transplantation-related complications, especially those involving the lung, have limited the success of bone marrow transplantation. Interstitial pneumonitis is a primary or contributing cause of mortality, accounting for more than 40 percent of deaths related to bone marrow transplantation in most large series. Of these pneumonias, approximately half were attributed to non-infectious idiopathic pneumonia syndrome (IPS). It is also possible that undetectable infectious agents are involved. For the purposes of this RFA, the definition of IPS will be that proposed in the NHLBI Workshop Summary: Idiopathic Pneumonia Syndrome after Bone Marrow Transplantation (Am Rev Respir Dis 1993;147:1601-1606). A better understanding of the immunological, cellular, and molecular basis of pathogenesis of post transplantation lung injury is needed to identify those at risk and eventually treat or prevent this type of lung tissue injury. Examples of specific aspects of research that are encouraged, but not limited to, under this initiative are as follows: cellular and biochemical mechanisms involved in the afferent phase of the cell-mediated immune response; characterization and regulation of the inflammatory cell population involved in IPS; assessment of the capacity of resident lung cells, (for example, macrophages, lymphocytes, epithelial and endothelial cells) to produce cytokines and their role in generating the inflammatory and immune responses associated with IPS; and immunopathologic roles of infectious agents. These might include latent viral gene expression as it relates to dysregulation of cytokine gene expression and alteration of immune recognition and role of Gram negative bacterial products such as lipopolysaccharide and other cell wall constituents. The overall objective of this initiative is to encourage basic research on the etiology, mechanisms of pathogenesis, and the host determinants that are involved in the initiation and progression of post bone marrow transplantation lung injury. Applications are invited for innovative multidisciplinary approaches to identify the cause(s) of IPS associated with bone marrow transplantation and to delineate cellular and molecular mechanisms involved in its pathogenesis. Applications submitted in response to this RFA should clearly define the rationale, background, and specific aims of the proposed studies, and should provide a succinct description of the methods and procedures to be used. The ability to make significant progress in understanding the basic mechanisms involved in IPS would be greatly enhanced by adaptation of animal models, especially small laboratory animals. For example, inbred strains might be used to learn about genetic determinants of post bone marrow transplantation lung injury, and models of pneumonitis, including CMV pneumonitis, might be helpful in determining the role of cytokine-mediated lung injury related to IPS. In addition to animal studies, innovative studies using human cells or tissues that can be obtained incidentally are desirable. Research involving human subjects should be formulated in the context of mechanistic studies and should address specific hypotheses. Large scale clinical studies are beyond the scope of this RFA. SPECIAL REQUIREMENTS Applications that propose descriptive studies and do not contain studies directed at uncovering mechanisms of disease or supporting hypotheses related to mechanisms of disease will not be acceptable. This program will not support studies directed at development of animal models alone. Models must be applied to the study of disease mechanisms associated with post bone marrow transplantation lung injury. Applications that focus on molecular biology and molecular immunology of these disorders are of particular interest. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are asked to submit, by December 1, 1994, 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 that it contains allows NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. NHLBI staff will not provide a response to a letter of intent. This letter is to be sent to Dr. C. James Scheirer, at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications must be received by January 19, 1995. Submit applications on form PHS 398, (rev. 9/91). Application kits containing this form and the necessary instructions are available in 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. Additional instructions for completing the PHS 398 are provided in the RFA. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness to this RFA by the NHLBI. 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 Division of Extramural Affairs, NHLBI, solely to review these applications. 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 be assigned a priority score. Applications determined to be non-competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. The personnel category will be reviewed for appropriate staffing based on the requested percent effort and any changes requested in future years. The budget request will be reviewed for consistency with the proposed methods and specific aims. The duration of support will be reviewed to determine if it is appropriate to ensure successful completion of the recommended scope of the project. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from the potential applicants are welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: Hannah H. Peavy, M.D. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 6A09 Bethesda, MD 20892 Telephone: (301) 594-7425 FAX: (301) 594-7487 Direct inquiries regarding review matters and address the letter of intent to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 557 Bethesda, MD 20892 Telephone: (301) 594-7478 FAX: (301) 594-7407 Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 594-7420 FAX: (301) 594-7492 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, 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 to review by a Health Systems Agency. $$R8 END ************************************************************ $$R9 BEGIN CA-94-030 FULL-TEXT ************************************** SMALL GRANTS FOR HISTORICALLY BLACK COLLEGES AND UNIVERSITIES NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFA AVAILABLE: CA-94-030 P.T. 34, FC; K.W. 0715035, 0710030 National Cancer Institute Letter of Intent Receipt Date: October 28, 1994 Application Receipt Date: January 20, 1995 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Cancer Biology Branch, Division of Cancer Biology, Diagnosis, and Centers (DCBDC), National Cancer Institute (NCI) invites new faculty at Historically Black Colleges and Universities (HBCUs) to apply for small research grants to pursue basic science projects that are relevant to the goals of the NCI. The aim of this RFA is to provide new HBCU faculty with an opportunity to establish a research program to which they will commit time both during the academic year and the summer. It is expected that this opportunity will not only increase the research base at HBCUs, but also broaden the educational experience for students and expand mentoring possibilities. 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, Small Grants for Historically Black Colleges and Universities, is related to the priority area of cancer. Potential applicants may obtain a copy of "Health 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 Historically Black Colleges and Universities. The faculty member who serves as Principal Investigator (PI) for the project must have had no more than seven years of experience beyond his or her post-doctoral training. Applications from From owner-sci-resources@net.bio.net Thu Sep 15 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-95-003 - V23(33) 09/16/94 Date: 15 Sep 1994 23:47:40 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 382 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <35bf2c$qnb@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HD95003 HD-95-003 P1O1 *************************************** SPECIALIZED RESEARCH CENTER PROGRAMS OR CENTER CORE GRANTS TO SUPPORT RESEARCH IN REPRODUCTION NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFA AVAILABLE: HD-95-003 P.T. 04; K.W. 0413002, 0710110, 0710115, 0710030 National Institute of Child Health and Human Development Letter of Intent Receipt Date: January 3, 1995 Application Receipt Date: May 18, 1995 PURPOSE The National Institute of Child Health and Human Development (NICHD) provides funding for a limited number of research centers in the reproductive sciences. These centers are broadly based investigative endeavors encompassing research of a biomedical nature. They are supported through either Center Core Grants (P30) or Specialized Research Center Grants (P50). These centers form a national network that fosters communication, innovation, and high quality research. Reproductive Sciences Research Centers provide a stimulating, multidisciplinary environment that attracts and nurtures both established and promising young investigators. Each Center works closely with the NICHD staff in participating in a Center Network and in carrying out its objectives in a manner consistent with the goals and mission of the NICHD. Background The Reproductive Sciences Branch (RSB) of the Center for Population Research (CPR) of the NICHD supports basic and clinical research on reproduction that relies on a variety of approaches in biomedical sciences. Among the grant mechanisms used to provide research support, the RSB uses: (1) Specialized Research Center Grants (P50s), which support integrated groups of research projects and supporting core service facilities. The research activities included in such project grants must comprise, by definition, a multidisciplinary approach to biomedical problems addressing the research objectives announced in this RFA. These research programs may have more than one theme, focus, or emphasis, but all of the subprojects involved must be responsive to one or more of the specific research areas of reproduction supported by the RSB. (2) Center Core Grants (P30s), which support Center Core facilities designed to enhance existing federally supported research projects within the purview of the RSB, CPR, NICHD. Such center awards require a critical mass of individual awards for which coordinated technical support would be cost-effective to the NIH. Core Grants provide no funds for the direct support of research projects other than for new program development; however, by making cost-effective resources and facilities available, they enhance the productivity of existing projects that are either integrated in a specialized research area or organized within a central theme of research that addresses the research objectives announced in this RFA. At present, the RSB supports a fixed number of centers with a commitment of five years of support that is competitively renewable for additional five-year periods. Committed support for three P50 Centers and three P30 Centers ends in FY 1996, and it is anticipated that these Centers will submit renewal applications. New groups of investigators, in addition to the current awardees, are invited to compete for up to six awards in FY 1996. 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 Request for Applications (RFA), Specialized Research Center Programs or Center Core Grants to Support Research in Reproduction, is related to the area of family planning. 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 Domestic institutions are eligible to apply for these centers. Applications prepared for this competition may not propose multi-institutional consortium arrangements. In order to receive funding, an individual domestic institution's application for a specialized reproductive research center (P50) must have three or more related, integrated, and high quality research subprojects that provide a multidisciplinary, yet thematic, approach to the problems to be investigated. These research subprojects may be accompanied by an appropriate number and type of core facilities, as described below, for providing them cost-effective technical support. MECHANISM OF SUPPORT The support mechanisms for these programs are the P50 Specialized Reproductive Sciences Research Center Grant and the P30 Reproductive Sciences Research Center Core Grant. The applications should be prepared in a manner consistent with the policy and instructional details of this RFA and the general guidelines presented in the publications entitled either P50 SPECIALIZED RESEARCH CENTER GRANT GUIDELINES or P30 CENTER CORE GRANT GUIDELINES that are available from the NICHD offices listed below. The current policies and requirements that govern the research grant programs of NIH will prevail (Code of Federal Regulations, Title 42, Part 52 and Title 45, Part 75). The total project period for applications submitted to this RFA is five years. The anticipated award date will be April 1, 1996. The concurrent submission of an R01 or R29 research project application to do essentially the same research as that proposed in a subproject of a P50 Center application is permissible within the context of extant NIH policy. As a general policy, preference in selection for funding by NICHD will be given to the subprojects of the P50 Center in order to maintain the integrity of the program and the validity of its merit assessment. The coincident R01 or R29 application(s) will usually be expected to be withdrawn or relinquished. P50 subprojects must address one or more of the biomedical topics announced in this RFA to be eligible for funding. A domestic institution's application for a reproductive sciences research Center Core facility (P30) must be predicated on the existence of a comprehensive research base in the reproductive sciences comprised of a substantial number of relevant, eligible, and funded research grants which will be active on April 1, 1996. Such grant projects must directly address one or more of the biomedical topics announced in this RFA to be eligible for inclusion in the center. A majority of these grants must be supported by the NICHD. In addition, the eligibility for funding a core in a P30 Center is determined by the demonstrated need of a minimal number of three relevant NIH (or other federally reviewed and funded) research grants from the research base in the application. P30 Center grant funds support only active users of the core facilities and services from the research base (projects) proposed in the Center grant application and only serve programs of scientific research relevant to the mission of the RSB, CPR. Core facilities eligible for support under this RFA are organized activities directly providing reagents, assays, sophisticated technical services and technical expertise in areas required by multiple projects of a center. Such Core facilities neither directly conduct project type research nor serve as a funding source for non-Center technical services available elsewhere at the institution. It is expected that such Core facilities will be organized to provide training only for eligible users and only to the extent necessary to utilize the Core effectively. The general guideline request for information demonstrating research training program history and availability pertains to discussing the overall richness of the environment of the Center's setting and should not be confused with Core service needs per se. If a New Program Development (NPD) component is requested, it must be a single investigator's subproject description with a research plan formatted in the usual NIH research project style. Sufficient detail should be provided to allow a full peer-review evaluation of its merits. New Specialized Research Center Grant (P50) applications may not request more than $600,000 in direct costs for the first year. New Center Core Grant (P30) applications may not request more than $500,000 in direct costs for the first year. Renewal applications from existing P30 or P50 Centers may not request initial year direct costs exceeding 120 percent of the Council recommended direct costs for the final year of the preceding project period. Unless prior written approval of the NICHD has been obtained, applications with requests exceeding these guidelines will be administratively withdrawn by the NICHD and returned to the applicant. FUNDS AVAILABLE Although this solicitation is included in the fiscal plans for FY 1996, support for these center grants is contingent upon the receipt of funds for these purposes. The number of grants to be awarded is also contingent upon a sufficient number of applications receiving high enough levels of merit to be considered for an award. It is expected that up to six awards will be made as a result of this announcement within the expected total costs limit of $4,100,000 available for the first year. RESEARCH OBJECTIVES The ultimate goals of biomedical research in the reproductive sciences are to develop new knowledge leading to clinical applications that will enable men and women to control their fertility with methods that are safe, effective, inexpensive, reversible, and acceptable to various population groups, and to overcome problems of infertility and reproductive disorders. Domestic U.S. Reproductive Sciences centers designated as "Specialized Reproductive Sciences Research Centers" (P50s) and as "Reproductive Sciences Research Centers" (P30s) are awarded funds for the support of comprehensive reproductive research programs of high quality that focus on topics deemed to be of high priority and significance because of their critically important relationship to the mission of the RSB, CPR. This RFA is specifically designed to stimulate the reproductive sciences research community to organize or to maintain reproductive sciences research centers of outstanding quality that, serving as national research resources, form a network that fosters communication, innovation, and high quality research. Applications are encouraged for the biomedical topics listed below: 1. Reproductive medicine: Fertility and infertility aspects 2. Mechanism(s) of follicular selection, atresia and ovulation 3. Neuroendocrinology of reproduction: Clarification of the regulatory mechanisms of the hypothalamo-pituitary-gonadal axis related to fertility 4. Regulatory mechanism(s) of gametogenesis 5. Mechanism of action of reproductive hormones, particularly at the cellular and genetic level; modification of action by growth factors 6. Mechanisms regulating gonadal or genital tract functions 7. Studies on fertilization, preimplantation embryo development, or blastocyst implantation 8. Immunological mechanisms regulating fertility SPECIAL REQUIREMENTS Applicants may request travel funds to attend an annual meeting of the directors of P50s and P30s. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is 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 rational 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 Population, 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. LETTER OF INTENT Interested applicants may contact the RSB staff for an advisory consultation regarding reproductive sciences center grants (P50s and P30s). Prospective applicants are asked to submit, by January 3, 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 intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NICHD staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Julia Lobotsky at the address listed under INQUIRIES. APPLICATION PROCEDURES The grant application form PHS 398 (rev. 09/91) is to be used to prepare these applications. The form PHS 398 is available from most 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 RFA number HD-95-003 and the type of center grant request (P50 or P30) must be indicated on the face page of the application in item 2a. The RFA label available in the form PHS 398 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. It is especially important that applicants obtain and follow the supplemental NICHD guidelines for preparing the application. These guidelines address special organizational aspects that require certain tabulations in addition to the usual instructions. Applications must be submitted by May 18, 1995. Send or deliver the original, completed, signed application and three, signed complete copies to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** In addition to those applications mailed to the Division of Research Grants, two copies of the application must be sent under separate cover directly to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development Building 6100, Room 5E03 Bethesda, MD 20892-7510 Late applications will not be accepted and will be returned to the applicants. REVIEW CONSIDERATIONS Upon receipt, the applications will be reviewed for completeness by DRG and responsiveness by NICHD. Incomplete applications will be returned to the applicant without further consideration. If NICHD staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with 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 noncompetitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score, and will also receive a second level of review by the National Advisory Child Health and Human Development Council. Applications determined to be noncompetitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. Those applications judged to be competitive will be further evaluated by peer review for scientific/technical merit. The Scientific Review Administrator (SRA) of the Population Research Committee (PRC), NICHD, may forward the application to selected members of the PRC for their evaluation to determine if a site visit is needed. A site visit, however, is not a prerequisite for consideration of an application by the PRC. If a site visit is required, the SRA will communicate with the applicant for the visit arrangements as described in the guidelines. The initial review for scientific merit will be carried out by the PRC in November 1995. The second-level review will be made by the National Advisory Child Health and Human Development Council in January 1996. The earliest possible funding date is April 1, 1996. Review procedures and criteria are detailed in the P50 SPECIALIZED RESEARCH CENTER GUIDELINES and P30 CENTER CORE GRANT GUIDELINES (available from the NICHD offices listed below). AWARD CRITERIA The anticipated date of award is April 1, 1996. Funding decisions will be based on the IRG and NACHHD Council recommendations, program relevance, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. For further information regarding programmatic issues, contact: Julia Lobotsky, M.S. Center for Population Research National Institute of Child Health and Human Development Building 6100, Room 8B01 Bethesda, MD 20892-7510 Telephone: (301) 496-6515 For information on budget and fiscal matters, contact: Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development Building 6100, Room 8A17K Bethesda, MD 20892-7510 Telephone: (301) 496-5481 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.864, Population Research. Awards will be made under the authority of the Public Health Service Act 301 (42 USC 241) and 441 (USC 289d) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to A-95 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. 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 Thu Sep 15 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-94-030 - V23(33) 09/16/94 Date: 15 Sep 1994 23:47:35 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 317 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <35bf27$qml@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA94030 CA-94-030 P1O1 *************************************** SMALL GRANTS FOR HISTORICALLY BLACK COLLEGES AND UNIVERSITIES NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFA: CA-94-030 P.T. National Cancer Institute Letter of Intent Receipt Date: October 28, 1994 Application Receipt Date: January 20, 1995 PURPOSE The Cancer Biology Branch, Division of Cancer Biology, Diagnosis, and Centers (DCBDC), National Cancer Institute (NCI) invites new faculty at Historically Black Colleges and Universities (HBCUs) to apply for small research grants to pursue basic science projects that are relevant to the goals of the NCI. The aim of this Request for Applications (RFA) is to provide new HBCU faculty with an opportunity to establish a research program to which they will commit time during both the academic year and the summer. It is expected that this opportunity will not only increase the research base at HBCUs, but also broaden the educational experience for students and expand mentoring possibilities. 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, Small Grants for Historically Black Colleges and Universities, is related to the priority area of cancer. Potential applicants may obtain a copy of "Health 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 Historically Black Colleges and Universities. The faculty member who serves as Principal Investigator (PI) for the project must have had no more than seven years of experience beyond his or her post-doctoral training. Applications from minority and women investigators are especially encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) small grant (R03) mechanism. Applicants will be responsible for the planning, direction, and execution of the proposed projects. The total proposed project period for each application submitted may not exceed three years. The total proposed direct costs for each year may not exceed $85,000, up to $35,000 of which may be used for equipment purchases in the first year. The anticipated award date is August 1, 1995. The award and level of support depends 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. At this time, the NCI has not determined whether this solicitation will be repeated. The present RFA is for a single solicitation with a specified deadline of January 20, 1995, for receipt of applications. The NCI anticipates making up to ten awards for project periods of up to three years, if meritorious proposals and funds are available. FUNDS AVAILABLE Approximately $1,000,000 in total costs per year will be committed to fund applications specifically submitted in response to this RFA. It is anticipated that 8 to 10 awards will be made. RESEARCH OBJECTIVES A. Background Historically Black Colleges and Universities (HBCUs) are a vital national resource for the education of African-American men and women; more than 50 percent of African-American physicians and Ph.D. scientists are graduates of an HBCU. Most HBCUs are primarily teaching institutions; like many non-minority teaching institutions, few HBCUs maintain a sizable research grant base. However, they continually attract high-quality, well-trained new faculty who have teaching as their principal goal, but who are also motivated to continue to pursue research. This RFA is designed to provide new HBCU faculty with an opportunity to initiate cancer-related research projects, to sustain their continued professional growth, and to build a research base in colleges and universities that often have less than a critical mass of researchers. B. Objective and Scope Many new HBCU faculty who are motivated to develop research programs, but initially fail to get grant support, abandon this important endeavor. New faculty may have fewer research resources than more established faculty with which to acquire preliminary data and less time during the academic year to perform research. This RFA for specialized small grants can support pilot projects that have less preliminary data and a more narrow scientific focus than is required for an investigator-initiated research project (R01). In addition to the opportunity to implement a research program, this RFA will enable HBCU faculty to involve students in an on-going research project. Because African-American scientists and physicians continue to be under-represented in the cancer research community, HBCUs afford a unique environment for significant numbers of minority students. The ability to observe and participate in on-going cancer research projects at the undergraduate or graduate level would broaden the educational experience for the students, provide mentoring opportunities for the faculty, and possibly attract more minority students into scientific and clinical careers in cancer research. The areas of basic in vitro and in vivo research supported by the NCI that are appropriate for this RFA, include, but are not limited to: the cellular and molecular biology of malignant cells; the role of the immune system in tumor growth and progression; the means to improve the diagnosis and prognosis of cancer; the mechanisms of cancer induction and promotion by chemicals, viruses, and environmental agents; drug discovery and synthesis of new anti-cancer agents; the biochemical and molecular mechanisms of anti-tumor drug action; the pharmacology and toxicology of anti-tumor agents; the identification and evaluation of agents that prevent carcinogenesis; the identification of biological markers of risk or exposure; the role of nutrition in cancer. Collaborations within, or external to, the applicant institution are encouraged whenever they are appropriate to provide resources and expertise that is germane to the research proposed in the application. STUDY POPULATIONS 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 on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting errors in the earlier publication, 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. LETTER OF INTENT Prospective applicants are asked to submit, by October 28, 1994, a letter of intent that includes a descriptive title of the research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel or collaborators, 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 that it contains 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 to be sent to Dr. Cheryl L. Marks at the address 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; 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 Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard MSC 7405 Bethesda, MD 20892-7405 (If using U.S. Postal Service) Rockville, MD 20852 (If hand-delivered or delivery service) It is important to send these copies at the same time that the original and three copies are sent to the Division of Research Grants (DRG); otherwise the NCI cannot guarantee that the applications will be reviewed in competition with other applications received on or before the designated receipt date. Applications must be received by January 20, 1995. If an application is received after that date, it will be returned. The Division of Research Grants 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 Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. If NCI staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA 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, a process (triage) may be used by the initial review group in which applications will be judged 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 determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. The second level of review will be provided by the National Cancer Advisory Board. The review group will assess the scientific merit of the studies according to the following criteria: 1. Scientific and technical feasibility and originality of the proposed research; 2. Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; 3. Qualifications of the Principal Investigator and his or her collaborators to perform the research; 4. Availability and adequacy of resources and facilities necessary to perform the research; 5. Appropriateness of the proposed budget in relation to the proposed research; 6. Evidence of commitment by the applicant institution to provide space and appropriate release time from teaching responsibilities to support the proposed 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. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA or the content of the intended research project are strongly encouraged. Direct inquiries regarding programmatic issues and address the letter of intent to: Dr. Cheryl L. Marks or Dr. Gladys M. Glenn Division of Cancer Biology, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 505 6130 Executive Boulevard Bethesda, MD 20892-7385 Telephone: (301) 496-7028 FAX: (301) 402-1037 Direct inquiries regarding fiscal matters to: Ms. Michelle Burr Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, Ext. 231 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.396, Cancer Biology Research. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, 42 USC 214, as amended; Public Law 100-607, 42 USC 285 and 285a) and administered under PHS grants policies. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. 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 Thu Sep 15 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-95-002 - V23(33) 09/16/94 Date: 15 Sep 1994 23:47:30 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 577 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <35bf22$qlt@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL95002 HL-95-002 P1O1 *************************************** MECHANISMS OF POST BONE MARROW TRANSPLANTATION LUNG INJURY NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFA: HL-95-002 P.T. National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 1, 1994 Application Receipt Date: January 19, 1995 PURPOSE The National Heart, Lung, and Blood Institute (NHLBI) invites research grant applications to support of research on immunological, cellular, and molecular mechanisms of post bone marrow transplantation lung injury. The primary objectives of this special grant program are to determine the etiology and to understand the cellular and molecular mechanisms involved in the pathogenesis of idiopathic pneumonia syndrome (IPS) that frequently follows bone marrow transplantation. 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), Mechanisms of Post Bone Marrow Transplantation Lung Injury, is related to the priority areas of immunization and infectious diseases and cancer. 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 Among the disciplines and expertise that may be appropriate for this research program are cell biology, virology, pharmacology, radiation biology, molecular biology, immunology, molecular immunology, infectious diseases, pathology, pulmonary medicine, pediatrics, oncology, and hematology. 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 or local governments, and eligible agencies of the Federal government. Applications from minority individuals, women, and new investigators are encouraged. All current policies and requirements that govern the research grant programs of the National Institutes of Health (NIH) will apply to grants awarded under this RFA. Awards under this RFA to foreign institutions will be made only for research of very unusual merit, need, and promise, and in accordance with PHS policy governing such awards. MECHANISM OF SUPPORT This program will be awarded using an incremental funding method being tested by the NIH. Refer to the special instructions below and in the APPLICATION PROCEDURES section. Funds must be requested in increments of $50,000 each (direct costs), or applications will be returned. This RFA will use the NIH individual research project grant (R01) support mechanism. However, specific application instructions have been modified to reflect streamlining efforts being examined by the NIH. It is hoped that these changes will reduce the administrative burden for the applicants, reviewers, and NHLBI staff. Up to four years of support may be requested for these R01s. For this RFA, funds must be requested in $50,000 direct cost increments and a maximum of four increments ($200,000 direct costs) per year may be requested. Only limited budget information will be required and any budget adjustments made by the Initial Review Group will be in increments of $50,000. Instructions for completing the Biographical Sketch have also been modified. In addition, Other Support information and the application Checklist page will be requested by NHLBI staff upon consideration for an award. The APPLICATION PROCEDURES section of this RFA provides specific details of modifications to standard application instructions. Upon initiation of the program, the NHLBI will sponsor periodic meetings to encourage exchange of information among investigators who participate in this program. Applicants should also include a statement in their applications indicating their willingness to participate in a 1-day meeting each year, most likely to held in Bethesda, Maryland. Travel costs for these meetings are to be covered by the grant. 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. Applicants (who will plan and execute their own research programs) are expected to furnish their own estimates of time required to achieve the objectives of the proposed research project. Since a variety of approaches would represent valid responses to this RFA, it is anticipated that there will be a range of costs among individual grants awarded. This RFA is a one-time solicitation. Future unsolicited competing continuation applications may be submitted for peer review and competition for support through the regular grant program of the NIH. It is anticipated that support for this program will begin in August 1995. Administrative adjustments in project period and/or amount may be required at the time of the award. While multidisciplinary approaches are encouraged, it is not the intent of this RFA to solicit applications for large studies encompassing a variety of individual subprojects, i.e., program projects. If collaborative arrangements through subcontracts with other institutions are planned, consult the program staff listed under INQUIRIES. The National Institute of Allergy and Infectious Diseases (NIAID) also has interest in the immunological/inflammatory/infectious aspects of post bone marrow transplant injury. Therefore, applications that are of mutual interest are likely to be given a secondary assignment to NIAID in accordance with the NIH referral guidelines. FUNDS AVAILABLE Approximately $1,500,000 total costs will be available for the first year of support for the entire program, and is included in the financial plans for fiscal year 1995; but, award of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. It is anticipated that no more than eight awards will be issued under this program. The specific number to be funded will, however, depend on the merit and scope of the applications received and the availability of funds. Funds will be awarded in lump sum direct cost amounts in increments of $50,000, less any overlap or other necessary administrative adjustments. Indirect costs will be awarded based on the negotiated rate at the time of each award. RESEARCH OBJECTIVES Background Bone marrow transplantation offers potentially curative treatment for a growing number of patients with a variety of diseases. Advances in transplant immunobiology, supportive care and the availability of suitable donors, make the technique both effective and feasible. In 1990 statistics from the International Bone Marrow Transplant Registry indicated that over 5,500 patients received allogeneic marrow transplants from matched or partially matched family members and more than 5,000 autologous transplant procedures were performed world wide. Through the National Marrow Donor Program, it is now possible to identify unrelated phenotypically HLA-matched donors for patients who do not have suitable donors among family members. Currently, more than 1,200,000 potential donors are registered in this program. This number doubled during the past two years. Approximately 650 allogenic bone marrow transplants involving unrelated donors and recipients were performed in 1993. In spite of these encouraging developments, transplantation-related complications, especially those involving the lung, have limited the success of bone marrow transplantation. Interstitial pneumonitis is a primary or contributing cause of mortality, accounting for more than 40 percent of deaths related to bone marrow transplantation in most large series. Of these pneumonias, approximately half were attributed to non-infectious idiopathic pneumonia syndrome (IPS). It is also possible that undetectable infectious agents are involved. Although progress has been made in diagnosis and treatment of infectious pneumonia, e.g., cytomegalovirus (CMV) and Pneumocystis carinii, IPS remains a major cause of morbidity and mortality. For the purposes of this RFA the definition of IPS will be that proposed in the NHLBI Workshop Summary: Idiopathic Pneumonia Syndrome after Bone Marrow Transplantation (Am Rev Respir Dis 1993;147:1601-1606). I. Evidence of widespread alveolar injury. Criteria include: a. Multilobar infiltrates on routine chest radiographs or CT scans. b. Symptoms and signs of pneumonia, e.g., cough, dyspnea, rales. c. Evidence of abnormal pulmonary physiology. 1. Increased alveolar to arterial oxygen gradient (compared with previous, if available). 2. New or increased restrictive pulmonary function test abnormality. II. Absence of active lower respiratory tract infection. Appropriate evaluation includes: a. Bronchoalveolar lavage negative for significant bacterial pathogens and/or lack of improvement with broad-spectrum antibiotics. b. Bronchoalveolar lavage negative for pathogenic nonbacterial microorganisms. 1. Routine bacterial, viral and fungal cultures. 2. Shell-vial CMV culture. 3. Cytology for CMV inclusions, fungi and Pneumocystis carinii. 4. Detection methods for respiratory syncytial virus, parainfluenza virus, and other organisms (e.g., fluorescent antibodies or culture). c. Transbronchial biopsy if condition of the patient permits. d. Ideally, a second confirmatory negative test for infection is done. This usually is performed 2 to 14 days after the initial negative bronchoalveolar lavage (BAL), and it may consist of a second BAL or an open lung biopsy. Although IPS is an important clinical entity, progress in understanding the mechanisms underlying its pathogenesis has been limited. The lack of progress is partly due to lack of uniform definitions of the disease, lack of uniform diagnostic criteria, and the relatively small number of patients available for study at most centers. These clinical diagnostic obstacles are being overcome. However, the fundamental mechanisms that result in the development of IPS are still poorly understood, even though the techniques for learning more about them are now becoming available to researchers. For example, there have been major advances in basic immunology, molecular virology, radiation biology and the biology of inflammation. But, the application of this knowledge to the problem of IPS has not been adequately pursued. A better understanding of the immunological, cellular and molecular basis of pathogenesis of post transplantation lung injury is needed to identify those at risk and eventually treat or prevent this type of lung tissue injury. Examples of specific aspects of research that would be encouraged under this initiative are as follows: cellular and biochemical mechanisms involved in the afferent phase of the cell-mediated immune response; characterization and regulation of the inflammatory cell population involved in IPS; assessment of the capacity of resident lung cells, (for example, macrophages, lymphocytes, epithelial and endothelial cells) to produce cytokines and their role in generating the inflammatory and immune responses associated with IPS; and immunopathologic roles of infectious agents. These might include latent viral gene expression as it relates to dysregulation of cytokine gene expression and alteration of immune recognition and role of Gram negative bacterial products such as lipopolysaccharide and other cell wall constituents. Objectives and Scope The overall objective of this initiative is to encourage basic research on the etiology, mechanisms of pathogenesis, and the host determinants that are involved in the initiation and progression of post bone marrow transplantation lung injury. Applications are invited for innovative multidisciplinary approaches to identify the cause(s) of IPS associated with bone marrow transplantation and to delineate cellular and molecular mechanisms involved in its pathogenesis. Applications submitted in response to this RFA should clearly define the rationale, background, and specific aims of the proposed studies, and should provide a succinct description of the methods and procedures to be used. Several topics relevant to the objectives of this RFA are cited below in order to provide a perspective of the scope of the research that would meet the goals of the program. Investigators are also encouraged to consider approaches that meet the goals of this program other than those cited below. Since immune factors related to graft versus-host disease (GVHD) appear to be significant risk factors for IPS, studies of IPS in animal models of GVHD would be appropriate. Several cytokines including TNF-alpha, TNF-beta, IL-2, IL-4, and gamma-interferon may be involved in the pathogenesis of GVHD. Animal models of GVHD could be used in mechanistic studies to look at cytokines and other factors associated with IPS. This might include lymphocyte-macrophage interactions as they relate to the lung. The work would have to focus on IPS; animal models of GVHD alone, which are not pertinent to IPS, would not be acceptable. Other animal models of immune mediated lung disease (e.g., those involving adoptive transfer) might also be relevant. It is possible that knockout mouse models may be useful in delineating the mechanisms involved in IPS. The late stages of IPS are characterized by a fibroproliferative reaction. Mechanisms responsible for the cellular proliferation and accumulation of collagen appear to involve interactions between fibroblasts and effector molecules including platelet-derived growth factor (PDGF), transforming growth factor beta (TGF-beta), and insulin-like growth factor-I (IGF-I). For instance, women receiving autologous bone marrow transplantation for advanced breast cancer were observed to have plasma TGF-beta levels that correlated strongly with the risk of developing IPS. More recently, TGF-beta has been observed to induce the production of fibroblast-derived cytokines IL-6 and IL-11 and it is suggested that IL-11 may play an important role in the pathogenesis of chronic inflammatory conditions including idiopathic pulmonary fibrosis. The ways in which these and related effector molecules and cytokines participate in the pathogenesis of IPS might be studied at the molecular level in cell systems and animal models. Graft versus-host disease appears to increase host sensitivity to endotoxin released in the gut. It may be possible to adapt models of GVHD to understand multiple causes of endothelial and epithelial permeability and related events occurring in the lung. For example, models could be adapted to study the immunological response to Gram negative bacteria, and responses to lipopolysaccharides and drugs as they relate to IPS. Latent viral gene expression as it relates to IPS could be studied in animal models or cell systems. Ways in which herpes viruses (e.g., CMV, EBV, HHV-6, etc.) and adenoviruses alter host cell regulation of cytokine gene expression could be examined. Other areas for investigators might include the influence of latent viral infection on the expression of cell surface receptors (e.g., ICAM) and responses to antigens that may be triggered when viral genes are expressed. The ability to make significant progress in understanding the basic mechanisms involved in IPS would be greatly enhanced by adaptation of animal models, especially small laboratory animals. For example, inbred strains might be used to learn about genetic determinants of post bone marrow transplantation lung injury, and models of pneumonitis, including CMV pneumonitis, might be helpful in determining the role of cytokine-mediated lung injury related to IPS. In addition to animal studies, innovative studies using human cells or tissues which can be obtained incidentally are desirable. Research involving human subjects should be formulated in the context of mechanistic studies and should address specific hypotheses. Large scale clinical studies are beyond the scope of this RFA. SPECIAL REQUIREMENTS Applications that propose descriptive studies and do not contain studies directed at uncovering mechanisms of disease or supporting hypotheses related to mechanisms of disease will not be acceptable. This program will not support studies directed at development of animal models alone. Models must be applied to the study of disease mechanisms associated with post bone marrow transplantation lung injury. Applications that focus on molecular biology and molecular immunology of these disorders are of particular interest. STUDY POPULATIONS 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 of March 18, 1994, Volume 23, Number 11. Investigators also may obtain copies of the policy from these sources or 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 December 1, 1994, 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 that it contains allows NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. C. James Scheirer at the address listed under INQUIRIES. APPLICATION PROCEDURES Submit applications on form PHS 398 (rev. 9/91), the application form for the traditional research project grant. This form is available in an applicant institution's office of sponsored research and 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. Use the conventional format for research project grant applications and ensure the points identified in the section, "Review Procedures and Criteria" are fulfilled. To identify the application as a response to this RFA, check "YES" on item 2a of page 1 of the application and enter the title "Mechanisms of Post Bone Marrow Transplantation Lung Injury," HL-95-002. Applicants are expected to conform to the 25-page limit as directed in the application kit (PHS 398). Appendices containing supporting materials may be submitted with the application, but may not be used to circumvent this requirement. Exceptions to this page limit must be explicitly granted by the scientific review administrator. The following modifications are to be made to the standard PHS 398 application instructions: o INITIAL BUDGET PERIOD - Only the names of personnel and level of effort should be itemized in the Personnel section of the "Detailed Budget for the Initial Budget Period" (Form Page 4). In addition, generally list consultants, equipment, supplies, travel, patient care activities, alterations and renovations and other needs, as appropriate. No costs need be associated with these individual items or categories. If Consortium/Contractual Costs are requested, then the "Subtotal Direct Costs" line should be completed and the "Consortium/Contractual Costs" section should include all Contractual direct, indirect, and total costs. The "Total Direct Costs" line at the bottom of the page must be completed based on the number of $50,000 increments being requested. Applicants may not request a change in the amount of each increment. A maximum of four increments ($200,000 direct costs) per year may be requested. Any large one-time purchases, such as large equipment requests, must be accommodated within these limits. APPLICATIONS NOT CONFORMING TO THESE GUIDELINES WILL BE CONSIDERED UNRESPONSIVE TO THIS RFA AND WILL BE RETURNED WITHOUT FURTHER REVIEW. o A sample budget is available upon request from Dr. Peavy at the number listed under INQUIRIES. o FUTURE BUDGET PERIODS - It is anticipated that direct cost budgets will remain constant throughout the life of the project (i.e., the same number of increments requested for all budget periods). Any necessary escalation should be considered when determining the number of increments to be requested. However, in the event that the number of increments changes in any future year, appropriate justification must be provided. The "Budget for Entire Proposed Project Period" (top section of Form Page 5) should include Total Direct Costs for each year and the Total Direct Costs for the Entire Proposed Project Period. If Consortium/Contractual Costs are requested, then the "Subtotal Direct Costs" and the "Consortium/Contractual Costs" lines should be completed. In addition, the Justification section should be completed based on instructions provided on Form Page 5. o SUBCONTRACTS - If collaborations or subcontracts are involved that require transfer of funds from the grantee to other institutions, it is necessary to establish formal subcontract agreements with each collaborating institution. A letter of intent from each collaborating institution should be submitted with the application. Budgets for subcontracts should be prepared using the same guidelines as for the main grant except that total subcontract costs need not be in $50,000 increments. Requested amounts should be based on individual needs of the subcontract and should reflect both direct and indirect costs. When subcontract funds are added to the main grant budget, the total amount must conform with the number of $50,000 increments requested. o BIOGRAPHICAL SKETCH - In addition to the standard information requested on Form Page 6, the applicant has the option of providing the title and source of any sponsored support relevant to the proposed research. o OTHER SUPPORT - No other support information is required on "Other Support" pages (Form Page 7). Selected other support information relevant to the proposed research may be included in the Biographical Sketch as indicated above. Complete other support information will be requested by NHLBI staff upon consideration for an award. o CHECKLIST - No "Checklist" page is required as part of the application. A completed Checklist page will be requested by NHLBI staff upon consideration for an award. The RFA label available in the PHS 398 application kit must be affixed to the bottom of the face page of the original completed application form PHS 398. 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. Send or deliver the completed application and three signed photocopies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Send two additional copies of the application to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 557 Bethesda, MD 20892 It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants (DRG). Otherwise the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by January 19, 1995. If an application is received after this date, it will be returned to the applicant without review. The 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 Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness to this RFA by the NHLBI. Incomplete applications will be returned without further consideration. Applications that are complete and responsive will be evaluated for scientific and technical merit by a special emphasis panel, convened by the Division of Extramural Affairs, NHLBI, solely to review these applications. 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 be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria. The factors to be considered in the evaluation of scientific merit of each application will be similar to those used in the review of traditional research project grant applications including the novelty, originality, and feasibility of the approach; the training, experience, and research competence of the investigator(s); the adequacy of the experimental design; the suitability of the facilities; and the appropriateness of the requested budget to the work proposed. The personnel category will be reviewed for appropriate staffing based on the requested percent effort and any changes requested in future years. The budget request will be reviewed for consistency with the proposed methods and specific aims. The duration of support will be reviewed to determine of it is appropriate to ensure successful completion of the recommended scope of the project. AWARD CRITERIA The anticipated date of award is August 1, 1995. In addition to the scientific merit of the applications, awards will be based on the availability of resources and program priorities. 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: Hannah H. Peavy, M.D. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 6A09 Bethesda, MD 20892 Telephone: (301) 594-7425 FAX: (301) 594-7487 Direct inquiries regarding review matters, address the letter of intent, and mail two copies of the application to: C. James Scheirer, Ph.D. National Heart, Lung, and Blood Institute Westwood Building, Room 557 Bethesda, MD 20892 Telephone: (301) 594-7478 FAX: (301) 594-7407 Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 594-7420 FAX: (301) 594-7492 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, 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 to review by a Health Systems Agency. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of American people. From owner-sci-resources@net.bio.net Thu Sep 15 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA RR-94-005 - V23(33) 09/16/94 Date: 15 Sep 1994 23:47:25 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 324 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <35bf1t$ql2@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA RR94005 RR-94-005 P1O1 *************************************** BIOENGINEERING FOR DISEASE PREVENTION AND CONTROL NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFA: RR-94-005 P.T. 34; K.W. 0706000, 0745027, 0795003 National Center for Research Resources The Whitaker Foundation Application Receipt Date: December 9, 1994 PURPOSE The National Center for Research Resources (NCRR) and The Whitaker Foundation invite investigator-initiated research project grant applications for the research and development of devices, instruments, and methodologies for the prevention and control of disease and disabling conditions, and the reduction of health care costs and risks. This solicitation is limited to novel, cost-effective bioengineering approaches in the following areas: (1) microsensors, (2) physiological monitoring, and (3) drug delivery systems. The Whitaker Foundation (Whitaker) is a private, non-profit foundation that encourages and supports biomedical engineering research and training. 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), Bioengineering for Disease Prevention and Control, is related to the priority area of disease prevention. 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, public and private, non-profit and for-profit organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT The mechanism of NCRR support for this program will be the individual research project grant (R01) and the total project period may not exceed four years (three years for foreign applicants). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The NCRR and Whitaker plan to make several awards each in Fiscal Year 1995. The earliest possible award date is July 1, 1995. Because the nature and scope of the research proposed in response to this RFA will vary, it is anticipated that the size of an award will vary also. 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 The NCRR and Whitaker anticipate making a total of six to eight awards for project periods of up to four years and anticipate that each will set aside $1 million for the initial funding period. Funding in response to this RFA is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCRR, the award of research grants pursuant to this RFA by NCRR is contingent on the availability of funds appropriated for Fiscal Year 1995. RESEARCH OBJECTIVES Background The recent explosion of new knowledge in both the physical and biological sciences offers unprecedented opportunities to develop devices, sensors, instruments, and novel methods for use in basic research and clinical care. Many of these technologies, if used appropriately, also should reduce health care costs. The overall goal of this program, jointly announced and sponsored by the NCRR and Whitaker, is to stimulate the development of new or improved technologies that (1) have the potential to prevent or detect disease and/or disabling conditions in the early stages, when often they can be most efficiently and effectively treated; (2) will reduce the length of hospital stay or eliminate the need for in-patient care altogether; (3) will transfer health care procedures from the hospital to the home or an ambulatory environment; and (4) will provide acute and/or rehabilitation therapy based upon the specific physiological or functional need of the patient. Objectives and Scope The objective of this program is to stimulate technological research and development of novel, cost effective bioengineering approaches to the prevention, treatment, or rehabilitation of disease or disabling conditions. Applications need to be based on sound scientific, engineering, and medical rationale. There must be a clearly identified target patient population to which the research is addressed. Since work in technological innovation typically involves many disciplines (e.g., physics, chemistry, biology, engineering), applicants should consider using appropriate multidisciplinary teams in many cases. Research supported under this program is restricted to the following areas: o Microsensors. The emphasis is on devices that are non-invasive, minimally invasive, miniature, stable, and durable. o Physiological monitoring. The emphasis is on innovative detection and accurate readout. The monitoring must be a cost effective alternative to current practices. o Drug delivery systems. The emphasis is on automating the delivery of the accurate amount of medication when needed by the patient. STUDY POPULATIONS 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 humans 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 (59 FR 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 NIH program staff or contact person listed below. 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). These forms 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 240, Bethesda, MD 20892, telephone (301) 594-7248. Instructions relating to the preparation of investigator-initiated R01 grant applications are provided with the PHS 398 form. 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 and number must be typed on line 2a of the face page of the application form and the YES box must be marked. The completed original and three permanent, legible copies of the PHS 398 including the Checklist and appendix material must be delivered by December 9, 1994, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the complete application including Checklist and appendix material must be sent to: Dr. Chhanda Ganguly Office of Review National Center for Research Resources Westwood Building, Room 10A15 Bethesda, MD 20892 Applications must be received by December 9, 1994. Any application received after this date 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. Timetable Application Receipt Date: December 9, 1994 Initial Review: February/March 1995 Council Review: June 1995 Earliest Award Start Date: July 1, 1995 Applicants are requested to submit a brief letter with their application, co-signed by the institutional official, authorizing that their application and summary statement be made available to Whitaker. The absence of this authorization letter will preclude the possibility of funding by Whitaker. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by NCRR. Incomplete applications will be returned to the applicant without further consideration. If NCRR staff find that the application is not responsive to this RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCRR in accordance with the peer 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 this RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator and the official signing for the applicant organization will be promptly notified. The following review criteria will be used by the Office of Review, NCRR to evaluate the scientific and technical merit of each application: o Originality or uniqueness of the approach(es) proposed. o Merit of the research plan for developing and testing the proposed device or method. o Appropriateness of the target patient population that will be addressed. o Project staffing with appropriate disciplines and training/prior experience, and adequate facilities and equipment to successfully achieve the stated goals. o Rational assessment of the anticipated health care cost reduction resulting from the application of the proposed technological innovation. A second level of review will be provided by the National Advisory Research Resources Council (NARRC), whose review may be based on policy considerations as well as scientific merit. Only applications recommended by NARRC may be considered for funding by the NCRR. Grants made by Whitaker need to be approved by its Foundation Governing Committee. AWARD CRITERIA The anticipated earliest award date is July 1, 1995. Applications judged meritorious may be eligible for funding by either the NCRR or by Whitaker. Whitaker is not required to base its funding solely on the priority assigned by the NCRR peer review group, and may use its own peer review process to determine which projects it will fund. Factors to be considered by both sponsors include scientific and technical merit, project content, and program relevance. The NCRR will administer grants funded by NIH in accordance with PHS policies. Grants funded by Whitaker will be subject to that foundation's policies, except that the indirect cost allowance of NIH will apply. 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 DuBois, Ph.D Biomedical Research Technology Program National Center for Research Resources 5333 Westbard Avenue, Room 8A-15 Bethesda, MD 20892 Telephone: (301) 594-7934 Peter Katona, Sc.D. Biomedical Engineering Programs The Whitaker Foundation 901 15th Street, N.W. Washington, DC 20005 Telephone: (202) 408-1505 Direct inquiries regarding fiscal matters to: Mr. Paul Karadbil Office of Grants and Contracts Management National Center for Research Resources 5333 Westbard Avenue, Room 849 Bethesda, MD 20892 Telephone: (301) 594-7955 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.371, Biomedical Research Technology. Awards will be made under authorization of the Public Health Service Act, Title III, Part A (Public Law 78-410, as amended, 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. 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 Thu Sep 15 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AG-95-001 - V23(33) 09/16/94 Date: 15 Sep 1994 23:47:19 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 374 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <35bf1n$qkd@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AG95001 AG-95-001 P1O1 *************************************** MINORITY DISSERTATION RESEARCH GRANTS IN AGING NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFA: AG-95-001 P.T. 34, FF National Institute on Aging Application Receipt Date: December 9, 1994 PURPOSE Small grants to support doctoral dissertation research will be available for minority doctoral candidates. Grant support is designed to aid the research of new minority investigators and to encourage individuals from a variety of academic disciplines and programs to study problems in aging. 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), Minority Dissertation Research Grants in Aging, is related to several priority areas applicable to aging. Potential candidates for the awards 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 For the purpose of this RFA, individuals who are eligible to apply are minority students who are defined as belonging to a particular racial or ethnic group. In awarding dissertation grants the National Institute on Aging (NIA) will give priority to African Americans, Hispanic Americans, Native Americans and Pacific Islanders or other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research. The student must also be conducting or intending to conduct dissertation research on aging or problems directly related to aging. Research topics should fit within one or more of the areas described below (see INQUIRIES). The doctoral candidate must have a dissertation topic approved by the named committee. This information must be verified in a letter of certification from the thesis chairperson and submitted with the grant application (see APPLICATION PROCEDURES). The applicant institution must be domestic and must administer the grant on behalf of the proposed investigator. The applicant for dissertation research grant support must be a citizen, or noncitizen national, of the United States or have been lawfully admitted for permanent residence. The performance site may be foreign or domestic. MECHANISM OF SUPPORT The mechanism of support is the NIH small grant (R03). Grants may be made for up to two years. Grants to support dissertation research will provide no more than $30,000 in total direct costs, and no more than $25,000 in direct costs in any one year. Dissertation research grants will be administered in accordance with the U.S. Code Annotated, Title 42, Part B, Section 284. Awards will depend on the availability of funds. FUNDS AVAILABLE The NIA anticipates funding approximately 20 grants with a total cost of up to $600,000. SPECIAL REQUIREMENTS Grant Conditions. The following conditions apply to dissertation grants: o The doctoral candidate must be the designated Principal Investigator on the grant and the doctoral candidate must be the only individual on the grant for whom salary support is requested. o The principal investigator's salary may not exceed $12,000 per twelve months. o Work on the funded project must be initiated within three months after the date of the award. o An awardee may be invited to participate in a meeting or presentation of other NIA dissertation awardees. o The dissertation constitutes the final report of the grant. Two copies of the dissertation must be submitted. The dissertation must be officially accepted by the faculty committee or university official responsible for the candidate's dissertation and must be signed by the responsible officials. Scope of Awards. Investigators may request support for up to 24 months. An application that requests support beyond this time will be returned. An applicant who receives support for dissertation research under a grant from the NIA may not at the same time receive support under a predoctoral or fellowship grant awarded by any other Federal agency nor be supported under any other research project grant. Allowable Costs. Expenses usually allowed under PHS research grants will be covered by the NIA dissertation research grants, but may not exceed $30,000 for the project. Allowable costs include the investigator's salary (not to exceed $12,000 per 12 months); direct research project expenses such as travel to one scientific meeting per year (limited to $800 per year), data processing, supplies, and dissertation costs. Any level of effort that is less than full time by the candidate must be fully justified. No tuition is allowed. It is expected that most equipment needed for the research will be available at the site or laboratory in which the dissertation is to be performed. Therefore, any requests for equipment must be specially justified. Indirect costs are limited to eight percent of requested direct costs, less equipment. STUDY POPULATIONS 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 prepared on the grant application form PHS 398 (rev. 9/91). The application form is 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 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 and number (Minority dissertation research grants in aging, AG-95-001) must be typed on line 2a of the face page of the application form and the YES box must be marked. Instructions for completing the applications are found in the PHS 398 form. These instructions should be followed except that under C. Specific Instructions - Research plan, no more than 10 pages should be used for items 1 to 4 (instead of 25 pages as stated in the standard instructions). Applications that exceed the 10 page limit for this section will be returned. Applications must be received by December 9, 1994. The investigator must submit the original and five copies of the completed application containing a detailed narrative project description (not to exceed 10 pages) and letters of support. The original and three of these copies must be submitted directly to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** An additional two copies of the application must be sent to: Chief, Scientific Review Office ATTN: Minority Dissertation National Institute on Aging Gateway Building, Suite 2C212 7201 Wisconsin Avenue MSC 9205 Bethesda, MD 20892-9205 Additional Material o A letter from the faculty committee or university official directly responsible for supervising the development and progress of the dissertation research must be submitted with the application. The letter must be countersigned by a representative of the graduate school of the sponsoring institution. The letter must: (a) fully identify the members of the committee and certify their approval of the dissertation topic, (b) certify that the candidate is eligible to apply under the guidelines described in this announcement, (c) certify that the author of the letter has read the application and that it reflects the work to be completed in the dissertation, and (d) note that the university official or faculty committee expects the doctoral candidate to proceed with the approved project proposal with or, without NIA support. o Transcript of investigator's graduate school record o Biography of mentor limited to 2 pages o Statement of the investigator's career goals to be placed under "Background" o Although not required, identification of the investigator's minority group would be helpful so that NIA may continue to monitor and improve the effectiveness of this program. REVIEW CONSIDERATIONS Dissertation research grants are competitive. Review will be conducted by a special committee convened by the NIA for this purpose. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIA in accordance with 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 be assigned a priority score. Applications determined to be non- competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Reviewers will be selected on the basis of their research accomplishments, knowledge, and experience in research training. All elements of the application will be considered in the review process. Emphasis will be given to the scientific merit, feasibility, and relevance of the project to aging research, and to the qualifications of the candidate. Review results and funding decisions will be announced within six months after the submission date. Review criteria, award criteria, and continuation of support are described below. Review Criteria. Review criteria include significance of the research problem, adequacy of the literature review, relevance of the topic to the NIA mission, research design, research methods, personal qualifications of the candidate, supervision to be provided the candidate, institutional facilities and support structure, and budgetary appropriateness. AWARD CRITERIA The anticipated date of award is May 1995. Final funding decisions are based on the recommendations of the reviewers, the relevance of the project to NIA priorities, and the availability of funds. Continuation of support. Grantees who are approved for two years of support must submit a satisfactory progress report no later than 10 months after the start of the first year of the grant. This report should contain a brief summary of the work completed to date together with copies of any publications supported wholly or in part by the dissertation grant. Investigators who need more than 24 months to complete the research project will be required to submit a request for an extension without funds for support beyond the first 24 months. An unfunded continuation of the grant may be awarded if satisfactory progress is being made, but the total direct costs of the entire project may not exceed $30,000 overall and $25,000 in any one year. INQUIRIES Interested investigators are strongly encouraged to contact the person named below who can provide clarifying information about material described in this RFA. The investigator will then be referred to the relevant program director to discuss the suitability of the research topic. Dr. Robin A. Barr Office of Extramural Affairs National Institute on Aging 7201 Wisconsin Avenue, Suite 2C218 MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9322 Direct inquiries relating to fiscal matters to: Mr. Joseph Ellis National Institute on Aging Gateway Building, Suite 2N212 7201 Winconsin Avenue MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 Program Areas and Contacts Richard L. Sprott, Ph.D. Biology of Aging Program National Institute on Aging Gateway Building, Room 2C231 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-4996 This program supports studies that focus on diseases associated with increasing age and the basic mechanisms involved in aging processes. The overall objectives of the program are related to understanding normal functions and alterations in them that can be induced by interaction with the environment and disease processes as aging proceeds. The program interests are in molecular and cellular biology, genetics, immunology, basic nutrition, and endocrinology. Ronald P. Abeles, Ph.D. Behavioral and Social Research Program National Institute on Aging Gateway Building, Room 5C533 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-3136 This program supports research on social and psychological aging processes and the place of older people in society and its social institutions. The emphasis is on promoting health, effective functioning, productivity and independence throughout the middle and later years. Areas of special interest include health and behavior; cognitive functioning; long term care; work, retirement and productivity; family and intergenerational relationships; aging demographics; and minorities, women, oldest old, rural and retarded older adults. Zaven Khachaturian, Ph.D. Neuroscience and Neuropsychology of Aging Program National Institute on Aging Gateway Building, Room 3C307 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 This program supports research on the structure and function of the aging nervous system and the behavioral manifestations of the aging brain. Areas of special interest include age-related changes in the nervous system, especially as these affect sensory processes, learning, cognition, memory and sleep. The study of Alzheimer's disease and other disorders associated with the aging nervous system, including the causes, diagnosis, epidemiology, treatment and management of such disorders are of special interest. Evan C. Hadley, M.D. Geriatrics Program National Institute on Aging Gateway Building, Room 3E327 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-6761 This program supports research on clinical problems that occur predominantly among older persons or that are associated with increased morbidity and mortality in older people. Areas of interest include cardiovascular-pulmonary diseases, infectious diseases, osteoporosis, digestive diseases, rehabilitation and physical function and performance in older persons. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.366. Awards are made under authorization of the Public Health Service Act Title IV, Part A (Public Law 79-410, as amended by Public Law 99-158, 42 DSC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. The requirements of Executive Order 12372, "Intergovernmental Review of Federal Programs," are not applicable to NIA research grant programs. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. 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 Thu Sep 15 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 33, pt. 3of3, 16 September 1994 Date: 15 Sep 1994 23:47:14 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 283 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <35bf1i$qjh@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940916 V23N33 P3O3 ************************************ 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, Drug Discovery for Opportunistic Infections Associated with AIDS is related to the priority area of human immunodeficiency virus /AIDS. 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. 017-001-00474-1) 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. Applications may be submitted from one institution or may include arrangements with several institutions, if appropriate. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applications from or involving minority institutions, individuals, and women are encouraged. MECHANISM OF SUPPORT Support for this PA will be by the investigator-initiated research project grant (R01), FIRST (R29) award, or the Interactive Research Project Grants (IRPG) mechanisms. If an IRPG is proposed, it must consist of a minimum of two independent applications (see PA-94-086, NIH Guide for Grants & Contracts, Volume 23, Number 28, July 29, 1994). An IRPG may consist of a combination of R01s and R29s or R01s only, but may not consist solely of R29 applications. An IRPG may also contain shared interactive resources (Cores), which must serve at least two of the research projects in order to facilitate achievement of the Group's common research goals. Collaborative arrangements involving more than one institution are especially encouraged, including participation of the pharmaceutical industry where appropriate. Successful applicants in response to this PA will be invited to participate in the National Cooperative Drug Discovery Groups for the Treatment of Opportunistic Infections Associated with AIDS (NCDDG-OI) program and annual meetings. It is anticipated that awards made in response to this program announcement are likely to provide the foundation for subsequent drug discovery research sponsored through the cooperative agreement mechanism. RESEARCH OBJECTIVES Background Although HIV is the primary cause of the progressive immunological deterioration seen in AIDS, the opportunistic infections (OIs) account for the vast majority of all AIDS-related deaths as well as diminishing quality of life. Pathologic consequences associated with OIs in AIDS are retinitis (cytomegalovirus), pulmonary disease (Pneumocystis carinii), encephalitis (Toxoplasma gondii), meningitis (Cryptococcus neoformans), tuberculosis (Mycobacterium tuberculosis), and disseminated nontuberculosis mycobacterial disease (Mycobacterium avium). The management of OIs in AIDS patients is often difficult and complicated due to: (1) simultaneous infections with other OIs; (2) toxicity and adverse side effects of therapeutic agents; (3) long-term drug use leading to patient intolerance or pathogen drug resistance; (4) occurrence of relapses after discontinuation of therapy; and (5) lack of effective therapies for newly emerging OIs. Objectives and scope The objective of this PA is to stimulate drug discovery through original and innovative research focused on key metabolic and pathophysiologic features, which will lead to the development of safe, well-tolerated, and effective new therapies for treatment and prophylaxis of AIDS-associated OIs. Applications based on sound scientific rationale encompassing in vitro culture systems and/or animal models to conduct the necessary preclinical studies are encouraged. The research scope encourages applications for studies on the following pathogens: human cytomegalovirus (CMV), Mycobacterium tuberculosis, Mycobacterium avium, Pneumocystis carinii, Toxoplasma gondii, and Cryptococcus neoformans. Innovative research focusing on other particularly prevalent or problematic infections associated with AIDS is also encouraged. Areas of research may include, but are not limited to, studies designed to: o Develop in vitro (culture) and in vivo (animal model) systems for drug evaluations against one (or more) opportunistic pathogens. o Identify and characterize biochemical, metabolic and molecular properties of the infectious organism that may serve as targets for chemotherapy. o Discover new therapeutic agents or prophylactic approaches (e.g., chemo-, immuno-, or gene-based therapies) through exploitation of biochemical, metabolic or molecular differences between pathogen and host. o Discover new therapeutic agents through identification and evaluation of promising natural products and synthetic chemical compounds, and elucidate their mechanism of action. o Elucidate mechanisms of drug resistance and study strategies to overcome such resistance. STUDY POPULATIONS 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. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91), the standard application form for research grants. 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. Receipt dates for applications for AIDS-related research are January 2, May 1, and September 1. Applications must adhere to the format and requirements specified in the PHS 398 application kit. FIRST (R29) 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. For independent R01 or R29 applications, each application must be identified by checking YES on line 2a of the PHS 398 face page, citing this program announcement number. If an IRPG is proposed, each application must be identified along with the number of the program announcement and the phrase "Investigator-initiated IRPG". All R01 or R29 applications constituting the proposed IRPG cohort must be submitted in a single package, whether or not the applications arise from the same institutions. For detailed instructions for preparation and submission of IRPG applications, refer to PA-94-086, NIH Guide for Grants and Contracts, Volume 23, Number 28, July 29, 1994. 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. Patent Coverage Attention is drawn to the reporting requirements of 35 U.S.C. Parts 200-212 and 37 CFR Part 401 or FAR 55.227-11. Instructions were also published in the NIH Guide for Grants and Contracts, Vol. 19, No. 23, June 22, 1990. Note that non-profit organizations (including universities) and small business firms retain the rights to any patent resulting from Government contracts, grants or cooperative agreements. It is also noted that a Presidential memorandum of February 18, 1983 extended to all business concerns, regardless of size, the first option to the ownership of rights to inventions as provided in P.L. 96-517. As a result of this memorandum, the relationships among industrial organizations and other participants are simplified, since all Group members can now be full partners in the research and in any inventions resulting therefrom. The specific patenting arrangements among institutions may vary, and could include joint patent ownership, exclusive licensing arrangements, etc. Applicants are encouraged to develop an arrangement that is most suitable for their own particular circumstances. Federal regulation clause 37 CFR 401 and HHS Inventions regulations at 45 CFR Parts 6 and 8 require that NIH be informed of inventions and licensing occurring under NIH funded research. Invention and licensing reports must be submitted to Extramural Invention Reports Office, Office of Extramural Research, Building 31, Room 5B41, NIH, 9000 Rockville Pike, Bethesda, Maryland 20892. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Upon receipt, applications and supporting material will be examined by the Division of Research Grants for completeness. Incomplete applications will be returned without further consideration. Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed independently for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Review criteria are: o Significance and originality of the research and methodological approaches. o Feasibility of the research and adequacy of the experimental design. o Interactive nature of the program and of the component IRPGs (where applicable). o Training, experience, research competence and commitment of the investigator(s). o Adequacy of the facilities and resources. o Provisions for the protection of human subjects, the humane care of animals, and biosafety conditions. Following scientific and technical merit review, applications will receive a second level review by the appropriate National Advisory Council(s). AWARD CRITERIA Applications will compete for available funds with all other applications found to have significant and substantial merit. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review. o If an IRPG is proposed, the interactive nature of the program and of the component IRPGs as determined by peer review. o Availability of funds. o Program balance among research areas. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Written instructions for the preparation of IRPG applications are available upon written request. This document, "Special Instructions for Preparing Applications for Investigator-Initiated Interactive Research Project Grants," is available from the Office of Grants Information, Division of Research Grants, NIH, 301-594-7248. Direct inquiries regarding programmatic issues to: Dr. Barbara Laughon Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C26 6003 Executive Boulevard, MSC 7620 Bethesda, MD 20892-7620 Telephone: (301) 402-2304 FAX: (301) 402-3211 Email: barbara_laughon@nih.gov Direct inquiries regarding fiscal matters to: Ms. Pamela Greenwald Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B22 6003 Executive Boulevard, MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.856, Microbiology and Infectious Diseases Research. Grants are awarded under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under the PHS grants policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of the Executive Order 12372 or Health Systems Agency review. $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Thu Sep 15 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 33, pt. 2of3, 16 September 1994 Date: 15 Sep 1994 23:47:08 -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: <35bf1c$qj2@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940916 V23N33 P2O3 ************************************ minority and women investigators are especially encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) small grant (R03) mechanism. Applicants will be responsible for the planning, direction, and execution of the proposed projects. The total proposed project period for each application submitted may not exceed three years. The total proposed direct costs for each year may not exceed $85,000, up to $35,000 of which may be used for equipment purchases in the first year. The anticipated award date is August 1, 1995. The award and level of support depends 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. At this time, the NCI has not determined whether this solicitation will be repeated. FUNDS AVAILABLE Approximately $1,000,000 in total costs per year will be committed to fund applications specifically submitted in response to this RFA. It is anticipated that 8 to 10 awards will be made. RESEARCH OBJECTIVES This RFA is designed to provide new faculty at HBCUs with an opportunity to initiate cancer-related research projects, sustain their continued professional growth, and build a research base in institutions that often have less than a critical mass of researchers. These specialized small research grants can support pilot projects that have less preliminary data and a narrower scientific focus than is required for an investigator-initiated research project (R01). In addition to the opportunity to implement a research program, this RFA will enable HBCU faculty to involve students in an on-going research project. The ability to observe and participate in on-going cancer research projects at the undergraduate or graduate level would broaden the educational experience for the students, provide mentoring opportunities for the faculty and possibly attract more minority students into scientific and clinical careers in cancer research. The areas of basic in vitro and in vivo research supported by the NCI, including biology, chemistry, and other disciplines, are appropriate for this RFA; specific examples are cited in the RFA. Collaborations within, or external to, the applicant institution are encouraged whenever they are appropriate to provide resources and expertise that is germane to the research proposed in the application. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are asked to submit, by October 28, 1994, a letter of intent that includes a descriptive title of the research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel or collaborators, 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 that it contains 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 to be sent to Dr. Cheryl L. Marks at the address 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; 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. Applications must be received by January 20, 1995. If an application is received after that date, it will be returned. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. If NCI staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA 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. The second level of review will be provided by the National Cancer Advisory Board. The review group will assess the scientific merit of the studies according to the following criteria: 1. Scientific and technical feasibility and originality of the proposed research; 2. Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; 3. Qualifications of the Principal Investigator and his or her collaborators to perform the research; 4. Availability and adequacy of resources and facilities necessary to perform the research; 5. Appropriateness of the proposed budget in relation to the proposed research; 6. Evidence of commitment by the applicant institution to provide space and appropriate release time from teaching responsibilities to support the proposed research. INQUIRIES Written and telephone requests for this RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA, inquiries regarding programmatic issues, and address the letter of intent to: Dr. Cheryl L. Marks or Dr. Gladys M. Glenn Division of Cancer Biology, Diagnosis, and Centers National Cancer Institute 6130 Executive Boulevard, Room 505 Bethesda, MD 20892-7385 Telephone: (301) 496-7028 FAX: (301) 402-1037 Direct inquiries regarding fiscal matters to: Ms. Michelle Burr Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, Ext. 231 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.396, Cancer Biology Research. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, 42 U.S.C. 214, as amended; Public Law 100-607, 42 U.S.C. 285 and 285a) and administered under PHS grants policies. $$R9 END ************************************************************ $$R10 BEGIN AI-94-029 FULL-TEXT ************************************* PEDIATRIC AIDS: FACTORS IN TRANSMISSION AND PATHOGENESIS NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFA AVAILABLE: AI-94-029 P.T. 34, AA; K.W. 0715008, 0765033 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: November 15, 1994 Application Receipt Date: February 16, 1995 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES" BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for research designed to study transmission and pathogenesis of HIV-1 in infants and children. Applications are sought for laboratory studies that elucidate: (1) the timing and mechanism of transmission of HIV from mother to infant or (2) factors that determine whether infected children become long-term asymptomatic survivors or suffer from rapidly progressive disease. The NIAID seeks applications for research studies that utilize advances in virology, immunology, and genetics to address these questions. Of special interest are those basic research studies that hold promise for development of clinical strategies to prevent mother-to-infant transmission of HIV-1 or to treat perinatally infected children to prolong and improve the quality of their lives. For applications proposing use of clinical specimens, documented access to an adequate number of samples to address the study hypotheses will be required. 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, pediatric AIDS: Factors in Transmission and Pathogenesis, is related to the priority areas of HIV infection, immunization and infectious diseases, and maternal and infant health. 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 202-782-3238). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State or 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 will be the individual research project grant (R01) and the FIRST (R29) award. Multidisciplinary approaches that involve collaborative efforts among investigators in the fields of basic immunology, molecular biology, genetics, virology, and infectious disease are strongly encouraged. The total project period for an application submitted in response to this RFA may not exceed five years. This RFA is a one-time solicitation for applications for new and competing renewal awards. Future competing 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 made under this RFA will be $2,000,000. In Fiscal Year 1995, the NIAID plans to fund approximately 12 R01s/R29s. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Applications may not request more than four percent annual inflationary increases for future years. The usual PHS policies governing grants administration and management will apply. Although this program is provided for in the financial plans of the NIAID, 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 availability of funds. RESEARCH OBJECTIVES Background Mother to infant transmission of HIV continues to be one of the fastest growing aspects in the worldwide pandemic of AIDS. The World Health Organization has estimated that over 10 million children worldwide will be infected by the year 2000. In the United States, the Centers for Disease Control and Prevention estimate that 10,000 children are currently infected with HIV, and approximately 6000 infants are born annually to HIV-infected women in the U.S. The recent success in the AIDS Clinical Trials Group (ACTG) Protocol 076 suggests that prevention strategies in the perinatal period may be highly efficient at decreasing mother to infant HIV-1 transmission. The ACTG 076 study indicated that women with greater than 200 CD4 cells x 106 /cc3 who initiate treatment with zidovudine (ZDV) during pregnancy can prevent transmission of HIV to their infants in about two-thirds of the cases. However, this study did not address the effectiveness of ZDV in women with less than 200 CD4 counts or who may be infected with ZDV-resistant variants. Unfortunately, other studies have indicated that women with lower CD4 counts may have an even higher likelihood of transmitting HIV to their infants. The recently initiated trial (ACTG 185) comparing HIV Immune Globulin (HIVIG) with IVIG placebo, both combined with ZDV, will include women with a wider range of CD4 counts and prior anti-retroviral therapy, but results of that trial will not be available for four to five years. In 1991, the NIAID funded a series of grants focused on two areas of basic research in Pediatric AIDS - - early diagnosis of HIV infection and studies to investigate factors involved in mother to infant transmission of HIV. These grants focused primarily on immunological and virological factors influencing mother to infant transmission and have led to many of the concepts about the mode and timing of perinatal HIV transmission. The objectives of this RFA are: to encourage coordinated basic research on the immunology, host genetics, and virology associated with perinatal HIV-1 transmission, its timing and mode, and to identify factors that appear to delay progressive manifestations of pediatric HIV-1 infection. Scope of Research Sought in This RFA The NIAID wishes to support continued research in Pediatric AIDS in the following targeted areas. o Studies attempting to define the timing of perinatal transmission relative to HIV-1 viral load and disease progression. o Coordinated studies of immunological, virological and host genetic factors that might influence perinatal HIV-1 transmission. o Studies that evaluate viral pathogenesis with a specific focus on infection of cell subsets in fetuses, neonates and young infants. o Studies that investigate oral or mucosal surfaces either as the exposure route for infants or as a source of perinatal infection by AIDS viruses. o Studies that evaluate the immunology, physiology, genetics and virology of children with long-term survival of HIV infection. These are examples of appropriate studies; other studies addressing risk for or timing of transmission of HIV-1 from mother to infant, or disease progression in the infant may be proposed. Clinical samples, if required, may be drawn from clinical trials or ongoing natural history studies. This solicitation is not intended for direct conduct of clinical trials, patient care, or maintenance of natural history cohorts. Availability of adequate numbers of clinical samples or animal resources to address the study hypotheses MUST BE documented in the application. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. Copies of these Guidelines may be obtained from program listed under INQUIRIES. LETTER OF INTENT Prospective applicants are asked to submit, by November 15, 1994, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, and the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the standard research grant application form PHS 398 (rev. 9/91). Application forms may be obtained from the institution's office for sponsored research or its equivalent and 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. Applications must be received by February 16, 1995. 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 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. For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number and the words "PEDIATRIC AIDS: FACTORS IN TRANSMISSION & PATHOGENESIS" must be typed in. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Division of Research Grants (DRG) and for responsiveness to the RFA by NIAID staff. Incomplete applications will be returned to the applicant without further consideration. If NIAID staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to this RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID. As part of the initial merit review, a process (triage) may be used by the initial review group in which the applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to this RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program priorities, and the availability of funds. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Requests for the RFA and the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, as well as inquiries regarding programmatic issues, may be directed to: Bonnie J. Mathieson, Ph.D. or Patricia E. Fast, M.D., Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard Solar Building, Room 2B06 Bethesda, MD 20892 Telephone: (301) 496-8200 FAX: (301) 402-1506 or (301) 480-5703 Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and five sets of appendices to: Dianne Tingley, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard Solar Building, Room 4C16 Bethesda, MD 20892 Telephone: (301) 496-0818 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Ms. Carol Alderson Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard Solar Building, Room 4B27 Bethesda, MD 20892 Telephone: (301) 496-7075 FAX: (301) 480-3780 Schedule Letter of Intent Receipt Date: November 15, 1994 Application Receipt Date: February 16, 1995 Scientific Review Date: June/July 1995 Advisory Council Date: September 1995 Earliest Award Date: September 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.856 Microbiology and Infectious Diseases Research and 93.855 Immunology, Allergy and Transplantation Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R10 END *********************************************************** $$R11 BEGIN CA-94-031 FULL-TEXT ************************************* SPECIALIZED PROGRAMS OF RESEARCH EXCELLENCE IN PROSTATE CANCER NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFA AVAILABLE: CA-94-031 P.T. National Cancer Institute Letter of Intent Receipt Date: November 18, 1994 Application Receipt Date: February 21, 1995 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Organ Systems Coordinating Branch of the Division of Cancer Biology, Diagnosis and Centers (DCBDC) at the National Cancer Institute (NCI) invites grant applications for Specialized Programs of Research Excellence (SPORE) in Prostate Cancer. The intent of this initiative is to expand the Prostate Cancer SPOREs from the current two SPOREs to a minimum of three SPOREs through open recompetition by making awards to those institutions that are judged to be able to conduct the highest quality balanced translational research approaches on the prevention, etiology, screening, diagnosis, and treatment of prostate cancer. Because basic research in prostate cancer has lagged behind that of the other major solid tumors, greater leeway is given for basic research studies on prostate cancer. However, such studies must have translational potential or significance. SPOREs are at institutions that have made or will make a strong institutional commitment to the organization and conduct of these programs. SPORE applicants will be judged on their current and potential ability to translate basic research findings into innovative research settings involving patients and populations. Each SPORE is encouraged to conduct rehabilitation and quality-of-life research. Each SPORE must provide career development opportunities for new and established investigators who wish to pursue active research careers in translational prostate cancer research; develop and maintain human prostate cancer tissue resources that will benefit translational research; develop extended collaborations in critical areas of research need with laboratory scientists and clinical scientists within the institution and in other institutions; and participate with other SPORES on a regular basis to share positive and negative information, assess scientific progress in the field, identify new research opportunities, and promote inter-SPORE collaborations to resolve areas of scientific controversy. Each SPORE and the "network" of SPOREs is expected to conduct research that will have the most immediate impact possible on reducing the incidence of and the mortality due to human prostate cancer. 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, Specialized Program of Research Excellence (SPORE) in Prostate Cancer, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full 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, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. To be eligible, applicant organizations must have (1) a minimum of three independent investigators who are successful in obtaining peer-reviewed research support directly related to prostate cancer, and who together represent experience in both laboratory and clinical research, or alternatively, a minimum of three independent investigators, each having published articles in peer-reviewed research journals that significantly address prostate cancer, and who as a group represent experience in both laboratory and clinical research; (2) access to a patient care and service facility that serves prostate cancer patients and, if the facility is not part of the parent institution, a statement that assures access to prostate cancer patients for clinical research; the statement must be signed by the responsible officials of the applicant institution and the consortial care facility; (3) while applications must be submitted from a single institution, they may include subcontracted collaborative scientific arrangements with scientists from other institutions as long as these arrangements are clearly delineated, and formally and officially confirmed by signed statements from the responsible officials of each institution. However, a full institutional commitment must come from the parent institution receiving the award. MECHANISM OF SUPPORT Support of this program will be through the P50 Specialized Center Grant mechanism. Applicants will be responsible for the planning, direction, and execution of the proposed SPORE program. Except as otherwise noted in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement. This RFA is a one-time solicitation. The total project period for a competing P50 renewal SPORE application may not exceed five years; new applicants or applicants that have received P20 SPORE feasibility awards in the past may request up to three years of support. Each new or competing renewal P50 SPORE application may request a maximum annual direct cost of $1.5 million and maximum annual total cost of $2.5 million. The earliest anticipated award date is December 1, 1995. FUNDS AVAILABLE The NCI anticipates making at least three awards and anticipates setting aside $2.5 million per award or $7.5 million total for the initial year's funding. Funding in response to this RFA is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of NCI, the award of grants pursuant to this RFA is contingent upon the anticipated availability of funds for this purpose. RESEARCH OBJECTIVES The goal of this RFA is to expand the current Prostate Cancer SPORE program with the addition of at least one new SPORE. Each SPORE assembles critical masses of laboratory and clinical scientists to work together on human prostate cancer and to focus on innovative translation of basic findings into research settings involving patients and populations. The ultimate objective is to reduce incidence and mortality, and to increase and improve survival to the disease. The essential characteristics of a SPORE include (1) a strong scientific program which will have a clear impact on the human disease, (2) a strong innovative developmental or pilot research program which can respond quickly to new research opportunities, (3) a strong career development program to develop and expand the scientific cadre of investigators dedicated to translational research on human prostate cancer, (4) a human prostate cancer tissue procurement resource, an animal model resource, and other resources specifically dedicated to translational research objectives, and (5) a willingness and commitment to work with other SPOREs and scientists in order to maximize research progress. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines on the inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are asked to submit by November 18, 1994, a letter of intent that includes the name and address of the principal investigator and identifies the component research projects, core units and their principal investigators, any collaborating institutions, and the number and title of the RFA in response to which the application is being submitted. Although a letter of intent is not required, is not binding and does not enter into the review of subsequent applications, the information that it contains allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review. Furthermore, NCI staff can discuss the most recent policies of the NCI relative to funding issues, potential problems in meeting eligibility requirements or clarification of the peer review process before the final application is submitted. The letter of intent is to be sent to Dr. Andrew Chiarodo at the address listed under INQUIRIES. APPLICATION PROCEDURES Complete applications are due no later than February 21, 1995. Applications received after this date will not be accepted. The regular 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; 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 Director listed under INQUIRIES. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed initially by the Division of Research Grants for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to this RFA is an NCI program staff function. Applications judged to be non-responsive will be returned without review. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit and for special SPORE characteristics and requirements as described in the complete RFA. Questions concerning the responsiveness of proposed programs to the RFA may be directed to program staff listed under INQUIRIES. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA, inquiries regarding programmatic issues to, and address the letter of intent to: Andrew Chiarodo, Ph.D. Division of Cancer Biology, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Suite 512 6130 Executive Boulevard MSC 7386 Bethesda, MD 20852-7386 Telephone: (301) 496-8528 Direct inquiries regarding fiscal matters to: Joan Metcalfe 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. 228 AUTHORITY AND REGULATIONS This program is described in the catalog of Federal Domestic Assistance no. 13.397. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410 as amended: 42 USC 241) and administered under PHS grant policies and Federal Regulations 42 CFR Part 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. $$R11 END *********************************************************** $$R12 BEGIN HL-95-001 FULL-TEXT ************************************* GENE-NUTRIENT INTERACTIONS IN THE PATHOGENESIS OF CONGENITAL HEART DEFECTS NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFA AVAILABLE: HL-95-001 P.T. National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 16, 1994 Application Receipt Date: April 21, 1995 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Division of Heart and Vascular Diseases invites applications to conduct research into the relationship between genes and nutrients in the etiology and prevention of Congenital Cardiovascular Malformations (CCVM). One goal is to foster basic research into the effects of nutrients on embryologic and fetal development of the cardiovascular system. Approaches may include cell and organ culture, the generation of genetically altered animal models and the use of molecular biology and molecular genetics to elucidate the mechanisms underlying those effects. A second goal is to encourage small epidemiologic investigations into the role of nutrients in the pathogenesis of human CCVM. 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, Gene-Nutrient Interactions in the Pathogenesis of Congenital Heart Defects, is related to the priority areas of maternal and infant health, infant mortality and nutrition. 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. Applications from minority individuals and women are encouraged. Awards in connection with this RFA will be made to foreign institutions only for research of very unusual merit, need and promise and in accordance with PHS policy governing such awards. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01). 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 five years. The anticipated award date is September 1995. Because the nature and scope of the research may vary, it is anticipated that the size of an award may vary also. 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 The total funds available for the first year of this program (direct plus indirect costs) are $2,000,000. Funding is expected to begin in September 1995. It is anticipated that no more than eight grants will be awarded under this program. RESEARCH OBJECTIVES Two general areas of research are appropriate for this RFA, namely molecular/genetic studies of cardiovascular morphogenesis in animal models and small epidemiologic investigations of the role of nutrients in the pathogenesis of human CCVM. It is anticipated that both approaches will yield much needed information on measures that eventually may prevent some cases of CCVM in humans. Successful applications will have hypotheses to direct the course of the research. The molecular/genetic research will test hypotheses regarding potential mechanisms by which a nutritional deficiency or toxicity may produce malformations comparable to human CCVM. Given the existing body of literature on Vitamin A/beta-carotene, studies involving retinoid related genes must address the mechanisms by which decreased RA affects normal morphogenesis of the cardiovascular system. Far less information is available regarding the role of other nutrients in organogenesis. Hence, research on the role of vitamins and trace elements in the pathogenesis of CCVM may be more broadly applied. The use of well-defined animal models, whether naturally occurring or transgenic, is encouraged. Researchers may propose to study gene-nutrient interactions in 'normal' animals fed a nutrient-deficient diet. Investigators also may wish to propose targeted interventions that may correct the abnormal phenotype of an animal model of inherited CCVM. Research resources, such as Keeshond Beagles, which suffer form conotruncal defects, or Yucatan miniature swine, which have a high frequency of ventricular septal defects, may be considered. Similar investigations in humans would be premature and are not appropriate for this RFA. Large new epidemiologic studies are not likely to be feasible with the budgets allotted for grants awarded under this RFA; 'add-on' projects may be proposed, however, to take advantage of existing or planned research programs. Studies which propose to make use of already existing epidemiologic data bases or cohorts with well-defined nutrient intake and pregnancy outcomes are acceptable. However, diagnosis of CCVM in children involved in studies must be performed by a pediatric cardiologist, using appropriate techniques such as echocardiography or angiography to avoid errors due to mis-diagnosis. STUDY POPULATIONS 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 clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and prevention strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. LETTER OF INTENT Prospective applicants are asked to submit, by December 16, 1994, 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 that it contains is helpful in planning for the review of applications. It allows NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Dr. C. James Scheirer Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 548B Bethesda, MD 20892 Telephone: (301) 594-7478 FAX: (301) 594-7407 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 may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 240, Bethesda, MD 20892, telephone 301/594-7248. Applications must be received by April 21, 1995. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NHLBI in accordance with 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 be assigned a priority score. Applications determined to be non- competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the National Heart, Lung, Blood Advisory Council. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: Dr. Abby G. Ershow Lipid Metabolism-Atherogenesis Branch National Heart, Lung, and Blood Institute Federal Building, Room 401 7550 Wisconsin Avenue MSC 9050 Bethesda, MD 20892-9050 Telephone: (301)496-1681 FAX: (301)496-9882 Direct inquiries regarding fiscal matters to: Mr. William Darby Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A11 Bethesda, MD 20892 Telephone: (301) 94-7458 FAX: (301) 594-7492 AUTHORITY AND REGULATIONS The programs of the Division of Heart and Vascular Diseases, National Heart, Lung, and Blood Institute, are identified in the Catalog of Federal Domestic Assistance, No. 93.837. Awards will be made under the authority of the PHS Act, Section 301 (42 USC 241) and administered under 42 CFR Part 52 and 45 CFR Part 74. This program is not subject tot he intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. $$R12 END *********************************************************** $$R13 BEGIN HD-95-003 FULL-TEXT ************************************* SPECIALIZED RESEARCH CENTER PROGRAMS OR CENTER CORE GRANTS TO SUPPORT RESEARCH IN REPRODUCTION NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFA AVAILABLE: HD-95-003 P.T. 34; K.W. 0413002, 0710030 National Institute of Child Health and Human Development Letter of Intent Receipt Date: January 2, 1995 Application Receipt Date: May 18, 1995 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Reproductive Sciences Branch (RSB), Center for Population Research (CPR), National Institute of Child Health and Human Development (NICHD), supports research on reproduction which relies on a variety of approaches in biomedical sciences. Among the grant mechanisms used to provide research support, the RSB uses: 1. Specialized Research Centers (P50s), which are integrated groups of research projects and supporting core service facilities. The research activities included in such project grants must comprise, by definition, a multidisciplinary approach to biomedical problems in reproduction. Although these research programs may have more than one theme, focus, or emphasis, all of the projects must be responsive to one or more of the specific areas of reproductive research which constitute the mission of the RSB, CPR, NICHD. 2. Center Core Grants (P30s), which support Center Core facilities designed to enhance a group of existing federally supported research projects within the purview of the RSB, CPR, NICHD. Such Center awards require a critical mass of individual, reproductive-oriented awards whose productivity and quality would be increased by support from central technical facilities. 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, Specialized Research Center Programs or Center Core Grants to Support Research in Reproduction, is related to the area of family planning. 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 domestic for-profit and non-profit organizations, public and private. Foreign organizations are not eligible. MECHANISM OF SUPPORT This RFA will use the Specialized Research Center Program (P50) and Center Core (P30) grant mechanisms to support research in reproduction. The total project period for an application submitted in response to this RFA is five years. The anticipated award date is April 1, 1996. New Specialized Research Center Grant (P50) applications may not request more than $600,000 in direct costs for the first year. New Center Core Grant (P30) applications may not request more than $500,000 in direct costs for the first year. Renewal applications from existing P30 or P50 centers may not request initial year direct costs exceeding 120 percent of the Council recommended direct costs for the final year of the preceding project period. Unless prior written approval of the NICHD has been obtained, applications with requests exceeding these guidelines will be administratively withdrawn by the NICHD and returned to the applicant. Applications prepared for this competition may not propose multi-institutional consortiums. FUNDS AVAILABLE Although this solicitation is included in the fiscal plans for FY 1996, support for these center grants is contingent upon the receipt of funds for these purposes by the NICHD. The number of grants to be awarded is also contingent upon a sufficient number of applications receiving high enough levels of merit to be considered for an award. It is expected that up to six awards will be made as a result of this RFA within the expected total costs limit of $4,100,000 available for the first year. At present, the RSB supports a fixed number of centers with a commitment of five years of support that is competitively renewable for additional five-year periods. Support for three P50 Centers and three P30 Centers ends in FY 1996 and it is anticipated that these Centers will submit renewal applications. Although there are no plans to make additional Center awards at this time, new groups of investigators are invited to compete with the current awardees for the existing six awards. RESEARCH OBJECTIVES The ultimate goals of biomedical research in the reproductive sciences are to develop new knowledge leading to clinical applications that will enable men and women to control their fertility with methods that are safe, effective, inexpensive, reversible, and acceptable to various population groups, and to overcome problems of infertility and reproductive disorders. Domestic U.S. Reproductive Sciences centers designated as "Specialized Reproductive Sciences Research Centers" (P50s) and as "Reproductive Sciences Research Centers" (P30s) are awarded funds for the support of comprehensive reproductive research programs of high quality that focus on topics deemed to be of high priority and significance because of their critically important relationship to the mission of the RSB, CPR. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are asked to submit, by January 2, 1995, a letter of intent that includes a descriptive title of the proposed research and relevant research projects to be associated with the proposed center; 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 that it contains is helpful in planning for the review of applications. It allows NICHD staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to Julia Lobotsky at the address listed under INQUIRIES. APPLICATION PROCEDURES Center grant applications must be structured in accord with the specific policy and formatting guidelines presented in the RFA and the instructions found in the publications entitled either "P50 Specialized Research Center Grant Guidelines" or "P30 Center Core Grant Guidelines" that are available from the NICHD office listed below. Such guidelines require, for example, certain tabulations in addition to the usual instructions for the grant application form PHS 398 (rev. 09/91) used to prepare these applications. The current policies and requirements that govern the research grant programs of NIH will prevail (CFR Title 42, Part 52 and Title 45, Part 75). REVIEW CONSIDERATIONS An administrative review of the application will be performed by NIH staff for conformance to NIH policy and NICHD guidelines, as well as for relevance to the program purview of the RSB. Applications that fail to comply with NIH policy and/or NICHD guidelines will be formally returned to the applicant. Applications will be evaluated by the Population Research Committee, NICHD, in November 1995. The second level review will be made by the National Advisory Child Health and Human Development Council in January 1996. Review procedures and criteria are detailed in the P50 Specialized Research Grant Guidelines and P30 Center Core Grant Guidelines (available from NICHD offices listed below). INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA, inquiries regarding programmatic issues, and address the letter of intent to: Julia Lobotsky, M.S. Center for Population Research National Institute of Child Health and Human Development Building 6100, Room 8B01 Bethesda, MD 20892-7510 Telephone: (301) 496-6515 To obtain copies of the NICHD Policy and Formatting Guidelines for P30 and P50 center grant applications, contact: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development Building 6100, Room 5E01 Bethesda, MD 20892-7510 For information on budget and fiscal matters, contact: Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development Building 6100, Room 8A17K Bethesda, MD 20892-7510 Telephone: (301) 496-5481 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.864, Population Research. Awards will be made under the authority of the Public Health Service Act 301 (42 USC 241) and 441 (USC 289d) and administered under PHS Grants Policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to A-95 or Health Systems Agency review. $$R13 END *********************************************************** ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-94-094 ************************************************ RESEARCH ON EFFECTIVENESS OF CHILDREN'S MENTAL HEALTH SERVICES NIH GUIDE, Volume 23, Number 33, September 16, 1994 PA NUMBER: PA-94-094 P.T. 34, AA; K.W. 0730057, 0403001 National Institute of Mental Health PURPOSE This program announcement, based on recommendations set forth in the National Plan for Research on Child and Adolescent Mental Disorders, is intended to encourage investigator-initiated research grant applications for studies of the effectiveness of mental health services that are being provided to children, adolescents, and their families through the Center for Mental Health Services (CMHS) Comprehensive Community Mental Health Services Program initiative. The purpose of this program announcement is to encourage research applications for studies that assess the impact of services funded under this major CMHS program initiative, yield data that can be used in health care reform efforts, and contribute to the development of more effective mental health service delivery systems for children. 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 the Effectiveness of Children's Mental Health Services, 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 "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 Applications may be submitted by domestic and foreign, public and private, non-profit and for-profit organizations, including 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 and small grants (R03). Women and minority investigators are encouraged to apply. MECHANISMS OF SUPPORT Research support may be requested through applications for regular research project grants (R01), small grants (R03), and FIRST award (R29). Since the R03 and R29 mechanisms have different requirements regarding eligibility, application format, and review criteria, applicants are strongly encouraged to consult with program staff (see INQUIRIES) and obtain specialized announcements. The small grant (R03) is especially suited for initial research by junior investigators and for pilot research prior to large-scale field trials. The Investigator-Initiated Interactive Research Project Grant (IRPG) may be used (see PA-94-086, NIH Guide, Vol. 23, No. 28, July 29, 1994). Because of the recent revisions to the IRPG, applicants who are considering this mechanism are particularly advised to consult with program staff. An application may request support for up to five years for regular research project grants (R01). A small grant (R03) is limited to two years and may not be renewed. A FIRST award (R29) is for five years and are not renewable. Annual awards will be made, subject to continued availability of funds and progress achieved. RESEARCH OBJECTIVES Background Recent reviews of prevalence studies indicate that approximately 14 to 20 percent of children and adolescents in the United States have a diagnosable mental, emotional, or behavioral disorder. Because children with serious emotional disturbances frequently manifest problems in many domains, including home, school, and community, they require the intervention of other agencies and systems to provide special education, child welfare, health, substance abuse, vocational, and, often, juvenile justice services. Service-providing agencies often have requirements and eligibility rules that make it difficult for families whose children have mental health needs to obtain requisite services. Consequently, in the past decade, a growing interest has emerged favoring the provision of a comprehensive array of mental health and other services to meet the needs of these youth and their families. In response to this interest, the Comprehensive Community Mental Health Services Program for Children with Serious Emotional Disturbances was created (as part of the ADAMHA Reorganization Act--P.L. 102-321, Sec.119). This program is administered by the Center for Mental Health Services (CMHS) of the Substance Abuse and Mental Health Services Administration (SAMHSA). Under this authority, grants are provided to States, political subdivisions of States, Indian tribes, or tribal organizations to provide a broad array of comprehensive community-based services for children with serious emotional, behavioral, or mental disorders in order to enable communities to develop local systems of care consisting of mental health, child welfare, education, juvenile justice, and other appropriate agencies. Funds for the CMHS program are authorized to be spent on services that are underdeveloped or nonexistent in most communities: respite care; day treatment; therapeutic foster care; intensive home-based services; school or clinic-based services; emergency services; and diagnostic and evaluation services. Additionally, each child must have an individualized service plan, developed with the participation of family and, where appropriate, the child. The plan must designate a case manager to assist the child and family by coordinating services among several systems. To date, 11 sites have been awarded five-year grants by CMHS under the Request for Applications that was announced in the Spring 1993. Up to 10 additional sites may be awarded by September 30, 1994, under a new CMHS Request for Applications. An evaluation plan that will encompass all of the sites is being developed by CMHS. Through this program announcement, NIMH invites applications for studies of the effectiveness, including cost-effectiveness, of these comprehensive service models. Research Topic Areas Listed below are examples of research topic areas. The list is illustrative, not exhaustive; it is expected that additional important research topics may be identified by researchers who respond to this program announcement. o Research on the functional, clinical, or service system outcomes of comprehensive services provided to children, adolescents, and their families, including factors that mediate the outcomes of such services o Studies of the effectiveness of different levels of service intensity within service programs, for children and adolescents with different diagnoses, functional abilities, and sociodemographic characteristics o Research on the effects of different structural relationships among components of the service systems on providers, children, adolescents, families, and organizational functioning o Studies of the relative cost-effectiveness of intervention programs and systems of care o Studies of the quality of care or appropriate matching of services to level of impairment o Research on the organization and delivery of mental health care across different community settings o Studies of the effectiveness and cost-effectiveness of integrating interventions or programs provided by other child-serving sectors, such as substance abuse, schools, child welfare, or juvenile justice, with mental health agencies o Research on the family context of mental health service delivery for children and adolescents, such as impact of parent training on families and siblings o Research on the effectiveness of interventions designed to prevent adverse mental health outcomes in family members and caregivers o Research on factors that are barriers to or facilitators of service integration o Studies of the impact of co-occurring conditions, such as emotional/behavioral disorders, drug or alcohol abuse, AIDS, or homelessness on service delivery o Development of improved methods for measuring and analyzing service integration and, within comprehensive systems, for measuring service intensity and service outcomes o Research on the financing of services for children and adolescents, including financial burden, cost of services for specific mental disorders, and adequacy of services for the uninsured or underinsured o Studies of the impact of Medicaid regulations on the delivery of mental health services to children, youth, and families STUDY POPULATIONS 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 the program staff or contact persons listed below. Program staff may also provide additional relevant information concerning the policy. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applicants are to use the research grant application form PHS 398 (rev. 9/91). The number (PA-94-094) and the title of this program announcement, "Research on Effectiveness of Children's Mental Health Services," must be typed in item number 2a on the face page of the PHS 398 application form. Applicants must also specify the mechanism under which they are applying (e.g., R01, R03, R29). FIRST (R29) 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. Application kits containing the necessary forms may be obtained from offices of sponsored research at most universities, colleges, medical schools, and other major research facilities 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 signed original and five legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be reviewed for scientific and technical merit by an initial review group (IRG) composed primarily of non-Federal scientific experts following the standard PHS review procedures. Final review is by the appropriate National Advisory Council; review by Council may be based on policy considerations as well as scientific merit. By law, only applications recommended for consideration for funding by the Council may be supported. Summaries of IRG recommendations are sent to applicants as soon as possible following IRG review. Review Criteria Criteria to be considered in evaluating applications for scientific/technical merit are: o Scientific and 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 investigators and staff, particularly but not exclusively in the area of the proposed research o Availability of resources necessary to the research o Appropriateness of the proposed budget and duration in relation to the proposed research o Adequacy of the proposed means for protecting against or minimizing adverse effects to human subjects AWARD CRITERIA Factors considered in determining which applications will be funded include IRG and Council recommendations, PHS program needs and priorities, and availability of funds. INQUIRIES NIMH staff are available for consultation concerning application development in advance of or during the process of preparing an application. Potential applicants may contact NIMH as early as possible for information and assistance in initiating the application process and developing an application. Direct inquiries regarding programmatic issues to: Kimberly Hoagwood, Ph.D. Child and Adolescent Mental Health Services Research Program National Institute of Mental Health 5600 Fishers Lane, 10C-06 Rockville, MD 20857 Telephone: (301) 443-4233 For further information on grants management issues, applicants may contact: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-3065 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance 93.242, Mental Health Research 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 Parts 74 and 92. The program is not subject to the intergovernmental review requirements of Executive Order 12372, as implemented through DHHS regulations at 45 CFR Part 100. $$P1 END ************************************************************ $$P2 BEGIN PA-94-095 ************************************************ DRUG DISCOVERY FOR OPPORTUNISTIC INFECTIONS ASSOCIATED WITH AIDS NIH GUIDE, Volume 23, Number 33, September 16, 1994 PA NUMBER: PA-94-095 P.T. 34; K.W. 0715008, 0755025 National Institute of Allergy and Infectious Diseases PURPOSE The purpose of this Program Announcement (PA) is to solicit new research grant applications aimed at novel approaches to discovery and preclinical development of therapeutic agents active against opportunistic infections in people with AIDS. The research scope will focus on basic and applied studies necessary to propel advances in improved therapies. The intent of this PA is to invite applications for support of investigator-initiated research grants and the Interactive Research Project Grants (IRPG) mechanisms. No clinical trials will be supported. HEALTHY PEOPLE 2000 From owner-sci-resources@net.bio.net Thu Sep 15 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-94-031 - V23(33) 09/16/94 Date: 15 Sep 1994 23:47:54 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 940 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <35bf2q$qop@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA94031 CA-94-031 P1O1 *************************************** SPECIALIZED PROGRAMS OF RESEARCH EXCELLENCE IN PROSTATE CANCER NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFA: CA-94-031 P.T. National Cancer Institute Letter of Intent Receipt Date: November 18, 1994 Application Receipt Date: February 21, 1995 PURPOSE The Organ Systems Coordinating Branch of the Division of Cancer Biology, Diagnosis and Centers (DCBDC) at the National Cancer Institute (NCI) invites grant applications (P50) for Specialized Programs of Research Excellence (SPORE) in Prostate Cancer. The intent of this initiative is to expand the Prostate Cancer SPOREs from the current two SPOREs to a minimum of three SPOREs through open recompetition by making awards to those institutions that can conduct the highest quality balanced translational research approaches on the prevention, etiology, screening, diagnosis, and treatment of prostate cancer. Because basic research in prostate cancer has lagged behind that of the other major solid tumors, greater leeway is given for basic research studies on prostate cancer. However, such studies must have translational potential or significance. SPOREs are at institutions that have made or will make a strong institutional commitment to the organization and conduct of these programs. SPORE applicants will be judged on their current and potential ability to translate basic research findings into innovative research settings involving patients and populations. Each SPORE is encouraged to conduct rehabilitation and quality-of-life research. Each SPORE must provide career development opportunities for new and established investigators who wish to pursue active research careers in translational prostate cancer research; develop and maintain human prostate cancer tissue resources that will benefit translational research; develop extended collaborations in critical areas of research need with laboratory scientists and clinical scientists within the institution and in other institutions; and participate with other SPORES on a regular basis to share positive and negative information, assess scientific progress in the field, identify new research opportunities, and promote inter-SPORE collaborations to resolve areas of scientific controversy. Each SPORE and the "network" of SPOREs is expected to conduct research that will have the most immediate impact possible on reducing incidence and mortality to human prostate cancer. Each SPORE should support a mix of basic and clinical researchers whose formal interactive and collaborative research efforts will result in new approaches for early detection, diagnosis, therapy, and prevention and control. The SPORE mechanism is not intended to support basic research to the exclusion of clinical research or vice versa. 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), Specialized Program of Research Excellence (SPORE) in Prostate Cancer, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full 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, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. To be eligible, applicant organizations must have (1) a minimum of three independent investigators who are successful in obtaining peer-reviewed research support directly related to prostate cancer, and who together represent experience in both laboratory and clinical research, or in the alternate, a minimum of three independent investigators, each having published articles in peer-reviewed research journals that significantly address prostate cancer, and who as a group represent experience in both laboratory and clinical research; (2) access to a patient care and service facility that serves prostate cancer patients and, if the facility is not part of the parent institution, a statement that assures access to prostate cancer patients for clinical research; the statement must be signed by the responsible officials of the applicant institution and the consortial care facility; (3) while applications must be submitted from a single institution, they may include subcontracted collaborative scientific arrangements with scientists from other institutions as long as these arrangements are clearly delineated and formally and officially confirmed by signed statements from the responsible officials of each institution. However, a full institutional commitment must come from the parent institution receiving the award. Support will not be provided for applications with research activities focused exclusively on basic research or clinical research or trials or epidemiological research. NCI staff (See INQUIRIES below) should be consulted if there are questions regarding any of the above eligibility requirements or exclusions. MECHANISM OF SUPPORT Support of this program will be through the P50 Specialized Center Grant mechanism. This mechanism supports any part of the full range of research and development from basic to clinical and intervention studies. The spectrum of activities comprises a multidisciplinary attack on a specific disease entity or biomedical problem. These grants differ from program project grants in that they are more complex and flexible in terms of the activities that can be supported. In addition to support for multidisciplinary research projects, support is also provided for career development, pilot research projects, specialized resources and shared core facilities. Applicants will be responsible for the planning, direction, and execution of the proposed SPORE program. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement. NCI policy for SPORE grants establishes the following limits to the requested budgets: All new and competing renewal P50 SPORE applications may request a maximum annual direct cost of $1.5 million and maximum annual total cost of $2.5 million per individual SPORE. In complying with the direct cost cap of $1.5 million, the indirect costs related to subcontracts to other institutions or organizations will not apply toward the direct cost cap, but the total dollar request may not exceed $2.5 million. Future year increases are limited to four percent but may not exceed this cap. Funding for successful P50 renewal applications will be for up to five years. Initial funding for new P50 SPOREs will be for no more than three years. Recognizing that the initial three year funding period for new SPOREs may be too short for multiple substantive scientific accomplishments, any future recompetition for this group will be evaluated on scientific accomplishment and on interim progress in pursuit of SPORE organizational, collaborative and research objectives. This would include, for example, progress toward planning, developing, and implementing new innovative translational research programs; progress toward developing the careers of new scientists; progress toward procuring and distributing tissue specimens; and progress toward developing substantive collaborative interactions. FUNDS AVAILABLE This RFA is a one-time solicitation. NCI anticipates making at least three awards. Each applicant applying for a competitive renewal may request up to five years of support. Each new applicant or applicant that has received P20 SPORE feasibility awards in the past may request up to three years of support. The NCI anticipates setting aside $2.5 million per award or $7.5 million total for the initial year's funding. Funding in response to this RFA is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of NCI, the award of grants pursuant to this RFA is contingent upon the anticipated availability of funds for this purpose. RESEARCH OBJECTIVES Background Prostate cancer is now the most common cancer in U.S. males and the second leading cause of cancer death in men. Mortality due to prostate cancer is two-fold higher in U.S. blacks than U.S. whites. At present, this disease costs more than $1 billion annually, requires a quarter of a million hospitalizations and results in more than 38,000 deaths. Prostate cancer research has lagged far behind research in other major forms of cancer and there has been a lack of new investigators entering the field. In part, this has been due to lack of accessibility to human prostate tissues and a lack of suitable in vitro and in vivo models. Effective reduction of incidence and mortality to prostate cancer will require a special effort to expand the scientific information base. Specialized Programs of Research Excellence must address the weaknesses in the scientific information base and provide focal points for sustaining and maintaining state-of-the-art research that will contribute to improved detection, diagnosis, treatment and prevention of prostate cancer. SPORES will not only be expected to conduct a wide spectrum of research activities, but also to contribute significantly to the development of specialized research resources, career development of new investigators, the development of improved research model systems and the expansion of the research base through collaborative research with scientists and clinicians in other institutions locally and nationwide. The research supported through this program must have translational significance. It will require interdependence between basic and clinical investigators in both the planning and implementation of research and would emphasize clinical application of basic research findings with patients and populations. Translational research also applies clinical findings to advance basic research that ultimately may lead to hypothesis-driven clinical trials or prevention and control interventions. It should be noted that clinical research that is not based on nor derived from laboratory findings is not considered translational for purposes of this RFA. Other The goal of this RFA is to expand the current Prostate Cancer SPORE program with the addition of at least one new SPORE. Each SPORE assembles critical masses of laboratory and clinical scientists to work together on human prostate cancer and to focus on innovative translation of basic findings into research settings involving patients and populations. The ultimate objective is to reduce incidence and mortality, and to increase and improve survival to the disease. The essential characteristics of a SPORE include (1) a strong scientific program which will have a clear impact on the human disease, (2) a strong innovative developmental or pilot research program which can respond quickly to new research opportunities, (3) a strong career development program to develop and expand the scientific cadre of investigators dedicated to translational research on human prostate cancer, (4) a human prostate cancer tissue procurement resource, an animal model resource, and other resources specifically dedicated to translational research objectives, and (5) a willingness and commitment to work with other SPOREs and scientists in order to maximize research progress. The special features of SPORE grants provide opportunities for investigators with mutual or complementary interests to engage in multidisciplinary research that will impact on prevention, diagnosis, or treatment of human prostate cancer, as well as rehabilitation or quality of life. Individual research projects must be highly interactive, and must be conceived, planned and implemented through the multidisciplinary interactions of independent laboratory and clinical scientists. Such interactions should demonstrate the potential for accelerating the translation of research findings into practical benefits for patients and populations. A distinguishing feature of a SPORE P50 grant is the highly dependent nature of the research objectives upon intra- and inter- project interactions. Thus, each project may, but ordinarily would not, be expected to stand on its own in the absence of interactions with other research projects. Developmental research funds provide support for highly innovative pilot projects that take maximum advantage of new research opportunities. This provides a flexible means for responding quickly to new research opportunities. Career development of new and established investigators will generate a cadre of scientists who could leave the SPORE with research experience to develop independent prostate cancer research programs that emphasize translational research objectives. In order to facilitate achievement of SPORE program goals, each SPORE must develop resources specialized for prostate cancer research activities. This must include human prostate cancer tissue collection, and development and maintenance of animal models for research activities of the SPORE and use by scientists who are concentrating on translational research within and outside the parent institution. The development of additional resources specialized for prostate cancer research is also encouraged. Interactions among SPOREs is an important objective of this initiative. This may be in the form of research collaborations, exchange of scientists on a visiting basis, exchange of resources and materials, and other innovative ways. Principal Investigators will be expected to attend an annual meeting coordinated by the Organ Systems Coordinating Branch of the NCI. The purpose of the meeting is to share scientific information, assess scientific progress, identify new research opportunities, and establish priorities that will accelerate the translation of basic research findings to applied settings in patients and populations. SPECIAL REQUIREMENTS Each SPORE must include the following elements: 1. A strong institutional commitment. An institution receiving this award should incorporate the SPORE high within its institutional priorities. The institution should demonstrate a strong commitment to the program's stability and success. The application must provide a plan that addresses how the institutional commitment will be established and sustained, how it will maintain accountability for promoting scientific progress, and how the SPORE research effort will be given a high priority within the institution relative to other research efforts. This institutional commitment may be in the form of commitments to recruit scientific talent, provision of discretionary resources to the SPORE director, faculty appointments for SPORE investigators, assignment of research space, cost sharing of resources, or other ways to be proposed by the applicant. 2. A qualified principal investigator. A leader should be selected as principal investigator who can oversee and conduct planning activities, provide direction to the SPORE and ensure a translational research emphasis. 3. A substantive prostate cancer patient population. Each SPORE should be recognized as a leading program in the treatment of prostate cancer. The grant application must demonstrate and document access to a patient population that can participate in and benefit from the innovative clinical and population research activities of the SPORE. 4. Research projects. Each SPORE application must include at least three approved research projects that together represent reasonably diverse experimental approaches. Each research project must be headed by basic and clinical co-investigators. It is not necessary that both co-investigators commit equal effort to the project, but it should be evident from this collaboration that translational research objectives will be accelerated. The research must be oriented toward the most critically needed areas of prostate cancer research, and toward translational activities which address new innovative possibilities in prostate cancer research. As indicated above, each project must involve multidisciplinary laboratory and clinical interaction in the conception, planning, design and implementation of research. Projects should be interactive with each other whenever possible. This program will not support basic research that is without translational potential or significance nor will it support clinical studies that are not "translated" from basic research. Research components involving clinical trials must include provisions for rigorous data management, quality assurance, and auditing procedures. Funds should be budgeted for these activities and should appear as a separate budget page in the application. They should not duplicate internal review and monitoring systems that are already in place at the institution. For any treatment protocols supported directly or indirectly by the SPORE, copies of Informed Consent forms, Early Stopping rules and procedures to detect and monitor Adverse Drug Reactions (ADR) must be provided in the application, or in the case of future protocols, to the NCI program director. At least one research project must be on prostate cancer prevention or early detection and screening. The NCI is particularly interested in early detection and screening efforts. There is also a strong interest in developing genetic methods for determining high risk to prostate cancer either through inheritance or through environmental exposures. However, the NCI is open to all novel innovative approaches to prevention. Collaborative arrangements within the SPORE, within the parent institution and with other institutions are encouraged. Collaborations with scientists outside the immediate SPORE should be documented with appropriate letters of commitment as applicable. Collaborations with other institutions may involve subcontracting arrangements but an award will be made to one institution only; that institution is expected to demonstrate the full institutional commitment noted in 1. above. It is expected that all SPOREs will have a balanced approach to prostate cancer that encompasses the areas of prevention, etiology, screening, diagnosis and treatment. This balanced approach may be either through research being conducted in their institution, or through collaborative associations they have developed or plan to develop with other SPOREs or with other investigators in the biomedical research community. 5. Developmental Research Funds. Each SPORE should continually allocate a significant proportion of its budget and effort to pilot projects that explore innovative ideas. It is important that SPOREs use developmental funds to stimulate projects that take maximum advantage of new research opportunities. Pilot projects may be collaborative among scientists within one or more SPOREs, or with scientists outside the SPORE environment. The SPORE application should propose an institutional review process that selects pilot projects for funding which represent the most innovative ideas and which are likely to have the greatest impact on reducing prostate cancer incidence and mortality, and increasing and improving survival and quality-of-life of prostate cancer patients. These funds are intended to remain flexible and to support feasibility and pilot studies of a limited duration, e.g., two years or less, rather than the duration of the entire grant period. The expectation is that successful feasibility studies will become fully developed projects within the SPORE, or funded through other forms of research support, e.g., R29, R01. 6. Specialized Resources. The SPORE is encouraged to develop and maintain resources of special significance to translational prostate cancer research. While all types of resources may be proposed, each SPORE must have a dedicated activity for the development of model systems for research, and for collecting and distributing human prostate cancer tissue. Tissue collection should include the essential pathologic and clinical information needed for conducting research. This resource should benefit the specific research activities of the SPORE as well as the research activities of other scientists within and outside of the parent institution who are concentrating on translational research issues. The SPORE must be willing to participate in any national prioritization for distribution of tissues through NCI supported tissue networks. A plan must be proposed for prioritizing distribution of tissues and animal models to SPORE scientists and others based on the most innovative ideas in translational prostate cancer research. This plan should be flexible enough to accommodate and complement broader national priorities as they are developed. 7. Career Development. The SPORE should demonstrate a consistent commitment to career development. A sufficient portion of the budget should be dedicated to the salaries and research activities of investigators who wish to pursue careers in translational research on prostate cancer and who would acquire the necessary research experience to develop independent prostate cancer translational research programs within or outside of the parent institution. These may be new investigators or established investigators who wish to change research directions. Candidates should be scientists who have demonstrated outstanding research potential, but who need additional time in a productive scientific environment to establish an independent prostate cancer research program. Candidates are expected to devote full time to research. Any deviation will require prior NCI approval. Recruitment should encourage the participation of qualified women and minorities. To this end, each applicant must include a clear policy and plans for recruiting minorities and women. The SPORE application should propose the number of slots available, the criteria for eligibility and for selection of candidates, and describe the selection process. Also, the application should indicate prospective mentors who are already in place at the proposed SPORE, briefly describe their research programs, and describe complementary activities that contribute to the environment for career development (e.g., existing training grants, other career development mechanisms and relevant programs). 8. Annual Meeting of SPORE. Prostate Cancer SPOREs will be expected to participate in an annual meeting with the Organ Systems Coordinating Branch of the NCI to share positive and negative results with other SPOREs, share materials, assess progress, identify new research opportunities, and establish interactions and research priorities and collaborations that will maximize the impact of the research on reducing incidence and mortality, and improving survival. Travel funds for the Principal Investigator and selected Project Investigators may be budgeted for this purpose. This may include Project Investigators from other institutions who are actively collaborating with SPORE investigators. In addition, travel funds should be budgeted for the SPORE Director to attend an annual SPORE Directors' administrative and planning meeting at the NCI. This Directors' meeting is in addition to the annual SPORE Investigators' meeting. A SPORE application can originate from an institution with or without an existing NCI Cancer Center Support Grant or P30 core grant. However, if a P30 grant already exists: (a) the Principal Investigator of the SPORE should be a senior leader in the cancer center; (b) the P30 Center Director may be the Principal Investigator of the P50 SPORE, but this is not necessary; (c) lines of authority should be indicated clearly such that the SPORE is an integral part of the Cancer Center and does not interfere with the P30 chain of authority; (d) a letter of commitment that delineates organizational relationships and lines of authority is required; the letter must be signed by the proposed Principal Investigator of the SPORE, the Cancer Center Director, and the appropriate institutional official; (e) the SPORE must be an integrated major programmatic element in the cancer center; however, there must also be a separate and distinctive institutional commitment specifically to the SPORE in addition to the institutional commitment to the NCI-designated Cancer Center; (f) the development of resources in the SPORE should not duplicate resources already provided by the existing P30 grant; however, SPORE resources can be used to augment existing center resources to orient these resources more effectively to SPORE research objectives, if this is a more efficient and more cost effective alternative; (g) the applicant should describe how the P50 SPORE will interact synergistically and effectively with the existing P30 programs in order to maximize SPORE research objectives and contribute to cancer center research objectives. STUDY POPULATIONS 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 on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting errors in the earlier publication, 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. LETTER OF INTENT Prospective applicants are asked to submit, by November 18, 1994, a letter of intent that includes the name and address of the principal investigator and identifies the component research projects, core units and their principal investigators, any collaborating institutions, and the number and title of the RFA in response to which the application is being submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. Furthermore, NCI staff can discuss the most recent policies of the NCI relative to funding issues, potential problems in meeting eligibility requirements, or clarification of the peer review process before the final application is submitted. The letter of intent is to be sent to Dr. Andrew Chiarodo, Ph.D. at the address listed under INQUIRIES. APPLICATION PROCEDURES Complete applications are due no later than February 21, 1995. Applications must meet all eligibility requirements as described above and must address all programmatic requirements (see SPECIAL REQUIREMENTS above) in the RFA. Applications received after this date will not be accepted. Also, the Division of Research Grants (DRG) will not accept any application in response to this RFA, any part of which is the same as one currently being considered by any other review group or NIH awarding unit. Specific instructions for preparing a SPORE grant application are available as a separate addendum to this RFA. These instructions should be used in preparing the application. They are available from the Organ Systems Coordinating Branch (see INQUIRIES below). 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; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892-4500, telephone (301) 594-7248; and from the NCI Program Director listed under INQUIRIES. The RFA label available in the application form PHS 398 (rev. 9/91) 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 "SPORE in Prostate Cancer" must be typed on line 2a of the face page of the application form. 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 Westwood Building, Room 240 Bethesda, MD 20892-4500** At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard MSC 7405 Rockville, MD 20852 (if hand-delivered or delivery service) Bethesda, MD 20892-7405 (if using U.S. Postal Service) It is important to send these copies at the same time that the original and three copies are sent to DRG; otherwise, the NCI cannot guarantee that the applications will be reviewed in competition with other applications received on or before the designated receipt date. REVIEW CONSIDERATIONS A. Review Procedures Upon receipt, applications will be reviewed initially by the Division of Research Grants for completeness. Incomplete applications that have not addressed all of the required elements noted above under SPECIAL REQUIREMENTS or do not meet the eligibility requirements as noted above, will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements stated in the RFA is an NCI program staff function; this will be done stringently and will be based primarily on the clear orientation of the application to human prostate cancer, translational research objectives, and an absence of duplication between the proposed research and currently supported research. Applications judged to be non-responsive to this RFA will be returned without review. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit and for special SPORE characteristics and requirements 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, 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 non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. Applications judged to be competitive will be discussed and be assigned a priority score. The second level of review will be provided by the National Cancer Advisory Board. B. Review Criteria The factors to be considered in the evaluation of all applications are given below. Additional factors are noted in a separate section below for applications from existing P20 SPORE feasibility grantees and for applications from P50 SPOREs applying for competitive renewal. 1. The Institutional Commitment (a) adequacy of facilities, equipment and space to promote translational research objectives; (b) adequacy of institutional procedures and plans for monitoring, evaluating and assuming accountability for the general success of the SPORE; adequacy of the institutional infrastructure for assessing progress and needs; (c) adequacy of recruitment objectives and plans to strengthen the scientific capabilities of the SPORE; (d) presence of other tangible commitments, i.e., discretionary resources, to the SPORE, e.g., dollars and space. 2. Overall Program Organization and Capability (a) the scientific qualifications and demonstrated scientific and administrative leadership capabilities of the SPORE Principal Investigator; adequacy of the time commitment of the Principal Investigator; (b) the depth and breadth of the proposed research activities and plans to effectively pursue translational research objectives; (c) the adequacy of access to patients and to a population for conducting current and projected therapeutic, prevention and control research; (d) the adequacy of the procedures, processes, and plans for promoting interactions; (e) if applicable, the adequacy of plans for synergistic and effective interactions with existing P30 programs. 3. Individual Research Projects (a) qualifications and demonstrated competence of the investigators to conduct the proposed research; the adequacy of the time commitment of all key laboratory and clinical researchers associated with the project; (b) clear evidence of significant multidisciplinary basic and clinical interactions in the conception, design and proposed implementation of the project; (c) degree to which the project addresses an issue of substantive importance for reducing incidence and mortality or for increasing survival in human prostate cancer; (d) the scientific merit and adequacy of experimental design of the project; (e) in clinical research components, clear evidence of full protection of human subjects, and appropriate mechanisms for the rigorous management and verification of research data; (f) the adequacy of quality assurance and audit processes, and related budget for research involving clinical trials; (g) the originality, novelty, and innovativeness of the experimental design and relevance to the overall goals and objectives of the SPORE; (h) the degree to which the project is interactive with other projects in the SPORE conceptually, experimentally, and translationally; (i) appropriateness of the budget to achieve research objectives. 4. Developmental Funds (a) adequacy of the proposed process for continuously reviewing and funding pilot projects for their quality, innovativeness and potential impact on reducing incidence and mortality, and/or improving survival to prostate cancer; (b) quality, innovativeness and potential impact of proposed pilot projects; (c) degree to which developmental funds will be used to stimulate pilot projects with multidisciplinary interactions and/or collaborative interactions with other scientists within or outside of the parent institution; (d) appropriateness of the proposed budget relative to the proposed pilot projects and potential of the program to generate innovative pilot projects on a consistent basis. 5. Career Development (a) the adequacy of the process for selecting candidates for career development who demonstrate potential for independent research careers or who are established investigators and are changing the direction of their research careers; (b) adequacy of the policies to seek out and include qualified minorities and women in the career development program; (c) adequacy of the individuals available in the program to serve as possible mentors of career development candidates; the current availability and adequacy of projects for career development candidates; (d) complementary activities that contribute to the environment for career development; (e) capacity of the overall program to absorb career development candidates and prepare them for independent prostate cancer research careers; (f) appropriateness of the budget relative to the proposed plans for sustaining a strong activity in career development. 6. Shared Resources (a) adequacy of the proposed plans to develop, maintain and distribute a fresh/frozen human prostate cancer tissue resource with pathological and clinical data; (b) willingness to participate in any national prioritization for distribution of tissues through NCI-supported tissue networks; (c) adequacy of the proposed plans to develop, improve, and distribute animal models; (d) confirmation that the plan does not duplicate resources already available within the institution (e.g., as part of a Cancer Center Support Grant or P30) or through readily available national resources; (e) adequacy of the justification for other specialized resources essential for the conduct of SPORE research; (f) adequacy of qualifications of proposed managers of resources to conduct high quality, reliable resource operations; (g) appropriateness of the requested budgets to conduct each resource operation. 7. Interactions with other SPOREs (a) adequacy of plans to promote and maintain communication and integration with other prostate SPOREs; (b) willingness to interact with other SPOREs and with the NCI in sharing information, assessing scientific progress, identifying new research opportunities, and establishing scientific priorities. The above criteria apply to all new and competing applications. Additional factors to be considered in the evaluation of competing applications from P20 Feasibility SPORE grantees, will be: (a) nature and quality of planning in the context of focusing on translational activities; (b) extent to which applied researchers (e.g., clinical researchers, prevention and control researchers) are interacting with basic investigators in planning translational approaches to the problem of prostate cancer; (c) how funds have been used to foster planning for a SPORE in prostate cancer; (d) positive and/or negative results of pilot projects, if applicable. (e) extent to which pilot projects, where applicable, have led to proposal of new full research projects in the current grant application. Additional factors to be considered in the evaluation of competing renewal applications from current P50 SPORE grantees, will be: 1. Research Projects (a) progress in establishing a high quality research effort and scientific productivity in translational research over the previous funding period; (b) degree to which applied researchers (e.g., clinical researchers, prevention and control researchers) are interacting with basic investigators in the planning, design, and implementation of research projects; (c) collaborative efforts that have been established within and outside the SPORE institution; (d) results (positive or negative) from each research project; (e) degree to which each project is interacting with other projects; (f) translational potential or significance of each individual research project; 2. Developmental Projects (a) progress in the effective use of developmental funds to explore new research opportunities and/or stimulate the field; (b) quality, innovativeness, and potential or actual impact of funded pilot projects; (c) positive and/or negative results for each developmental project; d) how the SPORE has set priorities in the use of developmental funds; (e) impact of developmental projects in stimulating new full translational research projects within the SPORE, or through other support mechanisms; (f) impact of developmental projects in stimulating new multidisciplinary or collaborative interactions within or outside the SPORE. 3. Career Development (a) progress toward recruiting candidates including women and minorities, for career development; (b) progress in developing the careers of new or established investigators in translational prostate cancer research; (c) quality and adequacy of the research activities of these individuals; (d) current status and research activities of individuals who have completed career development, if applicable. 4. Shared Resources (a) effectiveness and efficiency of previously funded resources in meeting the specific translational research needs of the scientific projects in the SPORE; (b) extent to which shared resources are being used by research and pilot projects, both within and outside the SPORE; (c) quality, utility, and efficiency of the shared resources; (d) progress toward establishing the prostate cancer tissue resource to include pathological and clinical data; nature, quality, and distribution of tissues being procured; plans for prioritizing distribution of tissues within and outside the SPORE; (e) progress toward developing new or improving existing animal models. 5. Other Considerations (a) special efforts to recognize unique research opportunities based on incidence and mortality rates in the community or region of the SPORE; (b) special efforts to enhance the research capability of the SPORE through interactions with individuals, organizations, and institutions within the community; (c) special efforts to promote and maintain communication and integration with other prostate SPOREs; (d) progress toward meeting previously stated (above) institutional commitments; (e) demonstrated effectiveness of the SPORE Director in terms of scientific and administrative leadership; (f) progress in refining and improving upon the translational research infrastructure of the SPORE during the previous funding period as it relates to (a) through (e) above. Each component of the application will receive a recommendation of approval or not recommended for further consideration. Approved components will receive an appropriate verbal descriptor of merit. The review group will critically examine the proposed budget for each component of the application. C. Scoring the Applications In addition to rating the merit of individual components, peer reviewers will be asked to judge the overall program in the following areas: (1) scientific merit and innovativeness; progress, if applicable; (2) evidence of interdependent, multidisciplinary design and conduct of the research; (3) impact, or potential for impacting on the disease; (4) institutional commitment. A verbal descriptor will be recorded for each of the above areas. A single numerical priority score will be assigned to the program as a whole. Although primary emphasis will be placed on scientific merit, innovativeness, and progress where applicable, significant consideration will be given to multidisciplinary interactions, potential for impacting on the disease, and institutional commitment. A recommendation for no further consideration for any required element of the program (see SPECIAL REQUIREMENTS above) will result in an overall evaluation of "not recommended for further consideration." AWARD CRITERIA The earliest anticipated date of award is December 1, 1995. Applications considered by the National Cancer Advisory Board will be considered for award based upon (a) priority score, (b) availability of funds, and (c) programmatic priorities. The NCI anticipates making at least three awards for project periods of five years for successful P50 competitive renewals, and for project periods of three years for applications from new applicants or current P20 SPORE feasibility grantees applying for P50 funding. INQUIRIES Written and telephone inquiries concerning the objectives and scope of the RFA, and inquiries about whether or not specific proposed research would be responsive, are encouraged. The program director welcomes the opportunity to clarify any issues or questions from potential applicants. For inquiries regarding programmatic issues, contact: Andrew Chiarodo, Ph.D. Division of Cancer Biology, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Suite 512 6130 Executive Boulevard MSC 7386 Bethesda, MD 20852-7386 Telephone: (301) 496-8528 For fiscal or administrative matters, contact: Joan Metcalfe 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. 228 AUTHORITY AND REGULATIONS This program is described in the catalog of Federal Domestic Assistance no. 13.397. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410 as amended: 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 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 Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. 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 Sep 16 23:00:00 1994 Path: biosci!biosci!not-for-mail From: "Andrew Knutsen" Newsgroups: bionet.announce,bionet.sci-resources Subject: Graduate and Postdoc fellowship opportunities. Date: 16 Sep 1994 18:57:32 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 131 Sender: biohelp@net.bio.net Approved: bionews-moderator@net.bio.net Distribution: world Message-ID: <9408167797.AA779754472@nas.edu> NNTP-Posting-Host: net.bio.net Xref: biosci bionet.announce:1428 bionet.sci-resources:1112 August 1994 The Fellowship Office of the National Research Council administers the predoctoral and postdoctoral fellowship programs outlined briefly below. Additional information and application materials will become available in September 1994. Telephone: (202) 334-2872 E-mail: infofell@nas.edu Snail mail address: Fellowship Office, National Research Council, 2101 Constitution Avenue, Washington, D.C. 20418 1. Howard Hughes Medical Institute Predoctoral Fellowships in Biological Sciences Application deadline: November 4, 1994 - Open to citizens or nationals of the United States or foreign nationals for graduate work in research-based doctoral programs (PhD or ScD) in biological sciences. - The following fields are eligible for support: biochemistry, biophysics, biostatistics, cell biology and regulation, developmental biology, epidemiology, genetics, immunology, mathematical biology, microbiology, molecular biology, neuroscience, pharmacology, physiology, structural biology, and virology. - These fellowships are intended for students at or near the beginning of their graduate study toward a PhD or ScD degree in the designated biological sciences. Applicants must not have completed, by the beginning of the fall 1994 term, one year or more of postbaccalaureate graduate study in biological sciences, whether or not that study was toward a master's or doctoral degree or was outside of a degree program. - The following will not preclude eligibility: 1) graduate study that took place more than 10 years prior to application, 2) graduate study toward a Master of Public Health degree, 3) study in biological sciences that was toward a medical or dental degree (MD, DO, DVM, or DDS), and 4) graduate study prior to entry into medical or dental school. - If study has been part time, the applicant must not have completed more than seven courses in a semester system or more than eight courses in a quarter system. To be considered part-time, the program of study must have been limited to no more than two courses each semester or quarter. - Individuals who are pursuing or who hold medical or dental degrees (MD, DO, DVM, or DDS) may also be eligible to apply for predoctoral fellowships. As in the case of other applicants, support is only for full-time study toward the PhD or ScD degree in the designated biological sciences and is intended for those at the beginning of their graduate study toward such a degree. These applicants also must not have completed, by the beginning of the fall 1994 term, the first year of a full-time graduate program in biological sciences, or the equivalent in part-time study. - Medical students who have received financial support through a funded MD/PhD program (whether formal or informal) are not eligible for these fellowships. - Applicants must have scores from the GRE General Test; if not provided, the fellowship application will be withdrawn from the competition. - Foreign nationals whose primary language is not English are required to submit scores from the Test of English as a Foreign Language (TOEFL). If a required TOEFL score is not provided to the NRC, the fellowship application will be withdrawn from the competition. 2. Ford Foundation Predoctoral and Dissertation Fellowships for Minorities Application deadline: November 4, 1994 - Open to United States citizens who are members of the following minority groups: Alaskan Natives (Eskimo or Aleut), American Indians, Black/African Americans, Mexican Americans/Chicanos, Native Pacific Islanders (Polynesian or Micronesian), and Puerto Ricans. - Awards are made for study in research-based doctoral programs (PhD or ScD) that will lead to careers in teaching and research at the university or college level in the behavioral and social sciences, humanities, engineering, mathematics, physical sciences, and life sciences. - Study in programs that are practice-oriented is not supported. Awards are not made for work leading to degrees in areas related to business, administration, management, health sciences, home economics, library science, speech pathology, audiology, personnel, guidance, social work, fine arts, performing arts, or education. - Awards are not made for work leading to terminal masters degrees, doctorates in education (PhD or EdD), Doctor of Fine Arts (DFA) degrees, professional degrees in such areas as medicine, law, or public health, or for study in joint degree programs such as MD/PhD, JD/PhD, and MFA/PhD programs. - Persons holding a doctoral degree earned in any field at any time are not eligible to apply. Predoctoral Fellowships are intended for students who are at or near the beginning of their graduate study. - Applicants must not have completed, by the beginning of the fall 1994 term, more than 30 semester hours, 45 quarter hours, or equivalent, of graduate-level study in fields supported by this program whether or not credit for that study is applied toward another advanced degree (including a master's degree). "Graduate-level study" includes course work, research, and seminars. This guideline is applied to graduate study completed after October 1, 1984. - Predoctoral Fellowship applicants are required to submit GRE General Test scores from tests taken since October 1, 1989. Dissertation Fellowships are intended for PhD or ScD degree candidates who have finished all course work, examinations, language requirements, and all other departmental and institutional requirements except for the writing and defense of the dissertation, and who have gained approval of the dissertation proposal/topic. - Applicants must have satisfied all of the above conditions by February 14, 1995, and expect to complete the dissertation during the 1995-96 academic year, but in no case later than fall 1996. - Fellowship support is intended for the final year of dissertation writing. 3. Ford Foundation Postdoctoral Fellowships for Minorities Application deadline: January 6, 1995 - Open to United States citizens who are members of the following minority groups: Alaskan Natives (Eskimo or Aleut), American Indians, Black/African Americans, Mexican Americans/Chicanos, Native Pacific Islanders (Polynesian or Micronesian), and Puerto Ricans. - Applicants are required to have earned the PhD or ScD degree by January 6, 1995, and may not have held the degree for more than seven years as of January 6, 1995. - Only those individuals already engaged in a teaching and research career or those planning such a career are eligible to apply in this program. - Awards are for postdoctoral research and will be made in the behavioral and social sciences, humanities, engineering, mathematics, physical sciences and life sciences, or for interdisciplinary programs composed of two or more eligible disciplines. - Awards will not be made in professions such as medicine, law, social work, library science, public health and in areas related to business, administration, management, fine arts, performing arts, speech pathology, audiology, health sciences, home economics, personnel, guidance, and education. From owner-sci-resources@net.bio.net Sun Sep 18 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 19 September 1994 Date: 19 Sep 1994 15:17:41 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 157 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <35l2m5$3vn@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: Media Tipsheet August 26, 1994 File size (bytes): 5443 STIS Filename: tip40826 Title: Media Tipsheet September 8, 1994 File size (bytes): 5541 STIS Filename: tip40908 Title: Media Tipsheet September 9, 1994 File size (bytes): 4809 STIS Filename: tip40909 Document Type: Press Release Title: COMET IMPACT "94 MEDIA BRIEFING SET FOR MAY 18 File size (bytes): 2030 STIS Filename: pr9434 Title: VORTEX PUTTING MOBILE INSTRUMENTS IN THE PATHS OF TORNADOES File size (bytes): 3038 STIS Filename: pr9435 Title: QUEST FOR THE MISSING CARBON- CANADA'S BOREAL FORESTS ARE FOCUS OF INTERNATIONAL GLOBAL CHANGE FIELD PROJECT File size (bytes): 4390 STIS Filename: pr9436 Title: THERMODYNAMICS SPECIALIST KENNETH R. HALL TO LEAD DIVISION OF CHEMICAL AND TRANSPORT SYSTEMS AT THE NATIONAL SCIENCE FOUNDATION File size (bytes): 2871 STIS Filename: pr9437 Title: NEW INDUSTRY OPTION FOR CHEMISTRY POSTDOCS File size (bytes): 2058 STIS Filename: pr9438 Title: SCIENCE AND PUBLIC POLICY THEME OF AUGUST BIOLOGY MEETING; NSF-SUPPORTED SCIENTISTS TO PRESENT PAPERS AT KNOXVILLE CONFERENCE File size (bytes): 4217 STIS Filename: pr9439 Title: NINE STATES TO RECEIVE EPSCoR EXPERIMENTAL AWARDS TO INCREASE S&T COMPETITIVENESS File size (bytes): 7988 STIS Filename: pr9440 Title: NSF SUPPORTS AGILE MANUFACTURING RESEARCH CENTERS File size (bytes): 5758 STIS Filename: pr9441 Title: EXPANSIN PROTEINS REVEAL HOW CELL WALLS GROW File size (bytes): 3535 STIS Filename: pr9442 Title: AUTOPSY REVEALS CLUES TO CAUSE OF DEATH FOR ANCIENT GIRL FOUND FROZEN IN ALASKA File size (bytes): 4066 STIS Filename: pr9443 Title: NSF AND ONR-SUPPORTED OCEANOGRAPHERS REPORT RESULTS OF "IRON EXPERIMENT"- FINDINGS SHED LIGHT ON OCEAN/ATMOSPHERE CLIMATE LINK File size (bytes): 4503 STIS Filename: pr9444 Title: CONSEQUENCES OF HABITAT LOSS MORE SEVERE THAN THOUGHT, SAYS NSF-FUNDED RESEARCHER File size (bytes): 4874 STIS Filename: pr9445 Title: STRANGE OBJECT IN MILKY WAY GALAXY EJECTS MATERIAL AT SUPER SPEEDS File size (bytes): 4285 STIS Filename: pr9446 Title: NSF ANNOUNCES MULTIMILLION DOLLAR AWARD TO DISTRICT OF COLUMBIA PUBLIC SCHOOLS File size (bytes): 4366 STIS Filename: pr9447 Title: NEW NSF GRANT OPPORTUNITY SEEKS TO INCREASE IDENTIFICATION OF EARTH'S BIOTA File size (bytes): 2973 STIS Filename: pr9448 Title: VISITING PROFESSORSHIPS BOOST WOMEN'S RESEARCH CAREERS File size (bytes): 8691 STIS Filename: pr9449 Title: NATIONAL SCIENCE FOUNDATION ESTABLISHES NEW ENGINEERING RESEARCH CENTERS File size (bytes): 7619 STIS Filename: pr9454 Document Type: Program Guideline Title: NSF 94-130 1995 Summer Institute in Japan File size (bytes): 39916 STIS Filename: nsf94130 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 59515 STIS Filename: sesvac ------------------------------------------------------------------------ ** 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, the text of your message should be as follows: get sesvac Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve sesvac, you would enter: ftp> get sesvac 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 Fri Sep 23 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 34, pt. 1of1, 23 September 1994 Date: 23 Sep 1994 19:28:08 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 776 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3602ro$kt4@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940923 V23N34 P1O1 ************************************ X-comment: RFAs described: DE-94-009, AI-94-027, PAR-94-096 NIH GUIDE - Vol. 23, No. 34 - September 23, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** TRIAGE AND STREAMLINED SUMMARY STATEMENT FORMAT TO BE USED BY THE DIVISION OF RESEARCH GRANTS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** TREATMENT OF ADMINISTRATIVE AND CLERICAL SALARIES UNDER NIH GRANTS AND COOPERATIVE AGREEMENTS AWARDED TO EDUCATIONAL INSTITUTIONS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** NIH SOUTHWEST REGIONAL SEMINAR IN PROGRAM FUNDING AND GRANTS ADMINISTRATION National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N4 ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOP National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** SPEECH PROCESSORS FOR AUDITORY PROTHESES (RFP NIH-DC-94-25) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX R2 ********************************************************** THE FEASIBILITY OF A COCHLEAR NUCLEUS AUDITORY PROTHESIS BASED ON MICROSTIMULATION (RFP NIH-DC-95-02) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX R3 01/18/95 ************************************************* RESEARCH ON THE BIOLOGY OF THE PULP (RFA DE-94-009) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX R4 02/21/95 ************************************************* ENHANCEMENT AWARDS FOR UNDERREPRESENTED MINORITY RESEARCHERS IN HIV/AIDS (RFA AI-94-027) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** RESEARCH INFRASTRUCTURE SUPPORT PROGRAM (PAR-94-096) National Institute of Mental Health INDEX: MENTAL HEALTH ERRATA $$INDEX E1 PA-94-025 ************************************************ POSTDOCTORAL TRAINING IN ALTERNATIVE MEDICINE (PA-94-025) Office of Alternative Medicine National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX E2 AI-94-029 ************************************************ PEDIATRIC AIDS: FACTORS IN TRANSMISSION AND PATHOGENESIS (RFA AI-94-029) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES ATTENTION: The new mailing list for the NIH Guide will be activated in September. Until then, the existing mailing list will be maintained. See INTENT TO MODIFY (NIH Guide, Vol. 23, No. 23, June 17, 1994) for additional information. This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** TRIAGE AND STREAMLINED SUMMARY STATEMENT FORMAT TO BE USED BY THE DIVISION OF RESEARCH GRANTS NIH GUIDE, Volume 23, Number 34, September 23, 1994 P.T. 34; K.W. 1014006 National Institutes of Health Beginning with the review of applications submitted for the October 1, 1994, receipt date, all Division of Research Grants standing study sections will triage investigator-initiated research project grant applications (R01s and R29s). Reviewers will designate approximately half of the applications as "noncompetitive" for support. A designation of "noncompetitive" requires unanimous agreement of the study section. For this purpose, "noncompetitive" means that the application is judged to be in the lower half, qualitatively, of research project grant applications normally reviewed by that study section. Applications determined to be "noncompetitive" will not receive full discussion at the study section meeting, will not receive a priority score, and will not routinely be taken to second level of review by the national advisory councils/boards. The summary statement for an application determined to be "noncompetitive" will consist of the customary administrative information and the reviewers' critiques, verbatim. The summary statement for an application that receives full discussion and a score will include, in addition to the reviewers' critiques and the administrative information, a "Resume and Summary of Discussion," which synopsizes the study section's discussion of the application. Subsequent to the study section meeting, all applicants will receive the customary snap-out mailer to advise them of the outcome of the initial review. INQUIRIES Office of Grants Information Division of Research Grants Westwood Building, Room 449 Bethesda, MD 20892 Telephone: (301) 594-7248 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** TREATMENT OF ADMINISTRATIVE AND CLERICAL SALARIES UNDER NIH GRANTS AND COOPERATIVE AGREEMENTS AWARDED TO EDUCATIONAL INSTITUTIONS NIH GUIDE, Volume 23, Number 34, September 23, 1994 P.T. 34; K.W. 1014006 National Institutes of Health In July 1993, OMB Circular A-21, "Cost Principles for Educational Institutions," Section F.6.b., was revised to define the criteria for charging salaries of administrative and clerical staff to Federally sponsored grants and cooperative agreements. This revision clarified the principle that the salaries of administrative and clerical staff should usually be treated as indirect costs, but that direct charging of these costs may be appropriate where the nature of the work performed under a particular project requires an extensive amount of administrative or clerical support that is significantly greater than the routine level of such services provided by academic departments. The charging of these costs directly would need to meet the general criteria for direct charging in Section D.1. - i.e., "be identified specifically with a particular sponsored project ... relatively easily with a high degree of accuracy," and the special circumstances requiring direct charging of these services would need to be justified to the satisfaction of the awarding agency in the grant or cooperative agreement application. Some examples of circumstances where direct charging the salaries of administrative or clerical staff may be appropriate are as follows: o Large, complex programs, such as General Clinical Research Centers, primate centers, program projects, environmental research centers, engineering research centers, and other grants and contracts that entail assembling and managing teams of investigators from a number of institutions. o Projects that involve extensive data accumulation, analysis and entry, surveying, tabulation, cataloging, searching literature, and reporting, such as epidemiological studies, clinical trials, and retrospective clinical records studies. o Projects that require making travel and meeting arrangements for large numbers of participants, such as conferences and seminars. o Projects where the principal focus is the preparation and production of manuals and large reports, books and monographs (excluding routine progress and technical reports). o Projects that are geographically inaccessible to normal departmental administrative services, such as seagoing research vessels, radio astronomy projects, and other research field sites that are remote from the campus. o Individual projects requiring significant amounts of project- specific database management; individualized graphics or manuscript preparation; human or animal protocol, IRB preparations and/or other project-specific regulatory protocols; and multiple project-related investigator coordination and communications. These examples are not exhaustive nor are they intended to imply that charging of administrative or clerical salaries would always be appropriate for the situations illustrated in the examples above. Where direct charges for administrative and clerical salaries are made (as with other administrative type costs, e.g., telephones, postage, books and journals), care must be exercised to assure that costs incurred for the same purpose in like circumstances are consistently treated as direct costs for all activities. This should be accomplished through a "Direct Charge Equivalent" or other mechanism that assigns the costs directly to the appropriate activities. NIH Implementation For those institutions subject to OMB Circular A-21, the NIH will implement the revision effective with budget period start dates on or after October 1, 1994, for competing grants and cooperative agreements. For noncompeting grants and cooperative agreements, the NIH will not make any adjustments to the committed level, nor will future year commitments be adjusted. Nonetheless, the principles of A-21 address the appropriate allocation of these costs with implementation based on the negotiated indirect cost rate agreement in effect for each institution. Thus, grantee institutions that have negotiated indirect rates based on the revised principles contained in Section F.6.b may not directly charge administrative or clerical salaries when inconsistent with the Circular, even though these costs may not have been deleted from the noncompeting award. This revision also affects any postaward rebudgeting of funds for the purpose of charging administrative or clerical salaries. Where grant or cooperative agreement applications do not anticipate the need to directly charge administrative and clerical salaries, institutions may rebudget funds, without awarding office prior approval, to cover these costs when consistent with the criteria and examples described above. For example, administrative or clerical salaries not identified in the application could be charged to the Training Related Expenses associated with Institutional National Research Service Awards (T32) when the activity involves a large amount of tracking and completion of forms directly related to the purpose of the grant. The implementation of this revision will not have any impact on the peer review of grant applications. Reviewers will continue to base any recommended budget reduction on whether the cost requested is warranted or justified for the project. Reviewers should not recommend deletion of requested administrative and clerical staff salary support based solely on the provisions contained in Circular A-21. The awarding unit staff will determine, in accordance with A- 21, whether or not the costs are allocable as a direct cost under the particular project. INQUIRIES Questions should be addressed to the awarding agency's Grants Management Officer when it is unclear whether or not administrative or clerical staff salaries may be charged directly. $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NIH SOUTHWEST REGIONAL SEMINAR IN PROGRAM FUNDING AND GRANTS ADMINISTRATION NIH GUIDE, Volume 23, Number 34, September 23, 1994 P.T. 34; K.W. 1014006 National Institutes of Health A regional seminar covering topics related to program funding and grants administration at the National Institutes of Health has been scheduled for November 17-18, 1994, in Albuquerque, New Mexico. The seminar, hosted by the Offices of Research Administration and Continuing Medical Education at the University of New Mexico, is intended to attract faculty and research administrators from the southwest region of the United States, although those interested from other regions are also invited and welcome. Staff from small and minority colleges, for-profit research organizations, hospitals, universities, and medical centers are encouraged to attend. This two-day seminar will have a dual focus of interest to both academic researchers and new and senior research administrators. Discussions of current issues that affect NIH funding and grants administration will be featured to give seminar participants a comprehensive view of NIH-sponsored research. There will be time available to network with colleagues and meet informally with NIH representatives to discuss topics of special interest. The faculty will include Geoffrey Grant, Joellen Harper, and Sue Ohata from the Office of Policy for Extramural Research Administration; Wayne Berry, Division of Financial Management; Faye Calhoun, Ph.D., Division of Research Grants; Joseph Ellis, NIA; Marvin Kalt, Ph.D, NCI; Mary Kirker, NIAID; Yvonne Maddox, Ph.D., NIGMS; and Carol Tippery, NIGMS. SEMINAR LOGISTICS Seminar Leader: Geoffrey Grant, Acting Director Office of Policy for Extramural Research Administration (OPERA) Seminar Coordinator (NIH): Joellen Harper, Grants Policy Office, OPERA, 301/496-5967 Seminar Coordinator (University of New Mexico): Dorrie Murray, Office of Continuing Medical Education, University of New Mexico, 505/277-3942 Dates: Thursday and Friday, November 17-18, 1994 Location Ramada Hotel Classic 6815 Menaul N.E. Albuquerque, NM 87110 Telepone: (505) 881-0000 or 800/252-7772 Participants need to make hotel reservations directly and should reference the regional seminar when you call. Reservations made by October 16, 1994, are guaranteed the special room rate of $68 (single) or $78 (double). Cost: $125 early-bird registration ($150 after November 3) Registration and Inquiries: Advance registration is required. You are encouraged to register early, as space is limited. To receive the draft program and registration materials, call 505/277-3942, or send a fax that provides your name, institution, address, telephone number, and anticipated number of registrants to 505/277-8604. FUTURE SEMINARS At this time, the dates and locations for regional seminars to be held in 1995 and beyond have not yet been finalized. If you have any questions about hosting a regional seminar, contact Ms. Joellen Harper in the NIH Grants Policy Office on 301/496-5967. $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOP NIH GUIDE, Volume 23, Number 34, September 23, 1994 P.T. 34; K.W. 0201011, 1014003 National Institutes of Health The National Institutes of Health (NIH), Office of Extramural Research (OER), Office for Protection from Research Risks (OPRR) is cosponsoring a National Animal Welfare Education Workshop with The Louisiana State University Medical Center and Xavier University of Louisiana on September 29-30, 1994. The topic is Use of Animals in Research and Alternatives. The day and a half program will be held at The Monteleone Hotel, 214 Royal Street, New Orleans, LA, telephone (504) 523-3341 or 1-800-535-9595. The day and a half program will address various aspects of the use of animals in research and the role of animals and alternatives in research and education. The workshop will address such issues as: Adequacy of Computer Searches: OPRR, USDA, AAALAC, FDA Perspectives on Alternatives: Occupational Health Program: Implementation, Update and Biosafety Concerns: Role of Animals and Alternatives in Education: NIH Plan for Use of Animals in Research: Fostering the three Rs and other relevant topics. The Workshop is open to all persons involved in the management and/or oversight of an institutional animal care and use program including institutional administrators, members of Institution Animal Care and Use Committees, laboratory animal veterinarians, investigators, and technicians. The registration fee is $150.00. INQUIRIES For information concerning registration, contact: Mrs. Lois Herbez Division of Animal Care, LSU Medical School 1542 Tulane Avenue New Orleans, LA 70112-2822 Telephone: (504) 568-4198 FAX: (504) 568-4843 For further information concerning future NIH/OPRR Animal Welfare Education Workshops, contact: Mrs. Roberta Sonneborn Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B63 Bethesda, MD 20892 Telephone: (301) 496-7163 FAX: (301) 402-2803 $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NIH-DC-94-25 ********************************************* SPEECH PROCESSORS FOR AUDITORY PROTHESES NIH GUIDE, Volume 23, Number 34, September 23, 1994 RFP AVAILABLE: NIH-DC-94-25 P.T. 34; K.W. 0740030, 0740060 National Institutes of Health The National Institute on Deafness and Other Communication Disorders, National Institutes of Health, has a requirement to design, develop, and evaluate laboratory-based speech processor emulators and wearable speech processors for auditory prostheses. In addition, a need exists for new auditory testing material to evaluate the advantages and disadvantages of changes in speech processor designs. A three-year term form, cost-reimbursement contract is anticipated. The solicitation is scheduled to be issued on or about September 30, 1994. Proposals will be due 60 days after the date of issuance of the solicitation. All responsible sources may submit a proposal that will be considered by the Government. INQUIRIES Copies of the solicitation may be obtained by sending a written request to: Barbara Oxenham Division of Grants and Contracts National Institutes of Health 6100 Executive Boulevard, Room 6E01 MSC 7540 Bethesda, MD 20892-7540 Telephone: (301) 496-4487 $$R1 END ************************************************************ $$R2 BEGIN NIH-DC-95-02 ********************************************* THE FEASIBILITY OF A COCHLEAR NUCLEUS AUDITORY PROTHESIS BASED ON MICROSTIMULATION NIH GUIDE, Volume 23, Number 34, September 23, 1994 RFP AVAILABLE: NIH-DC-95-02 P.T. 34; K.W. K.W. 0740030, 0745047 National Institutes of Health The National Institute on Deafness and Other Communication Disorders, National Institutes of Health, has a requirement to study the feasibility of an auditory prothesis based on microstimulating electrodes placed into the ventral cochlear nucleus. Although this research will be limited to animal studies, the ultimate goal is an auditory prosthesis for deaf individuals who cannot benefit from a cochlear prothesis. A three-year term form, cost reimbursement contract is anticipated. The solicitation is scheduled to be issued on or about September 28, 1994. Proposals will be due 60 days after the date of issuance of the solicitation. All responsible sources may submit a proposal that will be considered by the Government. INQUIRIES Copies of the solicitation may be obtained by sending a written request to: Barbara Oxenham Division of Grants and Contracts National Institutes of Health 6100 Executive Boulevard, Room 6E01 MSC 7540 Bethesda, MD 20892-7540 Telephone: (301) 496-4487 $$R2 END ************************************************************ $$R3 BEGIN DE-94-009 FULL-TEXT ************************************** RESEARCH ON THE BIOLOGY OF THE PULP NIH GUIDE, Volume 23, Number 34, September 23, 1994 RFA AVAILABLE: DE-94-009 P.T. 34; K.W. 0715148, 1002008, 0710085 National Institute of Dental Research Letter of Intent Receipt Date: December 15, 1994 Application Receipt Date: January 18, 1995 PURPOSE The National Institute of Dental Research (NIDR) encourages studies leading to a better understanding of the reactions of the pulp-dentin complex in health and disease and how these tissues are involved in responding to various challenges. A thorough understanding of pulp biology, its normal function and physiology, and its pathology and its interaction with the immune system is decisive for the success of operative dentistry and endodontics. The intent of this Request for Application (RFA) is to stimulate research in both basic and applied disciplines of dentistry by multi-methodological approaches. This aim can be achieved through interactions by researchers in such fields as cell biology, neurophysiology, operative dentistry, and endodontics, in academia, government and industry. 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, Research on the Biology of the Pulp, is related to the priority area of oral health. 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). INQUIRIES The RFA, which describes the research objectives, applications 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 (Internet) and by mail and email from the program contact listed below. Joyce A. Reese, D.D.S, M.P.H. Extramural Program National Institute of Dental Research Westwood Building, Room 509 Bethesda, MD 20892 Telephone: (301) 594-7648 $$R3 END ************************************************************ $$R4 BEGIN AI-94-027 FULL-TEXT ************************************** ENHANCEMENT AWARDS FOR UNDERREPRESENTED MINORITY RESEARCHERS IN HIV/AIDS NIH GUIDE, Volume 23, Number 34, September 23, 1994 RFA AVAILABLE: AI-94-027 P.T. 34, FF; K.W. 0715008, 0710030 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: December 23, 1994 Application Receipt Date: February 21, 1995 PURPOSE The goal of this support is to enable underrepresented minority investigators to establish clinical or basic AIDS research programs. To move towards this goal, the National Institute of Allergy and Infectious Disease (NIAID) encourages applications from underrepresented minority investigators for both basic and clinical investigations in AIDS and AIDS-related research. Several features have been employed to achieve these goals. These include the fostering of specific collaborations between more established investigators and the Principal Investigator (PI) to enhance refinement and implementation of each proposed project to maximize the chances for success. Support will also be provided for laboratory staff of the qualified PI, including postdoctoral scientists who will augment the research program established by the grantee. Applications in all basic and clinical areas of HIV/AIDS research are encouraged. The NIAID anticipates awarding four to six R01 awards, for a total (direct and indirect) cost of approximately $1.2 million for the initial year of funding. 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), Enhancement Awards for Underrepresented Minority Researchers in HIV/AIDS, is related to the priority area of HIV infection. 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). 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 (Internet) and by mail and email from the program contact listed below. Dr. Janet M. Young Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C36 Bethesda, MD 20892 Telephone: (301) 402-0755 FAX: (301) 480-5703 INTERNET: enhance@nih.gov $$R4 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PAR-94-096 FULL-TEXT ************************************* RESEARCH INFRASTRUCTURE SUPPORT PROGRAM NIH GUIDE, Volume 23, Number 32, August 26, 1994 PA AVAILABLE: PAR-94-096 P.T. 34; K.W. 0715095, 0730057 National Institute of Mental Health PURPOSE The National Institute of Mental Health (NIMH) is seeking to expand the number of institutions capable of supporting state-of-the-art mental health clinical and services research and thus increase the number of investigators in the Nation with the skills needed to conduct research in these areas. The Research Infrastructure Support Program (RISP) is in response to recommendations made by the National Advisory Mental Health Council and by the NIMH Extramural Science Advisory Board. This program announcement supersedes and replaces NIMH announcement PA-93-003, Research Infrastructure Program (RISP), dated September 1992. 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 Infrastructure Support Program (RISP), is supportive of 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 "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). INQUIRIES The program announcement, which describes the research objectives, applications procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (date line 301/402-2221) and the NIH GOPHER (Internet) and by mail and email from the program contact listed below. Thomas L. Lalley, M.A. Division of Epidemiology and Services Research National Institute of Mental Health Room 10C-06 Parklawn Building 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3364 Internet: TLALLEY@AOAMH2.SSW.DHHS.GOV $$P1 END ************************************************************ ERRATA $$E1 BEGIN P4 19940107 APPEND PA-94-025 BOTH *************************** POSTDOCTORAL TRAINING IN ALTERNATIVE MEDICINE NIH GUIDE, Volume 23, Number 34, September 23, 1994 PA NUMBER: PA-94-025 P.T. 44; K.W. 0720005, 0710030 Office of Alternative Medicine National Institutes of Health The following changes are made to PA-94-025, which was published in the NIH Guide for Grants and Contracts, Vol. 23, No 1, January 7, 1994: Under the section PURPOSE the first sentence should read: "The Office of Alternative Medicine (OAM) solicits applications for individual postdoctoral training awards using the National Research Service Award (NRSA) mechanism". Under the section MECHANISM OF SUPPORT, delete the last sentence, third paragraph. INQUIRIES Direct inquiries regarding programmatic issues to: Dr. John Spencer Office of Alternative Medicine National Institutes of Health 6120 Executive Boulevard, Suite 450 Rockville, MD 20892-9904 Telephone: (301) 402-4333 FAX: (301) 402-4741 $$E1 END ************************************************************ $$E2 BEGIN R10 19940916 APPEND RFA AI-94-029 BOTH ********************** PEDIATRIC AIDS: FACTORS IN TRANSMISSION AND PATHOGENESIS NIH GUIDE, Volume 23, Number 34, September 23, 1994 RFA: AI-94-029 P.T. 34, AA; K.W. 0715008, 0765033 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: November 15, 1994 Application Receipt Date: February 16, 1995 The following correction is issued for RFA AI-94-029, which was published in the NIH Guide for Grants and Contracts, Vol. 23, No. 33, September 16, 1994: REVIEW CONSIDERATIONS Whenever appropriate, the adherence to NIH guidelines concerning adequate representation of women and minorities in human subjects research will be evaluated and considered in the determination of the priority score. While the following review factors do not usually influence the priority score, they are nonetheless carefully considered by the initial review group: the appropriateness of the requested budget to the work proposed and the adequacy of protection of human subjects and/or animals in research. Any documented concerns expressed by the initial review group about any of these factors on a given application may influence the recommendation of the Advisory Council concerning funding of that application. INQUIRIES Direct inquiries regarding programmatic issues to: Bonnie J. Mathieson, Ph.D. or Patricia E. Fast, M.D., Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2B06 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8200 FAX: (301) 402-1506 or (301) 480-5703 $$E2 END ************************************************************ From owner-sci-resources@net.bio.net Fri Sep 23 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-94-096 - V23(34) 09/23/94 Date: 23 Sep 1994 19:28:13 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 320 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3602rt$ktd@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAR94096 PAR-94-096 P1O1 ************************************* RESEARCH INFRASTRUCTURE SUPPORT PROGRAM NIH GUIDE, Volume 23, Number 34, September 23, 1994 PA NUMBER: PAR-94-096 P.T. 34; K.W. 0715095, 0730057 National Institute of Mental Health PURPOSE The National Institute of Mental Health (NIMH) is seeking to expand the number of institutions capable of supporting state-of-the-art mental health clinical and services research and thus increase the number of investigators in the Nation with the skills needed to conduct research in these areas. The Research Infrastructure Support Program (RISP) is in response to recommendations made by the National Advisory Mental Health Council and by the NIMH Extramural Science Advisory Board. This program announcement supersedes and replaces NIMH announcement PA-93-03, Research Infrastructure Program (RISP), dated September 1992. 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 Infrastructure Support Program (RISP), is supportive of 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 "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 for RISP grants may be submitted by public and private, non-profit and for-profit domestic organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Eligible public agencies include State and local mental health agencies, health agencies, social services and welfare agencies, departments of education, and units of justice and corrections systems. Associations of these agencies are also eligible to submit applications. Women and minorities are encouraged to apply. MECHANISM OF SUPPORT Grants awarded in the RISP program will use the resource-related research projects (R24) mechanism of the National Institutes of Health. This mechanism is used to support projects that enhance capabilities to contribute to extramural research of the PHS. Grants funded under this program announcement are awarded directly to the applicant institution. The award is made to a particular institution and is not transferable. Grants must be administered in accordance with the PHS Grants Policy Statement (rev. 4/94). The funding cap for RISP grants is $300,000 per year plus negotiated indirect costs. Support is limited to a period of five years and is not renewable. Annual awards will be made subject to continued availability of funds and progress achieved. RESEARCH OBJECTIVES Background. RISP is designed to enable institutions with relatively small, but viable, research programs in mental health to develop into significantly stronger mental health clinical and/or services 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, and RISP. Together, these programs provide a continuum of research infrastructure support for institutions at varying levels of mental health research. RISP provides support for research infrastructure development in both academic and non-academic settings in which mental health research is conducted. Many agencies and organizations that provide mental health services have access to clinical populations and maintain important data bases, but lack the resources needed to conduct strong programs of scientific research. RISP grants may be used by non-academic agencies to develop these resources through such means as collaborative arrangements with universities and other scientific research institutions. Similarly, RISP may be used by academic institutions to strengthen their capacities to conduct mental health clinical and/or services research. A central philosophical principle underlying the RISP program is that different types of institutions will require different types of research infrastructure development activities and initiatives depending upon particular needs and circumstances. Accordingly, this program announcement provides general rather than specific guidance as to the types of development activities appropriate under RISP. The following types of support may be requested under this program: o Partial salary support for persons engaged in the project, particularly for women and members of minority groups 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 Developmental, pilot, and feasibility studies o Research subject costs o Data acquisition costs The application must present a plan for the proposed RISP. It should (1) assess the current institutional capacity to conduct mental health clinical and/or services research; (2) identify unmet needs; and (3) describe the activities that will be taken to develop and strengthen the institutional research infrastructure. The plan should cover a period of five years and by the end of this period should provide the applicant institution with significantly improved capacity to conduct mental health clinical or services research. The application must contain the following: o Specific aims o Summary of relevant ongoing mental health research o Assessment of institutional capacity to conduct state-of-the-art clinical and/or services research in mental health; identification of gaps that the RISP is intended to fill o Design and procedures to be used to accomplish the specific aims of the research infrastructure development plan over a period of five years, including plans for administrative structure, recruitment and retention of persons skilled in mental health clinical and/or services research, staff training and mentoring, statistical and other consultation and data management, and collaboration with other institutions o Brief descriptions (not to exceed one page each) of individual research studies that will be undertaken as part of infrastructure development, including plans for data collection and analysis o Description of procedures that will be used to evaluate and monitor other studies that may be supported in future years 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 mental health clinical and/or services research infrastructure development o Plans for recruitment of women and minorities for participation in research protocols o Plans for protection of human and vertebrate animal subjects of proposed research projects o The research plan section of the application is limited to 25 pages. The NIMH encourages RISP collaborations between academic research centers and public agencies that provide and finance care for persons with mental disorders. 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 the GCRC program director or principal investigator should 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 are 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 were published as a separate Part VIII in the Federal Register of March 28, 1994 (FR 14508-14513), and 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 Applicants are to use the research grant application form PHS 398 (rev. 9/91). The number and title of this program announcement must be typed in Item 2a on the face page of the PHS 398 application form and the YES box must also be marked. Applicants should specify in Item 2b that the R24 mechanism is being used. Application kits containing the necessary forms may be obtained from the office of sponsored research at most universities, colleges, medical schools, and other major research facilities 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. Applicants must submit, in one package, a signed original of the application, including the Checklist, and five signed copies to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be reviewed for scientific and technical merit by an initial review group (IRG) composed primarily of non-Federal scientific experts. Final review is by the National Advisory Mental Health Council; review by Council may be based on policy considerations as well as scientific merit. By law, only applications recommended for consideration for funding by the Council may be supported. Summaries of IRG recommendations are sent to applicants as soon as possible following IRG review. Criteria to be considered in evaluating applications for scientific/technical merit are: o Significance and public health relevance of the proposed research infrastructure development plan o Scientific and technical merit of the development plan o Potential of the principal investigator and other senior staff to contribute to implementation of the proposed development plan o Potential of the plan to effect significant and lasting improvements in the institution's capacity to conduct mental health clinical and/or services research o Nature, amount, and duration of non-Federal commitment to the development plan o Recruitment and retention plans for inclusion of women and minority subjects in research protocols o Appropriateness of the proposed budget o Adequacy of the procedures for protecting human and animal subjects Applications received after a given receipt date will be returned to the applicant without review. AWARD CRITERIA Applications recommended for approval by the National Advisory Mental Health Council will be considered for funding on the basis of overall scientific and technical merit of the research infrastructure development plan as determined by peer review, program needs and balance, and availability of funds. Preference will be given to institutions with NIMH research support not exceeding $3,000,000 (in total costs) in any of the three completed Federal fiscal years immediately preceding the date of application submission. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Applicants are encouraged to discuss their planned applications with NIMH staff before submitting a formal grant application. Direct inquiries regarding programmatic issues to: Thomas L. Lalley, M.A. Division of Epidemiology and Services Research National Institute of Mental Health Room 10C-06 Parklawn Building 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3364 Internet: TLALLEY@AOAMH2.SSW.DHHS.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 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance 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). Federal Regulations at 42 CFR Part 52 and 66, "Grants for Research Projects" and 45 CFR Parts 74 and 92 concerning administration of grants, are applicable to these awards. This program is not subject to the intergovernmental review requirements of Executive Order 12372, as implemented through DHHS regulations at 45 CFR Part 100, or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. 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 Sep 23 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-94-027 - V23(34) 09/23/94 Date: 23 Sep 1994 19:28:17 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 582 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3602s1$ktm@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AI94027 AI-94-027 P1O1 *************************************** ENHANCEMENT AWARDS FOR UNDERREPRESENTED MINORITY RESEARCHERS IN HIV/AIDS NIH GUIDE, Volume 23, Number 34, September 23, 1994 RFA: AI-94-027 P.T. 34, FF; K.W. 0715008, 0710030 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: December 23, 1994 Application Receipt Date: February 21, 1995 PURPOSE The goal of this support is to enable underrepresented minority investigators to establish clinical or basic AIDS research programs. To move towards this goal, the National Institute of Allergy and Infectious Disease (NIAID) encourages applications from underrepresented minority investigators for both basic and clinical investigations in AIDS and AIDS-related research. Several features have been employed to achieve these goals. These include the fostering of specific collaborations between more established investigators and the Principal Investigator (PI) to enhance refinement and implementation of each proposed project to maximize the chances for success. Support will also be provided for laboratory staff of the qualified PI, including postdoctoral scientists who will augment the research program established by the grantee. Applications in all basic and clinical areas of HIV/AIDS research are 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 Request for Applications (RFA), Enhancement Awards for Underrepresented Minority Researchers in HIV/AIDS, is related to the priority area of HIV infection. 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 investigators from underrepresented minority groups from domestic, for-profit, not-for-profit and non-profit organizations, private and public institutions such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Foreign institutions are ineligible for awards under this program. For this RFA, "underrepresented minorities" are defined as primarily African Americans, Hispanics, Native Americans, and Pacific Islanders. Institutions must have sufficient research infrastructure and a core of investigators already conducting basic, behavioral, clinical, or epidemiological biomedical research to ensure a nutritive environment for this award. Reviewers will give priority to investigators at those institutions having a graduate program in the medical sciences and a minimum of 10 NIH research grants (P01, R01, R03, R15, R29, R55, U01, U18) and/or a direct plus indirect cost funding level for these awards totalling $3 million. Successful applicants will have earned the Ph.D., D.V.M., D.D.S., M.D., or Pharmacy degree and must demonstrate training and expertise in research commensurate with the requirements of this award. In general, applicants should have successfully completed at least two years of postdoctoral training (or equivalent training for clinicians) in relevant biomedical research at the time of submission of the application. Participants in NIH minority programs, such as the NIH Research Supplements for Minority Investigators Program and Research Centers in Minority Institutions (RCMI) Program with the above qualifications are encouraged to apply, as well as those individuals who have been funded by minority supplements from NIAID (Initiatives for Underrepresented Minorities in Biomedical Research Supplement (IUMBRS)). More senior investigators with relevant experience in fields other than AIDS research (which may include R01-type funding) are also eligible to compete for this award as a vehicle for entry into AIDS research. However, investigators who have previously received funding in AIDS research at the unsolicited R01 or equivalent level are not eligible for this award and should refer to other programs supported by NIAID. NIAID staff listed under INQUIRIES should be consulted for details concerning eligibility requirements. Applications from minority women are especially encouraged. MECHANISM OF SUPPORT The support mechanism for this program is the individual research project grant (R01), under which it is the responsibility of the applicants to plan, direct and execute the proposed projects. This award is not a supplement to ongoing, funded studies. All potential applicants are strongly encouraged to consult with NIAID staff listed under INQUIRIES prior to preparation of the application regarding eligibility requirements and scientific scope. Because the nature and scope of the research proposed as well as the facilities available to the applicant in response to this RFA may vary, it is anticipated that the size of the awards will also vary. This RFA is a one-time solicitation. Following termination of this award, any future unsolicited applications from the awardee will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE The NIAID anticipates awarding four to six R01 awards, for a total (direct and indirect) cost of approximately $1.2 million for the initial year of funding. However, the total number and amount of funding is dependent on the receipt of a sufficient number of applications of high scientific merit and on the availability of funds. RESEARCH OBJECTIVES Background The disproportionate impact of the AIDS epidemic upon minority populations within the United States and Puerto Rico may be viewed from two different perspectives. First, the frequency of occurrence of the disease is increasing at a disproportionately high rate in minorities. Second, certain minorities are significantly underrepresented as investigators in clinical and basic AIDS and AIDS related research. Increasing the participation of underrepresented minority investigators in virtually all fields of biomedical research is a continuing NIH priority. The National Institutes of Health (NIH) currently supports a wide variety of minority programs for biomedical research, encompassing high school through postdoctoral training. These include the Minority Access to Research Careers (MARC) Program, Minority Biomedical Research Support (MBRS) Program, Research Centers in Minority Institutions (RCMI), the NIH Research Supplements for Minority Investigators Program (also called Initiatives for Underrepresented Minorities in Biomedical Research Supplement, (IUMBRS)), the AIDS Planning Grant to the Association of Minority Health Professions Schools (AMHPS), and the Minority Health Initiative (MHI). Although each of these minority programs has demonstrated success in specific areas, recent studies indicate that only a few minority investigators become well established in mainstream research, primarily because of an absence of essential components necessary for a competitive scientific career (see Science, "Minorities in Science", 258:1175-1237, 1992). Key components of a successful career in competitive AIDS research include: 1. Interaction with a critical mass of scientists at all levels, who are involved in biomedical research at the PIs institution and are available for advice and collaboration; 2. Establishment of collaborations with investigators at other institutions who are at the forefront of biomedical research; 3. Securing sufficient release from a heavy teaching load, which could otherwise significantly diminish the time available for research and training of junior colleagues; 4. Accessing a constantly increasing repertoire of current state-of-the-art technology, needed for the proposed investigations. This kind of growth is a career-long process that is enhanced and maintained by the close collaborations listed above. Goals and Objectives The goal of this program is to increase the number of underrepresented minority investigators performing independent competitive HIV/AIDS research and enhance their long-term research potential. Applicants may propose research in any clinical or basic AIDS and AIDS-related research areas including: o Pathogenesis: especially, clinically based, multidisciplinary research of HIV pathogenesis, HIV molecular biology, the study of correlations of host factors with disease course, the influence of cofactors such as cytokines or other infectious agents on disease course. o Epidemiology and natural history: clinical factors associated with disease, natural history of HIV infection and clinical predictors of disease course, behavioral change studies, design of more effective risk-reduction interventions. o Vaccine research and development: studies of the natural immune responses to HIV-related infection, mucosal immunity, genetic variation, mechanisms by which opportunistic pathogens avoid immune surveillance, novel ways of stimulating protective immune responses, development of methods for enrollment and retention of minorities and women in vaccine trials. o Therapeutics research and development: primary infection and opportunistic infections are targets for NIAID-funded research and include discovery and development of better therapeutic strategies and antiretroviral drugs, the emergence and mechanisms of viral resistance to drugs, immune-based strategies, other novel approaches to therapy including gene therapy and development of methods for enrollment and retention of minorities and women in therapeutic trials. o Pediatrics disease: mechanisms of perinatal transmission, prevention of perinatal transmission, and pediatric pathogenesis and therapeutics also encompassing opportunistic infections common to HIV-infected children. Specific research questions of the highest priority can be found in the current NIAID HIV/AIDS Research Agenda. Contact program staff listed under INQUIRIES for additional information. SPECIAL REQUIREMENTS The special requirements are: o The PI be a member of an underrepresented racial minority group. o The PI must establish a collaborative network with at least three established investigators with expertise relevant to the research proposed by the PI. At least two of the established investigators should have expertise in AIDS or AIDS-related research. See below and under Special Instructions for additional details. DAIDS staff may be consulted for assistance in identifying potential collaborators. However, responsibility for identifying and obtaining commitments from collaborators rests solely upon the applicant. The collaborators will have the following responsibilities to the grantee: 1. Assist in the development of the application responding to this RFA; 2. Provide assistance in scientific, technical and managerial areas required for fulfilling the goals of this award throughout its tenure. The PIs institution will have the following responsibilities: 1. To authorize release time. Each applicant is expected to commit at least 75 percent of his/her time and effort. Applicants should include a letter from the responsible institutional official guaranteeing release from all but 25 percent of administrative and teaching responsibilities should the grant be awarded. Failure to implement the agreed amount of release time may result in termination of the award. 2. To provide adequate facilities for the proposed studies. This may be confirmed during a pre-award site visit by DAIDS staff. An annual meeting be held. It is suggested that applicants include a request in the budget for funds to cover attendance of the PI and one collaborator (preferably, the more senior established investigator) at an annual meeting to be held at the NIH or at a site designated by NIAID. This will provide an opportunity to discuss significant research findings, problems, collaborations and overall progress and evolution of the program. 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 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 December 23, 1994, a letter of intent that includes a descriptive title of the proposed research, the names and affiliation(s) of the principal investigator and other key personnel, including members of the collaborative network and the number and title of this RFA. While the letter of intent is not required, is not binding, and does not enter into subsequent peer review deliberation, it provides NIAID staff with information on the number and scope of applications to be expected, allows estimation of the potential review workload, and avoids conflict of interest in the review. The letter of intent is to be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev.9/91), the standard application form for research grants. Application kits are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants (DRG), National Institutes of Health, Westwood Building, Room 449, Bethesda, Maryland 20892, telephone (301) 594-7248. Applications must adhere to the format and requirements specified in the PHS application kit. The official deadline for receipt of applications in response to this RFA is February 21, 1995. Applications that do not address the objectives of this RFA will be considered nonresponsive and applicants will be contacted, as described under REVIEW CONSIDERATIONS. Therefore, applicants are strongly encouraged to discuss their research plans with DAIDS program staff before preparing their applications. The RFA label available in the PHS 398 application kit must be affixed to the bottom of the face page of the application. To assure the identification of your application with this RFA, the "YES" box must be marked in item 2a of the face page of the application and the RFA number (RFA AI-94-027) and title "Enhancement Awards for Underrepresented Minority Researchers in HIV/AIDS" entered in the provided spaces in item 2. Submit, in one package, a signed typewritten original of the application including the Checklist and appendices, and three signed, exact single-sided photocopies of the application, to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission to the Division of Research Grants, also submit two additional exact copies of the application including five sets of appendices and letters of support and curricula vitae directly to Dr. Dianne Tingley at the address listed under INQUIRIES. Applications received after the receipt date will not be eligible for this award. DRG will not accept an application in response to this RFA that is essentially the same as one pending initial review, unless the applicant withdraws the pending application. DRG will not accept an application that is essentially the same as one already reviewed. This does not preclude the submission of a revision of an application already reviewed. Any revised application, however, must include an introduction addressing the previous critique. Special Instructions The following information is provided in addition to the instructions found in the PHS 398 form. Collaborative Network It is required that the PI establish an external committee consisting of at least three established scientists who will form a collaborative network, each scientist with expertise relevant to the proposed study. It is strongly recommended that one of the scientists be a more senior individual who has been involved in AIDS research for five to ten years, is a recognized leader in the field, has authored or co-authored peer-reviewed papers in AIDS or AIDS-related research, and is the leader of a substantial scientific program. The other two investigators (at least one of whom should be involved in AIDS or AIDS-related research) should be established scientists who are still very active in the laboratory, field, or community, who have published at least three substantial, peer-reviewed papers in their area of expertise, and are experienced in the area of technical or theoretical aspects of the proposed studies. It is important that the applicant include letters from the collaborators indicating their intent and availability to serve in this capacity. Collaborators should provide their curriculum vitae to be submitted with the application in response to the RFA to indicate the relevance of their area of expertise. Letters must be submitted with the original application and the entire package submitted by the submission deadline. DAIDS staff may be consulted for assistance in identifying potential committee members. However, responsibility for identifying and obtaining commitments from collaborators rests solely upon the applicant. The collaborators will have the following responsibilities to the grantee: 1. Assist in the development of the application responding to this RFA; 2. Provide advice and assistance, as needed, in experimental design, technical aspects of work and all areas of scientific and/or administrative concern required for fulfilling the goals of this award; 3. Visit the institution of the PI, as needed. It is anticipated that several trips by collaborators to the institution of the PI may be necessary, especially in the first year of the award. Collaborators will be reimbursed for limited travel to the laboratory of the PI and can be paid as consultants or through consortium/ contractual arrangements. One of the members of the collaborative network per award will be reimbursed for travel to the annual meeting of the program and this trip should be specifically included in the budget request. Travel and per diem fund requests for collaborators may not exceed $4000 per year. 4. Permit usage of equipment and facilities by the PI at the collaborator's institution, as appropriate. The cost of reagents and materials including animals used by the PI to perform critical experiments (as part of this proposal) that must be performed in the laboratory of a collaborator may also be requested. PIs can apply for travel to/from the collaborators' laboratories. Per diem expenses for performance of critical experiments at collaborating institutions by PIs may also be requested, when appropriate. Other responsibilities of the PI and the PI's institution: 1. Requests for support of one graduate student to begin year two through four is permitted as appropriate. 2. Requests for support of postdoctoral fellows are permitted as appropriate. If requested in later years, they will be supported with program and collaborators' approval. 3. The effort of the PI on this grant must be at least 75 percent. 4. A letter of commitment from the PI's institution confirming the release of 75 percent of the PI's time must be submitted with the application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIAID. Incomplete applications will be returned to the applicant without further consideration. If NIAID staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID in accordance with 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 be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. Review Criteria The submitted applications will be assessed by the following review criteria. o The significance and novelty of the proposed studies and their relevance to the AIDS epidemic should be clearly demonstrated. o The relative potential of the applicant to take maximum advantage of the unique features of this award and to achieve the goals described above is a critical factor in evaluation of the proposed research program. The applicant must have completed at least two years of postdoctoral research, must be able to interact effectively with administrators, colleagues, collaborators, subordinates and NIH staff, and must be capable of establishing and directing an independent research laboratory (see ELIGIBILITY REQUIREMENTS). o The scientific and technical merit of the proposed research, including choice of appropriately sensitive and reproducible assay systems, and/or culturally appropriate approaches to clinical studies, will be carefully evaluated. o The suitability and feasibility of the proposed experimental strategies for achieving the goals as outlined in the application. o The availability at the institution of appropriate equipment and space needed to perform the studies. o The presence of a critical mass of scientists at the institution funded by a minimum of 10 NIH research grants (P01, R01, R03, R15, R29, R55, U01, U18) and/or a direct plus indirect cost funding level for these awards totalling $3 M. o It should be documented that a minimum of three collaborators to form an external committee or collaborative network have been identified and are truly committed to facilitating the success of this award. The appropriateness and usefulness of the collaborators' scientific and technical expertise should be demonstrated. o The budget and time frame should be appropriate for all research proposed; AWARD CRITERIA The final number and specific amounts of awards to be made will depend upon the consideration of the following and upon the availability of funds: o Results of the initial scientific and technical merit review and pre-award site visit (if applicable); o Potential contribution of the proposed research to the goals and objectives of the RFA; o Program balance; o Diversity of applicants and scientific approaches; o In making awards, preference may be given to proposed projects that will impact upon the disease in minority populations disproportionately affected by the epidemic in the United States. INQUIRIES 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: Dr. Janet M. Young Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C36 6003 Executive Boulevard Bethesda, MD 20892-7620 Telephone: (301) 402-0755 FAX: (301) 480-5703 INTERNET: enhance@nih.gov Direct letters of intent and inquiries regarding the scientific review process to: Dr. Dianne Tingley Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C07 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-0818 FAX: (301) 402-2638 INTERNET: dianne_tingley@nih.gov Direct inquiries regarding fiscal matters to: Ms. Carol Alderson Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B27 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-7075; FAX: (301) 480-3780 INTERNET: carol_alderson@nih.gov Schedule Technical Meeting for Applicants: September 28, 1994 Letter of Intent Receipt Date: December 23, 1994 Application Receipt Date: February 21, 1995 Scientific Review Date: June 1995 Advisory Council Date: September 1995 Anticipated Award Date: September 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, 93.856 -Microbiology and Infectious Diseases Research and 93.855 - Immunology, Allergic and Immunological Diseases Research. Grants are awarded under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under the PHS grant policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of the Executive Order 12372 or Health Systems Agency Review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. 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 Sep 23 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DE-94-009 - V23(34) 09/23/94 Date: 23 Sep 1994 19:28:21 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 466 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3602s5$ktv@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DE94009 DE-94-009 P1O1 *************************************** RESEARCH ON THE BIOLOGY OF THE PULP NIH GUIDE, Volume 23, Number 34, September 23, 1994 RFA: DE-94-009 P.T. 34; K.W. 0715148, 1002008, 0710085 National Institute of Dental Research Letter of Intent Receipt Date: December 15, 1994 Application Receipt Date: January 18, 1995 PURPOSE The National Institute of Dental Research (NIDR) encourages studies leading to a better understanding of the reactions of the pulp-dentin complex in health and disease and how these tissues are involved in responding to various challenges. A thorough understanding of pulp biology, its normal function and physiology, and its pathology and its interaction with the immune system is decisive for the success of operative dentistry and endodontics. The intent of this Request For Application (RFA) is to stimulate research in both basic and applied disciplines of dentistry by multi-methodological approaches. This aim can be achieved through interactions by researchers in such fields as cell biology, neurophysiology, operative dentistry, and endodontics, in academia, government, and industry. 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, Research on the Biology of the Pulp, is related to the priority area of oral health. 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 domestic and foreign, for-profit and non-profit, public and private organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions and organizations are not eligible for the First Independent Research Support and Transition (FIRST) awards (R29). Domestic applications may include international components. Applications from minority individuals and women are encouraged. Applicants must meet special eligibility requirements specified in the pertinent guidelines for the various mechanisms available for support of this program. MECHANISMS OF SUPPORT This RFA will use the National Institutes of Health individual research project grant (R01) and the FIRST (R29) award. The earliest possible date for funding is December 1, 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 vary also. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all other investigator-initiated research grant applications and may be peer reviewed according to the customary peer review procedures. Responsibility for the planning, direction and execution of the proposed research will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed five years. FUNDS AVAILABLE Approximately $800,000 to $1,000,000 in direct costs per year for up to five years will be committed to fund applications that are submitted in response to this RFA. It is anticipated that six to seven awards will be made. The level of funding is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIDR, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Over twenty seven million root canal treatments costing more than $3 billion were performed in the United States during the last decade. This number will increase in the future due to population growth and greater numbers of teeth being preserved in older patients. In addition to conditions requiring removal of the pulp, many people experience dentin hypersensitivity in reaction to normally non-painful heat or mechanical stimulation. This has been attributed to a variety of causes, including pulp-dentin pathology, fluid movements through tubules, and excessive nerve excitability. An unusual combination of features makes the dental pulp a unique model for research. The pulp is extensively supplied with nerve fibers, a rich blood supply, and is surrounded by dentin making it an important model for the study of pain, inflammation, and the movement of fluids, bacteria, or their products through the dentinal tubules. The tooth is a hollow, porous hard tissue embedded in bone, projecting through an epithelial membrane into a septic environment. However, in spite of research advances during the last decade, there is limited understanding of the reactions of the pulp-dentin complex during pathologic states such as acute or chronic inflammation, dentin hypersensitivity and nerve excitation. This leads to an inability to diagnose correctly the pathologic state of the pulp according to clinical symptoms. More information is needed on pulpal reactions to restorative procedures and consequent regeneration and repair reactions. Although significant advances in the field have been made, further research is needed. For example, immunohistochemical analyses have led to a better understanding of the mechanisms of antigen presentation and processing, but little is known about pulpal reaction to infection and immunologic responses or pulpal injury, in general, in both normal and immunocompromised patients. Future studies should focus on possible interactions between immune cells in the pulp and the pulpal neurovascular system. Using molecular biology techniques, significant progress has been made in understanding the mechanisms which regulate the terminal differentiation of odontoblasts. However, the mechanism of action of non-collagenous proteins of odontoblast origin in dentogenesis, and in mineralization, in particular, is not well understood. More research is needed in this area to determine how these proteins modulate odontoblast differentiation, migration, adhesion, extracellular matrix production and secretion during both development and repair of dentin. Biochemical analysis is providing information about the neurochemical and humoral factors involved in the control of pulpal blood flow and the factors important in tissue response to damage, but continued studies are needed. Based on recommendations from the NIDR Long-Range Research Plan for the Nineties, as well as recommendations of both the NIDR's Dental Research Programs Advisory Committee and the International Conference on Pathobiology of the Dentin/Pulp Complex, the NIDR plans to strengthen its support of both basic and clinical research in the broad area related to this announcement. Accordingly, applications are invited for individual research project grants, and FIRST Awards, related to, but not limited to, the following areas: Dentin Hypersensitivity o hydraulic conductance of dentinal tubules and the dynamics of hydrodynamic stimulation of mechanoreceptor nerves. o the effect of oral hygiene procedures and non-invasive operative procedures on dentin sensitivity. o the etiology of dentin hypersensitivity as a function of age and immune suppression. Pulpal Reactions to Restorative Materials o the effect of nerve innervation on pulp reactions and pulp healing. o the reactive sprouting of sensory nerves in the pulp as a result of operative procedures and restorative materials. o the effect of hydraulic conductance in the dentinal tubules on the odontoblast layer, the junctional complexes between odontoblasts, and the release of neuropeptides. o the stimulation of secondary odontoblast differentiation and their function in reparative dentin formation. Reactivity of Periapical Pulp Tissue o the difference between the structure and function of the apical portion of the pulp and those of the radicular pulp and the apical periodontal membrane. o the reactivity and healing capacity of periapical tissues. o nerve sprouting in periapical tissue following trauma. o the application of immunohistochemical techniques in the studies of dentin resorption. Normal and Abnormal Dentinogenesis o development of odontoblast cell lines in vitro to elucidate the genetic regulatory mechanisms involved in odontoblast differentiation, modulation and regulation of odontoblast function, secretion of the dentin matrix, and its mineralization to make normal, reparative, and peritubular dentin. o development of cell cultures from undifferentiated pulp cells to study mechanisms involved in their differentiation into functional odontoblasts. o characterization of the protein matrix formed by secondarily differentiated odontoblast and its effect on mineralization of dentin. Dentin/Pulp Complex Reactions o the role of growth factors in normal pulp-dentin development and in pathological states. o cell-cell communication in the pulp among odontoblasts, mesenchymal cells, immune-competent cells, neurons, endothelial and perivascular cells. o the ultrastructure of normal and reparative dentin in response to growth factors and their receptors, as a function of age. o nerve distribution, nerve type and expression of nerve growth factors, cell-cell communication between and among odontoblast, neurons and endothelial cells in health and disease. o assessment of the healing potentials of the pulp at different ages and under a variety of experimental conditions using multi-methodological approaches. o the dynamics of wound healing and repair in the pulp at various ages, including the synthesis and assembly of proteins and their control. Pulpal Reactions: Regulatory and Immunological Factors o immunodefenses in the pulp, including mechanisms of antigen presentation, processing and responses, and changes in these processes as a function of normal aging and in immunocompromised individuals. o development of pulpal and periapical models to identify and characterize the bacteria and bacterial products that cause inflammation. The conditions under which pulpal disease may be reversible. The long-term consequences of chronic periapical inflammation on bone and pulpal nerves(neuromas). o the use of dentinal fluid to indicate the state of pulpal metabolism and/or the presence of pulpal inflammation by measuring changes in the levels of immunoglobulins, cytokines, or lysosomal enzymes. o the expression and regulation of stress or heat shock proteins in pulpal tissues. o determination of the way in which the regulatory proteins modulate odontoblast differentiation, migration, adhesion and matrix synthesis, secretion and its mineralization. Microcirculation o the role of nitric oxide in the control of pulpal blood flow and the effects of free radicals in the pulpal response to injury. Definition of the role of neuropeptides and endogenous mediators of inflammation on neurovascular activity of the normal tooth pulp, following injury and during repair. o development of noninvasive methods to quantitatively determine pulpal blood flow, dentin fluid flow and composition, and sensory functions in animals and humans, in acute and chronic disease states. o the effects of systemic vascular diseases, such as sickle cell anemia and diabetes, on pulpal circulation. o the development of the microcirculation, innervation, and dentin ultrastructure and the effect of aging on the dental pulp. o the transport of various sized molecules through the dentin into the systemic circulation and vice versa, in innervated and denervated teeth. Sensory Physiology o definition of the role and characteristics of inflammatory mediators, neuropeptides, and the autonomic nervous system, in the normal tooth pulp, after injury and during repair. o the mechanisms of sensory transduction within the pulp in normal and pathological states. o clarify the role of A and C fibers in tooth pulp, to determine the central pathways, relay centers, and reflex responses evoked by their activation, to determine the mechanisms of sensory transduction in pulpal nerves in normal and in pathological states. o the effects of tooth pulp pathophysiology on central nervous system processing of pulpal nerve input, such as the relation between tooth pulp loss and chronic pain, referred pain, and altered central nervous system excitability following periapical inflammation. 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 also may obtain copies from 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 December 15, 1994, a letter of intent that includes a descriptive title of the overall proposed research, the name, address, and telephone number of the Principal Investigator, and the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIDR staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Joyce A. Reese at the address 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; 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 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 YES box must be checked and the RFA number and the words, "Research on the Biology of the Pulp" must be typed in Section 2a on the face page of the application. 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. 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 Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must be sent to: H. George Hausch, Ph.D. Chief, Scientific Review Office National Institute of Dental Research Westwood Building, Room 519 Bethesda, MD 20892 Telephone: (301) 594-7632 Applications must be received by January 15, 1995. If an application is received after that date, it will be returned to the applicant. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by NIDR staff. Incomplete applications will be returned to the applicant without further consideration. If NIDR staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDR in accordance with 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 be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. Secondary review will be by the National Advisory Dental Research Council. Major factors to be considered in the evaluation of applications include: o scientific, technical, or medical 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 resources necessary to perform research; o appropriateness of the proposed budget and duration in relation to the proposed research; AWARD CRITERIA The anticipated date of award is September 1, 1995. Applicants should be aware that, in addition to scientific merit, program priorities and program balance, the total cost of the project to the NIDR will be considered by NIDR staff and the Council in making funding recommendations. Furthermore, the NIDR appreciates the value of complementary funding from other public and private sources, including foundations and industrial concerns, for activities that will complement and expand those supported by the NIDR. Such circumstances will be considered in making any award. INQUIRIES 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: Joyce A. Reese, D.D.S, M.P.H. Extramural Program National Institute of Dental Research Westwood Building, Room 509 Bethesda, MD 20892 Telephone: (301) 594-7648 Direct inquiries regarding fiscal matters to: Ms. Theresa Ringler Extramural Program National Institute of Dental Research Westwood Building, Room 510 Bethesda, MD 20892 Telephone: (301) 594-7629 Inquiries regarding review issues may be directed to Dr. H. George Hausch at the address listed under APPLICATION PROCEDURES. 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 78410, 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 Public Health Service strongly encourages all grant recipients to provide a smoke-free work place and promote the non-use of all tobacco products. 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 Sep 26 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 26 September 1994 Date: 27 Sep 1994 07:13:02 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 109 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <36999e$juf@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: Bulletin Title: BUL 94-10 NSF October Bulletin Vol 22; No. 2 File size (bytes): 86180 STIS Filename: bul9410 Document Type: Program Guideline Title: NSF 94-135A Faculty Early Career Development (CAREER) Program Program Characteristics FY 1995 (BIO) File size (bytes): 8592 STIS Filename: ns94135a Title: NSF 94-135B Faculty Early Career Development (CAREER) Program Program Characteristics FY 1995 (CISE) File size (bytes): 7902 STIS Filename: ns94135b Title: NSF 94-135C Faculty Early Career Development (CAREER) Program Program Characteristics FY 1995 (EHR) File size (bytes): 8966 STIS Filename: ns94135c Title: NSF 94-135D Faculty Early Career Development (CAREER) Program Program Characteristics FY 1995 (ENG) File size (bytes): 11267 STIS Filename: ns94135d Title: NSF 94-135E Faculty Early Career Development (CAREER) Program Program Characteristics FY 1995 (GEO) File size (bytes): 8894 STIS Filename: ns94135e Title: NSF 94-135F Faculty Early Career Development (CAREER) Program Program Characteristics FY 1995 (MPS) File size (bytes): 9176 STIS Filename: ns94135f Title: NSF 94-135G Faculty Early Career Development (CAREER) Program Program Characteristics FY 1995 (SBE) File size (bytes): 10095 STIS Filename: ns94135g Title: NSF 94-132 Group Infrastructure Grants File size (bytes): 15326 STIS Filename: nsf94132 Title: NSF 94-133 -- MINORITY POSTDOCTORAL RESEARCH FELLOWSHIPS AND SUPPORTING ACTIVITIES File size (bytes): 42073 STIS Filename: nsf94133 Also available: nsf94133.doc ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Program Guideline Title: NSF 94-135A Faculty Early Career Development (CAREER) Program Program Characteristics FY 1995 (BIO) File size (bytes): 8592 STIS Filename: ns94135a ------------------------------------------------------------------------ ** 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 ns94135a, the text of your message should be as follows: get ns94135a Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve ns94135a, you would enter: ftp> get ns94135a 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 Tue Sep 27 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: No NIH Guide for 9/30/94 Date: 27 Sep 1994 20:29:02 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 4 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <36antu$7l7@net.bio.net> NNTP-Posting-Host: net.bio.net $$MAIL BEGIN *********************************************************** There will be no NIH Guide for 9/30/94. $$MAIL END**************************************************************