From owner-sci-resources@net.bio.net Tue Apr 01 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 29 March 1997 Date: 1 Apr 1997 20:20:32 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 137 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5hsmqg$icp@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending March 29, 1997. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: International Document Title: INT 97-11 NSF/Tokyo Report: New Frontiers in Microbiology File size (bytes): 9075 STIS Filename: int9711.txt Document Type: News Title: RURAL AREAS KEEPING PACE IN THE INFORMATION AGE File size (bytes): 4475 STIS Filename: tip70324.txt Document Type: Press Release Title: Solution Found to Long-Standing Inconsistencies in Data Analysis File size (bytes): 6433 STIS Filename: pr9723.txt Title: Pultzer-Prize Winning Biologist to Share Expertise, Teaching Techniques on CD-ROM File size (bytes): 3977 STIS Filename: pr9724.txt Title: Natural Selection Study Shows Animals Can Adapt Dramatically Fast File size (bytes): 4080 STIS Filename: pr9725.txt Title: A SAFER WAY TO MONITOR VOLCANOES?WORLD'S SCIENTISTS FINDING AN ANSWER File size (bytes): 3838 STIS Filename: pr9726.txt Title: NSF ANNOUNCES NEW COMPUTER PARTNERSHIPS File size (bytes): 5938 STIS Filename: pr9727.txt Document Type: Program Guideline Title: NSF 94-108 -- Instrumentation for Materials Research Program File size (bytes): 15671 STIS Filename: nsf94108.txt Title: NSF 96144 -- Human Resource Development for Science, Math & Eng Edu File size (bytes): 115461 STIS Filename: nsf96144.txt Title: Synthesis & Modeling Project of the U.S. Joint Global Ocean Flux File size (bytes): 21111 STIS Filename: nsf9779.txt Title: NSF 97-80 -- Living Stock Collections File size (bytes): 29420 STIS Filename: nsf9780.txt Title: Long-Term Ecological Research (LTER) in Land/Ocean Margin Ecosystem File size (bytes): 20029 STIS Filename: nsf9782.txt Document Type: Recruit Title: Chemist (Program Director) File size (bytes): 6436 STIS Filename: vex9710.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Letter Title: MPS Office of Multidisciplinary Activities-Dear Colleague Letter File size (bytes): 4062 STIS Filename: lmps9501.txt Document Type: Phone Book Title: NSF Organization Directory File size (bytes): 128214 STIS Filename: phnorg.txt Document Type: Program Guideline Title: Synthesis & Modeling Project of the U.S. Joint Global Ocean Flux File size (bytes): 21111 STIS Filename: nsf9779.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf9779.txt, the text of your message should be as follows: get nsf9779.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9779.txt, you would enter: ftp> get nsf9779.txt 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". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Sat Apr 05 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF E-mail bulletins will be going away Date: 6 Apr 1997 12:40:28 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 37 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5i8u7c$3nm@net.bio.net> NNTP-Posting-Host: net.bio.net [News from NSF - D.K.] STIS Will Be Retired -------------------- As many of you know, the NSF is migrating to a completely Web-based information dissemination system. We anticipate that we will retire the STIS system, including the mailing lists, in the summer of this year. New System Duplicates Functions ------------------------------- We have created a Web-based system, called "Custom News Service" that can generate a weekly summary of new Web documents. If you have access to a Web browser, you'll want to move to this service immediately. The new service provides the following features: * Weekly summary of all new documents on the NSF Web site. You'll get a weekly e-mail with a list of URLs. If your e-mail software allows it, you can simply click on the URLs for immediate access to the documents. * Immediate notification when new documents are added. You can fill out a "profile" of the type of documents you are interested in, and the system will send you e-mail when a document is added that matches your profile. The e-mail notification will normally include just the URL of the document, but will contain the full text for smaller publications, such as vacancy announcements and press releases. In addition, a system we call "OnLine Documents" provides Web access to the same documents that exist on STIS, but with a more flexible and easier-to-use access mechanism. What's Next? ------------ Please try out the Custom News Service. Its URL is: http://www.nsf.gov/home/cns/start.htm From owner-sci-resources@net.bio.net Mon Apr 07 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 11, pt. 1of1, 4 April 1997 Date: 7 Apr 1997 18:34:31 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 397 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ic7b7$d7e@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 26, No. 11 - April 4, 1997 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** IMPLEMENTATION OF INVENTOR CERTIFICATIONS FOR INVENTIONS WAIVED TO THE INVENTOR UNDER THE BAYH-DOLE ACT National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** ASSESSMENT OF POTENTIAL COCAINE TREATMENT MEDICATIONS IN RODENTS (RFP N01DA-7-8076) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX R2 06/10/97 ************************************************* ONTOGENY OF PERINATAL HOST DEFENSES (RFA HD-97-002) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R3 06/12/97 ************************************************* LINKING ENVIRONMENTAL AGENTS, OXIDATIVE DAMAGE AND DISEASE (RFA ES-97-002) National Institute of Environmental Health Sciences National Heart, Lung, and Blood Institute INDEX: ENVIRONMENTAL HEALTH SCIENCES; HEART, LUNG, BLOOD The NIH GUIDE is available electronically via LISTSERV subscription, and is also on the nih gopher (gopher.nih.gov) and the NIH web site (http://www.nih.gov). Alternative access is available through the NIH Grant Line via modem (data line 301/402-2221); contact Dr. John James at 301/435-2801 for details on the NIH Grant Line. All competing (new, renewal, amended (revised) applications for grants, cooperative agreements, and fellowships from the National Institutes of Health must be sent to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) ASKNIH is a service of the Division of Extramural Outreach & Information Resources, Office of Extramural Research, Office of the Director, NIH. ASKNIH is the point of contact for obtaining general information about NIH extramural research & research training programs, requesting publications, and learning more about obtaining the NIH GUIDE and other information on the NIH web site. ASKNIH is also the contact to which organizations should request application kits and forms. ASKNIH NATIONAL INSTITUTES OF HEALTH EMAIL: ASKNIH@odrockm1.od.nih.gov FAX: (301) 480-0525 TELEPHONE: (301) 435-0714 INQUIRIES ABOUT THE NOTICES, PAS, AND RFAS IN THIS PUBLICATION SHOULD BE DIRECTED TO THE NIH STAFF MEMBER IDENTIFIED AT THE END OF EACH ITEM. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** IMPLEMENTATION OF INVENTOR CERTIFICATIONS FOR INVENTIONS WAIVED TO THE INVENTOR UNDER THE BAYH-DOLE ACT NIH GUIDE, Volume 26, Number 11, April 4, 1997 P.T. 34; K.W. 1014006 National Institutes of Health A. Purpose This notice sets forth the National Institutes of Health (NIH) policy and procedure for allowing the inventor(s) to take title to inventions in which the grantee/contractor organization and the government has not elected title under the Bayh-Dole Act. B. Policy It is the policy of the NIH that employee-inventors may request to retain title their inventions which have not been elected by the grantee/contractor and the government subject to certain conditions set forth by the regulations appearing in 37 CFR 401.9. To ensure that inventors who are permitted to retain title to inventions made with the NIH funding understand their obligations to file for patent protection, notify the government, and carry out other responsibilities set forth by 37 CFR 401.9, NIH is requiring that an inventor certification be completed by the inventor(s) before NIH will consider an inventor's request to retain title to an invention. It is the NIH policy that its approval of the inventors' request to retain title is equivalent to election of title to the invention by the grantee/contractor. Thus, consistent with 37 CFR 401.14 (c )(3), the inventor(s) has one year from the date of approval by NIH to seek patent protection. Rights to the invention will revert back to the government after one year unless an extension of time is requested. An extension of time will normally be approved if there is clear evidence that additional time is required to file a patent application on the invention. D. Procedures 1. Inventors who wish to retain title to their invention(s) should complete the inventor certification found on the Edison Home Page (http://era.info.nih.gov), bullet entitled "Inventor Waivers." 2. The responsible official at the grantee/contractor organization should sign the certification confirming that the grantee/contractor has no objection to release of rights to the inventors and send it to NIH. 3. While it is not required that an inventor certification accompany the notification of non-election of title by the grantee/contractor, a more expedient review of the inventor's request can be expected if this procedure is followed. 4. Grantee/contractor organizations will be notified electronically through Edison of NIHs determination. 5. Inventors will be notified by e-mail. F. Effective Date The policies and procedures set forth in this notice are effective immediately. INQUIRIES For additional information on this notice, contact: Ms. Sue Ohata Division of Extramural Inventions and Technology Resources National Institutes of Health 6701 Rockledge Drive - MSC 7750 Bethesda, MD 20892-7750 Telephone: (301) 435-1986 FAX: (301) 480-0272 Email: OhataS@odrockm1.od.nih.gov $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN N01DA-7-8076 ********************************************* ASSESSMENT OF POTENTIAL COCAINE TREATMENT MEDICATIONS IN RODENTS NIH GUIDE, Volume 26, Number 11, April 4, 1997 RFP AVAILABLE: N01DA-7-8076 P.T. 34; K.W. 0404009, 0740020, 0404001 National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) is soliciting proposals >From qualified organizations having in-house capability to screen compounds in the mouse locomotor activity and rat drug discrimination paradigms for assessment as potential pharmacotherapies for cocaine dependence. Proprietary compounds will be evaluated in established protocols, and the resulting data will be utilized by the Cocaine Treatment Discovery Program of the NIDA Medications Development Division. Offerors must indicate possession of current DEA registration for Schedule II-V substances prior to award and apply for Schedule I registration at the time of award. It is anticipated that one (1) cost reimbursement, completion type contract will be awarded for a period of four years, with possibilities for one option year and other option quantities for additional followup studies. RFP No. N01DA-7-8076 will be available electronically on or about March 28, 1997, and may be accessed through the NIH Gopher and/or the Internet by using the following electronic mail addresses and instruction: 1. NIH Home Page (via the World Wide Web): Access the NIH Home Page by using http://www.nih.gov. Once you are at the NIH Home Page, select "Grants and Contracts"; select "NIH Gopher directory: listed under the "Contracts Page" section. Once at the NIH R&D Gopher, select "RFPs Available"; select "NIDA"; and select "RFP N01DA-7- 8076". (URL: gopher://gopher.nih.gov:70/11/res/rd-rfp) 2. NIH Gopher: Point your Gopher client to GOPHER.NIH.GOV Port 70 (you should now be in the NIH Gopher). Select "Grant and Research Information"; select "R&D Request for Proposals (RFP)"; select "RFPs Available"; select "NIDA"; and, select "RFP N01DA-7-8076". Please note that the RFP for this acquisition will be streamlined to include only the Work Statement, deliverable and reporting requirements, special requirements and mandatory qualifications, Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Response to this RFP will be due on or about May 12, 1997. Any responsible offeror may submit a proposal which will be considered by the Government. This advertisement does not commit the Government to award a contract. INQUIRIES Kenneth E. Goodling Contracts Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 10-49 Rockville, MD 20857 Telephone: (301) 443-6677 FAX: (301) 443-7595 Email: kg25d@nih.gov $$R1 END ************************************************************ $$R3 BEGIN HD-97-002 FULL-TEXT ************************************** ONTOGENY OF PERINATAL HOST DEFENSES NIH GUIDE, Volume 26, Number 11, April 4, 1997 RFA AVAILABLE: HD-97-002 P.T. 34; K.W. 0775013, 0403020, 0710070, 1002004, 1002008 National Institute of Child Health and Human Development Application Receipt Date: June 10, 1997 PURPOSE The National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) invites innovative and hypothesis-driven basic research project grant (R01 and R29) applications designed to study the ontogeny of immunity and host defense mechanisms in the fetus, neonate and infant. The primary objectives are to promote research to study the: (1) cellular, molecular and genetic elements and mechanisms responsible for the ontogeny of host defenses; (2) developmental biology of host defense mechanisms in response to perinatal and postnatal infections; (3) key cells, cytokines, cytokine-receptors, their interactions, and signal transduction events involved in perinatal and postnatal host defense; (4) role, function, mechanisms and interactions of maternal transplacental and colostral transfer of specific immunity on the development and responsiveness of perinatal host defenses; and (5) abnormal host defenses in early development that result in infant morbidity and/or mortality. Of particular interest are applications studying the development of basic perinatal host defense mechanisms in humans and non-human primates. The estimated fiscal year 1997 funds available for the total (direct and facilities and administrative) first-year costs of all awards made under this RFA will be $1,500,000. It is anticipated that up to eight R01/R29 grants will be awarded for fiscal year 1997. 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), Ontogeny of Perinatal Host Defenses, is related to the priority areas of maternal and infant health, and immunization and infectious diseases. 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 202-512-1800). 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), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Allan Lock, D.V.M. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B01, MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5541 FAX: (301) 402-4083 Email: LockA@hd01.nichd.nih.gov $$R3 END ************************************************************ $$R2 BEGIN ES-97-002 FULL-TEXT ************************************** LINKING ENVIRONMENTAL AGENTS, OXIDATIVE DAMAGE AND DISEASE NIH GUIDE, Volume 26, Number 11, April 4, 1997 RFA AVAILABLE: ES-97-002 P.T. 34; K.W. 1007003, 0705048, 0765033 National Institute of Environmental Health Sciences National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: May 9, 1997 Application Receipt Date: June 12, 1997 PURPOSE The National Institute of Environmental Health Sciences (NIEHS) supports research to identify the role of environmental agents in perturbations of normal physiologic processes leading to human dysfunction and disease of all types. The National Heart, Lung, and Blood Institute (NHLBI) supports research to investigate the pathologic mechanisms in acute and chronic pulmonary diseases, and cardiovascular diseases. It has been shown that reactive oxygen species (ROS) are formed, and play a role, in the toxic manifestations of many xenobiotics. There are also preliminary data to show that oxidative damage may initiate or exacerbate specific diseases or dysfunctions including cardiovascular and pulmonary disease. However, in most cases no relationships have been developed to demonstrate that environmental agents act via oxidative damage, or if diseases and dysfunctions are the result of oxidative damage stimulated by such agents. Therefore, the goals of this Request for Applications (RFA) are to encourage research to develop biomarkers of oxidative damage and to focus on the oxidative stress mechanism as a result of exposure to injurious agents and the etiology, initiation or exacerbation of human disease including direct or indirect roles for ROS in pulmonary and cardiovascular disease. It is anticipated that research projects generated as a result of this RFA will stimulate scientists to explore oxidative damage as a critical pathway in pulmonary and cardiovascular disease as well as diseases induced by environmental agents in order to develop hypothesis-based research needed to establish cause and effect relationships. It is anticipated that approximately $1,200,000 will be available to support 16-18 small grant (R03) awards 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 RFA, Linking Environmental Agents, Oxidative Damage and Disease is related to the priority area of environmental health, unintentional injuries, heart disease and stroke, and chronic disabling diseases. 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) 512-1800). 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), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Jerrold J. Heindel, Ph.D. Organs and Systems Toxicology Branch National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 111 T.W. Alexander Drive, Building 3, Room 316 Research Triangle Park, NC 27709-2233 Telephone: (919) 541-0781 FAX: (919) 541-2843 Email: heindelj@niehs.nih.gov Robert A. Musson, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 10018, MSC 7952 Bethesda, MD 20892 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: rmusson@nih.gov $$R2 END ************************************************************ From owner-sci-resources@net.bio.net Mon Apr 07 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-97-002 - V26(11) 04/04/97 Date: 7 Apr 1997 18:34:55 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 539 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ic7bv$db4@net.bio.net> NNTP-Posting-Host: net.bio.net ONTOGENY OF PERINATAL HOST DEFENSES NIH GUIDE, Volume 26, Number 11, April 4, 1997 RFA: HD-97-002 P.T. 34; K.W. 0775013, 0403020, 0710070, 1002004, 1002008 National Institute of Child Health and Human Development Application Receipt Date: June 10, 1997 PURPOSE The National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) invites innovative and hypothesis-driven basic research project grant (R01 and R29) applications designed to study the ontogeny of immunity and host defense mechanisms in the fetus, neonate and infant. The primary objectives are to promote research to study the: 1) cellular, molecular and genetic elements and mechanisms responsible for the ontogeny of host defenses; 2) developmental biology of host defense mechanisms in response to perinatal and postnatal infections; 3) key cells, cytokines, cytokine-receptors, their interactions, and signal transduction events involved in perinatal and postnatal host defense; 4) role, function, mechanisms and interactions of maternal transplacental and colostral transfer of specific immunity on the development and responsiveness of perinatal host defenses; and 5) abnormal host defenses in early development that result in infant morbidity and/or mortality. Of particular interest are applications studying the development of basic perinatal host defense mechanisms in humans and non-human primates. 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), Ontogeny of Perinatal Host Defenses, is related to the priority areas of maternal and infant health, and immunization and infectious diseases. 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 202-512-1800). 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 the First Independent Research Support and Transition (FIRST) (R29) award. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Competing continuation applications for already funded projects will NOT be eligible for awards from NICHD under this RFA. MECHANISM OF SUPPORT The mechanisms of support will be the individual research project grant (R01) and FIRST (R29) awards. Applications for FIRST Awards and R01s from new investigators are particularly encouraged. The total project period for R29 applications is five years. R01 applications submitted in response to this RFA may not exceed four years; foreign applications may not request more than three years of support. The applicant will be responsible for planning, directing and executing the proposed project. The anticipated award date is September 30, 1997. This RFA is a one-time solicitation. Future competing renewal applications will compete with all unsolicited investigator-initiated applications and will be reviewed according to standard NIH peer review procedures. FUNDS AVAILABLE The estimated funds available for the total (direct and facilities and administrative) first-year costs of all awards made under this RFA will be $1,500,000. It is anticipated that the NICHD will award up to eight R01/R29 grants for fiscal year 1997. The awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. The usual PHS policies governing grants administration and management, including facilities and administrative (F & A) costs, will apply. Although this initiative is provided for in the financial plans of the NICHD, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES Background The Center for Research for Mothers and Children (CRMC) of the NICHD supports basic, translational and clinical research on maternal/child health; pregnancy and parturition; normal and abnormal embryonic, fetal and perinatal development; reproductive and developmental immunology; congenital, perinatal and postnatal infections; Sudden Infant Death Syndrome (SIDS); and therapeutic and prevention strategies to reduce infant morbidity and mortality. The Developmental Biology, Genetics and Teratology Branch, and Pregnancy and Perinatology Branch of the CRMC are particularly interested in supporting basic studies on the ontogeny of perinatal host defenses and developmental and reproductive immunobiology. The goal of these basic studies is to provide important fundamental knowledge, understanding and insights that will translate into safe and efficacious perinatal prophylactic and therapeutic modalities, as well as useful prevention strategies to reduce infant morbidity and mortality. Host defense mechanisms that protect the fetus, neonate and infant are varied, complex and interactive. Host genetic and environmental factors appear to play an important role in the development of host defenses. Non-specific, natural or innate host defense mechanisms include physical and chemical barriers; humoral components (e.g., serum opsonins, complement factors, fibronectin, c-reactive proteins, and lactoferrin); natural killer (NK) cells; phagocytic cells (e.g., neutrophils, monocytes, macrophages); as well as soluble plasma and tissue proteins that amplify the action of phagocytes to become natural immune effector cells. Specific, adaptive or acquired host defense mechanisms are comprised primarily of cell-mediated (T lymphocyte) and humoral (B lymphocyte and immunoglobulin) systems. Both non-specific and specific immune mechanisms are essential for immunocompetence of the host. Moreover, they are interdependent and intimately related. For example, monocytes and macrophages are important components of both non-specific and specific immune defense mechanisms. Macrophages act not only as important effector cells in the expression of non-specific immunity; they also act as antigen-processing and presenting cells that play a critical role in triggering specific immunity mediated by B and T lymphocytes. In recent years, our knowledge and understanding of human adult and rodent immunology and host defense mechanisms have advanced rapidly and significantly. This has been made possible by the rapid and revolutionary advances in biochemical, cellular, molecular, genetic and transgenic technologies. Nevertheless, large gaps in basic developmental immunobiology and the molecular mechanisms of host defenses in perinatal and postnatal humans and primates still remain and need to be addressed. These gaps cannot always be extrapolated >From adult human or rodent studies. For example, although the immune system of the full-term human fetus is almost functionally mature, in general it is not as efficient as the adult immune system. There are definite functional differences between the adult and neonatal immune systems. At birth the neonatal B and T lymphocytes are generally naive and unprimed, so they have not undergone antigen-induced clonal expansion or maturation. This partially accounts for the human neonate's susceptibility to infection. Although neonatal B lymphocytes are mature and functional, they are unable to produce some specialized antibodies such as IgA and IgG2 against some types of encapsulated bacteria. The neonatal T lymphocyte repertoire is somewhat functionally immature compared to adult T lymphocytes. Important functional differences in neonatal T lymphocytes include diminished capacity to provide help for or actual suppression of immunoglobulin production by B lymphocytes, diminished generation and activity of cytotoxic T lymphocytes, and decreased capacity to activate macrophages. Neonatal T lymphocytes also have a markedly diminished capacity to produce certain cytokines (e.g., IFN-gamma and IL-4). Recent studies indicate that antigenic naivete is the principal mechanism for selective lymphokine deficiency in neonates. It is clear that additional studies targeted to perinatal humans and primates, as well as relevant animal models, need to be conducted to fully elucidate and understand the ontogeny and mechanisms of perinatal host defenses. Other areas which require additional research are the role, mechanisms and interactions of maternal immunity in perinatal host immune defenses. This is especially important in humans and primates, where the molecular mechanisms and impact of perinatal transplacental and colostral transfer of specific immunity need better understanding. Clearly, a better knowledge and understanding of perinatal host defenses and maternal immune interactions have important clinical implications. Perinatal host defenses are not identical to adult host defenses. Fetuses and neonates are generally less capable of coping with perinatal infections. For example, primary HIV-1, herpes virus, and toxoplasma infections in a fetus are usually more severe and aggressive than in an adult. Thus, some of the parameters and criteria for diagnosing, staging and treating perinatal infections are different compared to an adult. A knowledge of the temporal development of immunity and perinatal host defense mechanisms is thus clinically important for treatment of congenital and perinatal infections. Understanding the sequential development of host immune defenses is also crucial for developing and administering vaccines. The timing for immunization should be based on a thorough and rational understanding of the ontogeny and sequential development of immunity. This would maximize the specificity, level and duration of immunologic protection. In recent years, modern advances in neonatal intensive care units have increased the survivability of premature and low birth weight babies. This new group of babies is generally not sufficiently developed to cope with the extrauterine environment without assistance. Their immaturity predisposes them to a multitude of problems, including pulmonary viral infections. Moreover, their underdeveloped immune system and host defenses severely compromise their ability to produce antibodies and mount a protective and specific host immune response. These preterm babies also tend to have lower maternal IgG levels compared to term babies. This leaves them vulnerable to the detrimental effects of many infectious agents. In these premature babies, it is essential to find effective means of enhancing or accelerating the development of their host immune defenses. This requires a basic understanding of how and when the components of the immune system and host defenses develop as well as the key cellular, molecular and genetic elements and mechanisms that drive their sequential development. Finally, the relationship of SIDS to the developing immune system and host defense response to infection needs further exploration. Several studies suggest that mild respiratory or gastrointestinal tract infections are predisposing factors in infants who succumb to SIDS. A few studies implicate toxigenic bacteria as etiologic agents. Other reports suggest that abnormal immune responses such as hypersecretion of immunoglobulins in the respiratory tract, elevated interleukins, or anaphylaxis play a role in SIDS pathogenesis. Thus it is important to understand how abnormal or delayed development of host immune defenses contribute to SIDS. The recent advances in molecular biology and genetics provide new opportunities, insights and technologies for studying the development of the immune system and perinatal host defense mechanisms. The temporal expression of important developmental genes and the actions and interactions of their gene products (e.g. cytokines) can now be studied. This makes it feasible to molecularly and biologically dissect and characterize the key elements, mechanisms and signal transduction pathways that are important in the ontogeny of host immune defense mechanisms. It also provides critical information for developing new approaches and biotechnologic and pharmaceutic products either for enhancing positive or blocking adverse host defense mechanisms in vivo. This RFA was developed primarily to address the large gaps in our basic knowledge and understanding of the developing immune system and perinatal host defenses in humans and primates. It was also stimulated by the 1996 Report of the NIH AIDS Research Program Evaluation Working Group. Although the report focused on AIDS, it also addressed the critical need for high-quality, novel or innovative, investigator-initiated, basic research studies to better understand the human and primate immune systems. Furthermore, it strongly encouraged increasing research support for selected understudied and underfunded areas of basic human immunobiology and physiology, and the development of host defense mechanisms against infection in the neonate. New knowledge in these areas would greatly benefit our understanding of pediatric AIDS and translate into effective prophylactic, therapeutic and prevention strategies. The work group described important gaps in our basic knowledge of the immune system, but it also revealed promising new opportunities, insights and approaches for future research. Research Scope The objective of this RFA is to encourage and promote innovative and hypothesis-driven basic research projects, primarily in humans and primates, but also in relevant animal models, to study the ontogeny of specific or acquired perinatal host defense mechanisms; the sequential acquisition of antigen-specific perinatal cell-mediated and antibody-mediated immune responses; and the major differences between perinatal and adult immunity and host defenses. This RFA is for applications focused primarily on the ontogeny and host defense mechanisms of perinatal and postnatal T lymphocytes, B lymphocytes, immunoglobulins, monocytes, macrophages, NK cells and their associated specific humoral components. Studies which address the role and mechanisms of transplacentally and colostrally acquired specific humoral and cellular elements on perinatal host defense are appropriate for this RFA. Studies on perinatal neutrophils, natural humoral factors (such as opsonins, complement, fibronectin, C-reactive protein and lactoferrin) and non-specific substances in breast milk are beyond the scope of this RFA. Applications on these latter topics will be considered non-responsive and returned to the applicant. The research scope includes basic studies listed in the PURPOSE section of this RFA. The following are examples of research topics that are appropriate for this RFA; however, they are not to be considered as exclusive or limiting: o Identify and characterize genes encoding specific proteins essential for the ontogeny of immunity and host defenses. o Elucidate the biochemical, cellular, molecular and genetic elements and mechanisms responsible for the development of host defenses during perinatal infections. o Identify specific cytokines, their receptors and transcription factors, and define their role in development of perinatal host defense mechanisms. o Identify and characterize the genes and their protein products involved in cytokine-receptor signaling pathways; elucidate the molecular mechanisms of signal transduction and pathways that are important for development and responsiveness of host defenses. o Identify MHC genes and their products that are important in the ontogeny of perinatal host defenses; determine the mechanisms of class I and class II HLA antigens in the induction and expression of perinatal cellular and humoral immunity. o Elucidate how specific congenital or perinatal infections may impair or delay the development of perinatal host defenses. o Determine how inherited and acquired immunodeficiencies may compromise the ontogeny of perinatal host immune defenses. o Elucidate the molecular mechanisms involved in transplacental and colostral transfer of specific immunity to the fetus and neonate. o Study the host genetic and environmental factors which affect the ontogeny of host defenses. o Characterize the molecular and cellular basis of immune recognition of perinatal infectious agents; determine the role and ontogeny of specific host defenses; and define the molecular basis for perinatal T cell receptor diversity and immunogenetic regulation of specific T cell responses. o Develop primate and other animal models that will be useful for understanding the basic development of perinatal host defenses and responsiveness to infection. o Develop and use appropriate transgenic mouse models to identify and elucidate important molecular genetic mechanisms responsible for ontogeny of perinatal host defenses. o Determine the role of host immune responses in the pathogenesis of SIDS. The areas of interest listed above are not in any order of priority. They are only suggested examples of areas of research to consider. Applicants are encouraged to propose other areas that are related to the objectives and scope of this RFA. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov; and from the NICHD program administrator listed under INQUIRIES. Since a letter of intent is not solicited or required, applicants are strongly encouraged to contact NICHD program staff listed under INQUIRIES in the early stages of preparing the application. For all applications, the RFA label available in the PHS 398 (rev. 5/95) 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 number, HD-97-002, and the RFA title, ONTOGENY OF PERINATAL HOST DEFENSES, must be typed on line 2 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 6701 ROCKLEDGE DRIVE, ROOM 1040 MSC-7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent or delivered under separate cover to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03 - MSC-7510 Bethesda, MD 20892-7510 Rockville, MD 20852-7510 (for express/courier service) Telephone: (301) 496-1485 FAX: (301) 402-4104 Email: StreufeS@HD01.nichd.nih.gov Applications prepared in response to this RFA must be received by June 10, 1997. 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 the same as one already reviewed. This does not preclude submission of a substantially revised application already reviewed, but such an application must include an introduction addressing the previous critique. 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 GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. Applications for the FIRST (R29) award must comply with the NIH Guidelines for FIRST awards and the Just-in-Time procedures announced in the NIH Guide, Vol. 25, No. 10, March 29, 1996. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NICHD. 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 NICHD in accordance with the review criteria stated below. As part of the initial merit review, a process 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, assigned a priority score, and receive a second level of review by the National Advisory Child Health and Human Development (NACHHD) Council. 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. A summary statement will be prepared for non-competitive applications. Review Criteria Review criteria for this RFA are generally the same as those for unsolicited NIH research project grant applications. o scientific, technical, or medical significance and originality of proposed research; o appropriateness, feasibility and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications, competence 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 and facilities necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o for research involving human subjects, 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. Furthermore, it will consider and evaluate how the proposed research would advance the goals targeted in this RFA. AWARD CRITERIA The anticipated date of award is September 30, 1997. Applications recommended by the NACHHD Council will be considered for awards. Awards will be based on the scientific merit of the proposed project as determined by peer review, program priorities and balance of research areas targeted in the RFA, and availability of funds. INQUIRIES Written, telephone and email inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct programmatic inquiries to: Allan Lock, D.V.M. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B01 - MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5541 FAX: (301) 402-4083 Email: LockA@hd01.nichd.nih.gov Direct fiscal inquiries to: Mr. E. Douglas Shawver Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17 - MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (301) 402-0915 Email: ShawverD@hd01.nichd.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865 - Research for Mothers and Children. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Apr 07 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA ES-97-002 - V26(11) 04/04/97 Date: 7 Apr 1997 18:35:11 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 468 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ic7cf$dfl@net.bio.net> NNTP-Posting-Host: net.bio.net LINKING ENVIRONMENTAL AGENTS, OXIDATIVE DAMAGE AND DISEASE NIH GUIDE, Volume 26, Number 11, April 4, 1997 RFA: ES-97-002 P.T. 34; K.W. 1007003, 0705048, 0765033 National Institute of Environmental Health Sciences National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: May 9, 1997 Application Receipt Date: June 12, 1997 PURPOSE The National Institute of Environmental Health Sciences (NIEHS) supports research to identify the role of environmental agents in perturbations of normal physiologic processes leading to human dysfunction and disease of all types. The National Heart, Lung, and Blood Institute (NHLBI) supports research to investigate the pathologic mechanisms in acute and chronic pulmonary diseases, and cardiovascular diseases. It has been shown that reactive oxygen species (ROS) are formed, and play a role, in the toxic manifestations of many xenobiotics. There are also preliminary data to show that oxidative damage may initiate or exacerbate specific diseases or dysfunctions including cardiovascular and pulmonary disease. However, in most cases no relationships have been developed to demonstrate that environmental agents act via oxidative damage, or if diseases and dysfunctions are the result of oxidative damage stimulated by such agents. Therefore, the goals of this Request for Applications (RFA) are to encourage research to develop biomarkers of oxidative damage and to focus on the oxidative stress mechanism as a result of exposure to injurious agents and the etiology, initiation or exacerbation of human disease including direct or indirect roles for ROS in pulmonary and cardiovascular disease. It is anticipated that research projects generated as a result of this RFA will stimulate scientists to explore oxidative damage as a critical pathway in pulmonary and cardiovascular disease as well as diseases induced by environmental agents in order to develop hypothesis-based research needed to establish cause and effect relationships. 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, "Linking Environmental Agents, Oxidative Damage and Disease" is related to the priority area of environmental health, unintentional injuries, heart disease and stroke, and chronic disabling diseases. 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) 512-1800). 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 or local governments and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Submission of an application precludes concurrent submission of a regular research grant application (R01 or R29) containing the same research proposal. In addition, small grant research support may not be used to supplement research projects currently supported by Federal or non-Federal funds or to provide interim support for projects under review by the Public Health Service. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Small Grants Program (R03) awards. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The requested costs and project period will be $50,000 (direct cost) for a maximum of one year. Small grants are not renewable. FUNDS AVAILABLE The total estimated funds available for support of this Small Grants Program is $1,200,000, which will support 16-18 awards. 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 within the financial plans of the NIEHS and the NHLBI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Reactive oxygen species (ROS) include the superoxide anion (O2), hydrogen peroxide (H2O2), the hydroxyl radical (OH), lipid peroxides, nitric oxide (NO), singlet oxygen (O21), ozone (O3), and hypochlorous acid (HOCl). They are partially reduced products of oxygen; some are free radicals. They are known to cause oxidation of membrane phospholipids; lipid peroxidation; protein damage, including cleavage of amino acid bonds; DNA strand breaks, or base modifications leading to point mutations; inhibition of RNA and protein synthesis; protein cross-linking; impaired maintenance of membrane ion gradients; and depletion of cellular levels of ATP, leading to cellular dysfunction and eventually to disease. Reactive oxygen species are continuously produced in living cells naturally as a result of leakage of electrons on the electron transport chain in mitochondria. In addition, they can be produced in cells by various enzymatic mechanisms (xanthine oxidase, cytochrome P450, etc.), auto-oxidation of small molecules (catecholamines, etc), or in response to xenobiotics, exogenous environmental exposures, ischemia, or inflammatory stimuli. Cells have well-developed antioxidant systems to protect themselves from ROS. These include low molecular-weight antioxidants like ascorbic acid; alpha-tocopherol and glutathione; and antioxidant enzymes such as catalase, glutathione peroxidases and superoxide dismutases (SODs). In addition, cells have the ability to repair damage caused by ROS (DNA repair enzymes, proteases, lipases, etc.). Many environmental and industrial agents such as tobacco smoke, stored food products, dietary trace element additives, some metals, pesticides, ozone, NO2, and TCDD will provoke an oxidative stress response, overwhelm antioxidant defense systems and result in oxidative damage to tissues. Transition metals including iron, copper, chromium, and vanadium undergo redox cycling that can result in generation of ROS. Cadmium, mercury and nickel deplete glutathione resulting in increased levels of ROS leading to lipid peroxidation, DNA damage, protein cross linking and altered calcium homeostasis. The toxicities produced by these metals usually involve tissue damage in the kidneys, liver or central nervous system. Bacterial products, such as endotoxin (lipopolysaccharide), and trauma can also induce production of reactive oxygen species and result in tissue damage and organ injury. In 1996 NIEHS held a workshop entitled, "Measurement of Oxidative Stress in Humans" to stimulate interaction between basic scientists and epidemiologists. The recommendations from this workshop emphasized the importance of the development, standardization and validation of biomarkers of oxidative stress in humans and the collaboration between basic scientists and epidemiologists in this process. In 1996, the NHLBI convened a Special Emphasis Panel of investigators in the areas of acute lung injury, interstitial pulmonary disease, and lung development to stimulate discussion and solicit recommendations for areas of research to be emphasized in the future. They recommended that generation of ROS, mechanisms of tissue injury, and mechanisms by which ROS generation is regulated in the lung should be considered areas of high interest to the NHLBI. This RFA has been developed, in part, to foster implementation of these recommendations. Research Goals The goals and scope of this RFA are to encourage and support mechanistically-based research designed to establish the linkage among three events: exposure to an environmental agent tested at environmentally relevant concentrations, resultant oxidative damage and the initiation or exacerbation of diseases. Laboratory research is encouraged that will increase our understanding of the oxidative stress pathways of damage in relation to environmentally-induced disease. Emphasis should be placed on developing the preliminary data that will lead to the development of cause and effect relationships among environmental agents, oxidative damage and the etiology of disease. The development of new biomarkers of oxidative damage in human populations is also encouraged. This includes research which will assess intra individual variability, sensitivity and specificity of these biomarkers. Collaborations between laboratory scientists and epidemiologists in the development and validation of biomarkers of oxidative stress in humans is strongly encouraged. Diseases of specific interest for this program include (but are not limited to): reproductive; immune; lung; cardiovascular; neural; as well as gastrointestinal disorders; osteoporosis and other bone diseases; renal diseases; and abnormalities in growth and development. Experiments using animal models or human tissue and/or cell lines would be appropriate. Biomarkers of ROS damage can be developed in animal models or human specimens but must be validated in exposed human populations. Environmentally-relevant concentrations using dose-response data are encouraged. The effect of age and the timing of exposure relative to the toxicity or effect should also be included as part of the experimental design. The purpose of this RFA is to expand data on non-cancer health endpoints. Therefore, research on the role of ROS on the initiation or progression of cancers of any type will be considered non-responsive. In addition, areas of science in which there are sufficient preliminary data that would support the submission of a regular research project grant application do not qualify under this RFA. ANIMAL WELFARE CONSIDERATIONS Investigators are encouraged to consider alternative methods and approaches in their research applications that do not require the use of whole animals, that use alternative species such as non-mammals or invertebrates, that reduce the number of animals required, and that incorporate refinements to procedures that will result in the elimination or further minimization of pain and distress to animals. 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 58 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by May 9, 1997, 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 application, the information that it contains allows NIEHS staff to estimate the potential work load and to avoid conflict of interest in the review. The letter of intent is to be sent to: Ethel B. Jackson, D.D.S. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, 111 T.W. Alexander Drive, Building 17, Room 1716 Research Triangle Park, NC 27709-2233 Telephone: (19) 541-7846 FAX: (919) 541-2503 Email: jackson4@niehs.nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov; and from the program administrator listed under inquiries. THE FOLLOWING ARE SUPPLEMENTAL INSTRUCTIONS: o Only one small grant application may be submitted by a principal investigator. o A detailed budget should be completed as instructed on Page II of the U.S. Department of Health and Human Services Public Health Service Grant Application (PHS 398, rev. 5/95). The budget may not exceed $50,000 direct costs. Equipment will be limited to $5,000. Indirect costs will be awarded at the grantee's current negotiated indirect cost rate at the time of the award. o The applicant must be explicit in describing either the proposed interface between an environmentally relevant agent, oxidative stress and the induction or exacerbation of a specific disease or dysfunction or the development of biomarkers of oxidative damage in humans that could be used to develop the relationship between ROS and diseases/dysfunctions. Background information must suggest, or at least not preclude, a possible interaction between these three parameters or discuss the potential relationship of ROS to the pathogenic mechanisms in pulmonary or cardiovascular diseases. o Since this award is to support pilot studies, preliminary data are not required except to indicate the expertise of the principal investigator to carry out the proposed studies. o The research plan (aims, background and significance, preliminary data and experimental design and methods) is limited to 10 pages. Tables and figures are included in the 10-page limitation. Applications that exceed page limitation or PHS requirements for type, size and margins (see PHS 398 directions) will be returned to the investigator. o Do not submit an appendix. The RFA label available in the PHS 398 application kit, (rev. 5/95), 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 the review. In addition, the RFA title and number must be typed on line two 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 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Ethel B. Jackson, D.D.S. Division of Extramural Research and Training National Institute of Environmental health Sciences P.O. Box 12233, 111 T.W. Alexander Drive, Building 17, Room 1716 Research Triangle Park, NC 27709-2233 If these two additional copies are not forwarded to Dr. Jackson, it will adversely affect the review of the grant application: Applications must be received by June 12, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIEHS in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score. Review Criteria o Scientific, technical, or medical significance and originality of proposed research as it relates to contributions to knowledge of health outcomes as a result of exposure to environmental agents; o feasibility of the proposed research; o appropriateness of the proposed budget and adequacy of the experimental approach and methodology proposed to carry out the research; o "high risk" with likelihood of "high gain;" o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o linkage of an environmental agent, oxidative stress/damage and initiation or exacerbation of a specific non cancer disease/dysfunction; o plausibility of the biological mechanism suggested linking the environmental exposure, oxidative damage and the etiology of disease; o examination of the role for reactive oxygen species in the pathogenesis of pulmonary or cardiovascular disease; and o availability of resources necessary to perform the research. AWARD CRITERIA The anticipated date of award is September 1997 pending availability of funds. The following will be considered in making funding decisions: o quality of the proposed project as determined by peer review; o availability of funds; and o program balance among research areas of the announcement. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed. Direct inquiries regarding programmatic issues to: Jerrold J. Heindel, Ph.D. Organs and Systems Toxicology Branch National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 111 T. W. Alexander Drive, Building 3, Room 316 Research Triangle Park, NC 27709-2233 Telephone: (919) 541-0781 FAX: (919) 541-2843 Email: heindelj@niehs.nih.gov Gwen W. Collman, Ph.D. Chemical Exposures and Molecular Biology Branch National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-04 111 T.W. Alexander Drive, Building 3, Room 306 Research Triangle Park, NC 27709-2233 Telephone: (919) 541-4500 FAX: (919) 541-2843 Email: collman@niehs.nih.gov Robert A. Musson, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 10018, MSC 7952 Bethesda, MD 20892 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: rmusson@nih.gov Momtaz Wassef, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung and Blood Institute 6701 Rockledge Drive, Room 10188, MSC 7956 Bethesda, MD 20892 Telephone: (301) 435-0550 FAX: (301) 480-2858 Email: wassefm@gwgate.nhlbi.nih.gov Direct inquiries regarding fiscal matters to: Mr. David L. Mineo Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 2-01 111 T.W. Alexander Drive, Building 2, Room 203B Research Triangle Park, NC 27709-2233 Telephone: (919) 541-7628 FAX: (919) 541-2860 Email: mineo@niehs.nih.gov Inquiries to other institutes with similar R03 Programs: The National Institute on Deafness and other Communication Disorders (NIDCD) is interested in research that is directed towards oxidative damage to the systems of hearing, balance, smell and taste. The NIDCD has an R03 Program that can be found on the NIH Home Page as PAR-97-012 under grants and contracts. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.113 and 93.115. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Apr 07 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 5 April 1997 Date: 7 Apr 1997 19:19:11 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 148 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ic9uv$k9r@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending April 5, 1997. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: NFS April Bulletin Vol-24, No.8 File size (bytes): 56884 STIS Filename: bul9704.txt Document Type: Dir of Awards Title: 1997 Graduate Fellowship Awards File formats File size (bytes): 2099 STIS Filename: gf97info.txt Title: Minority Graduate Fellowship Awards for Fiscal Year 1997 File size (bytes): 20106 STIS Filename: gf97mawd.txt Also available: gf97mawd.dlm Title: Minority Graduate Fellowship Honorable Mention Recipients - FY 1997 File size (bytes): 23315 STIS Filename: gf97mhm.txt Also available: gf97mhm.dlm Title: Graduate Fellowship Awards for Fiscal Year 1997 File size (bytes): 129517 STIS Filename: gf97rawd.txt Also available: gf97rawd.dlm Title: Graduate Fellowship Honorable Mention Recipients for Fiscal Year 1997 File size (bytes): 147477 STIS Filename: gf97rhm.txt Also available: gf97rhm.dlm Document Type: Grant Conditions Title: FDP-ONR97 Office of Naval Research Specific Requirements File size (bytes): 2944 STIS Filename: fdponr97.txt Document Type: Program Guideline Title: NSF 97-81 -- Institute for Civil Infrastructure Systems File size (bytes): 25143 STIS Filename: nsf9781.txt Title: NSF 97-85 - Activities in Science, Engineering, and Mathematics for Persons with Disabilities File size (bytes): 23953 STIS Filename: nsf9785.txt Title: NSF 97-87 - Faculty Early Career Development (CAREER) Program File size (bytes): 40682 STIS Filename: nsf9787.txt Document Type: Recruit Title: Director, Division of Electrical and Communications Systems File size (bytes): 8258 STIS Filename: vep973c.txt Title: Office Automation Clerk File size (bytes): 9010 STIS Filename: vgs9742.txt Title: Program Assistant (Office Automation) File size (bytes): 9209 STIS Filename: vgs9743.txt Title: Accountant File size (bytes): 9538 STIS Filename: vgs9747.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Letter Title: REULIST -- Current List of REU Sites File size (bytes): 99291 STIS Filename: reulist.txt Title: REULIST -- Current List of REU Sites File size (bytes): 99291 STIS Filename: reulist.txt Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 112759 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Directory File size (bytes): 128074 STIS Filename: phnorg.txt Document Type: Press Release Title: NSF ANNOUNCES NEW COMPUTER PARTNERSHIPS File size (bytes): 5938 STIS Filename: pr9727.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve pr9727.txt, the text of your message should be as follows: get pr9727.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve pr9727.txt, you would enter: ftp> get pr9727.txt 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". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Sat Apr 12 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-054 - V26(12) 04/11/97 Date: 13 Apr 1997 00:19:26 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 188 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5iq1du$b5@net.bio.net> NNTP-Posting-Host: net.bio.net ENVIRONMENTAL/OCCUPATIONAL MEDICINE ACADEMIC AWARD NIH GUIDE, Volume 26, Number 12, April 11, 1997 PA NUMBER: PAR-97-054 P.T. 34; K.W. 0725020 National Institute of Environmental Health Sciences Application Receipt Date: July 15, 1997 PURPOSE The National Institute of Environmental Health Sciences (NIEHS) announces its eighth national competition for Environmental/Occupational Medicine Academic Awards (E/OMAA), which last appeared in the NIH Guide for Grants and Contracts, Vol. 25, No. 13, April 26, 1996. The award will have the dual purpose of improving the quality of environmental/occupational medicine curricula and of fostering graduate research careers in environmental/occupational medicine. For the purposes of the E/OMAA, the term environmental/occupational medicine refers to the area of medicine concerned with the development of knowledge and the application of knowledge directed at the diagnosis, treatment, and prevention of adverse human health effects from environmental/occupational exposures to toxic agents. This includes adverse health effects in infants, children, and adults who are at risk of developing such health problems and the reduction of preventable complications or disability in persons of all ages who have already developed such diseases. HEALTH PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Environmental/Occupational Medicine Academic Award, is related to the priority area of environmental health. Potential applicants may obtain a copy of "Health 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 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Only schools of medicine or osteopathy in the United States and its possessions or territories are eligible to compete for E/OMAA for a project period that does not exceed five years and, to receive the Award once only. MECHANISM OF SUPPORT The mechanism of support for this activity will be for the academic career award (K07). RESEARCH OBJECTIVES The NIEHS initiated the E/OMAA Program to provide a stimulus for development of an environmental/occupational medicine curriculum in those schools that do not have one, and to strengthen and improve the environmental/occupational medicine curriculum in schools that do. Awards provide support to applicant faculty members for their educational development and for implementation or expansion of the curriculum in environmental/occupational medicine. 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The PHS 398 Application Kit can also be found on the NIH Home Page on the Internet at http://www.nih.gov/grants/phs398/phs398.html. The application receipt date is July 15, 1997. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be reviewed by a special study section of the NIEHS, and all will receive a written critique. Following the review, the applications will receive a second-level review by the National Advisory Environmental Health Sciences Council. In the review process, applications will be evaluated for evidence of commitment by both the sponsoring institution and the sponsoring department or division to the accomplishment of the objectives of the award, as well as the qualification, interest, and commitment of the candidate to undertake the responsibility for implementing a high quality environmental/occupational medicine curriculum. Additional criteria and other important information are included in the program guidelines available from NIEHS program staff. AWARD CRITERIA Applications will compete for available funds with all other approved applications in the Career (K) category assigned to the NIEHS. 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 of questions from potential applicants is welcome. Program Guidelines for the E/OMAA are essential to develop a competitive application and must be obtained. Direct inquiries regarding programmatic issues to: Annette G. Kirshner, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 104 Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-0488 FAX: (919) 541-2843 Email: kirshner@niehs.nih.gov Direct inquiries regarding fiscal matters to: David L. Mineo Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 2-01 104 Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-1373 FAX: (919) 541-2860 Email: mineo@niehs.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.894. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sat Apr 12 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-97-010 - V26(12) 04/11/97 Date: 13 Apr 1997 00:18:35 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 486 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5iq1cb$94@net.bio.net> NNTP-Posting-Host: net.bio.net GENE THERAPY CORE CENTERS NIH GUIDE, Volume 26, Number 12, April 11, 1997 RFA: DK-97-010 P.T. 04; K.W. 0745032, 1002019, 0715135, 0715085 National Institute of Diabetes and Digestive and Kidney Diseases Cystic Fibrosis Foundation Letter of Intent Receipt Date: January 12, 1998 Application Receipt Date: February 10, 1998 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)and the Cystic Fibrosis Foundation invite applications for Core Center Grants to support gene therapy research on cystic fibrosis and other genetic diseases of interest to NIDDK. Core Centers will provide shared resources to enhance the efficiency of research and foster collaborations within and among institutions with strong existing bases of research relevant to gene therapy. Centers will also support a Pilot and Feasibility Program and an Educational Enrichment Program. This program is intended to foster research toward the goal of gene therapy for cystic fibrosis. Therefore, applicants should propose a central focus on gene therapy for cystic fibrosis. However, many common principles are involved in the development of safe methods for targeting and achieving long-term expression of therapeutic genes for most genetic disease. Therefore, Core Center resources may also be made available to scientists developing gene therapy approaches for genetic endocrine, metabolic, digestive, liver, kidney, urologic and hematologic diseases. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Gene Therapy Core Centers, is related to the priority area of Chronic Diseases. 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: 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and nonprofit organizations, public or private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Foreign institutions are not eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA is a one-time solicitation. Support of this program will be through the NIH grant-in-aid core center (P30) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Except as otherwise stated in this announcement, awards will be administered under Public Health Service (PHS) grants policy as stated in the PHS Grants Policy Statement. 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. FUNDS AVAILABLE The NIDDK expects to award three P30 Core Centers on a competitive basis, two in late FY 1998 and one in early FY 1999. The receipt of three competing continuation applications is anticipated. These will compete together with new applications received in response to this announcement. NIDDK anticipates that approximately $2.8 million will be available for the total cost of these awards; however, this funding level 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 the NIDDK, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. In a separate award, the Cystic Fibrosis Foundation (CFF) will award up to $500,000 per year direct costs for a maximum of five years to each center for pilot and feasibility studies to develop gene therapy for cystic fibrosis. All pilot and feasibility projects will be reviewed as a single component of the Gene Therapy Core Center. To be eligible for CFF funding, applicants will need to provide the CFF with a copy of the review. The total project period for applications submitted in response to this RFA is five years. The maximum dollar request for the NIDDK award is limited to $750,000 in direct costs in any budget period. Pilot and feasibility studies proposed for funding by NIDDK are included in the $750,000 limit. An additional budget of up to $500,000 for pilot and feasibility projects on cystic fibrosis is excluded from the $750,000 limit. Any indirect costs related to subcontracts are not included in the $750,000 direct cost limit. Budget escalations in future years should be limited to 3% up to the $750,000 limit. The earliest anticipated award date is 09/30/98. RESEARCH OBJECTIVES Background Genetic diseases, although individually rare, in aggregate account for a considerable health care burden. For many genetic diseases, the genes have been cloned and characterized so that gene therapy could be a possible treatment especially for diseases where current therapy is inadequate. Over the past several years, gene therapy clinical trials have been undertaken in an attempt to develop treatments for several genetic diseases. Cystic fibrosis, one of the most common life-limiting genetic diseases affecting 30,000 Americans, has been at the forefront of testing this new technology to treat clinical disease. In 1989, the gene responsible for CF was cloned and was designated, the cystic fibrosis transmembrane conductance regulator (CFTR). Subsequently, CFTR was shown to function as a cAMP- regulated chloride channel whose disruption results in the CF phenotype. This discovery paved the way for the initiation of over 10 gene therapy clinical trials to express the normal CFTR gene. These have included a variety of viral and non-viral strategies using adenoviral vectors, adeno-associated viral vectors and cationic liposomes to deliver CFTR. The first completed studies using adenoviral vectors and liposomes have identified many limitations of the current technology for gene therapy including low transfection efficiency, immunological reactions to the viral proteins, and short duration of gene expression, as well as the need to identify reproducible surrogate clinical end-points. Clinical studies in other genetic diseases have also identified similar limitations for gene therapy. For some diseases, where the defective gene does not produce a protein product (so called null mutations), expression of the therapeutic gene can elicit an immune response which extinguishes expression. In addition, identification and targeting of stem cells for many tissues have been a significant road block to long-lasting correction. Although some issues, such as targeting the appropriate cell type, are unique for each disorder, progress toward gene therapy of cystic fibrosis and other genetic diseases depends on developing and testing technology relevant to a number of disorders. These problems cut across many different scientific disciplines and will require collaborative efforts to develop novel solutions. Such methods can most efficiently be developed if shared resources are available to support individual research projects. The NIDDK-supported Gene Therapy Core Centers are part of an integrated program of cystic fibrosis and metabolic disease research. These Core Centers provide increased, cost-effective collaboration among multidisciplinary groups of investigators at institutions with an established, comprehensive research base in cystic fibrosis and other genetic diseases. Additionally, NIDDK supports four Specialized Centers of Research (P50) and one Core Center Grant on cystic fibrosis. NIDDK supports a large body of research on cystic fibrosis and genetic metabolic diseases and gene therapy for these disorders through regular research and program project grants. Gene Therapy Core Center grants for cystic fibrosis and other genetic diseases are intended to improve the quality and multidisciplinary nature of research on gene therapy of these disorders by providing shared access to specialized technical resources and expertise. Objectives and Scope The objective of the Gene Therapy Core Centers is to provide shared resources to investigators with a wide variety of relevant expertise to promote a multifaceted approach to gene therapy research. Gene therapy research involves many specialized technologies which need to be integrated into a cohesive research program. A Gene Therapy Core Center would make these technologies available to many investigators to apply to their research. A biomedical research core is defined as a shared resource that provides essential services, techniques, or instrumentation to Center participants enabling them to conduct their funded individual research projects more efficiently and/or more effectively. Cores provide specialized technologies and expertise needed to accomplish the stated goals of the Center toward gene therapy of cystic fibrosis and other genetic diseases of interest to NIDDK. Each core should provide services to multiple funded research projects. Examples of possible biomedical core resources that would be considered responsive to this Request for Applications include: o Vector core to develop new vector designs, assist investigators with the construction of vectors, provide vectors for experimentation, and monitor vector preparations and patient samples for adventitious agents and replication competent viruses. o DNA Delivery core to develop, distribute and test new formulations for liposome or other DNA compacting and targeting reagents for delivery of DNA. o Animal Models core to develop, breed and maintain models for cystic fibrosis, to develop new models using knockout technology for other genetic metabolic diseases, and crossbreed mice on to new background strains to attain appropriate models for in vivo assessment of gene therapy. o Histology core to assess the efficiency of gene transfer to particular cell types by using enzymatic histochemistry, immunohistochemistry, in situ hybridization or in situ polymerase chain reaction (PCR). o Cell Transduction core to develop techniques for transfection of cells ex vivo and techniques for reimplantation of transduced cells. o Electrophysiology core to measure the functional correction of CFTR in cystic fibrosis cell lines and patient samples. o Immunology core to analyze in vivo immunological responses to transgene and viral proteins and study methods to suppress these reactions. o Clinical core to design, carry out, and provide statistical support for gene therapy clinical trials for cystic fibrosis and other genetic diseases. o GMP core facility to produce DNA or vectors for human use under Good Manufacturing Practice and to generate data for an Investigational New Drug application. These possible cores are not listed in any particular order nor do they represent a comprehensive list of cores that could be supported under this Request for Applications. Applicants are encouraged to propose other cores that address the program objectives as stated above. In addition to biomedical cores, an administrative core must be described which will be responsible for allocation of resources within the Center and distribution of resources to Center participants. The Administrative core will also be responsible for planning the Educational Enrichment Program consisting of a seminar series, guest lectures, and workshops, and convening a Committee to oversee the solicitation, review and selection of the pilot projects. Although funds are not provided directly for training purposes, the core laboratories and program enrichment activities should provide training opportunities for Center members. Each Core Center must develop a cohesive pilot and feasibility program to develop new research directions or provide an opportunity for new investigators or established investigators to enter the field of gene therapy. A pilot and feasibility project is intended to provide modest support which will allow an investigator the opportunity to develop sufficient preliminary data as a basis for an application for independent research support. Pilot and feasibility projects are not intended to support or supplement ongoing research of an established investigator. This Program should be integrated into the overall research goals of the Center and make use of the resources provided by the cores. Each Core Center application must include a minimum of two pilot studies in its requested NIDDK support. In addition, the CFF will support up to 10 pilot projects relevant to gene therapy of cystic fibrosis. Each pilot project may request a maximum of $50,000 for up to two years. SPECIAL REQUIREMENTS An existing program of excellence in biomedical research in the area of gene therapy for cystic fibrosis and related genetic metabolic diseases is required. This research base must consist of NIH and other peer-reviewed funded research projects and be substantial to justify the requested Core support. Suggestions for describing and presenting this research base in the application are included in the Administrative Guidelines (See Application Procedures). 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 are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by January 12, 1998, 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 NIDDK staff to estimate the potential review workload and avoid 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 45 Center Drive, Room 6AS-37F - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES Applicants should request a copy of "Administrative Guidelines for Gene Therapy Core Centers." These guidelines contain important additional information on the format, content, and review of applications and review criteria. Prospective applicants may obtain guidelines from Dr. Catherine McKeon at the address listed under INQUIRIES. The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The RFA label available in the PHS 398 (rev. 5/95) 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 2 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, plus three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At time of submission, two additional copies of the application must be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F - MSC 6600 BETHESDA, MD 20892-6600 Applications must be received by February 10, 1998. 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 previously reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. Review Criteria o Scientific excellence of the Center's research base which should have a central focus in gene therapy of cystic fibrosis and may extend to gene therapy of other genetic diseases relevant to the mission of NIDDK. The integration of the research base into the goals of the Center and collaboration between Center investigators must be described; o The scientific and administrative abilities of the Center Director and Associate Director and their commitment and ability to devote adequate time to the effective management of the Core Center; o Appropriateness, impact, relevance and uniqueness of the services provided by the cores. Renewal applications must demonstrate core usage, cost effectiveness and research progress; o For new applications, the pilot and feasibility program is judged on the basis of (1) scientific merit of the submitted projects and (2) the merit of the administrative process for selecting subsequent studies. In competitive renewal applications, emphasis is placed on the program as a whole, including past research accomplishments, success in attaining research support and management of the program; o The appropriateness of the Core Center budgets for the core facilities, pilot and feasibility studies, and for enrichment and the proportion of funds devoted to each component in relation to the total Center program; o Institutional commitment to the program, including lines of accountability regarding management of the Core Center grant and a commitment to establish new positions as necessary; and o Adequacy of plans to include patients of 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 applications submitted in response to this RFA and recommended by peer review. The following will be considered in making funding decisions: o Quality of the proposed Center as determined by peer review. o Availability of funds. o Overall balance in the Gene Therapy Core Center program. Schedule Letter of Intent Receipt Date: January 12, 1998 Application Receipt Date: February 10, 1998 Initial Review: June-July 1998 Second Level Review: September 17-18, 1998 Anticipated Date of Award: Sept 30, 1998 through January 1, 1999 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: Catherine McKeon, Ph.D. Metabolic Diseases and Gene Therapy Research Program National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive MSC 6600 BETHESDA, MD 20892-6600 Telephone: (301) 594-8810 FAX: (301) 480-3503 Email: McKeonC@ep.niddk.nih.gov Direct inquiries regarding fiscal and administrative matters to: Donna Huggins Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 CENTER DR MSC 6600 BETHESDA, MD 20892-6600 Telephone: (301) 594-8848 Email: HugginsD@ep.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99- 158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sat Apr 12 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-052 - V26(12) 04/11/97 Date: 13 Apr 1997 00:18:51 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1148 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5iq1cr$9n@net.bio.net> NNTP-Posting-Host: net.bio.net ACADEMIC RESEARCH ENHANCEMENT AWARD NIH GUIDE, Volume 26, Number 12, April 11, 1997 PA NUMBER: PA-97-052 P.T. 34; K.W. 1014006, 0710030, 0404000 National Institutes of Health Application Receipt Dates: June 25, 1997; September 25, 1997; January 25, 1998, May 25, 1998 PURPOSE The National Institutes of Health (NIH) is continuing to make a special effort to stimulate research in educational institutions that provide baccalaureate training for a significant number of the Nation's research scientists but that have not been major recipients of NIH support. Since Fiscal Year (FY) 1985, Congressional appropriations for the NIH have included funds for this initiative, which NIH has implemented through the Academic Research Enhancement Award (AREA) program and an annual Request For Applications. Since it is anticipated that funds will continue to be available each year, the NIH is now inviting applications for AREA grants (R15) through a standing, ongoing Program Announcement. AREA funds are intended to support new or ongoing health-related research projects proposed by faculty members of eligible institutions. The AREA will enable qualified scientists to receive support for small-scale research projects. These grants create a research opportunity for scientists and institutions otherwise unlikely to participate extensively in NIH programs to participate in the Nation~s biomedical and behavioral reserach effort. It is anticipated that investigators supported under the AREA program will benefit from the opportunity to conduct independent research; that the grantee institution will benefit from a research environment strengthened through AREA grants and furthered by participation in the diverse extramural programs of the NIH; and that students will benefit from exposure to and participation in research and be encouraged to pursue graduate studies in the health sciences. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Academic Research Enhancement Award, is related to the priority areas of biomedial and behavioral science research. 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 202-512-1800). ELIGIBILITY REQUIREMENTS Applicant Institutions: All health professional schools and other academic components of domestic 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 (in both direct and indirect costs) in each of four or more years during the period from FY 1990 through FY 1996. To verify the eligibility of a school or component with regard to this requirement, applicants should check the list of FY 1997 INeligible schools that is available on the NIH Home Page on the World Wide Web (http://www/nih.gov) under the Grants and Contracts sub-menu. If the name of the school does not appear on the list, it may be eligible to apply for AREA grants in FY 1997. For purposes of eligibility for the AREA program, the following definitions apply: 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 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 "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, R15, R21, R22, R23, R24, R29, R35, R37, R55, U01, U10, U24, U41, U42, and U54. o "Other academic components" means all schools, departments, colleges, and free-standing institutes of the institution EXCEPT the health professional schools, taken as a SINGLE eligible component. An applicant institution may submit several applications proposing different research projects from different investigators. Proposed Principal Investigator: o Must not be the principal investigator of any active NIH research grant (including an AREA grant) at the time of award of an AREA grant. o May not be awarded more than one AREA grant at a time. o May not submit an application to NIH for a research project grant (e.g., R01, R03, R21, R29) for essentially the same project proposed in a pending AREA application. o Are expected to conduct the majority of their research at their own institution, although limited use of special facilities or equipment at another institution is permitted. Scientists working in AREA-eligible, minority and women's educational institutions are encouraged to participate in this program. MECHANISM OF SUPPORT The R15 mechanism is used to designate applications and awards for AREA research grants to distinguish the special objectives of these grants. This award will enable scientists at eligible institutions to receive support for small research projects as well as for feasibility studies, pilot studies, and other small-scale programs that would provide data preliminary to a traditional research project grant. Through this mechanism, a maximum of $75,000 in direct costs plus indirect costs (at the rate negotiated for the institution) may be awarded for a period of up to three years. Allowable direct costs include salaries for the principal investigator and other research personnel, supplies, equipment, travel, and other items specifically associated with the proposed research project. In any one year of an AREA grant, no more than $35,000 in direct costs may be requested. If necessary, a no-cost extension of up to twelve months may be requested by the institution to allow the principal investigator to finish the proposed project. Supplemental Funding of Existing Grants The NIH recognizes the need to increase the number of underrepresented minority scientists participating in biomedical and behavioral research. As a result, the NIH is emphasizing the use of administrative supplements to existing grants in order to attract underrepresented minorities into biomedical and behavioral research. See the NIH Guide for Grants and Contracts, Vol. 22, No. 43, November 26, 1993, for a full discussion of this additional funding opportunity and of procedures for submitting a request for a supplement. This information may also be obtained from the Office of Extramural Outreach and Information Resources, Office of Extramural Research, NIH, at the address listed under APPLICATION PROCEDURES. Principal Investigators at domestic institutions who hold an active NIH research grant (including an active AREA grant) are eligible to submit a request for an administrative supplement to the awarding component which issued the parent grant. For purposes of the active AREA grant, the request will be to support a minority candidate who is a high school or undergraduate student. Exceptions to this rule may be made by the awarding component which issued the AREA grant. The NIH recognizes also the need to extend opportunities to individuals with disabilities who are capable of entering or resuming research careers. According to the Americans With Disabilities Act, a "disabled individual" is one who has a physical or mental impairment that substantially limits one or more major life activities, who has a record of such impairment, or who is regarded as having such an impairment. Accordingly, Principal Investigators of an active AREA grant may submit a request for an administrative supplement for this purpose also to the awarding component which issued the parent grant. See the NIH Guide for Grants and Contracts, Vol. 21, No. 3, January 24, 1992, for a full discussion of this additional funding opportunity and procedures for submitting a request for a supplement. This information may also be obtained from the Office of Extramural Outreach and Information Resources (see Inquiries below). RESEARCH OBJECTIVES Background The NIH is the principal research arm of the Department of Health and Human Services (HHS). At present, 21 awarding components (known as Institutes or Centers) and several support and service divisions constitute the NIH. The NIH fosters the development of new knowledge in the biomedical and behavioral sciences, the ultimate goal of which is to combat disease and improve the health of mankind. To achieve its goals, NIH conducts research in its own laboratories and clinics, and it funds research in research and academic institutions throughout the world by means of grants, cooperative agreements, and contracts. The majority of grantees are academic institutions, but other organizations (including for-profit organizations) participate significantly in NIH-supported research. The NIH provides funds for research projects, research training, career development of new and established scientists, and research and medical library resources. Research grants represent the largest proportion of all NIH extramural awards. The research plan for each research grant application is generated and developed by an investigator referred to as the "principal investigator." On behalf of the investigator, the institution submits the grant application to the NIH for consideration for support. Principal investigators of NIH grant applications are most frequently affiliated with universities or medical schools, and most of them hold doctorate degrees. The Division of Research Grants (DRG), a component of the NIH, receives all grant applications submitted to the NIH for support, assesses each one for relevance to the health mission of the NIH; and assigns those that are acceptable to the appropriate scientific review group (SRG) for initial scientific merit review, and to the appropriate NIH awarding component for consideration for an award. Since its inception, the NIH has used a dual peer review system for the evaluation of applications. This system, which has a statutory base, ensures that only the most meritorious and relevant proposals are considered for funding. The first level of review involves panels composed primarily of non-Federal experts, referred to as SRGs or study sections, which are organized according to scientific areas. These panels of experts render an impartial review and evaluation of each application. They consider not only the scientific merit of a proposal, but also the background and experience of the principal investigator, the research facilities available for the project, and the appropriateness of the direct costs requested. The second level of review is made by the National Advisory Council or Board of the awarding component to which the application is assigned. These groups, composed of scientists, physicians, and leaders in public affairs, are chosen for their expertise, interest, or activity in ing component's mission. The council or board will take into account the relevance of the goals of the ssion of the awarding component, program balance, and the availability of funds. The AREA program and its application, review, and award procedures have been developed within this established framework for NIH grant-supported research activities. RESEARCH OBJECTIVES AREA grants will support small-scale, new or ongoing health-related research projects, including pilot research projects and feasibility studies; development, testing, and refinement of research techniques; secondary analysis of available data sets; and similar discrete research projects that demonstrate research capability. Listed below, by awarding component, are research topics that may be of particular interest to potential principal investigators under the AREA program. Also listed in the Inquiries section is the appropriate awarding component program representative whom a potential applicant is encouraged to contact for additional scientific program information and for pre-application guidance. The research objectives of the AREA program are those of the individual NIH Institutes and Centers. They are as follows: National Institute on Aging (NIA) The NIA is interested in, and has responsibilities for, aging research that includes. fundamental studies of biological processes, including studies of aging at the molecular, organelle, cellular, organ, and organ system levels; the interaction of aging and diseases of aging; biomedical and psychosocial factors in maintaining health and effective functioning in the middle and later years, relevant social and behavioral relationships; and research that broadens the base of knowledge underlying adequate health services for the aging and the aged. The Institute is interested in normal physiological and biochemical changes with aging, involving areas such as immunology, neurobiology, endocrinology, nutrition, and exercise physiology, as well as clinical diseases and disorders of aging such as Alzheimer's disease, osteoporosis, osteoarthritis, falls, and urinary incontinence. The Institute also has responsibility for research concerned with the biological, social, psychological, cultural, and economic factors that affect both the process of growing old and the status and roles of older people in society. Under this broad mandate, health and wellbeing are viewed as the outcome of complex biological, physiological, medical, psychological, and socioenvironmental processes. National Institute on Alcohol Abuse and Alcoholism (NIAAA) The NIAAA supports basic and applied research on mechanisms of action of alcohol on blobehavioral processes and effects of alcohol on the mind and body. Support is available to develop new knowledge in a wide range of areas relevant to alcohol abuse and alcoholism; biochemical, physiologic, and behavioral mechanisms leading to pathologic drinking behavior; alcohol-induced organ damage; and clinical, behavioral, and epidemiological studies that will lead to more effective diagnosis, prevention, and treatment. The NIAAA supports alcohol-relevant research involving all of the life-science disciplines. National Institute of Allergy and Infectious Diseases (NIAID) The objective of NIAIID's research program is to acquire the knowledge which will eventually lead to the treatment and prevention of infectious, allergic, and immunologic diseases. The Institute's overall strategy of attacking the array of problems on a broad front relies on free-ranging research in microbiology and includes the following research problem areas: isolation, characterization, and biology of disease-causing microbes; antibiotic or drug resistance among bacteria, viruses, and parasites; development of successful and safe antimicrobial compounds, particularly for viruses and parasites; and new approaches to understand and manipulate the immune system. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) The NIAMS supports basic and clinical studies related to the rheumatic diseases and to diseases and disorders of connective tissue, bone, and skin. Areas of research include: inflammation, infectious agents and genetic factors related to rheumatic diseases; structure and function of cartilage and connective tissue; arthritis in children; systemic lupus erythematosus; rheumatoid arthritis; - osteoarthritis; spondylitis and related syndromes; gout and pseudogout; the structure and function of skeletal muscle; bone structure, formation, degradation and repair; osteoporosis; biomaterials, biomechanics, and joint replacement; inherited connective tissue diseases; bone immunology and transplantation; metabolism of epidermis, dermis and subcutaneous fat; immunologically mediated cutaneous disorders; photobiology, photoallergy, and phototoxic reactions; vitiligo; psoriasis, bullous diseases of the skin; and acne. National Cancer Institute (NCI) The NCI is the Federal Government's principal agency for cancer research and control. Programs of the NCI focus on: (1) cancer etiology including laboratory, field, and epidemiologic and biometric research on the cause and natural history of cancer and means for preventing cancer, as well as studies on the mechanisms of cancer induction and promotion by chemicals, viruses, and environmental agents; (2) cancer biology and diagnosis research in the areas of cell biology, inununology, molecular biology, developmental biology, biochemistry, genetics, and pathology; (3) cancer treatment research in the areas of drug development, biological response modifiers, and radiotherapy development, including diagnostic imaging and clinical trials for curing or controlling cancer; and (4) cancer prevention and control research, development, technology transfer, demonstration, and education and information dissemination programs to expedite the use of new information relevant to prevention, detection, and diagnosis of cancer and pretreatment evaluation, treatment, rehabilitation, and continuing care of cancer patients. National Institute of Child Health and Human Development (NICHD) The goal of NICHD's research programs is the improvement of maternal, infant, and child health through support of basic and clinical research to elucidate normal and abnormal growth, development, and maturation, from gametogenesis through maturity. To this end, NICHD supports research in: reproductive biology, chemistry, and medicine; fertility regulation; contraceptive development and evaluation; perinatology, pregnancy, and labor; developmental and clinical genetics; population dynamics; developmental endocrinology; social, cognitive, and affective development; and the biological bases of behavioral development. The NICHD also supports biomedical and behavioral research on mental retardation and developmental disabilities; pediatric, adolescent, and maternal HIV infection and AIDS; and, in the context of its National Center for Medical Rehabilitation Research, NICHD also supports the development of medical, behavioral, psychological, social, and technological interventions designed to optimize functioning after impairment, disability, or handicap. National Institute on Deafness and Other Communication Disorders (NIDCD) Programs of the NIDCD focus on the identification, encouragement, and support of research aimed at improved diagnosis, treatment, and prevention of disorders of human communication. This would include research in all aspects of speech, hearing, language, equilibrium, and the special senses (taste, touch, smell). Basic and clinical studies of anatomical, physiological, biochemical, behavioral, acoustical and pathological aspects of communicative disorders and otolaryngological diseases are encouraged. National Institute of Dental Research (NIDR) The mission of the NIDR is the advancement of knowledge concerning the oral-facial complex in all of its aspects. This includes the conduct and support of research into the etiology, epidemiology, prevention, diagnosis, and treatment of such dental diseases as caries and periodontal disease; increasing our knowledge about craniofacial development and malformations; studies of various oral soft tissue diseases, including herpes and oral cancer; and increasing knowledge about orofacial pain and other oral sensory and motor dysfunctions. Cutting across these oral disease or dysfunction areas are research activities in such areas as salivary glands and secretions, mineralization and fluorides, tooth pulp biology, nutrition, behavioral studies, and research related to dental implants, replants, and transplants and to dental restorative biologically comparable and derived materials. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) The NIDDK conducts and supports research focused on a number of diseases that are characterized by chronicity and long-term disabling effects. Areas of interest include: diabetes, cystic fibrosis, and other errors of metabolism; diseases of the gastrointestinal tract, including the liver and gallbladder; endocrine disorders; diseases of the blood; kidney and urological diseases, and studies of nutrition and nutrition-related disorders. NIDDK's responsibilities in these areas encompass investigations of etiology, pathogenesis, diagnosis, and treatment. National Institute on Drug Abuse (NIDA) The research programs of the NIDA are devoted to increasing the understanding of the causes and consequences of drug abuse. This goal is accomplished by support of extramural research projects that improve and refine the methods for the assessment, treatment and prevention of drug abuse. The scientific studies supported are broad and include: fundamental studies on the mechanisms of action of abused drugs; biochemical strategies for identifying and developing successful drug abuse treatment agents; behavioral and clinical pharmacology; services research; epidemiology, natural history and prevention of drug abuse; treatment research; community-based research on reduction of drug-taking behaviors; and studies of drug abuse as a contributing factor in the AIDS epidemic. National Institute of Environmental Health Sciences (NEEHS) The NIEHS is the principal Federal agency for biomedical research on the effects of chemical, physical, and biological environmental agents on human health and well-being. The Institute supports research and training focused on the identification, assessment, and mechanism of action of potentially harmful agents in the environment. Research results form the basis for preventive programs for enviromentally-related diseases and for action by regulatory agencies. The NIEHS, thus, has responsibility for providing knowledge to assist in societal decisions involving current and future chemicals, processes, and other factors which may have impact on human health either directly or indirectly by altering man's environment. This responsibility mandates efforts toward a thorough understanding of the early manifestations and the mechanism of human disease brought about by toxic agents and the development of more accurate and more rapid methods to predict and assess the toxicity of such agents. National Eye Institute (NEI) The mission of the NEI is to gain new knowledge concerning the normal functions of the eye and visual system and the pathology of visual disorders. Working to this end, the NEI supports research and research training aimed at improving the prevention, diagnosis, and treatment of visual disorders and fosters research in the rehabilitation of the visually handicapped. Both laboratory and clinical research are funded under the following major NEI programs: Retinal and Choroidal Diseases; Corneal Diseases; Cataract; Glaucoma; Strabismus, Amblyopia and Visual Processing. Within each program, research ranges from attempts to elucidate the fundamental biological processes that underlie disease to the development and clinical testing of new diagnostic and therapeutic techniques. National Institute of General Medical Sciences (NIGMS) The NIGMS supports non-disease-targeted research in the basic biomedical sciences. Research areas of interest include biophysics, cell biology, molecular biology, genetics, pharmacology, and those areas of chemistry which have relevance to biomedical problems. The emphasis is on understanding basic biological mechanisms, particularly at the cellular, subcellular, and molecular levels. National Heart, Lung, and Blood Institute (NHLBI) The NHLBI supports basic and clinical research pertaining to the structure, function, and diseases of the cardiovascular, pulmonary, and blood systems. The Institute's research program also includes transfusion medicine and blood resources. The NHLBI carries out its mission through a number of research programs that provide support for projects ranging from studies at the molecular level to whole body studies in man and animals. Examples of research areas supported by the Institute include atherosclerosis, hypertension, cerebrovascular disease (directed at the dependent variable of blood, heart, or blood vessel), coronary heart disease, peripheral vascular diseases, arrhythmias, heart failure, and shock, congenital and rheumatic heart diseases, cardiomyopathies and infections of the heart, circulatory assistance, structure and function of the lung, chronic obstructive lung diseases, pediatric pulmonary diseases, occupational and immunologic interstitial lung diseases, respiratory failure, pulmonary vascular diseases, bleeding and clotting disorders, disorders of the red blood cell, sickle cell disease, and blood resources. National Human Genome Research Institute (NHGRI) The NCHGR is currently engaged in a research program designed to characterize the human genome and the genomes of selected model organisms. This research program has the following interrelated goals: the construction of high resolution genetic linkage maps; the development of a variety of physical maps; the determination of the complete nucleotide sequence of the DNA of selected organisms; the development of the capability for collecting, storing, distributing, and analyzing the data produced; and the development of appropriate new technologies to achieve these goals. This project will develop a series of resources that will be available to the research community to facilitate both basic research and the application of the knowledge gained to the prevention, diagnosis, and therapy of disease. National Institute of Mental Health (NINM) The NIMH exerts leadership on behalf of the Nation's mentally ill citizens by creating a firm scientific foundation for the clinical care of mental disorders; by developing and assessing innovative approaches to diagnosis, treatment, and prevention of mental illnesses; and by exchanging information nationally and internationally with all relevant individuals and organizations to improve the state of mental health knowledge and its application. The NIMH conducts and supports an integrated program of basic and clinical research and research training in biology, neuroscience, epidemiology, and psychology and other behavioral sciences, as well as services research on the organization, administration, and financing of mental health services and service systems. These studies include theoretical, laboratory, epidemiologic, clinical, methodologic and field research on well and ill human subjects and populations of all ages, and on animals where appropriate to the research questions. National Institute of Neurological Disorders and Stroke (NINDS) The NINDS serves as the focal point at the NIH for research on the nervous system, including cerebrovascular disease (when the dependent variable is the nervous system), the neuromuscular apparatus, and the special senses of touch and pain. National Institute of Nursing Research (NINR) The NINR supports research on the biological and behavioral aspects of critical health problems that confront the Nation. According to its broad mandate, the Institute seeks to reduce the burden of illness and disability by understanding and easing the effects of acute and chronic illness; to improve health-related quality of life by preventing or delaying the onset of disease or slowing its progression; to establish better approaches to promoting health and preventing disease; and to improve clinical environments by testing interventions that influence patient health outcomes and reduce costs and demand for care. The NINR is interested in studies containing innovative ideas and sound methodologies in all aspects of nursing research consistent with its mission. Examples of areas of special interest include biobehavioral aspects of pain; management of symptoms associated with specific diseases or disorders; effects of life threatening illnesses; prevention or reduction of risk factors, particularly in young children; interactions among genetic factors, environment, and life style; developmental issues related to life-stage transitions; ameliorating effects of chronic illnesses; and health of minorities and other underserved populations. National Library of Medicine (NLM) The objective of NLM's research program is the support of investigations related to the generation, organization, and utilization of health knowledge. Such support may involve: (1) medical informatics research, a branch of investigation of the fundamental issues of health knowledge communication vis-a-vis advanced computer technologies; (2) research in health science librarianship and information science; or (3) assistance for the preparation and publication of scientific works in the health area. National Center for Research Resources (NCRR) The NCRR administers programs that develop and ensure the availability of resources essential to the efficient and effective conduct of human health-related research. NCRR programs are primarily institutional in nature but, while support is generally in the form of resource grants, the NCRR makes awards for support of projects which contribute to improvement of the capability of resources to serve biomedical research. The following are research areas appropriate to the NCRR interests: (1) Research and Development in Instrumentation and Specialized Technologies for Biomedical Research. This encompasses instruments, devices, and processes to facilitate research in blomolecular and cellular structure and function. (Instrumentation includes mass spectrometry, nuclear magnetic resonance, electron spin resonance, equipment for fast kinetic research, X-ray diffraction, electron microscopy, and flow cytometry.) The application of computer science, computer engineering, and biomedical engineering to biomedical research problems is also of interest. (This includes knowledge engineering, information technology, computer graphics, image processing, computer modeling and simulation, task dedicated computer systems, and development of implantable microsensors and transducers.); (2) Research in Laboratory Animal Sciences. (This includes the etiology, pathogenesis, and control of laboratory animal diseases, as well as the environmental requirements of laboratory animals.); and (3) Development of Biomedical Research Methods Employing Lower Organisms, Tissues/Cells in Culture, or Mathematical and Computer Simulations. 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 biiomedical and behavioral research projects involving human subjects, unless a clear and compellling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. APPLICATION PROCEDURES The PHS 398 (rev. 5/95) form must be used to apply for an AREA grant. In addition, applicants must observe the supplemental instructions for AREA applications contained in this Program Announcement, as the instructions identify the AREA program as a "just-in-time" mechanism and must be followed in preparing an application. The PHS 398 form may be downloaded from the NIH Home Page (http://www.nih.gov) from the Grants and Contracts submenu. It is also available at most institutional offices of sponsored research, and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. Supplemental Instructions The Department of Health and Human Services has designated the NIH a "reinvention laboratory." One reinvention objective is to simplify and improve all stages of the grant process: application, review, award, and administration. The AREA program is one of the first NIH programs where changes have been introduced that are designed to reduce the administrative burden in applying for a grant without compromising the information needed to assess the scientific and technical merit of the proposed project and the reasonableness of the proposed budget. The principle of "just-in-time" (JIT) is to avoid asking for information until it is actually needed in the process. As applied to the handling of AREA applications, JIT will postpone until after an application has been reviewed for scientific merit the collection of certain information that previously was required in all competing applications at the time of submission. Collection of the information just in time for an award to be issued means that the information will be current. Moreover, the information is collected only for those applications with a likelihood of funding, which significantly relieve the administrative burden for the majority of applicants. The instructions below refer to items in the PHS 398 application form where either the information requested has been modified or the item should not be completed, although the information may be requested after initial review by the NIH awarding component if there is a likelihood that the application will be funded. The instructions also indicate the information specific to AREA applications that must be provided. The Page Numbers in parentheses refer to the instruction pages of the application kit. GRANT APPLICATION" - Face Page (AA): Amended (revised) applications must indicate the number assigned to the previous application in the block in the upper right corner. Applicants may submit no more than two revised (amended) applications within a time period of two years from the receipt date of the initial, unamended application. Item 2 -- Check the "YES" box and enter PA-97-** and "Academic Research Enhancement Award." (Page 7) Item 3c -- Do not include the Social Security Number on the Face Page; please include this information on the Personal Data Page. Item 6 --The entire proposed project period must not exceed three years. (Page 9) Item 7b -- Do not complete. Indirect costs will be calculated at the time of award using the institution~s actual indirect cost rate. Identification of indirect cost exclusions will be requested at that time. Item 8a -- This amount must not exceed $75,000. (Page 9) Item 8b -- Do not complete. DETAILED BUDGET FOR INITIAL BUDGET PERIOD - Form Page 4 (DD): Do not submit this page. It is not required, nor will it be accepted at the time of application. NIH may request this information just prior to award. BUDGET FOR ENTIRE PROPOSED PERIOD OF SUPPORT - Form Page 5 (EE): o Do not provide the Budget Category Totals (i.e., Personnel, Consultant Costs, etc.); but, be sure to provide the "Total Direct Costs" for each year and the "Total Direct Costs for Entire Proposed Period of Support." o Begin the "Justification" in the space provided, and use continuation pages as needed. - Name all personnel (salaried or unsalaried), their percent effort, their role on the project, and provide a narrative justification based on their role and percent effort; - Name all consultants, their organizational affiliation, and describe the services they will perform; - For any major budget items other than personnel that are unusual for the scope of the research, provide a narrative justification; - If consortium/contractual costs are requested, provide the percentage of the subcontract total costs (direct and indirect) relative to the total direct costs of the overall project. The subcontract budget justification should be prepared according to the instructions above. With regard to all budget categories, if there are any unusual or unusually high costs, provide an explanation. (Page 14) BIOGRAPHICAL SKETCH - Form Page 6 (FF): For each key person, include within the two-page limit, in addition to the information required in the instructions, the research projects they have completed and/or the research grants they have participated in during the last five years that are relevant to the proposed project (title, principal investigator, funding sources, and role on project must be provided). For the principal investigator only, on a third, continuation page, provide information on his or her (a) experience in supervising students in research, and (b) other relationships within the institutional framework (e.g., cross-departmental research collaborations), which are among the criteria on which the merit of the application will be evaluated. (Page 14) OTHER SUPPORT - Format Page 7 (GG): Do not submit this page. This information may be requested by the NIH awarding component if the application is likely to be funded. (Page 14) However, the Biographical Sketch for each key personnel should include information on the other projects that the person is working on or has worked on that are relevant to the proposed project (see above). RESOURCES (HH), Form Page 8: In addition to the information requested under "Other" (Page 15), provide: o a profile of the students of the applicant School/academic component and any information or estimate of the number who have obtained the baccalaureate degree and gone on to obtain an academic or professional doctoral degree in the health-related sciences since 1986; o a description of the special characteristics of the School/academic component that make it appropriate for an AREA award, where the goals of the AREA program are to: (1) strengthen the research environment of schools that are not research intensive; (2) expose students at such institutions to research, and (3) provide support for meritorious research. o a description of the likely impact of an AREA award on the principal investigator and the School/academic component. How will the AREA award strengthen the research environment of the School/academic component? How will the AREA award expose students to research at your institution? o a statement of institutional support for the proposed research project (e.g., release time, other support, matching funds, etc.) RESEARCH PLAN: Do not exceed 20 pages for the entire Research Plan. An appendix may be included. (Page 15) o Introduction -- An Introduction, not to exceed three pages, is to be submitted only for a revised application. o Preliminary Studies/Progress Report -- This section is optional for new applications. It is required for renewal (competing continuation) applications; three to four pages are recommended and the list of publications and inventions is not included in the 20 page limit for the Research Plan. (Page 16) o Research Design and Methods -- There is no specific recommended number of pages for this section. However, the entire Research Plan (including Specific Aims; Background and Significance; Preliminary Studies/Progress Report, if used; and Research Design and Methods) may not exceed 20 pages. (Page 16) APPENDIX: May be submitted according to the instructions. (Page 19) CHECKLIST (II): Do not submit this page. A completed checklist will be required just prior to award. PERSONNEL REPORT (JJ): Do not submit this page for competing continuation applications. PERSONAL DATA PAGE (KK): Please add the Social Security Number to the upper right hand corner. REVIEW CONSIDERATIONS Applications will be accepted for the June 25, 1997, receipt date. Thereafter, the regular receipt dates for AREA applications will be January 25, May 25, and September 25. Applications are submitted to the NIH Division of Research Grants (DRG) and will be reviewed by DRG review groups for scientific and technical merit according to standard NIH peer review procedures, as described above (see Background). Applications will be assigned on the basis of established Public Health Service referral guidelines. As part of the initial merit review, a streamlined review process, which is employed for the review of most NIH research grant applications, will be used. Under this process, reviewers are asked to identify the approximate upper half of applications. These applications are discussed at the review group meeting and receive a "priority score" ranging from "best" (100) to "average" (250-300), while the lower half of applications are normally not discussed nor given a priority score. Nevertheless, all applicants will receive summary statements which will consist of the written critiques of two or more assigned reviewers. Following the initial scientific-technical review, applications receive a second-level review by the appropriate national advisory council. In conformance with the spirit of the House Committee Report 98-911 (to accompany H.R. 6028, HHS Appropriations for FY 1985), special consideration will be given in the funding decision process to applications from those "smaller, less prominent, four- year, public and private colleges and universities which provide undergraduate training for a significant number of our nation's research scientists but which have not shared adequately in the growth of the NIH extramural program." NIH implements this direction through the following policy: 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 1986-1996. The standard NIH review schedule will apply to AREA grant applications: Cycle I Cycle II Cycle III Application Receipt Date: Jan 25 May 25 Sep 25 Scientific Merit Review: Jun/Jul Oct/Nov Feb/Mar Advisory Council Review: Sep/Oct Jan/Feb May/Jun Earliest Project Start Date: Dec Apr Jul Applications received for the June 25, 1997 receipt date will be handled according to the schedule for Cycle II. In 1998 and subsequent years, the spring receipt date will be May 25. Review Criteria: In carrying out the scientific and technical merit review of AREA applications, the scientific review group will take into account: (a) the significance, originality, and technical merit of the proposed study, including, where appropriate, the project's potential for contribution in meritorious, small-scale research; (b) the adequacy of the methodology and the quality of any preliminary data or, in the case of competitive renewals, the progress report; (c) the competency of the principal investigator and of any collaborators and consultants, including academic qualifications, research experience and expertise, productivity, any special attributes, and the principal investigator~s experience in supervising students in research; (d) the facilities, resources, and environment of the applicant institution (including existing relevant equipment, animal and/or computer resources, and departmental or interdepartmental cooperation); and the suitability of the applicant School/academic component for an AREA award (the extent to which it fits the goals of the AREA program, the likely availability of well-qualified students, the evidence that students have in the past or are likely to pursue careers in the biomedical and behavioral sciences) and the likely impact of an AREA award on the School/academic component in terms of strengthening the research environment and exposing students to research; (e) the appropriateness of the proposed budget and duration, including the justification for requested items in terms of the aims and methods of the proposed study; and (f) the adequacy of the proposed means for protecting against or minimizing any adverse effects upon humans, animals, or the environment, where an application involves such activities. AWARD CRITERIA AREA grants are awarded on a competitive basis. The criteria for funding decisions on individual applications will be based on the proposed research project's scientific merit and its relevance to NIH programs, and on the applicant 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 1986-1996. Since a primary objective of the AREA program is to support investigators at undergraduate institutions that provide student training in the sciences, principal investigators are encouraged to include the participation of students in the proposed research to the extent practicable. Both annual Progress Reports and a Final Progress Report will be required of all AREA grantees. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. For inquiries of a scientific nature, potential applicants should contact the Program Contact person for one or more of the Institutes whose scientific interests are closest to those of the proposed research (see Research Objectives section above): National Institute on Aging Program Contact: Dr. Miriam Kelty Associate Director, Office of Extramural Affairs 7201 Wisconsin Avenue, Room 2C218 Bethesda, MD 20892-9205 Phone: (301) 496-9322 FAX: (301) 402-2945 E-mail: mk46u@nih.gov National Institute on Alcohol Abuse and Alcoholism Program Contact: Dr. Laurie Foudin Division of Basic Research 6000 Executive Boulevard, Suite 402 Bethesda, MD 20892-7003 Phone: (301) 443-0912 Fax: (301) 594-0673 E-mail: lf29z@nih.gov National Institute on Allergy and Infectious Diseases Program Contact: Mr. Al Czarra Director, Office of Program Coordination and Operations Division of Extramural Activities Solar Building, Room 3C28 Bethesda, MD 20892 Phone: (301) 496-7291 Fax: (301) 402-0369 E-mail: ac20a@nih.gov National Institute of Arthritis and Musculoskeletal and Skin Diseases Program Contact: Dr. Steven J. Hausman Deputy Director Building 31, Room 4C32 Bethesda, MD 20892-2350 Phone: (301) 402-1691 Fax: (301) 480-6069 E-mail: sh4lg@nih.gov National Cancer Institute Program Contact: Dr. Vincent T. Oliverio Associate Director for Program Coordination Division of Extramural Activities Executive Plaza North, Suite 600 Bethesda, MD 20892-7405 Phone: (301) 496-9138 Fax: (301) 402-0956 E-mail: vo3c@nih.gov National Institute of Child Health and Human Development Program Contact: Dr. Yvonne Maddox Deputy Director Building 31, Room 2A-03 Bethesda, MD 20892-2425 Phone: (301) 496-0104 Fax: (301) 402-1104 E-mail: ym5n@nih.gov National Institute on Deafness and Other Communication Disorders Program Contact: Dr. Jack Pearl Division of Human Communication Executive Plaza South, Suite 400-C Bethesda, MD 20892-7180 Phone: (301) 402-3464 Fax: (301) 402-6251 E-mail: jack_pearl@nih.gov National Institute of Dental Research Program Contact: Dr. Norman S. Braveman Assistant Director for Program Development Building 45, Room 4AN-24 Bethesda, MD 20892-6401 Phone: (301) 594-2089 Fax: (301) 480-8318 E-mail: nbl0u@nih.gov National Institute of Diabetes and Digestive and Kidney Diseases Program Contact: Dr. Walter S. Stolz Director, Division of Extramural Activities Building 45, Room 6AS-25C Bethesda, MD 20892-6600 Phone: (301) 594-8834 Fax: (301) 480-3504 E-mail: ws23e@nih.gov National Institute on Drug Abuse Program Contact: Dr. Teresa Levitin Director, Office of Extramural Program Review Parklawn Building, Room 10-42 5600 Fishers Lane Rockville, NM 20857 Phone: (301) 443-2755 Fax: (301) 443-0538 E-mail: tl25u@nih.gov National Institute of Environmental Health Sciences Program Contact: Dr. Jerrold Heindel P.O. Box 12233, North Campus MD 3-03 Research Triangle Park, NC 27709 Phone: (919) 541-0781 Fax: (919) 541-2843 E-mail: jhl90f@nih.gov National Eye Institute Program Contact: Dr. Ralph J. Helmsen Research Resources Officer Executive Plaza South, Suite 350 Bethesda, MD 20892-7164 Phone: (301) 496-5301 Fax: (301) 402-0528 E-mail: rh27v@nih.gov National Institute of General Medical Sciences Program Contact: Dr. Michael R. Martin Deputy Associate Director for Extramural Activities Building 45, Room 2AN-32K Bethesda, MD 20892-6200 Phone: (301) 594-3910 Fax: (301) 480-1852 E-mail: mm72k@nih.gov National Heart, Lung, and Blood Institute Program Contact: Dr. Ronald Geller Director, Division of Extramural Affairs 6701 Rockledge Drive, Room 7100 Bethesda, MD 20892-7922 Phone: (301) 435-0260 Fax: (301) 480-3460 E-mail: rg33k@nih.gov National Human Genome Research Institute Program Contact: Dr. Bettie J. Graham Chief, Research Grants Branch Building 38A, Room 610 Bethesda, MD 20894 Phone: (301) 496-7531 Fax: (301) 480-2770 E-mail: bg30t@nih:gov National Institute of Mental Health Program Contact: Dr. Richard Nakamura Division of Extramural Activities Parklawn Building, Room 9-105 5600 Fishers Lane Rockville, MD 20857 Phone: (301) 443-3367 Fax: (301) 443-0954 E-mail: rn3p@nih.gov National Institute of Neurological Diseases and Stroke Program Contact: Dr. Joseph S. Drage Training and Special Programs Officer Federal Building, Room 1016 Bethesda, MD 20892-9190 Phone: (301) 496-4188 Fax: (301) 402-4370 E-mail: jd66x@nih.gov National Institute of Nursing Research Program Contact: Dr. Lynn Amende Director, Division of Extramural Activities Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Phone: (301) 594-5968 Fax: (301) 480-8260 E-mail: lal8g@nih.gov National Library of Medicine Program Contact: Dr. Roger W. Dahlen Chief, Biomedical Information Support Branch Building 38A, Room 5S522 Bethesda, MD 20894 Phone: (301) 496-4221 Fax: (301) 402-0421 E-mail: rd57e@nih.gov National Center for Research Resources Program Contact: Dr. Louise E. Ramm Deputy Director Building 12A, Room 4009 Bethesda, MD 20892-5662 Phone: (301) 496-6023 Fax: (301) 402-0006 E-mail: lr34m@nih.gov 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 educational 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: Dr. Janet M. Cuca NIH AREA Coordinator Office of Extramural Research National Institutes of Health 6701 Rockledge Drive, Room 6192 Bethesda, MD 20892 Phone: (301) 435-2691 Fax: (301) 480-8443 E-mail: jc55g@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.390. Awards are 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 in accordance with the PHS Grants Policy Statement and Federal regulations at 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 PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sat Apr 12 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-053 - V26(12) 04/11/97 Date: 13 Apr 1997 00:19:09 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 455 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5iq1dd$ai@net.bio.net> NNTP-Posting-Host: net.bio.net ENTERIC AND HEPATIC INFECTIOUS DISEASES NIH GUIDE, Volume 26, Number 12, April 11, 1997 PA NUMBER: PA-97-053 P.T. 34; K.W. 0715085, 0715125, 0710070, 0765033 National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite investigator-initiated applications in research emphasis areas focused on infection and disease caused by enteric and hepatic pathogens. The PA identifies organism-specific gaps and opportunities with potential to lead to new diagnostics, vaccines, therapies, or other control strategies. Of special interest are: the protective immune response and strategies to invoke it; mechanisms determining the outcome of infection as well as mechanisms of pathogenesis and persistence; variability and genomic organization and component structure/function; modes of transmission, reservoirs of infection, and molecular epidemiology; and application of new technologies and scientific advances to vaccine and therapy development. Multi-disciplinary research is encouraged. This PA's research emphasis areas for enteric and hepatic diseases were, in part, identified by a comprehensive NIAID external program review conducted in the summer of 1996. The report can be accessed via the Internet through the NIAID HOMEPAGE at URL "http://niaid.nih.gov" or directly at: "http://www.niaid.nih.gov/dmid/enteric_summ.htm" 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, Enteric and Hepatic Infectious Diseases, is related to the priority areas of immunization and infectious diseases and chronic disabling conditions. 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) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). ELIGIBILITY Applications may be submitted by 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. Domestic and foreign institutions are eligible to apply for R01 and R03 grants. 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 Traditional research project grant (R01), FIRST award (R29), and small research grant (R03) applications may be submitted in response to this program announcement. Applications for R01 grants may request up to five years of support; applications for R29 grants must request five years of support; and applications for R03 grants may request up to three years of support (See APPLICATION PROCEDURES below for instructions on R03 applications). The NIAID and NIDDK use R03 grants to support highly innovative feasibility or pilot projects. R03 applicants are encouraged to establish collaborations with the NIAID supported Hepatitis C Cooperative Research Centers or NIDDK supported Digestive Diseases Centers Program. RESEARCH OBJECTIVES Background Infectious enteric and hepatic pathogens cause many different acute and chronic diseases which affect several organ systems. Enteric Infectious Diseases: Agents infecting the gut cause diarrhea - the second leading cause of morbidity and mortality worldwide. They especially affect children less than five years of age. Vibrio cholera, diarrheagenic E. coli, Campylobacter, Salmonella, Shigella and rotavirus continue to cause tremendous numbers of infections and deaths each year in the developing world as well as significant morbidity in travelers to endemic areas. Some are already public health threats in the United States and some have potential to emerge and become such threats. Sometimes infection with these diarrheagenic agents leads to severe chronic sequelae. Enterohemorraghic Escherichia coli (EHEC) is associated with secondary severe kidney damage (hemolytic uremic syndrome) resulting in death or impaired kidney function. Campylobacter jejuni is the second most common cause of bacterial diarrhea. Infection with it is the most often recognized precedent to Guillain Barre Syndrome (GBS), an acute and chronic neuromuscular disease. Antibiotic resistance to C. jejuni is rapidly increasing. [Check "http://www.niaid.nih.gov/dmid/gbssumfi.htm" on the internet for a summary of a GBS/C.jenuni workshop held at NIH in the summer of 1996.] Finally, infection with the enteric pathogen Helicobacter pylori causes ulcers. Hepatic Infectious Diseases: Viruses cause both the acute and chronic liver disease (hepatitis, cirrhosis) and produce significant morbidity and mortality. Because of their chronic manifestations hepatitis B virus (HBV) and hepatitis C virus (HCV) have the greatest impact. Respectively, there are 250,000 and 150,000 annual infections with HBV and HCV in the United States. Since HCV is more apt to become a chronic infection there are 4,000,000 chronic HCV carriers compared to 1,250,000 chronic HBV carriers in this country. In the United States, each agent causes about $800 million in annual direct health care costs; liver transplants resulting from hepatitis infection add substantial additional costs. Highly effective vaccines to prevent hepatitis B are available but underutilized; better therapies are needed. Effective means to treat chronic carriers and vaccines to prevent hepatitis C are urgently needed. HCV is associated with extra-hepatic disease manifestations. Research Objectives and Scope The Enteric Diseases and Viral Hepatitis programs (NIAID) and the Division of Digestive Diseases and Nutrition (NIDDK) seek to support basic and clinical research with potential to lead to diagnostics, vaccines, therapies, or other control strategies that will reduce the disease burden and health costs associated with enteric and hepatic infectious disease agents. Significant gaps in current research support and opportunities to develop new areas have been identified with the help of external advisors. This Program Announcement solicits applications, including multidisciplinary approaches, from the research community to address these gaps. Specific, significant scientific objectives and opportunities include, but are not limited to: ENTERIC PATHOGENS (see the following references) [1]=http://www.niaid.nih.gov/dmid/enteric_summ.htm [2]=http://www.niaid.nih.gov/dmid/gbssumfi.htm Hemolytic uremic syndrome (HUS) or central nervous system (CNS) damage due to Shiga or Shiga-like toxins: [1] o mechanism(s) of host cell and organ damage o mechanism(s) of toxin transport to the blood stream and strategies to prevent transport o crystal structure of SLT-I and II and their receptor complexes o new therapeutic strategies for treatment of patients presenting with bloody diarrhea Campylobacter jejuni: [1]&[2] o animal models of C. jejuni enteritis o lipopolysaccharide (LPS) structure o virulence factors o role of the organism, its components, and the host immune response in pathogenesis o mechanism(s) of inflammatory diarrhea o improved diagnostics, including LPS-based o epidemiology of the organisms and disease: reservoirs and seasonality o mechanism(s) of antibiotic resistance Clostridium difficile [NOTE: additional study of the toxin is not requested]: [1] o virulence factors o mechanism(s)of pathogenesis o host immune response Helicobacter pylori: [1] o mechanism(s) of colonization and persistence o role of host immune response in pathology o epidemiology: reservoirs and transmission o role of H. pylori induced achlorhydria in increased susceptibility to other enteric pathogens Caliciviruses and Astrovirus: [1] o genomic organization and partial sequence of new isolates as a means to more effective detection and complete epidemiological studies o contribution to incidence of viral diarrhea and clinical significance Immunity and Vaccine Development for Salmonella, Shigella, and diarrheagenic E. coli: [1] [NOTE: For these pathogens significant advances have been made with respect to the identification of virulence factors, understanding of their regulation, and verification of their role in pathogenesis. Molecular and genetic data have spurred vaccine development but effective vaccines are not yet available. High priority will be given to collaborative, multi-disciplinary studies] o understanding of protective immunity particularly at the mucosal surface in animal models and humans and verification of animal model findings in humans o creation of effective vaccine strategies to maximize protective immunity using humans or animal models Gastroenteritis due to Salmonella enteriditis Nucleic Acid Vaccines for: o bacterial enteric pathogens o non-toxic mutants of Shiga toxin(s) o enteric viruses Host Resistance to Enteric Pathogens: [1] o role of normal commensal flora o role of immune tolerance in establishment and maintenance of normal commensal flora o pathogen-flora interaction and impact on host resistance to infection o probiotic alteration of normal flora and role in preventing and treating disease. HEPATIC PATHOGENS: VIRAL HEPATITIS B AND C Viral and host factors and the mechanisms by which they operate and interact to: o determine the outcome of viral infection, o maintain viral persistence, o cause pathogenesis, o influence disease progression, and o alter liver function, physiology, cell biology, and architecture [NOTE that for HBV studies in the woodchuck/woodchuck hepatitis virus model are especially encouraged] [The NIDDK encourages applications with the overall scientific aim is the elucidation of liver physiology and/or pathogenesis] Model Systems o development of in vitro, cell culture and organ-like systems, animal models including novel systems such as mice with human livers. [Special need for HCV.] [NOTE that the NIDDK encourages applications generating new animal models applicable to liver disease-oriented research.] o studies related to examples in previous item, infection and its prevention [Special need for HCV], and replication. Adaptation of research findings to preventive and therapeutic strategies including assay development. Definition of the protective immune response to HCV, i.e., the response leading to recovery including roles of B cells, T cells, and the immune cascade. Vaccine development for HCV. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects of the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application for PHS 398 (rev. 5/95) and will be accepted on 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 Division of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: asknih@odrockm1.nih.gov. The title and number of the program announcement must be typed in Section 2 on the face page of the application. The completed, signed original and five legible, single-sided copies of applications must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) 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. NIAID and NIDDK use small grants (R03) submitted in response to this PA to support small, highly innovative or pilot projects. Applicants for R03 grants may request up to $50,000 annual direct costs for a period not to exceed three years. Funds and time requested should be appropriate for the research proposed. Applicants for R03 grants must follow the special application guidelines and Terms and Conditions of Award in the NIAID SMALL RESEARCH GRANTS brochure (September 1996); this brochure is available via the WWW at: http://www.niaid.nih.gov/ncn/tools/broch.htm ALL APPLICANTS REQUESTING $500,000 OR MORE IN ANNUAL DIRECT COSTS. The NIH Policy Update on Acceptance for Review of Unsolicited Applications that Request More Than $500,000 Direct Cost for Any One Year applies to applications in response to this PA. The Policy Update was published in the NIH Guide for Grants and Contracts, Vol. 25, No. 14, May 3, 1996, and became effective June 1, 1996. Potential applicants must contact the appropriate program staff listed in INQUIRIES to initiate clearance processes for acceptance of their applications. REVIEW CONSIDERATIONS Review Procedures Applications will be assigned on the basis of established PHS referral guidelines. Incomplete applications will be returned to the applicant without further consideration. R01 and R29 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. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level of review by the appropriate national advisory council. R03 applications that are complete will be evaluated by an appropriate peer review group convened by the sponsoring institutes. Review Criteria o scientific, technical, or medical significance and originality of the 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 favorably recommended applications. For applications assigned to the NIAID and NIDDK, 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 program announcement, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Leslye D. Johnson, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3A22 - MSC 7630 Bethesda, MD 20892-7630 Telephone: (301) 496-7051 FAX: (301) 402-1456 Email: lj7m@nih.gov Dennis R. Lang, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3A21 - MSC 7630 Bethesda, MD 20892-7630 Telephone: (301) 496-7051 FAX: (301) 402-1456 Email: dl73v@nih.gov Frank Hamilton, M.D., M.P.H. Digestive Diseases Program Branch National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8877 FAX: (301) 480-8300 Email: fh14e@nih.gov Thomas F. Kresina, Ph.D. Liver Diseases Program National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8871 FAX: (301) 480-8300 Email: tk13v@nih.gov Direct inquiries regarding fiscal matters to: Mr. Todd Ball Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B35 Bethesda, MD 20892-7610 Telephone: (301) 402-5512 FAX: (301) 480-3780 Email: tb22j@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.856 and No. 93.848. Awards are made under authorization of the Public Health Service Act, Sec. 301(c), Public Law 78-410, as amended. Awards will be 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 review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sat Apr 12 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 12, pt. 1of1, 11 April 1997 Date: 13 Apr 1997 00:18:17 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 687 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5iq1bp$8e@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 26, No. 12 - April 11, 21997 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIH GUIDE PUBLICATION DATES $$INDEX N2 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N3 ********************************************************** ACADEMIC RESEARCH ENHANCEMENT AWARD National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N4 ********************************************************** NEW AHCPR POLICY ON SUBMISSION OF REVISED APPLICATIONS Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH $$INDEX N5 ********************************************************** AHCPR STREAMLINES PROCESS FOR SUMMARY STATEMENTS OF REVIEWS OF GRANT APPLICATIONS Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH $$INDEX N6 ********************************************************** ACUTE INFECTION AND EARLY DISEASE RESEARCH NETWORK - REMINDER (PAR-96-060) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 02/10/98 ************************************************* GENE THERAPY CORE CENTERS (RFA DK-97-010) National Institute of Diabetes and Digestive and Kidney Diseases Cystic Fibrosis Foundation INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES; CYSTIC FIBROSIS FOUNDATION $$INDEX P1 ********************************************************** ACADEMIC RESEARCH ENHANCEMENT AWARD (PA-97-052) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX P2 ********************************************************** ENTERIC AND HEPATIC INFECTIOUS DISEASES (PA-97-053) National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX P3 ********************************************************** ENVIRONMENTAL/OCCUPATIONAL MEDICINE ACADEMIC AWARD (PAR-97-054) National Institute of Environmental Health Sciences INDEX: ENVIRONMENTAL HEALTH SCIENCES The NIH GUIDE is available electronically via LISTSERV subscription, and is also on the nih gopher (gopher.nih.gov) and the NIH web site (http://www.nih.gov). Alternative access is available through the NIH Grant Line via modem (data line 301/402-2221); contact Dr. John James at 301/435-2801 for details on the NIH Grant Line. All competing (new, renewal, amended (revised) applications for grants, cooperative agreements, and fellowships from the National Institutes of Health must be sent to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) ASKNIH is a service of the Division of Extramural Outreach & Information Resources, Office of Extramural Research, Office of the Director, NIH. ASKNIH is the point of contact for obtaining general information about NIH extramural research & research training programs, requesting publications, and learning more about obtaining the NIH GUIDE and other information on the NIH web site. ASKNIH is also the contact to which organizations should request application kits and forms. ASKNIH NATIONAL INSTITUTES OF HEALTH EMAIL: ASKNIH@odrockm1.od.nih.gov FAX: (301) 480-0525 TELEPHONE: (301) 435-0714 INQUIRIES ABOUT THE NOTICES, PAS, AND RFAS IN THIS PUBLICATION SHOULD BE DIRECTED TO THE NIH STAFF MEMBER IDENTIFIED AT THE END OF EACH ITEM. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** THE NIH GUIDE FOR GRANTS & CONTRACTS WILL NOT BE PUBLISHED APRIL 18. THE NEXT ISSUE OF THE NIH GUIDE WILL BE ON APRIL 25, 1997. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 26, Number 12, April 11, 1997 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services Notice is hereby given that the Office of Research Integrity (ORI) has made a final finding of scientific misconduct in the following case: Enrico Portuese, University of Pittsburgh: Based upon an investigation conducted by the University of Pittsburgh, information obtained by the Office of Research Integrity (ORI) during its oversight review, and Mr. Portuese~s own admission, ORI found that Mr. Portuese, a former graduate student in the Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, engaged in scientific misconduct by fabricating research data in biomedical research supported by two grants from the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), National Institutes of Health (NIH). Specifically, Mr. Portuese fabricated data in a study of angiotensin-converting enzyme polymorphism and complications from insulin-dependent diabetes mellitus. These fabricated data were included in an abstract that was submitted to the American Diabetes Association in January 1996; however, the abstract was not accepted, presented in public, or published. In addition, Mr. Portuese fabricated genetic data on lipoprotein lipase polymorphisms as related to diabetes complications and risk factors. These fabricated data were included in tables prepared by Mr. Portuese and presented by him to his doctoral committee in October 1996. None of the fabricated data in question has been published, presented at a scientific meeting, or used in any grant applications. Mr. Portuese has accepted the ORI finding and has entered into a Voluntary Exclusion Agreement with ORI in which he has voluntarily agreed, for the three year period beginning March 25, 1997: (1) to exclude himself from serving in any advisory capacity to the Public Health Service (PHS), including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant; and (2) that any institution that submits an application for PHS support for a research project on which Mr. Portuese~s participation is proposed or which uses him in any capacity on PHS supported research must concurrently submit a plan for supervision of his duties. The supervisory plan must be designed to ensure the scientific integrity of Mr. Portuese~s research contribution. The institution must submit a copy of the supervisory plan to ORI. No scientific publications were required to be corrected as part of this Agreement. INQUIRIES For further information contact: Acting Director, Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** ACADEMIC RESEARCH ENHANCEMENT AWARD NIH GUIDE, Volume 26, Number 12, April 11, 1997 P.T. 34; K.W. 1014006, 0710030, 0404000 National Institutes of Health This notice is to highlight for the research community recent changes to the Academic Research Enhancement Award (AREA) program. In response to comments and suggestions from interested parties, an NIH committee examined the program and recommended several changes to it. NIH extramural officials have decided that the following changes will be implemented immediately: o Applications will be accepted in response to ongoing Program Guidelines (which appear elsewhere in this issue of the NIH Guide as Program Announcement PA-97-052), and will not be solicited through a request issued annually. o Applications for these awards will be accepted and reviewed three times per year, instead of once per year. The receipt dates will be January 25, May 25, and September 25. However, in view of the short time frame, the May 25, 1997 receipt date will be extended to June 25, 1997. o Applications for competing continuations (or renewals or Type 2s) of AREA grants will be accepted. Thus, recipients of AREA awards may apply for an AREA grant to continue their research project. o Applications for AREA grants may now include appendices, and must follow the instructions for submitting these in the Application for a Public Health Service Grant PHS 398 Form. o As part of the initial merit review, a streamlined review process, which is employed for the review of most NIH research grant applications, will be used. Under this process, reviewers are asked to identify the approximate upper half of applications. These applications are discussed at the review group meeting and receive a "priority score" ranging from "best" (100) to "average" (250-300), while the lower half of applications are normally not discussed nor given a priority score. Nevertheless, all applicants will receive summary statements which will consist of the written critiques of two or more assigned reviewers. o Applications must provide specific information regarding the investigator~s experience in supervising students in research, the institution~s student population, its success in training students who pursue careers in the biomedical and behavioral sciences, and its suitability for an AREA award. And, in the initial scientific review, applications will be evaluated on these factors in addition to the usual scientific merit considerations. o AREA grantees will be required to submit both annual Progress Reports and a Final Progress Report. The AREA Program Guidelines are provided as PA-97-052, elsewhere in the issue of the NIH Guide. The Guidelines give detailed information on the features of AREA grants, including eligibility criteria, "just-in-time" application procedures, and the names of NIH officials to contact regarding scientific issues. The Program Guidelines are also available on the NIH Homepage on the World Wide Web (http://www.nih.gov) under the Grants and Contracts sub-menu. INQUIRIES For further information regarding this notice, contact: Dr. Janet M. Cuca Office of Extramural Research National Institutes of Health 6701 Rockledge Drive, Room 6192 Bethesda, MD 20892 Telephone: (301) 435-2691 Email: janet_cuca@nih.gov $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NEW AHCPR POLICY ON SUBMISSION OF REVISED APPLICATIONS NIH GUIDE, Volume 26, Number 12, April 11, 1997 P.T. 34; K.W. 1014004 Agency for Health Care Policy and Research Beginning with the October 1997 receipt date, the Agency for Health Care Policy and Research (AHCPR) will no longer consider any A3 or higher amendments to an application. Further, regardless of the number of amendments, AHCPR will not accept a revised (amended) application that is submitted later than two years beyond the receipt date of the initial, unamended application. This new policy applies to all mechanisms (e.g., R01, R03, R18) and is consistent with the NIH policy on amended/revised applications announced in the NIH Guide, Vol. 25, No. 19, June 14, 1996. A significant amount of applicant and review resources are devoted to revised (amended) applications. AHCPR believes that after two years, the research issues may be less timely and relevant to AHCPR priorities. Thus, applicants should reconsider their research plans, redesigning them to take into account more current and relevant information. The policy limiting the number of amendments to two allows principal investigators sufficient time to generate preliminary data if they are required as suggested by reviewers and to consider new findings. INQUIRIES Questions or comments concerning this policy may be directed to: Patricia Thompson, Ph.D. AHCPR Referral Office Agency for Health Care Policy and Research Telephone: (301) 594-1437, Extension 1607 FAX: (301) 594-0154 $$N4 END ************************************************************ $$N5 BEGIN ********************************************************** AHCPR STREAMLINES PROCESS FOR SUMMARY STATEMENTS OF REVIEWS OF GRANT APPLICATIONS NIH GUIDE, Volume 26, Number 12, April 11, 1997 P.T. 34; K.W. 1014006 Agency for Health Care Policy and Research The Agency for Health Care Policy and Research (AHCPR) is streamlining its process for preparing summary statements of reviews of grant applications. Changes are designed to improve the timeliness of information for AHCPR program decisions and for useful critiques to applicants. Resource constraints make it difficult for AHCPR to continue providing comprehensive, integrated summary statements of reviews in a timely manner. The planned changes have been reviewed by AHCPR internal and external grants streamlining work groups and recommended for implementation. Changes in the AHCPR process are consistent with streamlined review systems implemented by NIH, which have been favorably received by applicants and reviewers. Effective with the October 1997 application receipt cycle, AHCPR will begin to implement a streamlined system for preparation of summary statements. The transition phase is expected to take two review cycles; full implementation will begin with the June 1998 application receipt cycle. During this transition, reviewers will be oriented to the new process, and refinements to the system will be made as needed. The implementation of this process will not affect how applicants prepare or submit their applications. Applicants should expect the summary statement of the review of applications to appear in a different format than previously. The new format will consist of a summary of the review group's discussion (when applicable), a description of the proposed project from the investigator's abstract, and the reviewers' individual critiques. INQUIRIES For additional information about AHCPR's new process for preparing summary statements, contact the Office of Scientific Affairs, AHCPR, at (301) 594-1449. $$N5 END ************************************************************ $$N6 BEGIN ********************************************************** ACUTE INFECTION AND EARLY DISEASE RESEARCH NETWORK - REMINDER NIH GUIDE, Volume 26, Number 12, April 11, 1997 PA NUMBER: PAR-96-060 P.T. 34; K.W. 0715008, 0765033, 0745000, 0715125 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: July 21, 1997 Application Receipt Dates: September 1, 1997; September 1, 1998 This is a reminder of the next application receipt dates for the Acute Infection and Early Disease Network (AIEDRN), PAR 96-060, which was published in the NIH Guide, Vol. 25, No. 1, June 28, 1996. ADDENDA The 25 page limitation for items A-D indicated in the grant application form PHS 398 (rev. 9/95) does not apply to the applications in response to this PA. The total number of pages for items A-D may not exceed 60 pages, including all tables and figures. The NIH Policy Update on Acceptance for Review of Unsolicited Applications that Requires More Than $500,000 Direct Cost for Any One Year does not apply to solicited applications such as the one identified under this Program Announcement. However, it is recommended that investigators submitting grant applications requesting $500,000 or more in direct costs notify NIAID program staff (see INQUIRIES), and to identify, in the cover letter sent with the application, the name of the NIAID contact. The duration of the awards will be four years. INQUIRIES Direct inquiries regarding programmatic issues to: Frederick H. Batzold, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2B27, MSC 7620 Bethesda, MD 20892-7620 Telephone: (301) 496-8214 FAX: (301) 480-4582 Email: fb10c@nih.gov $$N6 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN DK-97-010 FULL-TEXT ************************************** GENE THERAPY CORE CENTERS NIH GUIDE, Volume 26, Number 12, April 11, 1997 RFA AVAILABLE: DK-97-010 P.T. 04; K.W. 0745032, 1002019, 0715135, 0715085 National Institute of Diabetes and Digestive and Kidney Diseases Cystic Fibrosis Foundation Letter of Intent Receipt Date: January 12, 1998 Application Receipt Date: February 10, 1998 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Cystic Fibrosis Foundation invite applications for Core Center Grants to support gene therapy research on cystic fibrosis and other genetic diseases of interest to NIDDK. Core Centers will provide shared resources to enhance the efficiency of research and foster collaborations within and among institutions with strong existing bases of research relevant to gene therapy. This program is intended to foster research toward the goal of gene therapy for cystic fibrosis. Therefore, applicants should propose a central focus on gene therapy for cystic fibrosis. However, many common principles are involved in the development of safe methods for targeting and achieving long-term expression of therapeutic genes for most genetic disease. Therefore, Core Center resources may also be made available to scientists developing gene therapy approaches for genetic endocrine, metabolic, digestive, liver, kidney, urologic and hematologic diseases. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Gene Therapy Core Centers, is related to the priority area of Chronic Diseases. 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: 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review consideration and award criteria for this solicitation may be obtained electronically through the NIH Grant Line (dataline (301) 402-2221), the NIH Gopher (gopher.nih.gov), the NIH Home Page (http:\\www.nih.gov), by mail and e-mail from the program contact listed below. Dr. Catherine McKeon Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 5AN.18B Bethesda, MD 20892-6600 Telephone: (301) 594-8810 FAX: (301) 480-3503 Email: McKeonC@ep.niddk.nih.gov $$R1 END ************************************************************ $$P1 BEGIN PA-97-052 FULL-TEXT ************************************** ACADEMIC RESEARCH ENHANCEMENT AWARD NIH GUIDE, Volume 26, Number 12, April 11, 1997 PA AVAILABLE: PA-97-052 P.T. 34; K.W. 1014006, 0710030, 0404000 National Institutes of Health PURPOSE The National Institutes of Health (NIH) is continuing to make a special effort to stimulate research in educational institutions that provide baccalaureate training for a significant number of the Nation's research scientists but that have not been major recipients of NIH support. Since Fiscal Year (FY) 1985, Congressional appropriations for the NIH have included funds for this initiative, which NIH has implemented through the Academic Research Enhancement Award (AREA) program and an annual Request For Applications. Since it is anticipated that funds will continue to be available each year, the NIH is now inviting applications for AREA grants through a standing, ongoing Program Announcement. AREA funds are intended to support new or ongoing health-related research projects proposed by faculty members of eligible institutions. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Academic Research Enhancement Award, is related to the priority areas of biomedical and behavioral science research. 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 202-512-1800). INQUIRIES The PA contains detailed, specific information about the AREA program research objectives, application procedures, review considerations, award criteria and, for each NIH Institute or Center, a brief description of its areas of scientific interest and the name of a program contact person. The PA may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. Applicants should also consult the list of schools and "other academic components" that are ineligible for an AREA award in FY 97 because the amount of monies they have received exceeded the eligibility requirements is available on the NIH Home Page. 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 educational 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: Janet M. Cuca, Ph.D. Office of Extramural Research National Institutes of Health 6701 Rockledge Drive, Room 6192 Bethesda, MD 20892-7910 Telephone: (301) 435-2691 FAX: (301) 480-8443 Email: janet_cuca@nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-97-053 FULL-TEXT ************************************** ENTERIC AND HEPATIC INFECTIOUS DISEASES NIH GUIDE, Volume 26, Number 12, April 11, 1997 PA AVAILABLE: PA-97-053 P.T. 34; K.W. 0715085, 0715125, 0710070, 0765033 National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite investigator-initiated research project (R01), FIRST (R29), and small research grant (R03) applications in research emphasis areas focused on infection and disease caused by enteric and hepatic pathogens. The PA identifies organism-specific gaps and opportunities with potential to lead to new diagnostics, vaccines, therapies, or other control strategies. Of special interest are: the protective immune response and strategies to invoke it; mechanisms determining the outcome of infection as well as mechanisms of pathogenesis and persistence; variability and genomic organization and component structure/function; modes of transmission, reservoirs of infection, and molecular epidemiology; and application of new technologies and scientific advances to vaccine and therapy development. Multi-disciplinary research is 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 PA, "ENTERIC AND HEPATIC INFECTIOUS DISEASES," is related to the priority area of immunization and infectious diseases and chronic and disabling diseases. 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) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). 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), the NIH GOPHER (gopher@nih.gov), and the NIH website (http://www.nih.gov), and by mail and email from the following: Leslye D. Johnson, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3A22 MSC 7630 Bethesda, MD 20892-7630 Telephone: (301) 496-7051 FAX: (301) 402-1456 Email: lj7m@nih.gov $$P2 END ************************************************************ $$P3 BEGIN PAR-97-054 FULL-TEXT ************************************* ENVIRONMENTAL/OCCUPATIONAL MEDICINE ACADEMIC AWARD NIH GUIDE, Volume 26, Number 12, April 11, 1997 PA NUMBER: PAR-97-054 P.T. 34; K.W. 0725020 National Institute of Environmental Health Sciences Application Receipt Date: July 15, 1997 PURPOSE The National Institute of Environmental Health Sciences (NIEHS) announces its eighth national competition for Environmental/Occupational Medicine Academic Awards (E/OMAA), which last appeared in the NIH Guide to Grants and Contracts April 26, 1996, Volume 25, Number 13. The award will have the dual purpose of improving the quality of environmental/occupational medicine curricula and of fostering graduate research careers in environmental/occupational medicine. For the purposes of the E/OMAA, the term environmental/occupational medicine refers to the area of medicine concerned with the development of knowledge and the application of knowledge directed at the diagnosis, treatment, and prevention of adverse human health effects from environmental/occupational exposures to toxic agents. This includes adverse health effects in infants, children, and adults who are at risk of developing such health problems and the reduction of preventable complications or disability in persons of all ages who have already developed such diseases. HEALTH PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Environmental/Occupational Medicine Academic Award, is related to the priority area of environmental health. Potential applicants may obtain a copy of "Health 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), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Annette G. Kirshner, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 104 Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-0488 FAX: (919) 541-2843 Email: kirshner@niehs.nih.gov $$P3 END ************************************************************ From owner-sci-resources@net.bio.net Sun Apr 13 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 12 April 1997 Date: 14 Apr 1997 14:47:34 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 120 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5iu8lm$b1i@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending April 12, 1997. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Letter Title: Dear Colleague Letter - Engineering File size (bytes): 4696 STIS Filename: eng972.txt Document Type: News Title: SCIENCE AND TECHNOLOGY CENTERS STIMULATE NEW APPLICATIONS OUT OF BASIC DISCOVERIES File size (bytes): 4946 STIS Filename: tip70408.txt Title: Science & Technology Centers Stimulate New Applications File size (bytes): 4911 STIS Filename: tip7048.txt Document Type: Press Release Title: NSF TO ADOPT NEW MERIT REVIEW CRITERIA File size (bytes): 3706 STIS Filename: pr9728.txt Title: EVOLUTION OF FISH ANTIFREEZE GENE SHEDS LIGHT ON CLIMATE HISTORY File size (bytes): 4524 STIS Filename: pr9729.txt Document Type: Program Guideline Title: Environment and Global Change Research Opportunities at the National Science Foundation (NSF 97-43) File size (bytes): 35654 STIS Filename: nsf9743.txt Document Type: Recruit Title: Director, Division of Electrical and Communications Systems File size (bytes): 6952 STIS Filename: vep973t.txt Title: Geophysicist (Program Director) File size (bytes): 6463 STIS Filename: vex9712.txt Title: Student Temporary Employment Program (STEP) File size (bytes): 4392 STIS Filename: vstep97.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Letter Title: REULIST -- Current List of REU Sites File size (bytes): 100757 STIS Filename: reulist.txt Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 112825 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Directory File size (bytes): 128006 STIS Filename: phnorg.txt Document Type: Program Guideline Title: NSF 97-87 - Faculty Early Career Development (CAREER) Program File size (bytes): 40685 STIS Filename: nsf9787.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf9787.txt, the text of your message should be as follows: get nsf9787.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9787.txt, you would enter: ftp> get nsf9787.txt 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". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Sun Apr 20 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 19 April 1997 Date: 20 Apr 1997 20:16:21 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 77 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5jem65$6ss@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending April 19, 1997. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Letter Title: Announcement of Fall 1997 Target Dates for Proposal Submissions File size (bytes): 3887 STIS Filename: nsf9786.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 22243 STIS Filename: cmmtg.txt Document Type: Letter Title: REULIST -- Current List of REU Sites File size (bytes): 99949 STIS Filename: reulist.txt Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 112828 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Directory File size (bytes): 128008 STIS Filename: phnorg.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov 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 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". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Sun Apr 20 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: BIOSCI/bionet miniFAQ & Fundraiser Date: 21 Apr 1997 16:56:37 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 240 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <199704200900.CAA25379@net.bio.net> NNTP-Posting-Host: net.bio.net (LAST REVISION: 30-JUL-95) This BIOSCI "miniFAQ" is designed to answer the questions that come up the *most frequently*. The main BIOSCI FAQ (Frequently Asked Questions) is accessible on the World Wide Web at URL http://www.bio.net/. If you can not find an answer to your question in this or other documentation, the BIOSCI technical support staff answers e-mail queries sent to biosci-help@net.bio.net We can only answer questions about the use of the newsgroups and mailing lists. We unfortunately do not have the staff to do Internet information searches or answer scientific questions. Please post those to the appropriate BIOSCI/bionet newsgroups. Contents: -------- 0) BIOSCI NEEDS YOUR SUPPORT!! 1) Using the WWW to access the BIOSCI/bionet newsgroups. 2) What to do about "spams," i.e., junk mail, ads, etc. 3) Examples of subscribing and unsubscribing to the mailing lists. 4) The BIOSCI user address and research interest directory. 0) BIOSCI NEEDS YOUR SUPPORT!! ------------------------------ BIOSCI's government funding has been expended, and we are now operating solely from advertising revenue that we have raised from our Web site at http://www.bio.net/. We need just a few minutes of your time to help us serve you. You can do two important things which will take very little time for you individually and will immensely help us continue to help you. First, please use our WWW system at http://www.bio.net/ to access the archives. You can post or reply to messages via your Web browser as described in item #1 below. Your usage helps attract sponsors. If you contact any of our sponsors, please be sure to thank them for supporting BIOSCI. It is critical for them to get this feedback if they are to continue their sponsorship for the long term. Second, if you work for a company or organization that provides products or services of interest to the biology community, please pass this message on to your marketing or marketing communications department or other appropriate group. Please ask them to help support BIOSCI by sponsoring our Web site and explain the uses and benefits of the system to the biology community. If they are interested, they can then contact us for further information at our tech support address, biosci-help@net.bio.net. 1) Using the WWW to access the BIOSCI/bionet newsgroups. -------------------------------------------------------- As of 10 December 1995, all BIOSCI/bionet full newsgroups are accessible through the World Wide Web (WWW) at URL http://www.bio.net. One can read and reply publicly or privately to both recent postings and archived messages through one's Web browser if it is configured properly to send e-mail. Each newsgroup is equipped with its own WAIS index. The main BIOSCI home page also has access to the BIO-JOURNALS Table of Contents database WAIS index and the BIOSCI user address database described in another item further below. 2) What to do about "spams," i.e., junk mail, ads, etc. ------------------------------------------------------- BIOSCI is a set of parallel USENET newsgroups (the "bionet" groups), mailing lists, and a hypermail archive at URL http://www.bio.net/. The same postings are distributed on all media (except for a small number of mailing-list-only groups at net.bio.net). Unfortunately it is becoming a despicable practice on the Internet (by a few people out to make a fast buck) to do automated mass postings to thousands of newsgroups and mailing lists. These attempts to grab free advertising are refered to as "spams" in the usual, somewhat boneheaded, net terminology. USENET is more susceptible to this practice, and many spams originate on the USENET groups and then are passed on to the mailing lists. However, spammers also get lists of mailing addresses and hit these too, so neither medium is immune. What should you do personally if you get junk mail? --------------------------------------------------- Just delete it and move on without reading it further. Filing a protest is becoming increasingly useless because spammers are often disguising the addresses where the messages are sent from. Unless you really understand Internet mail systems, your attempt at protest by sending replies to the message will often end up being sent to the address of an innocent person that the spammer is victimizing. What can BIOSCI/bionet do to protect its newsgroups? ---------------------------------------------------- The only solution currently available is to moderate the newsgroup. If this newsgroup is already moderated, then you are in good shape. Moderation protects the USENET distribution from about 95% of the spams that are being sent to date and protects the mailing lists completely. Moderation means, however, that someone has to take the time to review each message before it goes out. We have set up software here that simply allows the moderator to forward to an address at net.bio.net messages that (s)he wishes to have distributed. This takes no more time than that needed to read the message and pass it on, say about 1 min. per message. Most newsgroups currently have a discussion leader who is responsible for their newsgroup. The discussions leaders and their e-mail addresses are listed in the BIOSCI Information Sheet which is available on the Web at http://www.bio.net/. If a newsgroup is being hit with too many junk postings, please contact the discussion leader for that group and see if there is interest in moderating the group. Please do not assume that by simply posting a complaint to the newsgroup itself, anyone on the BIOSCI staff will act on your complaint. With close to 100 newsgroups to run, the BIOSCI staff has to rely on the discussion leaders of each newsgroup to report problems directly to us at biosci-help@net.bio.net. We will moderate any of our newsgroups if the discussion leader tells us that the readership of the group wishes to do so and if a moderator is willing to do the work. For most BIOSCI/bionet groups, this entails only a few minutes of work each day. Moderating a newsgroup will resolve probably 95% of the junk postings on the USENET distribution. Unfortunately there are easy ways for determined spammers to override the moderation mechanism on USENET, but we can protect our e-mail subscribers from unwanted postings if the newsgroup is moderated. You can also access our newsgroups over the WWW at URL http://www.bio.net. While this Web interface will not stop spammers from trying to post to the groups, this will give you yet another way, besides using USENET news, to keep the junk out of your personal mail files. For those of you with local USENET news systems, the Web interface will also give you faster access to new newsgroups and recent postings. 3) Examples of subscribing and unsubscribing to the mailing lists. ------------------------------------------------------------------ PLEASE NOTE: The BIOSCI management does NOT act on subscription/unsubscription requests that are posted improperly to the newsgroups and mailing lists. People who do this only bother everyone on the lists to no avail. Please be sure to follow the proper procedures below. Gory details are in the BIOSCI Information sheets on the Web at http://www.bio.net. Below we give an example utilizing the METHODS-AND-REAGENTS list at both of our two BIOSCI sites: Users in the Americas and Pacific Rim countries who use the BIOSCI ------------------------------------------------------------------ node at computer net.bio.net: ---------------------------- A) Determine the "listname" which is the <=8 character mail address ^^^^^^^^^^^^^ for the group. These can be found in the BIOSCI Info. Sheet. For the METHODS-AND-REAGENTS group the mailing address is methods@net.bio.net. The listname is the portion of the address to the left of the @ sign, i.e., "methods". The listname is used with the "subscribe" and "unsubscribe" commands illustrated below. B) Mail all commands in the body of a mail message addressed to biosci-server@net.bio.net. Do NOT send commands to the newsgroup posting addresses! Leave the Subject: line blank, any text on it will be ignored. C) In the body of your message put one or more of the following commands with an "end" command on the last line, e.g., subscribe methods unsubscribe methods end Do NOT put your e-mail address or other text on these lines. The server only allows you to cancel your subscription if the address on your mail header matches the address on our mailing list. Please ask for help at biosci-help@net.bio.net if your address has changed, e.g., if you know you are on the list but the server tells you that you are not a member. Users in Europe, Africa, and Central Asia who use the BIOSCI node at -------------------------------------------------------------------- computer daresbury.ac.uk (also known as dl.ac.uk): ------------------------------------------------- To subscribe and unsubscribe to/from the BIOSCI lists, you need to specify the full USENET newsgroup name with "bionet-news." prepended. The USENET newsgroup names are listed in the BIOSCI Information sheet on the Web at http://www.bio.net/. For the METHODS-AND-REAGENTS list the USENET newsgroup name is bionet.molbio.methds-reagnts, thus the appropriate commands are sub bionet-news.bionet.molbio.methds-reagnts unsub bionet-news.bionet.molbio.methds-reagnts These commands are included in a message addressed to mxt@dl.ac.uk, NOT to the newsgroup mailing addresses. As usual, include the text in the body of the message as text on the Subject: line is ignored. To unsubscribe from all the lists at the UK node, use unsub bionet-news Please note that if the address in the list is different than the one in your mail message header, you will not be able to unsubscribe by this method. If you have problems, please mail biosci@daresbury.ac.uk. 4) The BIOSCI user address and research interest directory. ----------------------------------------------------------- Please take this opportunity to add your name, address, and research interest information to the BIOSCI User Address Database if you have not already done so. You can fill out the address form directly through our Web page at URL http://www.bio.net/adrform.html. The address database is reindexed nightly for WWW access (the URL is http://www.bio.net/). If you are not directly on the Internet but can reach it by e-mail, please use our waismail server to access the user directory. waismail use is described above. You can also request a user address form by e-mail from biosci-help@net.bio.net. Please check your database entry from time-to-time to see if your address information is still up-to-date. Because of our limited personnel resources, we ask that you resubmit a *complete* form to revise your entry; we only replace complete entries and do not have resources to edit old forms. Sincerely, Dave Kristofferson BIOSCI/bionet Manager biosci-help@net.bio.net From owner-sci-resources@net.bio.net Mon Apr 21 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH MAIL No E-Guide for 4/18 Date: 21 Apr 1997 22:12:41 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 5 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5jhhc9$8iv@net.bio.net> NNTP-Posting-Host: net.bio.net $$MAIL BEGIN *********************************************************** There will be no NIH Guide for 04/18/97, the next issue will be 04/25/97. Thank you. $$MAIL END************************************************************** $$MAIL END************************************************************** From owner-sci-resources@net.bio.net Sun Apr 27 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-97-005 - V26(13) 04/25/97 Date: 28 Apr 1997 16:00:05 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 771 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5k3a5l$mj5@net.bio.net> NNTP-Posting-Host: net.bio.net TISSUE ENGINEERING, BIOMIMETICS, AND MEDICAL IMPLANT SCIENCE NIH GUIDE, Volume 26, Number 13, April 25, 1997 RFA: HL-97-005 P.T. 34; D.W. 0706000, 0740027, 0710030 National Heart, Lung, and Blood Institute National Institute of Dental Research National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: July 1, 1997 Application Receipt Date: August 25, 1997 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" PROCEDURES. THIS COMPLETE RFA INCLUDES THE MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS WHICH MUST BE USED WHEN PREPARING APPLICATIONS TO THIS RFA. PURPOSE The National Heart, Lung, and Blood Institute (NHLBI), the National Institute of Dental Research (NIDR), and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invite applications to design and engineer natural and novel approaches for the repair, restoration, and replacement of tissues and whole organs based on a comprehensive scientific understanding of biological structures and their function. The overall goal of this RFA is to facilitate multidisciplinary research, design, and training aimed at development of a new generation of natural and synthetic medical implants, including totally biological solutions for instances in which synthetic implants have historically been used. Research projects focusing on devices intended primarily for short term use, specifically 24 hours or less (e. g., hemodialysis and cardiopulmonary bypass), will not be considered to be responsive to this RFA. This Program will support both design directed and hypothesis driven research applicable to the missions of NHLBI, NIDR, and NIAMS. Applicants are encouraged to indicate to which institute, NHLBI, NIDR, or NIAMS, their application should be directed. 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, "Tissue Engineering, Biomimetics, and Medical Implant Science", is related to the priority areas of heart disease and stroke, oral health, immunization and infectious diseases, cancer, diabetes, and musculoskeletal injuries and 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 017-001-00474-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit organizations, public and private, such as universities, colleges, companies, 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. Applications from foreign institutions will not be accepted. However, subcontracts to foreign institutions are allowable, with sufficient justification. MECHANISMS OF SUPPORT Support of this program will be through NHLBI, NIDR, and NIAMS. The mechanisms available for support of applications to this RFA include individual research project grants (R01) and collaborative R01 projects. In the case of collaborative R01 projects, a group of investigators may submit simultaneously at least 3, and no more than 5, R01s with a common theme. Collaborative R01 projects may be from a single institution or several institutions, may include shared resources, and must demonstrate the interdependence of the individual components. All R01 applications, both collaborative and individual, must provide evidence that the research will be multidisciplinary in nature; applicants are encouraged to specify how the research will further the objectives of both NHLBI, NIDR, and NIAMS. Specific RO1 application instructions are modified to include "MODULAR GRANT" AND "JUST-IN-TIME" streamlining efforts being examined by the NIH. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budget information is required under this approach. The just-in-time procedure allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, applicant institutions, reviewers, and NIH staff. For this RFA, funds must be requested in $25,000 direct cost modules, up to a maximum of eight modules ($200,000 direct costs) per year, per RO1, whether individual or collaborative. A feature of the modular grant is that no escalation is provided for future years, and all anticipated expenses for all years of the project must be included within the number of modules being requested. Only limited budgetary information will be required and any budget adjustments made by the Initial Review Group will be in modules of $25,000. Instructions for completing the Biographical Sketch have also been modified. In addition, Other Support information and the application Checklist page are not required as part of the initial application. If there is a possibility for an award, necessary budget, Other Support and Checklist information will be requested by NHLBI, NIDR, or NIAMS staff following the initial review. The APPLICATION PROCEDURES section of this RFA provides specific details of modifications to standard PHS application kit procedures. Upon initiation of the program, NHLBI will sponsor annual meetings, most likely to be held in Bethesda, Maryland, to encourage exchange of information among investigators who participate in this program. In considering the number of modules to request, budget projections should include travel funds that will allow principal investigators, other key research scientists, and young investigators to participate in these meetings. Applicants are expected to furnish their own estimates of time required to achieve the objectives of the proposed research project. Since a variety of approaches would represent valid responses to this RFA, it is anticipated that there will be a range of costs among individual grants awarded. There may be another open competition at the end of this program. If not, future unsolicited competing applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. It is anticipated that support for this program will begin in April 1998. Administrative adjustments in project period and/or amount may be required at the time of the award. FUNDS AVAILABLE NHLBI and NIDR will each allocate approximately $2 million in direct costs (approximately $3 million in total costs) to support projects >From this RFA during FY 98. It is anticipated that about 4 or 5 collaborative R01 projects consisting of 3 to 5 individual R01s per project will be awarded, and that in addition 6 to 8 individual R01s will be awarded, provided that the applications are of high scientific merit. Although NIAMS has an interest in collaborative projects, for this RFA only, NIAMS will allocate approximately $400,000 in direct costs (approximately $600,000 in total costs) for FY 98 to support 2 to 3 individual R01's, provided that the applications are of high scientific merit. It is possible that a collaborative project in a topic area that overlapped the interests of NIAMS and NIDR could be co-funded by these two institutes if the project was of high scientific merit. The maximum total costs for the first year of a collaborative R01 project are $1 million. Direct costs will be awarded in modules of $25,000, less any overlap or other necessary administrative adjustments. Facilities and administrative (indirect) costs will be awarded based on the negotiated rates. Applicants may request up to five years of support. Although this program is provided for in the financial plans of NHLBI, NIDR, and NIAMS, the award of grants pursuant to this RFA is contingent upon the receipt of a sufficient number of high quality applications and the availability of funds for this purpose. Policies that govern research grant programs of the National Institutes of Health will prevail. RESEARCH OBJECTIVES Background Biomimetics is an emerging interdisciplinary field that combines information from the study of biological structures and their functions with physics, mathematics, chemistry and engineering in the development of principles that are important for the generation of novel synthetic materials and organs. Tissue engineering is the application of these principles for the restoration, repair, replacement and assembly of functional tissues and organs. Medical implant science is the application of scientific and clinical principles to the design, fabrication, and evaluation of medical implants. In the area of heart, lung, and blood diseases, principles >From tissue engineering, biomimetics, and medical implant science have been applied to the development and design of mechanical and bioprosthetic heart valves, prosthetic vascular grafts, vascular stents, infusion pumps, pacemakers, and implantable cardiac defibrillators. In the area of oral, craniofacial, and dental disease, principles from tissue engineering, biomimetics, and medical implant science are applied to developing dental and facial implants, temporomandibular joint (TMJ) prostheses, formation of bone matrix substitutes, and artificial replicas of bone, skin, and mucosa. In the area of musculoskeletal injury and disease, principles from tissue engineering, biomimetics, and medical implant science are applied to developing orthopaedic implants/prostheses, and assessing the biologic response to formation of bone and connective matrix substitutes and artificial replicas of bone, connective tissues, and skin. Advances in engineering materials for such uses include new biodegradable polymers for controlled, site-directed delivery of drugs, gene vectors, antisense oligonucleotides, and growth factors that stimulate angiogenesis, revascularization, and repair, or inhibit thrombosis, cellular hyperplasia, and infection; synthetic biodegradable polymeric scaffolds for construction of heart valve leaflets from autologous cells; construction of vascular grafts from autologous cells grown on synthetic templates or scaffolds; new polymers for guided tissue regeneration used in treating periodontal disease and bone and connective tissue defects; demineralized allogenic bone matrix for craniofacial and other bone reconstruction procedures; coral-based hydroxyapatite replicas for reconstruction of alveolar ridges and other osseous defects; dermal/epidermal skin substitutes; fibrin-based sealants to weld tissues and blood vessels in a variety of surgical settings; and synthetic, biodegradable polymeric scaffolds for bone, cartilage, ligament, tendon, and meniscal repair from autologous cells. Most implants have resulted in improving the quality of life and saving or prolonging lives. However some implants, such as TMJ prostheses and certain heart valve designs, have failed catastrophically. For orthopaedic implants, osteolysis has emerged as a major problem. Rationale There is a need for a firmer scientific and technical basis in order to develop the next generation of medical implants that are safe, reliable, "smart", and long-lasting. Integrated and multidisciplinary research should advance our understanding of biological systems and provide the bases for the design and development of novel synthetic medical materials that are compatible with the environment of the host and significantly increase the functional lifetime of implants. Future advances in this field will require materials and computer scientists, physicists, bioengineers, clinicians, biologists, and industry working together towards a shared vision rather than pursuing their separate objectives as has commonly been the case. Additional factors that have inhibited progress in tissue engineering, biomimetics, and medical implant science are the current concerns of medical device manufacturers over medical liability, regulatory issues, and public payment policy for experimental implants. In response to the scientific opportunities and public concerns in this area, the National Institutes of Health (NIH) convened two workshops, October 16-17, 1995 and September 24-26, 1996, bringing together more than 150 university, industry, and government specialists in biomaterial, biomimetics, tissue engineering, medical implant, biological and clinical sciences. These experts were charged with recommending research directions that would advance this important field. They agreed that progress in characterization and rational synthesis of advanced biomaterials, together with advances in understanding the molecular basis of biological responses, has set the stage for an integrated approach and ultrastructural basis for advancing biomaterials, tissue engineering, biomimetics, and medical implant science. The specific research and career recommendations of these two groups and which guide this RFA were: o Designing and developing biomaterials and implants endowed with desirable biological structures and functions for the treatment of various disorders. This will involve multidisciplinary approaches to synthesizing new, perhaps "smart" or self-monitoring, biomaterials designed for cell, drug, and gene based therapies. o Advancing the scientific basis for predicting quality and lifetime of implants, and improving the efficiency of assessing human acceptance of implants. Potential approaches include a focus on reliability, accelerated testing, failure analysis, imaging models, biosensors, and improved understanding of the tissue implant interface. o Fostering biomimetics, new tissue engineering processing and advanced manufacturing technologies. o Enhancing research careers with new cross-disciplinary strategies in tissue engineering, biomimetics and medical implant science. One intent of this RFA is to encourage and promote multidisciplinary research on tissue engineering, biomimetics, and medical implant science. Applicants for both individual and collaborative R01s are, therefore, encouraged to include on research teams individuals whose expertise broadens the scope of the scientific approach of the team. The type of expertise and justification for addition of the individual, proposed percent effort, biographical sketch, and letters of agreement to join the team from the applicant and his/her supervisor in the event that the application is funded, must be provided in the application. An additional intent of the RFA is to encourage new investigators to enter this area of research. These may be senior investigators who have no previous experience in this field, or scientists from any field who are at the beginning stages of their research careers. Applicants are encouraged to include either category of new investigator on their research team. In addition, applications are encouraged from new investigators of either category. PROPOSED RESEARCH The following research topics are provided as examples, and are not intended to be inclusive or restrictive: o explore novel scientific bases for designing and developing medical implants (e.g., autogeneration of a coronary artery, a tooth organ, or articular cartilage); o development of advanced methodologies for evaluating the cellular responses to implants, such as fibrous encapsulation, osteolysis, and infection; identification of inflammatory mediators; use of in vitro and in vivo models to predict short- and long-term human responses; understanding the biology of biointegration, biofilm formation, and osteolysis; o development of computer/mathematical modeling systems for evaluation of TMJ and other joint biomechanics; creation of a new generation of biomaterials which will permit effective repair or replacement of bone, cartilage, and other connective tissue structures in the TMJ and other joints and their associated muscles; o development of heart valves, small-diameter blood vessels, and other organs and tissues for use in the systemic, pulmonary, and craniofacial circulations, using autologous cells in bioreactors, and synthetic biodegradable matrices, scaffolds, mandrels, or other innovative means; o design of matrices that would promote the formation of facial musculature, neurological pathways, bone, connective tissues, and skin for use in the repair of orofacial, cardiovascular, pulmonary, and musculoskeletal disorders; o use of high resolution cellular and molecular imaging techniques to evaluate the interface between implants and their biological environment, including methods for imaging dynamic and living structures; o use of computational fluid mechanics for improved design of implants for the management of cardiovascular, pulmonary, hematologic, and musculoskeletal disorders; o advancement of the fundamental knowledge of biomineralization, including biomineralization precursor phases, microstructure formation, templating, growth, and morphogenesis of bones and teeth; o development, for drug and cell delivery in applications to tissue engineering, biomimetics, and medical implant science, of "smart" biomaterials that can act as molecular switches to control biological functions and sense environmental changes (e.g., delivery of iron chelators for the treatment of conditions characterized by iron overload); delivery of growth factors, cytokines, chemotactic agents, morphogenic proteins, and other biological factors influencing the repair and regeneration of myocardium, the orofacial complex, skin and musculoskeletal tissues; o development of cell-specific systems for gene delivery applicable to oral, craniofacial, and skin and musculoskeletal disorders (e.g., salivary gland disorders, orofacial neoplasias, or osteogenesis imperfecta); o use of combinatorial chemistry for rapid development of lead compounds for basic research and drug discovery applied to tissue engineering, biomimetics, and medical implant science, and development of time and site specific systems for their delivery; o identification of stem cells and immature committed cells for tissue repair other than for burns or other traumatic injury; development of culture systems (e.g., biodegradable scaffolds, templates, or extracellular matrix analogues) that allow cells to adopt their three-dimensional architecture and to be suitable for transplantation or repair; and o investigations of the molecular basis of tissue maintenance and regeneration as applied to tissue engineering, biomimetics, and medical implant science (e.g. cell-cell interactions, extracellular matrix, or apoptosis), in instances other than following burns or other traumatic injury. All submissions must be pertinent to the objectives of the RFA. 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 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, Vol. 23, No. 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff listed under INQUIRIES. LETTER OF INTENT Prospective applicants are asked to submit, by July 1, 1997, a letter of intent. This should include the number and title of this RFA (HL-97-005; "Tissue Engineering, Biomimetics, and Medical Implant Science"), a descriptive title of the proposed research, the names, addresses, and telephone numbers of the Principal Investigator(s), and the identities of other key personnel and participating institutions. The letter of intent is to be addressed to Dr.C. James Scheirer at the address listed under APPLICATION PROCEDURES. 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 is helpful in planning for the timely review of the applications. It allows NHLBI, NIDR, and NIAMS staff to estimate the potential review workload and to avoid possible conflicts of interest in the review. APPLICATION PROCEDURES Prospective applicants are encouraged to communicate with program and grants management staff of NHLBI's, NIDR's and NIAMS's Divisions of Extramural Research as early as possible in the planning phase of application preparation. Advice and suggestions by staff may materially assist applicants to ensure that the objectives and structure and the budget format are acceptable. Applications must be prepared on form PHS 398 (Rev. 5/95). An Application for a PHS Grant is available at most institutional business or grants and contracts offices and may be obtained from the Office of Grants Information, Division of Research Grants (DRG), National Institutes of Health, Suite 3032, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone: 301/ 435-1099). The instructions accompanying Form PHS 398 must be followed as far as possible. THE RFA LABEL FOUND 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, "Tissue Engineering, Biomimetics, and Medical Implant Science" HL-97-005," MUST BE TYPED ON LINE 2 OF THE FACE PAGE OF THE APPLICATION FORM AND THE YES BOX MUST BE MARKED. APPLICANTS WITHOUT PRIOR R29 OR R01 SUPPORT, AND NEW INVESTIGATORS TO THE FIELD, ARE STRONGLY ENCOURAGED TO IDENTIFY THEIR STATUS AS A NEW INVESTIGATOR IN A COVER LETTER AND IN THE APPLICATION. This RFA is restricted to R01 grants. All applications must be submitted as modular grants. The modular grant concept establishes specific modules (increments) in which direct costs may be requested, and the maximum level for requested direct cost. Only limited budgetary information is required in the application; a detailed budget need not be provided. Sample budgets and justification page will be provided upon request or following the submission of a letter of intent. In the case of collaborative R01 projects, the individual R01s comprising the project must be submitted as one packet accompanied by a cover letter which lists the principal investigators of each R01, their institution, and their project title, and defining how and why the individual participants propose to collaborate. BUDGET INSTRUCTIONS The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD Do not complete Form Page 4 of the PHS 398 (rev 5/95). It is not required nor will it be accepted at the time of application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT Do not complete the categorical budget tables on Form page 5 of the PHS 398 (rev. 5/95). Only the requested total direct costs line for each year must be completed based on the number of $25,000 modules being requested. Applicants may not request a change in the amount of each module. A maximum of EIGHT modules ($200,000 direct costs) per year may be requested and each applicant may request up to FIVE years of support for this RFA. Direct cost budgets will remain constant throughout the life of the project (i.e., the same number of modules requested for all budget periods). Any necessary escalation should be considered when determining the number of modules to be requested. However, in the event that the number of modules requested must change in any future year due to the nature of the research proposed, appropriate justification must be provided. Total Direct Costs for the Entire Proposed Project Period should be shown in the box provided. o BUDGET JUSTIFICATION Budget justifications should be provided under "Justifications" on Form Page 5 of the PHS 398. List the names, role on the project and proposed percent effort for all project personnel (salaried or unsalaried) and provide a narrative justification for each person based on his/her role on the project. Identify all consultants by name and organizational affiliation and describe the services to be performed. Provide a general narrative justification for individual categories (equipment, supplies, etc.) required to complete the work proposed. More detailed justifications should be provided for high cost items. Any large one-time purchases, such as equipment requests in excess of $10,000, must be accommodated within these limits. The budget should include a request for funds for attendance at an annual meeting of the principal investigators and other key investigators including young investigators and investigators new to the field. o CONSORTIUM/CONTRACTUAL COSTS - If collaborations or subcontracts are involved that require transfer of funds from the grantee to other institutions, it is necessary to establish formal subcontract agreements with each collaborating institution. A letter of intent >From each collaborating institution should be submitted with the application. Only the percentage of the consortium/contractual TOTAL COSTS (direct and indirect) relative to the total DIRECT COSTS of the overall project needs to be stated at this time. The following example should be used to indicate the percentage cost of the consortium, "The consortium agreement represents 27% of overall $175,000 direct costs requested in the first year.". A budget justification for the consortium should be provided as described in the "Budget Justification" section above (no Form Page 5 is required for the consortium). Please indicate whether the consortium will be in place for the entire project period and identify any future year changes in the percentage relative to the parent grant. If there is a possibility for an award, the applicant will be requested to identify actual direct and indirect costs for all years of the consortium. Please note that total subcontract costs need not be calculated in $25,000 modules. However, when subcontract funds are added to the parent grant budget, the total direct cost amount must be included in the number of $25,000 modules requested. o BIOGRAPHICAL SKETCH - A biographical sketch is required for all key personnel, following the modified instructions below. Do not exceed the two-page limit for each person. Complete the educational block at the top of the form page; List current position(s) and those previous positions directly relevant to the application; List selected peer-reviewed publications directly relevant to the proposed project, with full citation; The applicant has the option to provide information on research projects completed and/or research grants participated in during the last five years that are relevant to the proposed project. o OTHER SUPPORT - Do not complete the "Other Support" pages (Form Page 7). Selected other support information relevant to the proposed research may be included in the Biographical Sketch as indicated above. Complete Other Support information will be requested by NHLBI staff if there is a possibility for an award. o CHECKLIST - No "Checklist" page is required as part of the initial application. A completed Checklist will be requested by staff if there is a possibility for an award. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applicants from institutions which 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. In such a case, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. APPLICATIONS NOT CONFORMING TO THESE GUIDELINES WILL BE CONSIDERED UNRESPONSIVE TO THIS RFA AND WILL BE RETURNED WITHOUT FURTHER REVIEW. Submit a signed, typewritten original of the application, including a cover letter (if appropriate) and three signed photocopies, in one package to: Division of Research Grants (DRG) National Institutes of Health 6701 Rockledge Drive, Room 1040-MSC 7710 Bethesda, MD 20892 (use 20817 for Federal Express) At the time of submission, three additional copies of the application must also be sent to: Dr. C. James Scheirer Division of Extramural Affairs National Heart, Lung, and Blood Institute Rockledge Building 2, Room 7220 6701 Rockledge Drive Bethesda, MD 20892 Applications must be received by August 25, 1997. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by NHLBI, NIDR, and NIAMS. Incomplete applications will be returned to the applicant without further consideration. If NHLBI, NIDR, and NIAMS staff find that the application is not responsive to the RFA, it will be returned without further consideration. Remaining applications may be subjected to a streamlined review process by a Special Emphasis Panel convened by NHLBI, NIDR, and NIAMS Scientific Review Offices, to determine their scientific merit relative to other applications received in response to the RFA. The roster of reviewers for the RFA will be available on the NHLBI home page approximately four weeks prior to the scheduled review date. Applications determined to be meritorious will be evaluated for scientific and technical merit by the review committee, be discussed and receive a priority score. All other applications will not be discussed or scored. The initial review group will evaluate all R01s, whether single or collaborative, as individual investigator-initiated grant applications. Additionally the IRG will comment on the overall strength and likelihood of effective collaboration of each collaborative program, and on the multidisciplinary nature of both individual and collaborative R01s. Each R01 within a collaborative program will receive a priority score. Secondary review of the applications will be conducted by the National Heart, Lung and Blood Advisory Council (NHLBAC), the National Advisory Dental Research Council (NADRC), and the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council (NAMSAC). Major factors to be considered in the evaluation of the applications include: o the degree of innovativeness of the approaches proposed; o the likelihood of success of the research objectives proposed; o the scientific merit of all components of the proposed research project, including its significance, originality, feasibility, and experimental design; o the degree to which the project will represent collaborative research among investigators from different disciplines within an individual R01, or among individual R01s submitted as a collaborative R01 project, and the likelihood of effective collaboration among the investigators; o the qualifications and research experiences of the collaborating investigators; o the likelihood that the proposed research will advance the fund of knowledge in tissue engineering, biomimetics, and medical implant science for application to heart, lung, and blood diseases, oral health, musculoskeletal and skin diseases, as well as other fields; and o the ability to recruit individuals from appropriate study populations (i.e., women, subpopulations of minorities and disabled individuals) as defined by the NIH guidelines along with provisions for their protection from research risks and the humane treatment of animal research subjects that may be used. The personnel category will be reviewed for appropriate staffing based on the requested percent effort and justification provided. The direct costs budget request will be reviewed for consistency with the proposed methods and specific aims. Any budgetary adjustments recommended by the reviewers will be in $25,000 modules. The duration of support will be reviewed to determine if it is appropriate to ensure successful completion of the requested scope of the project. AWARD CRITERIA Applications will receive a secondary level of review by NHLBI's, NIDR's, and NIAMS's Advisory Councils in May 1998. The earliest anticipated date of award is July 1998. Applicants should be aware that, in addition to scientific merit, program priorities and program balance, the total cost of the proposed project and the availability of funds will be considered by NHLBI, NIDR, and NIAMS staff as well as the NHLBAC, NADRC, and NAMSAC in making funding recommendations. In addition, NHLBI, NIDR, and NIAMS appreciate the value of complementary funding from other public and private sources including foundations and industrial concerns. In circumstances in which applications have similar scientific merit, but vary in cost competitiveness, NHLBI, NIDR, and NIAMS are likely to select the more cost competitive application for funding. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Paul Didisheim Head, Biomaterials Program Division of Heart and Vascular Diseases National Heart, Lung and Blood Institute Rockledge 2 Building, Room 9180 Bethesda, MD 20892-7940 Telephone: 301-435-0513 FAX 301-480-1336 E-mail: pd16i@nih.gov Dr. Eleni Kousvelari Program Director for Biomaterials, Biomimetics, and Tissue Engineering Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN 18A Bethesda, MD 20892-6402 Telephone: 301-594-2427 FAX: 301-480-8318 E-mail: kousvelari@de45.nidr.nih.gov Dr. James S. Panagis Director, Orthopaedics Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS 37K Bethesda, MD 20892-6500 Telephone: 301-594-5055 FAX: 301-480-4543 E-mail: panagisj@ep.niams.nih.gov Direct inquiries regarding grants management issues to: Mr. William Darby Division of Extramural Affairs National Heart, Lung, and Blood Institute Rockledge Building 2, Room 7128 6701 Rockledge Dive Bethesda, MD 20892-7924 Telephone: 301-435-0177 FAX: 301-480-3310 Email: darbyw@gwgate.nhlbi.nih.gov Mr. Martin R. Rubinstein Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN 44A Bethesda, MD 20892-6402 Telephone: 301-594-4800 FAX: E-mail: Martin.Rubinstein@nih.gov Ms. Vicki Maurer Grants Management Specialist National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS 49A Bethesda, MD 20892-6500 Telephone: 301-594-3504 FAX: 301-480-5450 E-mail: maurerv@ep.niams.nih.gov The National Institute of General Medical Sciences (NIGMS) has an interest related to this RFA. Direct inquiries regarding this interest to: Dr. Scott Somers National Institute of General Medical Sciences Natcher Building, Room 2AS 49J Bethesda, MD 20892-6402 Telephone: 301-594-5560 FAX: 301-480-2802 E-mail: somerss@gm1.nigms.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.121, 93.837, 93.838, 93.839, and 93.846. 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 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 Sun Apr 27 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA ES-97-003 - V26(13) 04/25/97 Date: 28 Apr 1997 15:58:44 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 495 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5k3a34$mf7@net.bio.net> NNTP-Posting-Host: net.bio.net CANCER AND TEFS FOR DIOXIN AND DIOXIN-LIKE CHEMICALS NIH GUIDE, Volume 26, Number 13, April 25, 1997 RFA: ES-97-003 P.T. 34; K.W. 1007009, 0715035, 0705048 National Institute of Environmental Health Sciences Letter of Intent Receipt Date: June 6, 1997 Application Receipt Date: July 9, 1997 PURPOSE Environmental health research carried out by the National Institute of Environmental Health Sciences (NIEHS) provides a solid scientific foundation for understanding interrelationships between the environment, genetics and temporal factors as they relate to human disease and dysfunction. The NIEHS Division of Extramural Research and Training is responsible for developing and directing the investigator-initiated hypothesis-driven mechanistically-based research related to the NIEHS mission. Research conducted by the National Toxicology Program (NTP), centered at the NIEHS, focuses on the evaluation of environmental/industrial agents for their toxic effects using a broad array of test systems and generates data to strengthen the scientific foundations for risk assessment. The goal of this Request for Applications (RFA) is to provide data to aid the NIEHS in defining the mechanisms of action of agents under study by the NTP to improve the risk assessment process, and, thereby, better protect the public health. Therefore, the NTP and the Division of Extramural Research and Training, have designed a program to improve collaboration between government and non-government scientists, thereby providing broad-based input into this process. This program, as outlined in this RFA, utilizes the R03 Small Grants Program to encourage investigator-initiated applications that will utilize animals/tissues/cells or sera from an NTP study involving exposure to dioxin-like chemicals. It is anticipated that this investigator-initiated research will complement the NTP study on dioxin and dioxin-like compounds by providing additional information on their mechanism(s) of action. 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, Cancer and TEFs for Dioxin and Dioxin-like Chemicals is related to the priority area of environmental health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock no. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: (202) 512-1800). 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 or local governments and eligible agencies of the Federal government. Foreign institutions and organizations are not eligible. Applications from minority individuals and women are encouraged. Submission of an application precludes concurrent submission of a regular research grant application (R01 or R29) containing the same research proposal. In addition, small grant research support may not be used to supplement research projects currently supported by Federal or non-Federal funds or to provide interim support for projects under review by the Public Health Service. MECHANISM OF SUPPORT This RFA will use the NIH Small Grants Program (R03) awards. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The requested costs and project period will be a maximum of $50,000 (direct cost) for a maximum of one year. Small grants are not renewable but may be extended for an additional year with no additional funds at the discretion of the applicant organization. FUNDS AVAILABLE The total estimated funds available for this small grants program is $400,000 which will support approximately six (6) to eight (8) awards. 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 within the financial plans of the NIEHS/NTP, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background The delineation of human cancer risk following exposure to mixtures of chemicals have been difficult to quantify due to the lack of validated models. One methodology used is the Toxic Equivalency Factor (TEFs). The TEF methodology is a relative potency scheme for a strictly defined class of chemicals, namely the 2, 3, 7, 8-chlorine substituted dibenzo-p-dioxin and dibenzofurans. These chemicals are structurally-related and produce the same spectrum of toxic effects in animals. These chemicals bind to the aryl hydrocarbon (Ah) receptor and the subsequent activation of this receptor leads to a cascade of biochemical and toxic effects. There are limited data on the relative carcinogenic potency of almost all of these chemicals since only dioxin and a mixture of hexachlorodibenzo-p-dioxins have been tested. Hence the ability of these relative potency factors to predict the cancer risk of mixtures of these chemicals has been questioned. The TEF methodology does not include the interactions of dioxin-like chemicals with nondioxin-like chemicals. Since human exposures are to mixtures containing both dioxin-like and nondioxin-like chemicals, in order for the TEF methodology to accurately predict the risk of cancer or other endpoints, it must be expanded to include both dioxin-like and nondioxin-like chemicals, singly and in mixtures. Research Goals In order to determine whether the TEFs currently used for dioxin and dioxin-like chemicals are valid for the chemicals tested singly or in mixtures, the NTP proposes to test the following chemicals/mixtures in a two year bioassay: o 2,3,7,8 tetrachlorodibenzo-p-dioxin (cas#74601-6) o 1,2,3,7,8 pentachlorodibenzo-p-dioxin (cas#40321-76-4) o 2,3,4,7,8 pentachlorodibenzofuran (cas#57117-31-4) o 3,31,4,41,5 pentachlorobiphenyl(PCB126) (cas#57465-28-8) o 2,21,4,41,5,51 hexachlorobiphenyl (PCB153)(cas#35065-27-1) Each chemical will be tested individually. A mixture containing all four chemicals and a binary mixture of dioxin and PCB153 will also be tested. The objective of these NTP studies is to test the following hypotheses: o The USEPA interim TEFs for dioxins, dibenzofurans and PCBs can predict the relative carcinogenic potency of single congeners in female Sprague-Dawley rats. o The USEPA interim TEFs for dioxins, dibenzofurans, and planar PCBs can predict the relative carcinogenic potency of an environmentally relevant mixture of these chemicals in the female Sprague-Dawley rat. o The carcinogenicity of a dioxin is not altered by the presence of a nondioxin-like PCB. o The relative potencies for biochemical endpoints, such as CYP1A1 induction, in the two-year studies are equivalent to the relative potency for carcinogenesis when estimated based on administered dose. o The relative carcinogenic potencies of the individual congeners, based on target tissue dose, are the same as the relative potencies based on CYP1A1 induction using the same-target tissues. o The relative carcinogenic/biochemical potencies based on administered dose are the same as those based on tissue dose. o The relative potencies based on serum or whole blood concentrations are equivalent to administered dose and target tissue dose. To aid the NTP in developing the scientific data set necessary to substantiate these hypotheses and to provide additional information on the mechanism of tumor development by these agents or on the sites or mechanisms of additional toxicities of these chemicals/mixtures, the NTP, in coordination with the Division of Extramural Research and Training, proposes to add additional investigator-initiated studies >From this RFA to these studies. Projects that will provide additional support for these hypotheses are requested. They include but are not limited to proposals that will: o Establish the relationship between changes in tissue receptor levels for estrogen, epidermal growth factor or glucocorticoids and time, dose, chemical/mixture and TEF of chemicals. o Establish the relationship between measurements of tissue oxidative stress, tissue vitamin A metabolism, liver induction of porphyrins or other aspects of the pleotrophic action of dioxin-like chemicals and time, dose, chemical/mixture and TEF of chemical. o Establish the relationship between changes in the activity of cell cycle regulatory proteins like CDC2 or the protooncogene SRC and time, chemical/mixture and TEF of chemical. o Characterize the immunotoxicity of these chemicals singularly or in mixtures proposed and its relation to time, dose, carcinogenicity and TEF. o Characterize the reproductive, neuro- and other non-cancer organ toxicity of these chemicals/mixtures and their relationship to carcinogenicity and the TEFs. Research proposed needs to be hypothesis driven, mechanistically-based and must be justified as to how the animals >From this NTP study are unique in providing tissues needed for the studies proposed and how the studies can be accomplished within the budget and personnel proposed. Study Design Considerations A detailed statement of work, including test doses and tissues that will be analyzed by the NTP as well as special groups of animals available for investigator-initiated studies under this RFA, may be obtained from the NIEHS home page at the following address: http://www.niehs.nih.gov/dert/dioxin.htm The following additional information is intended to complement the information found on the web-site. o Tissues and sera from the "grantee" animals will be shared by those successful applicants to this RFA. Applicants should check with NTP (see inquiries section) for tissue/sera availability before finalizing their proposals and also take into account sharing tissues/sera with the NTP and other investigators. o Investigators must, in their proposal, be specific as to number of animals/tissues/cells/sera needed, preparation of tissues needed, doses needed, shipping requirements and ages (104 weeks or interim). Investigators requiring fresh tissues should fully define the tissue and shipping requirements. Attendance to the necropsy may be impractical depending on the extent of the study proposed. o Since these seven (7) studies will probably start one or more months apart, it will take a minimum of 18 months for the conclusion of the 52-week necropsies. Investigators must state in the application how they will account for this time factor in their study design and explain how they will analyze and control for variability of time (fresh or frozen) of samples, i.e., show a time-line of tissue availability and analysis with proper controls (will samples be collected and analyzed together or monthly?). o Because of the nature of the R03 Program (i.e., two-year maximum time frame; one year grant with one year no-cost extension) it will not be practical to design a study that encompasses the 13, 30, 52 and 104 week necropsies. Thus, investigators should concentrate on the 13, 30 and 52 week times or specify other times points needed. o Proposals need not cover all seven (7) studies or all time points or all dose levels. Investigators should carefully examine the protocol and design a proposal to specifically address a particular question related to the hypothesis being tested using the minimum number of animals, chemicals and necropsy times needed. Investigators are requested to set aside funds for a trip to NIEHS to discuss their results and to be prepared to integrate their results into an NTP final report. Inclusion of data in the NTP final report would not preclude independent publication. The investigator-initiated work may be published independently at the discretion of the investigators. Investigators may also have access to NTP data on, for example, blood, tissue, adipose tissue levels of chemicals which may be needed for analysis and interpretation of their data. SPECIAL REQUIREMENTS LETTER OF INTENT Prospective applicants are asked to submit, by June 6, 1997, 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, 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 application, the information that it contains is helpful in planning for the review of applications. It allows NIEHS staff to estimate the potential review work load and to avoid conflict of interest in the review. The letter of intent is to be sent to: Ethel B. Jackson, D.D.S. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 17-09 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-7826 FAX: (919) 541-2503 EMAIL: jackson4@niehs.nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3034, MSC 7762, Bethesda, MD 20892-7762, telephone 301/435-0714, EMAIL: girg@drgpo.drg.nih.gov. THE FOLLOWING ARE SUPPLEMENTAL INSTRUCTIONS: o The application must detail the specific budget categories and percent efforts that will be required. This will be a $50,000 maximum award - direct cost. The budget must be justified. Equipment will be limited to $5,000. o The applicant must be explicit in describing the proposed interface between the NTP study design and the proposed project. o Preliminary data are not required except to indicate the expertise of the Principal Investigator to carry out the proposed studies. o The Research Plan (Specific Aims, Background and Significance, Preliminary Studies, Research Design and Methods sections) is not to exceed Ten (10) pages. Tables and figures are included in the Ten-page limitation. Applications that exceed page limitations or PHS 398 requirements for font size (height or letters), type density (characters per inch), and margins (see PHS 398 directions) will be returned to the investigator. o Do not submit an appendix. The RFA Label available in the PHS 398 (rev. 5/95) 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 2 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 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to Dr. Ethel Jackson, Chief, Scientific Review Branch (see address below). If these two additional copies are not forwarded to Dr. Jackson, it will adversely affect the review of the grant application. Ethel Jackson, D.D.S. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 17-09 111 T.W. Alexander Drive Research Triangle Park, NC 27709-2233 Telephone: (919) 541-7846 FAX: (919) 541-2503 EMAIL: jackson4@niehs.nih.gov Applications must be received by July 9, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIEHS in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score. Review Criteria The following criteria will be considered: o Hypothesis driven, mechanistically-based nature of the study with justification as to how the animals are unique in providing tissues needed for the proposed studies. o Focus of the study on the relationship among exposure, toxicity endpoint, time and the TEFs of the chemical/mixtures. o Scientific, technical, or medical significance of the proposed research. o Efficiency of study design: Is this the best use of the tissues? o Appropriateness and adequacy of the experimental design and methods proposed to carry out the research; o Innovativeness or promise of the research idea; o Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o Reasonableness/appropriateness of the requested budget in relation to the proposed research; and o Availability of the investigators resources necessary to perform the research. NOTE: If the project can be completed without the aid of this NTP study, the proposal will not qualify under this RFA. AWARD CRITERIA The anticipated date of award is December 1997 pending availability of funds. The following will be considered in making funding decisions: o quality of the proposed project as determined by peer review; o availability of funds; and o program balance among research areas of the announcement. Because of the nature of the NTP studies actual funding of these projects may not all be made at the same time. Awards will be made so that the proposed project can be completed within the time frame of the award. INQUIRIES Written, telephone or Email 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: Jerrold J. Heindel, Ph.D. Organs and Systems Toxicology Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 111 T.W. Alexander Drive (Fed-x addr) Research Triangle Park, NC 27709-2233 Telephone: (919) 541-0781 FAX: (919) 541-2843 EMAIL: heindelj@niehs.nih.gov Direct inquiries regarding fiscal matters to: Mr. David L. Mineo Chief, Grants Management Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 2-01. 111 T.W. Alexander Drive (Fed-x addr) Research Triangle Park, NC 27709-2233 Telephone: (919) 541-7628 FAX: (919) 541-2860 EMAIL: mineo@niehs.nih.gov For clarification of NTP study design or for information on tissue availability contact: John R. Bucher, Ph.D. Environmental Toxicology Program National Institute of Environmental Health Sciences P.O. Box 12233, MD A2-08 111 T.W. Alexander Dr., Bldg. 101, Rm A222 Research Triangle Park, NC 27709-2233 Telephone: (919) 541-4532 FAX: (919) 541-0295 EMAIL: bucher@niehs.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.113 and 93.115. 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, 43 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 and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun Apr 27 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 13, pt. 1of1, 25 April 1997 Date: 28 Apr 1997 15:58:08 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1115 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5k3a20$mbi@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 26, No. 13 - April 25, 1997 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N2 ********************************************************** FY 1997 FUNDS FOR AHCPR SMALL PROJECT GRANTS Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** PROSTATE, LUNG, COLORECTAL AND OVARIAN CANCER (PLCO) CANCER SCREENING TRIAL EXPANSION FOR MINORITY ENROLLMENT (RFP N01-CN-75022-70) National Cancer Institute INDEX: CANCER $$INDEX R2 ********************************************************** IMMUNOLOGIC FACTORS IN SALIVA AND BLOOD AS DETERMINANTS OF HIV-RELATED DISEASES (RFP NIH-NIDR-3-97-9R) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX R3 ********************************************************** NEUROTOXICOLOGICAL TESTING OF CLINICAL CANDIDATE DRUGS (RFP N01DA-7- 8078) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX R4 ********************************************************** ANALYTICAL SERVICES CENTER FOR MEDICATIONS DEVELOPMENT PROGRAM (RFP N01DA-7-8074) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX R5 ********************************************************** PHASE II - CLINICAL TRIALS OF NEW CHEMOPREVENTIVE AGENTS (RFP N01-CN- 75023-82) National Cancer Institute INDEX: CANCER $$INDEX R6 07/09/97 ************************************************* CANCER AND TEFS FOR DIOXIN AND DIOXIN-LIKE CHEMICALS (RFA ES-97-003) National Institute of Environmental Health Sciences INDEX: ENVIRONMENTAL HEALTH SCIENCES $$INDEX R7 07/10/97 ************************************************* TREATMENT OF PRIMARY MOOD DISORDERS IN THE COMORBIDLY ILL (RFA MH-97-002) National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX R8 08/25/97 ************************************************* MOLECULAR APPROACHES TO MENTAL DISORDERS OF LATE LIFE (RFA MH-97-003) National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX R9 12/19/97 ************************************************* TISSUE ENGINEERING, BIOMIMETICS, AND MEDICAL IMPLANT SCIENCE (RFA HL-97-005) National Heart, Lung, and Blood Institute National Institute of Dental Research National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: HEART, LUNG, BLOOD; DENTAL RESEARCH; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES $$INDEX R10 ********************************************************* ALCOHOL RESEARCH CENTER GRANTS (RFA AA-97-005) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX P1 ********************************************************** PRIORITIES IN BEHAVIORAL RESEARCH IN CANCER PREVENTION AND CONTROL (PA-97-055) National Cancer Institute National Institute of Dental Research INDEX: CANCER; DENTAL RESEARCH $$INDEX P2 ********************************************************** INTEGRATED PRECLINICAL/CLINICAL AIDS VACCINE DEVELOPMENT (PAR-97-056) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX P3 ********************************************************** EPIDEMIOLOGY OF AIDS/RETROVIRAL-ASSOCIATED CANCERS (PA-97-057) National Cancer Institute INDEX: CANCER The NIH GUIDE is available electronically via LISTSERV subscription, and is also on the nih gopher (gopher.nih.gov) and the NIH web site (http://www.nih.gov). Alternative access is available through the NIH Grant Line via modem (data line 301/402-2221); contact Dr. John James at 301/435-2801 for details on the NIH Grant Line. All competing (new, renewal, amended (revised) applications for grants, cooperative agreements, and fellowships from the National Institutes of Health must be sent to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) ASKNIH is a service of the Division of Extramural Outreach & Information Resources, Office of Extramural Research, Office of the Director, NIH. ASKNIH is the point of contact for obtaining general information about NIH extramural research & research training programs, requesting publications, and learning more about obtaining the NIH GUIDE and other information on the NIH web site. ASKNIH is also the contact to which organizations should request application kits and forms. ASKNIH NATIONAL INSTITUTES OF HEALTH EMAIL: ASKNIH@odrockm1.od.nih.gov FAX: (301) 480-0525 TELEPHONE: (301) 435-0714 INQUIRIES ABOUT THE NOTICES, PAS, AND RFAS IN THIS PUBLICATION SHOULD BE DIRECTED TO THE NIH STAFF MEMBER IDENTIFIED AT THE END OF EACH ITEM. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ******************************************************** NOTICES $$N1 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 26, Number 13, April 25, 1997 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services Notice is hereby given that the Office of Research Integrity (ORI) has made a final finding of scientific misconduct in the following case: Manoj Misra, Ph.D., Dartmouth College: Based upon the Office of Research Integrity's (ORI) review of a report forwarded to ORI by Dartmouth College, Dr. Misra's admission of certain facts in that report, and ORI's own analysis, ORI found that Dr. Misra, a former postdoctoral research associate, Department of Chemistry, Dartmouth College, engaged in scientific misconduct by intentionally altering laboratory notebook data entries for research supported by a grant >From the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). Specifically, Dr. Misra altered laboratory notebook data entries in two instances in an effort to conceal prior manipulations of that data without disclosure or explanation to the principal investigator or anyone else. The experiment at issue involved an assay of the chemical activity of a carcinogen, and Dr. Misra's change in the readings of the "control" experiment, in which no carcinogen was present, changed the results. Dr. Misra has accepted the ORI finding and has entered into a Voluntary Exclusion Agreement with ORI in which he has voluntarily agreed, for the three (3) year period beginning April 7, 1997: (1) to exclude himself from serving in any advisory capacity to the Public Health Service (PHS), including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant; and (2) that any institution that submits an application for PHS support for a research project on which Dr. Misra's participation is proposed or which uses him in any capacity on PHS supported research must concurrently submit a plan for supervision of his duties. The supervisory plan must be designed to ensure the scientific integrity of Dr. Misra's research contribution. The institution must submit a copy of the supervisory plan to ORI. No scientific publications were required to be corrected as part of this Agreement. INQUIRIES For further information contact: Acting Director, Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** FY 1997 FUNDS FOR AHCPR SMALL PROJECT GRANTS NIH GUIDE, Volume 26, Number 13, April 25, 1997 P.T. 34; K.W. 1014006, 0730050, 0730023 Agency for Health Care Policy and Research The Agency for Health Care Policy and Research (AHCPR) announces that it has earmarked an additional $1 million available in Fiscal Year 1997 for its Small Project Grant Program. Applicants are encouraged to address the AHCPR strategic goals described in the Notice of Program Emphases for the AHCPR Small Project Grant Program published in the NIH Guide, Vol. 26, No. 9, March 21, 1997. To be considered for FY 1997 funding, applications should be received no later than July 7, 1997. The Small Project Grant Program Announcement and the Notice of Program Emphases are available through AHCPR's WEB site (http://www.ahcpr.gov) and AHCPR InstantFAX. For instructions on using InstantFAX, call (301) 594-2800, using a fax machine with a telephone handset. Use the key pad on the receiver when responding to prompts. AHCPR InstantFAX operates 24 hours a day, 7 days a week. Applicants are encouraged to obtain application kits from the AHCPR contractor : Global Exchange, Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone: (301) 656-3100 FAX: (301) 652-5264 Applications for AHCPR small project grants are accepted on an ongoing basis and are to be submitted to: Small Grants: Research Projects Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 400 Rockville, MD 20852-4908 $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN N01CN75022-70 ******************************************** PROSTATE, LUNG, COLORECTAL AND OVARIAN CANCER (PLCO) CANCER SCREENING TRIAL EXPANSION FOR MINORITY ENROLLMENT NIH GUIDE, Volume 26, Number 13, April 25, 1997 RFP AVAILABLE: N01-CN-75022-70 P.T. 34, FF; K.W. 0715035 National Cancer Institute The National Cancer Institute (NCI), Division of Cancer Prevention and Control, Early Detection Branch, is expanding the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial and is interested in soliciting proposals from organizations for a new minority population focused screening center. One additional screening center will be established to recruit no less than 2,500 subjects and 2,500 controls to the Trial, of which at least 60 percent are African American. Female subjects will be screened for colorectal, lung, and ovarian cancers. Male subjects will be screened for colorectal, lung, and prostate cancer. Screening will be annually for four years for prostate, lung, and ovarian cancers and only in years one and three for colorectal cancer. Subjects and controls will be followed for at least ten years. The PLCO Cancer Screening Trial was established in 1992 with ten screening centers, a Coordinating and Data Management Center, a steering Committee, and a Monitoring and Advisory Panel. The protocol is established. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the contracting officer their interest and capability to satisfy the governments requirement with a commercial item within 15 days of this notice. INQUIRIES All responsible sources may submit a proposal that will be considered by the agency. The RFP is now available and responses will be due approximately May 23, 1997. Requests for this solicitation must be in writing, reference RFP No. N01-CN-75022-70, and be addressed to: Ms. Erin C. Lange Research Contracts Branch, PCCS National Cancer Institute 6120 Executive Boulevard, Room 635 - MSC 7226 Bethesda MD 20892-7226 Telephone: (301) 435-3828 FAX: (301) 402-8579 Email: Langee@rcb.nci.nih.gov No collect calls will be accepted $$R1 END ************************************************************ $$R2 BEGIN NIH-NIDR-3-97-9R ***************************************** IMMUNOLOGIC FACTORS IN SALIVA AND BLOOD AS DETERMINANTS OF HIV-RELATED DISEASES NIH GUIDE, Volume 26, Number 13, April 25, 1997 RFP AVAILABLE: NIH-NIDR-3-97-9R P.T. 34; K.W. 0715008, 0710070 National Institute of Dental Research The National Institute of Dental Research (NIDR) has a requirement to develop methods and assays for selected immunological and viral characteristics in the saliva and serum of members of a cohort of HIV-positive U.S. military personnel. Approximately 2000 serum and 2000 saliva samples (to be furnished by the Government) will be tested for total IgG, IgM, and IgA; HIV-specific IgG, IgM, and IgA; nonspecific immune factors (lactoferrin, lysozyme and lactoperoxidase); levels of secretory leukocyte protease inhibitor; quantitative HIV virions; and infectivity of human peripheral blood mononuclear cells (PBMC). Special features of this project are the large number of samples and the need for the development of procedures to apply to saliva as the matrix and to conserve volume of specimen as much as possible. It is anticipated that one award will be made as a result of this solicitation. The Request for Proposal (RFP) will be available on or about April 17, 1997, with proposals due on or about June 2, 1997. INQUIRIES Verbal requests for the RFP will not be accepted; requests must be submitted in writing, addressed to: Marilyn R. Zuckerman Contracts Management Section National Institute of Dental Research 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 $$R2 END ************************************************************ $$R3 BEGIN N01DA-7-8078 ********************************************* NEUROTOXICOLOGICAL TESTING OF CLINICAL CANDIDATE DRUGS NIH GUIDE, Volume 26, Number 13, April 25, 1997 RFP AVAILABLE: N01DA-7-8078 P.T. 34; K.W. 1007009, 0740020 National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) is soliciting proposals >From qualified organizations having in-house capability to conduct studies of neurotoxicology in rodents. Clinical candidate test compounds will be evaluated and the resulting data will be utilized by the NIDA Medications Development Division. Offerors must indicate possession of current DEA registration for Schedule II-V substances prior to award and apply for Schedule I registration at the time of award. It is anticipated that one (1) cost reimbursement, completion type contract will be awarded for a period of three years, with possibilities for two one-year options and other option quantities for additional follow-up studies and/or compound evaluations. RFP No. N01DA-7-8078 will be available electronically on or about May 1, 1997, and may be accessed through the NIH Gopher and/or the Internet by using the following electronic mail addresses and instruction: 1. NIH Home Page (via the World Wide Web): Access the NIH Home Page by using http://www.nih.gov . Once you are at the NIH Home Page, select "Grants and Contracts"; select "NIH Gopher directory: listed under the "Contracts Page" section. Once at the NIH R&D Gopher, select "RFPs Available"; select "NIDA"; and select "RFP N01DA-7- 8078". (URL: gopher://gopher.nih.gov:70/11/res/rd-rfp) 2. NIH Gopher: Point your Gopher client to GOPHER.NIH.GOV Port 70 (you should now be in the NIH Gopher). Select "Grant and Research Information"; select "R&D Request for Proposals (RFP)"; select "RFPs Available"; select "NIDA"; and, select "RFP N01DA-7-8078". Please note that the RFP for this acquisition will be streamlined to include only the Work Statement, deliverable and reporting requirements, special requirements and mandatory qualifications, Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. INQUIRIES Response to this RFP will be due on or about June 16, 1997. Any responsible offeror may submit a proposal that will be considered by the Government. This advertisement does not commit the Government to award a contract. Kenneth E. Goodling Contracts Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 10-49 Rockville, MD 20857 Telephone: (301) 443-6677 FAX: (301) 443-7595 Email: kg25d@nih.gov $$R3 END ************************************************************ $$R4 BEGIN N01DA-7-8074 ********************************************* ANALYTICAL SERVICES CENTER FOR MEDICATIONS DEVELOPMENT PROGRAM NIH GUIDE, Volume 26, Number 13, April 25, 1997 RFP AVAILABLE: N01DA-7-8074 P.T. 34; K.W. 0404009, 1003008, 0780000 National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) is soliciting proposals >From qualified organizations having in-house capability to perform: (a) bio-analytical methods development and validation, (b) quantitative drug analyses in biological specimens, (c) federal good laboratory compliance requirements and (d) shipping and handling of biological specimens. Offerors must indicate possession of current DEA registration for Schedule II-V substances prior to award and apply for Schedule I registration at the time of award. It is anticipated that one cost reimbursement, completion type contract will be awarded for a period of four years, with possibilities for one option year and other option quantities for additional analyses and methods development. RFP No. N01DA-7-8074 will be available electronically on or about May 6, 1997, and may be accessed by using the following electronic mail addresses and instruction: (1) NIH Home Page: Access the NIH Home Page by using http://www.nih.gov . Once you are at the NIH Home Page, select "Grants and Contracts"; select "NIH Gopher directory: listed under the "Contracts Page" section. Once at the NIH R&D Gopher, select "RFPs Available"; select "NIDA"; and select "RFP N01DA-7-8074". (URL: gopher://gopher.nih.gov:70/11/res/rd-rfp) (2) NIH Gopher: Point your Gopher client to GOPHER.NIH.GOV Port 70 (you should now be in the NIH Gopher). Select "Grant and Research Information"; select "R&D Request for Proposals (RFP)"; select "RFPs Available"; select "NIDA"; and, select "RFP N01DA-7-8074". Please note that the RFP for this acquisition will be streamlined to include only the Work Statement, deliverable and reporting requirements, special requirements and mandatory qualifications, Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. INQUIRIES Response to this RFP will be due on or about June 20, 1997. Any responsible offeror may submit a proposal which will be considered by the Government. This advertisement does not commit the Government to award a contract. Kenneth E. Goodling Contracts Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 10-49 Rockville, MD 20857 Telephone: (301) 443-6677 Email: kg25d@nih.gov $$R4 END ************************************************************ $$R5 BEGIN N01-CN-75023-82 ****************************************** PHASE II - CLINICAL TRIALS OF NEW CHEMOPREVENTIVE AGENTS NIH GUIDE, Volume 26, Number 13, April 25, 1997 RFP AVAILABLE: N01-CN-75023-82 P.T. 34; K.W. 0715035, 0740018, 0755015 National Cancer Institute The Chemoprevention Branch, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI) is interested in establishing a Master Agreement (MA) pool with the objective of encouraging cancer chemoprevention clinical trails that use biochemical and biological markers as intermediate endpoints. The application of biological markers to clinical prevention trials carries great promise in relation to ultimate cancer prevention. When cancer incidence reduction itself is used as an endpoint in studies of this type, a very large number of subjects tested for long durations is often required. The design of phase 2a clinical trials will be small, short-term, efficient studies that determine the dose-response of a given chemopreventive agent on pharmacological and intermediate endpoints, the minimum dose at which this biological effect is observed, and the maximum safe dose. The second segment phase 2b study will involve a randomized, placebo-controlled, blinded trial in a small group of subjects in which the endpoint will be a modulation of a quantifiable biological effect that is correlated with cancer incidence reduction in the agent versus the placebo treated groups. This acquisition is for a five-year Master Agreement. MAA/RFP N01-CN-75023-82 will be available on or about April 28, 1997 and responses will be due on or about July 7, 1997. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the contracting officer their interest and capability to satisfy the governments requirement with a commercial item within 15 days of this notice. Following proposal submission and the initial technical review process, offerors whose proposals are judged acceptable will be awarded an MA and will then be eligible to compete for work as Master Agreement Order (MAO) RFPs are issued. INQUIRIES All responsible sources may submit a proposal, that will be considered by the agency. No collect calls will be accepted. Requests for the MAA/RFP must reference N01-CN-75023-82 and be submitted to: Ms. Michelle L. Scala Research Contracts Branch, PCCS National Cancer Institute 6120 Executive Boulevard, Room 635 - MSC 7226 Bethesda MD 20892-7226 Telephone: (301) 435-3829 Email: scalam@rcb.nci.nih.gov $$R5 END ************************************************************ $$R6 BEGIN ES-97-003 FULL-TEXT ************************************** CANCER AND TEFS FOR DIOXIN AND DIOXIN-LIKE CHEMICALS NIH Guide, Volume 26, Number 13, April 25, 1997 RFA AVAILABLE: ES-97-003 P.T. 34; K.W. 1007009, 0715035, 0705048 National Institute of Environmental Health Sciences Letter of Intent Receipt Date: June 6, 1997 Application Receipt Date: July 9, 1997 PURPOSE This Request for Applications (RFA) encourages research to utilize animals/tissues/cells or sera from a National Toxicology Program (NTP) two year carcinogenicity bioassay involving exposure to dioxin-like chemicals. This research will complement this NTP study by providing data on the mechanism of action of the test agents designed to improve the overall risk characterization of dioxin-like compounds and thereby provide a sound basis for protecting human health. It is anticipated that approximately $400,000 will be available to support six to eight 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 RFA, Cancer and TEFs for Dioxin and Dioxin-like Chemicals, is related to the priority area of environmental health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1), Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: (202) 512-1800). 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), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Jerrold J. Heindel, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences 111 T.W. Alexander Drive, P.O. Box 12233, MD 3-02 Research Triangle Park, NC 27709-2233 Telephone: (919) 541-0781 Email: heindelj@niehs.nih.gov $$R6 END ************************************************************ $$R7 BEGIN MH-97-002 FULL-TEXT ************************************** TREATMENT OF PRIMARY MOOD DISORDERS IN THE COMORBIDLY ILL NIH Guide, Volume 26, Number 13, April 25, 1997 RFA AVAILABLE: MH-97-002 P.T. 34; K.W. 0715129, 0404003, 0404009 National Institute of Mental Health Letter of Intent Receipt Date: June 5, 1997 Application Receipt Date: July 10, 1997 PURPOSE The NIMH announces the availability of competitive supplementary support for existing clinical therapeutic research grants to study the efficacy and effectiveness of treatment of primary mood disorders in individuals with co-occurring mental, alcohol or substance abuse disorders, with or without associated physical disorders. The purpose is to optimize mental health treatments for primary mood disorders in the presence of comorbid disorders that occur frequently in clinical settings, complicating usual treatment efforts, but which generally preclude participation in controlled clinical treatment trials. It is anticipated that at least $500,000 in direct costs will be made available. Direct costs for the first year of supplemental funding under this RFA may not exceed that of the previous year of the parent grant, up to a maximum of $200,000. HEALTHY PEOPLE 2000 The 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, Treatment of Primary Mood Disorders in the Comorbidly Ill, is related to the priority areas of tobacco, alcohol and other drugs, and mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). 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), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Matthew V. Rudorfer, M.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-4527 FAX: (301) 480-4417 Email: mrudorfe@nih.gov $$R7 END ************************************************************ $$R8 BEGIN MH-97-003 FULL-TEXT ************************************** MOLECULAR APPROACHES TO MENTAL DISORDERS OF LATE LIFE NIH GUIDE, Volume 26, Number 13, April 25, 1997 RFA AVAILABLE: MH-97-003 P.T. 34; K.W. 0715129, 1002030, 0710105 National Institute of Mental Health Letter of Intent Receipt Date: June 5, 1997 Application Receipt Date: July 10, 1997 PURPOSE The principal objective of this Request for Applications (RFA) is to attract new investigators to build upon and extend basic research on fundamental aspects of neuronal function to develop clinical approaches to the understanding of mechanisms, clinical course, and treatment of late life mental disorders. The results of these investigations are expected to lead to the development of novel therapeutic strategies that reduce symptoms of psychopathology and improve neurobehavioral functioning in late life. The major focus of this RFA is on late onset mental disorders: psychoses, affective disorders, and anxiety disorders. It is estimated that $750,000 (total costs) will be available to support up to 10 new small grant (R03) and First Independent Research Support and Transition (FIRST) (R29) 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, Molecular Approaches to Mental Disorders of Late Life, is related to the priority area of mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). 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), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Herbert W. Harris, M.D., Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health Parklawn Building, Room 18-101 Rockville, MD 20857 Telephone: (301) 443-1185 FAX: (301) 574-6784 Email: hharris@ngmsmtp.nimh.nih.gov $$R8 END ************************************************************ $$R9 BEGIN HL-97-005 FULL-TEXT ************************************** TISSUE ENGINEERING, BIOMIMETICS, AND MEDICAL IMPLANT SCIENCE NIH Guide, Volume 26, Number 13, April 25, 1997 RFA AVAILABLE: HL-97-005 P.T. 34; K.W. 0706000, 0740027, 0710030 National Heart, Lung, and Blood Institute National Institute of Dental Research National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: July 1, 1997 Application Receipt Date: August 25, 1997 THIS REQUEST FOR APPLICATIONS (RFA) USES "MODULAR GRANT" AND "JUST-IN-TIME" PROCEDURES. THIS RFA INCLUDES MODIFICATIONS TO THE STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA. PURPOSE The National Heart, Lung, and Blood Institute (NHLBI), the National Institute of Dental Research (NIDR), and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invite research project grant (R01) applications to design and engineer natural and novel approaches for the repair, restoration, and replacement of tissues and whole organs based on a comprehensive scientific understanding of biological structures and their function. The overall goal of this RFA is to facilitate multidisciplinary research, design, and training aimed at development of a new generation of natural and synthetic medical implants, including totally biological solutions for instances in which synthetic implants have historically been used. Research projects focusing on devices intended primarily for short term use, specifically 24 hours or less (e.g., hemodialysis and cardiopulmonary bypass), will not be considered responsive to this RFA. This Program will support both design directed and hypothesis driven research applicable to the missions of NHLBI, NIDR, and NIAMS. 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, Tissue Engineering, Biomimetics, and Medical Implant Science, is related to the priority areas of heart disease and stroke, oral health, immunization and infectious diseases, cancer, diabetes, and musculoskeletal injuries and diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock 017-001-00474-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). 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), the NIH Gopher (gopher.nih.gov), the NIH Home Page (http://www.nih.gov), or by mail and e-mail from any of the program contacts listed below. Dr. Paul Didisheim Division of Heart and Vascular Diseases National Heart, Lung and Blood Institute Rockledge II, Room 9180 Bethesda, MD 20892-7940 Telephone: (301) 435-0513 FAX: (301) 480-1336 Email: pd16i@nih.gov Dr. Eleni Kousvelari Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN 18A Bethesda, MD 20892-6402 Telephone: (301) 594-2427 FAX: (301) 480-8318 Email: kousvelari@de45.nidr.nih.gov Dr. James S. Panagis Orthopaedics Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS 37K Bethesda, MD 20892-6500 Telephone: (301) 594-5055 FAX: (301) 480-4543 Email: panagisj@ep.niams.nih.gov $$R9 END ************************************************************ $$R10 BEGIN AA-97-005 FULL-TEXT ************************************* ALCOHOL RESEARCH CENTER GRANTS NIH Guide, Volume 26, Number 13, April 25, 1997 RFA AVAILABLE: AA-97-005 P.T. 04, K.W. 0404003, 0710030 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: November 19, 1997 Application Receipt Date: December 19, 1997 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) provides grant support for Alcohol Research Centers to conduct interdisciplinary research on alcoholism and alcohol abuse. The Center grants program is interrelated with and complementary to all other research support mechanisms and scientific activities that comprise the NIAAA programs of research on the nature, causes, and consequences of alcohol abuse and alcoholism, including diagnosis, treatment, prevention, and health services research related to prevention and treatment of alcoholism. The NIAAA currently supports 14 Centers and anticipates that the level of support for this program will not expand during this competition. Support for three of the current 5-year Center grant awards will expire in late 1998. Research within each of these three Centers is organized around a central theme: medical epidemiology of alcohol abuse, clinical implications of alcohol in aging and the impact of alcohol on infectious disease. Applications for new Centers in these and other research areas will be accepted with applications from currently funded Centers seeking renewal support. It is estimated that approximately four to five million dollars will be available in FY 1999 to fund approximately three Centers. The total cost (direct plus indirect) for a Center may not exceed $1.7 million per year. 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, Alcohol Research Center Grants, is related to the priority area of alcohol abuse and alcoholism reduction. 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 202-512-1800). 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), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Ernestine Vanderveen, Ph.D. Centers Program National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 - MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-2530 FAX: (301) 594-0673 Email: tvander@willco.niaaa.nih.gov $$R10 END *********************************************************** $$P1 BEGIN PA-97-055 FULL-TEXT ************************************** PRIORITIES IN BEHAVIORAL RESEARCH IN CANCER PREVENTION AND CONTROL NIH Guide, Volume 26, Number 13, April 25, 1997 PA AVAILABLE: PA-97-055 P.T. 34; K.W. 0715035, 0404000, 0745027 National Cancer Institute National Institute of Dental Research PURPOSE The National Cancer Institute (NCI), and the National Institute of Dental Research invite researchers to submit research project grant (R01) applications that address behavioral research issues in cancer prevention and control. This Program Announcement (PA) addresses recommendations made by a special Behavioral Research in Cancer Prevention and Control Working Group in 1996 that consisted of leading national experts whose role was to identify behavioral research needs in cancer prevention and control during the coming years. This multi-disciplinary Working Group reviewed and refined the series of recommendations for priorities in behavioral research which was generated at a 1995 meeting. Members were asked to consider the successes and failures of behavioral research in the past decade, as well as the emerging challenges posed by scientific advances and changes in healthcare delivery. The recommendations that were generated based on these considerations and on the following criteria: (1) strength of the scientific evidence, (2) potential for reducing the cancer burden, (3) responsiveness to opportunities arising from advances in basic science and technology, (4) availability of technologies, (5) feasibility of implementation, and (6) achievable and measurable goals and outcomes. Copies of the Report of the Working Group: Priorities in Behavioral Research in Cancer Prevention and Control can be obtained from the National Cancer Institute, 6130 Executive Boulevard, Suite 232, MSC 7330, Bethesda, MD 20892-7330; telephone (301) 496-8520; or via the Internet: http://www.dcpc.nci.nih.gov/PCEB/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 PA, Priorities in Behavioral Research in Cancer Prevention and Control, is related to the priority areas of cancer, nutrition and tobacco. 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 202/512-1800). 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), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Ms. Veronica Chollett National Cancer Institute 6130 Executive Boulevard, Room 232, MSC 7330 Bethesda, MD 20892-7330 Telephone: (301) 435-2837 Email: vc24a@nih.gov Dr. Patricia Bryant Behavior, Health Promotion, and Environment Program National Institute of Dental Research 45 Center Drive, Room 4AN24E Bethesda, MD 20892 Telephone: (301) 594-2095 Email: BryantP@de45.nidr.nih.gov $$P1 END ************************************************************ $$P2 BEGIN PAR-97-056 FULL-TEXT ************************************* INTEGRATED PRECLINICAL/CLINICAL AIDS VACCINE DEVELOPMENT NIH Guide, Volume 26, Number 13, April 25, 1997 PA AVAILABLE: PAR-97-056 P.T. 34; K.W. 0715008, 0740075 National Institute of Allergy and Infectious Diseases Application Receipt Dates: July 30, 1997, July 30, 1998, July 30, 1999 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) gives special consideration for funding to scientifically meritorious applications in response to Program Announcements (PAs), including award of grants beyond our regular percentile and priority score paylines. NIAID PAs identify current areas of ongoing research emphasis for NIAID. The Division of AIDS (DAIDS), NIAID invites program project (P01) grant applications for research and development efforts directed toward obtaining a safe and efficacious vaccine to protect against HIV-1 infection or AIDS. The aim of this program, Integrated Preclinical/Clinical AIDS Vaccine Development, is to encourage the process of laboratory-to-clinic development, evaluation, and refinement of vaccine concepts. This PA expands upon the current National Cooperative Vaccine Development Groups (NCVDG) program to include limited human clinical trials. Applicants may apply for support for preclinical/basic research aimed at creation of vaccines and testing in animal models, vaccine lot production and toxicology testing, and limited clinical studies in humans. The information obtained in human studies can then be used to refine the vaccine approach, or advance the product further in human 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 PA, Integrated Preclinical/Clinical AIDS Vaccine Development, is related to the priority areas of HIV infection and immunization, and infectious diseases. 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) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). 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), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Dr. Steven Bende Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2A29 Bethesda, MD 20892-7620 Telephone: (301) 435-3756 FAX: (301) 402-3684 Email: sb22k@nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-97-057 FULL-TEXT ************************************** EPIDEMIOLOGY OF AIDS/RETROVIRAL-ASSOCIATED CANCERS NIH Guide, Volume 26, Number 13, April 25, 1997 PA AVAILABLE: PA-97-057 P.T. 34; K.W. 0715035, 0715008, 0760082 National Cancer Institute PURPOSE The Division of Cancer Epidemiology and Genetics of the National Cancer Institute (NCI) invites research project grant applications for innovative interdisciplinary studies to better understand the occurrence and molecular epidemiology of pre-neoplastic conditions and cancers that occur within the contexts of underlying infection with human retroviruses such as HIV/AIDS, non-infectious causes of immunosuppression such as organ transplantation, or subsequent to anti-retroviral therapies, particularly zidovudine and other nucleoside reverse transcriptase inhibitors. The mechanism of support will be research project grants (R01), First Independent Research Support and Transition (FIRST) (R29), exploratory/developmental (R21) grants, and supplements to existing NIH-funded research projects and cooperative agreements. 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, Epidemiology of AIDS/Retroviral-Associated Cancers, is related to the priority areas of cancer 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. 017-001-10473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). 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), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Dr. S.L. Melnick Division of Cancer Epidemiology and Genetics National Cancer Institute 6130 Executive Boulevard, Suite 535, MSC 7395 Bethesda, MD 20892-7395 Telephone: (301) 496-9600 FAX: (301) 402-4279 Email: JASONC@EPNDCE.NCI.NIH.GOV $$P3 END ************************************************************ From owner-sci-resources@net.bio.net Sun Apr 27 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA MH-97-003 - V26(13) 04/25/97 Date: 28 Apr 1997 15:59:48 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 496 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5k3a54$mhs@net.bio.net> NNTP-Posting-Host: net.bio.net MOLECULAR APPROACHES TO MENTAL DISORDERS OF LATE LIFE NIH GUIDE, Volume 26, Number 13, April 25, 1997 RFA: MH-97-003 P.T. 34; K.W. 0715129, 1002030, 0710105 National Institute of Mental Health Letter of Intent Receipt Date: June 5, 1997 Application Receipt Date: July 10, 1997 PURPOSE The principal objective of this Request for Applications (RFA) is to attract new investigators to build upon and extend basic research on fundamental aspects of neuronal function to develop clinical approaches to the understanding of mechanisms, clinical course, and treatment of late life mental disorders. The results of these investigations are expected to lead to the development of novel therapeutic strategies that reduce symptoms of psychopathology and improve neurobehavioral functioning in late life. The major focus of this RFA is on late onset mental disorders: psychoses, affective disorders, and anxiety disorders. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Molecular Approaches to Mental Disorders of Late Life, is related to the priority area of mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). 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. Foreign institutions are not eligible for these 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) First Independent Research Support and Transition (FIRST) (R29) award and the small grant program (R03) award. The anticipated award date is September 30, 1997. Investigators seeking support for topics relevant to this RFA through other mechanisms such as career development awards (K series) or other research grant mechanisms (R01, R10, etc.) are encouraged to submit investigator-initiated applications using regular NIH procedures. This RFA is 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. Because the small grants and FIRST awards have special eligibility requirements, application formats, and review criteria, applicants are strongly encouraged to consult with program staff listed under INQUIRIES and obtain the appropriate guidelines for these grant mechanisms. FUNDS AVAILABLE It is estimated that $750,000 (total costs) is available for support of up to 10 new awards. RESEARCH OBJECTIVES Background Dramatic advances have taken place in our understanding of the basic cellular and molecular biology of neuron function. Four areas of investigation have produced results that hold exceptional promise for application to the treatment of mental disorders of late life. These areas include: the molecular basis of signal transduction and its relation to neural plasticity and long term adaptation; neurotrophic growth factors and their effects on neural function and pathology; the mechanisms of programmed cell death in the aging brain; and the functional impact of cell death, growth factors, and signal transduction on patterns of neural connectivity and function. This RFA is intended to promote and facilitate the translation of these basic research findings into clinically applicable technologies. Major goals will be the elucidation of fundamental mechanisms of late life mental disorders with the intention of immediate or near-term development of novel therapeutic approaches. Clinical applications include depression, psychosis, and anxiety disorders of late life. As the molecular events associated with signal transduction are known in greater detail, it is increasingly appreciated that interactions between signaling molecules are a major determinant of how neurons respond to stimuli. Following activation of a receptor by its ligand, a cascade of biochemical events takes place. Changes in signal transduction systems are believed to form the basis for many phenomena associated with neural plasticity and adaptation to chronic stimuli. Thus chronic exposure to psychotropic drugs may lead to alterations in expression of G proteins, protein kinases, and many other signal transduction-associated molecules that alter the way neurons respond to synaptic transmitters. These chronic changes lead, in turn, to alterations in behavior, thought process, and affect. There is growing evidence that aging itself produces changes in signal transduction systems that alter neuronal function. The investigation of age-associated changes in signal transduction may lead to significant advances in our understanding of the mechanisms of mental disorders of late life and to the development of new treatment approaches. Molecular signaling processes often converge, overlap, and influence each other at many levels from receptors to transcription factors. Thus, a cell is constantly integrating signals from multiple neurotransmitters, growth factors, matrix and adhesion molecules, and hormones. This "crosstalk" between signaling systems may explain a wide variety of neurobiological phenomena ranging from LTP to cross-tolerance among addicting drugs. Crosstalk may also account for interactions that occur when combinations of psychotropic drugs are used to treat patients who have complex affective and psychotic symptoms or when augmentation strategies are employed to treat patients who are refractory to single agents. The aging process may produce alterations in patterns of crosstalk between signaling systems that result in significant functional changes in neurons. Interactions between growth factor-related signaling and neurotransmitter-associated systems is of special interest in understanding the effects of aging on central nervous system function. A major opportunity exists for the application of refined understanding of signal transduction mechanisms to the development of pharmacotherapeutics for late life mental disorders. In particular, the study of the effects of aging on signal transduction processes and neuronal plasticity will lead to new understanding of drug mechanisms and to the development of novel therapeutic strategies for mental disorders of late life. In addition, new augmentation strategies and drug combination protocols may be developed that exploit interactions between signaling systems. Moreover, signaling systems that are difficult to target with conventional pharmacotherapeutic agents such as growth factor or neuropeptide receptors may be influenced indirectly by activating or inhibiting distinct signaling pathways. Our knowledge of the mechanisms underlying destruction and degeneration of cell groups in the brain is rapidly advancing. Currently, there is substantial evidence that programmed cell death is a major mechanism underlying many neurodegenerative processes in the nervous system. Programmed cell death utilizes mechanisms and pathways that are common to many forms of injury including trauma, ischemia, infectious agents, and the aging processes. Neuronal cell death in specific brain regions is believed to be associated with the development of neuropsychiatric symptoms in late life. For example, degenerative changes of subcortical nuclei including the nucleus basalis of Meynert, the substantia nigra, the locus coeruleus, and the dorsal raphe may be associated with disorders of cognition, thought, affect, and anxiety in the elderly. In addition to neuronal cell death, mental disorders of aging may reflect dysregulation of growth factor activity leading to atrophic or dystrophic changes in neuron structure and function. Because of their role in preventing cell death, neurotrophic growth factors have been the subject of intense research as therapeutic agents in the treatment of neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, and Amyotrophic Lateral Sclerosis. In addition to blocking programmed cell death, neurotrophic growth factors are among the most potent modifiers of neuronal function known. Growth factors alter electrochemical activity, neurotransmitter synthesis and release, axonal transport, signal transduction, gene transcription, and cellular structure. Because of these properties, neurotrophic growth factors may be useful in the treatment of other mental disorders of aging that are believed to involve either atrophic or dystrophic changes in neurons. These disorders include late-onset psychoses, affective disorders, and anxiety disorders. Lastly, neurotrophic growth factors play a protective role in ischemic injury produced by stroke and microvascular disease. This suggests that growth factors may be useful in the treatment of vascular dementias, post-stroke depression, and other late life mental disorders associated with vascular insufficiency. In addition to growth factors, small molecules that influence growth factor signaling and apoptosis-related biochemical events are currently being developed and investigated. However, to facilitate this process, more research is needed into the basic mechanisms of cell death and growth factor action. In addition, research is needed to develop wider applications of neurotrophic and anti-apoptotic therapeutic strategies to diseases of the central nervous system. Neurotrophic growth factors and other drugs that exert trophic effects on neurons present an exceptional opportunity for investigation as novel therapeutic agents for mental disorders of late life. A central goal of this RFA is to stimulate the investigation of the mechanisms of action of neurotrophic growth factors and to explore potential therapeutic applications of growth factors and related agents to neuropsychiatric disorders of aging. Major opportunities for advancing the field exist in each of the following areas: 1) elucidation of basic biochemical mechanisms of programmed cell death and neurotrophic growth factor action; 2) application of growth factors to the treatment of neuropsychiatric disorders (including development of novel strategies for CNS delivery); 3) development of small molecules the mimic the effects of growth factors or modulate growth factor signaling; 4) exploration of other novel anti-apoptotic therapeutic agents. Neural cell death, atrophy, and other age-related changes profoundly alter patterns of connectivity and neural circuitry in the aging brain. In addition, neurotrophic growth factors have recently been shown to significantly influence connectivity. Moreover, biochemical changes in signal transduction mechanisms influence the functional and electrophysiological properties of neural circuits. Therefore, a pivotal step in the translation of molecular research into behavioral and clinical application is the investigation of neural connectivity in the aging brain. Rapid advances are being made in the study of neural circuitry and its relationship to behavior. A major area to be supported by this RFA focuses on investigation of molecular processes of aging at the level of neural connectivity emphasizing its implications for behavior and therapeutics. Research Issues Broad research objectives appropriate to this RFA include (but are not limited to) the following: Identification of changes in signal transduction systems that occur in normal aging and disease states Elucidation of the molecular mechanisms of enhanced receptor sensitivity following chronic dopaminergic receptor blockade Evaluation of the chronic effects of drug treatment and stress on signaling proteins in the aging brain Anatomical and electrophysiological studies of the effects of growth factors and chronic drug treatment on neural circuitry and behavior in the aging brain Investigation of interactions between signaling systems (e.g. growth factor-induced kinase activity that modulates neurotransmitter-associated signaling cascades)in the aging brain Investigation of changes in expression of neurotrophic growth factors, cytokines, growth factor-associated receptors and signaling molecules in the aging brain Identification of novel neurotrophic factors and cytokines expressed in the aging brain Investigation of the physiological role of growth factors and cytokines in the adult brain Investigation of non-neurotrophic effects of growth factors on neuronal functioning Elucidation of basic mechanisms of programmed cell death in the aging brain as it may relate to late life mental disorders Development and application of small molecules that influence (activate or inhibit) growth factor-related signaling and apoptotic cell death mechanisms such as tyrosine phosphatase inhibitors, ICE inhibitors, bcl-2-like molecules etc. Development of technology to improve delivery of growth factors and other large molecular ligands across the blood brain barrier Studies of neurobehavioral effects of neurotrophic growth factors and cytokines in the aging brain Application of antisense technology to modulate expression of key signaling, neurotrophin-related, or apoptosis-associated gene to determine effects of such procedures on behavior Development of clinical imaging technology to assess signal transduction systems in the aging brain Development of clinical pharmacological challenge protocols that assess signal transduction and trophic states in the aging brain 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 June 5, 1997, 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: Herbert W. Harris, M.D., Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health Parklawn Building, Room 18-101 Rockville, MD 20857 Telephone: (301) 443-1185 FAX: (301) 574-6784 E-mail: hharris@ngmsmtp.nimh.nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) 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 Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910; telephone (301) 435-0714; fax (301) 480-0525; Email: ASKNIH@ODROCKM1.OD.NIH.GOV. Applications for the FIRST award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The RFA label available in the PHS 398 (rev. 5/95) 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, MH-97-003, Molecular Approaches to Mental Disorders of Late Life, must be typed in section 2 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 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight mail service) At the time of submission, two additional copies of the application must be sent to: Henry J. Haigler, Sr., Ph.D. Division of Extramural Activities National Institute of Mental Health Parklawn Building, Room 9C-08 Rockville, MD 20857 Telephone: (301) 443-1340 Fax: (301) 594-0702 Email: hhaigler@nih.gov Applications must be received by July 10, 1997. 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 the NIH Division of Research Grants (DRG) and for responsiveness by NIMH staff. 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 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, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board, when applicable. Review Criteria o ability of investigators to engage a multi disciplinary research program spanning basic to clinical research with the endpoint of enhancing our understanding of mental disorders of late life o Focus of the investigation on the specific mental disorders of aging which include: major mood disorders, anxiety disorders, psychotic (thought) disorders with a lesser focus on Alzheimer's disease 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, 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 Award criteria are: scientific merit as determined by peer review, availability of funds, and programmatic priorities. 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: Herbert W. Harris, M.D., Ph.D. Mental Disorders of the Aging Research Branch Division of Clinical and Treatment Research National Institute of Mental Health Parklawn Building, Room 18-101 Rockville, MD 20857 Telephone: (301) 443-1185 FAX: (301) 574-6784 E-mail hharris@helix.nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Assistant Chief, Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994). PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the nonuse of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun Apr 27 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA MH-97-002 - V26(13) 04/25/97 Date: 28 Apr 1997 15:59:15 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 467 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5k3a43$mgc@net.bio.net> NNTP-Posting-Host: net.bio.net TREATMENT OF PRIMARY MOOD DISORDERS IN THE COMORBIDLY ILL NIH GUIDE, Volume 26, Number 13, April 25, 1997 RFA: MH-97-002 P.T. 34; K.W. 0715129, 0404003, 0404009 National Institute of Mental Health Letter of Intent Receipt Date: June 5, 1997 Application Receipt Date: July 10, 1997 PURPOSE The National Institute of Mental Health (NIMH) announces the availability of competitive supplementary support for existing clinical therapeutic research grants to study the efficacy and effectiveness of treatment of primary mood disorders in individuals with co-occurring mental, alcohol or substance abuse disorders, with or without associated physical disorders. The purpose is to optimize mental health treatments for primary mood disorders in the presence of comorbid disorders which occur frequently in clinical settings, complicating usual treatment efforts, but which generally preclude participation in controlled clinical treatment 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), Treatment of Primary Mood Disorders in the Comorbidly Ill, is related to the priority areas of reduction of tobacco use (objectives 3.4, 3.14, 3.16), increased evaluation and treatment of alcohol and substance use disorders (4.12, 4.19), reduction of rate of suicide (6.1), and enhanced recognition, diagnosis, and treatment of mood disorders (6.7, 6.8, 6.13). 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 202-512-1800). ELIGIBILITY REQUIREMENTS Applications for supplementary support may be submitted by Principal Investigators of National Institute of Mental Health (NIMH) grants focused on the treatment of mood disorders. 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. To be eligible for consideration for this competitive supplement, current treatment grants must be active and funded at the time of application, with a minimum of two years' funding remaining at the time of expected award. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use competitive supplements to the following NIH research project grant mechanisms: R01, R10, R18, R21, R37, P01, P30, P50, or U01. (Foreign institutions are not elibible to apply for P01, P30, or P50 supplements.) Questions about these grant mechanisms should be directed to Institute program staff (listed under INQUIRIES). This RFA is one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 1997. The total project period for an application submitted in response to this RFA may not exceed the tenure remaining on the parent grant to be supplemented. FUNDS AVAILABLE It is anticipated that at least $500,000 in direct costs will be made available. Direct costs for the first year of supplemental funding under this RFA may not exceed that of the previous year of the parent grant, up to a maximum of $200,000. Funding for subsequent years is dependent on demonstrated progress in meeting the goals of the project and on the continued availability of funds. TERMS AND CONDITIONS OF SUPPORT Supplemental funds may be used for expenses clearly related and necessary to conduct the proposed supplemental treatment research, including both direct and allowable indirect costs. Supplemental funds may not be used to conduct research that is an integral part of the parent grant, and may not be used to operate a treatment, rehabilitation, or other service program. RESEARCH OBJECTIVES Background The considerable advances made in the treatment of mood disorders over the past generation have largely been accomplished through the application of carefully controlled clinical trials. Rigorous attention to research methodology, including sharply focused inclusion and exclusion criteria designed to achieve homogenous study samples, has been necessary to assure the scientific validity of treatment trials in mood disorders. However, increasingly it is being recognized that an inadvertent limitation of this narrowly based research design has been difficulty in generalizing the resulting findings to nonprotocol clinical populations. In clinical settings, many patients with mood or other mental disorders presenting for treatment prove to suffer from coexisting mental health or substance use problems, which confound or interfere with treatment of a primary mood disorder and often constitute a focus for treatment in their own right. Such individuals as a rule are not represented in controlled clinical trials of mood disorder treatments, as comorbidity is a common exclusion criterion in such studies. Thus, frequently even a large research data base cannot be applied to nonprotocol patients in the clinic. Moreover, usual treatments for mood disorders may demonstrate an altered benefit:risk ratio in the presence of certain comorbidities, or may fail to work as expected under such circumstances. Examples of comorbid conditions affecting mood disorder patients, of interest for the present request for applications, include the following: o Other mental disorders. Depression in particular is often accompanied by other DSM-IV Axis I disorders. For example, speakers at a recent NIMH workshop identified comorbid panic disorder as a common cause of treatment-resistant depression. Of note, depression secondary to other mental disorders is not the focus of this RFA dealing with the treatment of primary mood disorders. As the multiaxial system of DSM-IV permits the diagnosis of personality disorders concurrently with Axis I mood disorders, these chronic Axis II conditions, affecting perhaps half of primary mood disorder patients and long associated with impaired response to conventional treatments of mood disorders, are appropriate candidates for study. o Alcohol and substance abuse and dependence disorders. The importance of substance use disorders as comorbid conditions accompanying mood disorders was highlighted by the NIMH Epidemiologic Catchment Area (ECA) study, a community-based survey that identified an increased risk for alcohol or substance abuse or dependence in individuals with diagnosed mood disorders that was even greater than the average enhanced risk evidenced by subjects with any mental disorder. For example, more than 60% of individuals with bipolar I disorder have an active substance abuse problem, with nonalcohol drug abuse or dependence 11-times greater than in people without bipolar disorder. While less common than in bipolar patients, alcohol and substance use diagnoses in unipolar depressed patients still exceed those found in the general population. These concurrent problems contribute to the morbidity of mood disorders, including frequency of hospitalizations, to difficulties with adherence to treatment regimens, and to refractoriness to conventional therapies of comorbid mood disorders. Certainly, mood disorders often occur secondary to alcohol or substance abuse or dependence. Applications regarding the treatment of such secondary mood disorders are not the province of this request for applications, and should be directed, as appropriate, to program staff at the National Institute on Alcohol Abuse and Alcoholism (NIAAA) or the National Institute on Drug Abuse (NIDA). o Physical health disorders. As with all individuals, people with mental disorders may also suffer from impairment of their physical health. Some evidence suggests that certain types of physical illness, such as cardiovascular disease, may be more prevalent in patients with mood disorders than in the general population. Expansion of current study inclusion criteria under this RFA to encompass mood disordered patients with comorbid conditions can be expected to increase the likelihood of co-existing physical illness, such as gastrointestinal and liver dysfunction in patients with active alcohol abuse or dependence. Investigators are encouraged to include such physically impaired subjects when scientifically justified and feasible. However, medical illness should not be the sole comorbid condition under study. Although depression in the medically ill is sometimes felt to be an "understandable" reaction to disease or disability, the DSM-IV multiaxial diagnostic system recognizes the independence of assessment of mood disorders (Axis I) and physical health impairments (Axis III). Consequently, for purposes of this request for applications, mood disorders need not be considered "secondary" to physical health problems and thus not appropriate for research under this RFA except when clearly organic in etiology, e.g. the direct result of injury to brain tissue, or medication (such as reserpine or steroids)-induced. Research Issues The aim of this announcement is to encourage research focusing on optimizing the efficacy and effectiveness of treatment of primary mood disorders in the context of comorbid mental disorders, including concurrent alcohol or substance abuse or dependence. For purposes of this announcement, the group of mood disorders are those recognized by the Diagnostic and Statistical Manual, 4th Edition (DSM-IV, 1994), including bipolar disorder, unipolar depression, dysthymia, and their defined subtypes. Except as specified below, the descriptor "primary" refers to temporal sequence of diagnostic entities, such that patients studied under the terms of this announcement would be expected to have been diagnosed with a mood disorder at a time prior to the diagnosis of any other Axis I disorder. This restriction is not absolute in terms of comorbid Axis II or III disorders (see above). Many of the issues involved are confronted regularly in clinical settings in the absence of an adequate well-researched data base. Studies that will advance the field by addressing the following or similar outstanding questions are encouraged: o Does the presence of a comorbid disorder alter the adverse effects of mood disorder treatments, either qualitatively or quantitatively? o How can adherence to treatment plans be maximized in the comorbidly ill mood disorder patient? o In the presence of comorbid mental or substance use disorders, is the pathophysiology of primary mood disorders altered in ways that have implications for treatment? o What is the optimal relationship and sequencing of treatment of the presenting mood disorder and comorbid disorders? How is this affected by the nature and severity of the comorbid condition? o Are there relevant pharmacokinetic and pharmacodynamic considerations in using antidepressant, antimanic, and mood-stabilizing medications in the face of additional concurrent psychopathology or alcohol/substance abuse, with or without physical illness? How should medication choice or dosing be adjusted in comorbidly ill patients? What are the gaps in knowledge regarding interactions between drugs used in the treatment of mood disorders and those prescribed for the most common comorbid physical illnesses? o For which patients is psychotherapy or psychosocial rehabilitation likely to be helpful? When should these interventions be attempted alone, as opposed to combined with pharmacotherapy? o What is the role of nonpharmacological somatic treatments, such as electroconvulsive therapy (ECT), bright light treatment, sleep deprivation, or repetitive transcranial magnetic stimulation (rTMS), in the treatment of primary mood disorders comorbid with other disorders? o Are there predictors of response or nonresponse to treatment for primary mood disorders with specific therapies in the presence of particular comorbid conditions? In addition, general issues confronting all treatment research are relevant for consideration in responses to the present announcement. These include: o Evaluation of any variation in efficacy, effectiveness, or toxicity of treatment of comorbid mood and other mental/physical disorders across ethnic, racial, or age groups o Need for development and utilization of valid and reliable measures of social and vocational skills, behavioral stability, functional capabilities, quality of life, and cost-effectiveness to complement the measures of psychopathology heavily emphasized in most treatment studies 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 June 5, 1997 a letter of intent that includes the title, number, and source of the existing PHS treatment grant for which supplementary funding is sought. Additional requested information includes a descriptive title of the proposed research, the name, mailing and Email address, and telephone / FAX numbers of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this request for applications. 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 should be sent to: Matthew V. Rudorfer, M.D. Assistant Chief, Clinical Treatment Research Branch Division of Clinical and Treatment Research National Institute of Mental Health Parklawn Building 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301)443-4527 FAX: (301)480-4417 Email: mrudorfe@nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research or from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910; telephone (301) 435-0714; fax (301) 480-0525; Email: ASKNIH@ODROCKM1.OD.NIH.GOV. The RFA label available in the PHS 398 (rev. 5/95) 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, Treatment of Primary Mood Disorders in the Comorbidly Ill, MH-97-002, must be typed in section 2 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 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight mail service) At the time of submission, two additional copies of the application must be sent to: Mary Lou Prince Clinical Treatment Research Branch Division of Clinical and Treatment Research National Institute of Mental Health Parklawn Building 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Applications must be received by July 10, 1997. 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 the NIH Division of Research Grants (DRG) and for responsiveness by NIMH staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the Request for Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened in July / August 1997 in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Mental Health Advisory Council in September 1997. Review criteria o suitability of the currently funded treatment research grant for adaptation to the presence of comorbid disorders; 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, including adequete numbers of appropriately diagnosed subjects; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. 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 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 Competitive supplements under this RFA will be awarded based on scientific merit as determined by peer review, availability of funds, and programmatic priorities. 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: Matthew V. Rudorfer, M.D. Division of Clinical and Treatment Research National Institute of Mental Health Parklawn Building 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301)443-4527 FAX: (301)480-4417 Email: mrudorfe@nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Assistant Chief, Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-08 Rockville, MD 20857 Telephone: (301)443-2805 FAX: (301)443-6885 Email: Diana_Trunnell@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994). PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the nonuse of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun Apr 27 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AA-97-005 - V26(13) 04/25/97 Date: 28 Apr 1997 16:00:24 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 878 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5k3a68$mmm@net.bio.net> NNTP-Posting-Host: net.bio.net ALCOHOL RESEARCH CENTER GRANTS NIH GUIDE, Volume 26, Number 13, April 25, 1997 RFA: AA-97-005 P.T. 34; K.W. 0404003, 0710030 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: November 19, 1997 Application Receipt Date: December 19, 1997 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) provides grant support for Alcohol Research Centers to conduct interdisciplinary research on alcoholism and alcohol abuse. The Center grants program is interrelated with and complementary to all other research support mechanisms and scientific activities that comprise the NIAAA programs of research on the nature, causes, and consequences of alcohol abuse and alcoholism, including diagnosis, treatment, prevention, and health services research related to prevention and treatment of alcoholism. The NIAAA currently supports 14 Centers and anticipates that the level of support for this program will not expand during this competition. Support for three of the current 5-year Center grant awards will expire in late 1998. Research within each of these three Centers is organized around a central theme: medical epidemiology of alcohol abuse, clinical implications of alcohol in aging and the impact of alcohol on infectious disease. Applications for new Centers in these and other research areas will be accepted with applications from currently funded Centers seeking renewal support. 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, Alcohol Research Center Grants, is related to the priority area of alcohol abuse and alcoholism reduction. 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, D.C. 20402-9325 (Telephone 202-512-1800). ELIGIBILITY Any domestic public (non-Federal) or private non-profit or for-profit institution may apply for a Center grant. However, the proposed Center must be affiliated with an institution, such as a university, medical center, or research center, that has the resources to sustain a long-term, coordinated research program. An applicant institution must demonstrate the ability to attract high-quality scientists from biomedical, behavioral, and/or social science disciplines who are willing to make a long-term commitment to research. An application must also have a detailed 5-year plan for a proposed research program. In addition, the applicant must assure that research training opportunities will be available. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The Alcohol Research Centers Grant program is designed to complement the regular research project grants program of the NIAAA by providing long-term (typically, for 5 years) support for interdisciplinary research programs with a distinct focus on a particular theme relating to alcoholism, alcohol abuse, and other alcohol-related problems. The program is intended to encourage outstanding scientists from biomedical, behavioral, social science, and other relevant disciplines to bring a full range of expertise, approaches, and advanced technologies to the study of problems related to alcohol abuse and alcoholism. Center grants help to provide a stable environment for investigators to engage in alcohol research in a coordinated and integrated effort. A Center is expected to be a source of scientific excellence, provide leadership to the field, and, through sustained excellence, to become a significant regional or national research resource. In addition, the applicant institution is expected to afford opportunities for research training to persons from various disciplines and professions. A specialized Center (P50) is a comprehensive, broad-based multidisciplinary, multi-investigator, long-term program of combined research and research support activity planned around a specific major research objective or research theme. In addition to providing support for shared resources, this type of Center supports a full range of basic, developmental, clinical, and/or applied research components; allows for growth and development through pilot projects; and is intended to provide state-of-the-art leadership in the alcohol field. FUNDS AVAILABLE It is estimated that approximately four to five million dollars will be available in FY 1999 to fund approximately three Centers. The total cost (direct plus indirect) for a Center may not exceed $1.7 million per year. Continuation support in the future years is anticipated. RESEARCH OBJECTIVES All proposed research to be conducted within a Center must be clearly directed toward one or more of the following goals: prevalence, etiology, diagnosis, prediction, clinical course, management or treatment of alcohol abuse, alcoholism, or alcohol-related health problems; health services research; consequences of alcoholism or alcohol abuse; and factors that relate to prevention of alcohol abuse, alcoholism, or other problems associated with alcohol consumption. Some examples are research to improve knowledge of the impact of alcohol use on related health issues, such as cardiovascular integrity; disease pathogenesis and progression; liver and gastrointestinal functioning; nicotine and other drug use; performance ability; neurological impairment; and mental disorders that co-occur with alcohol abuse disorders. The Alcohol Research Center grant provides a mechanism for fostering interdisciplinary cooperation in a group of established investigators conducting high-quality alcohol research. Therefore, existence of a strong research capability is fundamental to the establishment of a new Center or the continuation of an existing Center. A Center should be an identifiable organizational unit within an institutional or organizational structure such as a university, medical center, or a consortium of affiliated cooperating institutions. Unique scientific opportunities warrant collaboration with investigators in other centers and/or with scientists in institutions outside the United States. In such cases the director of the components in which collaborative activity with a foreign organization is proposed must be affiliated with a domestic institution. Center Components The following paragraphs describe the specific components of a Center application: Administrative Core Component A Center should promote synergistic interaction of broad and diverse elements that require clearly specified lines of authority and accountability by appropriate institutional officials. The purpose of the administrative core component is to provide the organizational framework for the management, direction, and coordination of the Center. The administrative core component must be managed by the Center Director or Scientific Director and may include funds for scientific enrichment activities such as special lectures, visiting scientists, symposia, seminars, workshops etc.; and for education and research dissemination activities for the public. Scientific Core Components Core components for this RFA are defined as shared research resources that enhance productivity or in other ways benefit a group of investigators working in alcohol-related research to accomplish the common goals of the Center. A core component is a laboratory, facility, service, or other resource that interacts synergistically with research projects of the Center. Cores should primarily be used to support projects which are part of the Center Grant award, but they may also be used for other support mechanisms such as Research Project Grants, Program Projects, or a combination thereof, that have relevance to the NIAAA mission. Core components should provide investigators with some technique, instrumentation, service, or resource in a way that will enhance research progress and contribute to efficiency and effectiveness. Each core component is directed by an investigator with established expertise relative to the support or service to be provided, usually a faculty-level individual. Some examples of research support that core components typically provide are: (1) technology that implements automation or large batch preparation; (2) tissue and/or cell culture facilities; (3) complex instrumentation, e.g., electron microscopy, mass spectrometry, electrophysiology; (4) animal care and preparation; (5) service and training; (6) patient coordination; and (7) information processing, data management, and statistical services. Research Components Research components are individual scientific research projects, interrelated within the overall Center program so that the components contribute collectively to the goals of the Center program to a greater extent than if each project were pursued separately. Each research component must be a highly focussed project under the direction of a component director. The component director should be an established researcher of independent and scientifically recognized standing who is responsible for the scientific direction and conduct of the individual research component. A Center Director or Scientific Director may also serve as a component director. Pilot Project Component The purpose of pilot projects is to provide the Center with a flexible means to develop and explore new research activities or directions, and unique scientific opportunities that could evolve into independently funded research projects. These funds are not intended to supplement ongoing research projects. Pilot projects must be in a separate pilot project component that incorporates all of the pilot studies of the proposed Center grant. SPECIAL REQUIREMENTS The following paragraphs describe the Special Requirements for a Center application. Details for preparing the application are provided in the "Supplemental Instructions," which are available from the program staff listed under INQUIRIES. It is essential that applicants carefully adhere to the Supplemental Instructions. Center grant applications should be organized into discrete components that comprise a proposed program of research. Each component is either a research component or a core component for which a separate detailed budget is included in the application. The application must include an administrative core and at least three research components; it may also include shared scientific resource cores and/or a pilot project component. The minimum acceptable combined number of research components and core components is four (an administrative core and three research components). The maximum combined number of research components and core components, including a pilot project component, is 10. More than a total of 10 components is not acceptable even if some components are in operation for less than the 5-year period. All proposed research components need not be ongoing at any one time, but may be phased in at different time points during the life of the proposed Center grant. At least three research components must be ongoing at all times, and no more than 10 research and/or core components may be proposed over the entire project period. This aspect should receive careful attention in the application and individual component preparation. The research plan for each core component and each research component is limited to 25 pages. Pages not used for one component may not be used to extend the page limit of other components/cores. These page limits do not apply to pilot projects. For pilot project requirements, see section entitled "Pilot Project Component," (below). Administrative Core Component The administrative core component plays a key role in the coordination and operation of the Center. This core should be described in sufficient detail to assure that all proposed components and related activities will function optimally and in an interactive synergistic manner. An important function of this core is the administration of the budget. Through this component, the Center Director provides substantive leadership and manages the administrative core component. This component may also include the costs of scientific enrichment, education, and information dissemination activities. The administrative core should also provide for integration of Center functions. Scientific Core Components Each shared scientific resource component should be clearly described in terms of the services/resources to be provided to investigators. The description should include a discussion of the core's contributions to the research objectives of the Center. Relevant aspects of cost effectiveness, time-saving, and increased efficiency attributable to the existence of the cores should also be addressed. A core component should support Center grant research components and may also support separately funded research project grants that are related to the Center's theme. Each separately funded research project associated with the Center and utilizing core facilities should have a brief description that includes its research objectives and how the Center's core facility will impact upon it. The minimum number of research components/projects supported by a core component is two. A core component director who has documented experience and scientific expertise relative to the purpose of the core must be designated for each core. This person should be an established scientist in his or her field. The description of the organization and mode of operation of the shared resource core should include discussion of quality control for the service or resource, and the procedures for evaluating and selecting projects eligible for use of the core facility. Training in complex techniques and methods should be described if they are functions in proposed cores. Core components are intended to enhance opportunities for investigators at the Center to include new technologies that broaden their research initiatives. While, research per se is not conducted as part of the scientific core, quality assurance activities that evaluate the operation, resources, quality and utilization of the core and that are directed at problem identification and improvement of core functioning are appropriate. In renewal applications, ongoing or completed core activity that has enhanced or facilitated alcohol research should be described. Past performance and accomplishments of cores should be described, as should the effect of services provided by cores on investigators' productivity. Research Components For each proposed research component, a clear description of the major goals, objectives, and its integration with the other components in relation to the overall Center program should be provided. o The question(s) to be addressed and the hypotheses to be tested by the proposed research should be highly focused and fully explained. o A discussion of the design and procedures should describe the strategies proposed to accomplish the specific aims of the project and highlight innovative aspects of the approach. o A description of the resources and working arrangements required to implement and conduct the proposed research should be fully elaborated with particular attention devoted to a description of necessary resources, subjects, clinical populations, tissue resources, etc., which will be involved in proposed studies. If core facilities are utilized, information on their use should be provided. Pilot Project Component The process for selecting pilot projects should be fully, though concisely described. For the first 2 years that funds are requested for pilot projects, the application must provide descriptions of the projects to be supported. For years 03-05, the application must provide the specific number of pilots planned in each year and a brief description of the anticipated direction of these pilots. While the specific number of pilot projects to be proposed is at the discretion of the applicant, requested funding for pilot studies may not exceed $100,000 or 10 percent (whichever is larger) of the direct cost budget proposed for any 1 year. All proposed pilot projects need not be ongoing at any one time, but may be phased in at different points during the life of the proposed Center grant. It is recognized that the relative priority or need for specific pilot projects may change over the course of time. While the Center's framework for management of pilot funds and the mechanism for operating the program are left to the discretion of the Center, the application must provide specific information to enable adequate scientific evaluation by a peer review committee. The application should include: o A full description of the management of the pilot project component, including a description of the process to be followed by the Center Director in selecting new pilot projects and replacing projects proposed in the application, should it become necessary. o A full description of each pilot study proposed in the first 2 years, including its rationale, objectives, approach, investigators, and significance for the Center. A description of the number and anticipated direction of pilot projects in the 03-05 years, including their significance to the Center. The research description of any individual pilot project may not exceed five pages; the entire narrative for this Pilot Project Component may not exceed 25 pages irrespective of the number of pilot projects proposed. o For competing renewal applications, information should be provided in the pilot project component description on the past experience of the Center in utilizing pilot funds to further the goals. The narrative should include an assessment of the overall benefits derived from the availability of pilot resources. A budget should be submitted for the pilot project component as a whole for each year in which pilots are proposed. For years 01 and 02 this budget will reflect costs of pilots proposed in the application. For years 03-05 the budget will estimate cost based on the number and kind of work to be pursued. In addition, budget information should be provided for each individual pilot project including those for the 03-05 years. See "Supplemental Instructions" for further information on pilot project description requirements. Renewal Applications A comprehensive progress report is required for competing continuation (renewal) applications. A statement must be included in the application regarding the progress made by the Center as a whole in its development as a national or regional research resource. In addition, for each research component of the existing Center grant, a succinct account of its published and unpublished results must be provided, indicating progress toward achieving aims regardless of whether the component has been submitted for renewal. More specific details are provided in the Supplemental Instructions. Facilities and Environment Applicants must demonstrate the availability of adequate laboratory, clinical, and office facilities needed to carry out the objectives of the proposed Center program. Although not required, it is desirable for all Centers to have a commitment for sufficient contiguous space so that the Center has a high degree of cohesion and visibility. Reference facilities affording access to relevant literature must be readily available. It is expected that such reference facilities will be the primary repository of additional reference materials that may be obtained through Center funding. Relevant support services, including adequate data processing facilities, must also be readily accessible within or through the institution. Assurances of such support must be included with the proposal. Organization and Administration A Center must be an identifiable organizational unit with an administrative structure and clear lines of authority which will facilitate coordination among Center personnel to assure maximum accountability and efficiency in Center operations. An applicant must designate an institutional official to serve as principal investigator for the Center grant and as Director of the Center. The institutional appointment of this person must provide sufficient authority to allocate space, personnel, and other resources essential to the Center. This individual must demonstrate the ability to organize, administer, and direct the Center. The Director of the Center will have responsibility for planning and coordination of the Center program, preparation of the budget and oversight of expenditures, staff appointments, space allocation, and other aspects of management and operation of the Center. Overall program management, coordination, communication, progress assessment, and quality control are typically responsibilities of the Director and are facilitated through the administrative core. The administrative core should be described in sufficient detail to assure that all proposed components and related activities will function optimally. In addition, day-to-day operations involving procurement, finances, personnel, planning, and budgeting should be detailed in the description of this core. The applicant may also designate a Scientific Director who will be responsible to the Center Director and provide direct supervision of the scientific and operational aspects of the research program. Such a person should be an individual who has established scientific credentials and who is capable of providing the leadership essential to the success of the research program. The Scientific Director will be responsible for assuring interaction and collaboration among scientists conducting research within the Center to facilitate a concerted approach to the research goals of the Center. The Scientific Director also will be responsible for the direct monitoring of ongoing research and for identifying (with the assistance of colleagues) research activities to be expanded or decreased and needs for additional resources or reallocation of resources. If the Center Director also serves as the Scientific Director, his or her functions as Scientific Director should also be described. Key professional staff, such as directors of individual research components and core components of the Center, should have the necessary training/experience to assure that the objectives and goals of the proposed studies will be achieved. Such persons must be independent investigators with scientifically recognized standing. A Program Advisory Committee shall be established and chaired by the Center Director. Its membership, selected by the Center Director >From individuals outside the Center, should be composed of at least five members who should be identified in the application. Members should be persons of recognized scientific standing who are generally familiar with the Center's activities and represent a cross-section of disciplines that are relevant to the work of the proposed Center. It shall be the responsibility of this Committee to review and make recommendations to the Center Director on the conduct of all activities of the Center, including the management of pilot projects. If committees other than the Program Advisory Committee are included, specific plans regarding committee selection and function should be provided in the application. Training While the primary function of each Center is the conduct of high-quality interdisciplinary research, an important component related to the Center and its research efforts is the training of research and clinical personnel. The applicant institution must therefore demonstrate or give reasonable assurances that it has: (a) the capacity to train predoctoral and/or postdoctoral students for careers in alcohol research; and (b) the capacity to conduct programs of continuing education in the Center's designated research theme in the medical, behavioral, or health service fields. While the Center need not necessarily have formal training programs of its own, there must be specific provision for coordination between the Center and the training programs of the applicant institution and/or affiliated institutions. Center grant funds may not be used to pay stipends or other trainee costs; however, Center staff may participate in the development of training programs, and Center resources may be made available for use of trainees. 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, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. Terms and Conditions of Support Center grant funds may be requested for support of core components and individual research components associated with the Center program. Administrative core resources may include, for example, salaries of personnel responsible for management of the Center, program enrichment activities such as special lectures, visiting scientists, symposia, seminars, workshops, etc., and costs related to dissemination of research information to the scientific community and lay public. Funds may be requested for costs associated with individual research components that are part of the Center program. Examples of such costs include: research staff salaries, supplies, travel, special consultation, research patient costs, publication costs, and the like. Funds also may be requested for the allowable indirect costs of the applicant organization. In addition, costs of advisory committees and consultants may be included in the administrative core. Consultants for specific research components should be included in the budgets for those components. Alcohol Research Center grant funds may be used only for costs that are necessary to carry out the research and research support activities of the Center program, and must be in conformance with HHS cost principles (encompassed in 45 CFR Part 74) and the Public Health Service Grants Policy Statement (rev. 4/94). This publication should be available from your office of sponsored research. Funds provided under this program may not be used for the purchase of land; nor for the purchase, construction, preservation, or repair of any building. However, costs of alteration and renovation of existing facilities necessary to accomplish the objectives of the grant may be allowed subject to PHS grants policy limitations. Funds provided through Center grants may not be used for support of trainee stipends, fees, or other expenses directly relating to training activities. Support will be provided for a period of up to 5 years (renewable for subsequent periods) subject to continued availability of funds and scientific progress. Applicants may request up to $1.7 million total cost (including direct and indirect costs combined) per year. The actual amount of support awarded will depend upon consideration of factors listed under AWARD CRITERIA. The Center grant is neither expected nor intended to cover all costs of running a successful Alcohol Research Center program. Research and training activities associated with the Center may receive additional funding from Federal sources as well as from State and local sources. The NIAAA expects and encourages the institution and scientists attracted to such Centers to seek and compete actively for such funding. Research staff in funded Centers may submit applications for independent research project grants for support of research projects that do not overlap with their Center project(s). Centers will be required to submit detailed annual progress reports including substantive information about research results to date, status of ongoing research, research plans for the next year, and any modifications in long-term research plans. Also required are reporting of inventions, reports of expenditures, final reports, and other reports in accordance with PHS policy. LETTER OF INTENT Prospective applicants are asked to submit, by November 19, 1997, 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 NIAAA 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: Ernestine Vanderveen, Ph.D. Centers Program National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 402 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-2530 FAX: (301) 594-0673 Email: tvanderv@willco.niaaa.nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained >From the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov; and from NIAAA staff listed under INQUIRIES. Applications must be received by December 19, 1997. The RFA label available in the PHS 398 (rev. 5/95) 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 2 of the face page of the application form and the YES box must be marked. Page limits and limits on size of type are strictly enforced. Non-conforming applications will be returned without being reviewed. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH Division of 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 in the application materials. Submit a signed, typewritten original of the application, including the checklist and three signed photocopies as well as sets of appendix materials in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application plus appendices must also be sent to: RFA AA-97-005 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 409 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) FAX: (301) 443-6077 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration as will any application that is not responsive to the RFA. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit based upon the review criteria that follow by an appropriate peer review group (initial review) convened by NIAAA in accordance with the following peer review procedures. All applications will receive a written critique. The initial peer review process will be used to determine the most competitive applications; site visits and/or applicant interviews may be used to further evaluate the latter group of applications. Issues to be considered in applicant interviews/site visits will be determined by NIAAA, will be consistent for all applications interviewed and/or site visited, and are likely to be limited to consideration of issues related primarily to the management and cohesiveness of the Center as an integrated whole. All applications will receive a second level review by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria The initial review for scientific and technical merit of applications will emphasize two major aspects: (1) review of the Center as an integrated research effort focused on a central theme, including the administrative core; and (2) the review of each research component, all other core components, and the pilot component as applicable. The review will also include an assessment of the academic and physical environment and special considerations, e.g., compliance with human subject and animal welfare requirements, and compliance with policies concerning inclusion of women and minorities in clinical research study populations. ADMINISTRATIVE CORE AND CENTER AS AN INTEGRATED WHOLE SIGNIFICANCE OF THE CENTER o Significance of the overall research goals o Development of a well-defined central theme o Multidisciplinary scope INTEGRATION OF THE CENTER o Center coordination and cohesiveness o Interrelatedness of cores and components with each other o Usefulness of scientific core components to research components and to independently supported investigators who use them o Synergistic potential among Center components and core units o Justification for each research component in terms of the central theme and the overall research goals of the Center o Justification for each scientific core component in terms of accomplishing center objectives QUALIFICATIONS OF KEY STAFF o Qualifications, experience, commitment and administrative competence of the Center Director o Ability of the Center Director to devote substantial time and effort to the Center o Scientific ability of the Scientific Director and his or her professional experience and leadership o Ability of the Scientific Director to devote substantial time and effort to the Center o Scientific qualifications and ability of the directors of the research components and core components and their commitment to the center ADMINISTRATIVE CORE ARRANGEMENTS AND ORGANIZATIONAL STRUCTURE o Processes to facilitate and monitor attainment of Center objectives o Plans for communication and cooperation among investigators involved in the Center o Quality control and oversight mechanisms for ongoing projects o Day-to-day management o Long-term management and periodic evaluation of goal attainment o Contractual and consortium arrangements (as applicable) o Procedures for replacement of key personnel, if necessary POTENTIAL OF THE CENTER AS A RESOURCE o Potential of the Center to become or maintain itself as a regional and national resource o Capacity to provide quality research training, opportunities for independent research career development o Plans for research information dissemination and educational activities RESOURCES AND ENVIRONMENT o Institutional strength, stability, commitment to research, and support of the Center, including fiscal responsibility and management capability to assist the Center Director and staff in complying with DHHS, PHS, and NIH policies. o Opportunities for research training and education for persons from various disciplines and professions o Potential for interaction with scientists from other departments and institutions o Academic and physical environment in which the research will be conducted, including availability of space, equipment, research subjects, and materials. RENEWAL APPLICATIONS o Degree to which the Center achieved stated goals with special attention to - scientific merit of completed research - recruitment of new scientists into alcohol research - development of a multidisciplinary team - coalescence of Center staff into an effective team RESEARCH COMPONENTS o Significance of the research o Scientific and technical merit o Qualifications, experience, and commitment of the component director o Adequacy of component director's time and effort o Adequacy of the resources and environment SCIENTIFIC CORE COMPONENTS o Need/justification for the core service/resource o Scientific and technical merit of the service/resource provided o Plans for resource allocation o Quality control procedures o Qualifications, experience, and commitment of the component director o Adequacy of component director's time and effort o Adequacy of the resources and environment PILOT PROJECT COMPONENT o Adequacy of the selection process for new and replacement pilot projects o Monitoring and oversight procedures and continuation decisions o Adequacy of the resources and environment for all projects o For INDIVIDUAL PILOT PROJECTS - Importance of topic - Grounding in the literature or empirical findings - Reasonableness of the approach - Potential to develop into an full-scale independent project - Qualifications of the project director OTHER CONSIDERATIONS: For the Center as a whole and all components/cores o When an application proposes research or research-related activity that involves potential risks to human subjects, animals, and/or the environment, the adequacy of the proposed means for protecting against such risks must be demonstrated for each component. o Specific statements addressing compliance with NIH policies on inclusion of women and minorities in studies involving human subjects. o Adequacy of the budget request for the work proposed. AWARD CRITERIA Applications recommended for approval by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of the overall merit of the application, as well as such considerations as program balance, relevance to the mission and goals of NIAAA, research program priorities, equitable geographic distribution, continuity of support, and availability of funds. Awards will be made for up to 5-year project periods with separate fiscal awards made annually. INQUIRIES Written and telephone inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ernestine Vanderveen, Ph.D. Centers Program National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 402 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-2530 FAX: (301) 594-0673 Email: tvander@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Edward Ellis Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4703 FAX: (301) 443-3891 Email: eellis@willco.niaaa.nih.gov RELATIONSHIP TO NIAAA In view of the special significance of this program, close coordination and communication between the NIAAA staff and staff of the Alcohol Research Centers is intended. The NIAAA program official will have responsibility for maintaining liaison with appropriate Center leadership, serving as resource consultant to the Center program, and keeping NIAAA staff informed on progress and accomplishments of the Centers. In addition, the program official with other NIAAA staff and consultants will, from time to time, make on-site visits for purposes of program coordination and exchange of information. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.891. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464J, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 549, "Grants for National Alcohol Research Centers;" Title 45 CFR Parts 74 and 92, "Administration of Grants;" and 45 CFR Part 46, "Protections of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun Apr 27 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-055 - V26(13) 04/25/97 Date: 28 Apr 1997 16:00:41 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 537 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5k3a6p$mnm@net.bio.net> NNTP-Posting-Host: net.bio.net PRIORITIES IN BEHAVIORAL RESEARCH IN CANCER PREVENTION AND CONTROL NIH GUIDE, Volume 26, Number 13, 1997 PA NUMBER: PA-97-055 P.T. 34; K.W. 0715035, 0404000, 0745027 National Cancer Institute National Institute of Dental Research PURPOSE The National Cancer Institute (NCI), and the National Institute of Dental Research invite researchers to submit research grant applications which address behavioral research issues in cancer prevention and control. This Program Announcement (PA) addresses recommendations made by a special Behavioral Research in Cancer Prevention and Control Working Group in 1996 which consisted of leading national experts whose role was to identify behavioral research needs in cancer prevention and control during the coming years. This multi-disciplinary Working Group reviewed and refined the series of recommendations for priorities in behavioral research which was generated at a 1995 meeting. Members were asked to consider the successes and failures of behavioral research in the past decade, as well as the emerging challenges posed by scientific advances and changes in health care delivery. The recommendations that were generated based on these considerations and on the following criteria: (1) strength of the scientific evidence, (2) potential for reducing the cancer burden, (3) responsiveness to opportunities arising from advances in basic science and technology, (4) availability of technologies, (5) feasibility of implementation, and (6) achievable and measurable goals and outcomes. The full copy of the Report of the Working Group: Priorities in Behavioral Research in Cancer Prevention and Control can be obtained from the National Cancer Institute, EPN, Suite 232, 6130 Executive Blvd MSC 7330, Bethesda, Maryland 20892- 7330; Phone (301) 496-8520; or via the Internet: http://www.dcpc.nci.nih.gov/PCEB/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 PA, Cancer Prevention and Control Research Small Grant Program, is related to the priority areas of cancer, nutrition and tobacco. 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, D.C. 20402-9325 (telephone (202) 512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for- profit and nonprofit 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 Support for this research will be through the NIH research project grant (R01) award. Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. RESEARCH OBJECTIVES Background Behavioral research is central to the prevention, early detection, and control of cancer. Approximately 65% of cancer deaths are attributable to behaviors such as smoking and diet (e.g., excess fat and inadequate fiber intake) (Doll & Peto, 1981). Use of smokeless tobacco or the exposure of oral tissues to the combined effects of smoked or smokeless tobacco and alcohol may account for up to 80% of oral cancers. Efforts to modify these and other behaviors have led to a reduction in the U.S. cancer burden. For example, since 1965, the proportion of Americans who smoke has decreased from 52% to 26% (Centers for Disease Control and Prevention, 1994a), and lung cancer rates in men have declined (Devesa et al., 1995). In addition, an increased understanding of barriers to cancer screening has made it possible to develop effective strategies to promote adherence to breast and cervical cancer screening (Hiatt, in press), although barriers to oral cancer screening in the dental office have received considerably less attention from researchers. Although neither correlations nor causation can be attributed, from 1987-1992, the period in which behavioral interventions increased substantially, the proportion of NHIS respondents who reported a recent mammogram increased at least twofold for women in every age and ethnic group (Breen & Kessler, 1996). Behavioral research has also made major contributions to our knowledge of individual and treatment-related variables that impact on quality of life in persons with cancer. This knowledge has been translated into effective psychosocial and behavioral interventions to reduce cancer pain, enhance quality of life, and in some cases, prolong survival (Fawzy et al., 1995). Despite these successes, important needs for behavioral research remain (Greenwald, in press). While overall smoking rates and mortality have declined in men, these rates have increased in women, in minorities, and most alarmingly, in children and teenagers (Centers for Disease Control and Prevention, 1994b, 1995; Johnston et al., 1995). There is also a need to develop effective treatments for heavily nicotine dependent smokers and smokeless tobacco users who have been least responsive to smoking cessation interventions. Despite evidence for the health benefits of fruit and vegetable consumption, only 23% of U.S. adults eat 5 or more servings of fruits and vegetables a day (Subar et al., 1995). In addition, avoidable mortality from breast, cervical and oral cancers can be reduced further by increasing adherence to screening, particularly among persons of low socio-economic status (Hiatt, in press). Rates of adherence to recommendations for colon cancer screening remain extremely low in all adults over age 50. To have optimum impact, behavioral research must also respond to new opportunities and challenges resulting from advances in basic science and technology and from changes in healthcare delivery. Breakthroughs in cancer genetics have created unprecedented opportunities for individuals to learn whether they carry mutations in cancer-predisposing genes. As yet, however, little is known about how to communicate this information in a way that will facilitate informed decision-making and minimize potential adverse psychosocial effects. Additional challenges to risk communication and informed consent are posed by the application of new screening tests with unproven benefits and possible risks (e.g., PSA) and by controversial medical recommendations (e.g., mammography for women in their 40's, estrogen replacement therapy for women who had breast cancer). Behavioral research can also make important contributions to our understanding of how cancer prevention and control interventions can be integrated successfully and efficiently into emerging models of primary healthcare delivery, such as managed care (Kaluzny, in press). Ultimately, the successful application of new knowledge from basic, clinical, and cancer control research will depend on the behavior of the public, patients, and health professionals. Thus, it is essential that the National Cancer Institute (NCI) support a strong program of behavioral research with collaboration across Divisions. Research Issues Examples of priority areas for behavioral research in cancer prevention and control areas which might be addressed by applicants are listed below. 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 announcement. 1. Prevention and Cessation of Smoked and Smokeless Tobacco Use among Children, Teenagers, and Adults: Children and teenagers are at significant risk to become regular smokers (Glynn et al., 1993). Overall, 19% of high school seniors are daily smokers, and there has been little change in this proportion for the last 10 years (Johnston et al., 1995). The reduction of adult use of tobacco has also slowed considerably in recent years (Centers for Disease Control, 1996). New efforts are therefore needed to identify determinants of smoking initiation and maintenance in U.S. youth and, especially, to design and evaluate innovative strategies to reduce the prevalence of this high risk behavior among both youth and adults. 2. Enhancing Risk Communication, Comprehension, and Informed Decision-Making Under Uncertainty: As new technologies are integrated into mainstream medical and dental care, patients are being challenged to make difficult decisions in the face of uncertain risks and benefits. Examples include prostate specific antigen (PSA), mammography for women in their 40's, colorectal screening, genetic susceptibility tests, and investigational treatments offered to patients with late-stage cancer. While people tend to overestimate their personal risks of cancer, there are circumstances in which significant under-estimation of risk and over-valuation of medical intervention occurs. This can lead to inappropriate use of diagnostic and treatment technologies. Research is needed to design and evaluate strategies to improve cancer risk communication, enhance comprehension, and facilitate informed decision-making about options for cancer prevention, screening and treatment (Rimer, 1995). This priority is consistent with the 1989 recommendations of the National Research Council which identified risk communication research as an important priority area (National Research Council, 1989). 3. Integrating Preventive and Early Detection Services into Changing Health Delivery Systems: The proportion of the insured population covered by a managed care arrangement has increased from 47% in 1991 to 65% in 1994, and continues to rise steadily (Eckholm, 1994). Increasingly, primary care providers, and physicians in particular, are becoming part of larger organizations. Over three-fourths of physicians now participate in managed care (Emmons & Simon, 1994). Behavioral research must respond to this change in healthcare delivery by designing and testing innovative cancer prevention and control interventions that can be integrated into healthcare systems in a cost-effective manner. Also, research directed toward health care providers, such as dentists, who deliver care in predominantly solo practice settings, is still needed to test innovative approaches to improve dissemination/adoption of up-to-date approaches in oral cancer prevention and detection, including appropriate dental office-based screening, identification of risk factors, and referral. 4. Improving the Outcomes of Genetic Testing for Cancer Susceptibility: Breakthroughs in cancer genetics have created unprecedented opportunities for individuals to learn whether they carry mutations in cancer-predisposing genes. These include rare cancer genes that confer an 80- 90% lifetime cancer risk (e.g., BRCA1) as well as more common, but less penetrant, genes that interact with environmental and lifestyle factors (e.g., CYP2D6). Genetic information has potentially far-reaching consequences for the psychological well-being and medical care of individuals at high risk for cancer (Lerman et al., 1996). A better understanding of the behavioral and social impact of disclosure of genetic information is critical to designing optimal education and counseling approaches. Efforts are also needed to evaluate behavioral interventions to enhance quality of life and maximize adoption of cancer control practices among participants in genetic testing programs. 5. Enhancing Survivorship of Cancer Patients: Due to advancements in early detection and treatment, people are living longer with cancer, dramatically increasing the number of cancer- affected life-years in our nation. There are now over eight million cancer survivors in the U.S. This raises the question of the quality of that extended survival time, including its effect upon productivity, family functioning, and both medical and psychiatric comorbidity (Lewis, in press). Behavioral and psychosocial interventions are needed to enhance functional health status (e.g., return to work), improve the delivery of palliative care, and promote health behaviors that may reduce the risk of second malignancies. 6. Promoting a Healthy Diet and Physical Activity: Nutrition and physical activity play a central role in the initiation, promotion, and progression of cancer. U.S. guidelines recommend diets that are low in fat and high in fiber, fruits, and vegetables. Yet, only a small proportion of the U.S. population adheres to recommended guidelines for diet or participates in regular physical activity (Glanz, in press). Efforts are needed to examine the determinants of changes in these behaviors and to design innovative interventions, particularly those that can be targeted to populations at high risk for cancer. Cross-Cutting Themes The following are relevant to all areas of priority behavioral research, and therefore, are strongly encouraged as cross- cutting themes to be considered in applications prepared in response to this Program Announcement. 1. Consideration of Race, Social Class, and Culture: To have the broadest impact on cancer morbidity and mortality, behavioral research must take into account the racial, cultural, and socioeconomic factors that influence adoption of cancer prevention and control practices. This is especially true since, for example, education and income are key predictors of cancer screening (Breen & Kessler, 1994). Special efforts are required to enroll these population subgroups into cancer prevention and control studies. There is a need to examine healthcare financing and utilization patterns to broaden our understanding of how barriers and incentives operate in underserved populations. Interventions and measurement tools that are practical and culturally appropriate are encouraged. 2. Theory-Driven Research: There is a need to expand existing theories of health behavior to take account of underserved populations, new healthcare technologies, and changes in service delivery. Cognitive and emotional variables (e.g., risk perception, distress), which receive insufficient attention in the dominant models of health behavior, need to be addressed (Glanz, Lewis, & Rimer, in press). Researchers are encouraged to use theory both to guide intervention development and to test hypotheses about mechanisms of intervention impact. 3. Multiple Level Interventions Targeted to Multiple Risk Factors: Cancer control interventions are likely to be most effective if aimed at multiple levels, including individuals, families, healthcare providers, and organizations. This could involve systemic changes such as broad policies and social norms. Wherever possible, multiple risk factors and health behaviors should be targeted by interventions in order to achieve the maximal benefit for the lowest cost. Hypothesis- driven interventions delivered in primary care settings and those which address public policy change are particularly important. 4. Research Settings: Behavioral research initiatives should span all phases of cancer control research and take place in a variety of settings. For example, basic behavioral research and longitudinal (non-intervention) studies in clinical settings are likely to be necessary in research areas that are relatively new (e.g., genetic testing, informed decision- making). For areas in which a considerable body of research is already available (e.g., smoked or smokeless tobacco use, screening adherence), it is anticipated that interventions addressing systemic change would be recommended. In these areas, research in community settings would be especially important. However, basic behavioral research in all areas of cancer control will be valuable to foster continued improvements in interventions. 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 policy results form the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) 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 Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, e-mail: asknih@odrockm1.od.nih.gov, and the program administrator listed under INQUIRIES. The title and number of the program announcement must be typed in Section 2 on the face page of the application. Following presentation of the research plan, include the discussion of Human Subjects and the literature cited. The completed original application and five copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, and assigned a priority score, and receive a second level review by the appropriate National Advisory Council or Board. Review Criteria 1. scientific, technical, or medical significance or originality of proposed research; 2. appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; 3. qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; 4. availability of the resources necessary to perform the research; 5. appropriateness of the proposed budget and duration in relation to the proposed research. 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 Applications will compete for available funds with all other approved applications. Funding decisions will be based upon quality of the proposed project as determined by peer review, availability of funds, and program balance among research areas of the announcement. The National Institute of Nursing Research (NINR) has an interest in behavioral research in cancer prevention and control. Applications that are of mutual interest may be given assignment to NINR in accordance with the NIH referral guidelines. Contact Dr. June R. Lunney, Division of Extramural Activities, NINR, telephone 301/594-6908, FAX 301/480-8260, email JLunney@EP.NINR.NIH.GOV. INQUIRIES Inquiries are encouraged. Direct inquiries regarding programmatic issues to: Ms. Veronica Chollett National Cancer Institute 6130 Executive Boulevard, Room 232 - MSC 7330 Bethesda, MD 20892-7330 Telephone: (301) 435-2837 Email: vc24a@nih.gov Dr. Patricia Bryant Behavior, Health Promotion, and Environment Program National Institute of Dental Research 45 Center Drive, Room 4AN24E Bethesda, MD 20892 Telephone: (301) 594-2095 Email: BryantP@de45.nidr.nih.gov Inquiries regarding fiscal matters may be directed to: Mr. Mark Hodor National Cancer Institute Executive Plaza North 6120 Executive Boulevard, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800 ext 215 Email: Hodorm@GAB.NCI.NIH.GOV Mr. Martin R. Rubinstein National Institute of Dental Research 45 Center Drive, Room 4AN44A Bethesda, MD 20892 Telephone: (301) 594-4800 FAX: (301) 480-8301 Email: mr49c@nih.gov 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 grant policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. References Breen, N. and Kessler, L. Changes in the use of screening mammography: Evidence from the 1987 and 1990 National Health Interview Surveys. American Journal of Public Health, 1994, 84(1), 62-67. Breen, N. and Kessler, L. Trends in cancer screening United States, 1987 and 1992. Morbidity and Mortality Weekly Report, 1996, 45(3), 57-61. Centers for Disease Control and Prevention. Cigarette smoking among adults United States, 1993. Morbidity and Mortality Weekly Report, 1994a, 43(50), 925-930. Centers for Disease Control and Prevention. Surveillance for selected tobacco-use behaviors United States, 1900-1994. Morbidity and Mortality Weekly Report, 1994b, 43(SS-3), 1-33. Centers for Disease Control and Prevention. Trends in smoking initiation among adolescents and young adults. Morbidity and Mortality Weekly Report, 1995, 44(28), 521-525. Devesa, D.S., Blot, W.J., Stone, B.J., Miller, B.A., Tarone, R.E., and Fraumeni, J.F. Recent cancer trends in the United States. Journal of the National Cancer Institute, 1995, 87(3), 175- 182. Doll, R., and Peto, R. The Causes of Cancer. New York, NY: Oxford University Press, 1981. Eckholm, E. RWhile Congress Remains Silent, Health Care Transforms Itself.S New York Times, December 18, 1994. Emmons, D.W., and Simon, C.J. RRecent Trends in Managed CareS. In M.L. Gonzalez (Ed.), Socioeconomic Characteristics of Medical Practice, 1994, American Medical Association, 1995. Fawzy, F.I., Fawzy, N.W., Arndt, L.A., and Pasnau, R.O. Critical review of psychosocial interventions in cancer care. Archives of General Psychiatry, 1995, 52, 100-113. Glanz, K. Behavioral research contributions and needs in cancer prevention and control: Dietary change. Preventive Medicine, in press. Glanz, K., Lewis, F.M., and Rimer, B.K. (Eds). Health Behavior and Health Education. Theory Research and Practice. San Francisco, CA: Jossey-Bass Publishers, in press. Glynn, T.J., Greenwald, P., Mills, S.M., and Manley, M.W. Youth tobacco use in the United StatesQproblems, progress, goals, and potential solutions. Preventive Medicine, 1993, 22, 568- 575. Greenwald, P. Consequential behavioral research and cancer prevention and control. Preventive Medicine, in press. Guggenheimer, J. Factors Delaying Early Detection of Oral Cancer. Cancer, 1989, 64, 963. Hiatt, R.A. Behavioral research contribution and needs in cancer prevention and control: Adherence to cancer screening advice. Preventive Medicine, in press. Johnston, L.D., O'Malley, P.M., and Bachman, J.G. National Survey Results on Drug Use from the Monitoring the Future Study, 1975-1994. Rockville, MD: National Institute on Drug Abuse, 1995. Kaluzny, A.D. Prevention and control research within a changing health care system. Preventive Medicine, in press. Lerman, C., Narod, S., Schulman, K., Hughes, C., Gomez- Caminero, A., Bonney, G., Gold, K., Trock, B., Main, D., Lynch, J., Fulmore, C., Snyder, C., Lemon, S.J., Conway, T., Tonin, P., Lenoir, G., and Lynch, H. BRCA1 testing in families with hereditary breast-ovarian cancer: A prospective study of patient decision-making and outcomes. Journal of the American Medical Association, 1996, 275, 1885-1893. Lewis, F.M. Behavioral research to enhance adjustment and quality of life in adults with cancer. Preventive Medicine, in press. National Research Council. Improving Risk Communication. Washington, DC: Academic Press, 1989. Rimer, B. Putting the RinformedS in informed consent about mammography. Journal of the National Cancer Institute, 1995, 87(10), 703-704. Subar, A.F., Heimendinger, J., Patterson, B., Krebs-Smith, S.M., Pivonka, E., and Kessler, R. Fruit and vegetable intake in the United States: The baseline survey of the Five A Day for Better Health Program. American Journal of Health Promotion, 1995, 9(5), 352-360. U.S. Department of Health and Human Services. Healthy People 2000: National Health Promotion and Disease Prevention Objectives. DHHS Publication No. (PHS) 91-50212. Washington, DC: U.S. Government Printing Office, 1991. From owner-sci-resources@net.bio.net Sun Apr 27 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 26 April 1997 Date: 28 Apr 1997 16:19:25 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 93 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5k3b9t$oh6@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending April 26, 1997. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: NSF May Bulletin Vol. 24; No. 9 File size (bytes): 53850 STIS Filename: bul9705.txt Document Type: News Title: Cloning Discovery Requires Debate, Says Lane - Tipsheet File size (bytes): 5287 STIS Filename: tip70425.txt Document Type: Press Release Title: URBAN SCHOOL SUPERINTENDENTS FORM COALITION TO SHARE INNOVATIONS AND TACKLE OBSTACLES File size (bytes): 3813 STIS Filename: pr9730.txt Document Type: Program Guideline Title: For US WOCE Activities: 1998-2002 Analysis, Interpretation, Modeling and Synthesis (AIMS) (NSF 97-88) File size (bytes): 20746 STIS Filename: nsf9788.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 112831 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Alphabetical Telephone Directory File size (bytes): 112831 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Directory File size (bytes): 129154 STIS Filename: phnorg.txt Title: NSF Organization Directory File size (bytes): 129154 STIS Filename: phnorg.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov 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 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". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Sun Apr 27 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-057 - V26(13) 04/25/97 Date: 28 Apr 1997 16:01:33 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 375 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5k3a8d$mpr@net.bio.net> NNTP-Posting-Host: net.bio.net EPIDEMIOLOGY OF AIDS/RETROVIRAL-ASSOCIATED CANCERS NIH GUIDE, Volume 26, Number 13, April 25, 1997 PA NUMBER: PA-97-057 P.T. 34; K.W. 0715035, 0715008, 0760082 National Cancer Institute PURPOSE The Division of Cancer Epidemiology and Genetics of the National Cancer Institute (NCI) invites grant applications for innovative interdisciplinary studies to better understand the occurrence and molecular epidemiology of pre-neoplastic conditions and cancers that occur within the contexts of underlying infection with human retroviruses such as HIV/AIDS, non-infectious causes of immunosuppression such as organ transplantation, or subsequent to anti- retroviral therapies, particularly zidovudine and other nucleoside reverse transcriptase inhibitors. 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 is related to the priority areas of "Cancer" and "HIV Infection." Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Stock No. 017-001-10473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or Local Government, and eligible agencies of the Federal Government. The total requested project period for an application submitted in response to this PA may not exceed five years; a foreign application may not request more than three years support and will receive no support for indirect costs. Domestic applications may include international components but these components will receive no support for indirect costs. 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 individual research project grant (R01), the First Independent Research Support and Transition Award (FIRST, R29), the Exploratory Grant (R21), and competitive supplements to existing NIH-funded research project grants and cooperative agreements. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. In the case of competitive supplements to existing grants and cooperative agreements, applicants will be required to obtain and attach to their applications a document indicating that the submission of their proposal has been approved by the principal investigator of the research project grant and, if appropriate, the governing body of the cooperative agreement. This will be especially important if the application will require access to biological specimens from a central repository or to existing databases. Except as otherwise stated in this program announcement, awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000 revised April 1, 1994. RESEARCH OBJECTIVES Background The National Cancer Institute has a continuing interest in the study of the occurrence, natural history, and molecular epidemiology of infection- associated pre-neoplastic conditions and cancers occurring in the context of immunosuppressive conditions such as HIV/AIDS, other retroviral infections, and organ transplantation. Some cancers, notably those associated with oncogenic human viruses, of the lymphoreticular system (non-Hodgkin's lymphoma and, to a lesser extent, Hodgkin's disease), soft tissue (Kaposi's sarcoma), and epithelial tissues (papillomavirus-associated pre-neoplastic conditions and possibly cancers) are significantly increased in incidence and display an aggressive pattern of development and progression in immunosuppressed individuals. There are reports of higher than expected numbers of other cancers, such as testicular seminomas, non-melanomatous skin cancers, hepatocellular carcinomas, and possibly bladder cancers, developing subsequent to immunosuppression. Further, some infection- associated tumors, while not necessarily occurring more frequently in the presence of underlying immunosuppression, may occur in unusual forms or be more refractory to standard therapies. In addition, it is possible that some antiretroviral therapies may place individuals at future malignancy risk, either in terms of frank cancer occurrence or of clastogenic and mutagenic changes that might predispose to subsequent tumor initiation or promotion. Infection by human retroviruses, particularly HIV-1/2, is a major public health problem throughout the world, but particularly in the developing world. Retroviruses may be directly oncogenic, or may foster the development of human cancers indirectly through immune suppression and subsequent reactivation of previously latent human oncogenic infectious agents. In terms of the contribution of oncogenic infectious agents to the public health burden of cancer incidence and mortality, viral-associated cancers tend to occur at younger ages than non-viral- associated cancers. The young age at which most people in the world become infected with HIV/AIDS and other retroviruses coupled with the time spent living in an immunodeficient condition that fosters reactivation of previously latent oncogenic viruses portends that retroviral-associated cancers will impose a greater cost in years of life lost than other cancers. While generally the burden is greater in the developing areas of the world, the increasing length of time that HIV-infected persons can be maintained by new treatments will result in these cancers increasing in the U.S. and Europe as well. The development of incident cancers occurring in renal transplant recipients was first reported in the 1960's, followed by a few studies nested within ongoing cohort studies in the 1970's. It was thought that the observed increases might be explained by detection bias occurring as a result of heightened scrutiny of transplant recipients. However, as transplantation has become more common, and survival post-transplant has lengthened, it has been possible to determine that increased likelihood of detection does not explain all of the increases. Research on AIDS-lymphomas was fostered by data on transplant- associated lymphomas which showed that such lymphomas were characterized not only by increasing risk, but also by a short induction period, rapid progression, and brain tropism. Similar parallels have been observed with Kaposi's sarcoma and its associated herpes virus. Other transplant-associated cancer data, while not quite as predictive of the AIDS experience as lymphoma, still has had applications, especially findings on anogenital tumors and skin cancers. A common theme in transplant-associated malignancies is the role of coinfections by recognized tumor viruses, just as is being demonstrated for retroviral-associated malignancies. Less well- understood are the mechanisms important to the development of skin tumors and solid tumors such as colon, lung, and bladder tumors. Although the immunosurveillance theory has been applied generally in the case of transplant-associated carcinogenesis, neither is it clear why not all tumors are increased, nor which components of the immune system might be contributing to host defense efforts. Also not clear is how the transplant situation might be used to forecast trends in AIDS-associated malignancies as longevity is enhanced, HIV viral load is decreased, and morbidity abates somewhat over time. Research Scope and Goals The program announcement seeks to encourage research on the incidence, etiology, and molecular epidemiology of infection-associated pre-neoplastic conditions and malignancies occurring in the context of host immunosuppression in the United States, comparative epidemiologic studies of these malignancies in several geographic areas, or such studies in areas outside of North America or Europe. A multidisciplinary approach that links the expertise of basic scientists with that of epidemiologic and clinical researchers is encouraged. Investigations may be conducted in adults and/or children. The areas of research listed below are not intended to be all-inclusive, but are designed to give the applicant some direction as to the types of research that the NCI is interested in stimulating. 1. Active surveillance of the prevalence, incidence, molecular epidemiology, and temporal trends of all cancers and pre-neoplastic changes occurring in persons already infected with or at high risk for infection by HIV/AIDS or other human retroviruses, or immunosuppressed from other conditions such as organ transplantation. 2. Studies conducted through population-based registries or programs to enhance and utilize tumor registries in areas with high prevalence of human retroviral infections, or in conjunction with existing cohorts of persons infected with, or at high risk of acquiring, human retroviral infections such as HIV/AIDS. 3. The (treated) natural history of cancers and pre-neoplastic changes in situations where the temporality of observed events, including timing of first infection or reactivation of existing infections, may be addressed. 4. The seroepidemiology and modes of transmission of human oncogenic agents, particularly human herpes virus 8/Kaposi sarcoma-associated herpes virus, and the relationship of new infection or reactivation of latent infection to subsequent development of cancers or pre-neoplastic conditions in the context of host immunosuppression >From co-infection by HIV/AIDS or other human retroviruses, or organ transplantation. 5. The association of anti-HIV chemotherapeutic agents on the occurrence and natural history of ensuing cancers and pre-neoplastic changes. 6. The role of co-infection by infectious agents, including, but not limited to, human polyoma/papilloma viruses, human herpes viruses, hepatitis viruses, and Helicobacter pylori in the etiology and molecular epidemiology of cancers and pre-neoplastic changes associated with host immune suppression from conditions such as HIV/AIDS, infection with other human retroviruses, and organ transplantation. 7. The effects of host genetics, hormonal changes, environmental conditions, and human behaviors on the clinical and molecular epidemiology of infection- associated pre-neoplastic conditions and cancers occurring within the context of immunosuppressive conditions, such as those resulting from HIV/AIDS, other retroviral infections, and organ transplantation. 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 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 contain 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 9, 1994 (FR 59 11146-11151) and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines for investigator-initiated applications: February 1, June 1, and October 1. Applications specific to HIV/AIDS may be submitted for expedited review instead on: January 1, 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, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-435-0714, email: ASKNIH@ODROCKML.OD.NIH.GOV. The title and number of the announcement must be typed in Item 2a on the face page of the application and the "YES" box 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. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. 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 competititve or non-competititve based on their scientific merit relative to other applications received in response to the PA. Applications judged to be competitive will be discussed and assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator 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 experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly but not exclusively in the area of the proposed research; o availability of resources necessary to perform 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. o conformity to the guidelines of the program announcement. The Initial Review Group will also examine the provisions for the protection of human subjects and animal welfare and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the NCI. 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, particularly during the planning phase of the grant applications. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. S.L. Melnick Division of Cancer Epidemiology and Genetics National Cancer Institute 6130 Executive Boulevard, Suite 535, MSC 7395 Bethesda, MD 20892-7395 Telephone: 301-496-9600 FAX: 301-402-4279 Email: JASONC@EPNDCE.NCI.NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Theresa Mercogliano Grants Administration Branch National Cancer Institute Executive Plaza South 6120 Executive Boulevard, Suite 243, MSC 7150 Bethesda, MD 20892-7150 Telephone: 301-496-7800, EXT. 243 FAX: 301-496-8601 Email: MERCOGLT@GAB.NCI.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.393 and No. 93.856. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-140, as amended by Public Law 99.158, 42 USC 241 and 285) and administered under DHHS policies and grant regulations 42 CFR 52 and 45 CFR Parts 74 & 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, The Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American People. From owner-sci-resources@net.bio.net Sun Apr 27 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-056 - V26(13) 04/25/97 Date: 28 Apr 1997 16:01:01 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 557 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5k3a7d$mou@net.bio.net> NNTP-Posting-Host: net.bio.net INTEGRATED PRECLINICAL/CLINICAL AIDS VACCINE DEVELOPMENT NIH Guide, Volume 26, Number 13, April 25, 1997 PA NUMBER: PAR-97-056 P.T.34; K.W. 0715008, 0740075 National Institute of Allergy and Infectious Diseases Application Receipt Dates: July 30, 1997, July 30, 1998, July 30, 1999 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) gives special consideration for funding to scientifically meritorious applications in response to Program Announcements (PAs), including award of grants beyond our regular percentile and priority score paylines. NIAID PAs identify current areas of ongoing research emphasis for NIAID. The Division of AIDS (DAIDS), NIAID invites applications for research and development efforts directed toward obtaining a safe and efficacious vaccine to protect against HIV-1 infection or AIDS. The aim of this program, Integrated Preclinical/Clinical AIDS Vaccine Development, is to encourage the process of laboratory-to-clinic development, evaluation, and refinement of vaccine concepts. This PA expands upon the current National Cooperative Vaccine Development Groups (NCVDG) program to include limited human clinical trials. Applicants may apply for support for preclinical/basic research aimed at creation of vaccines and testing in animal models, vaccine lot production and toxicology testing, and limited clinical studies in humans. The information obtained in human studies can then be used to refine the vaccine approach, or advance the product further in human 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 PA, "Integrated Preclinical/Clinical AIDS Vaccine Development", is related to the priority areas of HIV Infection and Immunization, and Infectious Diseases. 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) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). ELIGIBILITY Applications may be submitted by domestic non-profit and for-profit organizations, public and private organizations such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the federal government. While foreign organizations are not eligible to apply as the principal institution, foreign components may apply as sub-projects; however, these components will receive no support for indirect costs. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The administrative and funding mechanism will be the program project grant (P01). Program project grants support broadly-based, multidisciplinary research programs that have a well-defined, central research focus or objective. An important feature 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 (3) interrelated individual research projects that contribute to the program objective. This type of award can also provide support for certain shared resources termed cores which provide funds for tasks common to 2 or more projects within the award. NIH limits the time period for P01 grants to 5 years. In addition, P01 grant applications submitted in response to this PA may not request in excess of $1 million first-year total (direct plus indirect) costs. Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant under this type of award. RESEARCH OBJECTIVES Background NIAID has a history of strongly supporting efforts to obtain a safe and efficacious vaccine against AIDS. The complexity of vaccine research requires the contributions and collaboration of investigators from fields which typically do not need to interact significantly. In 1986, the National Cooperative Vaccine Development Groups (NCVDG) were conceived to foster the necessary collaborative efforts between immunologists, molecular biologists, and primatologists to ultimately develop an AIDS vaccine. A primary objective of the program was to facilitate the progression of HIV vaccines from basic research through to preclinical evaluation in non-human primates. A variety of vaccine strategies for both SIV and HIV have been evaluated through this mechanism, with participation >From academic institutions and industry. The intent of this PA is to continue the work of the NCVDG and also to expand it to include small-scale human clinical trials. Research Objectives and Scope As stated above, the overall goal of this program announcement is to support multidisciplinary research that will lead to a protective AIDS vaccine. To that end, research responsive to this PA will describe studies to move preclinical research through to testing in animal models and humans. Applications can include preclinical research, vaccine production, and in vivo testing in their application. Preclinical research alone, without clear, feasible, and realistic plans to progress to testing in animals and humans within the period of award, will not be considered responsive to this PA. Applications that describe only production and in vivo testing will be acceptable, as will testing only, if the applicant provides sufficient evidence that the product is indeed ready for production and/or trial. An iterative process of development, production and testing of candidate vaccines is the goal of this program. Studies responsive to this program announcement can include, but are not limited to, vaccine delivery and vector systems, methods of enhancing specific immune responses, dissection of viral and host contributions to immunity and combinations of these. Research directed toward optimization of existing vaccine concepts is also encouraged. The participation of the private sector is strongly encouraged because of its unique infrastructure and capital resources which make it especially appropriate for collaboration in these types of studies. For example, a pharmaceutical or biotechnology interest might compose a subproject of an application to provide production capabilities when a preclinical concept is ready to be tested and sufficient vaccine product is necessary for the studies. Applicants with viable vaccine concepts may apply for support of the preclinical research necessary to realize the concept, and ultimately produce and test a product. One or more subproject components of the application can be involved in this preclinical development phase for which funds will be used for the extensive immunologic characterization of the proposed vaccine. Applicants must delineate discreet goals, milestones, and criteria that will be used by the investigators to evaluate progress toward a testable vaccine. If preclinical evaluation of the concept shows that further studies are not warranted, funding for those latter phases of the project will not be released. Applicants may also request funds for production of clinical grade (manufactured under Food and Drug Administration (FDA)-Good Laboratory Practices (GLP) guidelines) vaccine and subsequent in vivo testing. Applicants seeking to move from preclinical research to lot production must detail the goals, milestones, and criteria, which will be reviewed by the Scientific Peer Review Group (SPRG), to justify the release of funds for this purpose. Those investigators who are not requesting support for preclinical research and are applying for lot production and in vivo testing only, must present sufficient preclinical data to justify that the vaccine concept is ready for production and animal or human trials. Applicants seeking to move from preclinical development to production during the period of award must document successful completion of the goals and milestones for the preclinical evaluation of the vaccine strategy to show that vaccine efficacy is a reasonable expectation. The application must contain all regulatory guidelines that the applicant is proposing to complete which will need to be satisfied before the release of funds. Applicants may apply to study their vaccine concept in small, focused human studies. Since these studies will require the filing of an IND application with the FDA, certain regulatory requirements must be met prior to the release of funds to initiate this part of the study. Additionally, information that may be useful in improving or refining the vaccine may arise during these clinical studies. The applicant should address how the results of the clinical evaluations will be used to either improve the vaccine concept or advance it to a traditional phase I trial. Investigators are encouraged to discuss clinical evaluation of their candidate vaccines by the NIAID-supported AIDS Vaccine Evaluation Group (AVEG) with NIAID Program Staff and with the Executive Group of AVEG. For clinical trials, NIAID Program Staff can arrange for review of data by the AIDS Vaccine Data and Safety Monitoring Board which reviews data for AVEG trials. Funds available under this PA are for small-scale clinical studies . Investigators interested in pursuing NIAID support for large-scale human vaccine trials should contact the AVEG (see below for contact information). Applications requesting support for small-scale human clinical studies must address: design of the clinical trial, plan for recruitment, enrollment, education and follow-up of clinical subjects, including attention to the possibility of social harms and discrimination arising from vaccine-induced positive screening tests that may be interpreted incorrectly as HIV infection, plus documentation of compliance with all applicable federal (FDA), state and local laws and regulations governing clinical research. The completeness and feasibility of these plans will be reviewed by the SPRG. If an application proposes preclinical development or evaluation of a vaccine concept and/or vaccine production, and subsequent limited human studies , the applicant must describe milestones and criteria that will be used to approve the transition. These criteria must be clearly stated in the application, approved by the SPRG, and attained during the study before funds will be released for the next phase of the project. SPECIAL REQUIREMENTS All awardees are strongly encouraged to attend the NIAID-sponsored annual meeting on AIDS vaccine development and may include a request for travel funds for this purpose. Patent Coverage Since applications may involve several institutions, including the private sector, complex patent situations may arise. To avoid delays in the implementation of new vaccines for HIV related to intellectual property issues, each multi-project group is requested to provide a plan as part of the application, detailing 1) the approach, agreed to by all parties, to be used for obtaining patent coverage and for licensing, where appropriate, and, 2) the procedures to be followed for the resolution of legal problems that potentially may develop. Attention is drawn to the reporting requirements of 35 U.S.C. Parts 200-212 and 37 CFR Part 401 or FAR 55.227-11. Instructions were also published in the NIH GUIDE FOR GRANTS AND CONTRACTS, Vol. 19, No. 23, June 22, 1990. Note that non-profit organizations (including universities) and small business firms retain the rights to any patent resulting from Government grants or cooperative agreements. It is also noted that a Presidential memorandum of February 18, 1983 extended to all business concerns, regardless of size, the first option to the ownership of rights to inventions as provided in P.L. 96-517. As a result of this memorandum, the relationships among industrial organizations and other participants are simplified, since all Group members can now be full partners in the research and in any inventions resulting therefrom. The specific patenting arrangements among the institutions may vary and could include joint patent ownership, exclusive licensing arrangements, etc. Applicants are encouraged to develop an arrangement that is most suitable for the Group's particular circumstances. The patent agreement among the institutions comprising the Group, signed and dated by the organizational officials authorized to enter into patent arrangements for each Group member and member institution, must be delivered prior to submission of the application to Dr. Steven Bende, at the address listed under INQUIRIES. A copy of the patent agreement should also be submitted with the application. If the Group wishes to place all inventions and discoveries resulting >From these studies within the public domain, a letter to that effect must be submitted to Dr. Bende in lieu of the patent agreement . The letter must be co-signed by the Principal Investigator, each of the Project Leaders, and each of the business officials representing the respective institutions. Federal regulation clause 37-CFR-401 and HHS Inventions regulations at 45 CFR Parts 6 and 8 require that NIH be informed of inventions and licensing occurring under NIH funded research. Invention and licensing reports must be submitted to the Extramural Invention Reports Office at 301 435 1986. For Awards Including a Clinical Component For awards including vaccine pilot lot production, release of funds for this purpose will be contingent on successful accomplishment of milestones and criteria proposed by the applicant. These criteria must include compliance with all applicable laws and regulations, shall be stated in the grant application, and reviewed by the SPRG. Production facilities for clinical material must meet FDA standards for Good Laboratory Practices, and clinical trials must be initiated and conducted via a US IND application. Release of funds for clinical research will be contingent on successful accomplishment of milestones and criteria for preclinical evaluation of the product and plans for its production and availability of funds. These criteria must include compliance with all applicable laws and regulations, shall be stated in the grant application, and reviewed by the SPRG. If an awardee group anticipates successful achievement of its milestones and applies to move from preclinical to clinical research during the period of award, funds to accommodate the potentially more costly clinical study should be budgeted into the application. The Principal Investigator is responsible for: 1. assuming responsibility for developing protocols and monitoring study performance, participant recruitment and follow-up, interim data and safety monitoring. All proposed protocols will be submitted by the Principal Investigator to the NIAID Program Officer (Dr. Steven Bende, address below) for review for safety issues by the DAIDS Prevention Sciences Review Committee. There will be additional reporting requirements to inform DAIDS/NIAID of recruitment, retention, and adverse events; 2. establishing procedures to comply with FDA regulations for studies involving investigational agents or devices and to comply with the requirements of 45 CFR Part 46 for the protection of human subjects. Terms of award for any human clinical trial component will be developed to ensure volunteer safety and monitoring of compliance with regulations and Good Clinical Practices. NIAID staff will provide guidance and technical advice on meeting FDA requirements for investigational substances. 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 the NIH Guide For Grants And Contracts of March 18, 1994, Volume 23, Number 11. APPLICATION PROCEDURES Applications are to be submitted on the grant application for PHS 398 (rev. 5/95). Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: asknih@odrockm1.nih.gov. The title and number of the PA must be typed in section 2. The application receipt dates for this program announcement are: July 30, 1997, July 30, 1998, and July 30, 1999. The completed, signed original and three legible, single-sided copies of the application must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) At the time of submission, two additional exact copies of the grant application and all five sets of any appendix material must be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. The NIH Policy Update on Acceptance for Review of Unsolicited Applications that Request More Than $500,000 Direct Cost for Any One Year applies to applications in response to this PA. The Policy Update was published in the NIH Guide for Grants and Contracts, Vol. 25, No. 14, May 3, 1996, and became effective June 1, 1996. NIAID has (1) policies that require pre-approval by the Institute before acceptance of Program Project applications and applications that request $500,000 or more in annual direct costs and (2) guidelines for preparation of multi-project (including P01) research grant applications. Potential applicants must contact the appropriate program staff listed under INQUIRIES to initiate clearance processes for acceptance of their applications and to obtain guidelines for the preparation of P01 applications. Applicants are strongly encouraged to contact program staff early in project development with any questions regarding their proposed project(s). Current NIH policy permits a component research project of a multi-project P01 grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multi-project P01 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 P01 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. Research Plan Page Limits. Sections a - d of the research plan are limited to 25 pages for: (1) the overview of the proposed program; (2) each research project; and (3) each core. Applicants from institutions that have a General Clinical Research Centers (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed clinical research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS Review Procedures Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID. Review Criteria For preclinical evaluation of vaccine concepts/strategies reviewers will consider: A. The overall scientific and technical merit of the proposed vaccine study with regard to impact on the AIDS epidemic. B. Appropriateness and adequacy of the experimental approach and the methodology proposed to carry out the research, specifically including the feasibility of the applicant's plans, and the availability of necessary facilities to conduct the research. In addition, the goals and milestones to be met for progression through to production and in vivo trial will be reviewed for adequacy, feasibility, and likelihood of attainment during the period of the grant. For production of clinical grade vaccine product, reviewers will consider: A. Appropriateness of the scientific rationale for advancing to the vaccine production stage. To obtain funds for optional vaccine production, milestones and criteria to be attained in order to merit that funding must be proposed in the application. The SPRG will judge the suitability of such criteria. If satisfactory proof that these criteria and milestones have already been met is supplied, funds to produce vaccine product will be released at the time of grant award. B. Completeness and feasibility of the plan to produce the vaccine. This includes adherence to any and all federal (FDA), state, and local regulations for the production of clinical grade material. For optional clinical studies, reviewers will consider: A. Scientific, technical, and clinical significance and originality of the proposed research. B. The completeness of plans for the design of the clinical trial, plan for recruitment, enrollment, education and follow-up of clinical subjects, including attention to the possibility of social harms and discrimination arising from vaccine-induced positive screening tests that may be interpreted incorrectly as HIV infection, and other harms such as true HIV infection as the result of vaccination, and compliance with all applicable Federal, State and local laws and regulations governing clinical research will be reviewed by the SPRG. Criteria and milestones to be met to permit release of funds and progression of the study to the clinical phase will be evaluated by the SPRG as well. For all applications: C. Leadership and research experience of the Principal Investigator and key staff in the areas of proposed research. For optional clinical-grade vaccine production, the track record and facilities of the proposed producer. For optional clinical trials research, the leadership, scientific ability and administrative competence of the applicant for the development, implementation and management of pilot clinical trials, and for effective interaction with designated NIAID staff. D. Adequacy of the proposed means for protecting against adverse effects of the research upon humans, animals or the environment, where such are involved. E. Justification of the usefulness of the core facilities to the various research projects, including the administrative core, if applicable. Each core unit must provide essential facilities or service for two or more approved individual projects. F. A sound institutional administrative and organizational structure that facilitates attainment of the objective(s) of the program, including fiscal responsibility and management capability to assist the PI and staff in following PHS policy. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications. 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 program announcement, and availability of funds. For applications assigned to the NIAID, preference will be given to applications that propose to pursue the complete iterative process of laboratory-to-clinic development, evaluation, and refinement of vaccine concepts. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Dr. Steven Bende Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2A29 Bethesda, MD 20892-7620 Rockville, MD 20852 (for express/courier service) Telephone: (301) 435-3756 FAX: (301) 402-3684 Email: sb22k@nih.gov Direct inquiries regarding review issues to: Dr. Dianne Tingley Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4C07 Bethesda, MD 20892-7610 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-2550 FAX: (301) 402-2638 Email: dt15g@nih.gov Direct inquiries regarding fiscal matters to: Laura Eisenman Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B23 Bethesda, MD 20892-7610 Rockville, MD 20852 (for express/courier service) Telephone: (301) 402-5541 FAX: (301) 480-3780 Email: le55d@nih.gov Direct inquiries regarding the AVEG to: Barbara Savarese, RN Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2A36 Bethesda, MD 20892-7620 Rockville, MD 20852 (for express/courier service) Telephone: (301) 435-3750 FAX: (301) 402-3684 Email: bs30g@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.855, 93.856. Awards are supported under authorization of the Public Health Service Act, Sec. 301(c), Public Law 78-410, as amended. Awards will be 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 review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.