From owner-sci-resources@net.bio.net Wed Jan 04 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 1 January 1995 Date: 4 Jan 1995 14:32:29 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 52 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ef7lt$6o@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. ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Letter Title: Current List of REU Sites File size (bytes): 88039 STIS Filename: reulist ------------------------------------------------------------------------ ** 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 reulist, the text of your message should be as follows: get reulist Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve reulist, you would enter: ftp> get reulist 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 Jan 05 22:00:00 1995 Path: biosci!biosci!not-for-mail From: Jay Snoddy Newsgroups: bionet.sci-resources Subject: Small Business Innovation Research solicitation is available (fwd) Date: 6 Jan 1995 13:40:31 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 86 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: Reply-To: snoddy@oerhp01.er.doe.gov NNTP-Posting-Host: net.bio.net Please excuse any cross-postings. RE: SMALL BUSINESS INNOVATION RESEARCH; DEPARTMENT of ENERGY Solicitation for grant applications Topics: Human Genome Computerized Processing of Biological Data Medical Applications Advanced Environmental Monitoring Technologies and other topics DUE DATE: March 1, 1995 ----------------------------------------- The Office of Health and Environmental Research of the Office of Energy Research would like to call your attention to the 1995 solicitation for grant applications to the Department of Energy (DOE) Small Business Innovation Research (SBIR) program. From this solicitation, about 200 Phase I grant applications from small businesses (500 employees or less) for up to $75,000 over a period of about 6 months will be funded for feasibility studies. Some of these will continue into Phase II, which is the principal research and development effort, funded at up to $750,000 over a two-year period. Grant applications are sought in 44 technical topics which are described in Appendix I of the published solicitation. The awards will be made on a competitive basis among all of the topics. Please note the following topics might be of particular interest for individuals on this electronic newsgroup. Topic No 9. Advanced Environmental Monitoring Technologies ** 10. Human Genome ** 11. Computerized Processing of Biological Data 13. Medical Applications Grant applications are invited only for specific subtopics that are further elaborated in the solicitation. That solicitation contains detailed descriptions of the technical topics and what is sought in grant applications; please note that the technical topics described in the solicitation are to be interpreted literally. Following the instructions and text descriptions found in the solicitation is critical in preparing an application. In many cases, a critical impetus in winning an SBIR grant has been the suggestion by a research scientist to a suitable small business of the need for new instrumentation or technology. Very much in line with the philosophy of the SBIR program, this catalytic action on the part of active researchers has helped interested and competent small businesses develop superior grant applications. Copies of the current DOE SBIR solicitation can be obtained by writing to the following address: SBIR Program Manager, ER-16 U.S. Department of Energy Washington, D.C. 20585 You may also call (301) 903-5707 to receive a copy. In addition you may send a request to sbir-sttr@mailgw.er.doe.gov. The due date for the receipt of grant applications is March 1, 1995. Questions about the program should be addressed to Kay Etzler, the SBIR spokesperson, on (301) 903-5867. However, since the solicitation is subject to the procurement regulations of the Federal Government, no further elaborations will be provided by the SBIR office on any of the written descriptions of the 44 technical topics. ---------------------------------------------------------------------- -Jay Snoddy- Internet: snoddy@er.doe.gov -DOE Human Genome Program- Phone: 301-903-2792 FAX: 301-903-8521 ---------------------------------------------------------------------- From owner-sci-resources@net.bio.net Mon Jan 09 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 8 January 1995 Date: 9 Jan 1995 16:44:24 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 143 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3esl98$hun@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: International Document Title: INT 95-001 -European Science Foundation Debates Future Role File size (bytes): 14032 STIS Filename: int95001.txt Title: INT 95-002 - Current Status of Programs to Support American Researchers in Japan File size (bytes): 4356 STIS Filename: int95002.txt Title: INT 95-003 - NEDO's International Joint Research Grants for Japan FY 1994 File size (bytes): 8727 STIS Filename: int95003.txt Title: INT 95-004 - 1994 Survey of Research and Development in Japan File size (bytes): 6525 STIS Filename: int95004.txt Title: INT 95-005 - White Paper on Science and Technology Japan FY 1994 File size (bytes): 4947 STIS Filename: int95005.txt Document Type: Program Guideline Title: NSF 94-170 - CISE Minority Institutions Infrastructure Program File size (bytes): 22383 STIS Filename: nsf94170.txt Title: NSF 94-171 -- Combined Research-Curriculum Development Program File size (bytes): 19569 STIS Filename: nsf94171.txt Title: NSF 94-173 THE U.S. TROPICAL OCEAN GLOBAL ATMOSPHERE PROGRAM COUPLED OCEAN-ATMOSPHERE RESPONSE EXPERIMENT File size (bytes): 14176 STIS Filename: nsf94173.txt Document Type: Recruit Title: Chemist (Program Director) File size (bytes): 5408 STIS Filename: vex952.txt Title: Mathematician (Program Director) File size (bytes): 4620 STIS Filename: vex955.txt Title: Mathematician (Program Director) File size (bytes): 5708 STIS Filename: vex956.txt Title: Secretary (Office Automation) File size (bytes): 6438 STIS Filename: vgs9544.txt Title: Supervisory Computer Specialist (Section Head) File size (bytes): 7099 STIS Filename: vgs9545.txt Title: Investigative Assistant (Office Automation) File size (bytes): 5047 STIS Filename: vgs9547.txt Title: Clerical and Administrative Support Positions File size (bytes): 7290 STIS Filename: vgs9548.txt Title: Secretary (Office Automation) File size (bytes): 7553 STIS Filename: vgs9549.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Form Title: NSF 94-3 - Grant Proposal Guide Forms Kit(Revised) File size (bytes): 1469 STIS Filename: nsf943.txt Also available: nsf943.zip nsf943.tar Document Type: Phone Book Title: NSF Alpha Telephone File size (bytes): 96782 STIS Filename: phnalpha.txt Title: NSF Organizational Directory File size (bytes): 99792 STIS Filename: phnorg.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg.txt, the text of your message should be as follows: get phnorg.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg.txt, you would enter: ftp> get phnorg.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Wed Jan 11 22:00:00 1995 Path: biosci!biosci!not-for-mail From: Ray Dobert Newsgroups: bionet.announce,bionet.sci-resources Subject: NIST UPDATE - DNA Diagnostics funding Date: 11 Jan 1995 22:58:55 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 52 Sender: kristoff@net.bio.net Approved: bionews-moderator@net.bio.net Distribution: world Message-ID: Reply-To: baum@micf.nist.gov NNTP-Posting-Host: net.bio.net Xref: biosci bionet.announce:1677 bionet.sci-resources:1215 Please forward requests for additional information to baum@micf.nist.gov or atp@micf.nist.gov R. Dobert Biotech Info. Center/USDA ---------- Forwarded message ---------- From:baum@micf.nist.gov DATE: January 9, 1995 CONTENTS: New `Tools for DNA Diagnostics' Competition Opened --------------------------------------------------------------------- ADVANCED TECHNOLOGY PROGRAM New `Tools for DNA Diagnostics' Competition Opened NIST's Advanced Technology Program has announced the second focused program competition in the area of Tools for DNA Diagnostics. The technical goal of the program is to develop cost-effective methods to determine, analyze and store DNA sequences for a wide variety of diagnostic applications, such as for agricultural, environmental and health care uses. The business goal of the program is to support the development of a new and potentially very large market for DNA diagnostic systems. An estimated $15 million is available for funding under this competition. Proposals are due by 3 p.m. EST, March 29, 1995. Details of the competition were published in the Dec. 21, 1994, issue of Commerce Business Daily and are available (along with proposal kits) from the ATP office by calling (800) ATP-FUND (283-3863) or sending e-mail to atp@micf.nist.gov (via Internet). Media Contact: Michael Baum, (301) 975-2763 baum@micf.nist.gov ------------------------------------------------------------------ This is the e-mail edition of NIST UPDATE. NIST UPDATE is a bi-weekly synopsis for journalists of current activites, research results, and program announcements from the National Institute of Standards and Technology. If you would like to subscribe to this e-mail edition, send an e-mail note to: MAILSERV@nist.gov In the body of the message, put the command: SUBSCRIBE NIST_UPDATE (don't forget the underbar between T and U). That's all there is to it. Send reports of problems to: baum@micf.nist.gov NIST UPDATE also may be found on the NIST gopher service: gopher-server.nist.gov --------------------------------------------------------------------- From owner-sci-resources@net.bio.net Fri Jan 13 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-95-013 - V24(01) 01/13/95 Date: 13 Jan 1995 16:50:36 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 470 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3f774s$onj@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL95013 HL-95-013 P1O1 *************************************** HIV-ASSOCIATED PATHOGENS OF THE LUNG: LIFE CYCLE REGULATION NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA: HL-95-013 P.T. 34; K.W. 0715008, 0715165, 1002027 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: March 3, 1995 Application Receipt Date: April 28, 1995 PURPOSE The purpose of this solicitation is to encourage research on the molecular basis of cell/life cycle regulation of pathogens and opportunistic microorganisms that cause lung disease in HIV-infected hosts. The request for applications (RFA) focuses on ways in which the environment in the host lung, including signals from host lung cells may affect the microbial mechanisms that determine growth and replication of the microbial agents. Examples of microorganisms that would be appropriate for study under this program are Mycobacterium tuberculosis, Pneumocystis carinii, Histoplasma capsulatum, and Coccidioides immitis. 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, HIV-Associated Pathogens of the Lung: Life Cycle Regulation, is related to the priority area of immunization and infectious diseases. 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 institutions, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments and eligible agencies of the Federal government. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) award (R29). Applications from minority individuals women and new investigators are encouraged. All current policies and requirements that govern the research grant programs of the 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. Among the disciplines and expertise that may be appropriate for this research program are cell biology, microbiology, genetics, immunology, molecular immunology, molecular biology, infectious diseases, pathology, and pulmonary medicine. MECHANISM OF SUPPORT The support mechanism for this program will be the National Institutes of Health (NIH) individual research project grant (R01) and the FIRST award (R29). 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. Upon initiation of the program, the NHLBI will sponsor periodic meetings to encourage exchange of information among investigators who participate in this program. In the budget for the grant application, applicants should request 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. 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. Up to five years of support may be requested for R01s; five years are required for FIRST awards. Requested budgets for FIRST awards may not exceed those specified in the FIRST award guidelines. Because 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 September 1995. Administrative adjustments in project period and/or amount may be required at the time of the award. The National Institute of Allergy and Infectious Diseases (NIAID) also supports research aimed at a better understanding of the interactions between the HIV-infected host and a variety of pathogenic and opportunistic infectious agents. 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 Although financial plans for fiscal year 1995 include approximately $2,000,000 for the total cost of the program for the first year, 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. RESEARCH OBJECTIVES Background The lung is the portal of entry for a variety of microorganisms many of which produce disease associated with the HIV epidemic. Furthermore, the lung is the site of the initial host response to these invading agents and as such is involved in both specific and non-specific mechanisms of defense against infection. In HIV- infected individuals and other immunocompromised hosts the ability of invading agents to disseminate systemically appears to be enhanced due to suppressed cellular immunity. Many of the organisms that threaten immunocompromised individuals have complex life/cell cycles that along with host factors may regulate pathogenic processes in the lung. Little is known about the mechanisms by which pathogenic and opportunistic microorganisms, some of which may have been dormant for years, become harmful to the host. For some of these organisms lack of progress in understanding aspects of their life/cell cycle that influence pathogenesis can be ascribed to difficulty of in vitro culture. For example, the pathogenic Mycobacteria grow very slowly and methods to maintain sustained growth of Pneumocystis carinii in vitro are still being sought. Rapid advances are occurring in understanding the molecular regulation of the order and timing of eukaryotic cell growth and division, including signals that limit growth and cause or prevent cell division. For example, cyclins acting through cyclic-AMP dependent protein kinase appear to be an important feature of the mechanism that integrates cell growth with cell division. A more detailed knowledge of the cell cycle indicates that cell replication appears to depend not just on cell size, but also on the rate of growth and it has become apparent that it is possible for one regulatory mechanism to override another, under certain environmental conditions. Although investigators have begun to define the homeostatic mechanisms that integrate cell growth and division in molecular terms, little is yet known about the enzymatic machinery that might control the rate and timing of life/cell cycling in many pulmonary pathogens and opportunistic agents that cause disease in humans. The mechanisms whereby host cells and specific forms of these microorganisms interact in the lung and the extent to which the intracellular environment of lung cells influence the life/cell cycle of these microbes are also poorly understood. Tuberculosis (TB) has reemerged as an urgent health problem in the United States in the 1980s in conjunction with the HIV epidemic as well as with other factors such as increased homelessness and immigration of people from areas where the incidence of TB is high. An estimated 15 million people in the United States are currently infected with Mycobacterium tuberculosis (Mtb). It is expected that in many of these individuals Mtb will remain dormant, yet a number of them will develop active disease at some point, most likely through reactivation of the organisms they harbor. This is particularly important because of the ease with which Mtb is communicated and because of the many individuals who have medical conditions, especially HIV infection, that increase their risk of developing active TB. A variety of host factors, in addition to HIV infection, put patients at increased risk of TB, presumably by compromising their immune responses. However, little is known about the actual mechanisms that control interactions between the host and Mtb and how such factors may alter the life cycle of the organism. Such knowledge might provide the basis for developing new strategies to prevent and treat TB. Pneumoncystis carinii pneumonia (PCP) continues to be an important complication in individuals infected with HIV. While the use of a number of drugs has had an overall suppressive effect on the incidence of PCP, there remain a number of problems associated with therapy for this infection. It is anticipated that a better understanding of the mechanisms involved in the interaction between host lung cells and the infectious forms of P. carinii might provide alternative approaches for treating this opportunistic infection. Objectives and Scope The objective of this program is to elucidate the role of life/cell cycle regulation of a variety of microorganisms that are associated with the pathogenesis of lung disease, particularly but not exclusively, in the setting of HIV infection. These could include various bacteria, fungi, and protozoa which act as opportunists or as well-recognized microbial pathogens either alone or in combination with HIV infection. Areas of interest under this program include the identification of markers of microbial replication and the interaction of host and microbial factors that allow organisms to continue to remain viable in cells or tissues for many months or years without replicating. Of particular interest are the cellular mechanisms responsible for a change in the relationship between the host cells and the microorganism that lead to active disease processes in the lung. Mycobacteria and P. carinii are likely candidates, but studies that propose to investigate other organisms are also encouraged. For example a variety of fungal organisms such as Histoplasma, Candida, Coccidioides and Aspergillus are also of particular interest. A better understanding of the enzymes controlling life/cell cycle processes might provide insight into the phenomena of microbial latency and activation/reactivation as well as provide novel targets for antimicrobial chemotherapy. The cell division machinery of Mycobacteria, especially Mtb, and the regulation of microbial division, especially in lung tissue, offer potential targets for study with respect to pulmonary tuberculosis. It is thought that the DNA synthetic mechanisms and cell division apparatus of Mtb are unique. The genome of Mtb is 70 percent guanine and cytosine, suggesting that its DNA polymerase has adapted to handle its more highly stable form of DNA. The cell division of Mtb is exceptionally slow for a pathogenic bacterium. It is unknown whether this is due to pauses in DNA synthesis, a low constant rate of DNA synthesis, gaps between DNA synthesis and cell division, or factors unrelated to DNA replication. The DNA replication process of Mtb is thought to be highly error prone which would help explain why the spontaneous occurrence of resistance to chemotherapeutic agents is much higher for Mtb than for other microorganisms. This also suggests that the DNA polymerase of Mtb may proofread inefficiently during replication. The signals that regulate DNA synthesis and the growth of Mtb, especially in the lung remain to be uncovered. The extent to which reactivation may be regulated by DNA replication processes and whether host cell factors influence these processes are completely unknown. While the tubercle bacilli can remain "dormant" for decades in host cells little is known about the signals that regulate the transition between active growth and the "dormant" state. Projects that are directed toward gaining mechanistic insights into the processes of reactivation of Mtb, particularly in the immunocompromised host are of interest. Projects dealing with fungal infections associated with immunocompromised hosts would also be responsive. For example these might focus on Coccidioides immitis which is characterized by a sequence which involves inhalation of infectious conidia into the respiratory tract where they undergo conversion to spherules. It has been suggested that leukocytes and carbon dioxide in the lung play a role in regulating this morphologic change. Once formed the spherules undergo a complex series of processes which give rise to endospores before being distributed locally in the lung or being disseminated to other organs of the body. In addition to the morphologic considerations, a number of other factors are thought to contribute to the virulence of these organisms. These include the antiphagocytic properties of the organism's cell wall, the thickness and large size of the spherule form of the organism and the large number of endospores released from each spherule. The way in which such processes are signalled and regulated are appropriate topics for study under this RFA. In vitro experiments, animal studies and innovative studies using human cells or tissues, are encouraged. Research involving humans 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 hypothesis driven research directed at understanding the mechanisms underlying cell/life cycles of microorganisms and how these contribute to the pathogenesis of lung disease will not be acceptable. Studies focused exclusively on microorganisms will not be acceptable; applications must address microbial-host interactions. Studies directed at understanding how lung cell signals from an immunocompromised host interact with microbial signals to direct microbial growth, replication, dormancy and reactivation are of special interest. Applications that focus on issues relevant to the HIV-immunocompromised host and that use molecular approaches are of particular interest. 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 March 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 of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIH 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 form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, 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 CONSIDERATIONS 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 "HIV-Associated Pathogens of the Lung: Life Cycle Regulation" HL-95-013. The RFA label found in form 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 the Chief, Review Branch, DEA 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. Applications must be received by April 28, 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. If the application is not responsive to the RFA, DRG staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Affairs, 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. 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; the appropriateness of the requested budget to the work proposed; and the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA The anticipated date of award is September 29, 1995. In addition to the scientific merit of the applications, awards will be based on significance to the subject of the RFA and the availability of resources. 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: 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 Email: hpv%nihhwb1.bitnet@cu.nih.gov Direct inquiries regarding review matters and mail the letter of intent to: C. James Scheirer, Ph.D. Division of Extramural Activities National Heart, Lung, and Blood Institute Westwood Building, Room 557 Bethesda, MD 20892 Telephone: (301) 594-7478 FAX: (301) 594-7407 Email: james_scheirer%nihhwb1.bitnet@cu.nih.gov 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 Email: raymond_zimmerman%nihhwb1.bitnet@cu.nih.gov 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 Fri Jan 13 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-020 - V24(01) 01/13/95 Date: 13 Jan 1995 16:50:43 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 372 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3f7753$oo0@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95020 PA-95-020 P1O1 *************************************** DECISION MAKING PROCESSES IN WOMEN'S HEALTH NIH GUIDE, Volume 24, Number 1, January 13, 1995 PA NUMBER: PA-95-020 P.T. 34, II; K.W. 0785035, 0730050 National Institute of Nursing Research Office of Research on Women's Health Agency for Health Care Policy and Research PURPOSE The National Institute of Nursing Research (NINR), the Office of Research on Women's Health (ORWH), and the Agency for Health Care Policy and Research (AHCPR) invite submission of research grant applications to study the treatment and intervention decision making processes associated with non-cancerous health problems of women that frequently result in the surgical procedure, hysterectomy. These health problems have symptoms that may lead to a decision for hysterectomy even when the underlying pathology is limited. These problems include dysfunctional uterine bleeding, leiomyota (fibroids), endometriosis, pelvic pain, and uterine prolapse. Cancerous conditions leading to hysterectomy are not included in this Program Announcement (PA). This PA is jointly sponsored by NIH and AHCPR and both agencies are interested in applications in all the areas described under RESEARCH OBJECTIVES. The AHCPR is particularly interested in studies that include an emphasis on the influence of market forces, cost factors, health care payers, practice variation, and access issues. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Decision-Making Processes In Women's Health, is related to the priority areas of health promotion and clinical preventive services. Potential applications 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. The AHCPR, by statute, can award grants to non-profit organizations only. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This PA will use the NIH/AHCPR individual research project grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Though the length of individual studies will vary, support will be provided for a period up to five years, based on availability of funds and sufficient scientific progress. Costs of individual projects will vary. RESEARCH OBJECTIVES Women and their health care providers confront an increasingly complex decision making process related to selecting hysterectomy and/or alternatives as treatment/intervention options. Current scientific investigations are focused on evaluating the efficacy of emerging medical and surgical treatments prior to, during and following hysterectomy; but little investigative effort has focused on the complexity of the decision making process itself. The interaction effect of endogenous and exogenous factors on decision making has not been thoroughly examined. Among these factors are the woman's preferences and symptoms, the clinical practitioner's assessment and treatment plan, and the utilization criteria of the health care payers leading to the decision to implement or not implement hysterectomy as a treatment option. The purpose of this program announcement is to encourage exploration of the treatment and intervention decision-making processes of women experiencing non-cancerous health problems that frequently result in a hysterectomy. These problems, including dysfunctional uterine bleeding, leiomyota (fibroids), endometriosis, and uterine prolapse, have symptoms that may lead to a decision for hysterectomy even with limited underlying pathology. The symptomatology associated with such problems include pelvic pain, excessive and/or frequent uterine bleeding, changes in urination, and related symptoms. In examining the decision making process, it is important to consider the varying perspectives of, and influences on, women having the health problems. In addition, the role of their significant others, their clinical practitioners (nurses, physicians, and others), and health care payers on decision outcomes need consideration. These differing viewpoints and interests are usually the major factors leading to decisions for surgical treatment, such as hysterectomy, rather than using alternative, less invasive and costly treatments or interventions when they are available. There is limited scientific information about how women make these decisions, how they are informed about their treatment options, and what influence, if any, clinical practitioners and health care payers have on their decision making. Numerous methodological approaches may be used to address the study of decision making. It is appropriate to propose both quantitative, qualitative and combined approaches. Currently, hysterectomy is the second most commonly performed major surgery for women in the US. Half of the hysterectomies are performed on women 40 years old or younger. There is considerable regional variation. Whether this variation is related to factors other than clinical decisions and recommendations by clinical practitioners is not clear. Although, total hysterectomy for benign disease historically has been justified on several grounds, there is no convincing evidence that hysterectomy conveys a benefit proportional to the risks of the surgery. Recent advances in technology have enabled us to follow more closely the status of many conditions which lead to hysterectomy. New conservative surgical approaches which spare the uterus are growing in use. A variety of conditions can be indications for hysterectomy, the most common of which are benign conditions, such as uterine leiomyomas, endometriosis, dysfunctional uterine bleeding, and uterine prolapse. Conditions such as endometriosis and leiomyoma usually stabilize or regress at the time of natural menopause. When the effects of these problems become more symptomatic, the usual first line of treatment consists of medical therapies or conservative surgical approaches or watchful waiting. Abnormal uterine bleeding may also be treated with drug therapy. Pelvic pain, which must have a differential diagnosis leading to a decision that it is occurring due to a non-cancerous or other less serious condition, needs to be explored to determine the extent to which it may be the important factor in a decision to treat surgically. Conventional treatment of chronic pelvic pain currently consists of oral contraceptives or nonsteroidal anti-inflammatory drugs. Other treatments or interventions for symptom management of pain may be less invasive and less costly in approach. Approaches to uterine prolapse may include exercise to strengthen the pelvic muscles in mild or moderate prolapse, placement of a pessary especially in older women, and surgery for severe prolapse. Family members are frequently important partners for many women when making health-related decisions. The role and influence of family members in treatment/intervention decisions generally remains unexplored, but could be of potential significance, especially for certain cultural/ethnic groups. Cultural beliefs, mores, and values are factors that are seldom addressed in clinical investigations, particularly in the area of health-related decision making. Such factors could be addressed from an individual, family and/or community perspective. The term clinical practitioner for this announcement refers to the health care professional who is the principal source of care for the patient's condition. This provider may be a primary care physician or nurse, an advanced nurse practitioner, a clinical nurse specialist, a certified nurse midwife, a women's health care specialist, a gynecologist, a general surgeon, or other health professionals who fulfills the above role. In situations where more than one provider is involved, the responsibilities of each provider should be clearly defined. Health care practitioners as well as patients are said to be influenced in making decisions by the policies and procedures of employing organizations, referring organizations, health care payers and other market forces. These include hospitals and other organizations providing clinical services, managed care organizations, health insurance plans, and other "third party" payers that can influence choices actually available or valued by practitioners, patients, and their families. Examples of possible research questions include, but are not limited to: What are the sources of information most frequently used/consulted by women in their self care of their uterine/pelvic symptoms, and for treatment/intervention decisions? What is the reliability of these sources? How do women resolve conflicting information, advice or recommendations in these sources? How do the various sources of information about treatment or control of their clinical problems influence women to seek or use one treatment over another? What are the relationships of symptoms and their management to the decision to have a hysterectomy or not? Are there different levels of symptom intensity related to these decisions? What are the methodological considerations in determining symptom influence on treatment decisions? How does the decision-making process vary within and across cultural/ethnic groups or in geographic regions for different practitioners? Are there specific components of the decision-making process that lead to satisfactory/unsatisfactory outcomes for the patient? To what extent is watchful waiting recommended and adhered to, or are other options sought by women with any frequency? What options are considered and used? How are the appropriateness and effectiveness of clinical decisions for hysterectomy best evaluated? What are the cost differentials across treatment/intervention options? Are these influential to women in making their treatment decisions? Does the type of decision made depend more on the different health care practitioners or on the individual characteristics and symptoms of the woman? Does the type of surgical procedure offered for hysterectomy (abdominal versus vaginal hysterectomy, inclusion of the ovaries or not) directly or indirectly influence the decision for surgery when other options are also indicated? What is the influence of clinical guidelines developed by professional societies and groups related to the noncancerous clinical conditions and their treatments, if any? INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH and AHCPR that women and members of minority groups and their subpopulations must be included in all NIH/AHCPR- supported biomedical, behavioral, and health services research projects involving human subjects, unless 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. The 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) 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 TO GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used and will be accepted at the standard application deadlines indicated in the application kit. 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, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The number and title of this program announcement must be typed in item number 2a on the application face page. The completed application and five signed, legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892-6300** REVIEW CONSIDERATIONS Applications received under this program announcement will be assigned to an appropriate NIH or AHCPR Initial Review group (IRG) in accordance with established PHS referral guidelines. The IRG, consisting primarily of non-Federal scientific and technical experts, will review the application for scientific and technical merit in accordance with standard NIH/AHCPR review procedures. Notification of the review recommendations will be sent to the applicant after the initial review. Applications assigned to the NIH, recommended for further consideration, and receiving sufficiently high priority will receive a second-level review by appropriate National Advisory Council, whose review will be based on policy considerations as well as scientific merit. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIH/AHCPR 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. AWARD CRITERIA Decisions to make awards are based on the overall scientific merit of the application reflected in the priority score, availability of funds, and research program priorities within the NINR, ORWH, and AHCPR. INQUIRIES Written and telephone inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding scientific or programmatic issues to: Patricia Moritz, Ph.D., R.N. National Institute of Nursing Research Building 45, Room 3AN-12 45 Center Drive MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5966 FAX: (301) 480-8260 Email: pmoritz@ep.ninr.nih.gov Virginia Cain, Ph.D. Office of Research on Women's Health Building 1, Room 201 Bethesda, MD 20892 Telephone: (301) 402-1770 FAX: (301) 402-1798 Email: virginia_cain@nih.gov Anne Bavier, M.N., R.N. Agency for Health Care Policy and Research 2101 E. Jefferson Drive Rockville, MD 20852-4908 Telephone: (301) 594-1357, ext. 129 FAX: (301) 594-2155 Email: abavier@po3.ahcpr.gov Direct inquiries regarding fiscal matters to: Sally A. Nichols Grants Management Officer National Institute of Nursing Research Building 45, Room 3AN-32 45 Center Drive MSC 6301 Bethesda, MD 20892-6301 Telephone: (301) 594-6869 Email: snichols@ep.ninr.nih.gov Ralph Sloat Grants Management Officer Agency for Health Care Policy and Research 2101 E. Jefferson Drive Rockville, MD 20852-4908 Telephone: (301) 594-1447 FAX: (301) 594-2155 Email: rsloat@po7.ahcpr.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361, Nursing Research; 93.180, Medical Treatment Effectiveness Research;and 93.226, Health Services Research and Development. 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 Federal Regulations 42 CFR 52. AHCPR Awards are made under authority of the PHS Act, Title IX (42 USC 299-299c-6) and Federal Regulations 42 CFR Part 67, Subpart A. Awards are administered under PHS grants policies and 45 CFR Part 74 (Part 92 for State and local governments). This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Fri Jan 13 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-019 - V24(01) 01/13/95 Date: 13 Jan 1995 16:50:22 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 358 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3f774e$omg@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95019 PA-95-019 P1O1 *************************************** H. PYLORI: BASIC, PRE-CLINICAL, AND CLINICAL RESEARCH NIH GUIDE, Volume 24, Number 1, January 13, 1995 PA NUMBER: PA-95-019 P.T. 34; K.W. 1002027, 0715085, 0765012 National Institute of Allergy and Infectious Diseases Application Receipt Dates: June 1, and October 1, 1995 and February 1, 1996 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), invites submission of investigator-initiated research applications for support of research on the definition of the natural history of infection, animal models, protective immune responses to infection, virulence determinants, bacterial genetics, and antibiotic resistance to Helicobacter pylori. This bacterium is known to be associated with chronic gastritis, duodenal and gastric ulcer disease, and possibly with certain malignancies of the stomach. The development of vaccines against this organism is also of interest to the NIAID. 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, H. Pylori: Basic, Pre-Clinical and Clinical Research, is related to the priority area of immunization and infectious diseases. 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 20402-0325 (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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) award (R29). MECHANISM OF SUPPORT The mechanisms of support will be the individual research project grant (R01) and the FIRST (R29) award. The total project period for an application submitted in response to this RFA may not exceed five years; a foreign application may not request more than three years of support. FUNDS AVAILABLE The estimated NIAID funds available for the total (direct and indirect) first-year costs of all awards made under this PA will $1,000,000. In Fiscal Year 1996, the NIAID plans to fund four to five R01 and/or R29 grants. 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 plans of the NIAID, awards pursuant to this program announcement 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. New applications submitted for the June 1 and October 1, 1995 and February 1, 1996 receipt dates will be eligible for funding under this program announcement. Competing continuation applications for already funded projects will NOT be eligible for award from NIAID under this program announcement. RESEARCH OBJECTIVES Background In 1983, a spiral shaped, urease producing, Gram negative bacterium, Helicobacter pylori, was identified in the stomachs of some individuals. Since then, there has been increasing evidence for its association with active and chronic gastritis, peptic ulcers, and duodenal ulcers. Effective treatment of the infection with antibiotics eliminates ulcer recurrences in more than 90 percent of cases. An epidemiologic relationship between atrophic gastritis, which develops in a small percentage of those infected with H. pylori, and gastric malignancies has also been noted. H. pylori colonizes the gastric mucosa of greater than 30 percent of persons in the U.S. and more frequently in African American, Hispanic, and socioeconomically disadvantaged populations in this country. In some developing countries, it is found in almost 100% of the population. Non-ulcer dyspepsia (NUD) and gastric and duodenal ulcer disease, are among the most common human ailments of the upper GI tract requiring medical attention. An estimated 10 percent of people in the United States will develop peptic ulcer disease, a chronic inflammatory condition of the stomach and duodenum, sometime in their lifetime. It is estimated that there are 300,000 new cases, 3.2 million recurrences, and 3,000 deaths due to duodenal ulcer disease each year in the U.S. NUD affects even greater numbers of individuals, but a causal relationship between NUD and H. pylori has not been definitively established to date. Defining this relationship, and identifying even a subset of NUD patients, would facilitate the prescription of appropriate antibiotic therapy for those individuals. A recent Consensus Conference sponsored by NIDDK, NIAID, and the NIH Office of Medical Applications of Research recommended that patients presenting with duodenal or gastric ulcers who were also seropositive for H. pylori be treated with antimicrobial triple therapy to eradicate the organism. The Panel recommended that basic research be conducted in order to generate much needed data on the biology of this organism. The development of an effective preventive strategy, including the development of a vaccine should also be pursued when sufficient information on pathogenesis is available. This initiative will focus on these basic issues, including definition of the natural history of infection, animal models, protective immune responses to infection, virulence determinants, bacterial genetics, and antibiotic resistance. It is known that a significant number (approximately 10 percent) of children under the age of 10 are seropositive for H. pylori. The source of infection, modes of transmission, identification of risk factors, and the consequence of this infection on the health of the young are not known, and are of special interest to the NIAID in the context of this Program Announcement. Research Objectives and Experimental Approaches Well-designed basic, pre-clinical and clinical studies are needed to provide a better understanding of H. pylori biology and pathogenesis so that effective intervention strategies can be designed. Topics of interest to the NIAID include, but are not limited to: o development or use of animals that can be infected with human isolates of H. pylori and that serve as models for stages of the human disease and are amenable to evaluation of prophylactic and therapeutic strategies; o identification of virulence factors of the organism, effect of deletion of virulence factor genes on pathogenesis; o biomarkers (antigens or nucleic acids) of strains of H. pylori that may be associated with particular outcomes of infection such as various forms of NUD, ulcer disease, or asymptomatic carriage; o definition of the genetics of the organism including characterization of plasmids, mechanism of gene transfer, etc; o development and mechanism of antibiotic resistance; o vaccine development; and o natural history of infection, particularly in children, including risk factors and modes of transmission. Multidisciplinary studies and collaboration among investigators with expertise in appropriate disciplines are encouraged. When investigators are at different institutions, individual R01 applications may include consortium arrangements. Collaborative arrangements with ongoing studies that provide patient populations, specimens and data are encouraged (a list of possible resources is included in this PA). Such arrangements should be clearly delineated in the application. The methodologies employed and personnel involved in the study, including statistical analyses, should be described in the application and evident in the study design. The hypothesis(es) to be tested should be clearly stated. The measurement of immunological and bacterial markers is highly dependent on the assay system chosen and its execution. Thus, it is very important that applicants clearly define the methodologies to be used, the rationale for choosing that methodology and for validating results as well as methods of collection, processing, and storage of samples. The value of studies of patients or their specimens will be directly related to the care exercised in selection and initial characterization of cases and controls. Therefore, a detailed description of case recruitment procedures, the criteria to be used for case definition and the manner in which the criteria are to be applied should be included. This is particularly true in the case of non-ulcer dyspepsia for which a generally accepted definition does not exist. Similar care should be given to descriptions of enrollment of comparison groups. 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 sub-populations 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 printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted on the standard application deadlines as indicated in the application kit. Requests for continued funding of already funded projects (Type 2) will NOT be considered under this program announcement. Applications may be submitted for the following receipt dates only: June 1, and October 1, 1995 and February 1, 1996. Awards resulting from this program announcement will be made on or about April 1, July 1, and December 1, 1996. 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. Each application must be identified by checking "YES" on line 2a of the PHS face page, and the number and title of this program announcement must be typed in section 2a. The completed original and five legible, single-sided copies of the application must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** 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. 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 Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific/technical review, the applications will receive secondary review by the appropriate national advisory council. 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 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 the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications assigned to the NIAID will compete for available set- aside funds. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among research areas of the announcement, availability of funds. 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: Dennis R. Lang, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A21 6003 Executive Boulevard MSC 7630 Bethesda, MD 20892-7630 Telephone: (301) 496-7051 FAX: (301) 402-1456 Email: dl73v@nih.gov Direct inquiries regarding fiscal matters to: Ms. Louise Kreh Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B35 6003 Executive Boulevard MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: louise_kreh@exec.niaid.pc.niaid.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856, Microbiology and Infectious Disease Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) 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 Fri Jan 13 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-95-005 - V24(01) 01/13/95 Date: 13 Jan 1995 16:50:15 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 450 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3f7747$om4@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AI95005 AI-95-005 P1O1 *************************************** INTERDISCIPLINARY PROGRAMS IN AUTOIMMUNE DISEASE NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA: AI-95-005 P.T. 34; K.W. 0715015, 0710030 National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases Juvenile Diabetes Foundation International Letter of Intent Receipt Date: March 15, 1995 Application Receipt Date: June 15, 1995 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) of the National Institutes of Health (NIH) and the Juvenile Diabetes Foundation International (JDFI) invite applications for program project grants to support interdisciplinary programs in autoimmune disease. This Request for Applications (RFA) will support programs combining investigations of basic, molecular, immunologic, and genetic mechanisms in the pathogenesis of autoimmunity and the development of innovative therapies for human autoimmune disease. These programs may incorporate investigation into any autoimmune disease, including, but not limited to, Insulin Dependent Diabetes Mellitus (IDDM), or any field of science with relevance to the mechanisms and treatment of autoimmunity. Programs utilizing investigators from different scientific disciplines are particularly desirable, so as to utilize expertise in several areas simultaneously. Applications should be submitted to and will be reviewed by the NIH according to the usual NIH peer review procedures. Funds for each Program Project to be awarded under this RFA will be provided by the NIAID and the JDFI. One or more program projects will be cofunded by NIDDK. 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, Interdisciplinary Programs in Autoimmune Disease, is related to the priority area of diabetes and chronic disabling diseases. 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 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 organizations are not eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanism of support will be the program project (P01) grant. This mechanism supports broadly based multi-disciplinary research programs that have a well-defined central research focus, theme, or objective. An important feature of the program project is that the interrelationships of the individual scientifically meritorious projects will result in a greater contribution to the overall program goals than if each project were pursued individually. The program project grant consists of a minimum of three interrelated individual research projects that contribute to the program objective. The program project grant also can provide support for certain common resources termed cores. Such resources should be utilized by two or more projects within the program project. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years. At this time, the NIAID is administratively limiting the duration of P01 grants to four years. The earliest anticipated award date is March 1996. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for this RFA will be $2.75 million: $1.5 million from NIAID; $1.0 million from JDFI; and $250,000 from NIDDK. In Fiscal Year 1996, the NIAID and the JDFI anticipate jointly funding approximately three or four program projects related to this RFA. Approximately 60 percent of the total costs of each grant will be funded by the NIAID and approximately 40 percent by the JDFI. One or more of these applications will be cofunded by the NIDDK. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Applications may not request budgets in excess of $750,000 total (direct and indirect) costs in the first year. The NIH is currently limiting annual inflationary increases to no more than four percent for future years. Funding rules and policies, including the determination of allowable indirect costs, of each funding organization will be applicable. Post award administration will conform to current policies and requirements that govern the research grant programs of the NIH and the JDFI as appropriate. Although this program is provided for in the financial plans of the NIAID, the JDFI, and the NIDDK, 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. At this time, it has not been determined whether or how this solicitation will be continued beyond the period stated in the present RFA. The National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS) is interested in research on the immune mechanisms involved in rheumatic diseases and the development of new therapies for these diseases based on manipulation of the immune system. Applications that are of mutual interest are likely to be given dual secondary assignment to the NIAMS in accordance with NIH Division of Research Grants (DRG) referral guidelines. RESEARCH OBJECTIVES Background Autoimmune diseases affect five to seven percent of the population, resulting in significant morbidity and mortality, and cost billions of dollars annually for health care and loss of productivity. Insulin Dependent Diabetes Mellitus (IDDM) disproportionately affects children and young adults. In addition to IDDM, other diseases included in this category are rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, and inflammatory bowel disease. There is no known cure or prevention for these diseases. However, recent developments, including new animal models, the ability to generate transgenic animals, recent new paradigms for the stimulation of T and B cells, the finding of new co-factors for stimulation, and the development of new methods for detecting self-antigens, have revolutionized our thinking about the development of tolerance, both central and peripheral. These new developments in basic immunology may lead to important insights into the pathogenesis and therapy of autoimmune disease. Research Objectives and Scope Application of recent advances in basic immunology to the understanding of the pathogenesis of autoimmune diseases, including the development of novel therapies and possible preventive strategies, is a major goal of this RFA. The specific objectives of this program are to: facilitate the application of new advances in immunology and immunogenetics to the understanding and treatment of autoimmune diseases, including IDDM; increase the understanding of the etiology and pathogenic mechanisms involved in development and progression of autoimmune diseases; enable investigators working on various different autoimmune diseases to come together to work in a collaborative and synergistic way; and promote the collaboration between investigators working in disease-specific models and investigators focusing on basic studies of self tolerance and the defects in this process in several experimental systems. In addition to investigation of the initiation of the autoimmune process, the mechanism of the target organ damage in autoimmune disease is unclear. The elucidation of the destructive pathways resulting from the autoimmune process in these diseases could be useful for the development of therapeutic strategies and is a relevant topic for this RFA. The inclusion of clinical investigators may allow earlier transfer of new information to the clinical setting. SPECIAL REQUIREMENTS The NIAID, the NIDDK, and the JDFI plan to sponsor an annual meeting to encourage the exchange of information among investigators supported under this RFA, foster collaborative efforts, and identify resources that would enhance the productivity of this research program. Applications should include a statement indicating the willingness of the applicant institution to participate in such annual meetings. For this purpose, travel funds for an annual two- day meeting, to be held in the Washington, DC area, should be included in the budget request. Letter of Authorization This RFA is co-sponsored by the JDFI. In order for an application to be considered for funding by the JDFI, applicants must submit a brief letter of authorization co-signed by the Principal Investigator and the official signing for the applicant institution, authorizing release of the application and all related materials to the JDFI. This letter of authorization may be combined with the letter of intent or may be submitted directly to Dr. Elaine Collier at the address listed under INQUIRIES. The summary statement for such applications will be shared with the JDFI at the time of their availability. Applications without such authorization will not be considered for funding by the JDFI. 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 sub-populations 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 printed 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 March 15, 1995, a letter of intent that includes a descriptive title of the overall proposed research, the name, address, and telephone number of the Principal Investigator, a list of the key investigators and their institution(s), 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. Mark Rohrbaugh 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 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. Applicants must adhere to the format and requirements specified in the PHS 398 application kit. In addition, applicants for multicomponent grants are strongly advised to read the information brochure "NIAID Program Project Grants and Multiproject Cooperative Agreements", available >From Dr. Elaine Collier 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 could be included with the application. For purposes of identification and processing, mark "YES" in item 2a on the face page of the application and type in the RFA number, AI-95-005, and the title "INTERDISCIPLINARY PROGRAMS IN AUTOIMMUNE DISEASE." The RFA label available in the form PHS 398 must be affixed to the bottom of the face page of the original 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. The signed, typewritten original of the application, including the Checklist, and three exact single-sided copies must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies and all five sets of appendices must also be sent to Dr. Mark Rohrbaugh at the address listed under INQUIRIES. To ensure their review, applications must be received by both the Division of Research Grants and Dr. Mark Rohrbaugh by June 15, 1995. Applications not received by June 15, 1995 will be considered non-responsive and will be returned to the applicant without review. Concurrent submission of an R01 and a Component Project of a Multi- project Application: Current NIH policy permits a component research project of a multi- project grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multi-project application and the R01 application are found to be in the fundable range, the investigator must relinquish the R01 and will not have the option to withdraw from the multi-project grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project grant, which may be seriously compromised if a strong component project(s) is removed >From the program. Investigators wishing to participate in a multi- project grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution. REVIEW CONSIDERATIONS Review Procedures Upon receipt, applications will be reviewed for completeness by the Division of Research Grants (DRG) and for responsiveness by the NIAID. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Complete and responsive applications 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 will 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 Advisory Allergy and Infectious Diseases Council and the National Institute of Diabetes and Digestive and Kidney Diseases Advisory Council. Review Criteria The review criteria for P01 grant applications are the review criteria for large, multicomponent, interdisciplinary program projects as outlined in the NIAID brochure entitled "NIAID Guidelines for Multiproject Research Awards." The program project grant application should include a justification for the appropriateness of that granting mechanism for the proposed project. The distinguishing features of a program project grant include: o A well-defined, unifying goal or problem area of research to which each project relates and contributes, thereby producing a research environment that allows each research effort to share the creative strengths of others. o A program director who possesses recognized scientific and administrative competence. He/she must demonstrate a substantial commitment to the program in time and effort thereby exercising leadership in providing overall direction and in upholding rigorous scientific conduct. o Each research project must, as assessed by peer review, stand on its own independent scientific merit, as well as complement other projects whenever feasible. o The projects require the participation of established investigators in several disciplines or investigators with special expertise in several areas of one discipline. All investigators must contribute to and share the responsibilities of fulfilling the program objective. o Ability of the proposed research to provide knowledge of basic, molecular and genetic mechanisms in the pathogenesis of autoimmunity and the development of innovative therapies for human autoimmune disease. The appropriateness of the proposed experimental plan to validate the utility of the chosen strategy will be considered in this regard. o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. 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. The opportunity to clarify any issues or questions from potential applicants is welcome. Requests for the brochure "NIAID Application Guidelines for Multiproject Research Awards," as well as inquiries regarding programmatic issues may be directed to: Elaine Collier, M.D. Division of Allergy, Immunology, and Transplantation National Institute of Allergy and Infectious Disease Solar Building, Room 4A20 6003 Executive Boulevard Bethesda, MD 20892-7640 Telephone: (301) 496-7104 FAX: (301) 402-2571 Email: EC5X@NIH.GOV Joan Harmon, Ph.D. Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 5AN-18G Bethesda, MD 20892 Telephone: (301) 594-8808 FAX: (301) 480-3503 Email: joanh@dvsgate.niddk.nih.gov Direct inquiries regarding review issues, mail two copies of the application and all five sets of appendices, and mail the letter of intent to: Mark L. Rohrbaugh, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C20 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-8424 FAX: (301) 402-2638 Email: MR28K@NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Jacqueline Johnson Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B26 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-7075 Email: JJ19E@NIH.GOV Schedule Letter of Intent Receipt Date: March 15, 1995 Application Receipt Date: June 15, 1995 Scientific Review Date: October 1995 Advisory Council Date: January 1996 Earliest Award Date: March 1996 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.855 and No. 93.847. Awards will be made under the authority of the Public Health Service Act, Title IV, Part A, (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free work place and promote the nonuse 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 Jan 13 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HS-96-001 - V24(01) 01/13/95 Date: 13 Jan 1995 16:50:08 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 444 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3f7740$olh@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HS96001 HS-96-001 P1O1 *************************************** RESEARCH ON THE OUTCOMES OF PHARMACEUTICAL THERAPY NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA: HS-96-001 P.T. 34; K.W. 0745005, 0730021 Agency for Health Care Policy and Research Letter of Intent Receipt Date: March 1, 1995 Application Receipt Date: April 12, 1995 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications to conduct research on the outcomes of pharmaceutical therapy. This request for applications (RFA) focuses on the effects on patient outcomes of various proposed or existing mechanisms for managing selection, utilization, and cost of pharmaceutical therapies and services. Current restructuring within the health care system provides an important opportunity to enhance understanding of the interrelationships of pharmaceutical treatments and services with patient outcomes. Of particular interest are studies involving the comparative effectiveness and/or cost effectiveness of pharmaceutical therapies within the changing health care system. This is an activity of the research component of AHCPR's Medical Treatment Effectiveness Program (MEDTEP). Section 1142 of the Social Security Act, a part of AHCPR's authorizing legislation, refers specifically to the need to study the outcomes of prescription drug therapy. Awards are a part of the Outcomes of Pharmaceutical Therapy (OPT) program, as introduced in RFA HS-92-03. 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. AHCPR urges applicants to submit grant applications with relevance to the specific objectives of this initiative. 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 non-profit organizations, public and private, including universities, clinics, units of State and local governments, non-profit firms, and non- profit foundations. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This request for applications will use the research project grant (R01) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This is a one-time solicitation. The total requested project period may not exceed five years. Annual progress reviews by AHCPR and the availability of funds will determine the continuation of grants up to the five year limit. FUNDS AVAILABLE The AHCPR expects to award up to $2 million for first year support of four to six awards. RESEARCH OBJECTIVES Background The enabling legislation for AHCPR authorizes studies of the effectiveness and appropriateness of health care services and procedures. Section 1142 of the Social Security Act recognizes drug therapy as an important form of treatment and refers to the need to study effectiveness and appropriateness. As a component of MEDTEP, a program was established in March 1992 with RFA HS-92-03, focusing on the patient outcomes of pharmaceutical therapy. As a result of that RFA, AHCPR has awarded sixteen grants focusing on outcomes of pharmaceutical therapy in ambulatory care settings. This RFA initiates an extension of that work, but is not limited to studies in any particular care setting. It focuses on the effects on patient outcomes of various programs, proposed or existing, for managing selection, utilization, and cost of pharmaceutical therapies and services within the changing health care environment. MEDTEP Research Themes This RFA incorporates the themes and concepts common to all MEDTEP research (MEDTEP-Summary PA-94-074). "Effectiveness" refers to outcomes experienced by, or observed in, patients in routine clinical practice. This is distinct from "efficacy" which refers to the potential benefit of clinical interventions provided under ideal circumstances to patients who meet specific criteria. Cost effectiveness summarizes the cost and effect of treatment in terms of specified outcomes measured in nonmonetary units; it indicates value obtained for resources expended. MEDTEP studies focus on clinical conditions that affect large numbers of people (or a large proportion of a major subpopulation); that result in substantial expense; that are significant in Medicaid or Medicare programs; and for which there are large, unexplained variations in treatment. The outcomes to be studied, in addition to traditional measures such as survival and morbidity, include patient- reported outcomes such as perceived health status, functioning, and quality of life. MEDTEP studies typically involve a multidisciplinary team of researchers with clinical and methodological expertise, plus understanding of the perspectives of patients, providers, and policymakers. Methods MEDTEP studies draw on a wide range of research methods that include, but are not limited to: experimental and quasi-experimental designs, case-control and cohort studies, effectiveness trials, meta-analysis, cost effectiveness analysis, decision modeling, and combinations of these methods. Primary data will generally be required; however, these may be combined with, and occasionally replaced by, secondary data when the latter will provide adequate information and efficient means to address the research question(s). Data sources should allow for the detection, measurement, and/or control of: drug exposure, indication for drug use, severity of illness, comorbidities, relevant confounders, and costs of care when appropriate. Measures of short- and long-term outcomes, as well as pre-treatment health status information, are critical data elements. Applications must be explicit and detailed in describing data, methods, and tools for data collection and analysis. The research plan must be justified in terms of potential for answering the proposed research question(s). Applicants who propose to use Medicare or Medicaid data must specify the required data files and explore the availability and cost of obtaining these data with the Health Care Financing Administration (HCFA). The estimated cost must be presented, along with documentation from HCFA, as part of the grant application. This cost should not be included in the total budget request for the project. For more information about data budgets, contact Mr. Ralph L. Sloat, AHCPR Grants Management Officer (see INQUIRIES). Topic Selection Current restructuring within the health care system provides an opportunity to enhance understanding of the interrelationships of pharmaceutical treatments and services, with patient outcomes. The changing mix of payment mechanisms, benefit plans, and cost- containment strategies has widespread implications for patient care. Of particular interest are studies involving the comparative effectiveness and/or cost effectiveness of pharmaceutical therapies within the changing health care system. Studies are expected to compare different clinical approaches to the prevention, diagnosis, treatment, and/or management of common clinical conditions. While most of these studies will involve comparisons among drug therapies and/or related services, studies of drug versus non-drug treatment options also are responsive to the RFA. If it is not feasible to address all important treatment options in a single study, applicants must identify the specific interventions the study will address and justify selections and exclusions. Studies should focus on one or both of the following topic areas: 1. Pharmaceutical Economic Analyses Evaluations of the economic impact of drug therapy are of particular policy relevance in the changing health care environment. Economic information is needed by large-volume purchasers such as managed care organizations to guide formulary decisions, price negotiations, and clinical decision making. Cost-effectiveness, cost-benefit, and cost-utility analyses are responsive to this RFA provided patient outcomes are the central focus. Studies that evaluate monetary cost alone are not responsive. Of special interest are studies that develop tools or analytic models that will be useful in other research. Examples of suitable topics include the following: o Comparative cost effectiveness of alternative drug therapies for treatment of a selected common condition. Choice of condition and treatment options should be justified in terms of clinical and policy relevance. o Cost-utility studies that include user-friendly (to patients and providers) methods or measures for assessing patient preferences, values, and utilities. 2. Effects of Changes in the Health Care Environment There is a trend in health care toward systems of managed care, including health maintenance organizations, individual practice organizations, preferred provider organizations, and coordinated care networks. Often, these systems include some form of case management or pharmaceutical benefit management, for coordination of services and patient monitoring. They also include mechanisms for managing selection, utilization, and cost for pharmaceutical therapies and services. Previous studies have explored the effects of policy and educational interventions on the appropriateness of drug prescribing and use. Many questions remain, however, about the long-term effects of programs that monitor and intervene in the drug management process. Innovations that affect patient outcomes and cost, and that warrant evaluation include: o Interventions designed to change prescribing practices. These range from face-to-face academic detailing, to computer-generated reminders, to adoption of clinical practice guidelines and treatment algorithms that address drug selection and use. o Interventions such as those implemented by large-volume drug purchasers including HMOs, Medicaid programs, and pharmaceutical benefit managers, to optimize the clinical and/or cost effectiveness of drug utilization review (DUR). o Interventions designed to encourage the provision or alter the content of pharmaceutical care. These include reimbursement programs for pharmacist cognitive services within managed care organizations. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of AHCPR that women and members of minority groups must be included in all AHCPR supported health services 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. A new NIH policy resulting from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) supersedes and strengthens NIH's previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which were in effect since 1990 and which AHCPR had adopted. The new NIH policy contains some provisions that are substantially different from the 1990 policies. AHCPR plans to publish guidelines specific to AHCPR. In the interim, AHCPR will follow the NIH guidelines, as applicable. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," 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 NIH policy from the AHCPR program staff listed under INQUIRIES. AHCPR program staff may also provide additional relevant information concerning this policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 1, 1995, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the Principal Investigator, co-investigators and other key personnel; the applicant institution and other participating organizations or institutions; and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the consideration of any subsequent application, the information allows AHCPR staff to estimate the potential review workload and avoid conflicts of interest in the review. The letter of intent is to be sent to: Joanne S. Book Center for Medical Effectiveness Research Agency for Health Care Policy and Research East Jefferson Street, Suite 605 Rockville, MD 20852-4908 APPLICATION PROCEDURES Applications are to be submitted on the research grant application form PHS 398 (rev. 9/91). State and local government agencies may use form PHS 5161 and follow those requirements for copy submission. These forms are available at most institutional offices of sponsored research; 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, for AHCPR applications, from Global Exchange Inc., 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3015, telephone (301) 656-3100 (FAX 301 652-5264). The RFA label available in the form PHS 398 (rev. 9/91) form must be affixed to the bottom of the face page of the original 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, type "RFA HS-96-001" in Section 2a on the face page of the application form and mark the "YES" box. 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: Center for Medical Effectiveness Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 605 Rockville, MD 20852-4908 Applications submitted under this RFA must be received in the Division of Research Grants, NIH, by April 12, 1995. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Referral Office, Division of Research Grants, NIH, for completeness, and by AHCPR staff for responsiveness to the RFA. Incomplete applications will be returned to the applicant without further consideration. Nonresponsive applications will be transferred to a standing AHCPR or other appropriate scientific review group for review through routine mechanisms. The determination of any application as nonresponsive will be the sole responsibility of AHCPR. Applications may undergo triage by the peer review group on the basis of relative scientific and technical competitiveness. The AHCPR will withdraw from further consideration those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. When an application is reviewed, the peer review committee may recommend further consideration or no further consideration. The committee also assigns priority scores to the applications for which further consideration is recommended. Recommendations of the peer review committee may be reviewed subsequently by AHCPR's National Advisory Council for Health Care Policy, Research, and Evaluation. The peer review process is rigorous, and only those applications judged to be of greatest merit will be recommended for further consideration. Review Criteria The general review criteria for AHCPR grant applications are: o significance and originality from a scientific and technical viewpoint; o adequacy of the proposed method(s); o availability of data or proposed plan to collect data required for the project; o adequacy of the plan for organizing and carrying out the project; o qualifications and experience of the Principal Investigator and proposed staff; o reasonableness of the proposed budget; o adequacy of the facilities and resources available to the applicant; and o adequacy of plans to include both genders and minorities and their subgroups, as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of experimental subjects, and the safety of the research environments. Special Review Criteria In addition to the general review criteria noted above, the following special scientific and technical review criteria will apply to this RFA: o scientific importance and policy relevance of the topic; o generalizability of results; o feasibility of answering proposed research question(s) within the project period; o attention to technical issues in case definition, case finding, data collection, and analysis; o quality and adequacy of proposed data; o justification for focus on outcome(s) specified; o adequacy of outcome measure(s); o sensitivity to patient heterogeneity and individual preference; o specification of useful findings or products, and identification of constituency(ies) for these; and o efficiency of the research plan. AWARD CRITERIA Applications will compete for available funds with all other applications for this RFA. In making funding decisions, AHCPR will consider: quality of the proposed project as determined by peer review, availability of funds, and program balance. INQUIRIES The AHCPR welcomes the opportunity to clarify any issues or questions >From potential applicants. Direct inquiries regarding program matters to: Richard J. Greene, M.D., Ph.D. Center for Medical Effectiveness Research Agency for Health Care Policy and Research East Jefferson Street, Suite 605 Rockville, MD 20852-4908 Telephone: (301) 594-1485 Email: JBook@po4.ahcpr.gov Direct inquiries regarding fiscal matters to: Ralph Sloat, Grants Management Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852-4908 Telephone: (301) 594-1447 Email: RSloat@po7.ahcpr.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.180. Awards are made under authorization of the Public Health Service Act, Title IX, and Section 1142 of the Social Security Act. Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR Part 67, Subpart A, and 45 CFR Part 74 (45 CFR Part 92 for State and local governments). This program is not subject to the intergovernmental review requirements of Executive Order 12372. 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 Jan 13 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-95-012 - V24(01) 01/13/95 Date: 13 Jan 1995 16:50:30 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 467 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3f774m$on7@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL95012 HL-95-012 P1O1 *************************************** LUNG SPECIFIC DRUG DELIVERY SYSTEMS FOR TUBERCULOSIS TREATMENT NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA: HL-95-012 P.T. 34; K.W. 0715165, 0740022, 1002027 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: February 24, 1995 Application Receipt Date: April 7, 1995 PURPOSE The National Heart, Lung, and Blood Institute (NHLBI) invites grant applications to encourage research on novel approaches to therapy, adjuvants to therapy, and prophylaxis of tuberculosis (TB), using the lung as the site of drug delivery. The primary objective of this special grant program is to develop new modalities of treatment for pulmonary TB based on delivery of the therapeutic agent(s) directly to the lung. 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), Lung Specific Drug Delivery Systems for Enhanced TB Treatment, is related to the priority area of immunization and infectious diseases. 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 institutions, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments and eligible agencies of the Federal government. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) award (R29). Applications from minority individuals women and new investigators are encouraged. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. Awards under this announcement 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. Among the disciplines and expertise that may be appropriate for this research program are molecular pharmacology, physical chemistry, cell biology, biochemistry, virology, molecular biology, molecular immunology, infectious diseases, pathology, and pulmonary medicine. MECHANISM OF SUPPORT The support mechanism for this program will be the National Institutes of Health (NIH), individual research grant (R01) and the FIRST award (R29). While multidisciplinary approaches are encouraged, it is not the intent of this announcement 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. Upon initiation of the program, the NHLBI will sponsor periodic meetings to encourage exchange of information among investigators who participate in this program. In the budget for the grant application, applicants should request 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. 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. Up to five years of support may be requested for R01s; five years are required for FIRST awards. Requested budgets for FIRST awards may not exceed those specified in the FIRST award guidelines. Because 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 September 1995. Administrative adjustments in project period and/or amount may be required at the time of the award. 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 and principal investigator should be included with the application. The National Institute of Allergy and Infectious Diseases (NIAID) also has interest in developing new delivery systems and new therapeutic agents for the treatment of tuberculosis. 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 Although financial plans for fiscal year 1995 include approximately $2,500,000 for the total cost of the program for the first year, award of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. It is anticipated that no more than 10 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. RESEARCH OBJECTIVES Background The spread of tuberculosis (TB) has reemerged as an urgent health problem. Rates for this disease have been increasing since the mid 1980s in association with the HIV epidemic. Recent projections of TB rates made by the Centers for Disease Control suggest that, worldwide, the current high rate of new TB cases in the population is likely to increase over the next 10 years. For industrialized countries, including the United States TB case rates are expected to remain stable or perhaps increase slightly over the next decade. The number of new active cases of TB reported annually in the U.S. population is now approximately 10/100,000 (new cases/100,000 people in the general population), with extremely high rates in HIV infected study populations, about 800/100,000. Current methods of treatment are far from optimal and better ones are being sought to overcome the increasing spread of TB and the problem of incompletely treated TB that contributes to the emergence of drug resistant strains. Since many patients with TB may have significant social problems, compliance with drug therapy is frequently difficult. The development of targeted drug delivery to the lungs as a means of treating TB is desirable for several reasons. Although TB is a systemic disease that can potentially affect any organ system, the lung is the major portal of entry for Mycobacterium tuberculosis (Mtb) and thereby the site of the initial immune response as well as an important site of reactivation disease. Technology for lung specific drug delivery systems is now at a point where aerosols and aerosols combined with liposomes and possibly timed-release methodology may offer advantages for more effective treatment and prevention of TB. Conventional antituberculous medications frequently have serious side effects. Although single drugs can be effective for prophylactic treatment of skin test converters, active disease must be treated using combinations of three or four drugs over a period of at least six to nine months to insure that disease will not recur after treatment is discontinued and to prevent the emergence of resistant strains. Targeted delivery of new formulations, directly to the lungs, could result in high pulmonary levels relative to systemic levels. Thus, increasing effectiveness and decreasing toxicity. Supplementing the dose of agent delivered to the diseased lung, when it is the only clinically involved organ, could make it possible to decrease the duration of treatment in these cases. Because the systemic dose will not be increased, undesirable toxicities would be avoided. Another advantage is that this mode of delivery might make it easier to provide prolonged treatment. It should be possible to design biopolymers or nanoparticles which slowly dissolve and therefore slowly release their drugs to the pulmonary environment. Improved targeted delivery approaches combined with development of new antituberculous drugs or with timed release formulations may reduce the frequency of dose delivery. This would be a major benefit in treating patients in whom it is hard to maintain effective compliance with treatment regimens. For example, longer intervals between treatment would make it easier to deliver directly observed therapy, which is an effective means of getting patients to complete a full course of treatment. Targeted drug delivery may be essential in carrying out future modes of TB therapy such as gene therapy resulting in increased cytokine expression or antisense oligonucleotide therapy blocking protein synthesis. Objectives and Scope The objective of this initiative is to encourage basic research aimed at developing new modalities of treatment for TB, using the lung as the site of drug delivery. Delivery of antituberculous agents to the lung might be used as a means of increasing local concentrations of drug to augment existing, conventional therapy or perhaps the lung could be used as the route of delivery for agents that are intended to work both locally and systemically. It is thought that lowered systemic toxicity provided by this approach would permit much more flexibility for treatment regimens such that smaller, more effective doses may be employed. Conversely, if a lung delivery system is intended as the only route for drug delivery, it would be essential to demonstrate that systemic levels of drug are adequate to treat TB elsewhere in the body. Drugs could be targeted to the lung as opposed to other organs, to airways of a specific size within the lungs, or perhaps to injured or diseased areas as compared to normal ones. Specific cells such as macrophages, endothelial cells, or epithelial cells might be targeted and it should even be possible to deliver drugs to specific organelles within a cell. Potential drug delivery sites could include the alveolar surface itself, or cells on the surface such as macrophages, lymphocytes, or neutrophils. Other targets might include cells and extracellular matrix beneath the epithelium. The nature of the material will affect its fate. For example, insoluble particulate material will largely be taken up by resident alveolar macrophages. Some surfactant phospholipids will be recycled into Type II epithelial cells. Soluble molecules will enter and pass through or between epithelial cells into the extracellular matrix. Some proteins will be found in phagocytic cells in the connective tissue and lymph nodes. Aerosol delivery of therapeutic agents to the lung has been used for many years in the treatment of airways obstructive diseases. Since the 1980s the aerosol application of interferon-alpha (INF-`) has been examined by several groups of investigators for the treatment of various types of lung cancer. Interferon-gamma has also been given to human subjects to activate alveolar macrophages. In general, it seems possible to deliver fairly high concentrations of these agents to the epithelial lung surface and minimize the systemic dose and toxicity. Drugs used in the treatment of TB including rifampin and streptomycin can be encapsulated in liposomes. Drugs such as these could be delivered to the lung in conjunction with antituberculous therapy (administered by mouth or parenterally) to augment therapy or given to replace conventional therapy, if adequate levels can be achieved in all parts of the body. Liposomal preparations of drugs or agents capable of potentiating immune responses may have enhanced uptake by lung cells. Furthermore, it appears to be possible to deliver liposomes by the aerosol route. Surfactant which may be useful as a vehicle for the delivery of other agents can be aerosolized and delivered to the lung. Research topics that could be applicable to the goals of this RFA might include, but are not limited to, the following areas: mechanisms of treatment, drug formulation issues, delivery strategies to get agents to the respiratory tract, targeting strategies to reach particular sites, evaluation of drug delivery and especially, evaluation of effectiveness of lung targeted drug delivery. These issues could be studied at a variety of levels including laboratory modeling animal testing, and human studies. Both animal studies and innovative studies involving human subjects or using human cells or tissues are encouraged. Research involving humans 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. Pharmacologic agents currently used in antituberculous regimens and agents that appear to show promise for future use are of interest. SPECIAL REQUIREMENTS Applications that propose descriptive studies and do not contain hypothesis driven studies directed at developing lung specific drug delivery systems to aid in the treatment of tuberculosis will not be acceptable. Treatment strategies must be clearly linked to the lung and to specific mechanisms of mycobacterial disease. This program will not support studies directed at development of animal models alone, therefore the models must be applied to the study of lung specific drug delivery strategies for use in the treatment of mycobacterial disease. This RFA is not intended to support in vitro studies of drug screening. Studies to verify that drug in an active state reaches the site intended for deposition should be included. Applications that focus on molecular pharmacologic approaches are of particular interest. 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 February 24, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIH 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 form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, The Westwood Building, 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 CONSIDERATIONS 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 "Lung Specific Drug Delivery Systems for Enhanced TB Treatment" HL-95-012. The RFA label found in form 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 the Chief, Review Branch, DEA 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. Applications must be received by April 7, 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. If the application is not responsive to the RFA, DRG staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Affairs, 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. 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; the appropriateness of the requested budget to the work proposed and the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA The anticipated date of award is September 29, 1995. In addition to the scientific merit of the applications, awards will be based on responsiveness to the RFA and the availability of resources. 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: 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 Email: hpv%nihhwb1.bitnet@cu.nih.gov Direct inquiries regarding review matters to: C. James Scheirer, Ph.D. Division of Extramural Activities National Heart, Lung, and Blood Institute Westwood Building, Room 557 Bethesda, MD 20892 Telephone: (301) 594-7478 FAX: (301) 594-7407 Email: james_scheirer%nihhwb1.bitnet@cu.nih.gov 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 Email: raymond_zimmerman%nihhwb1.bitnet@cu.nih.gov 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 the American people. From owner-sci-resources@net.bio.net Fri Jan 13 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-95-004 - V24(01) 01/13/95 Date: 13 Jan 1995 16:50:50 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 943 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3f775a$ood@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA95004 CA-95-004 P1O1 *************************************** BREAST CANCER SURVEILLANCE RESEARCH NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA: CA-95-004 P.T. 34; K.W. 0715036, 0745020, 0710030 National Cancer Institute Letter of Intent Receipt Date: February 14, 1995 Application Receipt Date: April 21, 1995 PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites applications from domestic institutions for cooperative agreements to the Surveillance Program (SP). New applicants and applicants currently funded under SP initiatives are invited to respond to this Request For Applications (RFA) to design and conduct breast cancer surveillance research. This is a follow-up to a cooperative agreement in which three awards began in 1994. Cancer surveillance research requires a strong interface between methodologic techniques and cancer control initiatives in prevention, early detection, and treatment. The purpose of the Breast Cancer Surveillance Research initiative outlined in this RFA is to examine thoroughly the operational aspects of breast cancer screening practices in the United States by conducting analytic research designed to assess the effectiveness, efficiency, and cost of screening programs as they relate to the reduction of breast cancer mortality. This may include studies of medical decision models for workup of women with positive screening tests, studies of utilization of emerging new technologies in breast cancer screening and diagnosis, and studies of biological differences among cancer related to detection methods. The intent of this RFA is to broaden the current Surveillance projects in areas that have not as yet been adequately covered, specifically among urban African-Americans and rural areas. This initiative also encourages interdisciplinary approaches to research on the basic biology and immunobiology of breast cancer to determine if there is a difference in screened detected and non- screened detected cases. It is not only important to determine the need for change in screening practices but to stimulate other breast cancer research. In order to more fully understand the effect of breast cancer screening on cancer outcome, data on breast cancer screening practices and tumor biologic characteristics need to be collected and linked to data from quality controlled population-based tumor registry programs. Examples of such registry programs are those affiliated with the NCI's Surveillance, Epidemiology, and End Results (SEER) Program or members of the North American Association of Central Cancer Registries (NAACCR) who meet comparable standards for completeness, quality, and timeliness of reporting and registry operations. A description of the NCI guidelines for these standards is available upon request from the program staff listed under INQUIRIES. Responses to this RFA would initiate mechanisms to accomplish these goals, study the utilization of state-of-the-art and emerging new technologies in breast cancer screening, and increase knowledge of the differences in basic biology and immunology of breast cancer by method of detection. 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, Breast Cancer Surveillance Research, is related to the priority area of cancer surveillance and data systems. This information (surveillance and data systems) is used to understand the health status of the population and to plan, implement, describe and evaluate public health programs that control and prevent adverse health events. 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, such as universities, colleges, cancer centers, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. Since this RFA concerns breast cancer surveillance research in the United States, a domestic application may not include an international component. New applicants and those with currently funded programs are eligible as described below. A Breast Cancer Surveillance Research applicant may be, but is not limited to, a hospital, a clinic, a group of practicing physicians, or a consortium of hospitals and/or clinics and/or physicians that agree to work together with a Principal Investigator and a single administrative focus. Although a Health Maintenance Organization (HMO) can be part of an application, it should not serve as the sole population base for the surveillance activities. It is essential that an applicant show evidence of the ability to access and organize data collection from at least three different facilities, which include: mammography facilities, pathology laboratories, and a quality-controlled, population-based cancer registry. If this expertise does not reside within one institution, an applicant may put together a group with the necessary expertise, which may involve the use of several institutions and/or organizations. Each applicant must have access to a resource unit that supports research data management and statistical analyses locally. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) cooperative agreement mechanism (U01). The cooperative agreement is an assistance mechanism in which substantial NCI programmatic involvement with the recipient during performance of the planned activity is anticipated to assist awardees in the planning, direction, and execution of the proposed project. The anticipated average amount of the direct cost awards will be $250,000 per year per award. The anticipated date of award is December 1995. The total project period for applications submitted in response to the RFA may not exceed five years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all other unsolicited applications and be reviewed by a standing Division of Research Grants (DRG) study section. If the NCI determines that there is a sufficient continuing program need, a request for new and competitive continuation applications will be announced. FUNDS AVAILABLE The NCI has determined that it will continue its support of programs that monitor progress against cancer through breast cancer screening. Approximately $8,000,000 in total costs for five years will be committed to fund applications that are submitted in response to this RFA. It is anticipated that up to three awards will be made to applicants who successfully demonstrate that they can develop a "multi-institutional group" with the ability to access mammography and pathology facilities, and a cancer registry. Awards will be made to applicants who demonstrate a willingness to collaborate with researchers working in the same research area, principally awardees who have formed the working Consortium as a response to the previous RFA. First year costs may include development of computer systems dedicated to this research, if needed. Following is the estimated total cost support available for all awards by fiscal year: FY 96 $1,000,000 FY 97 1,500,000 FY 98 1,500,000 FY 99 2,000,000 FY 2000 2,000,000 Total $8,000,000 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 plans of the NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. For purposes of budgeting, funds should be requested for up to three persons to attend two meetings in Bethesda, Maryland, during each of the five years of award. RESEARCH OBJECTIVES A. Background Breast cancer is the second leading cause of death among women. In 1993, an estimated 46,000 women will die of breast cancer, while 182,000 new female cases will be diagnosed. Approximately one woman in every eight will develop breast cancer in her lifetime (Miller, Ries, Hankey et al, 1992). Screening for breast cancer can reduce mortality among women aged 50 and older. A controlled trial that started in the early 1960s demonstrated a 30 percent reduction in breast cancer mortality among women screened by mammography and clinical breast examinations (Shapiro, Venet, Strax, Venet, 1988). More recent studies confirmed the effectiveness of screening mammography in reducing breast cancer mortality, (DHHS, PHS, "Healthy People 2000") notwithstanding the recent conflicting results from the Canadian study (Miller, Baines, To, Wall, 1992). A review of the breast cancer screening data indicates an under utilization of mammography in surveys conducted as late as 1979 (Howard, 1987). Eight to eleven years later, breast cancer screening with mammography had become an increasing part of the health care picture. Data from 1987 and 1990 National Health Interview Surveys (NHIS) showed that screening with mammography had reached 59 percent of women over 40 years of age at some time by 1990 (compared to 45 percent in 1987), and 33 percent had a screening exam in the last year (compared to 17 percent in 1987) (Kessler, Breen, 1992). Although data from the 1992 NHIS show increases in screening across all age and race groups, these increases are smaller than the increases in the late 1980s (Breen and Kessler, unpublished data from the 1992 NHIS public use data tapes). These percentages were higher than previous surveys, and were part of an increasing trend that suggested annual mammography was as high as 40 percent in surveys of the Behavioral Risk Factor Surveillance System (BRFSS) of the Centers for Disease Control (CDC). In addition, analyses of the 1987 BRFSS data showed considerable state-to-state variation in screening rates. Rates of participation by population characteristics are also obtained. This project will provide the opportunity to investigate differences in the actual provision of screening services, and by doing so, assist in evaluating the population benefit of these increased screening activities. Data on another critical component of breast cancer screening, the physical examination, are also available from the NHIS. Makuc, Freid, and Kleinman reported on breast physical examination rates >From 1973 and 1985 (Makuc, Freid, Kleinman, 1989). They showed a substantial increase in prevalence of examinations during this interval for black women in the U.S., but virtually no change among white women. By 1985, approximately 70 percent of white and black women had received a breast physical examination within the past two years. Recent survey results indicate that while the usage of mammography is increasing, the usage of clinical breast exam along with mammography may be declining. A comparison of mammography utilization rates among white women 64 to 75 years of age in five communities of the NCI Breast Cancer Screening Consortium showed that rates had increased significantly (from 19-33 percent in 1978-88 to 35-59 percent in 1991 across all five areas). However, among women who had a mammogram, the percent who also had a clinical breast examination decreased between the 1978-88 survey and the 1991 survey (p=.001 using logistic regression pooled across all sites) (Coleman, Feuer, NCI Breast Cancer Screening Consortium, 1992). Since clinical breast exam, along with mammography, is recommended as a screening test for breast cancer detection, data need to be collected on this screening test as well when feasible. Research is needed on the effectiveness, efficiency, and cost of breast cancer screening programs in the United States, on the medical decision models for workup of women with abnormal screening tests, and on the utilization of emerging new technologies in breast cancer detection. Of major interest is whether or not there are differences in biology, clinical management, and outcome between screened detected and non-screened detected cases. These areas of cancer surveillance research require a strong interface between methodologic techniques and cancer control initiatives in prevention, early detection, and treatment. Investigators affiliated with mammography facilities, pathology laboratories, and a population-based cancer registry are encouraged to work together to answer these questions. B. Goals and Scope The objectives of this RFA are to foster research collaborations and interactions among basic researchers, clinical investigators, and applied researchers affiliated with quality-controlled population- based tumor registries. The focus of these collaborations is to advance research in breast cancer screening methods, technology, clinical work-up of women with abnormal screening tests, and differentials in the biology and immunobiology of breast cancers in relationship to detection methods. Specifically, the objectives of the Breast Cancer Surveillance Research Project are to conduct analytic research on breast cancer screening in order to assess the operation (including cost) of screening programs and policies in the U.S., and associated decision models for workup of women with positive screening tests. The research must be amenable to extending implementation in a multi- group setting using comparable data, which may include, but is not limited to, the following: o recommended screening policies o target groups for screening o rates of women screened o influence of screening on trends in breast cancer incidence and intermediate outcomes (e.g., stage) o quality assurance procedures o use of state-of-the-art technology o results of screening examinations, including predictive values, sensitivity, and specificity o follow-up of screened women o effect of screening on changes in breast cancer prognosis Under the previous release of this RFA, three awards were made. However, incomplete coverage of several key populations will limit our understanding the current implementation of breast cancer screening in the U.S. Specifically, coverage of African-Americans and rural populations is less than optimal. This RFA encourages applicants who can address one of these two groups, although consideration will be given to applicants who can perform unique and important research in other populations. Secondary objectives of the Breast Cancer Surveillance Research Project extend the operational focus of breast cancer screening programs to incorporate basic and clinical research on emerging technologies in breast cancer detection and on biological differences of tumors associated with detection modality. Specifically, these objectives are to conduct research such as, but not limited to, the following: 1. Studies of the utilization of state-of-the-art and emerging new technologies in breast cancer screening and diagnosis. Technologies of interest include, but are not limited to, o improvement in conventional mammography such as technological development in grid design and composition o magnetic resonance and stereotactic fine needle aspiration and biopsy o cytology of nipple aspirate. 2. Studies designed to determine whether or not there are differences in biology, clinical management, and outcome between screened detected and non-screened detected cases. Studies may include, but are not limited to, o basic biology and immunology of breast cancer to determine whether there is a difference in screened detected cases and non-screened detected cases o genetic alterations among women with breast cancer detected through screening and those with breast cancer which was non-screened detected. The above research topics are given as examples. Each applicant may submit more than one research plan, and each research plan, depending upon the nature of the proposed study, may or may not be a collaborative study. However, the potential for extension to a multi-institutional setting should be addressed. An additional five- page limit will be allowed for each additional research plan. The Breast Cancer Surveillance Research Project by its very nature will bring together multidisciplinary health professionals to accomplish the goals and objectives of the proposal. Thus, it is important that applicants for this project demonstrate a track record of interdisciplinary activity and interactive "know-how." Furthermore, this concept builds on several ongoing efforts related to data collection in breast cancer screening programs. Examples include CDC's projects in providing breast and cervical cancer screening to low income populations, NCI's Specialized Programs of Research Excellence in Breast Cancer (SPORES), the American College of Radiology's mammography lexicon, and NCI's SEER Special Studies. The applicant must establish the availability and potential of a linked data base between breast cancer screening, registry, and pathology data sources. This data must serve as a foundation or "core" for the conduct of health services and basic biologic research. The quality of this data base must be demonstrated in the application clearly; however, this should be seen as a basic component and not as research in itself. The research topics suggested in the paragraphs about objectives above must build on this data base. As such, an applicant may wish to limit their application to one or two strong research proposals along with the establishment of the data base to maintain a balance in the application and allow for a reasonable budget. SPECIAL REQUIREMENTS Study Organization The NCI will convene a meeting for new award recipients to join the NCI's Breast Cancer Surveillance Consortium. This Consortium consists of one voting member from each award recipient (the Principal Investigator or designee) and one voting member from the NCI (the Program Director or designee). The awardees to this Consortium will review the established group procedures and goals, and work with other investigators to plan and set priorities for cooperative group studies. The NCI Program Director will coordinate and facilitate the interactions of the Consortium institutions and will review their activities for relevance to the objectives of the RFA and programmatic considerations. Terms and Conditions of Award Under the cooperative agreement, a partnership will exist between the recipient of the award and the NCI, with assistance from the NCI in carrying out the planned activity. The following terms and conditions pertaining to the scope and nature of the interaction between the NCI and the investigators will be incorporated in the Notice of Grant Award. These terms will be in addition to the customary programmatic and financial negotiations which occur in the administration of grants. The "Nature of NCI Staff Involvement" and "Responsibilities of Awardees" described in this section are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines; DHHS grant administration regulations 45 CFR 74; DHHS grant administration regulations 45 CFR 92; other DHHS, PHS, and NIH grant administration policy statements; and other NCI administrative terms of award. The inability of an awardee to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of award. 1. Awardee Rights and Responsibilities a. Nature of Involvement with Consortium The award recipients must be willing to join the established NCI Breast Cancer Surveillance Consortium for the purpose of planning, developing, and conducting collaborative projects which share a common protocol, study design and research objectives, and comparable data collection procedures. Within this framework, the awardees will have primary and lead responsibility for the project as a whole, including research design and protocol development, and the planning, conduct, analysis, publication and interpretation of their studies. Data from these collaborative projects will be pooled for joint analysis, interpretation and publication of results in accord with policies and procedures established by the Consortium. The Consortium will convene as needed to discuss collaborative study progress and address scientific-technical aspects of implementation. In addition, when relevant, the award recipients will provide reports on progress of other funded projects external to the collaborative activities. The award recipients (Principal Investigator or designee) must attend Consortium strategy session meetings and cooperate fully as active participants in the development and implementation of collaborative projects. Each awardee must access three different kinds of facilities for the purpose of data collection and analysis regarding breast cancer screening practices. Access to existing records and collection of new information is required for: mammography facilities, pathology laboratories, and a quality-controlled, population-based cancer registry. Since this project includes substantial involvement in the use of the facilities' records and practices, the awardee must ensure collaboration among the three facilities throughout the award for purposes of this research project. b. Strategy Sessions and Meeting Attendance The awardee must agree to send at least one representative to each of the Consortium meetings. In most cases, two representatives will be necessary because of the wide range of substantive and methodological discussions during these strategy sessions. c. Data Collection and Management Award recipients: 1. Must cooperate in the establishment of comparable data collection techniques for collaborative studies; 2. Ensure that the tripartite multi-institutional group is able to implement the data collection procedures to be developed by the Consortium members; 3. Ensure that the population-based registry data are compatible with SEER Program standards; and 4. Make all data required by any collaborative Consortium study available for pooled analyses. Awardees are required to collect prospective detailed data directly >From breast cancer screening facilities and from pathology records, and to link these data to population-based cancer registry data. These unique linkages are required in order to conduct research on breast cancer screening programs and to facilitate investigator initiated research on the immunobiology, cell biology, molecular genetics and endocrinology of breast cancer. The awardees will retain custody of and primary rights to their data. However, the NCI Program Director or designee will have access to all data generated under collaborative studies conducted under this award. The NCI Program Director or designee may review data management and analysis procedures for collaborative studies under mutually agreeable circumstances. Data must also be available for external monitoring if required by NCI's agreement with other Federal agencies, such as the FDA. 2. NCI Staff Responsibilities a. Establishment of Consortium The NCI Program Director will convene a meeting for the recipients of this RFA to join the Consortium, when the awards have been made. Principal Investigators from each of the award recipients will meet with the NCI Program Director to build a cooperative organizational unit, referred to as the Consortium. The Program Director may designate a staff person in the Surveillance Program to assume some duties of this role as needed. b. Strategy Sessions The NCI Program Director or designee, in cooperation with the Consortium Coordinator, will sponsor strategy sessions when indicated, attended by Principal Investigators and other appropriate staff from the Consortium and appropriate NCI staff. c. Data Management Each awardee will retain custody of and primary rights to their data and is responsible for statistical analysis of local data, computer processing and statistical interpretations. However, for any collaborative studies among the Consortium members, the NCI is willing to assist in providing data analysis and statistical evaluation from existing resources for pooled analyses. For these collaborative studies, the Consortium members will be responsible for the study design, planning and interpretation of the data. The NCI Program Director will have access to all data generated under this award and will periodically review the data management and analysis procedures for the Consortium. Data must also be available for external monitoring if required by NCI's agreement with other federal agencies, such as the Food and Drug Administration (FDA). d. Monitoring and Program Review In addition to normally prescribed duties of program and grants staff, an on-site program review will occur as early as 10 months but no later than 18 months after award. The program review will be conducted to evaluate progress of the Consortium, particularly the collaborative projects. The inability of a Consortium member to meet the performance requirements set forth in the Terms of Cooperation in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. 3. Collaborative Responsibilities Awardees to this request must agree to join the existing Breast Cancer Surveillance Consortium. The Consortium members will establish a leader (Consortium Coordinator, chosen from awardees) who will administratively preside at all Consortium meetings. The Consortium Coordinator, other members of the Consortium, and the NCI Program Director (Associate Director, Surveillance Program, DCPC) have established administrative procedures (i.e., meeting dates, guidelines for reporting, etc.) and methods by which all scientific/analytic requirements of the RFA will be met. The new awardees will review these procedures and work with the Consortium to determine the need for any changes. Awardees will be required to accept and implement the common protocol and procedures approved by the Consortium. The Consortium will convene as needed to discuss collaborative study progress and address scientific-technical aspects of implementation. At Consortium meetings, members will strive to develop collaborative protocols and comparable standards for data collection and management, examine the areas of commonality, and discuss progress toward the agreed upon goals in all of the RFA scope of activities. These range from development of data collection instruments to more complex procedures such as the study protocol required to answer research questions in the collaborative studies proposed by the Consortium. Timelines will be established, revised and refined; Consortium members will collectively address and solve problems within the project; outstanding research questions will be defined and existing ones will be prioritized; data will be analyzed and prepared for "pooled" statistical analyses to answer agreed upon research questions requiring pooled analyses. At these meetings, information relevant to collaborative studies will be reviewed and discussed, including such issues as overall Consortium performance and the science of current or proposed collaborative studies. Data will be analyzed and the outstanding research questions established and prioritized into national research goals by the Consortium investigators and the NCI Program Director. The Principal Investigators will have the primary responsibility for analyzing and prioritizing the research questions to be developed into collaborative studies. The NCI Program Director will provide assistance and guidance as needed, for example, in developing shared study protocols, selecting data elements, obtaining cooperation from the three types of facilities, linking databases, and analyzing pooled data on the operational aspects of screening. Communication at the various stages of protocol development is encouraged. 4. Arbitration Process The Terms and Conditions of Award require that the NCI Program Director make post-award decisions related to program performance and programmatic decisions on scientific-technical matters. NCI will establish an arbitration process when a mutually acceptable agreement cannot be obtained between the awardee and the NCI Program Director. An arbitration panel (with appropriate expertise) composed of one member selected by the recipient group, one NCI nominee, and a third member chosen by the other two will be formed to review the NCI decision and recommend a course of action to the Director, NCI. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS regulations 45 CFR Part 16. 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. 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 February 14, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information 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. Brenda K. Edwards at the address listed under INQUIRIES. APPLICATION PROCEDURES Because the Terms of Cooperation (discussed in the Special Requirements Section above) will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to these terms. Plans must describe how the applicant will comply with NCI staff involvement as well as how all the responsibilities of awardees will be fulfilled. 1. In addition to providing a complete research plan based on the kind of resources immediately available to the applicant, each applicant must delineate its catchment area for each of the three facilities (mammography, pathology, and tumor registry). Each applicant will project how the research plan could be expanded as resources within the Consortium become available. 2. A designated Principal Investigator is required. An associate Principal Investigator should be named to assure continuity in the event of resignation of the Principal Investigator. The qualifications and experience of both must be described. 3. Each applicant must provide the qualifications and experience of all proposed support personnel, as well as a description of the proposed duties for each position. 4. Multiple research affiliations and related funded research are permitted provided they are not conflicting. The affiliation agreements must state specifically how the problem of competing projects will be resolved. 5. Quality control procedures must be described in detail. It is essential that the quality control of the cancer registry be described. 6. The availability of facilities, including mammography facilities, pathology laboratories, and quality controlled population-based cancer registries, must be described. A statement of commitment from each participating institution or organization and/or documentation of collaborative arrangements must be provided. Each applicant must have a defined space for administrative activities and administrative personnel which will serve as a focus for data management, quality control, and communication. 7. Each applicant's capability and expertise to manage the data must be described. Data management includes development of data collection forms, procedures for data transmittal, procedures for data entry, data editing, compilation, and analysis, as well as procedures for quality control and verification of submitted data. Statistical data collection comparability must exist among the tripartite local facilities and the collaborative research project. Each applicant must provide evidence of their willingness to pool statistical data for analysis as required for collaborative studies. Each applicant's ability to manage data from local facilities and to participate in multi-institutional collaborative studies must be described. 8. Applicants need to demonstrate that they can successfully develop a tripartite organization of local facilities and show evidence that they will successfully participate in a Consortium and conduct collaborative studies. This will be the primary mechanism by which the NCI Program Director will relate to all principal award recipients over the duration of the period of the RFA. 9. The applicant must describe how the issue of confidentiality will be addressed, describing how the records of patients will be protected. The applicant must include evidence and knowledge of legal issues pertaining to the collection and analysis of data. Specific state laws and their impact on the project must be fully explained. 10. Each applicant must submit at least one research plan separate >From the construction of the research data base in the application, with an additional five page limit being allowed to describe each additional study. 11. In the event several projects or components are proposed, the format of the program project grant should be used in which separate budgets are used. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for cooperative agreements. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the NCI program official named below. 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, 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. Submit a signed, typewritten original of the application, including the Checklist, and three signed, clear and single-sided 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 also be sent to: Ms. Toby Friedberg, Referral Officer Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 Bethesda, MD 20892 Failure to submit these copies may delay the review and consideration of an application for award in FY 1996. 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 Review Procedures Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit in accordance with the review criteria stated below by an appropriate peer review group convened by the NCI. 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 following factors will be considered in evaluating the scientific merit of each response to the RFA: 1. Scientific merit of each research plan within the application that includes analytic research on breast cancer screening plus one or more of the following: utilization of state-of-the-art and emerging new technologies in breast cancer screening and diagnosis, biology of screened detected and non-screened detected cases, and other investigator proposed studies. 2. Appropriateness of plans to develop or modify current data collection practices to conform to standards set by Consortium members which should include: o evidence of obtaining cooperation of radiologists, pathologists, surgeons, tumor registrars, etc., necessary for data collection efforts; o description of how data systems in the area will be linked to cancer registry and plans to solve anticipated problems with data linkage. The development of a data base linking breast cancer screening facilities to registries and pathology laboratories will be considered as a basic requirement of the application. The establishment of this data base is necessary for the research priorities for this RFA to be completed. Establishment of this data base must be described succinctly so that reviewers can determine its viability. However, the mere establishment of the data base is not equivalent to responsiveness to the RFA. 3. Scientific, technical, or medical significance and originality of proposed breast cancer research that uses the database; i.e., whether or not new technologies are employed in breast cancer screening and diagnosis, basic biology and immunobiology of screened detected versus non-screened detected breast cancer, genetic alterations among women with breast cancer detected through screening versus those with breast cancer that was non-screened detected, economics of breast cancer screening techniques, or some other area of breast cancer research which uses the database. The scientific merit of the study objective(s), design, and methodology. 4. Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. 5. Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research should include: o demonstration of a track record of interdisciplinary activity and interactive "know-how"; o experience in the management of large data sets; o personnel with credentials and experience in cancer registration, breast cancer pathology, mammography and other breast cancer screening technology, breast cancer biology, biostatistics, and computer programming. 6. Adequacy of time (effort) that the Principal Investigator and staff would devote to establishing the database and conducting the proposed studies. 7. Availability of resources necessary to perform the research. 8. Commitment to conduct pooled analyses of combined data across cooperative agreements in the Consortium for research objectives that require pooled analyses of data. 9. Availability of a population for surveillance coverage and research which complements the existing projects. Current studies sponsored by NCI include the ethnically diverse population in and around San Francisco, a Health Maintenance Organization in the Seattle area, a relatively homogeneous population although representative of the catchment area, and the area surrounding Denver, Colorado, which has a sizable Hispanic population. Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. Subsequent to the scientific merit of the proposed projects, consideration will be given to the appropriateness of the proposed budget and duration in relation to the proposed research as part of the review process. AWARD CRITERIA The anticipated date of award is December 1995. In addition to the technical merit of the application, the NCI will consider how well the proposed research meets the goals and objectives of the program as described in the RFA, as well as the level of total costs requested. Awards will be given to Principal Investigators/ applicants who demonstrate they can successfully develop the essential elements required in a tripartite local organization, which shows evidence that they will successfully participate in collaborative studies conducted by the Consortium. The Consortium is the primary entity by which the NCI Program Director will relate to all principal award recipients over the duration of the period of the project. Funding criteria will be weighted toward those applications that demonstrate a capability for collaborative studies involving all three facilities (clinical/radiology, pathology/laboratory science, and population-based quality controlled cancer registry) and scientifically meritorious research studies that address the full scope of the RFA. Strong consideration will be given to the potential of having geographical and racial representation in the study population within the Consortium. 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: Brenda K. Edwards, Ph.D. Surveillance Program National Cancer Institute Executive Plaza North, Room 343 Bethesda, MD 20892 Telephone: (301) 496-8506 FAX: (301) 402-0816 Email: edwardsb@dcpceps.nci.nih.gov Direct inquiries regarding fiscal matters to: Robert E. Hawkins Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 213 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93,399. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74; DHHS grant regulations at 45 CFR part 92. 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. References Coleman EA, Feuer EJ, NCI Breast Screening Consortium. Breast cancer screening among women 65-74 years of age in 1987-88 and 1991. Ann Intern Med. 1992;117:961-966. Howard J. Using mammography for cancer control: an unrealized potential. Cancer. 1987;37:33-48. Kessler LG, Breen N. Screening mammography doubles between 1987 and 1990. 1992(in review). Makuc DM, Freid VM, Kleinman JC. National trends in the use of preventive health care by women. Am J Public Health. 1989;79:21-26. Miller AB, Baines CJ, To T, Wall C. Canadian National Breast Screening Study. Can Med Assoc J. 1992;147:1459-1488. Miller BA, Ries LAG, Hankey BF, Kosary CL, Edwards BK (eds). Cancer Statistics Review: 1973-1989, National Cancer Institute. NIH Pub. No. 92-2789, 1992. Shapiro S, Venet W, Strax P, Venet L. Periodic screening of breast cancer: the Health Insurance Plan Project and its sequelae, 1963-1986. Baltimore, MD: The Johns Hopkins University Press; 1988. From owner-sci-resources@net.bio.net Fri Jan 13 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AG-95-003 - V24(01) 01/13/95 Date: 13 Jan 1995 16:49:48 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 400 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3f773c$oke@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AG95003 AG-95-003 P1O1 *************************************** MINORITY DISSERTATION RESEARCH GRANTS IN AGING NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA: AG-95-003 P.T. 40, FF; K.W. 0710010 National Institute on Aging Application Receipt Date: March 20, 1995 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 REQUIREMENTS 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. Within this group, women and persons with disabilities are particularly encouraged to apply. 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 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). Research topics should be on aging-related issues and should fit within one or more of the areas described below for each individual program (see RESEARCH OBJECTIVES). The applicant organization must be a domestic institution supporting doctoral level training, such as a university or college. 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. These grants are not eligible for competitive renewal. RESEARCH OBJECTIVES This research initiative is to provide minority students assistance to complete their dissertation research on an aging-related topic and thereby increase the pool of minority researchers in aging. The description of the four extramural programs below is provided to help potential applicants to determine whether their topic may be appropriate for this initiative. Questions on the relevance of a particular topic can be addressed to the program contact listed under INQUIRIES. Biology of Aging Program 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. Behavioral and Social Research Program 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. Neuroscience and Neuropsychology of Aging Program 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. Geriatrics Program 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. SPECIAL REQUIREMENTS Additional Material. In addition to the completed PHS 398 form described under APPLICATION PROCEDURES, applicants must also submit: o A letter from the faculty committee or university official directly responsible for supervising the development and progress of the dissertation research. 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 RFA, (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 A transcript of the investigator's graduate school record o Biography of mentor limited to 2 pages (use the Biographical Sketch page in PHS form 398) o Statement of the investigator's career goals to be placed under "Background" (see the Research Plan instructions in PHS form 398) 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. 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. o Investigators may request support for up to 24 months. An application that requests support beyond this time will be returned. o 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. 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. 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 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, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248 and from the program administrator listed under INQUIRIES. 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-95-003) 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. Submit a signed typewritten original of the application (with the supporting letter and graduate school transcript), 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 (with the supporting letter and the graduate school transcript) must be sent to: Dr. Michael Oxman Chief, Scientific Review Office National Institute on Aging Gateway Building, Suite 2C212 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 ATTN: Minority Dissertation Applications must be received by March 20, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by NIA. Applications that are either incomplete or nonresponsive will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate 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 deemed 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 noncompetitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria. o scientific, technical, or medical significance and originality of the proposed research; o appropriateness and adequacy of the literature review, experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator (the student); o qualifications, research and training experience of the mentor; o quality and availability of research resources needed to complete the dissertation; o appropriateness of the proposed budget and duration in relation to the proposed research; o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA The anticipated date of award is September 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 Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. 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 to discuss the suitability of the research topic. Dr. Robin A. Barr Office of Extramural Affairs National Institute on Aging Gateway Building, Suite 2C218 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9322 FAX: 301-402-9245 Email: barr%nihniagw.bitnet@cu.nih.gov Direct inquiries relating to fiscal matters to: Mr. Joseph Ellis Grants and Contracts Management Office Gateway Building, Suite 2N212 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: 301-402-3672 Email: EllisJ@gw.nia.nih.gov 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 Fri Jan 13 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AR-95-003 - V24(01) 01/13/95 Date: 13 Jan 1995 16:49:43 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 358 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3f7737$ojv@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AR95003 AR-95-003 P1O1 *************************************** CLINICAL STUDIES: SKIN DISEASES IN HIV/AIDS NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA: AR-95-003 P.T. 34; K.W. 0715008, 0715185, 0745070 National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: March 15, 1995 Application Receipt Date: April 21, 1995 PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invites applications for clinical studies on the treatment of skin diseases associated with HIV infection, including AIDS. These studies are designed primarily to evaluate innovative or new treatments and/or combination therapy in the treatment of any of the skin diseases seen in association with HIV infection, including AIDS, and compare them to more standard therapeutic approaches for these diseases, particularly in relation to efficacy, side effects and costs. It is not intended that large scale multicenter clinical trials be supported in response to this RFA, but rather that clinical studies be designed that may, once validated, form the basis for subsequent clinical trials. 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), Clinical Studies in Skin Diseases Associated with HIV/AIDS, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Summary 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. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01), FIRST (R29) awards, and interactive research project grant (IRPG) mechanisms. The IRPG mechanism is described in PA-94-086, NIH Guide, Vol. 23, No. 28, July 29, 1994. 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 three years. The anticipated award date is September 15, 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 investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the entire program is anticipated to be 1.5 million dollars. The anticipated number of new awards is four to five. RESEARCH OBJECTIVES Background Previously supported studies of the natural history of HIV infection, including AIDS, focusing on the incidence and prevalence of skin disease, have indicated that essentially all individuals infected with HIV manifest skin diseases at some time during their infection. These diseases may be similar in nature to those seen in the non-HIV infected population, but are often more chronic and resistant to treatment. These diseases include, but are not limited to seborrheic dermatitis, psoriasis, verruca vulgaris, molluscum contagiosum, superficial fungal infections, folliculitis, both bacterial and of other etiologies, and pruritus. Other skin manifestations associated with HIV infection are more specific to individuals infected with HIV. Malignancies associated with HIV infection are not within the scope of this RFA. Although many of these diseases respond reasonably well to standard dermatologic therapy, many of them eventually become resistant to therapy and necessitate either combination treatment or innovative therapies (utilization of medications for non-FDA approved indications). These approaches have been anecdotally reported and discussed in clinical dermatologic circles, but there are no controlled clinical studies to determine the efficacy, side effects, or cost attendant with these approaches. As individuals with HIV live longer, it becomes even more likely that they will suffer significant skin manifestations potentially requiring the use of innovative therapeutic approaches. This RFA is designed to initiate studies that have the long term potential of indicating whether novel agents or therapeutic combinations are likely to be effective for these diseases. Applications in response to this RFA are not expected to be for large scale multicenter clinical trials. Rather, it is expected that applications will be for clinical studies designed to develop and test protocols that have the potential for providing statistically valid information concerning efficacy, side effects and cost of innovative approaches to these diseases. These studies should have reproducible and quantifiable end points and appropriate control groups. Outcome measures or endpoints taking into account meaningful clinical improvement are preferred. Consideration should be given to the level of improvement (for example 20, 30, or 50 percent) that would be accepted as meaningful to clinicians or subjects. The validity of outcome measures or endpoints should be addressed. It is strongly recommended that applicants have or enlist individuals with clinical trial and biostatistical expertise and training in order to ensure proper design of these clinical investigations. The NIAMS strongly supports the provision of training or experience in biostatistics and clinical trials for individuals interested in careers in these disciplines within dermatology as a component of projects submitted in response to this RFA. The sample size considerations for the pilot study should be addressed. The application should include a plan for data management and analysis. A plan for data safety monitoring is strongly recommended, particularly for studies incorporating larger numbers of subjects or testing interventions with potentially significant adverse effects. It is also expected that there will be a discussion of the size of subsequent studies that would have sufficient power to prove the hypothesis once the clinical studies have demonstrated the validity of the approach to be taken. Therefore, the clinical studies supported under this RFA are expected to be of three years duration to allow enough time for study design, development of the protocol, and field testing and evaluation. These studies are not to be designed to be definitive tests of therapeutic interventions that typically would require larger multicenter approaches and budgets well in excess of those expected in responses to this RFA. The specific disease or diseases to be investigated, the interventions to be tested, and the control groups, are to be proposed by the applicant. These should be adequately justified by literature citations and/or clinical experience, which may be anecdotal. 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. 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. LETTER OF INTENT Prospective applicants are asked to submit, by March 15, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIAMS 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. Alan N. Moshell 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, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the program administrator listed under INQUIRIES. 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. 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. 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 also be sent to: Tommy L. Broadwater, Ph.D. Chief, Grants Review Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-25U 45 Center Drive, MSC 6500 Bethesda, MD 20892-6500 Applications must be received by April 21, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIAMS. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIAMS 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 (ICD) 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 Advisory ICD Council/Board. Review criteria for this RFA are generally the same as those for unsolicited research grant applications. o scientific, technical, or clinical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA The anticipated date of award is September 15, 1995. Awards will be based upon the following criteria: o priority score o availability of funds o programmatic priorities of the funding ICD 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: Alan N. Moshell, M.D. Skin Diseases Program Director National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-25L 45 Center Drive Bethesda, MD 20892-6500 Telephone: (301) 594-5017 FAX: (301) 480-4543 Email: moshella@ep.niams.nih.gov Direct inquiries regarding fiscal matters to: Mary L. Graham Grants Management Officer National Institute of Arthritis, Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-49A Bethesda, MD 20892-6500 Telephone: (301) 594-3504 FAX: (301) 480-5450 email: Grahamm@ep.niams.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The 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 Jan 13 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-016 - V24(01) 01/13/95 Date: 13 Jan 1995 16:49:38 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 262 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3f7732$oji@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95016 PA-95-016 P1O1 *************************************** FAILURE TO HEAL: CHRONIC WOUND HEALING IN THE SKIN NIH GUIDE, Volume 24, Number 1, January 13, 1995 PA NUMBER: PA-95-016 P.T. 34; K.W. 0715185, 0715027 National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute on Aging National Institute of Child Health and Human Development National Institute of General Medical Sciences National Institute of Nursing Research PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute on Aging (NIA), the National Institute of Child Health and Human Development (NICHD), National Institute of General Medical Sciences (NIGMS), and the National Institute of Nursing Research (NINR) invite applications for research on wounds that fail to heal, including decubitus (pressure) ulcers, venous (stasis) ulcers and diabetic ulcers. The purpose of this Program Announcement is to encourage research investigations that will provide new knowledge of the mechanisms of abnormal wound healing and/or to apply new findings or interventions to the treatment and prevention of chronic wounds in man. 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 (PA), Failure to Heal: Chronic Wound Healing in the Skin, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Summary 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. Women and minority investigators are encouraged to apply. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) individual research project grant (R01), FIRST (R29) awards, and interactive research project grant (IRPG) mechanisms. The IRPG mechanism is described in PA-94-086, NIH Guide, Vol. 23, No. 28, July 29, 1994. The total project period for applications submitted in response to the PA may not exceed five years. RESEARCH OBJECTIVES Background In spite of recent advances in the basic mechanisms of wound healing, knowledge of the factors involved in the development and treatment of chronic wounds remains limited. Future progress in the treatment of chronic wounds will require greater understanding of their pathogenesis and failure to heal. These two aspects were the subject of a Workshop sponsored by the Skin Diseases Interagency Coordinating Committee of the National Institutes of Health held on January 10 and 11, 1993. The Workshop brought together a multidisciplinary group of scientists working in the field of wound repair. A summary of this Workshop was published in the Journal of Investigative Dermatology (v.102, pp 125-7, 1994). Identified below is a selection of the areas covered in that Workshop that are relevant to this solicitation. This list is illustrative and not exclusive or restrictive. o Cytokines and growth factors in wound healing o Keratinocyte migration in the wound bed o The chronic wound environment o Changes in composition of extracellular matrix with advancing age o Matrix degrading metalloproteinases in wound healing o Metabolic changes, both systemic and in the wound environment, including changes as a consequence of chronic disease or disability o Local tissue hypoxia o Fibrin formation and removal in wound healing o Wound infection o Alterations in wound healing with advancing age, chronic disease or disability o Characterizing risk factors for recurring wounds o Clinical therapeutics in wound healing and prevention of recurring wounds o Factor affecting the rate of healing of decubitus ulcers, and success of treatment 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) 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, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff or contact persons 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) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available from 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 number and title of this program announcement must be typed in item number 2a on the fact page of the application. The completed original and five permanent, legible copies of the PHS 398 form must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications received under this program announcement will be assigned to an appropriate Initial Review Group (IRG) in accordance with established NIH Referral Guidelines. The IRG, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit in accordance with standard NIH review procedures. 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. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Notification of the review recommendations will be sent to the applicant after the initial review. Applications recommended for further consideration and receiving sufficiently high priority will receive a second-level review by an appropriate National Advisory Council, whose review may be based on policy considerations as well as scientific merit. AWARD CRITERIA Applications recommended by a National Advisory Council will be considered for funding on the basis of overall scientific and technical merit of the research as determined by peer review, program needs and balance, and availability of funds. INQUIRIES Inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Alan N. Moshell, M.D. National Institute of Arthritis, Musculoskeletal and Skin Diseases Natcher Building,Room 5AS-25L 45 Center Drive Bethesda, MD 20892-6500 Telephone: (301) 594-5017 FAX: (301) 480-4543 Hilary D. Sigmon, Ph.D., R.N. National Center of Nursing Research Natcher Building, Room 3AN-12 45 Center Drive Bethesda, MD 20892-6300 Telephone: (301) 594-5970 FAX: (301) 480-8260 David Finkelstein, Ph.D. National Institute on Aging Gateway Building, Room 2C231 Bethesda, MD 20892 Telephone: (301) 496-6402 FAX: (301) 402-0010 Danuta Krotoski, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Building 61E, Room 2A03 Bethesda, MD 20892 Telephone: (301) 402-2242 FAX: (301) 402-0832 Yvonne T. Maddox, Ph.D. National Institute of General Medical Sciences Natcher Building, Room 2AS-49H 45 Center Drive Bethesda, MD 20892-6200 Telephone: (301) 594-5560 FAX: (301) 480-2802 Direct inquiries regarding fiscal matters to: Mary Graham National Institute of Arthritis, Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-49A 45 Center Drive Bethesda, MD 20892-6500 Telephone: (301) 594-3504 FAX: (301) 480-5450 Sally A. Nichols Grants Management Office National Institute of Nursing Research Natcher Building, Room 3AN-32 45 Center Drive Bethesda, MD 20892-6300 Telephone: (301) 594-6869 FAX: (301) 480-8256 Carol Tippery Grants Management Officer National Institute of General Medical Science Natcher Building, Room 2AN-24C 45 Center Drive Bethesda, MD 20892-6200 Telephone: (301) 594-5135 FAX: (301) 480-1969 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the nonuse 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 Jan 13 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA MH-95-001 - V24(01) 01/13/95 Date: 13 Jan 1995 16:49:31 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 350 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3f772r$oiu@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA MH95001 MH-95-001 P1O1 *************************************** SERVICES RESEARCH SUPPLEMENTS TO CLINICAL THERAPEUTIC GRANTS NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA: MH-95-001 P.T. 34; K.W. 0715129, 0730057 National Institute of Mental Health Letter of Intent Receipt Date: April 15, 1995 Application Receipt Date: May 5, 1995 PURPOSE The National Institute of Mental Health (NIMH) announces the continued availability of competitive supplements to expand ongoing funded clinical therapeutic research grants into the area of services research. The purpose of these supplements is to help move mental health treatments from the testing of efficacy (i.e., whether the treatment works under highly controlled conditions in a population with a well-defined mental disorder) into testing of effectiveness (i.e., whether the same promising treatment works when applied to a wider and diverse range of settings, providers, populations, and outcome assessment). Services research is a major NIMH priority and is responsive to Public Law 102-321 (July 10, 1992), which requires NIMH to obligate not less than 15 percent of its budget to health services research. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Services Research Supplement to Clinical Therapeutic Grants, is related to the priority areas 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 These supplemental applications will only be considered for currently funded NIMH grants with at least one year remaining at the time of award, and ending no later than June 30, 1998. Applicants who previously submitted supplemental applications in response to the original RFA are eligible to resubmit. Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospital, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISMS OF SUPPORT This RFA will use the National Institutes of Health (NIH) competitive supplement (S01) mechanism and can supplement the following types of grants: R01, R10, R37, P01, P20, P30, P50. PHS policy prohibits any foreign institution from applying for a P mechanism. FUNDS AVAILABLE It is anticipated that at least $1,000,000 in direct costs will be made available. Awards will have a maximum yearly direct cost amount of $200,000, but may not exceed the total costs of the prior year of the parent grant. RESEARCH OBJECTIVES Following are examples of the types of clinical services research issues that would benefit from expansion of ongoing clinical therapeutic research grants. The list is illustrative rather than comprehensive. It is expected that additional relevant and important research topics will be identified by investigators responding to this RFA. o Studies testing promising treatments with new populations, such as racial or ethnic minorities, patients with co-occurring mental, substance abuse, or medical conditions o Studies testing the effectiveness of proven mental health treatments when employed in everyday practice and settings (e.g., primary care settings, nursing homes, community mental health centers, outpatient clinics) o Studies testing the effectiveness of proven mental health treatments when administered by providers who more fully represent the range and expertise of providers expected to deliver the treatment in everyday practice and settings o Studies of the delivery of treatment, such as how to provide coordinated treatment and rehabilitation services and select modalities which best match the patient's/client's needs o Studies that measure an expanded range of outcomes (beyond symptom reduction), such as functional capacity, quality of life, or cost o Financing and cost issues relating to therapeutic interventions, e.g., cost-effectiveness, cost-benefit, and cost-utility research SPECIAL REQUIREMENTS o Supplemental requests should address the need to establish the effectiveness of efficacious treatments, thereby increasing the generalizability of research findings. o Supplemental funds may be used for expenses clearly related and necessary to conduct the proposed additional services research, including both direct and allowable indirect costs. o Supplemental funds may not be used to operate a treatment, rehabilitation, or other service program, nor may such funds be used to fund research that is an integral part of the parent grant. 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 April 15, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIMH staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Robert F. Prien 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 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. 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. 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 also be sent to: Mary Lou Prince Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-4527 FAX: (301) 443-6000 Applications must be received by May 5, 1995. If an application is received after this date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIMH. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, DRG staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIMH 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. Review Criteria o Ability to move mental health treatments from the testing of efficacy (i.e., whether the treatment works under highly controlled conditions in a population with a well-defined mental disorder) into testing of effectiveness (i.e., whether the same promising treatment works when applied to a wider and diverse range of settings, providers, populations, and outcome assessment). o Capability to expand and complement an existing parent grant 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 the resources necessary to perform the research o Appropriateness of the proposed budget and duration in relation to the proposed research o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications recommended for further consideration by the National Advisory Mental Health Council will be considered for funding on the basis of overall scientific and technical merit of the proposal as determined by peer review, appropriateness of budget estimates, program needs and balance, policy consideration, adequacy of provisions for the protection of human subjects, and availability of funds. Upon completion of the project's period of award made under this RFA, grantees may submit competitive renewal applications. 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: Robert F. Prien, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-4527 FAX: (301) 443-6000 Email: rprien@aoamh4.ssw.dhhs.gov George Niederehe, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-1185 FAX: (301) 594-6784 Email: gniedere.aoamh4.ssw.dhhs.gov Peter S. Jensen, M.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-5944 FAX: (301) 443-6000 Email: pjensen.aoamh4.ssw.dhhs.gov Kathryn Magruder, Ph.D., M.P.H. Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10C-06 Rockville, MD 20857 Telephone: (301) 443-3364 FAX: (301) 443-4045 Email: kmagrude.aoamh2.ssw.dhhs.gov Direct inquiries regarding fiscal matters to: Diana Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-3065 FAX: (301) 443-6885 Email: dtrunnel.aoamh1.ssw.dhhs.gov AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance No. 93.242 Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, a amended by Public Law 99-158, 42 PSC 241 and 285) and administered under PHS grants and Federal Regulations 42 CFR, Part 52 "Grants for Research Projects" and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Execute Order 12372. 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 Jan 13 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 1, pt. 2of2, 13 January 1995 Date: 13 Jan 1995 16:49:24 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 350 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3f772k$oia@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950113 V24N01 P2O2 ************************************ The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and email from the program contacts listed below. Alan N. Moshell, M.D. National Institute of Arthritis, Musculoskeletal and Skin Diseases Natcher Building,Room 5AS-25L 45 Center Drive Bethesda, MD 20892-6500 Telephone: (301) 594-5017 FAX: (301) 480-4543 Hilary D. Sigmon, Ph.D., R.N. National Center of Nursing Research Natcher Building, Room 3AN-12 45 Center Drive Bethesda, MD 20892-6300 Telephone: (301) 594-5970 FAX: (301) 480-8260 David Finkelstein, Ph.D. National Institute on Aging Gateway Building, Room 2C231 Bethesda, MD 20892 Telephone: (301) 496-6402 FAX: (301) 402-0010 Danuta Krotoski, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Building 61E, Room 2A03 Bethesda, MD 20892 Telephone: (301) 402-2242 FAX: (301) 402-0832 Yvonne T. Maddox, Ph.D. National Institute of General Medical Sciences Natcher Building, Room 2AS-49H 45 Center Drive Bethesda, MD 20892-6200 Telephone: (301) 594-5560 FAX: (301) 480-2802 $$P1 END ************************************************************ $$P2 BEGIN PA-95-017 FULL-TEXT ************************************** SYRINGOMYELIA NIH GUIDE, Volume 24, Number 1, January 13, 1995 PA AVAILABLE: PA-95-017 P.T. 34; K.W. 0715140 National Institute of Neurological Disorders and Stroke National Institute of Child Health and Human Development PURPOSE The National Institute of Neurological Disorders and Stroke (NINDS) and the National Center for Medical Rehabilitative Research (NCMRR) of the National Institute of Child Health and Human Development (NICHD) announce the issuance of a program announcement to notify the scientific community of their interest in the submission of research grant applications concerning syringomyelia. The mechanisms of support will be the research project grant (R01), program project (P01), center grants (P50), (NINDS only), and FIRST Award (R29). 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 priorities. This PA, Syringomyelia, is related to the priority areas of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-474-0), 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 PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Dr. Judy A. Small Division of Convulsive, Developmental, and Neuromuscular Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 8C04 7550 Wisconsin Avenue MSC 9165 Bethesda, MD 20892-9165 Telephone: (301) 496-5821 FAX: (301) 480-1080 Email: js134h@nih.gov Dr. David B. Gray National Center for Medical Rehabilitative Research National Institute of Child Health and Human Development Building 6100E, Room 2A03 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 FAX: (301) 402-0832 Email: yga@cu.nih.gov $$P2 END ************************************************************ $$P3 BEGIN PAR-95-018 FULL-TEXT ************************************* BIOMEDICAL RESEARCH SUPPORT SHARED INSTRUMENTATION GRANT NIH GUIDE, Volume 24, Number 1, January 13, 1995 PA AVAILABLE: PAR-95-018 P.T. 34; K.W. 1002024, 1014001 National Center for Research Resources Application Receipt Date: March 24, 1995 PURPOSE The National Center for Research Resources (NCRR) announces the availability of a Program Announcement (PA), the purpose of which is to continue the competitive NCRR Biomedical Research Support (BRS) Shared Instrumentation Grant (SIG) Program initiated in Fiscal Year 1982. The (1992) National Report on Academic Research Equipment and Equipment Needs for Biological Sciences, cosponsored by the National Institutes of Health (NIH) and the National Science Foundation, identified research equipment of the type provided through this program as top-priority. The objective of the program is to make available to institutions with a high concentration of NIH-supported biomedical investigators research instruments which can only be justified on a shared-use basis and for which meritorious research projects are described. Awards under this PA will use the Biomedical Research Support Shared Instrumentation Grant mechanism (S10). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and email from the program contact listed below. Marjorie A. Tingle, Ph. D. Director, Biomedical Research Support Program National Center for Research Resources Westwood Building, Room 848 Bethesda, MD 20892 Telephone: (301) 594-7947 FAX: (301) 594-9153 Email: brspsig@ep.ncrr.nih.gov $$P3 END ************************************************************ $$P4 BEGIN PA-95-019 FULL-TEXT ************************************** H. PYLORI: BASIC, PRE-CLINICAL, AND CLINICAL RESEARCH NIH GUIDE, Volume 24, Number 1, January 13, 1995 PA AVAILABLE: PA-95-019 P.T. 34; K.W. 1002027, 0715085, 0765012 National Institute of Allergy and Infectious Diseases Application Receipt Dates: June 1, and October 1, 1995 and February 1, 1996 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), invites submission of investigator-initiated research applications for support of research on the definition of the natural history of infection, animal models, protective immune responses to infection, virulence determinants, bacterial genetics, and antibiotic resistance to Helicobacter pylori. This bacterium is known to be associated with chronic gastritis, duodenal and gastric ulcer disease, and possibly with certain malignancies of the stomach. The development of vaccines against this organism is also of interest to the NIAID. The estimated NIAID funds available for the total (direct and indirect) first-year costs of all awards made under this PA will $1,000,000. In Fiscal Year 1996, the NIAID plans to fund four to five R01 and/or R29 grants. 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, H. Pylori: Basic, Pre-Clinical and Clinical Research, is related to the priority area of immunization and infectious diseases. 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 20402-0325 (telephone 202-783-3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Dennis R. Lang, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A21 6003 Executive Boulevard MSC 7630 Bethesda, MD 20892-7630 Telephone: (301) 496-7051 FAX: (301) 402-1456 Email: dl73v@nih.gov $$P4 END ************************************************************ $$P5 BEGIN PA-95-020 FULL-TEXT ************************************** DECISION MAKING PROCESSES IN WOMEN'S HEALTH NIH GUIDE, Volume 24, Number 1, January 13, 1995 PA AVAILABLE: PA-95-020 P.T. 34, II; K.W. 0785035, 0730050 National Institute of Nursing Research Office of Research on Women's Health Agency for Health Care Policy and Research PURPOSE The National Institute of Nursing Research (NINR), the Office of Research on Women's Health (ORWH), and the Agency for Health Care Policy and Research (AHCPR) invite submission of research grant applications to study the treatment and intervention decision making processes associated with non-cancerous health problems of women that frequently result in the surgical procedure, hysterectomy. These health problems have symptoms that may lead to a decision for hysterectomy even when the underlying pathology is limited. These problems include dysfunctional uterine bleeding, leiomyota (fibroids), endometriosis, pelvic pain, and uterine prolapse. Cancerous conditions leading to hysterectomy are not included in this Program Announcement (PA). This PA is jointly sponsored by NIH and AHCPR and both agencies are interested in applications in all the areas described under RESEARCH OBJECTIVES. The AHCPR is particularly interested in studies that include an emphasis on the influence of market forces, cost factors, health care payers, practice variation, and access issues. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Decision-Making Processes In Women's Health, is related to the priority areas of health promotion and clinical preventive services. Potential applications may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Patricia Moritz, Ph.D., R.N. National Institute of Nursing Research Building 45, Room 3AN-12 45 Center Drive MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5966 FAX: (301) 480-8260 Email: pmoritz@ep.ninr.nih.gov Virginia Cain, Ph.D. Office of Research on Women's Health Building 1, Room 201 Bethesda, MD 20892 Telephone: (301) 402-1770 FAX: (301) 402-1798 Email: virginia_cain@nih.gov Anne Bavier, M.N., R.N. Agency for Health Care Policy and Research 2101 E. Jefferson Drive Rockville, MD 20852-4908 Telephone: (301) 594-1357, ext. 129 FAX: (301) 594-2155 Email: abavier@po3.ahcpr.gov $$P5 END ************************************************************ ERRATA $$E1 BEGIN R4 19941021 APPEND RFA GM-95-001 BOTH *********************** INITIATIVE FOR MINORITY STUDENTS: BRIDGES TO THE BACCALAUREATE DEGREE NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA: GM-95-001 P.T. 44, FF; K.W. 0725005, 0710030 National Institute of General Medical Sciences Letter of Intent Receipt Date: November 18, 1994 Application Receipt Date: January 20, 1995 The following modification is issued for RFA GM-95-001, which was published in the NIH Guide, Vol 23, No. 37, October 21, 1994. The third paragraph under ELIGIBILITY REQUIREMENTS should read: Programs developed or modified under this initiative must be specifically designed to target underrepresented minority undergraduates majoring in the sciences. For purposes of this announcement, underrepresented minority students are individuals belonging to a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical or behavioral research. Historically, individuals who have been found to be underrepresented in biomedical or behavioral research include, but are not limited to, U.S. citizens who are African Americans, Hispanic Americans, Native Americans, and Pacific Islanders. The term "science" is used in this RFA to mean the natural, physical, and behavioral sciences and mathematics relevant to biomedical research. $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Fri Jan 13 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 1, pt. 1of2, 13 January 1995 Date: 13 Jan 1995 16:49:18 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1500 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3f772e$ohm@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950113 V24N01 P1O2 ************************************ X-comment: RFAS described: AG-95-003, HL-95-012, HS-96-001, DA-95-001, AR-95- 003, CA-95-004, NR-95-001, HL-95-013, MH-95-001, A I-95-005, PA-95-016, PA-95-017, PAR-95-018, PA-95-019, PA-95-020 NIH GUIDE, Volume 24, Number 1, January 13, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** LIMITED COMPETING CONTINUATION COOPERATIVE AGREEMENT DA-95-006 - MAXIMIZING EFFICACY OF PSYCHOTHERAPY National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX N2 ********************************************************** CLINICAL TRIALS USING TIPS PROCEDURE FOR PORTAL HYPERTENSION (PA-95-003) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** NIDCD NATIONAL TEMPORAL BONE, HEARING AND BALANCE PATHOLOGY RESOURCE REGISTRY (RFP NIH-DC-95-01) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX R2 ********************************************************** PERFORMANCE OF RADIOIMMUNOASSAYS AND RADIOIODINATIONS (RFP NICHD- IRP-95-12) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R3 ********************************************************** HIV-2 AS A MOLECULAR AIDS VACCINE: A PRIMATE MODEL (RFP NIH-NIDR-1- 95-2R) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX R4 ********************************************************** ESTIMATION OF DIFFERENCES IN FLUORIDE EXPOSURE AND EXPRESSION IN ADOLESCENTS (RFP NIH-NIDR-1-95-4R) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX R5 ********************************************************** DETERMINATION OF SERUM ANTIBODIES TO PERIODONTAL PATHOGENS IN THE U.S. POPULATION (RFP NIH-NIDR-1-95-5R) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX R6 ********************************************************** CLOSED LOOP CONTROL OF FUNCTIONAL NEUROMUSCULAR STIMULATION (RFP NIH- NINDS-95-01) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX R7 ********************************************************** MICROSTIMULATION OF THE LUMBOSACRAL SPINAL CORD - MAPPING (RFP NIH- NINDS-95-08) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX R8 ********************************************************** MICROSTIMULATION OF THE LUMBOSACRAL SPINAL CORD - CHRONIC STIMULATION (RFP NIH-NINDS-95-09) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX R9 ********************************************************** MICROMACHINED STIMULATING ELECTRODES (RFP NIH-NINDS-95-10) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX R10 03/20/95 ************************************************ MINORITY DISSERTATION RESEARCH GRANTS IN AGING (RFA AG-95-003) National Institute on Aging INDEX: AGING $$INDEX R11 04/07/95 ************************************************ LUNG SPECIFIC DRUG DELIVERY SYSTEMS FOR TUBERCULOSIS TREATMENT (RFA HL-95-012) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R12 04/12/95 ************************************************ RESEARCH ON THE OUTCOMES OF PHARMACEUTICAL THERAPY (RFA HS-96-001) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY RESEARCH $$INDEX R13 04/19/95 ************************************************ NEUROSCIENCE NETWORKS IN BASIC DRUG ABUSE RESEARCH (RFA DA-95-001) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX R14 04/21/95 ************************************************ CLINICAL STUDIES: SKIN DISEASES IN HIV/AIDS (RFA AR-95-003) National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES $$INDEX R15 04/21/95 ************************************************ BREAST CANCER SURVEILLANCE RESEARCH (RFA CA-95-004) National Cancer Institute INDEX: CANCER $$INDEX R16 04/26/95 ************************************************ COMMUNITY PREVENTION MODELS: RURAL MINORITY GROUPS (RFA NR-95-001) National Institute of Nursing Research INDEX: NURSING RESEARCH $$INDEX R17 04/28/95 ************************************************ HIV-ASSOCIATED PATHOGENS OF THE LUNG: LIFE CYCLE REGULATION (RFA HL-95-013) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R18 05/05/95 ************************************************ SERVICES RESEARCH SUPPLEMENTS TO CLINICAL THERAPEUTIC GRANTS (RFA MH-95-001) National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX R19 06/15/95 ************************************************ INTERDISCIPLINARY PROGRAMS IN AUTOIMMUNE DISEASE (RFA AI-95-005) National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases Juvenile Diabetes Foundation International INDEX: ALLERGY, INFECTIOUS DISEASES; DIABETES, DIGESTIVE, KIDNEY DISEASES; JUVENILE DIABETES FOUNDATION INTERNATIONAL $$INDEX P1 ********************************************************** FAILURE TO HEAL: CHRONIC WOUND HEALING IN THE SKIN (PA-95-016) National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute on Aging National Institute of Child Health and Human Development National Institute of General Medical Sciences National Institute of Nursing Research INDEX: ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; AGING; CHILD HEALTH, HUMAN DEVELOPMENT; GENERAL MEDICAL SCIENCES; NURSING RESEARCH $$INDEX P2 ********************************************************** SYRINGOMYELIA (PA-95-017) National Institute of Neurological Disorders and Stroke National Institute of Child Health and Human Development INDEX: NEUROLOGICAL DISORDERS, STROKE; CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX P3 ********************************************************** BIOMEDICAL RESEARCH SUPPORT SHARED INSTRUMENTATION GRANT (PAR-95-018) National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX P4 ********************************************************** H. PYLORI: BASIC, PRE-CLINICAL, AND CLINICAL RESEARCH (PA-95-019) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX P5 ********************************************************** DECISION MAKING PROCESSES IN WOMEN'S HEALTH (PA-95-020) National Institute of Nursing Research Office of Research on Women's Health Agency for Health Care Policy and Research INDEX: NURSING RESEARCH; WOMEN'S HEALTH; HEALTH CARE POLICY RESEARCH ERRATA $$INDEX E1 ********************************************************** INITIATIVE FOR MINORITY STUDENTS: BRIDGES TO THE BACCALAUREATE DEGREE (RFA GM-95-001) National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES This publication is available electronically via BITNET or INTERNET, by subscription, and is also on the NIH GOPHER (gopher.nih.gov). Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221); contact Dr. John James at 301/594- 7270 for details. THE 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 ********************************************************** LIMITED COMPETING CONTINUATION COOPERATIVE AGREEMENT DA-95-006 - MAXIMIZING EFFICACY OF PSYCHOTHERAPY NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA: DA-95-006 P.T. 34; K.W. 0745060, 0404009 National Institute on Drug Abuse Application Receipt Date: January 18, 1995 PURPOSE The National Institute on Drug Abuse (NIDA) has supported for the past four to five years a cooperative agreement with a coordinating center and four sites. The cooperative agreement was issued under the announcement entitled, "Maximizing the Efficacy of Psychotherapy and Drug Abuse Counseling Strategies in the Treatment of Cocaine Abusers," (RFA #DA-90-01) published in the NIH Guide in January 1990. Grants to the coordinating center and one site were awarded in FY 1990, and three grants were awarded to three additional sites in FY 1991. The project is designed to compare the efficacy of four treatments for cocaine abuse: group therapy, individual drug counseling, individual supportive-expressive therapy, and individual cognitive therapy (the latter three in combination with group therapy). In addition, the study will examine the interaction of patients characteristics (such as psychiatric severity or sociopathy) with type of psychotherapy/counseling. Because the project is ongoing but has not been completed, NIDA is soliciting competing continuation applications from the CURRENT grantees ONLY. NO OTHER APPLICATIONS WILL BE CONSIDERED. The applications must be directed to completing the existing research protocols established under the current cooperative agreement; proposals for new research in addition to the existing protocols are not acceptable. The total project period for applications submitted in response to the present solicitation may not exceed three years. The anticipated award date is September 1, 1995. The completed original application and three copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** An additional two copies must be sent or delivered to: Mrs. Eleanor C. Friedenberg Director, Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 INQUIRIES Additional information may be obtained by contacting: John Boren, Ph.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-30 Rockville, MD 20857 Telephone: (301) 443-0107 Email: jboren@aoada.ssw.dhhs.gov $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** CLINICAL TRIALS USING TIPS PROCEDURE FOR PORTAL HYPERTENSION NIH GUIDE, Volume 24, Number 1, January 13, 1995 PA NUMBER: PA-95-003 P.T. 34; K.W. 0715115, 0755015 National Institute of Diabetes and Digestive and Kidney Diseases Planning grant (R21) applications may be submitted in response to this PA in addition to the previously indicated R01 applications. The same receipt dates apply for this mechanism. Refer to the NIH GUIDE, Vol. 23, No. 37, October 21, 1994, INQUIRIES section to request information regarding the R21 mechanism. $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NIH-DC-95-01 ********************************************* NIDCD NATIONAL TEMPORAL BONE, HEARING AND BALANCE PATHOLOGY RESOURCE REGISTRY NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFP AVAILABLE: NIH-DC-95-01 P.T. 34; K.W. 0715050, 0775005, 0780030 National Institutes of Health The National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health, has a requirement to continue and further develop the NIDCD National Temporal Bone, Hearing and Balance Pathology Resource Registry that serves as a national resource for both the public and the biomedical research communities to promote research on the pathology underlying diseases and disorders of hearing and balance. The Registry provides information and outreach services to the public and to health care practitioners on the donorship of temporal bone and related brain tissues for research purposes. It also serves the biomedical research community by establishing and maintaining a catalog of currently active and inactive human temporal bone and brain tissue collections and by conserving temporal bone and brain collections by brokering the transfer of tissue specimens from inactive collections to active research centers. The Registry enables investigators to identify and locate all known processed temporal bones and related brain tissue specimens held in the United States by clinical and histopathologic diagnoses and by other pertinent data, so that further studies may be pursued. Additional contract activities will continue to encourage the pursuit of research on the diseases and disorders of hearing and balance, particularly utilizing the newer techniques of antigen retrieval and DNA extraction, by: disseminating pertinent information to the auditory and vestibular research communities, developing and fostering temporal bone professional education activities and encouraging investigator collaborations in the study of the human temporal bone and the related brain structures of hearing and balance. This acquisition is a recompetition of a contract currently being performed by the Massachusetts Eye and Ear Infirmary (contract number N01-DC-2-2111, September 30, 1992 - September 29, 1995). A three-year cost-reimbursement type contract is anticipated. The solicitation is scheduled to be issued on or about January 13, 1995. Proposals will be due 45 days after the date of issuance of the solicitation. All responsible sources may submit a proposal which shall be considered by the Government. INQUIRIES Copies of the solicitation can be obtained by sending a written request to the Contracting Officer at the following address: John P. DeCenzo Research Contracts Branch, DCG/OD National Institutes of Health 6100 Executive Boulevard, Room 6E01 MSC 7540 Bethesda, MD 20892-7540 Telephone: (301) 496-4487 $$R1 END ************************************************************ $$R2 BEGIN NICHD-IRP-95-12 ****************************************** PERFORMANCE OF RADIOIMMUNOASSAYS AND RADIOIODINATIONS NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFP AVAILABLE: NICHD-IRP-95-12 P.T. 34; K.W. 0755000, 0755010, 0780000 National Institute of Child Health and Human Development The National Institute of Child Health and Human Development (NICHD) has a requirement for immunoassay, bioimmunoassay, and radioiodination services. These services will support ongoing research conducted by NICHD's Intramural Research Program and other Intramural Investigators of NIH. The tests will be quantitated utilizing radioisotopic and fluorescent markers. Immunoassays will routinely be developed that are capable of detecting picomole or femtomole concentrations of antigen. Custom iodinations will be performed in support of such assays with 125I using standard chloramine-T, lactoperoxidase, and Bolton-Hunter reagents, and electrolytic and iodogen methodologies. Among the purification procedures employed will be Sephadex gel, ion exchange, concanavalin- A, electrophoresis, and high pressure liquid chromatography. Specific activity, binding efficiency with excess antibody trichloroacetic acid precipitation, and chromatographic elution patterns will be included with each preparation. The performance of immuno-and in vitro bioimmunoassays for hormones and certain drugs in human, monkey, rat, and mouse shall be required. A minimum of 50,000 assays shall be performed for each year of the contract(s). This number may be adjusted depending on the number of actual awards. The laboratory of the successful Offeror(s) must be certified by the Nuclear Regulatory Commission. In addition, the Contractor must be available for frequent discussions and monthly meetings with the Project Officer and the Intramural staff. The RFP will be available on or about January 20, 1995. INQUIRIES All responsible sources are encouraged to submit a proposal. Several awards will be considered. Organizations desiring a copy of the RFP should send a self-addressed mailing label along with their written requests to: Mrs. Dorothy McKelvin Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 7A07 MSC 7510 Bethesda, MD 20892-7510 $$R2 END ************************************************************ $$R3 BEGIN NIH-NIDR-1-95-2R ***************************************** HIV-2 AS A MOLECULAR AIDS VACCINE: A PRIMATE MODEL NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFP AVAILABLE: NIH-NIDR-1-95-2R P.T. 34; K.W. 0715008, 0740075, 0755020 National Institute of Dental Research The National Institute of Dental Research (NIDR) has a requirement to develop a primate model to assay the viral interactions of HIV-1 and HIV-2. This acquisition will involve in vivo and ex vivo studies in order to determine if HIV-2 or the related simian immunodeficiency virus (SIV) can inhibit HIV-1 replication in vivo and ex vivo and to determine if recombination occurs in vivo and ex vivo between HIV-1 and HIV-2. INQUIRIES Request for Proposals (RFP) NIH-NIDR-1-95-2R will be available on or about January 27, 1995, with proposals due on or about March 16, 1995. It is anticipated that one award will be made as a result of this solicitation. Verbal requests for the RFP will not be accepted; requests must be submitted in writing, addressed to: Marilyn R. Zuckerman Contracts Management Section National Institute of Dental Research Natcher Building, Room 4AN-44J 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 $$R3 END ************************************************************ $$R4 BEGIN NIH-NIDR-1-95-4R ***************************************** ESTIMATION OF DIFFERENCES IN FLUORIDE EXPOSURE AND EXPRESSION IN ADOLESCENTS NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFP AVAILABLE: NIH-NIDR-1-95-4R P.T. 34; K.W. 0745010 National Institute of Dental Research The National Institute of Dental Research (NIDR) has a requirement for the development and implementation of a cross-sectional evaluation of the exposure to fluorides of adolescents living in nonfluoridated or fluoridated communities and the dental caries and fluorosis status of these individuals. The general objectives of the study are: to quantify fluoride exposure of individuals in both fluoridated and nonfluoridated communities; to establish individual variation and response to fluoride exposure by estimating fluoride distribution in body fluids and tissues, as well as disease and tissue expression (dental caries and fluorosis); to correlate the fluoride levels from different body fluids and tissues with each other and with reported current intake, past fluoride experience presenting as dental fluorosis, and dental caries experience; and to contrast these relationships in fluoridated and nonfluoridated communities and between groups of individuals with different fluorosis manifestations. INQUIRIES RFP No. NIH-NIDR-1-95-4R will be available approximately February 3, 1995, with proposals due on or about March 17, 1995. Requests for the RFP must be submitted in writing, addressed to: Ms. Marion L. Blevins Contract Management Section National Institute of Dental Research Natcher Building, Room 4AN-44D Bethesda, MD 20892 $$R4 END ************************************************************ $$R5 BEGIN NIH-NIDR-1-95-5R ***************************************** DETERMINATION OF SERUM ANTIBODIES TO PERIODONTAL PATHOGENS IN THE U.S. POPULATION NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFP AVAILABLE: NIH-NIDR-1-95-5R P.T. 34 K.W. 0715148, 0710070 National Institute of Dental Research The National Institute of Dental Research (NIDR) has a requirement for a state-licensed laboratory or a laboratory certified under the Clinical Laboratory Improvement Act of 1988 (CLIA) capable of processing thousands of serum samples for antibodies to periodontal pathogens, including the capability of receiving and transporting the samples. The objective of this study is to determine the occurrence of elevated serum antibodies to periodontal pathogens in a sample of persons examined in the Third National Health and Nutrition Examination Survey (NHANES III). Serum from the NHANES III subjects has already been collected, frozen and stored for further analysis. The serum must be assayed by ELISA procedures. INQUIRIES Request for Proposals (RFP) NIH-NIDR-1-95-5R will be available on or about February 3, 1995, with proposals due on or about March 9, 1995. It is anticipated that one award will be made as a result of this solicitation. Verbal requests for the RFP will not be accepted; requests must be submitted in writing, addressed to: Marilyn R. Zuckerman Contracts Management Section National Institute of Dental Research Natcher Building, Room 4AN-44J 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 $$R5 END ************************************************************ $$R6 BEGIN NIH-NINDS-95-01 ****************************************** CLOSED LOOP CONTROL OF FUNCTIONAL NEUROMUSCULAR STIMULATION NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFP AVAILABLE: NIH-NINDS-95-01 P.T. 34; K.W. 0715140, 0745047, 0706040, 0415003 National Institute of Neurological Disorders and Stroke The Neural Prosthesis Program of the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), has a requirement for the continued research, development, and feasibility testing of methods to enhance the function and control of functional neuromuscular stimulation (FNS) grasp systems. Functional neuromuscular stimulation is being used to restore functional hand movements in quadriplegic individuals by electrically stimulating the paralyzed muscles in their hands and arms. Further research is needed to solve fundamental control problems of hand posture, command signals, and muscle excitation as well as developing means of providing sensory feedback. The proposed research project will include: (1) the evaluation of closed-loop FNS systems in quadriplegic individuals outside the laboratory environment; (2) investigation of the feasibility of implementing arm control such as elbow extension and wrist control; (3) development of a biomechanical model of the human hand to improve strategies for hand posture control; and (4) evaluating the combination of closed loop FNS with surgical procedures such as tendon splicing, tendon transfer and arthrodesis to enhance hand posture control. Performance of work under this project will require personnel with established expertise in neural prostheses, hand surgery, control theory, biomechanics, and biomedical engineering. It is anticipated that one award will be made for a period of three years. Award is anticipated for August 1995. INQUIRIES This is not a Request for Proposals (RFP). An RFP was issued on December 21, 1994 and proposals are due on or about February 21, 1995. All responsible sources may submit a proposal that will be considered by the agency. To receive a copy of the RFP, submit a written request along with two self-addressed mailing labels to: Contracting Officer Contracts Management Branch, DEA ATTN: RFP No. NIH-NINDS-95-01 National Institute of Neurological Disorders and Stroke Federal Building, Room 901 7550 Wisconsin Avenue - MSC 9190 Bethesda, MD 20892 $$R6 END ************************************************************ $$R7 BEGIN NIH-NINDS-95-08 ****************************************** MICROSTIMULATION OF THE LUMBOSACRAL SPINAL CORD - MAPPING NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFP AVAILABLE: NIH-NINDS-95-08 P.T. 34; K.W. 0740050, 0745047 National Institute of Neurological Disorders and Stroke The Neural Prosthesis Program of the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), supports the development of aids for the neurologically handicapped. These aids, known as neural prostheses, replace or supplement neurological function by directly interfacing with the nervous system. One means of accomplishing this is by microstimulation with microelectrodes implanted directly into neural tissue. Animal studies have shown the potential value of microstimulation with respect to increased stimulus selectively as compared to larger electrodes placed on the surface of neural tissue. The proposed project will investigate the feasibility of microstimulation of the lumbosacral spinal cord as a method of controlling genito-urinary and skeletal motor functions. Performance of work under this project will require personnel with established expertise in neuroanatomical tracing, in electrophysiology, and in genito-urinary physiology. It is anticipated that one award will made for a period of three years. Award is anticipated for September 1995. INQUIRIES This is not a Request for Proposals (RFP). The RFP will be issued on or about January 19, 1995 with proposals due on or about March 20, 1995. All responsible sources may submit a proposal that will be considered by the agency. To receive a copy of the RFP, submit a written request along with two self-addressed mailing labels to: Contracting Officer Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 901 7550 Wisconsin Avenue - MSC 9190 Bethesda, MD 20892 ATTN: RFP No. NIH-NINDS-95-08 $$R7 END ************************************************************ $$R8 BEGIN NIH-NINDS-95-09 ****************************************** MICROSTIMULATION OF THE LUMBOSACRAL SPINAL CORD - CHRONIC STIMULATION NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFP AVAILABLE: NIH-NINDS-95-09 P.T. 34; K.W. 0740050, 0745047 National Institute of Neurological Disorders and Stroke The Neural Prosthesis Program of the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), supports the development of aids for the neurologically handicapped. These aids, known as neural prostheses, replace or supplement neurological function by directly interfacing with the nervous system. One means of accomplishing this is by microstimulation with microelectrodes implanted directly into neural tissue. Animal studies have shown the potential value of microstimulation with respect to increased stimulus selectively as compared to larger electrodes placed on the surface of neural tissue. The proposed project will develop a method of chronic microstimulation of the lumbosacral spinal cord to evaluate its effects on neural and surrounding tissue in non-human animals. Performance of work under this project will require personnel with established expertise in neuroanatomical tracing, in electrophysiology, and genito-urinary physiology. It is anticipated that one award will made for a period of three years. Award is anticipated for September 1995. INQUIRIES This is not a Request for Proposals (RFP). The RFP will be issued on or about January 19, 1995 with proposals due on or about March 20, 1995. All responsible sources may submit a proposal that will be considered by the agency. To receive a copy of the RFP, submit a written request along with two self-addressed mailing labels to: Contracting Officer Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 901 7550 Wisconsin Avenue - MSC 9190 Bethesda, MD 20892 ATTN: RFP No. NIH-NINDS-95-09 $$R8 END ************************************************************ $$R9 BEGIN NIH-NINDS-95-10 ***************************************** MICROMACHINED STIMULATING ELECTRODES NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFP AVAILABLE: NIH-NINDS-95-10 P.T. 34; K.W. 0740050, 0745047, 0750005, 0740027 National Institute of Neurological Disorders and Stroke The Neural Prosthesis Program of the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), has a requirement for developing safe and effective methods of selective electrical stimulation of the nervous system for restoration of function in neurologically impaired individuals. Many potential neural prostheses, require electrodes that are small enough to permit small clusters of neurons to be independently stimulated. This project involves research and development on thin-film microelectrodes capable of stimulating such small numbers of cells. Specifically, these microelectrodes will be designed to provide intracortical microstimulation at multiple sites in the visual cortex for visual prostheses and in the spinal cord for future bladder, sexual function, and motor prostheses. Expertise in materials science, micromachining, integrated circuit design, and bioengineering will be needed to perform this research. No animal or human testing is required. The proposed research project will include: (1) developing a thin-film electrical insulating layer and a compatible thin-film conductor material for making low-resistance electrically conductive traces on stimulating probes; (2) designing passive, thin-film stimulating microelectrode arrays suitable for stimulation in the CNS; (3) designing and fabricating biocompatible, implantable probes that include active electronic multiplexing and stimulus driving circuitry for the purpose of reducing the number of interconnecting leads on a probe; and (4) designing and fabricating a 3 dimensional array of at least 8 probes, each with 16 shanks. It is anticipated that one award will made for a period of 38 months. Award is anticipated for September 1995. INQUIRIES This is not a Request for Proposals (RFP). The RFP will be issued on or about January 19, 1995 with proposals due on or about March 20, 1995. All responsible sources may submit a proposal that will be considered by the agency. To receive a copy of the RFP, submit a written request along with two self-addressed mailing labels to: Contracting Officer Division of Extramural Activities National Institute of Neurological Disorders and Stroke 7550 Wisconsin Avenue, Room 901 - MSC 9190 Bethesda, MD 20892 ATTN: RFP No. NIH-NINDS-95-10 $$R9 END *********************************************************** $$R10 BEGIN AG-95-003 FULL-TEXT ************************************* MINORITY DISSERTATION RESEARCH GRANTS IN AGING NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA AVAILABLE: AG-95-003 P.T. 40, FF; K.W. 0710010 National Institute on Aging Application Receipt Date: March 20, 1995 PURPOSE Small grants to support doctoral dissertation research will be available for minority doctoral candidates intending to study problems in aging. Total direct costs are limited to $30,000 for two years. No more than $25,000 may be requested in any one year. $600,000 is available for this initiative in FY 95. 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 grants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and Email from the program contact listed below. Dr. Robin A. Barr Office of Extramural Affairs 7201 Wisconsin Avenue, Suite 2C218 MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9322 FAX: 301-402-2945 Email: barr%nihniagw.bitnet@cu.nih.gov $$R10 END *********************************************************** $$R11 BEGIN HL-95-012 FULL-TEXT ************************************* LUNG SPECIFIC DRUG DELIVERY SYSTEMS FOR TUBERCULOSIS TREATMENT NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA AVAILABLE: HL-95-012 P.T. 34; K.W. 0715165, 0740022, 1002027 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: February 24, 1995 Application Receipt Date: April 7, 1995 PURPOSE The purpose of this solicitation is to encourage research on novel approaches to therapy, adjuvants to therapy, and prophylaxis of tuberculosis (TB), using the lung as the site of drug delivery. The primary objective of this special grant program is to develop new modalities of treatment for pulmonary TB based on delivery of the therapeutic agent(s) directly to the lung. Treatment strategies must be clearly linked to the lung and to specific mechanisms of mycobacterial disease. Applications that focus on molecular pharmacologic approaches are of particular interest. This RFA solicits applications for the National Institutes of Health (NIH) individual research project grant (R01) and First Independent Research Support (FIRST) award (R29) support mechanisms. Up to five years of support may be requested. The estimated funds (total costs) available for the first year of support for the entire program is $2.50 million. It is anticipated that no more than 10 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. 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), Lung Specific Drug Delivery Systems for Enhanced TB Treatment, is related to the priority area of immunization and infectious diseases. 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 (gopher.nih.gov) and by mail and email from the program contact listed below. 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 Email: hpv%nihhwb1.bitnet@cu.nih.gov $$R11 END *********************************************************** $$R12 BEGIN HS-96-001 FULL-TEXT ************************************* RESEARCH ON THE OUTCOMES OF PHARMACEUTICAL THERAPY NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA AVAILABLE: HS-96-001 P.T. 34; K.W. 0745005, 0730021 Agency for Health Care Policy and Research Letter of Intent Receipt Date: March 1, 1995 Application Receipt Date: April 12, 1995 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications to conduct research on the outcomes of pharmaceutical therapy. This request for applications (RFA) focuses on the effects on patient outcomes of various proposed or existing mechanisms for managing selection, utilization, and cost of pharmaceutical therapies and services. Current restructuring within the health care system provides an important opportunity to enhance understanding of the interrelationships of pharmaceutical treatments and services with patient outcomes. Of particular interest are studies involving the comparative effectiveness and/or cost effectiveness of pharmaceutical therapies within the changing health care system. This is an activity of the research component of AHCPR's Medical Treatment Effectiveness Program (MEDTEP). Section 1142 of the Social Security Act, a part of AHCPR's authorizing legislation, refers specifically to the need to study the outcomes of prescription drug therapy. Awards are a part of the Outcomes of Pharmaceutical Therapy (OPT) program, as introduced in RFA HS-92-03. The AHCPR expects to award up to $2 million for first year support of four to six awards. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. AHCPR urges applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Richard J. Greene, M.D., Ph.D. Center for Medical Effectiveness Research Agency for Health Care Policy and Research East Jefferson Street, Suite 605 Rockville, MD 20852-4908 Telephone: (301) 594-1485 Email: JBook@po4.ahcpr.gov $$R12 END *********************************************************** $$R13 BEGIN DA-95-001 FULL-TEXT ************************************* NEUROSCIENCE NETWORKS IN BASIC DRUG ABUSE RESEARCH NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA AVAILABLE: DA-95-001 P.T. 34; K.W. 0404009, 1002030 National Institute on Drug Abuse Letter of Intent Receipt Date: March 16, 1995 Application Receipt Date: April 19, 1995 PURPOSE The National Institute on Drug Abuse (NIDA) invites applications to establish networks of investigators currently engaged in neuroscience research programs for the purpose of bringing relevant aspects of those programs to bear upon drug abuse research. Each network will be assembled by a Principal Investigator to form a multidisciplinary, multi-institutional consortium of neuroscience expertise centered upon a particular theme related to drug abuse research. These themes may be broad in scope, but should be concerned with identifying fundamental brain processes susceptible to the actions of drugs of abuse and the mechanisms through which drugs of abuse affect those processes. The intent of the Request for Applications (RFA) is to encourage cooperative efforts among network investigators to stimulate novel insights and innovative approaches to drug abuse research not presently achievable through collaborative efforts limited by geographical constraints. This RFA also is intended to extend existing research programs in the basic neurosciences into avenues directly relevant to drug abuse research with the goal of acquiring additional knowledge that ultimately may lead to new therapeutic and prevention strategies applicable to the public health problem of drug abuse. A minimum of three research projects must constitute the network, plus a core component concerned with establishing communication and information links among network members. In addition to stimulating substantive new research programs in drug abuse through this RFA, NIDA anticipates that the neuroscience networks created through this initiative will serve as experimental prototypes for new research enterprises devoted to studies on drug abuse within the environment of rapidly advancing communications and information technologies now revolutionizing contemporary biomedical research. The mechanism of support will be the program project grant (P01). In FY 1995, the NIDA anticipates funding approximately two P01 awards. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Neuroscience Networks in Basic Drug Abuse Research, is related to the priority areas of tobacco, alcohol and other drugs, maternal and infant health, and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH Gopher (gopher.nih.gov), and by mail and email from the program contact listed below. The RFA is also available from the Grants Management Branch, Office of Planning and Resource Management, National Institute on Drug Abuse, 5600 Fishers Lane, Room 8A-54, Rockville, MD 20857, telephone 301-443-6710. Karen J. Skinner, Ph.D. Division of Basic Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-19 Rockville, MD 20857 Telephone: (301) 443-1887 Email: kskinner@aoada.ssw.dhhs.gov $$R13 END *********************************************************** $$R14 BEGIN AR-95-003 FULL-TEXT ************************************* CLINICAL STUDIES: SKIN DISEASES IN HIV/AIDS NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA AVAILABLE: AR-95-003 P.T. 34; K.W. 0715008, 0715185, 0745070 National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: March 15, 1995 Application Receipt Date: April 21, 1995 PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invites applications for clinical studies on the treatment of skin diseases associated with HIV infection, including AIDS. These studies are designed primarily to evaluate innovative or new treatments and/or combination therapy in the treatment of any of the skin diseases seen in association with HIV infection, including AIDS, and compare them to more standard therapeutic approaches for these diseases, particularly in relation to efficacy, side effects and costs. It is not intended that large scale multicenter clinical trials be supported in response to this RFA, but rather that clinical studies be designed that may, once validated, form the basis for subsequent clinical trials. The estimated funds (total costs) available for the first year of support for the entire program is anticipated to be 1.5 million dollars. The anticipated number of new awards is four to five. 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), Clinical Studies in Skin Diseases Associated with HIV/AIDS, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Summary 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 (gopher.nih.gov), and by mail and email from the program contact listed below. Alan N. Moshell, M.D. Skin Diseases Program Director National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-25L 45 Center Drive Bethesda, MD 20892-6500 Telephone: (301) 594-5017 FAX: (301) 480-4543 email: moshella@ep.niams.nih.gov $$R14 END *********************************************************** $$R15 BEGIN CA-95-004 FULL-TEXT ************************************* BREAST CANCER SURVEILLANCE RESEARCH NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA AVAILABLE: CA-95-004 P.T. 34; K.W. 0715036, 0745020, 0710030 National Cancer Institute Letter of Intent Receipt Date: February 14, 1995 Application Receipt Date: April 21, 1995 PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites applications from domestic institutions for cooperative agreements to the Surveillance Program (SP). New applicants and applicants currently funded under SP initiatives are invited to respond to this Request For Applications (RFA) to design and conduct breast cancer surveillance research. This is a follow-up to a cooperative agreement in which three awards began in 1994. The purpose of the Breast Cancer Surveillance Research initiative outlined in this RFA is to examine thoroughly the operational aspects of breast cancer screening practices in the United States by conducting analytic research designed to assess the effectiveness, efficiency, and cost of screening programs as they relate to the reduction of breast cancer mortality. This may include studies of medical decision models for workup of women with positive screening tests, studies of utilization of emerging new technologies in breast cancer screening and diagnosis, and studies of biological differences among cancer related to detection methods. The intent of this RFA is to broaden the current Surveillance projects in areas that have not as yet been adequately covered, specifically among urban African- Americans and rural areas. Three awards are anticipated under this RFA. The anticipated average amount of the direct cost awards will be $250,000 per year per award. The anticipated date of award is December, 1995. 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, Breast Cancer Surveillance Research, is related to the priority area of cancer surveillance and data systems. This information (surveillance and data systems) is used to understand the health status of the population and to plan, implement, describe and evaluate public health programs that control and prevent adverse health events. 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 (gopher.nih.gov) and by mail from the program contact listed below. Brenda K. Edwards, Ph.D. Surveillance Program National Cancer Institute Executive Plaza North, Room 343 Bethesda, MD 20892 Telephone: (301) 496-8506 FAX: (301) 402-0816 Email: edwardsb@dcpceps.nci.nih.gov $$R15 END *********************************************************** $$R16 BEGIN NR-95-001 FULL-TEXT ************************************* COMMUNITY PREVENTION MODELS: RURAL MINORITY GROUPS NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA AVAILABLE: NR-95-001 P.T. 34; K.W. 0730075, 0730050, 0745027 National Institute of Nursing Research Letter of Intent Receipt Date: March 31, 1995 Application Receipt Date: April 26, 1995 PURPOSE The National Institute of Nursing Research (NINR) invites research grant applications on comprehensive, community-based health care strategies aimed at primary, secondary and tertiary prevention of disease and disabilities in rural populations lacking adequate health care services. The purpose is to determine the impact of comprehensive, community-based strategies incorporating culturally specific approaches on the health of underserved, rural, minority population groups. Targeted populations include ethnic minority groups such as Native Americans, Asians and Pacific Islanders, Hispanic Americans, and African Americans. Approximately $1.8 million in total costs for the first year will be committed to fund four to five R01 grants under this RFA. 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), Community Prevention Models: Rural Minority Groups, is related to all of the special populations targets. 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 (gopher.nih.gov) and by mail and email from the program contact listed below. Dr. Patricia Moritz Chief, Nursing Systems Branch National Institute of Nursing Research Building 45, Room 3AN-12 45 Center Drive MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5956 FAX: (301) 480-8260 Email: pmoritz@ep.ninr.nih.gov $$R16 END *********************************************************** $$R17 BEGIN HL-95-013 FULL-TEXT ************************************* HIV-ASSOCIATED PATHOGENS OF THE LUNG: LIFE CYCLE REGULATION NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA AVAILABLE: HL-95-013 P.T. 34; K.W. 0715008, 0715165, 1002027 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: March 3, 1995 Application Receipt Date: April 28, 1995 PURPOSE The purpose of this solicitation is to encourage research on the molecular basis of cell/life cycle regulation of pathogens and opportunistic microorganisms that cause lung disease in HIV-infected hosts. The RFA focuses on ways in which the environment in the host lung, including signals from host lung cells may affect the microbial mechanisms that determine growth and replication of the microbial agents. Examples of microorganisms that would be appropriate for study under this program are Mycobacterium tuberculosis, Pneumocystis carinii, Histoplasma capsulatum, and Coccidioides immitis. Studies focused exclusively on microorganisms will not be acceptable; applications must address microbial-host interactions. Studies directed at understanding dormancy and reactivation are of special interest. This RFA solicits applications for the National Institutes of Health (NIH) individual research project grant (R01) and First Independent Research Support (FIRST) award (R29) support mechanisms. Up to five years of support may be requested. The estimated funds (total costs) available for the first year of support for the entire program is $2.00 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 announcement, it is anticipated that there will be a range of costs among individual grants awarded. 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), HIV-Associated Pathogens of the Lung: Life Cycle Regulation, is related to the priority area of immunization and infectious diseases. 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 (gopher.nih.gov) and by mail and email from the program contact listed below. 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 Email: hpv%nihhwb1.bitnet@cu.nih.gov $$R17 END *********************************************************** $$R18 BEGIN MH-95-001 FULL-TEXT ************************************* SERVICES RESEARCH SUPPLEMENTS TO CLINICAL THERAPEUTIC GRANTS NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA AVAILABLE: MH-95-001 P.T. 34; K.W. 0715129, 0730057 National Institute of Mental Health Letter of Intent Receipt Date: April 15, 1995 Application Receipt Date: May 5, 1995 PURPOSE The National Institute of Mental Health (NIMH) announces the continued availability of competitive supplements to currently funded NIMH grants to expand ongoing funded clinical therapeutic research grants into the area of services research. The purpose of these supplements is to help move mental health treatments from the testing of efficacy (i.e., whether the treatment works under highly controlled conditions in a population with a well-defined mental disorder) into testing of effectiveness (i.e., whether the same promising treatment works when applied to a wider and diverse range of settings, providers, populations, and outcome assessment). This RFA will use the National Institutes of Health (NIH) competitive supplement (S01) mechanism and can supplement the following types of grants: R01, R10, R37, P01, P20, P30, P50. PHS policy prohibits any foreign institution from applying for a P mechanism. It is anticipated that at least $1,000,000 in direct costs will be made available. Awards will have a maximum yearly direct cost amount of $200,000, but may not exceed the total costs of the prior year of the parent grant. 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, Services Research Supplement to Clinical Therapeutic Grants, is related to the priority areas 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 This RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and email from the program contact listed below. Robert F. Prien, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-4527 FAX: (301) 443-6000 Email: rprien@aoamh4.ssw.dhhs.gov $$R18 END *********************************************************** $$R19 BEGIN AI-95-005 FULL-TEXT ************************************* INTERDISCIPLINARY PROGRAMS IN AUTOIMMUNE DISEASE NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA AVAILABLE: AI-95-005 P.T. 34; K.W. 0715015, 0710030 National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases Juvenile Diabetes Foundation International Letter of Intent Receipt Date: March 15, 1995 Application Receipt Date: June 15, 1995 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) of the National Institutes of Health (NIH) and the Juvenile Diabetes Foundation International (JDFI) invite applications for program project grants (P01) to support interdisciplinary programs in autoimmune disease. This Request for Applications (RFA) will support programs combining investigations of basic, molecular, immunologic, and genetic mechanisms in the pathogenesis of autoimmunity and the development of innovative therapies for human autoimmune disease. These programs may incorporate investigation into any autoimmune disease, including, but not limited to, Insulin Dependent Diabetes Mellitus (IDDM), or any field of science with relevance to the mechanisms and treatment of autoimmunity. Programs utilizing investigators from different scientific disciplines are particularly desirable, so as to utilize expertise in several areas simultaneously. The mechanism of support will be the program project (P01) grant. The estimated total funds (direct and indirect costs) available for the first year of support for this RFA will be $2.75 million: $1.5 million from NIAID; $1.0 million from JDFI; and $250,000 from NIDDK. In Fiscal Year 1996, the NIAID and the JDFI anticipate jointly funding approximately three or four program projects related to this RFA. One or more of these applications will be cofunded by the NIDDK. 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, Interdisciplinary Programs in Autoimmune Disease, is related to the priority area of diabetes and chronic disabling diseases. 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). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and email from the program contact listed below. Elaine Collier, M.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A20 Bethesda, MD 20892-7640 Telephone: (301) 496-7104 FAX: (301) 402-2571 Email: EC5X@NIH.GOV $$R19 END *********************************************************** $$P1 BEGIN PA-95-016 FULL-TEXT ************************************** FAILURE TO HEAL: CHRONIC WOUND HEALING IN THE SKIN NIH GUIDE, Volume 24, Number 1, January 13, 1995 PA AVAILABLE: PA-95-016 P.T. 34; K.W. 0715185, 0715027 National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute on Aging National Institute of Child Health and Human Development National Institute of General Medical Sciences National Institute of Nursing Research PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute on Aging (NIA), the National Institute of Child Health and Human Development (NICHD), National Institute of General Medical Sciences (NIGMS), and the National Institute of Nursing Research (NINR) invite applications for research on wounds that fail to heal, including decubitus (pressure) ulcers, venous (stasis) ulcers and diabetic ulcers. The purpose of this Program Announcement is to encourage research investigations that will provide new knowledge of the mechanisms of abnormal wound healing and/or to apply new findings or interventions to the treatment and prevention of chronic wounds in man. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Health People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Failure to Heal: Chronic Wound Healing in the Skin, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Health People 2000" (Summary Report: Stock No. 017-001-00474-0 or "Healthy People 000" (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 From owner-sci-resources@net.bio.net Fri Jan 13 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-017 - V24(01) 01/13/95 Date: 13 Jan 1995 16:50:00 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 358 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3f773o$ol3@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95017 PA-95-017 P1O1 *************************************** SYRINGOMYELIA NIH GUIDE, Volume 24, Number 1, January 13, 1995 PA NUMBER: PA-95-017 P.T. 34; K.W. 0715140 National Institute of Neurological Disorders and Stroke National Institute of Child Health and Human Development PURPOSE The National Institute of Neurological Disorders and Stroke (NINDS) and the National Center for Medical Rehabilitative Research (NCMRR) of the National Institute of Child Health and Human Development (NICHD) announce the issuance of a program announcement to notify the scientific community of their interest in the submission of research grant applications concerning syringomyelia. 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 priorities. This PA, Syringomyelia, is related to the priority areas of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-474-0), or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards, program projects (P01), and center grants (P50). Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The mechanisms of support will be the research project grant (R01), program project (P01), center grants (P50), (NINDS only), and FIRST Award (R29). Prospective applicants are encouraged to communicate with the NINDS or NICHD program contacts listed under INQUIRIES regarding the appropriate funding mechanism. RESEARCH OBJECTIVES Summary Syringomyelia may be defined as a chronic progressive degenerative disorder of the spinal cord. Pathologically, syringomyelia is characterized by formation of a syrinx, or fluid-filled cyst, in the spinal cord, which expands and elongates over time. Clinically, there is damage to the spinal cord, which results in chronic pain, weakness in the extremities, and loss of sensation. There are two main forms of syringomyelia, congenital and acquired. In most cases, there is a congenital abnormality of the brain, the type I Chiari malformation, where the cerebellar tonsils protrude into the subarachnoid space at the level of the foramen magnum. Although this abnormality is thought to be present at birth, the onset of syringomyelia does not occur until adulthood. A syrinx may form in the cervical region of the spinal cord. About 50 percent of adults with Chiari I malformations will develop syringomyelia. The second major form of syringomyelia occurs as a complication of trauma, inflammation, or a tumor. In this case, the syrinx forms at the site of the injury. The diagnosis of syringomyelia has been greatly facilitated by the use of magnetic resonance imaging (MRI). Once the syrinx has been confirmed, the patient and doctor can decide the course of treatment based on symptoms and size of the syrinx. The treatment of syringomyelia is a subject of much debate among neurosurgeons. Surgical treatment could involve decompression of the foramen magnum, with or without a dural graft, to relieve the pressure on the spinal cord. In many cases, this will collapse the syrinx, and prevent progression of the disease. Some surgeons prefer to place a shunt in the cavity, to drain the syrinx and prevent its re-expansion. There are complications because of infection and shunt blockage. In all surgical treatments, there are complications due to scarring and possible tethering of the cord. Unfortunately, in many cases there is no reversal of the symptoms already present. There is also no consensus among neurosurgeons about the time course for treatment. Some prefer to treat all syrinxes immediately hoping to prevent some of the more serious symptoms. Others follow the more cautious route and wait to see if the syrinx will expand. These patients may be followed by electrophysiological testing to determine if there are presymptomatic indications that the syrinx is expanding. In both cases, there are risks. Some individuals will be treated who would never have developed syringomyelia. Others will develop the symptoms and life-long disability associated with syringomyelia because of delay in treatment. A controlled clinical study has not been done to study the short- and long-term outcomes of the various treatment options. This information would be very important for determining which treatment is appropriate for each individual. Although the technologies available are making it easier to diagnose syringomyelia, there is not enough known about the causes. MRI has allowed the physician to identify syrinxes in the patient at a very early time, before the onset of symptoms. In some patients, there is never a progression to syringomyelia. In other patients, the syrinx expands and symptoms appear. The trigger that causes the syrinx to expand is not known. Several research groups are working to develop animal models of syringomyelia so that studies can be done to understand the basic pathophysiology of syrinx formation and expansion. Spinal cord cavitation can be induced by injection of kaolin into the spinal cord in mice. Other agents, such as excitatory amino acids, are known to induce cavitation. Various manipulations can be easily performed in animal models that cannot be done in humans. Animal models will be important for fully understanding syrinx formation and expansion in syringomyelia. The NINDS encourages submission of research grant applications in the area of syringomyelia. Some areas of interest include, but are not limited to: o Comparative studies of spinal cord structure and function between normal and syringomyelia subjects, including anatomy, pharmacology, and physiology o MRI flow studies, electrophysiology, and metabolic studies of the cord in syringomyelia patients o Clinical studies of syringomyelia that incorporate information about treatment procedures and short- and long-term outcomes o Clinical studies to determine the pathophysiology of the various types of syringomyelia, including Chiari Type I and Type II, and post-traumatic o Clinical trials to assess various treatment options for syringomyelia o Studies on biomaterials, to determine which types of sutures, shunts, and dura grafting materials are most appropriate, and to develop new types of biomaterials o Studies to improve imaging technologies, toward real time imaging and non-invasive pulse pressure measurements o Studies to determine the causes of gliosis toward prevention of scarring and cord tethering o Assessment of existing animal models to determine their usefulness for studies of syringomyelia. o Development of new animal models of syringomyelia In addition, the NCMRR is interested in research areas including, but not limited to: o Studies to develop and validate ecologically appropriate, sensitive, and practical functional status measures to track functional changes during conservative management or evaluate the effects of surgical interventions in cases of syringomyelia o Studies of surgical and non-surgical interventions that reduce pain associated with syringomyelia o Prospective studies using imaging techniques, behavioral observation and self-report to study the natural course, prevalence, and risk factors that predict acute episodic and gradual functional loss in people with syringomyelia 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 projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248. The title and number of the program announcement must be typed in Section 2a on the face page of the application. Applicants for program project grants or centers should request a copy of the NINDS Guidelines: Program Project and Research Center Grants (rev. May 1994), from the NINDS program staff listed under INQUIRIES. Receipt dates for new research project grant applications and FIRST Awards (R01 and R29, respectively) and for program project and center grant applications (P01 and P50, respectively) are February 1, June 1, and October 1. FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The 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** If the application is for a program project or center grant, send the original and three copies to the Division of Research Grants. Send an additional two copies of the program project (P01) or center grant (P50) application to Dr. Judy Small at the address listed under INQUIRIES. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. 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. 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 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 the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that Institute or Center. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Judy A. Small Division of Convulsive, Developmental, and Neuromuscular Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 8C04 7550 Wisconsin Avenue MSC 9165 Bethesda, MD 20892-9165 Telephone: (301) 496-5821 FAX: (301) 480-1080 Email: js134h@nih.gov Dr. David B. Gray Deputy Director National Center for Medical Rehabilitative Research National Institute of Child Health and Human Development Building 6100E, Room 2A03 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 FAX: (301) 402-0832 Email: yga@cu.nih.gov Direct inquiries regarding fiscal matters to: Mr. King P. Bond, Jr. Grants Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 Bethesda, MD 20892-9190 Telephone: (301) 496-9231 FAX: (301) 402-0218 Email: kb33s@nih.gov Ms. Mary Ellen Colvin Office of Grants and Contracts National Institute of Child Health and Human Development Building 6100E, Room 8A17 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (301) 402-0915 Email: colvinm@hd01.nichd.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance, No. 93.853, Clinical Research Related to Neurological Disorders, and 93.854, Biological Basic Research in the Neurosciences. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to 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 Jan 13 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-95-018 - V24(01) 01/13/95 Date: 13 Jan 1995 16:49:54 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 396 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3f773i$oko@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAR95018 PAR-95-018 P1O1 ************************************* BIOMEDICAL RESEARCH SUPPORT SHARED INSTRUMENTATION GRANT NIH GUIDE, Volume 24, Number 1, January 13, 1995 PA NUMBER: PAR-95-018 P.T. 34; K.W. 1002024, 1014001 National Center for Research Resources Application Receipt Date: March 24, 1995 PURPOSE The National Center for Research Resources (NCRR) is continuing its competitive Biomedical Research Support (BRS) Shared Instrumentation Grant (SIG) Program initiated in Fiscal Year 1982. The (1992) National Report on Academic Research Equipment and Equipment Needs for Biological Sciences, cosponsored by the National Institutes of Health (NIH) and the National Science Foundation, identified research equipment of the type provided through this program as top-priority. The objective of the program is to make available to institutions with a high concentration of NIH-supported biomedical investigators research instruments which can only be justified on a shared-use basis and for which meritorious research projects are described. Awards under this Program Announcement (PA) will use the Biomedical Research Support Shared Instrumentation Grant mechanism (S10). ELIGIBILITY REQUIREMENTS Under the general research support authority of Section 301 (a)(3) of the Public Health Service Act, BRS Shared Instrumentation Grant awards are made to public and non-profit institutions only. For purposes of these guidelines, an "institution" is defined as the organizational component identified in item 14 on page 1 of the Form PHS 398 (rev. 9/91), for which descriptive information is provided on page 15 in the PHS 398 kit. These institutions include health professional schools, other academic institutions, hospitals, health departments, and research organizations. Federal institutions, foreign institutions, and for-profit institutions are not eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. An eligible institution may submit more than one application for different instrumentation for the March 24, 1995, deadline. However, if several applications are submitted for similar instrumentation >From one or more eligible institutions on the same campus of a university, documentation from a high administrative official must be provided, stating that the several applications are part of a campus- wide institutional plan, not an unintended duplication. MECHANISM OF SUPPORT BRS Shared Instrumentation Grants (S10) provide support for expensive state-of-the-art instruments utilized in both basic and clinical research. Applications are limited to instruments that cost at least $100,000 per instrument or system. The maximum award is $400,000. Because the nature and scope of the instruments that may be requested will vary, it is anticipated that the size of an award will vary also. RESEARCH OBJECTIVES This program is designed to meet the special problems of acquisition and updating of expensive shared-use instruments which are not generally available through other NIH mechanisms, such as the regular research project, program project, and center grant programs, or the Biomedical Research Technology Grant Program. Proposals for the development of new instrumentation will not be considered. Types of instrumentation supported include, but are not limited to, nuclear magnetic resonance systems, electron microscopes, mass spectrometers, protein sequencer/amino acid analyzers and cell sorters. Support will not be provided for general purpose equipment or purely instructional equipment, personal computers, personal workstations, printers, and ethernet interfaces. Proposals for "stand alone" computer systems will only be considered if the instrument is solely dedicated to the research needs of a broad community of NIH-supported investigators. Awards will be made for the direct costs of the acquisition of new, or the updating of existing, research instruments. The institution must meet those costs (not covered in the normal purchase price) required to place the instrumentation in operational order as well as the maintenance, support personnel, and service costs associated with maximum utilization of the instrument. There is no upper limit on the cost of the instrument, but the maximum award is $400,000. Grants will be awarded for a period of one year and are not renewable. Supplemental applications will not be accepted. The program does not provide indirect costs or support for construction or alterations and renovations. Cost sharing is not required. If the amount of funds requested does not cover the total cost of the instrument, the application should describe the proposed sources(s) of funding for the balance of the cost of the instrument. Documentation of the availability of the remainder of the funding, signed by an appropriate institutional official, must be presented to NCRR prior to the issuance of an award. Requests for a multiple instrument purchase totalling over $400,000 must specify and justify which instrument(s) should be supported within the $400,000 ceiling. Applicants proposing the direct purchase of an instrument that the institution has secured or is planning to secure via a leasing agreement are strongly encouraged to consult with their institutional sponsored projects office regarding applicable PHS policy prior to executing the leasing agreement. If the leasing agreement was executed more than one year prior to submission of the SIG application, the applicant must provide strong justification for the requested Federal funds. Further, the instrument must be considered state-of-the-art at the time of submission of the SIG application. A major user group of three or more investigators should be identified. A minimum of three major users must be Principal Investigators on NIH peer reviewed research grants at the time of the application and award. For purposes of this program research grants are defined as those grants awarded with the following activity codes: P01, R01, U01, R29, R35, and R37. The application must show a clear need for the instrumentation by projects supported by multiple NIH research awards and demonstrate that these projects will require at least 75 percent of the total usage of the instrument. Major users can be individual researchers, or a group of investigators within the same department or from several departments at the applicant institution. NIH extramural awardees from other nearby institutions may also be included. If the major user group does not require total usage of the instrument, access to the instrument should be made available to other users upon the advice of the internal advisory committee. These users need not be NIH awardees, but priority should be given to NIH-supported scientists engaged in biomedical/behavioral research. To encourage optimal sharing among individual investigators, research groups, and departments, and to foster a collaborative multidisciplinary environment, instruments should be integrated into central core facilities, whenever possible. Each applicant institution must propose a Principal Investigator who can assume administrative/scientific oversight responsibility for the instrumentation requested. An internal advisory committee to assist in this responsibility should also be utilized. The Principal Investigator and the advisory group are responsible for the development of guidelines for shared use of the instrument, for preparation of all reports required by the NIH, for relocation of the instrument within the grantee institution if the major user group is significantly altered, and for continued support for the maximum utilization and maintenance of the instrument in the post-award period. A plan should be proposed for the day-to-day management of the instrument including designation of a qualified individual to supervise the operation of the instrument and to provide technical expertise to the users. Specific plans for sharing arrangements and for monitoring the use of the instrument should be described. If a grant award is made, a final progress report will be required that describes the use of the instrument, listing all users and indicating the value of the instrumentation to the research of the major users and to the institution as a whole. This report is due within 90 days following the end of the project period. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Application kits are available at most institutional offices of sponsored research and may be requested from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. The title and number of the program announcement must be typed in Section 2a on the face page of the application. 1. Form page 1 (Face page of the application) - Item 1. Name the type of instrument requested. (Note at the bottom of the face page if a duplicate application has been sent to another agency.) Item 4. If human subjects are involved in the research, follow the instructions for completing Item 4 on the Face Page of Form PHS 398, certifying that an Institutional Review Board (IRB) approved by PHS has reviewed and approved the protocols involving human subjects. If the protocols are ongoing and have already received prior IRB review and approval within one year of the submission date of this application, then additional IRB review is not necessary. However, this fact must be noted in Item 4 on the Face Page, and, if space is insufficient, the date(s) of prior IRB review and approval of each protocol involving human subjects should be listed in the "Research Plans." Item 5. If live vertebrate animals are involved in the research, follow the instructions for completing Item 5 on the Face Page of Form PHS 398, verifying that an Institutional Animal Care and Use Committee (IACUC) approved by PHS (OPRR) has reviewed and approved the protocols involving animals. If the protocols are ongoing and have already received prior IACUC review and approval within three years of the submission date of this application, then additional IACUC review is not necessary. However, this fact must be noted in Item 5 on the Face Page and, if space is insufficient, the date(s) of prior IACUC review and approval of each protocol involving animals should be listed in the "Research Plan." Item 6. Write in April 1, 1996 - March 31, 1997. Item 8A. Use this block to give the total amount requested from NCRR for this instrument or system. Item 14. Insert the appropriate code identification. 2. Form page 2. Complete the abstract as directed. Under "Personnel engaged on project", give data on the Principal Investigator and the major user group as required. 3. Form page 4. Describe the instrument requested including manufacturer and model number. The model chosen should be justified by comparing its performance with other available instruments. Provide a detailed budget breakdown of the main equipment and accessories requested including tax and import duties, if applicable. An itemized quote from a vendor should be included. If a project involves a potential biohazard, funds for accessory containment equipment for the instrument or instrument system may be included in the requested budget. 4. Form page 5. Budget Estimates for All Years. Not applicable; do not complete. 5. Form page 6 - Biographical Sketch. In addition to the personnel listed on page 2, include a biographical sketch of the person(s) who will be in charge of maintenance and operation of the instrument and a brief statement of the qualifications of the individual(s). Biographical sketches should not exceed 2 pages for each individual. 6. Form page 7 - Other Support. Provide the requested information for each major user. 7. Section 2 of the application. (If this is a revised application, note the special instructions in the PHS 398 kit regarding completion of Section 2 of the application.) Provide information relative to the points identified under criteria for review including: a. Inventory similar instruments existing at the institution or otherwise accessible; describe (with supporting documentation) why they are unavailable or inappropriate for the proposed research and provide a clear justification why new or updated equipment is needed, including accessories. b. The major users should describe their research projects and indicate how the requested instrumentation and/or accessories would enhance the progress of their research projects. While most projects are included in currently funded applications, some represent new directions. In the case of funded projects, the description should not exceed four pages per user but should point out the benefit of the proposed instrument to the research objectives of each major user. New directions and their requirements for the proposed instrumentation should be described in sufficient detail to allow adequate review (including preliminary data or supplemental materials). Use a table to list the names of the users, brief titles of the projects, the NIH grant numbers and the estimated percentage of use. List the page number of this table under "Table of Contents" (Form page 3) after "Resources and Environment." Make a separate table to indicate the major users' needs for requested accessories. If possible, each user should highlight those publications that demonstrate the user's expertise in using the requested instrumentation. c. Describe the organizational plan including the internal advisory committee for administration of the grant. d. Submit a specific plan for long-term operation and maintenance of the instrument. Provide documentation (e.g., separate letters signed by appropriate institutional officials) describing the required institutional commitment in support of the proposed plan. Applications must be received by March 24, 1995. Applications received after this date will not be accepted for review in this competition and will be returned to the applicant. The original and four copies of the application and any appendix material, must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** One copy of the application and appendix material must be addressed to: Biomedical Research Support Program National Center for Research Resources Westwood Building, Room 848 Bethesda, MD 20892 REVIEW CONSIDERATIONS Applications are reviewed by specially convened initial review groups of the Division of Research Grants (DRG) for scientific and technical merit and for program considerations by the National Advisory Research Resources Council (NARRC) of the NCRR. Approximately half of the applications will be reviewed at the September 1995 NARRC meeting and the remainder at the NARRC meeting in February 1996. Funding decisions on all applications received for the March 24, 1995, deadline will not be made until the program receives an appropriation for FY 1996. The Council date will not affect funding decisions. Applications that request a single instrument with a total purchase cost of more than $500,000, and that would normally be eligible for submission to both NIH and NSF, may be submitted to NIH for joint funding with NSF by including necessary NSF documentation. The Agencies will review such proposals in a special review group that will be convened by NIH as a special NIH study section with NSF participation. Under this arrangement, the agencies may offer joint funding in excess of the current award limit of $400,000. Contact the NSF Division of Biological Instrumentation and Resources for additional information on the NSF documentation (cover sheet and cost sharing agreement). 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 program announcement. 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 o The extent to which an award for the specific instrument would meet the scientific needs and enhance the planned research endeavors of the major users by providing an instrument that is unavailable or to which availability is highly limited. o The availability and commitment of the appropriate technical expertise within the major user group or the institution for use of the instrumentation. o The adequacy of the organizational plan and the internal advisory committee for administration of the grant including sharing arrangements for use of the instrument. o The institution's commitment for continued support of the utilization and maintenance of the instrument. o The benefit of the proposed instrument to the overall research community it will serve. AWARD CRITERIA In making funding decisions, the NCRR will give consideration to ensure program balance among various types of instruments supported and/or geographic distribution of awards. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic or scientific issues to: Marjorie A. Tingle, Ph. D. Director, Biomedical Research Support Program National Center for Research Resources Westwood Building, Room 848 Bethesda, MD 20892 Telephone: (301) 594-7947 Email: brspsig@ep.ncrr.nih.gov Direct inquiries regarding fiscal matters to: Ms. Mary V. Niemiec Office of Grants and Contracts Management National Center for Research Resources Westwood Building, Room 849 Bethesda, MD 20892 Telephone: (301) 594-7955 Email: maryn@ep.ncrr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance number 93.337, Biomedical Research Support. Awards will be made under authorization of the Public Health Service Act, Titles III and IV, (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 287) 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 Jan 13 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA NR-95-001 - V24(01) 01/13/95 Date: 13 Jan 1995 16:50:58 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 518 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3f775i$op4@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA NR95001 NR-95-001 P1O1 *************************************** COMMUNITY PREVENTION MODELS: RURAL MINORITY GROUPS NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA: NR-95-001 P.T. 34; K.W. 0730075, 0730050, 0745027 National Institute of Nursing Research Letter of Intent Receipt Date: March 31, 1995 Application Receipt Date: April 26, 1995 PURPOSE The National Institute of Nursing Research (NINR) invites research grant applications on comprehensive, community-based health care strategies aimed at primary, secondary and tertiary prevention of disease and disabilities in rural populations lacking adequate health care services. The purpose is to determine the impact of comprehensive, community-based strategies incorporating culturally specific approaches on the health of underserved, rural, minority population groups. Targeted populations include ethnic minority groups such as Native Americans, Asians and Pacific Islanders, Hispanic Americans, and African Americans. 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), Community Prevention Models: Rural Minority Groups, is related to all of the special populations targets. 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Collaboration of investigators funded under this RFA is planned, see SPECIAL REQUIREMENTS section below. The total project period for an application submitted in response to this RFA may not exceed five years. The anticipated award date is September 30, 1995. Because the nature and scope of the research proposed in response to this RFA may vary, 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 Approximately $1.8 million in total costs for the first year will be committed to fund applications submitted in response to this RFA. It is anticipated that four to five applications will be funded. 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 plans of the NINR, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background The NINR, in its ongoing development of the National Nursing Research Agenda, convened a panel of scientific experts to examine the state of the science on community-based health care models, focusing on those that involve nursing practice. This panel has recommended strategies that respond to the growing number of programs that focus on community-based health care and preventive health strategies. The panel has specifically recommended studies of comprehensive community-based health care models for rural populations from the perspective of primary health care, which focuses on promoting health and preventing disease across the continuum of care. In their review of existing research, the panel determined that further study of community-based models for rural residents was a very promising area for expansion of our scientific knowledge. In the public health/community health context, primary health care includes primary, secondary, and tertiary prevention. Primary prevention includes health promotion and protection (such as immunizations of children and elders, nutrition counseling, and life style alterations) aimed at intervening before disease arises in individuals. Secondary prevention measures aim to prevent disease and disability through screening, early detection and diagnosis, and prompt treatment of pre-symptomatic or very early clinical disease (such as obesity, hypercholesterolemia) of populations thought to be at-risk. Tertiary prevention measures seek to limit disabilities in persons with various stages of disease and rehabilitation (such as those requiring restorative care or those with chronic illness). Different definitions of "community" arise from the different types of settings (worksites, senior centers, ambulatory clinics) and types of populations (those with low-incomes, frail elderly, children and adolescents) that are appropriate for community studies. The major defining element of community-based care, however, is the involvement of clients and other community members in (a) assessing environmental influences, health status, and health care use; (b) determining related-health priorities; (c) designing and implementing health programs; (d) encouraging participation in the resulting health programs; and (e) evaluating the impact of the health programs. The panel's review of the research on community-based models revealed the existence of many categorical health care programs, but found that the effect of these programs on specific population groups has not yet been scientifically well established. There are also indications that some fundamental factors thought to be needed for community-based health care success (accessibility, appropriateness, availability, adequacy, affordability, and acceptability) have not been included in programs and that the unique cultural requirements of groups such as ethnic minorities have not been part of the design. The lack of cultural specificity in the design of prevention programs is thought to be a potential major factor in the infrequent participation of ethnic minority groups in these programs. Several current studies indicate that identifying and incorporating unique cultural factors into intervention strategies may result in increased acceptability, use, and adherence. Other prevention studies have identified intervention strategies that were efficacious but which had only limited continued use after the controlled circumstances of a specific study were withdrawn. There is evidence that certain population groups use health care services only in crises and may choose not to use prevention measures even when strongly advised to do so (for example, known HIV risk factors and use of condoms or other safety measures). At the same time, there are indications that the explanation may be less the population groups themselves than the approaches and design of health care systems available to them. Our understanding is further clouded by a tendency to uniformly stereotype the health-related behaviors of all population groups when indeed they relate to only one or some part of the groups. An example is the over-generalization that all minority groups have poor pregnancy outcomes, when this is true for many African-Americans but not for most Hispanic-Americans. Including cultural factors unique for specific populations in the design of community-based health care programs has been shown to increase participation in these programs, the use of certain interventions or treatments, and earlier recognition of risk factors. It is believed but not well tested that prevention strategies and interventions developed with the involvement of community participants and implemented through partnerships between community members and practitioners may achieve a higher participation rate and may be maintained for longer periods of time. Some studies have shown, for example that members of specific cultural groups, including indigenous health workers and ethnic healers, should be involved in (a) designing of actual health care practices and services so as to assure acceptance; (b) establishing methods for gaining participation in health promoting behaviors and self care, use prevention techniques, and adherence to treatments; (c) understanding individual, family and community decision making processes; and (d) gaining acceptance of practitioners who are not group members. Understanding the lifestyle and unique needs of a community appears to be essential for successful collaboration in such settings, and some have speculated that these factors themselves may play a determining role in the understanding of health status across various population groups. It is not known to what extent the limited inclusion of cultural factors represents barriers to health care participation generally and the use of prevention strategies in particular. The inter- relationship of these factors and economic factors on the use and acceptability of health care among rural minority groups is also unclear. Some investigators have found that certain ethnic minority groups and rural residents use health care services differently than others, have illnesses diagnosed at a later stage than other groups, and seek care later in a disease process than others. Intervention studies with subsets of minority groups, such as certain rural Native Americans, migrant Hispanics, southern African American churchgoers and rural pregnant women indicate that use of prevention strategies increase, involvement in prenatal care starts earlier, and chronic illness risk factors are modified when the clinical care is modified according to cultural expectations. Research Objectives and Scope The objective of this initiative is to examine the effect of comprehensive community-based primary health care models designed to include culturally appropriate approaches. The specific populations of focus are rural, minority groups. Applicants should focus on models targeted to populations as a whole, such as rural residents including a specific focus on minority groups, or to specific subpopulation groups, such as ethnic minority groups. Individuals, families and other community participants as well as clinical practitioners and other providers may be included as foci of research questions. Contextual and system factors, such as environmental factors, specific aspects of community involvement or ethnic group involvement, non-health care cultural, social and economic factors should be addressed. Where appropriate, it is preferred that primary, secondary and tertiary prevention strategies be included in the models examined. It is not required that all three prevention foci be included in the proposed model. The term rural has several definitions. This diversity has been problematic because of a lack of precision in defining rural for research purposes. For example, subcomponents of rural could represent population groups that were relatively close to urban centers, moderately distant, or far away and, therefore, more frontier-like in nature. As there is no one agreed-upon definition of rural for research purposes, those applying in response to this RFA must use one of two definitions of rural. These are: (1) the U.S. Bureau of the Census (1987) designation that an area with 2,500 or more persons is urban and that those areas not classified as urban are rural; or (2) the U.S. Office of Management and Budget (1983) identification of metropolitan statistical areas (MSA) as cities of 50,000 or more persons, or an urbanized area with at least 50,000 persons that is part of a county or counties having at least 100,000 in its populations, therefore, non-MSAs are rural. In addition, applicants should indicate: (a) the total number of persons in the geographic area of the proposed study; (b) the distance of the geographic area in the proposed study from a MSA; and (c) the population density of the area. The focus of research areas and questions that could be addressed under this initiative include, but are not limited to: o Do comprehensive, culturally specific, community-based primary health care models targeted to rural, minority groups result in improved health of, or health-related behavioral changes among community members? Does a culturally specific approach effect participation in the prevention strategies incorporated in the model? o What are the effects of culturally specific prevention strategies targeted to particular age groups of populations, such as rural, minority pre-school and school-age children, that include family and community participation in the planning, design, and implementation? Such strategies targeted to those of different socioeconomic level? o What are the differences among subpopulations in the use of, and effects of, targeted primary, secondary and tertiary prevention strategies? What factors can be differentiated as most influential? To what extent are they culturally driven? o What, if any, behavioral changes result from implementing primary, secondary and tertiary strategies targeted for specific cultural groups when there is direct family/community involvement? o Are there differences in health status, risk factors, clinical and cost outcomes between comprehensive community- based prevention programs and the more traditional practitioner-individual patient- focused, episodic primary care programs? o Do targeted, culturally relevant health care strategies change participation, timeliness of health seeking behaviors, frequency of crisis-oriented care seeking behaviors, appropriateness and acceptability of care, and costs? A variety of research designs could be proposed. However, research designs should include: a prospective, experimental or quasi- experimental approach; a well defined, specified rural population or subpopulation group(s); clear access to such a population/group(s); a theoretical basis for the model or organizing subcomponents; and demonstration of community involvement. The terms used to identify ethnic minority groups can vary in many ways. Some note traditional identifiers of origin, such as Mexican Americans; others refer to linguistic identifiers, such as Hispanics; and still others are more self descriptors, such as Latinos. It is important for population(s) targeted in a study to be clearly identified and their relationship to community boundaries described. SPECIAL REQUIREMENTS Applicants are asked to plan for an annual meeting of investigators. A meeting will be held early in the first year of funding to facilitate collaboration among the funded investigators and to determine the feasibility of coordination of aspects of research designs and of holding regular meetings. The cost of attending these meetings, which will be held in Bethesda, Maryland, should be included in the applicant's budget request. 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 March 31, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NINR staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Dr. Ernest Marquez Chief, Office of Review National Institute of Nursing Research Building 45, Room 3AN-24 45 Center Drive, MSC 6302 Bethesda, MD 20892-6302 Telephone: (301) 594-5965 FAX: (301) 480-8256 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, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NINR Information Office listed under INQUIRIES. 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. 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: Dr. Ernest Marquez Chief, Office of Review Building 45, Room 3AN-24 45 Center Drive, MSC 6302 Bethesda, MD 20892-6302 Telephone: (301) 594-5965 FAX: (301) 480-8256 Applications must be received by April 26, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by NINR staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether it should be returned or submitted 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 NINR 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. Review Criteria o The review criteria for this RFA are essentially the same as those for unsolicited research project grant applications: o Scientific, technical, or clinical significance and originality of proposed research; o Appropriateness and adequacy of the experimental or quasi-experimental approach and methodology proposed to carry out the research; o Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o Availability of the resources necessary to perform the research; o Appropriateness of the proposed budget and duration in relation to the proposed research; o In addition, applicants are expected to address the issues identified under "SPECIAL REQUIREMENTS," as well as criteria specific to the objectives of this RFA. These criteria include: o Applicants must be specific in defining the rural areas to be included in the study. o The applicant must provide documentation supporting access to the population(s) and community involved in the proposed study. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Awards will be made based on scientific merit determined by peer review and expressed in the priority score, availability of funds, and programmatic priorities. Award decisions will also take into consideration the extent of diversity of approaches among the primary health care models proposed. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct requests for copies of the RFA or other NINR documents to: NINR Information Office Building 31, Room 5B13 Bethesda, MD 20892 Telephone: (301) 496-0207 FAX: (301) 480-4969 Direct inquiries regarding scientific/programmatic issues to: Dr. Patricia Moritz Nursing Systems Branch National Institute of Nursing Research Building 45, Room 3AN-12 45 Center Drive MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5956 FAX: (301) 480-8260 Email: pmoritz@ep.ninr.nih.gov Direct inquiries regarding fiscal matters to: Ms. Sally Nichols Grants Management Officer National Institute of Nursing Research Building 45, Room 3AN-32 45 Center Drive MSC 6301 Bethesda, MD 20892-6301 Telephone: (301 594-6869) FAX: (301 480-8256) Email: snichols@ep.ninr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361, Nursing Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99- 158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The 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. References U.S. Bureau of the Census. (1987). Statistical abstract of the United States: 1988 (108th ed.). Washington, D.C.: U.S. Government Printing Office. U.S. Office of Management and Budget. (1983). Metropolitan statistical areas (NTIS No. PB83-218891). Washington, D.C.: U.S. Government Printing Office. From owner-sci-resources@net.bio.net Fri Jan 13 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DA-95-001 - V24(01) 01/13/95 Date: 13 Jan 1995 16:51:07 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 699 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3f775r$oph@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DA95001 DA-95-001 P1O1 *************************************** NEUROSCIENCE NETWORKS IN BASIC DRUG ABUSE RESEARCH NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA: DA-95-001 P.T. 34; K.W. 0404009, 1002030 National Institute on Drug Abuse Letter of Intent Receipt Date: March 16, 1995 Application Receipt Date: April 19, 1995 PURPOSE The National Institute on Drug Abuse (NIDA) invites applications to establish networks of investigators currently engaged in neuroscience research programs for the purpose of bringing relevant aspects of those programs to bear upon drug abuse research. Each network will be assembled by a Principal Investigator to form a multidisciplinary, multi-institutional consortium of neuroscience expertise centered upon a particular theme related to drug abuse research. These themes may be broad in scope, but should be concerned with identifying fundamental brain processes susceptible to the actions of drugs of abuse and the mechanisms through which drugs of abuse affect those processes. The intent of the request for applications (RFA) is to encourage cooperative efforts among network investigators to stimulate novel insights and innovative approaches to drug abuse research not presently achievable through collaborative efforts limited by geographical constraints. This RFA also is intended to extend existing research programs in the basic neurosciences into avenues directly relevant to drug abuse research with the goal of acquiring additional knowledge which ultimately may lead to new therapeutic and prevention strategies applicable to the public health problem of drug abuse. A minimum of three research projects must constitute the network, plus a core component concerned with establishing communication and information links among network members. In addition to stimulating substantive new research programs in drug abuse through this RFA, NIDA anticipates that the neuroscience networks created through this initiative will serve as experimental prototypes for new research enterprises devoted to studies on drug abuse within the environment of rapidly advancing communications and information technologies now revolutionizing contemporary biomedical research. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Neuroscience Networks in Basic Drug Abuse Research, is related to the priority areas of tobacco, alcohol and other drugs, maternal and infant health, and 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 domestic for profit and non-profit, public and private organizations, e.g., colleges, universities, hospitals, laboratories, units of State and local government and their agencies, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanism of support will be the program project grant (P01). Studies involving collaborative efforts among investigators in all aspects of basic neuroscience relevant to drug abuse research are encouraged. The NIDA is employing the P01 mechanism initially for its Neuroscience Network initiative to determine the feasibility, synergy, and productivity of the Network concept. The total project period for applications submitted in response to this RFA may not exceed five years. During this period, network members may wish to submit individual R01 grants to more fully expand efforts started under this network initiative while continuing their participation within the network. FUNDS AVAILABLE The estimated total funds (direct and indirect) available for first year support for all awards under this RFA will be $2 million. Applications must not request budgets in excess of $1 million total costs in the first year. Because the nature and scope of the work proposed in response to this RFA may vary, the size and number of the awards will also vary. In Fiscal Year 1995, NIDA anticipates funding approximately two P01 awards. This number 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 NIDA, awards made pursuant to this RFA will be contingent upon the continued availability of funds for this purpose. The earliest feasible start date for the awards will be September 1995. RESEARCH OBJECTIVES Background A recurring theme in contemporary biomedical research is the existence of homologous molecules and mechanisms in diverse, but critical biological processes. In the explosive field of neuroscience, this theme has become particularly evident on a variety of fronts; for example, studies on the membrane protein, bacteriorhodopsin, have provided important insights into receptors for neurotransmitters and modulators that play a role in sensory perception, and that also may be involved in learning and memory, as well as attention and arousal. Other studies are revealing key roles for neurotransmitters, neuropeptides, and cytokines in linking interactions between neuronal and immune systems; and a compelling body of evidence now is accumulating that indicates that vital brain processes -- such as the activity driven plasticity through which developing synapses are refined and adult synapses are modified in learning and memory -- may share similar mechanisms and molecules. In drug abuse research as well, this theme has emerged in a particularly pronounced fashion as investigators have recognized two important facts: first, that the neuronal changes related to the accumulated effects of addiction -- including tolerance, dependence and sensitization -- represent drug induced neuronal plasticity governed by principles and mediated through processes consonant with those for other forms of neuronal adaptations; and, second, that understanding the interplay between genetic and environmental influences upon brain function is intimately involved with identifying brain sites and processes vulnerable to the actions of drugs of abuse, as well as the consequences of those actions on nervous system function and behavior. Today, myriad findings from drug abuse research have intriguing counterparts in other areas of neuroscience research. We know, for example, that systems involving adenylate cyclase and its related kinase (long-studied in a variety of processes, including simple models of learning and memory) are affected in the nerve cells of the locus ceruleus after chronic opioid administration. We know that morphine affects the phosphorylation state of cyclic AMP response element binding protein (CREB), a critical transcription factor studied in a host of biological phenomena. We know that long-term potentiation and long-term depression (extensively investigated as models of cellular adaptations in the hippocampus and cortex) also occur in the nucleus accumbens, an important brain site implicated in the "reward" processes associated with drug abuse. We know that nitric oxide, a novel neurotransmitter gaining great attention because of its diverse role in processes ranging from development to neurotransmitter secretion, also functions in the development of morphine tolerance. We know that certain neurotrophins -- well studied for their roles in development and regeneration -- attenuate some of the cellular effects of morphine, and may be affected in their expression by morphine. And we know that contemporary theoretical and experimental work focused on understanding rules governing how the brain anticipates learning also may be relevant to elucidating how reward and reinforcement influence learning. Examples such as these underscore the importance of leveraging limited research resources in ways that encourage and enable investigators to explore several biomedical consequences of their work. In particular, they illustrate the possibility that ongoing research programs in the basic neurosciences not presently addressing drug abuse may, indeed, also have direct relevance to revealing brain mechanisms associated with addiction; and they emphatically emphasize the need for creative research approaches that will stimulate such considerations. A second recurring theme in contemporary biomedical research is the growing importance of interdisciplinary collaborations. In drug abuse research, which by its nature has always relied upon a variety of scientific approaches (from the pharmacological to the behavioral sciences), this theme is gaining unprecedented importance. Indeed, the field of drug abuse research now may be among the most rapid embracing interdisciplinary approaches, for accessible to it are animal models that permit prominent features of drug addiction to be studied in the laboratory -- a tool not elsewhere available to many neuroscientists. This advantage facilitates extensive studies at the molecular and cellular level, opening the way for achieving detailed biological insights into complex and clinically important behaviors. With the recent cloning of genes for the receptors of every major drug of abuse, and the possibility of temporally controlled, tissue specific gene manipulations waiting upon the horizon, the stage now is set for moving the field of drug abuse research beyond cloning, to sophisticated, mechanistic investigations exploring relationships among protein function and regulation, brain structure and function, and behavior, and how drugs of abuse affect these relationships. Clearly, however, such explorations will require new and creative approaches integrating expertise and perspectives from all aspects of the basic neurosciences. Now, more than ever, it is critical that behavioral scientists recognize the opportunities and limitations of molecular neurobiology, and that molecular neurobiologists develop appropriate behavioral assays to assess the consequences of their molecular manipulations. Similarly, it is vital that clinicians, imaging scientists, psychologists, and others collaborate to design safe, appropriate, informative, and reliable experiments when investigating fundamental aspects of human brain function; and that those engaged in human studies interact effectively with those involved in animal studies to achieve appropriate interpretations of results across species. A third theme emerging from contemporary biomedical research is the growing importance of communication and information technologies. The advent of high performance computing research already has greatly advanced many areas of investigation, such as structural biology, neuroscience, and cell biology. Even greater opportunities appear to exist as information and communication technologies become increasingly integrated. Today, desktop conferencing systems include software enabling multiple users to work on a variety of applications, including text, graphics, images and data, while seeing and talking to each other. Additionally, prototype projects already have demonstrated the feasibility of accessing and operating costly equipment, such as higher voltage electron microscopes, at remote sites. Elsewhere, new software applications are providing opportunities to utilize simulations for safer, less costly means of gaining experience in performing biological procedures and for investigating biological mechanisms. These, and other developments signal the evolving structure of contemporary research communities: a structure rapidly becoming as dependent upon information and telecommunication links, as it is upon traditional laboratory configurations. As drug abuse research relies increasingly upon the creativity and strength of multidisciplinary approaches and the power of new technologies to move its research programs more vigorously into the basic neurosciences, it is critical that NIDA develop experimental prototypes for new research enterprises responsive to the evolving nature of biomedical research communities. In particular, NIDA recognizes the importance of contemplating and initiating the creation of thematic, electronically linked "virtual research centers" to complement its traditional centers program, which heavily relies upon geographical contiguity. Research Scope This initiative has three principal objectives: (1) to stimulate novel insights and innovative approaches in drug abuse research through the establishment of national, collaborative networks of investigators active in the neurosciences; (2) to encourage and enable neuroscientists not currently focused on drug abuse research to explore applications of their expertise to the field; and (3) to develop experimental prototypes of research enterprises that exploit emerging communication and information technologies to form "virtual research centers" in the drug abuse field. Scope of the Neuroscience Research Component The first two objectives focus on increasing understanding of basic neural processes susceptible to the actions of drugs of abuse, and how drugs of abuse affect those processes. To accomplish these objectives, a Principal Investigator is invited to submit an application proposing a multi-institutional, multidisciplinary consortium (i.e., a network) of collaborators presently engaged in established research programs in the neurosciences, for the purpose of focusing the network's expertise upon a particular scientific theme relevant to drug abuse research. NIDA especially encourages applications that develop a theme based on the concept of drug abuse as a model system for investigating all aspects of neurobiological mechanisms associated with plasticity, and particularly the role of use-dependent synaptic modifications in understanding behaviors and brain mechanisms related to drug abuse and the actions of drugs. Network themes may focus upon a series of studies aimed at elucidating the interplay of mechanisms at the cellular level, or they may choose to focus on a multilevel approach, exploring brain function and drug action from the systems level to a molecular one. Themes may focus on a particular central nervous system function implicated in drug abuse, or on mechanistic studies associated with a particular drug of abuse. Themes focused on particular drugs of abuse should clearly articulate any broad principles regarding neuronal function and drug abuse that may derive from studies on specific drugs or related compounds. Studies may also explore interactions among the nervous system and other physiological systems, such as neuroendocrine and neuroimmune systems, in efforts to elucidate the causes and consequences of drug seeking behavior and mechanisms of drug actions. (In those cases where a network theme or project also may have relevance to AIDS-related research, applicants are strongly encouraged to discuss this relevance explicitly in the background section of their application.) Investigators are encouraged to recognize that a network's theme may be broad in scope, and creativity and originality are encouraged in identifying and developing a research theme. Examples of possible network themes include, but are not limited to, the following: o the neural basis of drug abuse, from molecules to behavior; o the neurobiology of motivation in understanding drug seeking behaviors; o the role of post-transcriptional processes in drug-related neuronal adaptations; o drug regulation of protein turnover, including protein processing, targeting, trafficking, and regulation; o drug abuse and the neurobiology of brain development; o the role of certain endogenous systems (such as the opioid, cannabinoid, and nicotinic systems) in normal CNS function, and how drugs of abuse perturb those roles; o mechanisms of neuronal adaptations in critical brain regions affected by drugs of abuse, such as the nucleus accumbens; o explorations of relationships between drug induced brain "rewards" and learning and memory; o the effects of drugs of abuse on neuroimmune and neuroendocrine function; o the role of novel neurotransmitters in drug-induced neuronal plasticity; o the function of endogenous systems (such as the opioids) in neuromodulatory mechanisms, and the effects of drugs of abuse upon those systems. o investigations into pre- and post-synaptic mechanisms by which drugs of abuse alter synaptic efficacy. Network applications must consist of at least three interactive and interdependent projects conducted at independent laboratory sites and a communication core. Network members should be engaged in an active neuroscience research program, which, although not directly centered on drug abuse, has potential relevance to drug abuse research; however, the Principal Investigator may designate one network component as an "Exploratory Project." This project need not be based on an active, ongoing program or extensive preliminary data. It should represent a highly innovative study for which the potential significant scientific contribution offsets potential concerns about project feasibility. Funds for an "Exploratory Project" may be applied to testing the feasibility of an approach, gathering additional data, or conducting other activities that demonstrate the project's significance. Applicants should note that the initiative described in this RFA is not to be construed as a means for merely assembling and supplementing existing, ongoing programs in drug abuse research. This initiative is intended to provide limited funds to encourage and enable applications of basic neuroscience projects to drug abuse research. Investigators currently engaged in drug abuse research may be network members, but network projects for such investigators should represent novel avenues of study that would benefit greatly >From network participation and/or contribute greatly to a network's theme. Conversely, this initiative is not intended to merely supplement existing research programs in the basic neurosciences. Network applications must clearly articulate a coherent theme relevant to drug abuse research, and explicitly and carefully describe the potential relevance of each network component to drug abuse research, the scientific interactions anticipated among network members, and the expected benefits to be derived to drug abuse research from the network approach. Communication Core To achieve the third objectives of this RFA, applications must include plans for a Communication Core. Principal Investigators may request support for equipment and personnel necessary to achieve the communications and interactions essential to the Network's theme and activities. An important aspect of this core will be to exploit emerging communication and information technologies among geographically dispersed communities of investigators. Issues to consider in the communications core may include, but are not limited to, the following: o Diversity and compatibility among communications and information hardware and software available to Network laboratories; o "Real time" versus other modes of communications, such as Email and bulletin boards; o Mechanisms and procedures for safeguarding and sharing information, generating new information from shared information resources, and crediting investigators' work when information is obtained or generated from shared resources. Although data development and sharing may be an important and integral activity of a Network's communication core, this RFA is not intended to provide a means for largely establishing and manipulating extensive neuroscience data bases. This RFA is focused on hypothesis driven projects that may involve data sharing. Applications focused principally on data base development and informatics should consider submitting applications under the Human Brain Project (HBP) Initiative. For additional information about the HBP initiative, investigators are encouraged to contact the program representative listed under INQUIRIES. SPECIAL REQUIREMENTS Advisory Panel Because network members may be either newcomers to the field of drug abuse research, or investigators established in one aspect of drug abuse research (but not necessarily another), applications should include plans for utilizing an Advisory Panel to assist the network in periodic evaluation of its program. The Advisory Panel should be composed of at least three investigators, two of whom should be well respected for their expertise in the field of drug abuse research. These plans should explicitly delineate the nature and extent of interactions with Advisory Panel members and should include at least one annual meeting between network and Advisory Panel members. The Principal Investigator may also schedule additional meetings at network sites, if appropriate. Principal Investigators are requested to notify the NIDA program official responsible for the network grant at least 45 days prior to any scheduled meetings, so that the official may have the opportunity to attend. Applications should specifically identify Advisory Panel members, their areas of expertise, and the relevance of that expertise to accomplishing the research goals related to the network's theme. Letters of collaboration from Advisory Panel members must be included with the application. Composition of Network To encourage collaborations and diversity in perspectives among laboratories, networks may not contain more than two component projects from a single institution or campus or other non-academic organization eligible under this RFA. Director Each Network will have a Director responsible for organizing, administering, and directing the Network's activities. The Director must commit at least 20 percent effort to the grant and be Principal Investigator of one of the projects. Progress Reports Annual progress reports accompanying noncompeting continuation applications should specifically address the nature of Network interactions, including opportunities and problems associated with those interactions, and proposed solutions for addressing any identified problems. This discussion should be useful to NIDA for evaluating the feasibility of potential future Network initiatives. Principal investigators and subproject leaders in the Network will be requested to voluntarily submit manuscripts accepted for publication to the Network's NIDA program administrator at least two weeks prior to publication, so that a current summary of program accomplishments may be maintained during the funding period of the grant. 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 494B 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 may also obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. LETTER OF INTENT Prospective applicants are asked to submit, by March 16, 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 this RFA. 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 NIDA staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent (or faxed) to: Eleanor Friedenberg Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 FAX: (301) 443-0538 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, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. The RFA label available in the application form PHS 398 (rev. 9/91) must be affixed to the bottom of the original 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 on 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 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: Director of Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 Applications must be received by April 19, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIDA. Incomplete applications or applications that are not responsive will be returned to the applicant 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 NIDA in accordance with the review criteria stated below. As part of the initial merit review, triage will 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 this RFA. Applications judged to be competitive will be discussed and assigned a priority score. Applications determined to be noncompetitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria The IRG review of scientific and technical merit of the Program Project grant application will emphasize two major aspects: (1) review of the program as an integrated research effort focused on a central theme, and (2) the review of each component project and core unit(s). The review will also include an assessment of the academic climate and physical environment and special considerations, e.g., compliance with the human subjects and animal welfare regulations. The IRG will assign a priority score for the entire program rather that for each individual project recommended for further consideration. The assessment of the scientific and technical merit will include the following: Program as an Integrated Effort o The significance of the overall program goals and the development of a well-defined central research focus of importance and relevant to the goals of this RFA. o The multidisciplinary or multifaceted character of the program, i.e., the coordination, cohesiveness, interrelationship, and synergistic potential among the individual projects and core(s). o The justification for, and usefulness of the core facilities to the research projects. Each core unit must provide essential facilities or services for two or more approved individual projects. For the communication core, the feasibility of proposed approaches for using information and communication technologies in establishing networks of neuroscientists focused on scientific aspects of drug abuse research. o Administrative arrangements and/or organizational structure, through an administrative and/or communication core, to facilitate and monitor the attainment of objectives and quality control. For example, these factors will include plans to enhance communication and cooperation among the investigators involved in the program and utilization of the advisory panel mechanism to assist the network in advancing its progress. o The scientific leadership, ability, stature, experience, and administrative competence of the Program Director and his or her commitment and ability to devote substantial time and at least 20 percent effort to the program. o The scientific stature of the Principal Investigators and the extent to which each contributes to the overall program goals as well as their commitment to the program. o Accomplishments and progress of the program to date, if appropriate. o Reasonableness of the overall budget for the proposed work. Individual Projects and Core Units o The scientific and technical merit of each research project and core unit. o The accomplishments and progress for the projects and the core units to date for ongoing projects. o The qualifications, experience, and commitment of the investigators responsible for the research projects or core units, including their ability to devote adequate time and effort to the project. o For any component designated as an "Exploratory Project," the potential for significant scientific contribution, the uniqueness of the scientific approach, and the qualifications of the investigator. o The appropriateness of the budget for each of the proposed projects and core units. Resources and Environment o The academic climate and physical environment in which the research will be conducted, including the availability of space, equipment, research subjects, etc., and the potential for interaction with scientists from other departments and/or institutions in addition to network members. o Institutional strength, stability and commitment to research and support for the proposed program, including fiscal responsibility and management capability to assist the Program Director and staff in following DHHS, PHS, and NIH policies. Other Considerations o When an application involves potential adverse effects on humans or animals, adequacy of the proposed means for protecting against such effects must be demonstrated. o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA The anticipated date of award is September 1995. In making awards, the scientific/technical merit of applications, availability of funds, and program balance among research areas will be considered. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding program issues to Karen J. Skinner, Ph.D. Division of Basic Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-19 Rockville, MD 20857 Telephone: (301) 443-1887 FAX: (301) 594-6043 Email: kskinner@aoada.ssw.dhhs.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gfleming@aoada.ssw.dhhs.gov AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 of 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 Mon Jan 16 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 15 January 1995 Date: 16 Jan 1995 20:06:35 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 56 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3fffob$l31@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. ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alpha Telephone File size (bytes): 96429 STIS Filename: phnalpha.txt Title: NSF Organizational Directory File size (bytes): 98454 STIS Filename: phnorg.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg.txt, the text of your message should be as follows: get phnorg.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg.txt, you would enter: ftp> get phnorg.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Mon Jan 16 22:00:00 1995 Path: biosci!biosci!not-for-mail From: Frank Norman Newsgroups: bionet.announce,bionet.sci-resources Subject: Medical Research Council (UK) WWW Home Page Date: 16 Jan 1995 21:05:13 -0800 Organization: MRC Human Genome Resource Centre Lines: 23 Sender: kristoff@net.bio.net Approved: bionews-moderator@net.bio.net Distribution: world Message-ID: <3fbfcg$le2@mercury.hgmp.mrc.ac.uk> NNTP-Posting-Host: net.bio.net Xref: biosci bionet.announce:1690 bionet.sci-resources:1234 A Medical Research Council WWW Home Page is now available: http://www.nimr.mrc.ac.uk/MRC The Medical Research Council (MRC) promotes the balanced development of medical and related biological research in the UK. The Council receives an annual Grant in aid from Parliament via the Office of Science and Technology. It also receives funds for or works with a number of government departments, industry and charities. It has close links with the Health Departments and the other Research Councils. The Home Page includes information about MRC Institutes and Units, Interdisciplinary Research Centres, and about other UK Research Councils. Hyperlinks are provided where available. Frank Norman Deputy Librarian National Institute for Medical Research The Ridgeway Mill Hill London NW7 1AA f.norman@nimr.mrc.ac.uk From owner-sci-resources@net.bio.net Wed Jan 18 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 2, pt. 1of1, 20 January 1995 Date: 18 Jan 1995 17:45:36 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1103 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3fkg80$jh@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950120 V24N02 P1O1 ************************************ X-comment: RFAS described: DK-95-004, LM-95-001, AR-95-004, PA-95-015, PA-95- 021, PA-95-022 NIH GUIDE - Vol. 24, No. 2 - January 20, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** PHS GRANTS POLICY STATEMENT: HIGHLIGHTED CHANGES AND AVAILABILITY ON THE NIH GOPHER National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** SUPPLEMENTAL GUIDANCE ON THE NIH STREAMLINED NONCOMPETING CONTINUATION PROCESS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** SALARY LIMITATION ON GRANTS AND CONTRACTS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N4 ********************************************************** MODIFICATIONS TO PAR-94-083 AND PAR-94-084 National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX N5 ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 04/19/95 ************************************************* SUPPORT OF MINORITIES IN DIABETES, DIGESTIVE AND KIDNEY DISEASE RESEARCH (RFA DK-95-004) National Institute of Diabetes and Digestive and Kidney Diseases Office of Research on Minority Health INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES; MINORITY HEALTH $$INDEX R2 05/18/95 ************************************************* INTERNET CONNECTION FOR MEDICAL INSTITUTIONS (RFA LM-95-001) National Library of Medicine INDEX: NATIONAL LIBRARY OF MEDICINE $$INDEX R3 07/12/95 ************************************************* PROGRAM ON MECHANISMS OF IMMUNOTHERAPY IN RHEUMATIC DISEASES (RFA AR- 95-004) National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES $$INDEX P1 ********************************************************** ACADEMIC RESEARCH ENHANCEMENT AWARD (PA-95-015) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX P2 ********************************************************** MODELS FOR AIDS AND AIDS-RELATED MALIGNANCIES (PA-95-021) National Cancer Institute National Institute of Allergy and Infectious Diseases INDEX: CANCER; ALLERGY, INFECTIOUS DISEASES $$INDEX P3 ********************************************************** DRUG ABUSE HEALTH SERVICES RESEARCH AND HIV/AIDS (PA-95-022) National Institute on Drug Abuse INDEX: DRUG ABUSE This publication is available electronically via BITNET or INTERNET, by subscription, and is also on the NIH GOPHER (gopher.nih.gov). Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221); contact Dr. John James at 301/594- 7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. **THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD BUILDING IS: 5333 Westbard Avenue Bethesda, MD 20816 $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** PHS GRANTS POLICY STATEMENT: HIGHLIGHTED CHANGES AND AVAILABILITY ON THE NIH GOPHER NIH GUIDE, Volume 24, Number 2, January 20, 1995 P.T. 34; K.W; 1014006 National Institutes of Health In early 1994, a revised PHS Grants Policy Statement was published, and a single copy was sent to the sponsored projects office (or its equivalent) of all current PHS grantees. Only one copy is provided to each grantee; grantees may photocopy the document as needed. NIH grantees who did not receive a copy may contact the NIH Division of Research Grants, Office of Grants Information, on 301/594-7248 to request a single copy. The revised version is effective for all PHS grants with budget periods beginning on or after April 1, 1994. It is recommended that grantees maintain the previous PHS Grants Policy Statement dated October 1, 1990 and interim update of September 1, 1991, for active awards with budget periods that started prior to April 1, 1994. In the near future, the PHS Grants Policy Statement will be available on the NIH Gopher. The NIH Gopher contains information about NIH, including the NIH Guide for Grants and Contracts, and has text- searching capabilities. It is possible to "tunnel" to the NIH Gopher if you have access to a system with Gopher. Local computer support staff should be consulted for additional information or assistance. The information below highlights changes and clarifications appearing in the April 1, 1994, edition of the PHS Grants Policy Statement. The page numbers indicate where to find the complete discussion of the referenced topic. o TREATMENT OF PROGRAM INCOME (pp. 8-9 through 8-10): PHS has elaborated on the discussion and further defined program income. Specifically highlighted are general program income; the sale of real property, equipment, and supplies; and other income, e.g., copyright income, patent income. The policy also elaborates on the treatment, disposition, and reporting of general program income. Much of the guidance provided reiterates the NIH GUIDE notice of June 11, 1993 on the reporting of program income using the long-form Financial Status Report (SF 269). o REVIEW OF UNOBLIGATED BALANCES (p. 8-6): Discussion has been added regarding unobligated balances in excess of 25 percent of the total amount awarded or $250,000, whichever is less. In such cases, the Grants Management Officer shall review the circumstances resulting in the large balance to assure that these funds are necessary to complete the project. The GMO may request additional information including a revised budget, withdraw the unobligated funds, authorize the grantee to spend the unobligated funds, or leave the unobligated funds in the grant account in the payment system for utilization as determined by the PHS awarding office. o SIGNIFICANT REBUDGETING (pp. 8-1 and 8-7): Under Changes in Project, significant rebudgeting continues to be an indicator for a possible change in scope. Significant rebudgeting occurs when the cumulative amount of transfers among direct cost categories for the current budget period exceeds 25 percent of the total amount awarded or $250,000, whichever is less. When this occurs, the grantee shall consult with the GMO for a decision as to whether the rebudgeting constitutes a change of scope. If it does constitute a change of scope, prior approval of the awarding component is required. o SMOKE-FREE WORKPLACE (p. 4-11): The Assistant Secretary for Health, PHS, has put in place a policy that strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of tobacco products. PHS will gather information about this by including a new question in the upcoming revision to the PHS 398 grant application regarding whether or not the applicant institution provides a smoke-free workplace. The response to this question will not affect either the review or funding of the application. o GUIDANCE ON EXPENDITURES FOR LOBBYING ACTIVITIES (pp. 4-10 and 7- 9): Lobbying activities continue to be generally unallowable. o THE ESTABLISHMENT OF THE SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION (SAMHSA) (p.1-1): Effective October 1, 1992, NIDA, NIMH, and NIAAA, formerly of the Alcohol Drug Abuse and Mental Health Administration (ADAMHA), became components of the National Institutes of Health. At the same time, SAMHSA was established to assume the remaining programs of ADAMHA. The mission of SAMHSA is to provide leadership and national focus for Federal efforts to reduce national health problems resulting from the abuse of alcohol and other drugs and to foster improvements in the mental health of Americans through increased knowledge and the advancement of effective strategies for dealing with these health problems. o AUDIT REQUIREMENTS FOR FOR-PROFIT RECIPIENTS (p. A6-1): The following exception has been added regarding audit requirements for SBIR Phase I grantees: Recipients of SBIR Phase I awards receiving no more than $100,000 in cumulative Federal awards are exempt from the audit requirements of OMB Circular A-133. However, the organization should have its records available for review by the PHS agency should the agency elect to do so. o ALLOWABILITY OF FEE UNDER SMALL BUSINESS INNOVATION RESEARCH GRANTS (p. A6-1): Appendix 6 contains the following new information: Beginning July 1, 1992, PHS awarding offices shall negotiate fixed fees for competing grants awarded under the Small Business Innovation Research (SBIR) program when (1) requested by the grantee organization and (2) the amount of the fixed fee, together with the direct and indirect costs to be awarded, is within the Phase I and Phase II award limitations set by the program. The STTR Program, although not explicitly identified, is also subject to this provision. o OUTPATIENT DRUG PROVISIONS UNDER THE VETERANS HEALTH CARE ACT OF 1992 (p. 4-11): Section 602 of the Veterans Health Care Act of 1992 (Public Law 102-585) established section 340B of the Public Health Service Act, Limitation on Prices of Drugs Purchased by Covered Entities. Effective December 1, 1992, certain health services delivery grantees of PHS ("covered entities") shall receive drug discounts from drug manufacturers for outpatient drugs. Grantees that receive grant funds related to the treatment of sexually transmitted diseases or tuberculosis, or receive certain assistance under Title XXVI of the PHS Act, must be certified by the Secretary of HHS before they become eligible for drug discount prices. Section 340B contains prohibitions requiring covered entities to develop alternative drug management systems and identifies potential problem areas concerning drug diversion. Information regarding HHS-approved alternative tracking systems, rebates to State Medicaid agencies required under the Omnibus Budget Reconciliation Act of 1990, and mechanisms to prevent double price reductions, is also provided. o INSURANCE REQUIREMENTS FOR REAL PROPERTY CONSTRUCTED OR ACQUIRED WITH PHS GRANT FUNDS (p. 8-12): The section on insurance requirements for real property constructed or acquired with PHS grant funds, and specifically the term "immediately upon acquiring real property," has been expanded. The policy states that a grantee shall, at a minimum, provide the same insurance coverage as provided to other property owned by the recipient at the time the facility is turned over to the grantee institution, e.g. the date of the final acceptance of the building, or the point of beneficial occupancy, whichever comes first. o USE OF STATE-CERTIFIED OR LICENSED REAL ESTATE APPRAISERS WHERE APPRAISALS ARE NEEDED ON REAL PROPERTY (p. 8-13): All real estate transactions funded in whole or in part with PHS funds that require the use of real estate appraisals, including but not limited to appraisals to determine the Federal share of real property and appraisals to determine required insurance levels, must by performed by appraisers certified or licensed by the applicable State in accordance with the requirements established by Title XI of the Financial Institutions Reform, Recovery, and Enforcement Act of 1989 (FIRREA) (Public Law 101-73). o SEISMIC SAFETY STANDARDS FOR FEDERALLY ASSISTED CONSTRUCTION (p. A2-1): A new design requirement has been added to those applicable to PHS-assisted construction. Seismic safety standards for federally assisted construction -- Earthquake Hazard Reduction Act of 1977 (Public Law 95-124), as amended, and Executive Order 12699, Seismic Safety of Federal and Federally Assisted or Regulated New Building Construction, dated January 5, 1990, has been added under the design requirements to be included in the review and evaluation of all working drawings and specifications. o PUBLIC HEALTH SYSTEM REPORTING REQUIREMENTS (p. 4-14): The external review process now includes instructions regarding Public Health System Reporting Requirements for community-based, nongovernmental organizations applying for health services grants. These organizations will be notified in the application materials if the program is subject to these requirements. Such applicants are instructed to submit the application face page (SF-424) and a one- page summary of the project called the Public Health System Impact Statement (PHSIS). This summary should include a description of the population to be served, a summary of the services provided, and a description of any coordination planned with the appropriate State or local health agency(ies). For additional information, contact the grants management specialist of the NIH awarding component that issued your grant award. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** SUPPLEMENTAL GUIDANCE ON THE NIH STREAMLINED NONCOMPETING CONTINUATION PROCESS NIH GUIDE, Volume 24, Number 2, January 20, 1995 P.T. 34; K.W. 1014006 National Institutes of Health On October 28, 1994, an announcement was published in the NIH Guide for Grants and Contracts (Volume 23, Number 38) which introduced a streamlined noncompeting continuation award process for certain types of NIH research grants and career awards. This notice is to provide clarification and guidance for submitting the streamlined noncompeting continuation application (PHS Form 2590) for the grants covered by the process. NIH grant recipients are expected to use the following guidelines (in addition to the October 28 notice) in submitting the streamlined noncompeting continuation application for R01, R03, R13, R15, R18, R21, R24, R25, R29, R37, R42, R44, or the "K" series mechanisms. The instructions for submitting the streamlined noncompeting grant application require that three questions be answered at the beginning of the Progress Report Summary (Form Page 6) of the PHS Form 2590 application. In responding to the questions, the following guidance applies. o Other support for key personnel: The format of Form Page 5 (Other Support) of the noncompeting application (PHS 2590) is to be completed only when active support has changed. If a previously active grant has terminated and/or if a previously pending grant is now active, the change in support is to be reported. Submission of other support information is not necessary when support is pending. Other support information should be submitted only for the principal investigator and for those individuals who are considered by the principal investigator to be key to the project. Key personnel is defined as an individual who contributes in a substantive way to the scientific development or execution of the project, whether or not salaries are requested. Key personnel is defined on Form Page 4 (Biographical Sketch) and on Form Page 5 (Other Support) of the PHS 2590. Changes in level of effort for active support that has been reported previously does not require the submission of other support pages. o Significant rebudgeting: Significant rebudgeting occurs when the cumulative amount of transfers among direct cost categories for the current budget period exceeds 25 percent of the total amount awarded, or $250,000, whichever is less. This policy is stated in the PHS Grants Policy Statement (rev. April 1, 1994), Pages 8-1 and 8-7. o A change in the level of effort for key personnel: A significant change in level of effort is defined in Federal regulations as a 25 percent reduction in time devoted to the project. For example, if a key person on the project is expected to reduce their effort from 40 percent to 30 percent, which represents a 25 percent reduction in the level of effort, the detailed budget page (Form Page 2) and the budget justification page (Form Page 3) are to be submitted in the noncompeting continuation application. This requirement applies regardless of whether or not the key person is compensated from the grant. o Estimated unobligated balance: An estimated unobligated balance (including prior year carryover) that is greater than 25 percent of the current year's total budget or more than $250,000 is to be reported on the Progress Report Summary page (Form Page 6). An explanation of why there is a significant balance and how it will be spent if carried forward into the next budget period is to be provided. Cumulative unobligated balances resulting from prior year carryover are compared against the current years's authorized total budget. The questions regarding other support and significant rebudgeting and/or change in level of effort must be answered by stating that no change has occurred or is planned. If a change has occurred or is planned, the appropriate forms and/or justification are to be submitted in the noncompeting continuation application. The third question must be answered when it is anticipated that there will be an unobligated balance (including prior year carryover) of 25 percent of the current year's total budget or more than $250,000. The Progress Report Summary (Form Page 6) is to be used to answer the three questions before the progress report begins. Blank pages should be used to begin the progress report if inadequate space remains on the first page to answer the questions and to report on the research progress. As a guideline, the progress report (sections 1-6) should not exceed two pages. Information about publications should continue to be submitted as outlined in the Form PHS 2590. Separate progress reports are required for supplements which were awarded specifically to support the addition of an individual to the project. The Research Supplement for Underrepresented Minorities and the Research Supplement to Promote the Recruitment of Individuals with Disabilities into Biomedical Research Careers are examples of special supplements and require a separate progress report. A separate budget for these special supplements is not required unless there is a significant change as discussed above. INQUIRIES questions concerning the simplified noncompeting continuation application may be directed to the grants management specialist or program administrator identified on the notice of grant award. $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** SALARY LIMITATION ON GRANTS AND CONTRACTS NIH GUIDE, Volume 24, Number 2, January 20, 1995 P.T. 34; K.W. 1014006 National Institutes of Health The purpose of this notice is to provide updated information regarding the salary limitation as it relates to NIH grant and cooperative agreement awards. This information also applies to extramural research and development contract awards. The last notice in the NIH Guide for Grants and Contracts regarding the salary limitation was contained in Vol. 23, No. 7, February 18, 1994. In addition, this notice reiterates the way that NIH Institutes and Centers (ICs) are treating salaries in excess of the limit for any FUTURE years in competing grant awards. Fiscal Year (FY) 95 is the sixth consecutive year for which there is a legislatively mandated provision for the limitation of salary. Specifically, the Department of Health and Human Services (HHS) Appropriations Act for FY 95, Public Law 103-333, restricts the amount of direct salary of an individual under a grant or cooperative agreement (hereafter referred to as grant) or applicable contract to a RATE of $125,000 per year. Direct salary is exclusive of fringe benefits and indirect costs/general and administrative expenses. The salary limit of $125,000 has not increased from the FY 94 level. NIH will continue to apply the limitation to all grant and applicable contract awards, and to all funding amendments to existing awards, made with FY 95 funds. Therefore, NIH grant and applicable contract awards for applications/ proposals that request direct salaries of individuals in excess of a RATE of $125,000 per year will be adjusted in accordance with the legislative salary limitation and will include a notification such as the following. According to the HHS Appropriations Act, "None of the funds appropriated in this title for the National Institutes of Health and the Substance Abuse and Mental Health Services Administration shall be used to pay the salary of an individual, through a grant or other extramural mechanism, at a rate in excess of $125,000 per year." An individual's institutional base salary is the annual compensation that the applicant organization pays for an individual's appointment, whether that individual's time is spent on research, teaching, patient care, or other activities. Base salary excludes any income that an individual may be permitted to earn outside of duties to the applicant organization. The following are examples of the adjustments that NIH will make when salaries exceed the limitation: EXAMPLE 1. INDIVIDUAL WITH FULL-TIME APPOINTMENT. Individual's institutional base salary for a FULL-TIME (twelve month) appointment $150,000 Research effort requested in application/proposal 50% Direct Salary requested $75,000 Fringe benefits requested (25% of salary) $18,750 Subtotal $93,750 Applicant organization's indirect costs at a rate of 45% of subtotal $42,188 Amount requested - salary plus fringe benefits plus associated indirect costs $135,938 If a grant/contract is to be funded, the amount included in the award for the above individual will be calculated as follows: Direct salary - restricted to a RATE of $125,000 multiplied by effort (50%) to be devoted to project $62,500 Fringe benefits (25% of allowable salary) $15,625 Subtotal $78,125 Associated indirect costs at 45% of subtotal $35,156 Total amount to be awarded due to salary limitation $113,281 Amount of reduction due to salary limitation ($135,938 requested minus $113,281 awarded) $22,657 EXAMPLE 2. INDIVIDUAL WITH HALF-TIME APPOINTMENT. Individual's institutional base salary for a HALF-TIME appointment (50% of a full-time twelve month appointment) $65,000 Research effort requested in application/proposal 30% Direct Salary requested $19,500 Fringe benefits requested (25% of salary) $4,875 Subtotal $24,375 Applicant organization's indirect costs at a rate of 45% of subtotal $10,969 Amount requested - salary plus fringe benefits plus associated indirect costs $35,344 If a grant/contract is to be funded, the amount included in the award for the above individual will be calculated as follows: Direct salary - restricted to a RATE of $125,000 multiplied by 50% appointment by 30% effort to be devoted to project $18,750 Fringe benefits (25% of allowable salary) $4,688 Subtotal $23,438 Associated indirect costs at 45% of subtotal $10,547 Total amount to be awarded due to salary limitation $33,985 Amount of reduction due to salary limitation ($35,344 requested minus $33,985 awarded) $1,359 Other important points relating to both NIH grants and contracts are: o An individual's base salary, per se, is NOT constrained by the legislative provision for the limitation of salary. The rate limitation simply limits the amount that may be awarded and charged to NIH grant and applicable contract awards. An institution may supplement an individual's salary with non-federal funds. o The salary limitation does NOT apply to payments made to consultants under an NIH grant or contract although, as with all costs, such payments must meet the test of reasonableness. o The salary limitation provision DOES apply to those subawards/subcontracts for substantive work under an NIH grant or contract. In addition, the following three paragraphs apply to GRANT applications/awards only: o COMPETING grant applications submitted to the NIH may continue to request funding at the regular/actual rates of pay of all individuals for whom reimbursement is requested, even when these rates exceed the salary limitation. NIH staff will make necessary adjustments to requested salaries prior to award. o There was a change in the way that NIH ICs treated salaries in excess of the limit for any FUTURE years beginning with COMPETING grant awards funded with FY 94 funds. NIH competing awards issued in FY 95 will reflect adjustments to all years of a project, including future years, so that no funds are awarded or committed for salaries over the limitation. o NON-COMPETING continuation grant applications submitted to NIH should request funds for salaries at rates of pay that DO NOT exceed the salary limitation. If the current committed level includes funds for salaries at a rate that exceeds the salary limitation, the excess may not be rebudgeted for any other purpose and NIH staff will delete it from the award. INQUIRIES Questions concerning this notice or other policies relating to grants or contracts should be directed to the grants management or contracts management offices in the NIH institutes or centers. $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** MODIFICATIONS TO PAR-94-083 AND PAR-94-084 NIH GUIDE, Volume 24, Number 2, January 20, 1995 P.T. 34; K.W. 1002002 National Center for Research Resources The National Center for Research Resources (NCRR) announces the following modifications to its ongoing Program Announcements PAR-94-083, "Developing and Improving Institutional Animal Resources" and PAR-94-084, "Animal Facility Improvement for Small Research Programs, both of which appeared in the NIH GUIDE, Volume 23, Number 27, July 22, 1994. The first modification is to reflect the NCRR intent to triage those applications submitted for the February 1, 1995, and later receipt dates. Applicants should substitute the following language for the first paragraph under "REVIEW CONSIDERATIONS," which appeared in the July 22, 1994 GUIDE: "Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCRR. Incomplete applications will be returned to the applicant without further consideration. If staff find that the application is not responsive to this program, it will be returned without further consideration. Applications that are complete and responsive to this program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCRR 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 this program announcement. 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 notified." The second modification is a change in the address to which the two additional copies of applications are to be sent. Substitute the following for the address that appeared in each program announcement under APPLICATION PROCEDURES: Dr. Jill Carrington Office of Review National Center for Research Resources Westwood Building, Room 10A15 Bethesda, MD 20892-4500 INQUIRIES If you have any questions regarding these modifications, contact: Dr. Leo A. Whitehair Director, Comparative Medicine Program National Center for Research Resources Telephone: (301) 594-7933 $$N4 END ************************************************************ $$N5 BEGIN ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS NIH GUIDE, Volume 24, Number 2, January 20, 1995 P.T. 42; K.W. 0201011, 1014003 National Institutes of Health The National Institutes of Health, Office for Protection from Research Risks is continuing to sponsor workshops on implementing the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Each of the workshops scheduled for Fiscal Year 1995 will focus on a specific theme. The workshops are open to institutional administrators, members of Institutional Animal Care and Use Committees, laboratory animal veterinarians, investigators and other institutional staff who have responsibility for high-quality management of sound institutional animal care and use programs. Ample opportunities will be provided to exchange ideas and interests through question and answer sessions and informal discussions. DATES: March 12-14, 1995 TOPIC: Animal Care and Research: Challenges and Changes for the Institutional Animal Care and Use Committee LOCATION San Diego Princess 1404 West Vacation Road San Diego, CA 92109-7994 Telephone: (619) 274-4630 or (1-800) 344-2626 FAX: (619) 581-5929 SPONSORS Tufts University School of Veterinary Medicine Public Responsibility in Medicine and Research REGISTRATION Ms. Danielle Demko Public Responsibility in Medicine and Research 132 Boylston Street Boston, MA 02116 Telephone: (617) 423-4112 FAX: (617) 423-1185 FEE: $300 DESCRIPTION: The Workshop will focus on revisions to the Institutional Animal Care and Use Committee Guidebook; assessment and reduction of pain and distress in animal research; occupational health risks ad biohazards; and a host of other regulatory and administrative issues that are central to the successful operation of laboratory animal care and research programs. Immediately preceding the Tufts University School of Veterinary Medicine/NIH/OPRR Workshop, Applied Research Ethics National Association (ARENA) will sponsor its annual animal issues meeting on Sunday, March 12, also at the San Diego Princess. INQUIRIES For further information concerning these workshops and future NIH/OPRR Animal Welfare Education Workshops, contact: Mrs. Roberta Sonneborn Office of Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, MSC 7507 Bethesda, MD 20892-7507 Telephone: (301) 496-7163 FAX: (301) 402-2071 $$N5 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN DK-95-004 FULL-TEXT ************************************** SUPPORT OF MINORITIES IN DIABETES, DIGESTIVE AND KIDNEY DISEASE RESEARCH NIH GUIDE, Volume 24, Number 2, January 20, 1995 RFA AVAILABLE: DK-95-004 P.T. National Institute of Diabetes and Digestive and Kidney Diseases Office of Research on Minority Health Letter of Intent Receipt Date: March 2, 1995 Application Receipt Date: April 19, 1995 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Office of Research on Minority Health recognizes the need to increase the number of underrepresented minorities committed to scientific careers in research areas served by the Institute. This program will utilize the small research grant (R03) mechanism of support and will provide up to $50,000 direct costs for up to two years. This solicitation is aimed primarily at recently trained M.D. and/or Ph.D. minority investigators. The program will enable the minority applicant to accept a tenure earning position, gain additional research experience and obtain preliminary data on which to base a subsequent research grant application in an area of diabetes, endocrinology, metabolism, digestive diseases and nutrition, kidney, urology or hematology. 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, Support of Minorities in Diabetes, Digestive and Kidney Disease Research, is related to the priority area of increasing underrepresented minority health scientists. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by email from the program contact listed below. Charles H. Rodgers, Ph.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 19J MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7716 Email: chuckr@dvsgate.niddk.nih.gov $$R1 END ************************************************************ $$R2 BEGIN LM-95-001 FULL-TEXT ************************************** INTERNET CONNECTION FOR MEDICAL INSTITUTIONS NIH GUIDE, Volume 24, Number 2, January 20, 1995 RFA AVAILABLE: LM-95-001 P.T. National Library of Medicine Letter of Intent Receipt Date: April 10, 1995 Application Receipt Date: May 18, 1995 PURPOSE The National Library of Medicine (NLM) is encouraging the development of a communications infrastructure to promote the rapid interchange of medical information nationally and throughout the world. This infrastructure is based upon the Internet, a network of networks that was developed with the support of the National Science Foundation. The proposed evolution of the Internet into the National Research and Education Network (NREN) is a key element in important federal initiatives in High Performance Computing and Communication and a National Information Infrastructure. Internet access provides health professionals engaged in education, research, clinical care, and administration with a means of accessing remote databases, libraries, NLM's Grateful Med, DOCLINE and Loansome Doc, transferring files and images, and interacting with colleagues throughout the world. To accelerate the pace with which health-related institutions become part of the electronic information web, NLM is offering grants to support Internet connections. This RFA will use the National Library of Medicine (NLM) resource grant (G08) mechanism. Funds available for this RFA are approximately $600,000; however, expenditure of this amount is conditional upon the receipt of applications of high merit. Number of awards to be made is estimated to be between 10 and 16. 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), Internet Connection for Medical Institutions, is related to the priority area of surveillance and data systems. 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 (gopher.nih.gov), and by mail and email from the program contact listed below. Ms. Frances E. Johnson Division of Extramural Programs National Library of Medicine Building 38A, Room 5S-520 Bethesda, MD 20894 Telephone: (301) 496-4221 FAX: (301) 402-0421 Email: FRANCES_JOHNSON@OCCSHOST.NLM.NIH.GOV $$R2 END ************************************************************ $$R3 BEGIN AR-95-004 FULL-TEXT ************************************** PROGRAM ON MECHANISMS OF IMMUNOTHERAPY IN RHEUMATIC DISEASES NIH GUIDE, Volume 24, Number 2, January 20, 1995 RFA AVAILABLE: AR-95-004 P.T. National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: April 12, 1995 Application Receipt Date: July 12, 1995 APPLICANTS RESPONDING TO THIS RFA WILL BE ASKED TO USE A MODIFIED (ABBREVIATED) GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR COMPLETING THE APPLICATION ARE DESCRIBED IN THE FULL TEXT OF THE RFA. PURPOSE The Rheumatic Diseases Branch of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invites applications for small basic research projects linked to separately funded ongoing or completed clinical trials of new and innovative immunotherapies in rheumatic diseases. The aim of the basic research projects will be to identify the mechanisms related to the efficacy of the therapy or to demonstrate the relevance of new or known pathogenic mechanisms leading to target tissue injury. Projects that apply current basic science approaches to the study of the mechanisms of immunotherapies through formal collaborations are strongly encouraged. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Program on Mechanisms of Immunotherapy in Rheumatic Diseases, is related to the priority area of chronic disabling conditions. 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 (gopher.nih.gov) and by mail and email from the program contact listed below. Susana A. S. Sztein, M.D. Rheumatic Diseases Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases 45 Center Drive, Room 5AS-37G MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-5032 FAX: (310) 480-4543 Email: arthrit@ep.niams.nih.gov $$R3 END ************************************************************ $$P1 BEGIN PA-95-015 FULL-TEXT ************************************** ACADEMIC RESEARCH ENHANCEMENT AWARD NIH GUIDE, Volume 24, Number 2, January 20, 1995 PA AVAILABLE: PA-95-015 P.T. 34; K.W. 1014006 National Institutes of Health Application Receipt Date: June 21, 1995 PURPOSE The National Institutes of Health (NIH) is making a special effort to stimulate research in educational institutions that provide baccalaureate training for a significant number of the Nation's research scientists, but historically have not been major recipients of NIH support. Since Fiscal Year (FY) 1985, Congressional appropriations for the NIH have included funds for this initiative, the Academic Research Enhancement Award (AREA) program. The AREA funds are intended to support new research projects or expand ongoing research activities proposed by faculty members of eligible institutions in areas related to the health sciences. Applications received in June 1994 for AREA grants to be awarded this year (FY 1995) have been reviewed for scientific merit and program relevance. Approximately $12.7 million will be available for the NIH AREA program in FY 1995. As a result, about 125 AREA grants will be made from the applications received June 1994. Since it is anticipated that additional funds will be available next year, the NIH is inviting grant applications at this time for AREA grants to be awarded competitively in FY 1996. INQUIRIES Supplemental instructions/application forms Those individuals and institutions meeting the eligibility requirements may contact the office listed below to receive the AREA Program Guidelines and/or form PHS 398 application packages. Academic Research Enhancement Award Office of Grants Information Division of Research Grants National Institutes of Health Westwood Building, Room 449 Bethesda, MD 20892 Telephone: (301) 594-7248 FAX: (301) 594-7045 Questions regarding eligibility, policies, procedures, and other administrative aspects of the NIH AREA program should be referred FIRST to the Office of Sponsored Programs at the institution. Issues that remain AFTER consultation with the institutional Office of Sponsored Programs and that are NOT ADDRESSED in the AREA Program Guidelines may be directed to: Research Training and Special Programs Office Office of Extramural Research National Institutes of Health Building 31, Room 5B44 Bethesda, MD 20892-2186 Telephone: (301) 496-1968 FAX: (301) 496-0166 Email: sk13n@nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-95-021 FULL-TEXT ************************************** MODELS FOR AIDS AND AIDS-RELATED MALIGNANCIES NIH GUIDE, Volume 24, Number 2, January 20, 1995 PA AVAILABLE: PA-95-021 P.T. National Cancer Institute National Institute of Allergy and Infectious Diseases PURPOSE This Program Announcement (PA) is a joint effort by the National Cancer Institute (NCI) and the National Institute of Allergy and Infectious Diseases (NIAID) to encourage investigators to develop useful and predictive biochemical, cellular, and in vivo models that could be used for the preclinical evaluation of new therapies against HIV disease and AIDS-related malignancies. The development of well- characterized in vitro and in vivo models would accelerate and facilitate the discovery of successful treatments, including drugs, vaccines, gene therapy, and immune modulators. Support for the PA will be by the investigator-initiated research project grant (R01), FIRST (R29) award, or the Interactive Research Project Grants (IRPG) mechanisms. The NCI has set aside approximately $2.0 million total costs in Fiscal Year 1995 for the first year of funding and NIAID will give special consideration for the support of applications received in response to this initiative. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Models for AIDS and AIDS-Related Malignancies, is related to the priority areas of human immunodeficiency virus/AIDS 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). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Dr. Nava Sarver Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C01 6003 Executive Boulevard MSC 7620 Bethesda MD 20892-7620 Telephone: (301) 496-8197 FAX: (301) 402-3211 Email: ns18p@nih.gov Dr. Mary K. Wolpert Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 832 6130 Executive Boulevard MSC 7450 Bethesda, MD 20892-7450 Telephone: (301) 496-8783 FAX: (301) 496-8333 Email: mkwolper@helix.nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-95-022 FULL-TEXT ************************************** DRUG ABUSE HEALTH SERVICES RESEARCH AND HIV/AIDS NIH GUIDE, Volume 24, Number 2, January 20, 1995 PA AVAILABLE: PA-95-022 P.T. National Institute on Drug Abuse PURPOSE This Program Announcement will support a program of research on health services to drug abusers at high risk for HIV/AIDS at the client, program, and service system level. This program will use the NIH research project grant (R01), FIRST Awards (R29), and small grants (R03). HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Drug Abuse Health Services Research, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Copies of the full document may also be obtained by calling Grants Management Branch, OPRM/NIDA, Room 8A-54 5600 Fishers Lane, Rockville, MD 20857, telephone 301-443-6710. Direct inquiries regarding programmatic issues to: Frank M. Tims, Ph.D. Services Research Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-30 Rockville, MD 20857 Telephone: (301) 443-4060 Email: FTIMS@AOADA.SSW.DHHS.GOV Direct inquiries regarding fiscal matters to: Gary Fleming Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: GFLEMING@AOADA.SSW.DHHS.GOV $$P3 END ************************************************************ From owner-sci-resources@net.bio.net Wed Jan 18 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-015 - V24(02) 01/20/95 Date: 18 Jan 1995 17:45:57 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 192 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3fkg8l$m5@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95015 PA-95-015 P1O1 *************************************** ACADEMIC RESEARCH ENHANCEMENT AWARD NIH GUIDE, Volume 24, Number 2, January 20, 1995 PA NUMBER: PA-95-015 P.T. 34; K.W. 1014006 National Institutes of Health Application Receipt Date: June 21, 1995 PURPOSE The National Institutes of Health (NIH) is making a special effort to stimulate research in educational institutions that provide baccalaureate training for a significant number of the Nation's research scientists, but historically have not been major recipients of NIH support. Since Fiscal Year (FY) 1985, Congressional appropriations for the NIH have included funds for this initiative, the Academic Research Enhancement Award (AREA) program. The AREA funds are intended to support new research projects or expand ongoing research activities proposed by faculty members of eligible institutions in areas related to the health sciences. Applications received in June 1994 for AREA grants to be awarded this year (FY 1995) have been reviewed for scientific merit and program relevance. Approximately $12.7 million will be available for the NIH AREA program in FY 1995. As a result, about 125 AREA grants will be made from the applications received June 1994. Since it is anticipated that additional funds will be available next year, the NIH is inviting grant applications at this time for AREA grants to be awarded competitively in FY 1996. ELIGIBILITY REQUIREMENTS Applicant Institutions o All domestic health professional schools and other academic institutions offering baccalaureate or advanced degrees in the sciences related to health are eligible, EXCEPT those that have received research grants and/or cooperative agreements from the NIH totaling more than $2 million per year (direct and indirect costs) in each of four or more years during the period from FY 1988 through FY 1994. o For purposes of eligibility for the AREA program, "research grants and cooperative agreements" include the following activity codes ONLY: K01, K02, K04, K05, K06, K08, K11, K12, K14, K15, K16, K20, K21, P01, P40, P41, P42, P50, P60, R01, R03, R10, R21, R22, R23, R24, R29, R35, R37, R55, U01, U10, U24, U41, U42, and U54. o "Health professional schools" (schools of medicine, dentistry, osteopathy, pharmacy, nursing, veterinary medicine, public health, optometry, allied health, and podiatry) means an accredited public or non-profit private school in a State that provides training leading to a degree granted by that school, for example, a doctor of medicine, a doctor of dentistry, or equivalent degree. The term "accredited" means a school or program that is accredited by a recognized body or bodies approved for such purpose by the Secretary of Education. o "Other academic institutions" means, as a SINGLE eligible component, all other schools, departments, colleges and free-standing institutes of the institution, EXCEPT the health professional schools. o Several applications proposing different research projects may be submitted by an applicant institution. Proposed Principal Investigators o Must not have active research grant support at the time of award of an AREA grant. o May not submit a regular NIH research grant application for essentially the same project as a pending AREA application. o Are expected to conduct the majority of their research at their own institution, although limited access to special facilities or equipment at another institution is permitted. o May not be awarded more than one AREA grant at a time nor be awarded a second AREA grant to continue the research initiated under the first AREA grant. APPLICATION PROCEDURES Applications for the AREA program will be accepted under the application submission procedures of the Division of Research Grants (DRG), NIH. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for an AREA grant. Applicants must obtain the AREA Program Guidelines containing supplemental instructions for AREA applications from the Grants Information Office, DRG, NIH (see address below). These instructions must be followed in preparing an application. AREA grants are awarded on a competitive basis. Applicants may request support for up to $75,000 for direct costs (plus applicable indirect costs) for a period not to exceed 36 months. No more than $35,000 may be requested for direct costs for any one year. Although this award is non-renewable, it will enable qualified individual scientists within the eligible institutions to receive support for feasibility studies, pilot studies, and other small-scale research projects preparatory to seeking more substantial funding from the NIH research grant programs. REVIEW CONSIDERATIONS Applications for the AREA program will be subjected to the standard peer review process involving two sequential levels of review. The first level of review is performed by initial review groups composed primarily of non-Federal scientists selected for their competence in particular scientific fields. The second level of review is made by the National Advisory Council or Board of the NIH awarding component to which the grant application has been assigned by the DRG for potential funding. These groups are composed of both scientific and lay representatives who are chosen for their expertise, interest, or activity in matters related to the mission of the individual awarding component. Council or Board recommendations are based on both scientific merit and relevance to awarding component program goals. AWARD CRITERIA Funding decisions will be based on the proposed research project's scientific merit and relevance to NIH programs and the institution's contribution to the undergraduate preparation of doctoral-level health professionals. Among projects of essentially equivalent scientific merit and program relevance, preference will be given to those submitted by institutions that have granted baccalaureate degrees to 25 or more individuals who have obtained academic or professional doctoral degrees in the health related sciences during the period 1985-1994. Scientists working in eligible minority and women's educational institutions are encouraged to participate in this program. Since a primary purpose of the AREA program is to furnish support to those undergraduate institutions that provide student training in the sciences, principal investigators are encouraged to include the participation of students in the proposed Research Plan to the extent practicable. INQUIRIES Supplemental instructions/application forms Those individuals and institutions meeting the eligibility requirements may contact the office listed below to receive the AREA Program Guidelines and/or form PHS 398 application packages. Academic Research Enhancement Award Office of Grants Information Division of Research Grants National Institutes of Health Westwood Building, Room 449 Bethesda, MD 20892 Telephone: (301) 594-7248 FAX: (301) 594-7045 Questions regarding eligibility, policies, procedures, and other administrative aspects of the NIH AREA program should be referred FIRST to the Office of Sponsored Programs at the institution. Issues that remain AFTER consultation with the institutional Office of Sponsored Programs and that are NOT ADDRESSED in the AREA Program Guidelines may be directed to: Research Training and Special Programs Office Office of Extramural Research National Institutes of Health Building 31, Room 5B44 Bethesda, MD 20892-2186 Telephone: (301) 496-1968 FAX: (301) 496-0166 Email: sk13n@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.390. Grants will be awarded under authority of the Public Health Service Act, Title III, Section 301 (Public Law 78- 410, as amended; 42 USC 241) and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR Part 52 and 45 CFR Part 74. 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 Wed Jan 18 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-021 - V24(02) 01/20/95 Date: 18 Jan 1995 17:45:52 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 352 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3fkg8g$lg@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95021 PA-95-021 P1O1 *************************************** MODELS FOR AIDS AND AIDS-RELATED MALIGNANCIES NIH GUIDE, Volume 24, Number 2, January 20, 1995 PA NUMBER: PA-95-021 P.T. National Cancer Institute National Institute of Allergy and Infectious Diseases PURPOSE This Program Announcement (PA) is a joint effort by the National Cancer Institute (NCI) and the National Institute of Allergy and Infectious Diseases (NIAID) to encourage investigators to develop useful and predictive biochemical, cellular, and in vivo models that could be used for the preclinical evaluation of new therapies against HIV disease and AIDS-related malignancies. The development of well- characterized in vitro and in vivo models would accelerate and facilitate the discovery of successful treatments, including drugs, vaccines, gene therapy, and immune modulators. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Models for AIDS and AIDS-Related Malignancies, is related to the priority areas of human immunodeficiency virus/AIDS 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 may be submitted from one institution or may include arrangements with several institutions, if appropriate. Applications involving minority institutions are encouraged. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Support for the 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 and Contracts, Vol. 23, No. 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. FUNDS AVAILABLE The NCI has set aside approximately $2.0 million total costs in Fiscal Year 1995 for the first year of funding and NIAID will give special consideration for the support of applications received in response to this initiative. The level of support is dependent on the receipt of a sufficient number and diversity of applications of high scientific merit and the availability of funds. Although the goal of this PA is to stimulate the development of diverse types of efficient and predictive biochemical, cellular, and in vivo models that could be used for the evaluation of new agents for the treatment of HIV disease and AIDS-related malignancies, priority will be given to in vivo models if the number of meritorious applications exceeds funds available. Because the nature and scope of the research proposed in response to the PA may vary, it is anticipated that the sizes of awards will vary also. The total project period for applications submitted in response to this PA may not exceed five years. Although the NCI and NIAID have a continuing interest in the research areas of this PA, the latest anticipated award date with set aside funds is September 30, 1995. RESEARCH OBJECTIVES Background Despite advances in our knowledge of the molecular biology of HIV-1 (human immunodeficiency virus) and HIV-2 and increased understanding of HIV pathogenesis in the development of acquired immunodeficiency syndrome (AIDS), no cure has been identified for AIDS or AIDS-related malignancies, including high-grade B cell non-Hodgkin's lymphoma, Kaposi's sarcoma, Hodgkin's disease, anogenital dysplasia and cancer, and basal cell carcinoma. As of mid-1994, the World Health Organization (WHO) estimated that over four million AIDS cases have occurred worldwide, and that 16 million people are infected with HIV as the pandemic continues unabated. Objectives and Scope The goal of this PA is to foster the development of useful and predictive biochemical, cellular, and in vivo models that could be used for the evaluation of new therapies against HIV disease and AIDS-related malignancies. New relevant and cost-effective models are needed for various stages of preclinical therapy development, including lead discovery, lead optimization, and final evaluation of the most promising candidates for clinical trial. While progress has been made with cell-based and mechanism-based screens, such as those for reverse transcriptase and proteases, many other suitable targets exist but need to be employed in assays. There is an urgent need for simpler, safer, more relevant, and less expensive in vivo models to assess the in vivo efficacy of potential therapeutic candidates. The research scope encourages applications in the following areas, which are illustrated by but not limited to the examples provided: o Biochemical Assays. Rapid, resource efficient, and cost effective assays to block steps in HIV virus replication are encouraged. Since considerable effort is being expended on reverse transcriptase and proteases, applications on these enzymes are not encouraged for this initiative. However, applicants should consider high volume screens which would accommodate the needs of combinatorial chemistry programs. For those AIDS-related cancers in which a putative cofactor may be involved, approaches are sought to identify and define the precise role of the cofactor in the specific malignancy and to exploit this information for therapeutic advantage. o Cell Culture Assays. It is desirable that new cell culture models be developed for HIV replication and AIDS-related malignancies that more closely simulate the in vivo state. For example, models that mimic the three dimensional, multicellular environment or those based on single cycle replication kinetics would be of utility. For AIDS- related cancers, cell culture systems predictive of in vivo events that allow for studies of the mechanism(s) of action of specific cofactors and that would be useful for evaluating potential therapies are highly encouraged. o In Vivo Models. Models that reflect the current state of knowledge of AIDS pathogenesis and are simpler, safer and less expensive than currently available models are urgently needed for the evaluation of therapies for AIDS and AIDS-related malignancies. Novel approaches using transgenic and gene knockout animals are especially encouraged. While the use of small animals such as mice is most practical because of their availability and low cost, other animal models can be proposed. However, non-lentivirus models are not encouraged. For the models of both AIDS and AIDS-related malignancies, the development of valid surrogate endpoints for survival is favored in the interest of conserving resources and reducing assay time and animal discomfort. Applicants are reminded to provide a rationale for their model; to justify and perhaps demonstrate its potential utility over existing models, if applicable; and to provide a research plan involving a testable hypothesis. Relevance to the in vivo disease state, reproducibility and other important parameters of the assay should be documented using appropriate statistical analysis. Although the intent of this PA is to restrict studies to those which are preclinical, clinical specimens may be used whenever required for the appropriate development of in vitro and animal models. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Receipt dates for applications for AIDS-related research are January 2, May 1, and September 1. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The title and number of the announcement must be typed in Section 2a on the face page of the application. 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. If an IRPG is proposed, each application must be identified along with the number of the PA 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. The complete 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 Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by an appropriate national advisory board/council. 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. 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 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 the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications. For Fiscal Year 1995, the NCI has set aside $2 million for this initiative. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Nava Sarver Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C01 6003 Executive Boulevard MSC 7620 Bethesda MD 20892-7620 Telephone: (301) 496-8197 FAX: (301) 402-3211 Email: ns18p@nih.gov Dr. Mary K. Wolpert Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 832 6130 Executive Boulevard MSC 7450 Bethesda, MD 20892-7450 Telephone: (301) 496-8783 FAX: (301) 496-8333 Email: mkwolper@helix.nih.gov Direct inquiries regarding fiscal matters to: Ms. Jane Unsworth Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B25 6003 Executive Boulevard, MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: ju3a@nih.gov Ms. Michelle Burr Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 242 6120 Executive Boulevard MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, Ext. 231 FAX: (301) 496-8601 Email: MICHELLE BURR@NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.395, Cancer Treatment Research and 93.856, Microbiology and Infectious Diseases Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health System 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 Wed Jan 18 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-95-004 - V24(02) 01/20/95 Date: 18 Jan 1995 17:45:45 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 337 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3fkg89$km@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DK95004 DK-95-004 P1O1 *************************************** SUPPORT OF MINORITIES IN DIABETES, DIGESTIVE AND KIDNEY DISEASE RESEARCH NIH GUIDE, Volume 24, Number 2, January 20, 1995 RFA: DK-95-004 P.T. National Institute of Diabetes and Digestive and Kidney Diseases Office of Research on Minority Health Letter of Intent Receipt Date: March 2, 1995 Application Receipt Date: April 19, 1995 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Office of Research on Minority Health (ORMH) recognizes the need to increase the number of underrepresented minorities committed to scientific careers in research areas served by the Institute. This program is aimed primarily at recently trained M.D. and/or Ph.D. minority investigators. The program will enable the minority applicant to accept a tenure-earning position, gain additional research experience and obtain preliminary data on which to base a subsequent research grant application in an area of diabetes, endocrinology, metabolism, digestive diseases and nutrition, kidney, urology or hematology. 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, Support of Minorities in Diabetes, Digestive and Kidney Disease Research, is related to the priority area of increasing underrepresented minority health scientists. 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, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. The applicant must be African-American, Hispanic, Native American, Pacific Islander, or other ethnic or racial group members underrepresented in biomedical or behavioral research. To apply, one must be a citizen of, or have been lawfully admitted to, the United States for permanent residence. An applicant must have a doctoral degree (M.D., Ph.D., D.O., D.D.S., D.V.M.). He or she should have received at least two years of postgraduate research training in an area of research applicable to research supported in this institute, and have direct access to an expert in the area of the proposed research. Applicants may not hold, nor apply concurrently for any other PHS research project grant at the time of this application. Priority will be given to those applicants who have not previously been a Principal Investigator on a major research grant. Applicants are encouraged to apply for other research project grants (R01, R29) during the course of, or following, this award. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) small research grant (R03). Responsibility for the planning, direction, and execution of the proposed project will be that of the applicant. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. This RFA is a one-time solicitation. If the NIDDK determines that there is a sufficient continuing program need, a request for new applications will be announced. The total project period for applications submitted in response to the present RFA may be for one year, but should not exceed two years. Direct costs requested must not exceed $50,000 per year. A grant cannot be renewed. The anticipated award date is September 30, 1995. FUNDS AVAILABLE For FY 1995, $250,000 in total direct costs for year 01 will be committed in each of the three research divisions in the NIDDK. It is anticipated that a total of five awards will be made in each of the three divisions in FY 1995. This level of support depends 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 NIDDK, the award of grants pursuant to this RFA is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The primary purpose of this RFA is to increase the number of underrepresented minority Principal Investigators conducting research in the areas of research supported by the NIDDK. Surveys of research and training programs administered by the NIDDK disclose the need to increase the access to NIDDK support of recently-trained minority scientists who are U.S. citizens or permanent residents. Those who receive several years of training via an individual postdoctoral fellowship or an institutional training grant funded by a National Research Service Award, still require research experience and preliminary data to support an independent research career at this stage of development. An additional period of training may not be feasible for minority individuals with pressing economic burdens. Such individuals may be lost to academic research through a lack of opportunity to obtain an additional one or two years of support essential for establishing a research career. This program was designed to help alleviate some of the noted problems experienced by underrepresented minorities who may wish to pursue a career in academic research. The program will allow the minority investigator to hold a tenure-earning position, gain additional research experience and to obtain preliminary data on which to base a subsequent research grant application. SPECIAL REQUIREMENTS Applicants are required to have available a recognized expert in the area of proposed research for guidance and consultation. It is expected that this expert will assist the applicant in the design and conduct of his/her research. It is not necessary that the expert be at the same institution as the applicant, but he/she should be within a reasonable proximity to be available for guidance and consultation. Following the research plan, the applicant is required to provide a brief summary of his/her long-term career plans and objectives. The application should state how this award would make a difference in and enhance the applicant's development as a scientist. The department chairman/head should provide a brief paragraph indicating his/her plans for the applicant. This official should indicate the extent to which time, space and other necessary support will be provided to the applicant to conduct the proposed investigation(s). A letter from a recognized expert in the area of the proposed research should accompany the application packet. The letter should attest to his/her willingness to provide counsel and advice to the applicant, and an initial plan for ongoing contacts with the applicant. 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 March 2, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, his/her institution, the name and address of the expert who has agreed to serve as a consultant and advisor, and the number and title of this RFA. A letter of intent is not required, is not binding and is not considered in the review of applications. It is used by NIDDK staff to initiate planning for the review of applications, 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: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AS 37F 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8886 FAX: (301) 480-3505 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. The 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, 5333 Westbard Avenue, Room 449 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. 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, on line 2a of the face page of the application check the YES box, type the RFA number and the following title: "SUPPORT OF MINORITIES IN DIABETES, DIGESTIVE AND KIDNEY DISEASE RESEARCH." 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** Send two additional copies of the application to: Robert Hammond, Ph.D. Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AS 37F 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Applications must be received by April 19, 1995. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Applications for the R03 will receive initial technical merit review by an initial review committee appointed by the NIDDK, and second level review by the NIDDK program division to which the application has been assigned. Factors to be considered in the review of applications include: the applicant's previous research training, experience and publications; his/her ability to complete the proposed research plan; the overall scientific merit of the research plan; whether the aims and scope of the research plan can provide definitive data within a one or two year period; the potential of the proposed research to provide the bases for future studies; the institution's willingness to commit facilities and departmental support to the applicant; the applicant's plans and career goals; and the availability of a recognized expert in the area of the proposed research for counsel and advice as attested to by a letter of agreement. AWARD CRITERIA Applications will compete for available funds with all other applications submitted in response to this RFA and recommended by the initial review group. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the RFA. 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: Charles H. Rodgers, Ph.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AS 19J 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7716 Email: chuckr@dvsgate.niddk.nih.gov Judith M. Podskalny, Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AN 12E 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8876 Email: judyp@dvsgate.niddk.nih.gov Ronald Margolis, Ph.D. Division of Diabetes, Endocrinology and Metabolism National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 5AN 12J 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8819 Email: ronm@dvsgate.niddk.nih.gov Direct inquiries regarding fiscal matters to: Ms Nancy C. Dixon Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AN 44C 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8854 Email: nancyd@dvsgate.niddk.nih.gov Schedule Letter of Intent Receipt Date: March 2, 1995 Application Receipt Date: April 19, 1995 Technical/Scientific Review: June 1995 Review by Divisions/NIDDK: September 1995 Anticipated Award Date: September 30, 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The 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 Wed Jan 18 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA LM-95-001 - V24(02) 01/20/95 Date: 18 Jan 1995 17:46:03 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 344 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3fkg8r$mu@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA LM95001 LM-95-001 P1O1 *************************************** INTERNET CONNECTION FOR MEDICAL INSTITUTIONS NIH GUIDE, Volume 24, Number 2, January 20, 1995 RFA: LM-95-001 P.T. National Library of Medicine Letter of Intent Receipt Date: April 10, 1995 Application Receipt Date: May 18, 1995 PURPOSE The National Library of Medicine (NLM) is encouraging the development of a communications infrastructure to promote the rapid interchange of medical information nationally and throughout the world. This infrastructure is based upon the Internet, a network of networks that was developed with the support of the National Science Foundation. The proposed evolution of the Internet into the National Research and Education Network (NREN) is a key element in important federal initiatives in High Performance Computing and Communication and a National Information Infrastructure. Internet access provides health professionals engaged in education, research, clinical care, and administration with a means of accessing remote databases, libraries, NLM's Grateful Med, DOCLINE and Loansome Doc, transferring files and images, and interacting with colleagues throughout the world. To accelerate the pace with which health-related institutions become part of the electronic information web, NLM is offering grants to support Internet connections. 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), Internet Connection for Medical Institutions, is related to the priority area of surveillance and data systems. 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 public and private, non-profit institutions engaged in health sciences administration, education, research, and/or clinical care are eligible to apply. "Health sciences" is defined as medicine, dentistry, nursing, public health, pharmacy, veterinary medicine, and other sciences related to health. Hospitals are encouraged to apply. Racial/ethnic minority individuals, women, and those with disabilities are encouraged to apply as Principal Investigators. Domestic applications may not have international components. Consortia of health-related institutions are also eligible to apply. Consortium applications must be submitted by a single, lead institution; letters of agreement defining mutual responsibilities must be provided in the application and signed by authorized officials of each participating institution. MECHANISM OF SUPPORT This RFA will use the National Library of Medicine (NLM) resource grant (G08) mechanism. Indirect costs are not provided. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed one year. The anticipated award date is September 15, 1995. For single institutions, support is available up to $30,000; consortia may receive up to $50,000. Additional funding may be provided on a case-by-case basis to support development and enhancement of multi-institution networks including extending connectivity to outlying hospitals, or otherwise furthering NLM's goal of expanding information outreach. The overall cost of a campus or local connection to the Internet includes: gateway equipment, associated communication hardware (CSU/DSU), the leased line and its installation, local network user support staff, space, air conditioning, maintenance, and mid-level network management fees. The NLM grant is expected to support the purchase and installation of the gateway system and associated connection hardware and to defray the cost of installation and leasing of communication circuits to connect to the mid-level network. In some cases the award may also be used to defray the cost of mid-level management fees and local network staff. Institutions will usually be expected to fund the local or campus network and support other costs of the gateway system, although in some instances, NLM will consider use of the grant funds to expand access to the Internet in an institution that already has a connection. FUNDS AVAILABLE Funds available for this RFA are approximately $600,000; however, expenditure of this amount is conditional upon the receipt of applications of high merit. Number of awards to be made is estimated to be between 10 and 16. Although the PHS budget is expected to permit support of these projects, funding of any applications pursuant to this RFA are contingent upon the availability of funds at the appropriate time. RESEARCH OBJECTIVES Background The Internet currently is a collection of interconnected networks connected by the NSFnet which was developed with the support of the National Science Foundation (NSF). The Internet comprises three types of networks: (1) a national backbone network, (2) mid-level regional networks usually based around some geographical region of the country, and (3) local networks at educational, research and clinical institutions. Individual institutions are connected to a mid-level network in the appropriate geographical region. The mid- level network is in turn attached to the high-speed national backbone network, usually at its network operation center. The backbone is connected to other national networks including the Defense Research Internet, NASA Science Network, and the Energy Sciences Network; these interconnected networks and many others worldwide comprise the Internet. The Internet provides electronic mail service and access to a variety of scientific facilities including: digital libraries, unique databases such as MEDLINE via Grateful Med as well as a host of federal and private sector databases, supercomputers, and remote scientific sensing instruments. The Internet promotes interaction and collaboration with a single, well-integrated connection to end users using the Defense Data Network protocols: Transmission Control Protocol/Internet Protocol referred to as TCP/IP. Network management and operations services as well as information services are provided by each of the levels. The national backbone network provides for technical and information services to the mid- level networks which in turn provide technical expertise and information services, including training and documentation, to local level network administrators. Local network officials provide technical and information services to the overall local network administration and also provide consultative and liaison services to end-users of the network. Objectives and Scope The purpose of this RFA is to encourage U.S. medical institutions including medical research institutions, health science schools, and hospitals to connect to the Internet. Some institutions may belong to organizations that are already connected to the Internet, for example, medical schools adjacent to university campuses. In such a case, the NLM grant can be used by a health science school or hospital to connect to an existing campus network. In other cases, the project will aid the institution in connecting directly to the mid-level regional network. In general, it is expected that institutions will use an existing local or campus network to distribute access to the Internet, or will build a new local or campus network and connect it to the Internet. A local or campus network is connected to the Internet by installing an IP router/gateway. This gateway will link the campus or local network to an appropriate mid-level network by means of leased or dial-up communication circuits of varying speeds (9600 bits per second to 1.5 million bits per second). The resultant connections to the Internet provided by the gateway should be made widely available to all appropriate health professionals, -- researchers, faculty, students, clinicians, and administrators. Ideally the institution will have installed a high-speed campus or local area network and have adopted the TCP/IP protocols as the standard communication protocol. Where other networking protocols are used, the institution will be responsible for the installation of any additional network gateway systems required to resolve the protocol conversion issues so as to provide connectivity to the Internet gateway. LETTER OF INTENT Prospective applicants are asked to submit, by April 10, 1995, a letter of intent that includes a descriptive title of the proposed project, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel in the sponsoring institution and in participating institutions, the identities of consultants, and the number and title of this RFA. It is particularly helpful if consortia provide complete lists of key people who will be associated with the project for all participants. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NLM staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Ms. Frances E. Johnson 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, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248; and from the program administrator listed under INQUIRIES. Supplemental Application Guidelines Applicants should not feel constrained by the emphasis on research in the language used by the forms. It may be useful for an applicant to read "project" whenever the form refers to "research". NLM considers these grants to be projects, not research applications, and will evaluate the applications in that spirit. NLM recommends that those writing the application keep the "project" concept in mind. Internet uses may support administration, education, research and/or patient care endeavors. Applicants are encouraged to include their health science library in the proposed Internet connection. "Resources and Environment," form page (HH). Other applicable headings may be substituted such as computers, communications, and networking resources in place. "Biographical Sketch," form page (FF). Include computer, communications, and networking skills. In Section 4 of the "Research Plan" (read "Project Plan") also provide: (1) plans for user training and user support and (2) plans for future support. The success of an Internet connection depends upon training users in establishing accounts and passwords and in teaching Internet capabilities. Describe user training plans including topics to be covered and the personnel who will provide the training and follow-up training. Library involvement in user training is strongly encouraged. In regard to future support, the Internet Connection Grant is intended to provide seed money to initiate an Internet connection; therefore, plans for budgeting ongoing costs for Internet access must be described. All applicants, particularly those relatively unfamiliar with the application review form and with NIH procedures, are encouraged to consult Ms. Frances Johnson (address below) for assistance as needed in completing the application. Additional Application Procedures 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. 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 also be sent to Ms. Frances E. Johnson at the address listed under INQUIRIES. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants (DRG) and responsiveness by NLM. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for merit by an appropriate peer review group convened by the NLM in accordance with the review criteria stated below. As part of the review procedure, a triage process will be used by the initial review group in which applications will be determined to be competitive or non-competitive based on merit relative to other applications received in response to the RFA. Applications determined to be non-competitive will be withdrawn from further consideration; the Principal Investigator and the official signing for the applicant organization will be notified. Applications judged to be competi