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 ot