From owner-sci-resources@net.bio.net Mon Jul 05 23:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 4 July 1993 Message-ID: Date: 6 Jul 93 17:45:47 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 477 Approved: sci-resources-moderator@net.bio.net ** NEW DOCUMENTS ON STIS ** Document Type: Antarctic EAM Title: USAP environmental documents list File size (bytes): 12999 STIS Filename: opp93000 Title: Sanitary wastewater management, McMurdo File size (bytes): 46726 STIS Filename: opp93003 Title: Explosives in the Sirius program< File size (bytes): 1161 STIS Filename: opp93005 Title: Blasting for fill rock, McMurdo< File size (bytes): 9103 STIS Filename: opp93008 Title: Installation of runway-Pegasus File size (bytes): 7972 STIS Filename: opp93009 Title: Water under floor of laboratory File size (bytes): 10714 STIS Filename: opp93010 Title: Collection of earth fill, McMurdo File size (bytes): 3521 STIS Filename: opp93011 Title: Waste minimization, McMurdo File size (bytes): 3282 STIS Filename: opp93012 Title: Recovery of D-8 tracked vehicle File size (bytes): 2206 STIS Filename: opp93013 Title: Packet radio tests, Lake Fryxell File size (bytes): 1666 STIS Filename: opp93014 Title: Addt'l. Earth Fill-McMurdo File size (bytes): 7631 STIS Filename: opp93015 Title: Mgmnt. of wastes-Drifting Stn., Weddell File size (bytes): 3530 STIS Filename: opp93016 Title: ROV Survey of Winter Quarters Bay File size (bytes): 2884 STIS Filename: opp93017 Title: Clean-up of old Palmer File size (bytes): 2665 STIS Filename: opp93018 Title: Steel fuel tanks-Marble Point File size (bytes): 20187 STIS Filename: opp93019 Title: Deck addition at Palmer < File size (bytes): 2694 STIS Filename: opp93020 Title: Palmer boathouse addition < File size (bytes): 2609 STIS Filename: opp93021 Title: Fuel spill reports-Format File size (bytes): 1671 STIS Filename: opp93022 Title: No Household Plants in Antarctica File size (bytes): 4670 STIS Filename: opp93023 Title: Cleaning Palmer's Pond File size (bytes): 4157 STIS Filename: opp93024 Title: McMurdo's Wastewater-dispersion File size (bytes): 3369 STIS Filename: opp93025 Title: Temporary incinerator, McMurdo < File size (bytes): 13475 STIS Filename: opp93026 Title: Site Cleanup of East Base File size (bytes): 2848 STIS Filename: opp93027 Title: Black Island Comm. Upgrade File size (bytes): 13284 STIS Filename: opp93028 Title: All-Terrain Vehicle use at McMurdo File size (bytes): 3759 STIS Filename: opp93029 Title: Supplmnt. EAM to Temp. Incinerator EAM File size (bytes): 52355 STIS Filename: opp93030 Title: Inorganic Tracer Use - Lake Fryxell File size (bytes): 2139 STIS Filename: opp93031 Title: All-terrain vehicle at Lake Bonney File size (bytes): 13206 STIS Filename: opp93032 Title: Final SEIS, U.S. Antarctic Prog. File size (bytes): 16803 STIS Filename: opp93033 Title: Balloon Payload building File size (bytes): 10370 STIS Filename: opp93034 Title: EAM-Weddell Sea Ice Camp File size (bytes): 11717 STIS Filename: opp93035 Title: IEE, accelerated waste mgt, McM < File size (bytes): 94822 STIS Filename: opp93036 Title: Establishmnet of CARA-effects File size (bytes): 1886 STIS Filename: opp93037 Title: Patent Development File size (bytes): 6509 STIS Filename: opp93038 Title: Hydrocarbon Transport File size (bytes): 4565 STIS Filename: opp93039 Title: Palmer Automatic Weather Station File size (bytes): 5685 STIS Filename: opp93040 Title: Liquor Storage Facility -McMurdo File size (bytes): 9258 STIS Filename: opp93041 Title: Potable Water Well-South Pole File size (bytes): 13177 STIS Filename: opp93042 Title: Summer Camp Modules-South File size (bytes): 14105 STIS Filename: opp93043 Title: Stanchion System Upgrade File size (bytes): 10801 STIS Filename: opp93044 Title: Astro Building-South Pole File size (bytes): 13717 STIS Filename: opp93045 Title: Waste containment area-McMurdo File size (bytes): 7319 STIS Filename: opp93046 Title: Waste Food Storage at Fortress Rocks File size (bytes): 8674 STIS Filename: opp93047 Title: Temp. Satellite Earth Station, McMurdo File size (bytes): 7326 STIS Filename: opp93048 Title: Shelter for Seismological Instrmnts. File size (bytes): 5911 STIS Filename: opp93049 Title: Constrctn. of Bird Blind, Palmer File size (bytes): 6003 STIS Filename: opp93050 Title: "STARS" at Black Island Comms. File size (bytes): 9623 STIS Filename: opp93051 Title: Addition to S-40's Field Camp Hut File size (bytes): 7733 STIS Filename: opp93052 Title: Phas II-clean-up of East Base File size (bytes): 12900 STIS Filename: opp93053 Title: Addendum to EAM -Blk. Isld.Comms File size (bytes): 26292 STIS Filename: opp93054 Title: Addendum to Liquor EAM File size (bytes): 7931 STIS Filename: opp93055 Title: Fuel Bladder Replacement-South Pole File size (bytes): 13717 STIS Filename: opp93056 Title: Shelter for radio repeater-Palmer File size (bytes): 8542 STIS Filename: opp93057 Title: Wind energy, Humble Island File size (bytes): 8307 STIS Filename: opp93058 Title: Installation-Lights-McMurdo File size (bytes): 17364 STIS Filename: opp93059 Title: Waste Dairy Product-Disposal-McMurdo File size (bytes): 14251 STIS Filename: opp93060 Title: Airdrop of Fuel-Weddell File size (bytes): 10284 STIS Filename: opp93061 Title: Follow-up to Airdrop of Fuel File size (bytes): 2721 STIS Filename: opp93062 Title: Fuel Removal-Weddell File size (bytes): 22065 STIS Filename: opp93063 Title: Ice wharves at McMurdo < File size (bytes): 43391 STIS Filename: opp93064 Title: Hydroponics Project--South Pole File size (bytes): 16403 STIS Filename: opp93065 Title: Human Waste Handling-Kooyman File size (bytes): 2336 STIS Filename: opp93066 Title: S.Pole Camp Upgrade-2 new modules File size (bytes): 22242 STIS Filename: opp93067 Title: New Traffic Control Tower-South Pole File size (bytes): 11570 STIS Filename: opp93068 Title: Fuel Pumping Station-Palmer File size (bytes): 14124 STIS Filename: opp93069 Title: Soil sample for balloon flight File size (bytes): 9690 STIS Filename: opp93070 Title: Comms. Repeater system-Dry Valleys File size (bytes): 10832 STIS Filename: opp93071 Title: Use of 51Cr by S-035 File size (bytes): 2663 STIS Filename: opp93072 Title: Human Waste-Testa/S-004 File size (bytes): 1823 STIS Filename: opp93073 Title: Improvements to Scott Base Road File size (bytes): 12445 STIS Filename: opp93074 Title: Human Waste Disposal-McMurdo File size (bytes): 20667 STIS Filename: opp93075 Title: Two Day Tanks-McMurdo File size (bytes): 11736 STIS Filename: opp93076 Title: Fuel Cache at Patriot Hills File size (bytes): 10813 STIS Filename: opp93077 Title: Cnsctn. of containment-McMurdo's Tanks File size (bytes): 19014 STIS Filename: opp93078 Title: Hut Point Initiiative-McMurdo File size (bytes): 9510 STIS Filename: opp93079 Title: Replacement of Fuel Cache-South Pole File size (bytes): 13553 STIS Filename: opp93080 Title: Storage Tanks-Marble Point File size (bytes): 20186 STIS Filename: opp93081 Title: Release of dye into McM Wastewater File size (bytes): 15278 STIS Filename: opp93082 Title: South Pole CARA Building File size (bytes): 16098 STIS Filename: opp93083 Title: UV Monitoring Building as an addition File size (bytes): 11013 STIS Filename: opp93084 Title: Demolition of Bldg.56,EBC-McMurdo File size (bytes): 15853 STIS Filename: opp93085 Title: Envnmntl. Assmnt.-Women's Expdtn. File size (bytes): 1568 STIS Filename: opp93086 Title: Reverse Osmosis Unit-McMurdo File size (bytes): 6971 STIS Filename: opp93087 Title: S.Pole Power Upgrade File size (bytes): 11292 STIS Filename: opp93088 Title: Installation of T-306 Antenna File size (bytes): 14834 STIS Filename: opp93089 Title: Replcmnt. of Woodstove-Palmer File size (bytes): 9555 STIS Filename: opp93090 Title: Earth Fill Materials-McMurdo File size (bytes): 27552 STIS Filename: opp93091 Title: Robot Operations, Mt. Erebus File size (bytes): 7687 STIS Filename: opp93092 Title: Bicycles at McMurdo Station File size (bytes): 11036 STIS Filename: opp93093 Title: Rock Splitting-USAP project S-015 File size (bytes): 10116 STIS Filename: opp93094 Title: Waste Staging Area-Fortress Rock File size (bytes): 14868 STIS Filename: opp93095 Title: Sewer Outfall Quay Project-McMurdo File size (bytes): 19585 STIS Filename: opp93096 Title: Fuel Tanks & Berms-McMurdo File size (bytes): 15765 STIS Filename: opp93097 Title: USAP's Mngmnt. of Food Wastes-McMurdo File size (bytes): 94994 STIS Filename: opp93098 Title: Underground Freezer at Lake Bonney File size (bytes): 11463 STIS Filename: opp93099 Title: New Storage Tanks-McMurdo File size (bytes): 19673 STIS Filename: opp93100 Title: Wood Waste Staging Pile-McMurdo File size (bytes): 13100 STIS Filename: opp93101 Title: Automatic Weather Stations File size (bytes): 18449 STIS Filename: opp93102 Title: Blue-ice and snow runways < File size (bytes): 61092 STIS Filename: opp93103 Document Type: Directions Title: Directions, Spring 1993 Issue File size (bytes): 32315 STIS Filename: dir9306 Document Type: General Publication Title: NSF 93-74 Engineering News File size (bytes): 66719 STIS Filename: nsf9374 Document Type: Letter Title: NSF 93-60 Dear Colleague Letter for Jointly funded Cross-Discipl File size (bytes): 6503 STIS Filename: nsf9360 Title: NSF 93-68 - Federal Advanced Materials Processing Program File size (bytes): 12177 STIS Filename: nsf9368 Document Type: Report Title: NSF 93-69 - Summary of NSF Workshop on Research Opportunities in Manufacturing in the Process Industries File size (bytes): 126357 STIS Filename: nsf9369 Title: NSF 93-70 - Beyond National Standards and Goals- Excellence in Math. & Science Ed., K-16 File size (bytes): 342275 STIS Filename: nsf9370 f ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet) or stisinfo@NSF (BITNET). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserv@nsf.gov (Internet) or stisserv@NSF (BITNET). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf9370, the text of your message should be as follows: get nsf9370 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9370, you would enter: ftp> get nsf9370 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet) or "firstop@nsf" (BITNET). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet) or "stis@NSF" (BITNET). From owner-sci-resources@net.bio.net Sun Jul 11 23:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 12 July 1993 Message-ID: Date: 12 Jul 93 20:27:50 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 172 Approved: sci-resources-moderator@net.bio.net ** NEW DOCUMENTS ON STIS ** Document Type: Antarctic EAM Title: OPP93104 Sea water desalination system, McMurdo File size (bytes): 42071 STIS Filename: opp93104 Document Type: Program Guideline Title: NSF 93-88 Visiting Professorships for Women (VPW) File size (bytes): 33670 STIS Filename: nsf9388 Title: NSF 93-89 The 1994 U.S./Canada Arctic Ocean Section File size (bytes): 13164 STIS Filename: nsf9389 Title: NSF 93-94 - Chemistry Research Instrumentation and Facilities File size (bytes): 48152 STIS Filename: nsf9394 Document Type: Recruit Title: Science Education Administrator (Program Director) File size (bytes): 4877 STIS Filename: vex9323 Title: Science Education Administrator (Program Director) File size (bytes): 4949 STIS Filename: vex9324 Title: Science Education Administrator (Program Director) File size (bytes): 4706 STIS Filename: vex9325 Title: Secretary (Office Automation File size (bytes): 4992 STIS Filename: vgs9374 Title: Secretary (Office Automation) File size (bytes): 5358 STIS Filename: vgs9375 Title: Program Assistant (Office Automation) File size (bytes): 5421 STIS Filename: vgs9376 Title: Auditor File size (bytes): 6336 STIS Filename: vgs9377 Document Type: Report Title: NSF 93-47 - Research Abstracts for Student Presentations File size (bytes): 328 STIS Filename: nsf9347 Also available: nsf9347.wp5 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alphabetical Listing File size (bytes): 91065 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 95677 STIS Filename: phnorg Document Type: Press Release Title: NSF PR93-43 OUTSTANDING SCIENCE STUDENTS AWARDED NSF MINORITY GRADUATE FELLOWSHIPS File size (bytes): 4242 STIS Filename: pr9343 Title: NSF PR 93-44 NSF, WHITAKER FOUNDATION SEEK RESEARCH IDEAS File size (bytes): 4592 STIS Filename: pr9344 Title: NSF 93-45 BLINDED PHYSICIST, DETERMINED TO CONTINUE NSF-FUNDED RESEARCH, DEVELOPS NEW BRAILLE TECHNOLOGY FOR SCIENCE AND MATH File size (bytes): 4479 STIS Filename: pr9345 Title: NSF PR 93-46 NORMAN HACKERMAN RECEIVES NSB VANNEVAR BUSH AWARD File size (bytes): 4341 STIS Filename: pr9346 Title: NSF PR 93-47 ANTARCTIC FOSSILS GIVE NEW CLUES TO BIRD EVOLUTION File size (bytes): 4476 STIS Filename: pr9347 Title: NSF PR 93-48 SWEEPING EDUCATION REFORM FUNDED FOR FIVE MORE STATES File size (bytes): 5905 STIS Filename: pr9348 Title: NSF PR 93-49 WORKSHOP ON ARCTIC CONTAMINATION HIGHLIGHTS NEED FOR RESEARCH File size (bytes): 5364 STIS Filename: pr9349 Title: NSF PR 93-50 SF SEEKS NOMINATIONS FOR NINETEENTH ALAN T. WATERMAN AWARD File size (bytes): 3353 STIS Filename: pr9350 Title: NSF PR 93-51 NSB REAFFIRMS COMMITMENT TO BASIC RESEARCH File size (bytes): 2232 STIS Filename: pr9351 Title: NSF PR 93-52 LONG-TERM ECOLOGICAL RESEARCH IN THE DESERT SOUTHWEST--HUNDREDS OF PLANTS, BIRDS, INSECTS, AND MAMMALS HAVE BEEN DOCUMENTED IN THIS ARID REGION WHERE MAJOR LIFE ZONES MEET File size (bytes): 7673 STIS Filename: pr9352 Title: NSF PR 93-53 SOUTH POLE RESEARCHERS OBSERVE EARLY STRUCTURE OF THE UNIVERSE File size (bytes): 5846 STIS Filename: pr9353 ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet) or stisinfo@NSF (BITNET). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserv@nsf.gov (Internet) or stisserv@NSF (BITNET). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve pr9353, the text of your message should be as follows: get pr9353 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve pr9353, you would enter: ftp> get pr9353 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet) or "firstop@nsf" (BITNET). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet) or "stis@NSF" (BITNET). From owner-sci-resources@net.bio.net Mon Jul 12 23:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 25, pt. 3, 16 July 1993 Message-ID: Date: 13 Jul 93 22:19:26 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 596 Approved: sci-resources-moderator@net.bio.net $$XID RFA CA93034 CA-93-034 P1O1 *************************************** DEVELOPMENTAL RESEARCH IN NATIVE PACIFIC POPULATIONS NIH GUIDE, Volume 22, Number 25, July 16, 1993 RFA: CA-93-034 P.T. 34, FB; K.W. 0715035, 0795003, 0745027 National Cancer Institute Letter of Intent Receipt Date: August 18, 1993 Application Receipt Date: October 20, 1993 PURPOSE The National Cancer Program is mandated to address the unique cancer prevention, early detection, and treatment needs of all populations within the U.S. and its territories. An excerpt from the FY 1992 Committee on Appropriations to the U.S. Department of Health and Human Services stated: "The Committee also urges NCI to expand its efforts to develop an appropriate response to the needs of American Samoans. Access to timely treatment intervention is especially important for this native American population...." (Senate Report No. 102-104, page 86) Therefore, the Division of Cancer Prevention and Control (DCPC) of the National Cancer Institute (NCI) invites applications from various organizations for developmental studies that: (1) assess cancer control need, (2) determine barriers to cancer control, and/or (3) validate intervention methods and assessment instruments in native Pacific populations; i.e., American Samoans, Guamanians (Chamorros), Palauians, and Northern Marianians. This initiative will define the cancer prevention and control needs of native Pacific populations and those of similar ancestry located in the Pacific as well as the U.S. mainland. 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), Developmental Research in Native Pacific Populations, is related to the priority area of cancer. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000 (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic (including U.S. Territorial possessions) public and private, for-profit and non-profit organizations serving native Pacific populations such as universities, public health departments, voluntary organizations, research centers, hospitals, consortia of health providers, units of State and local governments and eligible agencies of the Federal government. Teams of applicants are encouraged. Among a team of applicants, one institution must be proposed as the lead institution to serve as the applicant and to assume responsibility for the conduct and administration of the project. Note that awards will not be made to foreign institutions and that applications from domestic organizations may not include international components. MECHANISM OF SUPPORT The mechanism of support for this RFA will be the National Institutes of Health (NIH) research project grant (R01). Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. In addition to the requirements stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1991. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. It is anticipated that four awards will be made at approximately $300,000 total costs per year. FUNDS AVAILABLE Approximately $1.2 million in total costs per year for three years will be set-aside to specifically fund applications that are submitted in response to this RFA. It is anticipated that up to four awards will be made. The total project period of these awards may not exceed three years. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of a grant pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background The National Cancer Program is mandated to address the unique cancer prevention, early detection, and treatment needs of all populations within the U.S. and its territories. The cancer control objectives for the nation are aimed at (1) reducing the cancer death rates for all Americans and (2) eliminating differentials in cancer rates between population segments. The means to obtain these objectives include the development and implementation of cancer control and prevention strategies directed at the general U.S. population and targeted initiatives directed at minority and medically underserved populations that are differentially affected by cancer. These populations include those who experience high cancer incidence/mortality rates or low survival rates, or who are underserved in terms of cancer prevention and control programs that include the native Pacific populations. The paucity of data on effective cancer prevention and control intervention methods in the target populations reflect both a dearth of such programs and of validated instruments to evaluate their effectiveness. The need for the development of sensitive intervention methods and assessment instruments has to be established in many areas of health (e.g., mental health, cardiovascular diseases) and other sectors (e.g., education). In recent years, the Division of Cancer Prevention and Control (DCPC) has carried out intervention research initiatives directed at the American Indian/Alaska Native, Black, Native Hawaiian, and Hispanic populations. These experiences, combined with information gathered through external working groups and experts in the cancer prevention and control needs of minority and medically underserved populations and extensive conversations with experienced investigators, has clarified the need for Phase I and Phase II cancer control studies for native Pacific populations. It is clear that the concepts of health and healing vary significantly, and this diversity is not captured by a single design, method, or instrument. Studies conducted under this RFA will seek to define cancer prevention and control needs/services of the native Pacific population segments (Phase I). Studies to test ways in which existing intervention methods can be used or adapted for the target populations (Phase II); studies of new methods designed to be sensitive to the needs of the target populations (Phase II); and methodologic research on validation of assessment instruments in target populations (Phase II) are eligible for consideration under the RFA. This "developmental cancer control research" (Phase I and Phase II) is absolutely essential to future development of cancer prevention and control research for native Pacific populations. The following definitions apply to this RFA: 1. Native Pacific Populations -- The term "native Pacific populations" refers to those population segments indigenous to the Pacific region and/or populations of similar ancestry located within the U.S. mainland, such as American Samoan populations. 2. Cancer Control -- Cancer control is defined as the reduction of cancer incidence, morbidity, and mortality through an orderly sequence from research on interventions and their impact in defined populations to the broad, systematic application of the research results. 3. Phases of Cancer Control -- Cancer control research studies are classified in the five phases that represent the orderly progression noted in the above definition: (I) Hypothesis development; (II) Intervention methods development and testing; (III) Controlled intervention trials to establish cause and effect relationships; (IV) Research in defined human populations; and (V) Demonstration and implementation studies. The research of interest in this RFA falls into either Phase I or Phase II studies. Hypothesis development (Phase I) studies should focus on the assessment of cancer prevention and control needs in communities or organizations within native Pacific populations, or studies that identify barriers to cancer prevention and control within these indigenous populations. Methods development and testing studies, Phase II, should focus on: (1) validating the use of existing intervention methods (e.g., dietary modification, health services, tobacco cessation) as applied in the target populations described above; (2) developing and pilot testing unique methods that are sensitive to the needs of the target populations described above, or (3) developing and validating assessment instruments to measure the cancer control related needs of the target populations or for use in evaluating the effectiveness of intervention methods in the target populations. It is the interest of this RFA that the projects should be multidisciplinary in design. Applicable disciplines may include epidemiology, oncology, public health, pathology, health services research, behavioral, and social sciences. The research team should include individuals with knowledge of the culture and language of the native Pacific populations. Because validation and intervention studies may depend on the review of case records, investigators should assure in the application that a mechanism to access pertinent records has been identified. A. Goals and Objectives The goals of this program initiative are to identify cancer control needs, to determine barriers to cancer control, and to validate intervention methods and assessment instruments. The objectives relating to Phases I and II are described below: Phase I Studies 1. Assess cancer prevention and control needs/services in communities with native Pacific populations. 2. Identify barriers to cancer prevention and control in native Pacific population communities. Phase II Studies 1. Validate the use of existing intervention methods (e.g., dietary modification, health services, tobacco cessation) applied in the target populations. 2. Develop and pilot test unique intervention methods sensitive to the needs of the target populations. 3. Develop and validate assessment instruments (e.g., dietary intake, risk factor surveys) to measure the cancer control related needs of the target populations and to evaluate the effectiveness of intervention methods in the target populations. B. Project Approach It is important that applicants describe fully and in detail all aspects of the proposed project in the application, including cancer sites to be studied, the target population for which the research is being conducted, available population data bases, hypotheses to be considered, the planned intervention approaches, methods of assessment and validation, and the overall research design approach to the proposed study. It is essential to select and justify in the application, cancer sites on the basis of the significance in the target population and the potential for reduction of mortality rates. It is also essential that the population for which the study(ies) will be carried out be specified and characterized using population-based estimates of the demographic characteristics of the target population. All collaborative arrangements that are planned should be described in detail, including areas of responsibility, coordinating, decision-making authority, and financial relationships. Letters of commitment from each participating organization should be included in the application. C. Research Plan The applicant should include a detailed protocol outlining the proposed project methods for determining outcome effects. The protocol should detail the research project as conceived and should provide the complete methodological approach to the problem under investigation. The design for the project should provide enough information to determine an adequate "test" of the concepts, whether validation or intervention outcomes. It is important that the design permits statistically valid results to be achieved within the period of award. D. Options in Project Design Applicants must choose from the three types of projects described below: o Type One - Validation study of an existing intervention method for use in a native Pacific population group. o Type Two - Develop and pilot test a "unique" intervention method that is sensitive to the needs of the target population. o Type Three - Develop and validate needs assessment instruments or assessment instruments that could be used to measure effectiveness of cancer control methods in the target population. Applicants must specify which type they have selected in the first line of section 2(a), "Specific Aims", in the application. E. Time Schedule A detailed time schedule should be presented in the application. This schedule is important because it will provide the milestones against which progress will be validated. SPECIAL REQUIREMENTS Awardees should include in the proposed budgets travel to the NCI for up to two persons to attend two meetings of Principal Investigators and NCI program staff to discuss such issues as the validation of stated hypotheses, determination of population characteristics/size relative to the intervention specified, research progress, and results. These meetings will be held approximately three months prior to the scheduled completion of years 01 and 03, respectively. Awardees should anticipate that NCI staff may conduct a site visit as a part of program management in order to assure that projects are proceeding according to the plans specified in the application. This anticipated site visit is not intended to reduce the requirements for the customary detailed progress report in accordance with the instructions appearing in form PHS 2590. STUDY POPULATIONS The targeted population intended under this RFA is the native Pacific populations and those of similar ancestry located in the Pacific as well as the U.S. mainland; i.e., American Samoans, Guamanians (Chamorros), Palauians, and North Marianians. Applicants responding to this RFA are expected to successfully access a significant portion of this population to decrease cancer incidence and mortality, increase cancer survival, and increase the diagnosis of cancers at earlier stages. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaska Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by August 18, 1993, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is extremely helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. In addition, if it appears that the potential applicant has misunderstood the objectives of the RFA or opted for an inappropriate funding mechanism, NCI staff will respond to such letters. The NCI would like to emphasize the benefits to the applicant and to staff of having a Principal Investigator submit a letter of intent. The letter establishes communication between the potential applicant and program staff initiating the RFA. Program staff may be able to assist prospective applicants in several areas, i.e., scientific content and objectives of an application, size and focus of a research program, organization of an application, and appropriate use of core components and consultants. The letter of intent is to be sent to: George A. Alexander, M.D. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 240 6130 Executive Boulevard Bethesda, MD 20892-4200 Telephone: (301) 496-8589 FAX: (301) 496-8675 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information Division of Research Grants, National Information of Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892; telephone 301/594-7248. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number should be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies in one package to the Division of Research Grants at the address below. The photocopies must be clear and single-sided. Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg, Referral Officer Division of Extramural Activities National Cancer Institute Westwood Building, Room 838 5333 Westbard Avenue Bethesda, MD 20892 Applications must be received by January 25, 1993. 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 announcement 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 a substantial revision of an application already reviewed, but the revised application must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Review Procedures Upon receipt, applications will be reviewed (initially) by the DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the RFA is an NCI program staff function. If an application is judged to be non-responsive, the applicant will be contacted and given an opportunity to withdraw the application or have it considered with other unsolicited applications received by NIH in the next review cycle. Questions concerning responsiveness to the RFA may be directed to NCI program staff listed under INQUIRIES. If the number of applications submitted is large compared to the number of awards to be made, the NCI may conduct a preliminary scientific peer review to eliminate those that are clearly not competitive. The NCI will remove from competition those applications judged to be noncompetitive for award and notify the applicant and institutional business official. Those applications that are complete and responsive will be initially evaluated in accordance with the review criteria stated below for scientific/technical merit by an ad hoc review committee convened by the Division of Extramural Activities, NCI. The second level of review will be provided by the National Cancer Advisory Board. Responsiveness Criteria Applicants must be responsive to this RFA in the sense of being directed towards the attainment of the stated programmatic goals. Five considerations are of paramount importance to this RFA: 1. Descriptions of the cancer problem with justification for the selection of specific cancer site(s) in terms of potential for reduction of mortality rates, cancer control intervention strategy, research method, procedures, analysis plans, and time schedule must be clearly delineated. 2. Studies must be limited to Phase I and/or Phase II only. 3. Assurance of access to a community with characteristics appropriate for the proposed intervention: written documentation must be included. 4. The target population must be a native Pacific population indigenous to the U.S. Pacific territorial region, i.e., American Samoa, Guam, Palau, Northern Marianas; or of similar ancestry located in Hawaii and the U.S. mainland, i.e., American Samoans. 5. Agreements with communities, organizations, agencies, or institutions that are critical to ensure access to appropriate records and to the implementation of the research plan must be included. Review Criteria Each application will be reviewed on its own merit. All applicants must clearly define the target population and geographic location where the program efforts will be demonstrated as well as the project team's ability to access the target population. All applicants should include in the application a succinct discussion of previous relevant efforts and plans to meet the terms of award. Applicants are encouraged to submit and describe the approach that they think would best meet the goals of this RFA and to identify in-kind contributions and/or co-sponsors for specific personnel, activities, and facilities. Each application will be reviewed according to the following criteria: 1. Scientific merit of the research approach, design, and methodology. 2. Scientific and technical significance and originality of the proposed research. 3. Experience (research or clinical or service) and/or competence of the Principal Investigator and staff. 4. Adequacy of time (effort) that the Principal Investigator and staff would devote to the proposed project. 5. Characterization of the native Pacific population to be used (cultural, spiritual or language considerations) in the proposed project. 6. Adequacy of the approaches to produce valid assessment instruments for use in larger community intervention studies for cancer control. 7. Likelihood of intervention (Phase II studies) to be readily accepted and feasible in terms of cost. 8. Potential for generalizability of the findings and adaptability of the intervention approaches and assessment instruments in other communities with similar cancer control problems. 9. Adequacy of the plans for inclusion of women. The ad hoc review group will recommend an appropriate budget for each approved application. AWARD CRITERIA The anticipated date of award is July 1, 1994. Applicants will compete for funding based on the quality and merit of the proposed research study as determined by peer review, availability of funds, and programmatic priorities, as well as geographic location. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: George A. Alexander, M.D. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 240 Bethesda, MD 20892-4200 Telephone: (301) 496-8589 Direct inquiries regarding fiscal issues to: Crystal Elliott National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800 Ext. 19 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control Science Program. 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 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. From owner-sci-resources@net.bio.net Mon Jul 12 23:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 25, pt. 2, 16 July 1993 Message-ID: Date: 13 Jul 93 22:18:39 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 534 Approved: sci-resources-moderator@net.bio.net $$XID RFA HS94002 HS-94-002 P1O1 *************************************** MEDICAL TREATMENT EFFECTIVENESS RESEARCH -- PORT-IIs NIH GUIDE, Volume 22, Number 25, July 16, 1993 RFA: HS-94-002 P.T. 34; K.W. 0745027, 0745035, 0745070, 0730050, 0408006 Agency for Health Care Policy and Research Letter of Intent Receipt Date: October 1, 1993 Application Receipt Date: November 16, 1993 PURPOSE This announcement solicits applications to conduct innovative and timely research that will provide convincing evidence for or against the effectiveness and cost effectiveness of alternative clinical interventions for the prevention, diagnosis, treatment, and management of common clinical conditions. The Agency for Health Care Policy and Research (AHCPR) developed this solicitation as part of the Medical Treatment Effectiveness Program (MEDTEP). These awards will constitute a new generation of MEDTEP research and an extension of work carried out by AHCPR's Patient Outcomes Research Teams (PORTs). The new projects, called PORT-IIs, will have potential to make substantial contributions to the improvement of health outcomes. Their results will be relevant to patients, health care providers, and policymakers. 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. The AHCPR urges applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-004374-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign non-profit organizations, public and private, including universities, clinics, units of State and local governments, non-profit firms, and non-profit foundations. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT This RFA will use the research project grant (R01) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation. The total requested project period for applications submitted in response to this RFA may not exceed five years. While the grants under this solicitation may vary in cost, most individual projects are expected to request less than $1 million total direct costs per year. The earliest possible award date will be July 1, 1994. Annual progress reviews by AHCPR and the availability of funds will determine the continuation of grants up to the five year limit. FUNDS AVAILABLE The AHCPR expects to award up to $7 million in Fiscal Year 1994 to support the first year of 5 to 10 studies. The number of awards will be contingent on the availability of funds and the quality of the applications. RESEARCH OBJECTIVES Background and Conceptual Framework Since 1989, AHCPR has made a major investment and major advances in medical effectiveness/patient outcomes research, especially through the set of special, multi-faceted projects known as Patient Outcomes Research Teams (PORTs). This RFA announces the second generation of special projects, PORT-IIs, a pragmatic program that continues to put the patient foremost and to emphasize the policy significance of understanding what health care is most effective. What is new in PORT-IIs is the effort to expand the potential for discovery by encouraging individual customization and creativity in research designs. The individual methods common in PORTs (e.g., meta-analysis and variations studies based on analysis of administrative data) are available for, but not required in, PORT-IIs. PORT-IIs will focus on the establishment of direct linkages between practice and outcomes and on research methods that facilitate direct comparisons of alternative clinical strategies. They are expected to start with carefully formulated research questions and employ research strategies tailored to the selected condition and the population at risk. Emphasis is placed on research designs that can answer convincingly and efficiently questions about which clinical strategies lead to the desired outcomes. Research under AHCPR's Medical Treatment Effectiveness Program is concerned with enhancing the "effectiveness," "cost effectiveness," and "appropriateness," of health care, as defined below. "Effectiveness," as distinct from "efficacy," refers to the outcomes experienced by or observed in patients in routine clinical practice. Effectiveness studies take into account the complexities that result from the many clinical and non-clinical variables that influence practice and outcomes. At a minimum, these include relevant comorbidities, medical history, and adherence to treatment recommendations; relevant demographic, socioeconomic, and cultural characteristics; and patients' values and preferences. They may include differences in clinicians' training, skills, and practice styles. Differences in organizational factors, such as financial incentives and composition of the clinical team, also may be considered as important independent variables. It is expected that the result of this inclusionary approach will be a set of studies the findings of which can be generalized to health care as it is typically received and practiced in the community. The PORT-II's emphasis on the generalizability of findings excludes from consideration, under this RFA, typical "efficacy" studies. A traditional randomized controlled trial, the findings of which relate only to the potential benefits of clinical interventions under ideal circumstances and in patients who meet narrow eligibility criteria would be non-responsive to this RFA. However, the RFA does include clinical trials that are designed to answer effectiveness questions, i.e., questions about outcomes in persons who are representative of those with the condition that is being studied. Such studies are referred to as "effectiveness trials." "Cost-effectiveness" analyses most often compare the direct monetary costs of health care plus the associated indirect costs (e.g., lost work) with the benefits and burdens of the intervention. Applications responsive to this RFA should address questions of cost effectiveness if or when the interventions to be compared are associated with significant differences in cost or significant differences in effect. The MEDTEP concept of "appropriateness" encompasses both clinical and non-clinical dimensions. It includes consideration not only of the fit between the intervention and the objective and technical aspects of the patient's condition, but also consideration as to whether the known risks and costs of the intervention, and the predicted outcomes, are acceptable to individual patients and to the public. In assessing effectiveness, cost effectiveness, and appropriateness, investigators are encouraged to measure outcomes that emphasize the patient's perspective and to consider how patient preferences influence evaluations of the outcomes. In general, outcomes are to include survival, symptom relief, patient-reported quality of life, functional status, satisfaction with care, and costs. Analysis of a broad set of outcomes is desirable, but it is essential that the research address the most significant outcomes for the particular condition under study, whether these are long - or short-term. SPECIAL REQUIREMENTS Topic Selection This RFA accommodates an extremely wide range of clinical subjects. Public interest in health care reform and more cost-effective use of health care resources makes it important that AHCPR focus on questions with significant potential to improve outcomes and/or decrease costs. The AHCPR's authorizing legislation places special emphasis on conditions that are common and costly in the Medicare program. Applicants are expected to present a strong case for their selected topic in a critical literature review. The review should address the clinical and policy significance of the condition, provide evidence of controversy or information gaps regarding current clinical strategies, and support the formulation of the proposed research question(s). The formulation of the problem should reflect understanding of the issues regarding clinical decisionmaking and the translation of study findings into clinical practice. Further, the discussion should satisfy reviewers that the important questions about outcomes can be answered within the proposed grant period. Most PORT-II studies will be condition-specific or technology-specific. Condition-specific studies should focus on an important clinical condition and the most important interventions for its prevention, diagnosis, treatment, and/or management. In addition to clinical problems that are significant in the Medicare population, this announcement includes conditions and technologies that are common and costly in children, adolescents, and adults under age 65. This includes well-defined diseases (e.g., breast cancer, pediatric asthma), as well as symptoms and conditions (e.g., headache, fatigue, obesity). While acute or chronic conditions may be selected, the AHCPR is especially interested in studies of chronic problems and those treated in ambulatory settings. To be responsive to this RFA, the selected condition must meet all of the following MEDTEP criteria: o high incidence or prevalence in the general population or in major population subgroups; o controversy or open questions over the effectiveness and relative effectiveness of available clinical strategies; and o high cost, whether due to the number of people needing care, high cost of care, or high indirect cost. This announcement encompasses studies that compare two or more distinctly different clinical approaches to the prevention, diagnosis, treatment, management, or rehabilitation of common clinical conditions. Examples of responsive studies include comparisons of: medical vs. surgical treatment, radical vs. conservative surgery, psychotherapy vs. pharmacotherapy, or invasive vs. non-invasive screening tests. Other possible comparisons could include care prescribed or provided by different kinds of health care professionals (e.g., physicians, nurses, therapists) and care provided in different settings. If it is not feasible to address all important treatment options in a single study, applicants must identify the specific interventions the study will address and provide justification for these selections. In general, studies that can carry out the most comprehensive assessments of the pertinent clinical strategies will be of greater interest to AHCPR. Methods Investigators are encouraged to design new research strategies, to use new combinations of methods, or to tailor existing methods to their research question(s) so that convincing evidence will be obtained for, or against, the effectiveness of alternative clinical interventions. Research methods that can be employed include, but are not limited to, quasi-experimental designs, case-control studies, cohort studies, effectiveness trials, meta-analyses, cost-effectiveness analyses, decision modeling, and combinations of these methods. Sources of data about patient outcomes can include: new, established, or adapted surveys of patients and providers; clinical registries; and clinical records from practice-based networks, health maintenance organizations, and other health care providers. In many cases, primary data, collected prospectively, may be most appropriate to the questions and methods involved. However, when secondary data will provide adequate information and an efficient means to address the research questions, applicants are encouraged to use such data. For example, administrative data, although they generally lack clinical detail, may be useful in identifying cases and controls, estimating costs, or measuring selected outcomes. The application should be explicit in its strategy for case-finding and its justification that the results will be generalizable to patients cared for in routine clinical practice. The application should also define the strategy for making direct comparisons of alternative treatments. The application should be explicit and detailed in describing the data collection and analysis. In all cases, the methods and data employed must be justified in terms of their potential for answering the effectiveness research questions under study. There should be evidence of adequate attention to relevant characteristics of each of the following: o the patients and persons at risk for the condition, especially characteristics that may affect case-finding, case-definition, and generalizability; o the condition, especially characteristics that affect quality of data and complexity of analysis (e.g., diagnosis is definite vs. equivocal, course is steady vs. sporadic); o the clinical interventions (duration and timing, stability of technology); o the outcomes (e.g., measurability, timing, stability); o the providers (e.g., training, financial incentives, liability concerns, accessibility); o available data and measures; and o the social and cultural context of illness and health care, especially characteristics that affect disease prevalence, health behavior, access to care, and conduct of research. Project Organization To adequately address the clinical and non-clinical dimensions of effectiveness questions, most studies will require multidisciplinary research teams. In all cases, the composition of the team and relative time commitments of each member should be well justified in terms of substantive knowledge, methodological expertise, and experience in conducting or managing related research projects. It is further expected that the team include at least one individual who is actively involved in the type(s) of patient care central to the study and who contributes understanding of how and why clinical decisions are made in routine clinical practice. Applicants are encouraged to take full advantage of opportunities for efficient enhancements of available expertise, data, and other research resources. This might include collaboration with researchers and practitioners outside their own institutions, creative use of existing data, or "piggybacking" on other data collection activities. Another possibility for leveraging research resources is to conduct comparisons of outcomes where existing practice patterns are known to differ (e.g., across care settings, health care systems, or international borders). STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS CONCERNING INCLUSION OF WOMEN AND MINORITIES IN RESEARCH STUDY POPULATIONS The AHCPR requires all applicants for research grants to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study. Special emphasis must be placed on including minorities and women in studies of diseases, disorders, and conditions which disproportionately affect them. This policy applies to males and females of all ages. If women or minorities are excluded or inadequately represented in research, a clear and compelling rationale must be provided. This policy applies to all AHCPR research grants. The AHCPR will not award grants for applications which do not comply. If the application does not contain the required information, it will be returned without review. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1 to 4 of the Research Plan and summarized in Section 5, Human Subjects (or in the program narrative section of form PHS 5161 for State and local governments). Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, AHCPR recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., American Indians/Alaskan Natives, Asian/Pacific Islanders, Blacks, Hispanics). Where appropriate, the applicant must provide the rationale for studies on single minority population groups. For foreign awards, the policy on inclusion of women applies fully. Since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. Peer reviewers will address specifically whether the applicant's research plan conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed and the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in the priority score assigned to the application. LETTER OF INTENT Prospective applicants are asked to submit by October 1, 1993, a letter of intent that includes a descriptive title of the proposed research; the names, addresses (including institutions), and telephone numbers of the Principal Investigator and other key personnel; and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows AHCPR staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to Dr. Richard Greene at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used. (State and local government agencies may use form PHS 5161 and follow those requirements for copy submission.) These forms are available at most institutional offices of sponsored research; the Office of Grant Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248; and the Scientific Review Branch, Agency for Health Care Policy and Research, 2101 East Jefferson Street, Suite 602, Rockville, MD 20852, telephone 301-227-8449 (after July 31, telephone 301-594- 1449). The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. The completed, signed, original application and four legible copies of form PHS 398 must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Completed applications must be received by the Division of Research Grants by November 16, 1993. If an application is received after that date, it will be returned to the applicant. One copy, labeled "Advance Copy," must be submitted simultaneously to: Center for Medical Effectiveness Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 605 Rockville, MD 20852 Failure to provide this advance copy will result in the return of the application to the applicant. REVIEW CONSIDERATIONS Applications will be reviewed initially by the Division of Research Grants, NIH, for completeness and by AHCPR program staff for responsiveness to the RFA. Incomplete and unresponsive applications will be returned to applicants without further consideration. Review criteria for AHCPR grant applications are significance and originality from a scientific and technical viewpoint; adequacy of the method; availability of data or proposed plan to collect data required for the project; qualifications and experience of the principal investigator and proposed staff; adequacy of the plan for organizing and carrying out the project; reasonableness of the proposed budget; and adequacy of the facilities and resources available to the applicant. Applications will be evaluated in accordance with the criteria stated above for scientific/technical merit and the special review criteria listed below by an appropriate peer review group. Applications requesting total direct costs in excess of $50,000 may be reviewed by AHCPR's National Advisory Council for Health Care Policy, Research, and Evaluation. Special Review Criteria The major scientific criterion for evaluating applications under this solicitation is the potential for obtaining convincing, new evidence for, or against, the effectiveness of alternative interventions that are significant in preventing, diagnosing, treating, or managing the selected condition. The selected condition must meet the MEDTEP criteria listed above under Topic Selection. Separate consideration is given to the significance of the research question(s). The review committee will independently evaluate each application received in response to this RFA against the following special scientific and technical review criteria: o scientific importance of the clinical topic and particular clinical interventions to be studied, as justified in a review of the literature; o evidence that the proposed research plan can answer the research question(s) within the project period, i.e., that the science base is adequate, data are available or can be obtained, length of follow-up is sufficient; o attention to technical issues in case-definition, case-finding, data collection, and analysis; o quality and adequacy of the proposed data; o justification for focus on specified outcomes; o adequacy of outcome measures, including measurement of costs if applicable; o extent to which research design permits direct comparisons of treatment effectiveness and of cost effectiveness; o evidence of understanding of the issues in clinical decisionmaking and the translation of research findings into clinical practice; o sensitivity to patient heterogeneity and individual preferences; o generalizability of results; o specification of useful findings or products and identification of constituency(ies) for these; o cost effectiveness of research plan; o composition of the research team, including evidence of necessary experience and expertise, and appropriateness of relative time commitments; and o evidence of productive collaborations (e.g., with other institutions, appropriate professional groups, other sources of support). AWARD CRITERIA Applications will compete for available funds with all other applications for this RFA. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review and availability of funds. The earliest anticipated date of award for applications will be July 1, 1994. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Inquiries regarding programmatic issues and the letter of intent may be addressed to: Richard Greene, M.D., Ph.D. Director, Center for Medical Effectiveness Research Agency for Health Care Policy and Research 2101 East Jefferson Street Rockville, MD 20852 Telephone: (301) 227-8485 (through July 31, 1993) or (301) 594-1485 (effective August 1, 1993) Direct inquiries regarding fiscal matters to: Ralph L. Sloat, Grants Management Officer Agency for Health Care Policy and Research 2101 East Jefferson Street Rockville, MD 20852 Telephone: (301) 227-8447 (through July 31, 1993) or (301) 594-1447 (effective August 1, 1993) AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.180. Awards are made under authorization of the Public Health Service Act, Title IX, as amended by Public Laws 101-239 and 102-410, (42 U.S.C. 299-299c-6) and Section 1142 of the Social Security Act (42 U.S.C. 1320b- 12). Awards are administered under the PHS Grants Policy Statement; and Federal Regulations 42 CFR Part 67, Subpart A, and 45 CFR Part 74 (45 CFR Part 92 for State and local governments). This program is not subject to the intergovernmental review requirements of Executive Order 12372. From owner-sci-resources@net.bio.net Mon Jul 12 23:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 25, pt. 1, 16 July 1993 Message-ID: Date: 13 Jul 93 22:17:32 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1178 Approved: sci-resources-moderator@net.bio.net NOTE: The NIH Guide may be split into more than one mail message to avoid truncation during e-mail distribution. The first message always begins with the RFP/RFA summary sections followed by the appended texts of the full RFP/RFAs. ---------------------------------------------------------------------- $$XID NIHGUIDE 19930716 V22N25 P1O1 ************************************ X-comment: RFAs described: CA-93-034, HS-94-002, ES-93-002 NIH GUIDE - Vol. 22, No. 25 - July 16, 1993 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** RECRUITMENT OF UNDERREPRESENTED MINORITIES INTO INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARD PROGRAMS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** NEW PROPHET SOFTWARE AVAILABLE National Center for Research Resources INDEX: RESEARCH RESOURCES NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** CLINICAL EVALUATION OF PSYCHOTHERAPEUTIC MEDICATIONS (NIMH-OP-93-0007) National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX R2 ********************************************************** CORRELATES OF HIV IMMUNE PROTECTION LABORATORY (NIAID-DAIDS-94-12) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R3 10/20/93 ************************************************* DEVELOPMENTAL RESEARCH IN NATIVE PACIFIC POPULATIONS (CA-93-034) National Cancer Institute INDEX: CANCER $$INDEX R4 11/16/93 ************************************************* MEDICAL TREATMENT EFFECTIVENESS RESEARCH -- PORT-IIs (RFA HS-94-002) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH $$INDEX R5 11/24/93 ************************************************* ENVIRONMENTAL HEALTH SCIENCES EDUCATION (RFA ES-93-002) National Institute of Environmental Health Sciences INDEX: ENVIRONMENTAL HEALTH SCIENCES This publication is also available electronically to institutions via BITNET or INTERNET and is on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** RECRUITMENT OF UNDERREPRESENTED MINORITIES INTO INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARD PROGRAMS NIH GUIDE, Volume 22, Number 25, July 16, 1993 P.T. 22, 44, FF; K.W. 0720005 National Institutes of Health The purpose of this notice is to clarify the policy and to update previous notices about the recruitment of underrepresented minorities into institutional National Research Service Award (NRSA) (T32) supported research training programs. Previous notices related to this requirement have appeared in the NIH Guide for Grants and Contracts (Vol. 18, No. 20, June 9, 1989 and Vol. 15, No. 4, March 28, 1986). Those notices announced current NIH policy which requires all competing applications for NRSA institutional research training grants to contain a plan for recruitment of individuals from underrepresented minority groups into the research training program. In most respects the policy articulated in this notice remains as described in 1989. All competing applications for institutional research training grants must continue to include a plan to recruit individuals from underrepresented minority groups and competing renewal applications must continue to report accomplishments in recruiting and retaining individuals from underrepresented groups during the previous award period. In addition, all applications will continue to be examined for these components during initial review. The only substantive difference is that review procedures have been updated to permit evaluation of recruitment strategies that have been in place for five or more years in compliance with the NIH requirement. As a consequence, beginning with research training grant applications received for the September 10, 1993 receipt date, the adequacy of the recruitment and retention efforts and the success in identifying and appointing minority trainees during the previous award period will be considered by a peer review panel. In all respects, the NIH remains strongly committed to increasing the participation of individuals from underrepresented minority groups in biomedical and behavioral research. Since the NRSA research training grant program currently supports approximately 14,000 predoctoral and postdoctoral trainees in biomedical and behavioral research, this program is considered an ideal mechanism to accomplish these goals. At the present, time minority groups considered to be underrepresented in biomedical and behavioral sciences include: Alaskan Natives, Blacks, Hispanics, Native Americans, and Pacific Islanders. This policy is implemented at the NIH as described below: Administrative Procedures As announced in 1989, all competing applications for institutional NRSA research training grants must include a plan to recruit minorities and renewal applications must also include a report on the recruitment and retention record during the previous award period. If an application is received without a plan, or without a report on the previous award period, the application will be considered incomplete and will not be reviewed until this information is provided. During initial review, reviewers will first assign a priority score for the overall technical and educational merit of the application. Then, one or more assigned reviewers will discuss the minority recruitment plan and any record of recruitment and retention for evaluation by the review panel. The recruitment components of each application will be judged to be either acceptable or unacceptable. The findings of the review panel will appear in an administrative note in the summary statement for each reviewed application. The administrative note will include a description of the minority recruitment strategies used in the previous award period, the plans for the next award period, and the achievements of the training program in recruiting and retaining underrepresented minority trainees. If the minority recruitment section of the application is judged to be unacceptable, funding will be withheld until a revised plan that addresses the deficiencies is received. Staff within the awarding component, with guidance from the appropriate national advisory board or council, will determine whether or not amended plans and reports submitted after the initial review are acceptable. Acceptable Plans The notice that appeared in the NIH Guide for Grants and Contracts (Vol. 18, No. 20, June 9, 1989) contained a list of strategies that might be used to facilitate minority recruitment. For example, advertisements, posters, flyers, visits to minority institutions, the development of cooperative programs with minority institutions, interactions with scientific and professional societies, appointment of minority faculty and a variety of other suggestions were offered. The minority recruitment efforts that seem to be most successful are those that combine a number of different strategies tailored to the needs of the particular training program. Reviewers will judge the acceptability of the plan, considering the size of the training program, the geographic location, and the availability of minority applicants. For example, more aggressive recruitment efforts may be required in programs where there has traditionally been a shortage of minority applicants. Although institutional efforts to increase the ethnic diversity are important and commendable, they will not be accepted as substitutes for the active involvement of the program director and the participating faculty in recruiting underrepresented minorities into specific training programs. To help locate future minority trainees, the NIH has recently published a booklet that lists the names, addresses, and telephone numbers for all NRSA research training program directors, including directors of Minority Access to Research Careers (MARC) Honors Undergraduate Research Training Grants. The booklet also contains information on Principal Investigators of Minority Biomedical Research Support (MBRS) research grants. This resource booklet will permit training program directors to make contact with individuals who may have knowledge of minorities interested in appointment to a research training grant. Booklets can be obtained by writing to Dr. Walter Schaffer, NIH Research Training and Research Resources Office, Building 31, Room 5B44, Bethesda, MD 20892. Underrepresented minority students should, of course, be recruited from all institutions. Reports of Accomplishments Competing renewal applications for research training grants must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous award period including information on the types of recruitment strategies used and which types have been successful or unsuccessful. Also, the report should provide information on the racial/ethnic distribution of: (a) students and or postdoctorates in the department(s) relevant to the training grant, (b) individuals who applied for training, (c) individuals who were offered admission, and (d) individuals who were appointed to the research training grant. For those trainees who were appointed to the grant, the report should include information about the duration of training and whether or not those trainees have finished training in good standing. Peer reviewers will carefully examine and evaluate the record of the program in recruiting and retaining underrepresented minority trainees during the previous award period. They will also consider whether or not the experience in recruitment during the previous award period has been incorporated into the formulation of the recruitment plan for the next award period. Information on the recruitment and retention of underrepresented minority trainees appointed during the previous budget period must also be provided in progress reports included in non-competing applications for all institutional research training grants. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NEW PROPHET SOFTWARE AVAILABLE NIH GUIDE, Volume 22, Number 25, July 16, 1993 P.T. 34; K.W. 1004017, 1004005, 0710030, 0760053 National Center for Research Resources The Biomedical Research Technology Program, National Center for Research Resources (NCRR), is now making available a new release of its low-cost PROPHET information management, analysis, and visualization package. With a vastly improved graphical user interface, you can choose commands from pull-down menus, provide information through dialogue boxes tailored for each task, and readily invoke a variety of analysis tools. The new graphical interface is a dynamic window environment with full color, multiple fonts, and multi-object screen management. PROPHET can increase research productivity because it runs on powerful networked workstations, and its graphical interface provides easy access to the system's extensive capabilities. The PROPHET software package is fully documented, engineered, and supported by scientific software professionals. PROPHET offers the following features for biomedical scientists: o Spreadsheet-style data entry and organization o Clinical study data management o Statistical and mathematical modeling o Detailed two-dimensional graphs (scatterplots, histograms, bargraphs, and boxplots) o Biological simulation and modeling o Molecular modeling and display o Nucleic acid and protein sequence manipulation, analysis, and display o Developing custom applications via a high-level programming language and debugger o Interfaces to Ingres, SAS, Genbank, and PIR Protein Sequence Database o On-line system with integrated text and graphics o Hotline and electronic mail support Scientists at universities, research centers, hospitals, government laboratories, and commercial facilities use PROPHET in many disciplines including: o Clinical research o Molecular Biology o Biochemistry o Chemistry o Immunology o Biology o Pharmacology o Microbiology o Physiology o Biomedical Engineering o Epidemiology o Oncology PROPHET is currently available on UNIX and ULTRIX workstations with Motif, OpenLook, and DECwindows windowing systems. These workstations include Sun-4, SPARCstation, and DECstation 5000. Additional ports and continuing enhancements are planned. INQUIRIES For further information, contact: Dr. Richard DuBois Biomedical Research Technology Program National Center for Research Resources Westwood Building, Room 8A-15 Bethesda, MD 20892 Telephone: (301) 594-7934 $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NIMH-OP-93-0007 ****************************************** CLINICAL EVALUATION OF PSYCHOTHERAPEUTIC MEDICATIONS NIH GUIDE, Volume 22, Number 25, July 16, 1993 RFP AVAILABLE: NIMH-OP-93-0007 P.T. 34; K.W. 0745060, 0740025, 0755015 National Institute of Mental Health The purpose of this procurement is to conduct Phase I and Phase II clinical trials of compounds to evaluate their utility as new and effective psychotherapeutic medications. The contractor must have the capability to plan the clinical development of an investigational compound, design and develop protocol, provide clinical trial sites, monitor clinical studies to Good Clinical Practice standards, manage data acquisition, and prepare quality written final summary reports in support of a NDA submission. A twenty-eight month cost reimbursement type contract with three one-year options is anticipated. This announcement appeared in the Commerce Business Daily April 29, 1993. Persons who responded to the Commerce Business Daily announcement are already on the mailing list for RFP No. NIMH-OP-93-0007 and are not required to respond to this notice. The RFP is scheduled for issuance on or about July 1, 1993 and will close approximately 60 calendar days thereafter. INQUIRIES All requests must be made in writing or by FAX to: LouEllen M. Rice, Contracting Officer Contracts Management Branch Parklawn Building, Room 7C-18 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-2696 FAX: (301) 443-6885 Telephone requests will not be honored. $$R1 END ************************************************************ $$R2 BEGIN NIAID-DAIDS-94-12 **************************************** CORRELATES OF HIV IMMUNE PROTECTION LABORATORY NIH GUIDE, Volume 22, Number 25, July 16, 1993 RFP AVAILABLE: NIAID-DAIDS-94-12 P.T. National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID), NIH has a requirement for a Correlates of HIV Immune Protection Laboratory that will provide extensive, coordinated, in-depth evaluation of the immunology and/or virology of recipients of acquired immunodeficiency syndrome (AIDS) vaccine(s) who are not protected against HIV-1. Vaccinees or subjects in natural history cohorts who are apparently exposed to, but not infected by, HIV and when available, their infected partners, also will be included in these extensive evaluation studies. Control subjects will include infected placebo recipients and uninfected vaccine responders who may have been exposed to HIV during the same or parallel vaccine studies, recent seroconverters, and HIV-infected subjects with evidence of prolonged asymptomatic periods following infection who have been identified in natural history cohorts. Therefore, this proposed Contract will establish the Correlates of HIV Immune Protection Laboratory, which will provide extensive, in-depth evaluation of the humoral and cellular immune responses of vaccinee and cohort study subjects and controls. In addition, from infected subjects, this laboratory will isolate and characterize the genotype and both the serological and biological phenotype of infecting HIV. This contract is intended to support the NIAID mission of development and clinical testing of AIDS vaccines. It is anticipated that a single contract will be awarded to carry out highly coordinated immunological, virological, and molecular biological assessments. It is further anticipated that a consortium of laboratories with the distinct expertise will be required for the successful completion of the different technical tasks. This is an announcement for an anticipated Request for Proposals (RFP). The issuance of RFP No. NIH-NIAID-DAIDS-94-12 will be on or about August 15, 1993 and proposals will be due by the close of business on November 15, 1993. It is anticipated that one contract will be awarded to carry out highly coordinated immunological, virological, and molecular virological assessments as a result of this solicitation. It is expected that the contract will have a five-year period of performance and a completion type cost- reimbursement contract is anticipated. INQUIRIES Requests for the RFP are to be directed in writing to: Mr. Lawrence Butler Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 6003 Executive Boulevard Bethesda, MD 20892 (use Rockville, Maryland 20852 for overnight mail service) Please provide this office with three self-addressed mailing labels. Telephone inquiries will not be honored and all inquiries must be in writing. A short-form version of the RFP will be provided, which includes the Statement of Work and the Evaluation Criteria to be used for selection of the awardee. All proposals from responsible sources will be considered by the NIAID. This advertisement does not commit the Government to award a contract. No collect calls will be accepted. $$R2 END ************************************************************ $$R3 BEGIN CA-93-034 FULL-TEXT ************************************** DEVELOPMENTAL RESEARCH IN NATIVE PACIFIC POPULATIONS NIH GUIDE, Volume 22, Number 25, July 16, 1993 RFA AVAILABLE: CA-93-034 P.T. 34, FB; K.W. 0715035, 0795003, 0745027 National Cancer Institute Letter of Intent Receipt Date: August 18, 1993 Application Receipt Date: October 20, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The National Cancer Program is mandated to address the unique cancer prevention, early detection, and treatment needs of all populations within the U.S. and its territories. Therefore, the Special Populations Studies Branch (SPSB) of the Division of Cancer Prevention and Control (DCPC) of the National Cancer Institute (NCI) invites applications from various organizations for developmental studies that: (1) assess cancer control need, (2) determine barriers to cancer control, and/or (3) validate intervention methods and assessment instruments in native Pacific populations; i.e., American Samoans, Guamanians (Chamorros), Palauians, and Northern Marianians. This initiative will define the cancer prevention and control needs of native Pacific populations and those of similar ancestry located in the Pacific as well as the U.S. mainland. 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, Developmental Research in Native Pacific Populations, is related to the priority area of cancer. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000 (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic (including U.S. Territorial possessions) public and private, for-profit and non-profit organizations serving native Pacific populations such as universities, public health departments, voluntary organizations, research centers, hospitals, consortia of health providers, units of State and local governments and eligible agencies of the Federal government. Teams of applicants are encouraged. Among a team of applicants, one institution must be proposed as the lead institution to serve as the applicant and to assume responsibility for the conduct and administration of the project. Note that awards will not be made to foreign institutions and that applications from domestic organizations may not include international components. MECHANISM OF SUPPORT The mechanism of support for this RFA will be the National Institutes of Health (NIH) research project grant (R01). Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. In addition to the requirements stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1991. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. It is anticipated that four awards will be made at approximately $300,000 total costs per year. FUNDS AVAILABLE Approximately $1.2 million in total costs per year for three years will be set-aside to specifically fund applications that are submitted in response to this RFA. It is anticipated that up to four awards will be made. The total project period of these awards may not exceed three years. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of a grant pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Studies conducted under this RFA will seek to define cancer prevention and control needs/services of the native Pacific population segments (Phase I). Studies to test ways in which existing intervention methods can be used or adapted for the target populations (Phase II); or studies of new methods designed to be sensitive to the needs of the target populations (Phase II); or methodologic research on validation of assessment instruments in target populations (Phase II) are eligible for consideration under the RFA. This "developmental cancer control research" (Phase I and Phase II) is absolutely essential to future development of cancer prevention and control research for native Pacific populations. The following definitions apply for this RFA: Cancer Control -- Cancer control is defined as the reduction of cancer incidence, morbidity, and mortality through an orderly sequence from research on interventions and their impact in defined populations to the broad, systematic application of the research results. Phases of Cancer Control -- Cancer control research studies are classified in the five phases that represent the orderly progression noted in the above definition: (I) Hypothesis development; (II) Intervention methods development and testing; (III) Controlled intervention trials to establish cause and effect relationships; (IV) Research in defined human populations; and (V) Demonstration and implementation studies. The research of interest in this RFA falls into either Phase I or Phase II studies. Hypothesis development (Phase I) studies should focus on the assessment of cancer prevention and control needs in communities or organizations within native Pacific populations or studies that identify barriers to cancer prevention and control within these indigenous populations. Methods development and testing studies, Phase II, should focus on: (1) validating the use of existing intervention methods (e.g., dietary modification, health services, tobacco cessation) applied in the target populations described above; (2) developing and pilot testing unique methods that are sensitive to the needs of the target populations described above; or (3) developing and validating assessment instruments to measure the cancer control related needs of the target populations or for use in evaluating the effectiveness of intervention methods in the target populations. STUDY POPULATIONS The targeted population of this RFA is the native Pacific populations and those of similar ancestry located in the Pacific as well as the U.S. mainland; i.e., American Samoans, Guamanians (Chamorros), Palauians, and North Marianians. Applicants responding to this RFA are expected to successfully access a significant portion of this population to decrease cancer incidence and mortality, increase cancer survival, and increase the diagnosis of cancers at earlier stages. SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by August 18, 1993, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the Principal Investigator (PI); the identity 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 is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to Dr. George A. Alexander at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). These forms are available at most institutional offices of sponsored research and the Office of Grants Information Division of Research Grants, National Institutes of Health, Westwood Building, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248. Applications must be received by October 20, 1993. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed (initially) by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the RFA is an NCI program staff function. If an application is judged to be non-responsive, the applicant will be contacted and given an opportunity to withdraw the application or to have it considered with other unsolicited applications received by NIH in the next review cycle. Questions concerning responsiveness to the RFA may be directed to NCI program staff identified under INQUIRIES. Those applications that are complete and responsive will be initially evaluated in accordance with the review criteria stated within the RFA for scientific/technical merit by an ad hoc review committee convened by the Division of Extramural Activities, NCI. The second level of review will be provided by the National Cancer Advisory Board. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: George A. Alexander, M.D. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 240 6130 Executive Boulevard Bethesda, MD 20892-4200 Telephone: (301) 496-8589 FAX: (301) 496-8675 Direct inquiries regarding fiscal issues to: Crystal Elliott Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6130 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7800 Ext. 19 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control Science Program. 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 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. $$R3 END ************************************************************ $$R4 BEGIN HS-94-002 FULL-TEXT ************************************** MEDICAL TREATMENT EFFECTIVENESS RESEARCH -- PORT-IIs NIH GUIDE, Volume 22, Number 25, July 16, 1993 RFA AVAILABLE: HS-94-002 P.T. 34; K.W. 0745027, 0745035, 0745070, 0730050, 0408006 Agency for Health Care Policy and Research Letter of Intent Receipt Date: October 1, 1993 Application Receipt Date: November 16, 1993 THE REQUEST FOR APPLICATION (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE This announcement solicits applications to conduct innovative and timely research that will provide convincing evidence for or against the effectiveness and cost effectiveness of alternative clinical interventions for the prevention, diagnosis, treatment, and management of common clinical conditions. The Agency for Health Care Policy and Research (AHCPR) developed this solicitation as part of the Medical Treatment Effectiveness Program (MEDTEP). These awards will constitute a new generation of MEDTEP research and an extension of work carried out by AHCPR's Patient Outcomes Research Teams (PORTs). The new projects, called PORT-IIs, will have the potential to make substantial contributions to the improvement of health outcomes. Their results will be relevant to patients, health care providers, and policymakers. 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. The AHCPR urges applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-004374-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign non-profit organizations, public and private, including universities, clinics, units of State and local governments, non-profit firms, and non-profit foundations. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT This RFA will use the research project grant (R01) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation. The total requested project period for applications submitted in response to this RFA may not exceed five years. While grants under this solicitation may vary in cost, most individual projects are expected to request less than $1 million total direct costs per year. The earliest possible award date will be July 1, 1994. Annual progress reviews by AHCPR and the availability of funds will determine the continuation of grants up to the five year limit. FUNDS AVAILABLE The AHCPR expects to award up to $7 million in Fiscal Year 1994 to support the first year of 5 to 10 studies. The number of awards will be contingent on the availability of funds and the quality of the applications. RESEARCH OBJECTIVES Background and Conceptual Framework. Since 1989, AHCPR has made a major investment and major advances in medical effectiveness/patient outcomes research, especially through the set of special, multi-faceted projects known as Patient Outcomes Research Teams (PORTs). This RFA announces the second generation of special projects, PORT-IIs, a pragmatic program that continues to put the patient foremost and to emphasize the policy significance of understanding what health care is most effective. PORT-IIs will focus on the establishment of direct linkages between practice and outcomes and on research methods that facilitate direct comparisons of alternative clinical strategies. They should start with carefully formulated research questions and employ research strategies tailored to the selected condition and the population at risk in order to ascertain convincingly and efficiently which clinical strategies lead to the desired outcomes. The AHCPR's Medical Treatment Effectiveness Program is concerned with enhancing the effectiveness, cost effectiveness, and appropriateness of health care. "Effectiveness," as distinct from "efficacy," refers to the outcomes experienced by or observed in patients in routine clinical practice. MEDTEP studies take into account the many clinical and non-clinical variables that influence practice and outcomes. This includes characteristics of patients, clinicians, the health care system, and the social environment. The ability to generalize findings to health care as it is typically received and practiced in the community is emphasized. Typical "efficacy" studies, because their results have limited generalizability, are not responsive to this RFA. The RFA does, however, include clinical trials that are designed to answer effectiveness questions, i.e., questions about outcomes in persons who are representative of those with the condition that is being studied. In assessing effectiveness, cost effectiveness, and appropriateness, investigators are encouraged to measure outcomes that emphasize the patient's perspective and to consider how patient preferences influence evaluations of the outcomes. SPECIAL REQUIREMENTS Topic Selection. This RFA accommodates an extremely wide range of clinical subjects. Greater importance will be placed on questions with significant potential to improve outcomes and/or decrease costs. The formulation of the problem should reflect understanding of the issues regarding clinical decisionmaking and the translation of findings into clinical practice. The important questions about outcomes should be answerable within the proposed grant period. Most PORT-II studies will focus on a particular condition or technology. This includes conditions and technologies that are significant in the Medicare population, adults under age 65, children, or adolescents. It includes well-defined diseases as well as symptoms and conditions (e.g., headache, fatigue, obesity). While acute or chronic conditions may be selected, the AHCPR is especially interested in studies of chronic problems and those treated in ambulatory settings. The selected condition must have all of the following characteristics: high incidence or prevalence in the general population or in major population subgroups; controversy or open questions over the effectiveness and relative effectiveness of available clinical strategies; and high costs. PORT-IIs are expected to compare two or more distinctly different clinical approaches to the prevention, diagnosis, treatment, management, or rehabilitation of common clinical conditions, e.g., comparisons of medical vs. surgical treatment, psychotherapy vs. pharmacotherapy; and care prescribed or provided by different kinds of health care professionals. Methods. Investigators are encouraged to design new research strategies, to use new combinations of methods, or to tailor existing methods to their research question(s) so that convincing evidence will be obtained for, or against, the effectiveness of alternative clinical interventions. Research methods that can be employed include, but are not limited to, quasi-experimental designs, case-control studies, cohort studies, effectiveness trials, meta-analyses, cost-effectiveness analyses, decision modeling, and combinations of these. Sources of data can include: new, established, or adapted surveys of patients and providers; clinical registries; and clinical records from practice-based networks, health maintenance organizations, and other health care providers. Project Organization. To adequately address the clinical and non-clinical dimensions of effectiveness questions, most studies will require multidisciplinary research teams. It is expected that the team include at least one individual who is actively involved in the type(s) of patient care central to the study and who contributes understanding of how and why clinical decisions are made in routine clinical practice. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS CONCERNING INCLUSION OF WOMEN AND MINORITIES IN RESEARCH STUDY POPULATIONS The AHCPR requires applicants to include minorities and women in study populations so that research findings can be of benefit to all persons. If women or minorities are excluded or inadequately represented in research, a clear and compelling rationale must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by October 1, 1993, a letter of intent that includes a descriptive title of the proposed research, the names, addresses (including institutions), and telephone numbers of the Principal Investigator and other key personnel, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows AHCPR staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to Dr. Richard Greene at the address listed under INQUIRIES. APPLICATION PROCEDURES The RFA contains important information for applicants and may be obtained from Dr. Richard Greene at the address listed under INQUIRIES. The application receipt date is November 16, 1993. The research grant application form PHS 398 (rev. 9/91) is to be used. This form is available at most institutional offices of sponsored research and the Office of Grant Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248. REVIEW CONSIDERATIONS Applications will be reviewed initially by the Division of Research Grants, NIH, for completeness and by AHCPR program staff for responsiveness to the RFA. Incomplete and unresponsive applications will be returned to applicants without further consideration. Applications will be evaluated in accordance with the criteria stated in the RFA for scientific/ technical merit by an appropriate AHCPR peer review group. Review considerations and special review criteria are listed in the RFA. INQUIRIES Requests for the RFA, inquiries regarding programmatic issues, and the letter of intent may be addressed to: Richard Greene, M.D., Ph.D. Director, Center for Medical Effectiveness Research Agency for Health Care Policy and Research 2101 East Jefferson Street Rockville, MD 20852 Telephone: (301) 227-8485 (through July 31, 1993) or (301) 594-1485 (effective August 1, 1993) Direct inquiries regarding fiscal matters to: Ralph L. Sloat Agency for Health Care Policy and Research 2101 East Jefferson Street Rockville, MD 20852 Telephone: (301) 227-8447 (through July 31, 1993) or (301) 594-1447 (effective August 1, 1993) AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.180. Awards are made under authorization of the Public Health Service Act, Title IX, as amended by Public Laws 101-239 and 102-410, (42 U.S.C. 299-299c-6) and Section 1142 of the Social Security Act (42 U.S.C. 1320b-12). Awards are administered under the PHS Grants Policy Statement; and Federal Regulations 42 CFR Part 67, Subpart A, and 45 CFR Part 74 (45 CFR Part 92 for State and local governments). This program is not subject to the intergovernmental review requirements of Executive Order 12372. $$R4 END ************************************************************ $$R5 BEGIN ES-93-002 FULL-TEXT ************************************** ENVIRONMENTAL HEALTH SCIENCES EDUCATION NIH GUIDE, Volume 22, Number 25, July 16, 1993 RFA AVAILABLE: ES-93-002 P.T. 34; K.W. 0725010, 0502017, 0503016 National Institute of Environmental Health Sciences Letter of Intent Receipt Date: September 20, 1993 Application Receipt Date: November 24, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN THE INQUIRIES, BELOW. PURPOSE Human health and human disease result from three interactive elements: environmental factors, genetic susceptibility, and age. The mission of the National Institute of Environmental Health Sciences (NIEHS) is to reduce the burden of human illness and dysfunction from environmental causes by further understanding each of these elements and how they interrelate. The NIEHS achieves its mission through a multidisciplinary biomedical research program, prevention and intervention efforts, and a communication strategy that encompasses training, education, technology transfer, and community outreach. The ultimate goal of NIEHS activities is to define and understand the mechanism of action of environmental agents on human health and to transfer this knowledge to the public benefit. This RFA is for the development of educational materials that teach basic biologic concepts in grades K-12 using environmental health sciences issues. The intent of this announcement is to promote the development of instructional materials that will increase students' comprehension of basic science concepts and will also enhance students' understanding and interest in environmental 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 RFA, Environmental Health Sciences Education, is related to the priority area of environmental health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No.017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Organizations with a scientific or educational mission are eligible to submit applications. Such groups include colleges and universities; state and local education agencies; professional societies; museums; research laboratories; media producers; private foundations and industries; and other public and private education-related organizations, for-profit and non-profit. Applicants are strongly encouraged to form consortia entailing active participation by more than one of these groups. Applicants must include teachers or other school personnel in the planning and evaluation of materials/activities. Only applications that include research scientists, technical writers, and educators will be considered responsive to this RFA. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Education Project Grant (R25). The project period for applications may not exceed three years, and projects are not renewable. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the entire program is anticipated to be $500,000. The maximum award will be $100,000 in direct costs per year. Indirect costs will be paid at eight percent of direct costs less appropriate exclusions. It is expected that four to six awards will be made. Although this program is provided for in the financial plans of the NIEHS, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. EDUCATION OBJECTIVES This RFA is for the development of environmental health sciences education materials for three major divisions of students, K-4th, 5th-8th, and 9th-12th grades. This RFA will support grants for support of groups of scientists, technical writers, and educators to develop materials for students in any or all of the grade groups that will improve understanding and interest in environmental health sciences. It is essential that this be a collaboration between scientists who are familiar with environmental health sciences issues, technical writers who are knowledgeable about health issues, and educators who are familiar with teaching these grade levels. The ultimate goal of these activities is to foster environmental health sciences education and to improve the understanding of the implications of environmental health sciences for these student groups. It is important to note that proposed projects should focus on the interrelationship between environmental factors and human health. Programs addressing only ecology or only health and biology will be considered unresponsive. The objective of this program is to teach or demonstrate a basic science concept or element by exploring the relationship between a biological process and an environmental factor. The NIEHS recognizes that teachers must be prepared to use the materials developed through this RFA. Therefore, the applicant must include a plan for the dissemination and demonstration of the materials developed at appropriate meetings, such as the National Science Teachers Association national meeting or other comparable meeting. The application should include a plan for the national distribution of the materials developed under this program. Although it may be necessary to validate the materials locally or regionally, applications that are not targeted to the national student population will be considered unresponsive. Because the NIEHS believes there should be a thematic approach to EHS issues throughout the three groups, applications should address the development of materials on an issue that could be infused sequentially into the science curriculum of the three groups. The intent of this RFA is for the development of a sequence of materials in which the student is introduced at the K-4 level to a basic science concept using an environmental health sciences topic. Subsequently, the student would be reintroduced in the 5-8 and 9-12 grades to the same science element, but there would be more depth in the material. This spaced learning approach has been demonstrated to be successful. Applicants must take into account the developing National Science Standards, and specifically address how the materials will be infused into the curriculum of the target populations. Applications submitted under this RFA should focus on basic biology elements and use environmental health sciences topics to teach such elements. Specific examples of the types of activities that may be proposed include, but are not limited to: o Developing innovative materials, techniques, and/or curriculum materials for environmental health sciences areas. The applicant should address in the application how these materials will be infused into the curriculum, how the materials will be tested and evaluated, and the number of students to be impacted after the materials are completed. o Preparation and/or presentation of materials or media programs for environmental health sciences education. Projects will not be supported, however, that are for stand-alone media activities. These must be tied to a program to infuse these materials into an existing curriculum. The development of articles for magazines used in biology, general science, chemistry or other publications used in the three grade groups will be considered responsive to the program. Specific examples of instructional topics/units that may be used to demonstrate basic biological principles are included in the RFA, and applicants should carefully read them. LETTER OF INTENT Prospective applicants are asked to submit, by September 20, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIEHS staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Michael J. Galvin, at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. This form is available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Submit a signed, typewritten original of the application, including the checklist and three signed photocopies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Dr. Allen Dearry Division of Extramural Research and Training National Institute of Environmental Health Sciences 104 T.W. Alexander Drive P.O. Box 12233 Research Triangle Park, NC 27709 Applications must be received by November 24, 1993. REVIEW CONSIDERATIONS Applications will be administratively reviewed for completeness and responsiveness to this RFA. Applications may be triaged on the basis of relative competitiveness. Those applications judged to be competitive will undergo further merit review. The second level of review will be provided by the National Advisory Environmental Health Sciences Council. Potential applicants are strongly encouraged to consider carefully the specific review criteria listed in the RFA before submitting an application or contacting staff. INQUIRIES The NIEHS welcomes the opportunity to clarify any issues or questions from potential applicants, therefore, written and telephone inquiries concerning this RFA are encouraged. However, potential applicants are expected to have reviewed the material in the RFA before contacting the NIEHS. Direct inquiries regarding programmatic issues, requests for the RFA, and address the letter intent to: Michael J. Galvin, Jr., Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-7825 FAX: (919) 541-2843 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 Research Triangle Park, NC 27709 Telephone: (919) 541-1373 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.113 and 93.115. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 43 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. $$R5 END ************************************************************ From owner-sci-resources@net.bio.net Mon Jul 12 23:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 25, pt. 4, 16 July 1993 Message-ID: Date: 13 Jul 93 22:20:21 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 609 Approved: sci-resources-moderator@net.bio.net Received: from jhuvm.hcf.jhu.edu by net.bio.net (5.65/IG-2.0) with SMTP id AA11463; Tue, 13 Jul 93 12:01:10 -0700 Message-Id: <9307131901.AA11463@net.bio.net> Received: from JHUVM.HCF.JHU.EDU by JHUVM.HCF.JHU.EDU (IBM VM SMTP V2R2) with BSMTP id 8869; Tue, 13 Jul 93 14:56:23 EDT Received: from JHUVM.HCF.JHU.EDU (NJE origin LISTSERV@JHUVM) by JHUVM.HCF.JHU.EDU (LMail V1.1d/1.7f) with BSMTP id 8868; Tue, 13 Jul 1993 14:54:46 -0400 Date: Tue, 13 Jul 1993 14:50:10 EDT Sender: NIH Guide Primary Distribution From: Becky Duvall Subject: NIH GUIDE - RFA ES-93-002 - V22(25) 07/16/93 To: Multiple recipients of list NIHGDE-L $$XID RFA ES93002 ES-93-002 P1O1 *************************************** ENVIRONMENTAL HEALTH SCIENCES EDUCATION NIH GUIDE, Volume 22, Number 25, July 16, 1993 RFA: ES-93-002 P.T. 34; K.W. 0725010, 0502017, 0503016 National Institute of Environmental Health Sciences Letter of Intent Receipt Date: September 20, 1993 Application Receipt Date: November 24, 1993 PURPOSE Human health and human disease result from three interactive elements: environmental factors, genetic susceptibility, and age. The mission of the National Institute of Environmental Health Sciences (NIEHS) is to reduce the burden of human illness and dysfunction from environmental causes by further understanding each of these elements and how they interrelate. The NIEHS achieves its mission through a multidisciplinary biomedical research program, prevention and intervention efforts, and a communication strategy that encompasses training, education, technology transfer, and community outreach. The ultimate goal of the NIEHS activities is to define and understand the mechanism of action of environmental agents on human health and to transfer this knowledge to the public benefit. The NIEHS is playing an increasingly important role in numerous public health issues because of the desire of the public to understand the effects and risks to human health from exposure to physical and chemical agents. Although the public is challenged daily to make decisions on the risk and benefits of agents that permeate society, there have been few if any programs that prepare the public to meet this challenge. For example, in the past few years there have been media reports concerning the hazards of electromagnetic radiation, chemicals in drinking water, and pesticides in food. While the scientific community has been tasked with making scientifically based recommendations on the safety of chemicals and physical agents, the general public has become increasingly involved in the regulatory decision-making process. Therefore, there is a critical need to develop a mechanism for educating the general public about environmental health issues. In recognition of the above challenge, a mandate in the 1990s is to reach out to students in grade school and high school to improve their science literacy. In the fall of 1992 the NIEHS established a priority to develop an environmental health sciences education program at the K-12 levels. The objective of this program is to improve the understanding of environmental health issues by all students and to expand career awareness for those interested in pursuing further education leading to research and service occupations in environmental health sciences. This Request for Applications (RFA) is for development of educational materials related to environmental health sciences in grades K-12. The specific intent of this announcement is to promote development of instructional materials that will enhance students' comprehension and interest in environmental 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 RFA, Environmental Health Sciences Education, is related to the priority area of environmental health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Organizations with a scientific or educational mission are eligible to submit applications. Such groups include colleges and universities; state and local education agencies; professional societies; museums; research laboratories; media producers; private foundations and industries; and other public and private education-related organizations, for-profit and non-profit. Applicants are strongly encouraged to form consortia entailing active participation by more than one of these groups. Applicants must include teachers and other school personnel in the planning and evaluation of materials/activities. In addition, because of the wide range of environmental health science and education issues to be addressed, only applications that include research scientists, technical writers, and educators will be considered. At a minimum, applications must include one active researcher in an environmental health science area relevant to the mission of the NIEHS, a technical writer with demonstrated expertise in the development of education materials, and an educator with demonstrated expertise in curriculum development/implementation. Applications from education institutions with significant minority enrollments and from Principal Investigators who are women or minority group members are especially encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Education Project Grant (R25). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed three years, and projects are not renewable. This RFA is a one-time solicitation. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the entire program is anticipated to be $500,000. The maximum award will be $100,000 in direct costs per year. Indirect costs will be paid at eight percent of direct costs less appropriate exclusions. It is expected that four to six awards will be made. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIEHS, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. EDUCATION OBJECTIVES Background The "High School and Beyond" Surveys, which have been widely discussed, show a steady decline in the numbers of students interested in careers in natural science or engineering. As an example, of 4 million high school sophomores in school in 1977 only 9,700 were projected to reach the Ph.D. degree in 1992. In response to this and other evidence of a decline in the performance of American students in science and mathematics, a new urgency has led to a national awareness of the need to improve the teaching and learning in these fields. The momentum for major changes in the way that science is taught in grades K-12 has been increasing rapidly in recent years as has the amount of money provided from public and private sources to support retraining of teachers, development of curricula, and provision of educational technology. The initiative to support K-12 science education has received high priority from the Director, NIEHS; and the commitment of the NIH, the PHS, Department of Health and Human Services, and the President is well documented. Also at the national level, the National Science Foundation, through its Directorate for Education and Human Resources, and the Department of Education, through its Eisenhower program, are supporting major reform activities by the American Association for the Advancement of Science (AAAS), the National Science Teachers Association, the National Research Council and other organizations. Likewise, various other Federal Agencies, Departments of Energy and Agriculture, National Aeronautics and Space Administration, Environmental Protection Agency, and the NIH, to name a few, are all investing in K-12 programs related to their missions. The NIEHS has established a "Summers of Discovery" program to support high school teachers and students in summer research opportunities as part of its intramural program and has conducted a variety of career awareness and education programs for students and teachers. While the approach and content of the science curriculum is undergoing change, in none of the national efforts to develop new curricula or teaching standards is there a systematic approach to educational activities linking the environment to human health concerns. The various approaches may call on related issues or use examples from the environmental health sciences (EHS) as the basis for problem-solving, hands-on experiences, and critical thinking skill development, but materials are lacking, teachers are not well prepared, and the relationship of EHS, as a concept, to the standard K-12 curricula is not evident. On December 14-15, 1992, the NIEHS Office of Institutional Development convened a forum of teachers, scientists, science educators, administrators, and persons representing various associations to advise on the establishment of an Environmental Health Sciences Education Program. The Forum discussed and made recommendations in four areas: (1) Curriculum: Environmental Health Sciences curriculum should be multi-disciplinary and be infused into existing curricula at appropriate grade levels. (2) Needs that must be addressed in developing programs: There should be defined outcomes, teacher training, equipment and materials, community support, appropriate assessment, involvement of the science community, and inclusion of underrepresented groups. (3) Identification of existing models: There are many programs that exist in related fields which could be used as framework for the EHS Program. (4) Barriers to the development of K-12 programs in EHS: Lack of public awareness, poor science background of teachers, overloaded curricula, lack of materials, and inadequate funding impede the implementation of EHS in the curriculum. The recommendations of this Forum provide the basis for a comprehensive NIEHS Environmental Health Sciences Education Program, of which this RFA is a component. Goals for the NIEHS Education Program For Students: The enhancement of critical thinking skills to develop a sense of personal involvement in the issues and challenges created by the linkage of human health with environmental factors; competence in identifying problems, assembling relevant data, arriving at solutions; deeper understanding of concepts of environmental health sciences through applications of the scientific process to issues of health and the environment, awareness of career opportunities in environmental health fields and the background essential to those careers. For Teachers: Greater awareness of environmental health science issues as a means of teaching science concepts and generating social responsibility in students; stronger knowledge base of environmental health sciences concepts through real life applications; a broader range of techniques and methods of teaching science; enhanced professional stature through opportunities to interact with scientists in team situations. For Parents and Communities: Opportunities to participate with students and teachers in educational activities based on real problems found in homes and communities and to influence outcomes. Description of this Initiative This RFA is for the development of environmental health sciences education materials for three major divisions of students, K-4th, 5th-8th, and 9th-12th grades. While other student groupings are used, this grouping has been adopted for use in this document to help describe the intent of the RFA. It is not an endorsement of such a grouping approach, but it is used in this RFA as a convenience. This RFA will support grants for support of groups of scientists, technical writers and educators to develop materials for students in any or all of the grade groups that will improve their understanding and interest in environmental health sciences. Applications can be for the development of materials either for a specific grade group or all three grade groups. It is essential that this be a collaboration between scientists who are familiar with environmental health sciences issues, technical writers who are knowledgeable about health issues, and educators who are familiar with teaching these grade levels. The ultimate goal of these activities is to foster environmental health sciences education and to improve the understanding of the accomplishment and implications of environmental health sciences for these student groups. It is important to note that proposed projects should focus on the interrelationship between environmental factors and human health. Programs addressing only ecology or only health and biology will be considered unresponsive. Applicants are encouraged to concentrate on emerging issues of broad scope that clearly portray interactions between human health and the environment. The NIEHS recognizes the need to include teacher training in the Education Program, however, for this RFA, teacher training is not a part of the RFA. However, the applicant is expected to include a plan for the dissemination/demonstration of the materials developed at appropriate meetings such as the National Science Teachers Association national meeting or other comparable meeting. The application should include a plan for the national distribution of the materials developed under this initiative. While it may be necessary to validate the materials locally or regionally, applications which are not targeted to the national student population will be considered unresponsive. Because the NIEHS believes there should be a thematic approach to EHS issues throughout the three educational levels, applications should address the development of materials on an issue which could be infused into the science curriculum of the three groups. However, an applicant can produce materials for a single educational level. The intent of this RFA is for the development of a sequence of materials in which the student is introduced at the K-4 level to an environmental health sciences concept. Subsequently, the student would be reintroduced in the 5-8 and 9-12 grades to the same topic but there would be more depth in the material. This spaced learning approach has been demonstrated to be successful. For example, the K-4 material could be an introduction to a biological concept and environmental health sciences issue, the 5-8 material could be the identification of an appropriate topic and exploration of the phenomenon underlying its environmental health science consequences, and the 9-12 material could deal with further exploration of the issue, e.g., abstract thinking or specific scientific experiments. Thus an issue/theme could be infused into the science curriculum at each level. Since other approaches are possible, the applicants are encouraged to use their expertise and experience to develop the framework for the program. Also, any materials produced should take into account current knowledge of research, practices, and standards specifically related to science learning, attitudes, motivation and instructional strategies. In addition, the applicant should address how the materials will be infused into the curriculum of the target population. The NIEHS encourages and supports the initiation of cooperative efforts among the diverse elements in the scientific and education communities. The NIEHS seeks to focus on the improvement of environmental health sciences literacy through partnerships between public and private sector organizations and active scientists. At a minimum, applications should include an active researcher in an environmental health science area relevant to the mission of the NIEHS, an educator with demonstrated expertise in the classroom, and a technical writer with experience in the development of science education materials. Each application should include a plan for the evaluation of the materials and the assessment of its effectiveness in meeting the learning objectives. Applications submitted under this RFA should focus on basic biology elements and use environmental health sciences topics to teach such elements. Specific examples of the types of activities that may be proposed include, but are not limited to: o Developing innovative materials, techniques, and/or curriculum materials for environmental health sciences areas. The applicant should specifically address in the application how these materials will be infused into the curriculum, how the materials will be tested and evaluated, and the number of students to be impacted initially and after the materials are completed. Applications in this area should include a mechanism for testing materials at both the local and national level. o Preparation and/or presentation of materials for environmental health sciences education or of media programs in this area of science. These may include television, radio, videotape, videodisc, magazine articles or books aimed at the general student. Projects will not be supported, however, that are for stand-alone media activities. These must be tied to a program to infuse these materials into an existing curriculum. The development of articles for the currently used magazines in biology, general science, chemistry or other science publications used in the three grade groups will be considered responsive to the program. However these applications should be comprehensive in scope, address several areas of environmental health sciences, and have a capacity for evaluation of the materials. Specific examples of instructional topics/units that may be proposed include, but are not limited to, the contribution of environmental factors to: o Aging o Cancer o Cardiovascular diseases o Cellular events o Diseases of the workplace o Genetics and susceptibility to disease o Immune function o Lung diseases and asthma o Neurological dysfunction o Reproductive and developmental effects Relationships to Other Federal Programs in Science Education Applications that propose working relationships with major science education projects/groups such as the NSF Statewide Systemic Initiatives program, the Department of Education Regional Consortia for Science and Mathematics, American Chemical Society, the National Science Teachers Association, American Chemical Society, National Association Biology Teachers, or other federal, state, or national organizations/programs are particularly encouraged. SPECIAL REQUIREMENTS Awardees under this program will submit final copies of all materials developed with support from the NIEHS to the Program Administrator. These materials will be made available to the general public. In addition, each application should include a provision for attending an annual meeting at the NIEHS in Research Triangle Park, NC. Publications or audiovisual materials costing over $25,000 each may be produced with project funds only if prior written approval is obtained from the NIEHS. Two copies of the finished product must be supplied along with the annual or final progress report. Any products derived from the project activity must be publicized, and must be available in the public domain. Any project funded under the RFA may not be used to endorse or publicize any profit-making activities. An annual progress report must be filed with the Grants Management Officer of the NIEHS, and a final report is due within 90 days of the end of the project period. Annual reports are expected to summarize goals, methods, and results of activities undertaken. The following features must be specifically addressed: student learning outcomes; performance of female and minority students; changes in student attitudes toward environmental health sciences; and changes in instructional approaches brought about by new instructional materials. It should also be accompanied by at least two copies of any materials intended for dissemination developed as part of the project. The general requirements cited above represent only a portion of the applicable PHS policy under which the R25 awards will be administered. All awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000 (Rev) October 1, 1990. All grant awardees should have available to them a copy of this document. LETTER OF INTENT Prospective applicants are asked to submit, by September 20, 1993, a letter of intent that includes a descriptive title of the proposed project, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIEHS staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Michael J. Galvin, Jr. at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (Rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7378. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist and three signed photocopies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Dr. Allen Dearry Division of Extramural Research and Training National Institute of Environmental Health Sciences 104 T.W. Alexander Drive P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-4943 Applications must be received by November 24, 1993. If an application is received after that date, it will be returned to the applicant. REVIEW CONSIDERATIONS Applications will be administratively reviewed for completeness by the Division of Research Grants (DRG) and responsiveness to this announcement by NIEHS staff. Applications found to be incomplete or nonresponsive will be returned to the applicant without further consideration. Those applications that are complete and responsive may be subjected to triage to determine their educational and scientific merit relative to other applications received in response to this RFA. The NIEHS will administratively withdraw from competition those applications judged to be noncompetitive and so notify the applicant and institutional official. Those applications judged to be competitive will undergo further scientific merit review. These applications will be evaluated in accordance with the criteria stated in the RFA for scientific/technical merit by an appropriate peer review group convened by the NIEHS. The second level of review will be provided by the National Advisory Environmental Health Sciences Council. REVIEW CRITERIA Merit and significance of the proposed project as determined by such factors as content, originality, feasibility, relationship to established state and national standards, the quality and usefulness of instructional materials to be developed, and the likely applicability of these materials to national efforts to improve students' understanding of environmental health sciences. Capacity of the project to develop or enhance students' critical thinking and problem solving abilities. Emphasis of the project upon depth of study rather than breadth of material. Qualifications and research/education experience of the Principal Investigator and staff, particularly, but not exclusively, in areas relevant to the mission of the NIEHS. Individuals with strong subject matter skills are expected to play key roles. Personnel should demonstrate knowledge of the needs of their target audience in educational settings. The technical writer(s) and educator(s) should have appropriate qualifications in curriculum development/implementation. There should be evidence of cooperation and interaction among scientific, educational, and writing staff. Availability of resources necessary to perform project objectives. Appropriateness of the proposed budget and duration in relation to proposed objectives. Design of the project for success of all students, regardless of background or ability, especially those from underrepresented populations, including women, minorities, persons with disabilities, and the economically disadvantaged. This may be accomplished through inclusion of culturally familiar examples and/or incorporation of appropriate role models. Feasibility of plans for independently continuing the program. Evidence of continuing commitment on the part of the proposing institution and of long-term impact of the proposed project is especially important. Applicants may consider cost sharing in order to continue their program beyond the period of NIEHS funding. Plans for evaluation of factors contributing to the project's effectiveness. While descriptive or numeric data related to the number of students served could be a component, evaluations limited to such data alone will be considered unacceptable. Evaluations should include a measure of the impact of the project on students' knowledge of environmental health sciences. Assessment before and after using the developed materials will be necessary. Strategies for student assessment of developed materials may also be appropriate. Plans for distribution of results and products in the educational arena. Programs limited to a segment of the national student population or to a local or regional school system(s) will be considered unresponsive. Projects should be national in scope and significance. Strength of institutional commitment as evidenced by provision of appropriate resources, services, technical support, and allocation of space. Demonstration of current knowledge of research practices and standards, specifically those related to science learning, attitudes, motivation and instructional strategies. AWARD CRITERIA The anticipated date of award is July 1, 1994. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance and relevance to mission of NIEHS o Number of students impacted by the project INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and address the letter of intnet to: Michael J. Galvin, Jr., Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-7825 FAX: (919) 541-2843 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 Research Triangle Park, NC 27709 Telephone: (919) 541-1373 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.113 and 93.115. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 43 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Sun Jul 18 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 18 July 1993 Message-ID: Date: 19 Jul 93 23:29:32 GMT Sender: kristoff@net.bio.net Lines: 126 Approved: biosci-moderator@net.bio.net ** NEW DOCUMENTS ON STIS ** Document Type: Directions Title: Directions, Spring 1993 Issue File size (bytes): 32093 STIS Filename: dir9307 Document Type: General Publication Title: NSF 93-99 ELEMENTARY AND SECONDARY TEACHER ENHANCEMENT IN SCIENCE AND MATHEMATICS File size (bytes): 5321 STIS Filename: nsf9399 Document Type: Press Release Title: PR 93-54 West Virginia Receives EPSCoR Award File size (bytes): 4825 STIS Filename: pr9354 Title: PR 93-55 Field of Molecular Evolution Advanced by New Joint Agreement File size (bytes): 4197 STIS Filename: pr9355 Title: PR 93-56 Unconventional Course Teaches News Readers to View Statistics with a Healthy Dose of Doubt File size (bytes): 4344 STIS Filename: pr9356 Title: PR 93-57 World's Deepest Ice Core Yields Unique Climate Archive File size (bytes): 6341 STIS Filename: pr9357 Document Type: Report Title: NSF93-64 Partners in Progress- The Role of Professional Societies in Science, Technology, Engineering, and Mathematics Education. File size (bytes): 101024 STIS Filename: nsf9364 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Letter Title: NSF 93-68 Federal Advanced Materials and Processing Program (AMPP) File size (bytes): 11569 STIS Filename: nsf9368 Document Type: Phone Book Title: NSF Alphabetical Listing File size (bytes): 91065 STIS Filename: phnalpha Title: NSF Alphabetical Listing File size (bytes): 91038 STIS Filename: phnorg Document Type: Press Release Title: PR 93-53 South Pole Researchers Observe Early Structure of the Universe File size (bytes): 5543 STIS Filename: pr9353 Document Type: Program Guideline Title: NSF 93-42 File size (bytes): 10204 STIS Filename: nsf9342 Document Type: Recruit Title: Auditor File size (bytes): 6336 STIS Filename: vgs9377 ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet) or stisinfo@NSF (BITNET). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserv@nsf.gov (Internet) or stisserv@NSF (BITNET). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve vgs9377, the text of your message should be as follows: get vgs9377 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve vgs9377, you would enter: ftp> get vgs9377 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet) or "firstop@nsf" (BITNET). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet) or "stis@NSF" (BITNET). ------------------------------------------------------------------------ From owner-sci-resources@net.bio.net Mon Jul 19 23:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: Accessing E-Guide via Gopher Message-ID: Date: 20 Jul 93 19:07:26 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 30 Approved: sci-resources-moderator@net.bio.net From: Bill Jones Subject: NIH MAIL Accessing E-Guide via Gopher $$MAIL BEGIN *********************************************************** In the past few months, I have had several questions about accessing the E-Guide via Gopher. The following describes how to do that, feel free to make it available to your user community. Bill Jones Gopher is a network based utility for browsing, searching, and retrieving information. Gopher operates in a client-server fashion: The user runs a program called the "client", which makes queries to a "server" running on another host on the network. The NIH offers a gopher server at Internet address gopher.nih.gov, port 70. You can obtain a gopher client for connecting to the NIH server (clients exist for Macs, PCs, Unix systems and VAXs) from the developers of gopher, via anonymous ftp to boombox.micro.umn.edu; or ask your system administrator to install one on the system you are using. If you already have access to another gopher server, NIH can be reached through the Gopher Tunnels menu selection. Look for "National Institutes of Health" under the listing of USA sites. Once you have connected to the NIH Gopher server you will find the NIH Guide to grants listed under the "Information for Researchers" directory. You can either, search the Guides using keywords, or browse through the flat test files. $$MAIL END************************************************************** From owner-sci-resources@net.bio.net Mon Jul 19 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 26, pt. 1, 23 July 1993 Message-ID: Date: 20 Jul 93 19:53:52 GMT Sender: kristoff@net.bio.net Lines: 1110 Approved: biosci-moderator@net.bio.net NOTE: The NIH Guide may be split into more than one mail message to avoid truncation during e-mail distribution. The first message always begins with the RFP/RFA summary sections followed by the appended texts of the full RFP/RFAs. ---------------------------------------------------------------------- $$XID NIHGUIDE 19930723 V22N26 P1O1 ************************************ X-comment: RFAs described: CA/HD-93-033, CA-93-035 NIH GUIDE - Vol. 22, No. 26 - July 23, 1993 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** RESOURCES AVAILABLE FOR CONDUCTING RESEARCH ON AGING National Institute on Aging INDEX: AGING $$INDEX N2 ********************************************************** GENETICS AND PHYSIOLOGY OF HUMAN OOCYTES (RFA HD-93-004) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX N3 ********************************************************** POLICY REGARDING EVALUATION OF CLINICAL PRACTICE GUIDELINES Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** MASTER AGREEMENT CONTRACT FOR HIV PRECLINICAL VACCINE DEVELOPMENT (RFP NIAID-DAIDS-94-20) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R2 11/09/93 ************************************************* REHABILITATION AND PSYCHOSOCIAL RESEARCH IN YOUNGER WOMEN WITH BREAST CANCER (RFA CA/HD-93-033) National Cancer Institute National Institute of Child Health and Human Development INDEX: CANCER; CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R3 11/16/93 ************************************************* CANCER PAIN MANAGEMENT IN THE OUTPATIENT SETTING (RFA CA-93-035) National Cancer Institute INDEX: CANCER ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** RESEARCH INVOLVING HUMAN IN VITRO FERTILIZATION (PA-93-101) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT ERRATUM $$INDEX E1 ********************************************************** DRUG USE AND ABUSE IN MINORITY AND UNDERSERVED POPULATIONS (PA-93-046) National Institute on Drug Abuse INDEX: DRUG ABUSE This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** RESOURCES AVAILABLE FOR CONDUCTING RESEARCH ON AGING NIH GUIDE, Volume 22, Number 26, July 23, 1993 P.T. 34; K.W. 0710010, 0780000, 1002002, 0780015 National Institute on Aging The National Institute on Aging (NIA), recognizing that most investigators have neither the facilities nor the fiscal resources needed to develop and maintain colonies of aged animals, has made provision of resources one of its highest priorities. The availability of high quality material for conducting research on aging continues to be a priority area for NIA, with current resources spanning a broad spectrum, including a cell bank, a nematode bank, rodent colonies, and nonhuman primate colonies. Calorically-restricted rodents With this notice, the NIA announces the availability of a new resource, a colony of calorically-restricted rodents for the conduct of research on aging. The NIA has had a colony of calorically-restricted rodents for several years; however, these animals were available only to investigators engaged on the Biomarkers Project. Animals are now available to investigators outside of the Biomarker Project. The colony includes three rat genotypes (F344NNia, BN/BiRijNia, and F344 x BNF1Nia) and three mouse genotypes (C57BL6NNia, DBA/2NNia and B6D2F1Nia). These animals are maintained under conditions similar to our other colonies except that they are individually caged, and each calorically-restricted animal has a matching ad libitum-fed control. Distribution of these animals will be as pairs, i.e., caloric-restricted and ad libitum control. Mice In addition to this new resource, specific pathogen-free rodent resources currently available from NIA include three rat and eight mouse genotypes that are raised in barrier facilities and range in age from 1 to 42 months. Mouse genotypes currently available are the inbred strains BALB/c, CBA/Ca, C57BL/6 and DBA/2; hybrid stocks of B6C3F1 (C57BL/6 x C3H), B6D2F1 (C57BL/6 x DBA), and CB6F1 (BALB/c x C57BL/6); and an outbred stock of Swiss Webster. Inbred and hybrid mice in the NIA colony were derived from NIH pedigreed breeding stock in 1974 and for many years were maintained as closed inbred colonies. As mutations occur in both the NIA colony and the NIH breeding colonies, the NIA and NIH genotypes would undoubtedly drift apart. To minimize this potential drift the NIA initiated in 1983 a policy of rederivation from pedigreed stock every six years. Because of limited numbers of breeding pairs from NIH, and recognizing that many investigators use mice from the Jackson Laboratory, the rederivation of NIA mice that occurred in 1989 used breeding stock from the Jackson Laboratory rather than from NIH. Therefore, the mouse genotypes listed above are currently available from either NIH progenitor origin or Jackson Laboratory progenitor origin. The last animals of NIH origin were entered into the NIA colony in March 1993, and when the supply of these mice is exhausted, only mice of Jackson Laboratory origin will be available. Rats The rat genotypes currently available are the inbred strains of Fischer 344 (F344NNia) and Brown Norway (BN/BiRijNia) and the hybrid stock F344 x BNF1 (F344NNia x BN/BiRijNia). The F344 is of NIH origin, and the BN of REP Institutes TNO, Rijswijk, The Netherlands origin. All rodents are regularly monitored for genetic purity and health status. Animals are housed at contractor facilities behind specific pathogen barriers, maintained at 70x F, plus or minus 2 degrees, and are fed NIH 31 diet (ad libitum). Cage position on cage racks are routinely rotated to prevent retinal degeneration from lighting. Ad libitum access to acidified, chlorinated drinking water is provided. A health monitoring report for the room in which animals are raised accompanies each shipment of animals. These colonies have been developed to facilitate research on aging; therefore, holders of NIA grants always receive priority in access to animals. Non-human primates The NIA maintains approximately 300 nonhuman primates (M. mulatta) at four regional primate centers for conducting research on aging. These animals are in an approximate age range of 18 to 35 years. Animals are available for both noninvasive and invasive research studies. Some animals are maintained in group housing while others are individually caged. For information on any of the above resources contact: Office of Biological Resource Development National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892 Telephone: (301) 496-0181 Cell cultures The NIA, under contract, operates the Aging Cell Culture Repository. The purpose of this repository is to acquire, develop and characterize, store, and supply cell cultures for gerontological research. Currently, this repository contains over 900 cell cultures available for research on aging. Included are over 200 skin fibroblast cultures from healthy individuals of various ages who are participating in the Baltimore Longitudinal Study on Aging at the Gerontology Research Center; skin fibroblast cultures from individuals with premature aging syndromes, including Werner, Hutchinson- Guilford (progeria), cultures from clinically documented and at-risk individuals, as well as entire families exhibiting familial Alzheimer disease. Human endothelial cell cultures as well as mammary epithelial cell cultures are also available. Also available are human fibroblasts from female (IMR-90) and male (IMR-91 and MRC-5) fetal lung tissues and WI-38 female diploid lung cells available at early, middle, and late population doubling levels. Cultures of animal origin include skin fibroblasts from a variety of species of nonhuman primates; and many differentiated cell cultures derived from bovine, equine, canine and porcine origin. For additional information about the Repository, including catalog requests, availability and cost of cultures, contact: Richard Mulivor, Ph.D. Coriell Institute for Medical Research 401 Haddon Avenue Camden, NJ 08103 Telephone: 800/752-3805 Nematodes As a part of an overall NIA strategy to foster quality research through support of quality model resources, the NIA in collaboration with the National Center for Research Resources (NCRR), supports the Caenorhabditis Genetics Center to acquire, store and distribute genetic stocks of Caenorhabditis elegans (a nematode species) and relevant bibliographic and genetic information. This Center receives nematode strains and mutants, reprints of related publications and data (raw and analyzed) relevant to nematode genetics; stores these materials, verifies genetic status and/or scientific accuracy; distributes mutant strain bibliographic and genetic information to individual scientists, and through publications, to the scientific public at large; and distributes mutant strains to interested scientists. For further information on this resource, contact: Robert K. Herman, Ph.D. Department of Genetics and Cell Biology University of Minnesota St. Paul, MN 55108 Telephone: (612) 624-6203 Except for the Caenorhabditis Genetics Center, which is a multi- Institute supported resource, recipients of NIA grant support receive first priority for use of any of these resources when supplies are limited. When supplies permit resources are made available to other than NIA grantees. To aid graduate students interested in pursuing research on aging, limited numbers of rodents for dissertation research can be obtained free of cost (supply permitting) by application. Limited numbers of rodents are also available at reduced cost for the conduct of pilot research projects. The application process is relatively simple, requiring three to four months for review of proposed studies. To obtain information about these programs and/or an application contact Dr. DeWitt G. Hazzard. Any questions you may have regarding any aspect of the NIA resources program may be directed to: DeWitt G. Hazzard, Ph.D. Office of Biological Resources and Resource Development National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892 Telephone: (301) 496-0181 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** GENETICS AND PHYSIOLOGY OF HUMAN OOCYTES NIH GUIDE, Volume 22, Number 26, July 23, 1993 RFA: HD-93-004 P.T. 34; K.W. 0413002, 1002061, 1002019 National Institute of Child Health and Human Development Letter of Intent Receipt Date: July 26, 1993 Application Receipt Date: September 8, 1993 This revision to RFA HD-93-004 is intended to notify potential applicants that the President has signed into law the NIH Revitalization Act of 1993, which contains certain Miscellaneous Repeals (Sec. 121), one of which may be important for your application. The repeal of note is for the provision in the current Code of Federal Regulations pertaining to the protection of human subjects, 45 CFR 46.204(d), which requires a federal level Ethics Advisory Board (EAB) review for applications involving human in vitro fertilization (IVF). With the lifting of this requirement, the NIH can now conduct and support clinically related research involving human IVF as recommended by a grantee organization's Institutional Review Board (IRB) without the necessity for federal level EAB review in all cases. It is anticipated, however, that proposals for certain types of research that relate to human IVF may still be subject to special review on a case-by-case basis. INQUIRIES Further information on human IVF research eligible for NIH support may be obtained by contacting: Donna Vogel, M.D., Ph.D. Center for Population Research National Institute of Child Health and Human Development Building 61E, Suite 8B01 6100 Executive Boulevard Bethesda, MD 20892 Telephone: (301)496-6515 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** POLICY REGARDING EVALUATION OF CLINICAL PRACTICE GUIDELINES NIH GUIDE, Volume 22, Number 26, July 23, 1993 P.T. 34; K.W. 0730050 Agency for Health Care Policy and Research This notice provides the policy of the Agency for Health Care Policy and Research (AHCPR) regarding the award of grants, cooperative agreements, and contracts for the evaluation of clinical practice guidelines. This policy is designed to protect the integrity of AHCPR-supported guidelines by preventing, to the extent possible, the perception of bias or lack of objectivity in AHCPR grant and contract activities relevant to such guidelines. As part of its legislative mandate, AHCPR arranges for the development and periodic updating of clinical practice guidelines, medical review criteria, standards of quality, and performance measures. The guidelines are to assist health care providers, consumers, payers, and policy makers in making decisions on how diseases, disorders, and other health conditions can be most effectively and appropriately prevented, diagnosed, treated, and managed. These guidelines may be developed by panels of health care experts and consumers or by contractors assisted by panels of experts and consumers. The AHCPR will consider research grant applications and contract proposals to evaluate clinical practice guidelines. However, the AHCPR generally will not award grants or recommend award of contracts to evaluate AHCPR-supported clinical practice guidelines until the guideline has been in the public domain for three months. For purposes of this policy, evaluation of a clinical practice guideline involves empirical assessment of the direct effects of the guideline on clinical practice patterns, on patient outcomes, or on the costs of health care. If a current or former chair, member, consultant, or contractor staff of an AHCPR-supported practice guideline panel is involved in seeking a grant or contract to evaluate an AHCPR guideline that the individual helped develop, this prior relationship must be disclosed in the grant application or contract proposal. The Administrator of the AHCPR generally will not make an award to that applicant or recommend award to that offeror because of the possible perception of bias or lack of objectivity. This policy may be waived where the Administrator determines that the interests of scientific progress or public health outweigh the possibility of an applicant/proposal being perceived as biased or lacking objectivity. If the AHCPR determines that an application or proposal does not disclose a prior relationship to the guideline development process, the AHCPR will administratively withdraw the application or proposal from consideration for funding. INQUIRIES Questions regarding AHCPR's Policy on Award of Grants and Contracts for Evaluation of Clinical Practice Guidelines may be directed to: Office of the Administrator Agency for Health Care Policy and Research 2101 E. Jefferson Street, Suite 600 Rockville, MD 20852 Telephone: (301) 227-6662 (through July 31) or (301) 594-6662 (effective after August 1) $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NIAID-DAIDS-94-20 **************************************** MASTER AGREEMENT CONTRACT FOR HIV PRECLINICAL VACCINE DEVELOPMENT NIH GUIDE, Volume 22, Number 26, July 23, 1993 MAA/RFP AVAILABLE: NIAID-DAIDS-94-20 P.T. 34; K.W. 0755010, 0740075 National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID), NIH has a requirement for a number of contractors to provide a variety of assays and services in support of preclinical AIDS vaccine research and development. The purpose of this program is to provide resources to the NIAID in its mission to stimulate research towards discovery and testing of prototype vaccines for Acquired Immunodeficiency Syndrome (AIDS). The NIAID requires virological, immunological, molecular biological assays and services, evaluation of candidate vaccines in animals and the GMP or GLP production of quantities of candidate vaccines sufficient for Phase I/II human clinical trials. This effort will support the research of AIDS investigators, including three SIV Vaccine Evaluation Groups (NCVDG), the AIDS Vaccine Evaluation Group (AVEG), the NIAID AIDS Vaccine Working Group, and other programs initiated by NIAID. This is an announcement for an anticipated Master Agreement Announcement Request for Proposals (RFP). The issuance of RFP No. NIAID-DAIDS-94-20 will be on or about August 2, 1993, and proposals will be due by the close of business on November 15, 1993. It is anticipated that multiple Master Agreements will be awarded as a result of this solicitation. It is expected that the Master Agreements will be awarded for five-year terms, with no funding until the subsequent solicitation and award of Master Agreement Orders for specific tasks. The Master Agreement Orders are anticipated to be completion-type, cost-reimbursement contracts. INQUIRIES Requests for the Master Agreement RFP may be directed in writing to: Kristiane Hofacker Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 6003 Executive Boulevard Bethesda, MD 20892 Provide this office with three self-addressed mailing labels. Telephone inquiries will not be honored and all inquiries must be in writing. All proposals from responsible sources will be considered by the NIAID. This advertisement does not commit the Government to award a contract. $$R1 END ************************************************************ $$R2 BEGIN CA/HD-93-033 FULL-TEXT *********************************** REHABILITATION AND PSYCHOSOCIAL RESEARCH IN YOUNGER WOMEN WITH BREAST CANCER NIH GUIDE, Volume 22, Number 26, July 23, 1993 RFA AVAILABLE: CA/HD-93-033 P.T. 34; K.W. 0715035, 0415001, 0415003, 0414014 National Cancer Institute National Institute of Child Health and Human Development Letter of Intent Receipt Date: August 31, 1993 Application Receipt Date: November 9, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI) and the National Center for Medical Rehabilitation Research (NCMRR), National Institute of Child Health and Human Development (NICHD) invite investigator-initiated grant applications for research directed at decreasing the medical and psychological morbidity and disability associated with breast cancer diagnosis and treatment in younger women. Applications must develop and test interventions that address health issues, psychosocial problems, and potential disability faced by women diagnosed with breast cancer during early adult life. 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, Rehabilitation and Psychosocial Research in Younger Women with Breast Cancer, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-783-3238. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed four years. The anticipated award date is July 1, 1994. Because the nature and scope of research proposed in response to this RFA may vary, it is anticipated that the size of award will vary also. The anticipated amount of the direct costs per award will vary from $100,000 to $400,000. This RFA is a one-time solicitation. Future unsolicited competitive continuation applications will compete with all investigator-initiated and be reviewed according to the customary NIH peer review procedures. FUNDS AVAILABLE Total costs of $2,400,000 per year for four years will be committed to specifically fund applications that are submitted in response to this RFA. It is anticipated that four to seven awards will be made. RESEARCH OBJECTIVES The goal of this RFA is to enhance the quality of life of younger women with breast cancer. Objectives are to: (1) identify and describe the medical, psychosocial, and disability-related sequelae of breast cancer diagnosis and treatment in younger women and (2) develop and test interventions directed at the specific problems associated with breast cancer diagnosis and treatment in this age group. Projects will develop, implement, and evaluate interventions directed at problems including (1) medical sequelae of therapy; (2) body image, sexuality, and reproductive issues; (3) interpersonal and family relationships; (4) concrete needs; (5) education, career development/advancement, employment, and insurance; (6) living with medical uncertainty; (7) special needs of younger patients during periods of progressive disease and/or terminal care; or (8) the impact of ethnic and cultural factors on issues listed above. Younger women are defined by chronologic age (<50 years) or by menopausal status (pre- and/or peri-menopausal) at diagnosis and study entry, depending on the study intervention. Formal evaluation of efficacy is required, with outcome variables of health-related quality of life (QOL), domains reflecting medical and psychological morbidity, and relevant aspects of disability, such as personal productivity and community participation. A multidisciplinary research approach is recommended. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women and minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by August 31, 1993, a letter of intent that includes a descriptive title of the proposed research; the name, address, telephone and FAX numbers of the Principal Investigator; the identities of other key personnel and the 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, it contains information that is helpful in planning for the review. The letter of intent allows NCI and NICHD staff to estimate the potential review workload and helps to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Susan G. Nayfield at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. The application package is available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248; and from the NCI Program Director listed under INQUIRIES. Applications must be received by close of business November 9, 1993. REVIEW CONSIDERATIONS Applications responsive to this competitive solicitation will be reviewed according to the following criteria: (1) scientific merit, clinical significance and originality, and feasibility of the proposed research; (2) appropriateness and adequacy of the research approach and proposed methodology to the goal and objectives of the RFA; (3) appropriateness of the study population and inclusion of or direction of research toward special populations; (4) feasibility of interventions for the community setting; (5) qualifications and experience of the Principal Investigator and staff; (6) use of multidisciplinary expertise from related health care specialty fields (7) adequacy of facilities and resources; and (8) adequacy of protection from hazardous or unethical research procedures. Scientific merit, availability of funds, and program balance among research areas will be considered in funding decisions. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA, inquiries regarding programmatic issues, and address the letter of intent to: Susan G. Nayfield, M.D., M.Sc. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 300-F Bethesda, MD 20892 Telephone: (301) 496-8541 Louis A. Quatrano, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 2A-0 Bethesda, MD 20892 Telephone: (301) 402-2242 FAX: (301) 402-0832 Direct inquiries regarding fiscal matters to: Ms. Victoria Price Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-7800, Ext. 52 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control Research. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R2 END ************************************************************ $$R3 BEGIN CA-93-035 FULL-TEXT ************************************** CANCER PAIN MANAGEMENT IN THE OUTPATIENT SETTING NIH GUIDE, Volume 22, Number 26, July 23, 1993 RFA AVAILABLE: CA-93-035 P.T. 34; K.W. 0715035, 0715150 National Cancer Institute Letter of Intent Receipt Date: August 12, 1993 Application Receipt Date: November 16, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The National Cancer Institute (NCI) invites investigator-initiated grant applications for research directed at developing and testing interventions to improve the management of cancer pain outside of the acute care or hospice settings, thereby improving the quality of life of persons with cancer living at home or being managed on an out-patient basis. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Cancer Pain Management in the Outpatient Setting, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-783-3238. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01). The applicant has sole responsibility for planning, direction, and execution of the proposed project. Total project period for applications submitted in response to this RFA may not exceed four years. The anticipated award date is July 1994. This RFA is a one-time solicitation. Future unsolicited competitive continuation applications will compete with all other investigator-initiated research grant applications and be reviewed according to the customary NIH peer review procedures. FUNDS AVAILABLE Total costs of $1,500,000 per year for four years will be committed to specifically fund applications submitted in response to this RFA. It is anticipated that five awards will be made. 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 NCI, the awards pursuant to this RFA are also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The objectives of this initiative are to develop and test interventions to improve the management of cancer pain outside of acute care or hospice settings. The specific objectives are to: (1) test interventions to promote the transfer of technology in a variety of health care delivery systems to improve knowledge about pain management for cancer patients living at home, (2) evaluate interventions to address patient and health care provider factors that are barriers to effective transfer and use of state of the art cancer pain management techniques, and (3) improve the acceptability and use of pain control strategies through improved management of the side effects of analgesics and/or modifications of attitudes towards the use of narcotics for pain management. Research applications should address issues in at least one of the following areas: effect of patient concerns, choices, decision making strategies, and care giver values on effective pain management; impact of systematic use of clinical practice guidelines and documentation of the effect of the intervention on patient care outcomes; overcoming barriers to application of state of the art knowledge about cancer pain management; interface of ethical and legal codes; and the effect of adherence to each on the quality of pain management. The application should define the study population, identify the problem, describe the intervention, and outline the evaluation plan. The design must include a testable intervention and a systematic plan of evaluation of the intervention using qualitative and quantitative methods. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without documentation will not be accepted for review. LETTER OF INTENT Prospective applicant are asked to submit, by August 12, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, telephone/FAX numbers of the Principal Investigator, the names 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 is helpful in planning for the review. It allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to the Program Director named in INQUIRIES. APPLICATION PROCEDURES Applications must be received by close of business November 16, 1993. Application form PHS 398 (rev. 9/91) and information about application procedures may be obtained from the NCI Program Director named in INQUIRIES. REVIEW CONSIDERATIONS Applications that are competitive and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate NCI peer review group according to specific review criteria. A second level of review will consider special needs and research priorities of the NCI. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: Claudette Varricchio D.S.N., R.N., O.C.N., F.A.A.N. National Cancer Institute Executive Plaza North, Suite 300 Bethesda, MD 20892 Telephone: (301) 496-8541 Directed inquiries regarding fiscal matters to: Mrs. Crystal Elliott National Cancer Institute Executive Plaza South, Suite 242 Bethesda, MD 20892 Telephone: (301) 496-7800 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control Research, and 93.361, Nursing Research. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74, and 45 CFR 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R3 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-93-101 ************************************************ RESEARCH INVOLVING HUMAN IN VITRO FERTILIZATION NIH GUIDE, Volume 22, Number 26, July 23, 1993 PA NUMBER: PA-93-101 P.T. 34; K.W. 0413002, 1002017 National Institute of Child Health and Human Development PURPOSE The National Institute of Child Health and Human Development (NICHD) invites investigator-initiated research grant applications to conduct basic and clinical research involving human in vitro fertilization (IVF), for the purpose of enhancing the treatment of certain forms of human infertility. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement, Research Involving Human In Vitro Fertilization, is related to the priority area of family planning. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Women, members of minority groups, and persons with disabilities are encouraged to apply. Applicants for First Independent Research Support and Transition (FIRST) Awards (R29) must meet specific eligibility requirements. In addition, foreign institutions are not eligible for the FIRST Award. MECHANISM OF SUPPORT Mechanisms available for the support of this program are the research project grant (R01) and the FIRST Award (R29). RESEARCH OBJECTIVES Many infertile couples have been treated with a variety of assisted reproductive techniques, ranging from such simple methods as timed natural intercourse or artificial insemination, through ovulation induction, to in vitro technologies such as IVF. Many of these techniques are being used empirically, without appropriate rigorous scientific evaluation. The President has signed into law the NIH Revitalization Amendments of 1993 that contain certain Miscellaneous Repeals (Sec. 121), one of which is directly relevant to this program announcement. This repeal is for the provision in the current Code of Federal Regulations pertaining to the protection of human subjects, 45 CFR 46.204(d), that requires a Federal-level Ethical Advisory Board review for applications involving human IVF. With the lifting of this requirement, the NIH can now conduct and support research involving human IVF, in accord with the recommendations of the grantee institution's Institutional Review Board, without the need for a special Federal-level Ethical Advisory Board in each case. It is anticipated that applications involving certain types of research that relate to human IVF will still be subject to special review on a case-by-case basis. This program announcement is designed to encourage investigators to apply for research support for basic and clinical studies that will enhance the outcome of IVF in the normal course of treatment for human infertility. Such research might include, but not be limited to: o improved patient selection procedures for treatment with IVF o improved ovulation induction in IVF protocols o improved methods for gamete collection o improved conditions for fertilization o improved conditions for embryo transfer o IVF outcome in different racial and ethnic groups STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are found in the PHS 398 (rev. 9/91) instructions. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The title and number of the announcement must be typed in Section 2a on the face page of the application. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required numbered of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. The second level of review will be provided by an appropriate national advisory council. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Donna L. Vogel, M.D., Ph.D. Center for Population Research National Institute of Child Health and Human Development Building 61E, Room 8B01 Bethesda, MD 20892 Telephone: (301) 496-6515 FAX: (301) 496-0962 Direct inquiries regarding fiscal matters to: Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development Building 61E, Room 8A07 Bethesda, MD 20892 Telephone: (301) 496-5481 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.864, Population Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12374 or Health Systems Agency review. $$P1 END ************************************************************ ERRATUM $$E1 BEGIN P1 19930205 APPEND PA-93-046 BOTH *************************** DRUG USE AND ABUSE IN MINORITY AND UNDERSERVED POPULATIONS NIH GUIDE, Volume 22, Number 26, July 23, 1993 PA NUMBER: PA-93-046 P.T. 34, FF; K.W. 0404009, 0745027, 0411005 National Institute on Drug Abuse The purpose of this notice is to amend program announcement PA-93-046, Drug Use and Abuse in Minority and Underserved Populations, published in the NIH Guide, Volume 22, No. 5, February 5, 1993, Part II of II. The National Institute on Drug Abuse wishes to add the following research area at the end of the Areas of Research Interest. All other aspects of the announcement published February 5, 1993, remain the same, including receipt dates. Prevention Intervention Research: Controlled experimental or quasi-experimental research is needed to assess the efficacy of theory-based drug prevention intervention strategies specific to culturally diverse populations. Prevention interventions may target general populations or high-risk groups and be implemented in a variety of settings to include the home, school, community, and workplace. Prevention intervention research should focus attention on ethnic, cultural, and gender-relevant issues, concerns, and risk/protective factors that directly impinge upon the successful design and testing of theory-based drug abuse prevention interventions that best meet the needs of those at risk to drug use onset and progression to abuse. Proposed studies should: assess theories of drug prevention; evaluate the explanatory power of key mediating program variables; test the effectiveness of theory-based programs to prevent or reduce the use/abuse of a variety of drugs to include: alcohol, nicotine, marijuana, cocaine/crack, inhalants and other illicit drugs; develop or refine prevention research methods and measures, and analyze diffusion models of innovative practices. INQUIRIES Questions regarding this notice may be directed to: Mario de la Rosa, Ph.D. Division of Epidemiology and Prevention Research National Institute on Drug Abuse Rockwall II, Suite 615 Rockville, MD 20857 Telephone: (301) 443-2755 $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Mon Jul 19 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 26, pt. 2, 23 July 1993 Message-ID: Date: 20 Jul 93 19:54:36 GMT Sender: kristoff@net.bio.net Lines: 588 Approved: biosci-moderator@net.bio.net $$XID RFA AHD93033 CA/HD-93-033 P1O1 *********************************** REHABILITATION AND PSYCHOSOCIAL RESEARCH IN YOUNGER WOMEN WITH BREAST CANCER NIH GUIDE, Volume 22, Number 26, July 23, 1993 RFA: CA/HD-93-033 P.T. 34; K.W. 0715035, 0415001, 0415003, 0414014 National Cancer Institute National Institute of Child Health and Human Development Letter of Intent Receipt Date: August 31, 1993 Application Receipt Date: November 9, 1993 PURPOSE The Division of Cancer Prevention and Control (DCPC) National Cancer Institute (NCI) and the National Center for Medical Rehabilitation Research (NCMRR) National Institute of Child Health and Human Development (NICHD) invite investigator-initiated grant applications for research directed at decreasing the medical and psychological morbidity and disability associated with breast cancer diagnosis and treatment in younger women. The goal of this Request for Applications (RFA) is to enhance the quality of life of younger women with this disease through effective interventions directed at the specific problems associated with breast cancer and its treatment in this age group. This initiative requests research applications to develop and test interventions that address health issues, psychosocial problems, and potential disability faced by women diagnosed with breast cancer during early adult life. 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, Rehabilitation and Psychosocial Research in Younger Women with Breast Cancer, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-783-3238. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit, public and private organizations, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) research project grant (R01). Applicants will be responsible for the planning, direction, and execution of the proposed project. The total project period for applications submitted in response to this RFA may not exceed four years. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990 and as stated in this RFA. Because the nature and scope of research proposed in response to this RFA may vary, it is anticipated that the size of award will vary also. The anticipated amount of the direct costs per award will vary from $100,000 to $400,000. Allowable direct costs for the intervention will NOT include payment for cancer screening tests or for services and procedures that are a routine part of cancer treatment and patient care. Expenses incurred in development and implementation of the proposed research, including baseline and follow-up surveys, design of materials, and professional education are allowable costs. Annual budgets should include travel funds for the Principal Investigator and co-investigators to one two-day meeting in Bethesda, MD, to facilitate review with program staff and to foster sharing of work in progress with other investigators. This RFA is a one-time solicitation. Future unsolicited competitive continuation applications will compete with all other investigator-initiated research grant applications and be peer reviewed by a chartered study section in the Division of Research Grants (DRG), NIH. If the NCI and the NICHD determine that there is a sufficient continuing program need, a request for competitive continuation applications will be announced. Only recipients of awards under this RFA will be eligible to apply. FUNDS AVAILABLE Total costs of $2,400,000 per year for four years will be committed to specifically fund applications that are submitted in response to this RFA. It is anticipated that four to seven awards will be made. 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 NCI and the NICHD, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Approximately one-fifth of all women newly-diagnosed with breast cancer are under age 50 (1). These women are faced with the diagnosis of a life-threatening illness at the same time that they are confronting the complex personal issues associated with adult life. Career development plans and employment may be interrupted by diagnosis and treatment. Decisions regarding marriage, pregnancy, and raising a family (perhaps as a single parent) are often postponed or reconsidered, and existing interpersonal relationships are challenged by the stress associated with cancer diagnosis and treatment. The possibility of surgical deformity and sexual dysfunction may be especially threatening to women in this age group. The possibility of premature menopause and its health consequences, and the uncertainty of disease relapse have long-term implications. Younger women with recurrent or advanced disease face premature mortality with inability to realize life dreams or to see children grow into adulthood. The proportion of breast cancer patients under age 50 increases to approximately one-third for black women newly-diagnosed with breast cancer (1). Breast cancer is diagnosed at later stages among younger black women compared to younger white women (45 percent localized vs 51 percent localized), and five-year relative survival rates are poorer for younger black women compared to younger white women for all stages of disease, particularly for localized disease (79 percent vs 91 percent (2). In addition to differences in age at diagnosis, extent of disease, and relative survival, differences in ethnicity and cultural background may intensify medical and psychosocial issues for younger women from culturally diverse populations (3). The special problems of younger women with breast cancer were the focus of the recent NIH Conference on Breast Cancer in Younger Women, held January 28-29, 1993, in Bethesda, MD. Speakers from varied medical and scientific backgrounds summarized current knowledge about breast cancer in this age group and identified areas for future research. The recommendations from the conference for research topics in these areas of medical consequences of therapy, psychosocial and survivorship issues, and disability form the basis for this funding initiative (4). The NIH Task Force on Medical Rehabilitation Research (June 1990) highlighted similar areas for future research (5). Although the report did not target specific age groups of cancer patients, many of the recommendations are particularly relevant to younger women with breast cancer. For example, functional and psychosocial problems associated with new and emerging treatments are issues related to intensive chemotherapy and bone marrow transplantation, approaches more frequently considered for younger breast cancer patients. Long-term sequelae of breast-conserving surgery and radiotherapy are particularly germane to younger women because greater proportions are diagnosed at early stages and these procedures are more often performed in younger women. Issues of infertility, premature menopause, and sexual dysfunction may be more problematic for younger women because of their developmental life stage. Economic and vocational problems associated with cancer and barriers to employment become threatening issues early in career development or when dual income is required to support a young family. These issues are also consistent with research needs highlighted in the Research Plan for the NCMRR (6). Research Goals and Scope This initiative supports research directed at decreasing the medical and psychological morbidity and disability associated with breast cancer diagnosis and treatment in younger women. The goal of this RFA is to enhance the quality of life of younger women with this disease through the study of effective interventions directed at the specific problems associated with breast cancer and its treatment in this age group. The objectives of the RFA are to: o identify and describe the medical, psychosocial, and disability-related sequelae of breast cancer diagnosis and treatment in younger women, and to explore factors contributing to the occurrence of these problems; and o develop and test interventions directed at decreasing morbidity associated with breast cancer and improving quality of life for younger breast cancer patients. This RFA invites applications that address specific health issues, psychosocial problems, and disability faced by women diagnosed with breast cancer during early adult life. Research projects will focus on developing, implementing, and evaluating interventions directed at younger women with breast cancer. Problems targeted by these interventions include issues confronting women during this life-development period that may be impacted by breast cancer diagnosis or treatment, such as career development and employability, marriage and family planning, medical sequelae of treatment, and living with the uncertainty of recurrent disease. Projects will include two phases of research: (1) a descriptive phase, in which baseline data is collected and descriptive analyses are performed; and (2) an evaluative phase, in which the impact of the study intervention on physical and psychologic morbidity, disability, and quality of life of younger women with breast cancer is assessed. The duration of the descriptive phase may vary among applications based on the prior research efforts of the Principal Investigator in this area. However, for most applications, initial data collection and analysis should not extend beyond the first year of the proposed project, to allow sufficient time a comprehensive evaluative phase. For the purposes of this RFA, younger women may be defined either by chronologic age (<50 years) or by menopausal status (pre- and/or peri-menopausal) at the time of diagnosis of breast cancer and at entry into the research project. The choice of definition must be appropriate to the intervention under study. Population subgroups for specific focus may be identified by medical, social, or cultural characteristics or needs. Disability is defined as inability or limitation in performing tasks, activities, and roles to levels expected within physical and social contexts (6). Applications should address at least one of the following aspects of care for younger breast cancer patients: o Medical sequelae of therapy; o Body image, sexuality, and reproductive issues; o Interpersonal and family relationships; o Tangible needs (e.g., dual income, assistance with child care); o Education, career development/advancement, employment, and insurance; o Medical uncertainty (e.g., recurrent disease); o Special needs of younger patients during periods of progressive disease and/or terminal care; o Impact of ethnic and cultural factors on issues listed above. Applications may include pharmacologic interventions as a component of an integrated intervention program. However, applications that present pharmacologic approaches as the only method of intervention (e.g., clinical trials of drug therapy for psychological distress or menopausal symptoms) will not be considered for review. Because of the controversy surrounding the safety of hormone replacement therapy (HRT) for women with a prior diagnosis of breast cancer, applications that involve HRT will not be considered for review. The proposed intervention must be described clearly in the research application. Interventions should be based on background information (including preliminary research) and modified, as appropriate, for results from the descriptive phase. Interventions should focus on the breast cancer patient but may involve the extended family and caregiver network. The proposed intervention should be explained in sufficient detail to assess its appropriateness for the problem and population chosen. Potential modifications of interventions based on results of the descriptive phase should be discussed in the application. For formal evaluation of efficacy, a study design including random assignment to control and intervention groups is recommended. However, randomization at the level of physician practices, clinics, or hospitals (rather than of individual patients) may be considered to avoid selection bias or contamination effects. A quasi-experimental design may be utilized if randomization is not possible and if this approach provides reasonable assessment of efficacy. Required outcome variables include the patient's global health-related quality of life and QOL domains reflecting medical and psychological morbidity (physical function, symptomatology, psychological function, and social function). Relevant aspects of disability, such as personal productivity and community participation should be assessed as appropriate to test the study hypotheses. Outcomes assessment strategies and analyses must be based on established health research methods and utilize standard measures of QOL and QOL domains with demonstrated reproducibility, validity, and responsiveness (7-9). Assessment methods must be sensitive to specific needs of the study population and appropriate for its educational and social background. Other psychologic and/or physiologic endpoints should be included if they are relevant to the study hypothesis, but they do not obviate the requirement for standard quality of life measures as major outcome variables. Because of the complexities of the problems faced by younger women with breast cancer, a multidisciplinary research approach is recommended. Expertise from areas of medical and surgical oncology and oncology nursing, health psychology and psychiatry, rehabilitative medicine, endocrinology and reproductive medicine, health economics and health services research, and other social science disciplines should be included as appropriate for the target problem and population. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources (NCRR) 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 the Principal Investigator should be included with the application. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear and compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations [i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics]. The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the Research Plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to the NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by August 31, 1993 a letter of intent that includes a descriptive title of the proposed research; the name, address, telephone and FAX numbers of the Principal Investigator; the names of other key personnel; the participating institution(s); 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, it contains information that is helpful in planning for the review. The letter of intent allows NCI and NICHD staff to estimate the potential review workload and helps to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Susan G. Nayfield at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. The application package is available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248; and from the NCI Program Director listed under INQUIRIES. The RFA label available in the application form PHS 398 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 and title must be typed on line 2A of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact clear and single-sided photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Referral Officer, Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 Bethesda, MD 20892 Applications must be received by close of business November 9, 1993. If an application is received after that date, it will be returned to the applicant. The DRG will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application, nor will it accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision to an already reviewed application, but such an application must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Review Procedure Upon receipt, applications will be reviewed initially by the DRG for completeness. An incomplete application will be returned to the applicant without further consideration. Evaluation for responsiveness to the RFA is an NCI and NICHD program staff function. Applications will be judged to determine how well they meet the goals and objectives of the program as described in the RFA. Applications judged non-responsive will be returned, but may be submitted as investigator-initiated research grant applications at the next regular receipt date. Questions concerning the relevance of proposed research to the RFA may be directed to the Program Directors listed under INQUIRIES. If the number of applications is large compared to the number of awards to be made, the NCI and NICHD may conduct a preliminary scientific peer review to triage applications on the basis of relative competitiveness and to eliminate those applications that are clearly not competitive. The NCI and NICHD will withdraw from further competition those applications judged to be noncompetitive and notify the applicant and institutional business official. Those applications judged to be both competitive and responsive will be further evaluated according to the review criteria stated below for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review by the National Cancer Advisory Board and the Advisory Council for the NICHD will consider the special needs and the research priorities of the NCI and NICHD. Review Criteria Applications responsive to this competitive solicitation will be reviewed in accordance with the criteria stated below: o Scientific merit of the research design for both descriptive and evaluative phases, clinical significance and originality of the proposed research, and feasibility of the procedures to be used. o Appropriateness and adequacy of the experimental approach and proposed methodology to the goal and objectives of the RFA, and the potential for evaluation of the efficacy of the proposed intervention. o Appropriateness of the study population to the goal and objectives of the RFA, and inclusion of or direction of research toward special populations. o Feasibility of applying successful interventions in community practice settings. o Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research project; inclusion of professionals representing diverse disciplines relevant to the proposed research at the leadership level. o Availability and proposed use of multidisciplinary expertise from related fields of behavioral and social sciences, health services evaluation, and health care specialties as appropriate for the proposed research. o Adequacy of existing or proposed facilities and resources. o Adequacy of the proposed means for protecting against hazardous or unethical research procedures. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each scored application. AWARD CRITERIA The earliest feasible start date for the initial awards will be July 1, 1994. The following factors will be considered in making funding decisions: (1) the scientific merit of the proposed project as determined by peer review; (2) availability of funds; and (3) program balance among research areas of the RFA. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA, and inquiries about whether or not specific proposed research would be responsive, are encouraged. The opportunity to clarify any scientific or programmatic issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and address the letter intent to: Susan G. Nayfield, M.D., M.Sc. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 300-F Bethesda, MD 20892 Telephone: (301) 496-8541 FAX: (301) 496-8667 Louis A. Quatrano, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 2A-0 Bethesda, MD 20892 Telephone: (301) 402-2242 FAX: (301) 402-0832 Inquiries regarding budgetary, administrative, and/or policy issues may be directed to: Ms. Victoria Price Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-7800, Ext. 52 FAX: (301) 496-8601 Other institutes and agencies are also interested in research focused on rehabilitation and psychosocial aspects of breast cancer. These include the National Institute of Nursing Research (NINR). Inquiries may be directed to: June R. Lunney, Ph.D., R.N. Health Promotion and Illness Prevention Branch National Institute of Nursing Research Westwood Building, Room 754 Bethesda, MD 20892 Telephone: (301) 594-7397 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control Research. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. References 1. Surveillance, Epidemiology, and End Results Program, National Cancer Institute, 1989 data (unpublished). 2. Miller BA, Ries LAG, Hankey BF, Kosary CL, Edwards BK (eds). Cancer Statistics Review: 1973- 1989. National Cancer Institute, NIH Publication Number 92-02789, 1992. 3. Jones LA (ed). Minorities and Cancer. Springer-Verlag, New York, NY, 1989. 4. Breast Cancer in Younger Women. J Natl Cancer Inst Monograph, Volume 16, NIH Publication Number 93-03559 (in press). 5. Report of the Task Force on Medical Rehabilitation Research (June 28-29, 1990; Hunt Valley, MD). National Institutes of Health, Bethesda, MD. U.S. G. P. O. 1992-312-122:6006. 6. Research Plan for the National Center for Medical Rehabilitation, March, 1993. National Institutes of Health, Bethesda, MD. NIH Publication No. 93-3509. 7. Wilkin D, Hallam L, Doggett MA. Measures of Need and Outcome for Primary Health Care. Oxford University Press, New York, NY, 1992. 8. Osoba D (ed). Effect of Cancer on Quality of Life. CRC Press, Inc., Boca Raton, FL, 1991. 9. Spilker B (ed). Quality of Life Assessment in Clinical Trials. Raven Press, New York, NY, 1990. From owner-sci-resources@net.bio.net Mon Jul 19 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 26, pt. 3, 23 July 1993 Message-ID: Date: 20 Jul 93 19:55:18 GMT Sender: kristoff@net.bio.net Lines: 561 Approved: biosci-moderator@net.bio.net $$XID RFA CA93035 CA-93-035 P1O1 *************************************** CANCER PAIN MANAGEMENT IN THE OUTPATIENT SETTING NIH GUIDE, Volume 22, Number 26, July 23, 1993 RFA: CA-93-035 P.T. 34; K.W. 0715035, 0715150 National Cancer Institute Letter of Intent Receipt Date: August 12, 1993 Application Receipt Date: November 16, 1993 PURPOSE The Division of Cancer Prevention and Control (DCPC) of the National Cancer Institute (NCI) invites investigator- initiated grant applications for research directed at developing and testing interventions to improve the management of cancer pain outside of the acute care or hospice settings, thereby improving the quality of life of persons with cancer living at home or being managed on an out-patient basis. 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), Cancer Pain Management in the Outpatient Setting, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-783-3238. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit, public and private organizations, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) individual research project grant (R01). Applicants will be responsible for the planning, direction, and execution of the proposed project. The total project period for applications submitted in response to this RFA may not exceed four years. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. The anticipated amount of the direct costs per award will vary from $100,000 to $300,000. Allowable direct costs for the intervention will NOT include payment for cancer screening tests or services and procedures which are a routine part of cancer treatment and patient care. Expenses incurred in development and implementation of the proposed research, including baseline and follow-up surveys, design of materials, and professional education are allowable costs. Budgets should include travel funds for the Principal Investigator and co-investigator to one two-day meeting in Bethesda, MD, in year four to facilitate review with program staff and to foster sharing of work in progress with other researchers. This RFA is a one-time solicitation. Future unsolicited competitive continuation applications will compete with all other investigator-initiated research grant applications and be peer reviewed by a chartered study section in the Division of Research Grants (DRG), NIH. However, if the NCI determines that there is a sufficient continuing program need, a request for competitive continuation applications will be announced. Only recipients of awards under this RFA will be eligible to apply. FUNDS AVAILABLE Total costs of $1,500,000 per year for four years will be committed to specifically fund applications that are submitted in response to this RFA. It is anticipated that five awards will be made. This funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. The earliest feasible start date for the initial awards will be July 1994. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Effective cancer pain management is a topic that continues to receive much attention. Undertreatment of pain of all types, in all age groups, has been apparent for almost two decades. There is agreement that the scientific basis for effective pain management exists, but that the dissemination of information and transfer to clinical practice has not kept up with the science. The focus has been most often on the acute care setting or effective palliation in the hospice setting. Current practice in oncology settings is shifting from the acute care cancer center to outpatient and community settings for continuing care, maintenance, and follow-up. Many patients who are followed in these settings are those with pain from bone metastases of breast or prostate cancer. These patients are relatively healthy and can manage the usual activities of daily living. They would have a greater comfort level and greater quality of life if their pain were managed optimally. The shift in care setting results in many patients with cancer being managed by primary care physicians, home health care providers, and others not associated with cancer care. The current literature addresses concerns with management of cancer pain in the acute care and hospice settings. Families are assuming the responsibility for pain management at home. Ferrel et al (1,2 ) recently reported that family members play an important role in pain management. This is increasingly true in an era of health care cost containment. Advances in technology now require that families manage complex medication regimens, parenteral infusion devices and even epidural catheters in the home. The management of pain for those individuals who are at home, cared for by a family member, a community physician and/or visiting nurse or other health care provider outside of major cancer centers has not had the same attention as pain management in acute care settings and hospice. There are attitudinal influences, legal barriers or obstacles, knowledge deficits by the professional as well as the lay care givers that contribute to less than optimal pain management in these settings. The 1989 conference "Drug treatment of cancer in a drug oriented society" (4) produced a consensus that ... "Despite more knowledge about pain and wider dissemination of that knowledge through conferences and volumes such as this, progress in improving the quality of pain treatment in cancer patients has been inadequate, resulting in many cancer patients suffering needlessly" (3, 4). The reasons for the problem can be divided into three categories according to Hill et al: (1) cultural and attitudinal barriers to rational and appropriate use of narcotics; (2) knowledge deficits about pain and narcotics; (3) influence of drug regulatory agencies. The first two reasons are within the scope of this RFA, the last is beyond this announcement. Research Goals and Scope The goals of this research initiative are to develop and test interventions to improve the management of cancer pain outside of the acute care or hospice settings, thereby improving the quality of life of persons with cancer living at home or being managed on an out-patient basis. The specific objectives of the research are to: o test interventions to promote the transfer of technology in a variety of health care delivery systems to improve knowledge about pain management for cancer patients living at home. o evaluate interventions to address patient and health care provider factors that are barriers to effective transfer and use of state-of- the-art cancer pain management techniques. o improve the acceptability and use of the pain control strategies through improved management of the side effects of analgesics and/or modifications of attitudes towards the use of narcotics for pain management. The application should define the population, identify the problem, describe the intervention, and outline the evaluation plan. Applications should reflect a strong research orientation with attention to quality of life and its dimensions reflected by effectiveness of pain management, patient satisfaction or other appropriate end points. A multidisciplinary approach including expertise in cancer pain management, clinical oncology, nursing, social work, and health services research is recommended. Study Design This is a request for applications for research that will develop and test interventions for the delivery of appropriate and effective pain management to cancer patients outside of acute care and hospice settings. The settings where this intervention could be tested include in-home care, out-patient based care for patients experiencing chronic pain from metastatic disease or the sequelae of disease or therapy, or acute pain episodes during a more stable course of disease. The proposed interventions should build on current knowledge and research findings that indicate appropriate pain management approaches in different types of pain etiology (i.e., bone pain from metastatic disease such as from breast or prostate cancer, or neurogenic pain from surgery, other therapy or disease progression) as well as using different drug combinations for optimum effect. This is not to be structured as a clinical trial of drug effectiveness, nor as a comparison of the acceptability or effectiveness of competitive drug delivery techniques. Some examples of target areas for the development of interventions might include, but are not limited to, the following: o Effects of patient concerns, patient choices, decision making strategies, and care giver values on effective pain management. o Impact of systematic use of clinical practice guidelines and documentation of the effect of the intervention on patient care outcomes. o Overcoming barriers to application of state of the art knowledge about cancer pain management, (attitudes of the health care provider; feasibility, cost effectiveness and effectiveness of hi-tech vs. low-tech delivery techniques for the drugs in outpatient settings; structure of the care delivery system). o Interface of ethical and legal codes and the effect of adherence to each on the quality of pain management outside of the acute care setting. The cultural, ethnic, and developmental aspects of the population targeted for study must be considered in designing interventions. Validation of established assessment guides in low literacy and non-English speaking populations should be considered as part of a broader intervention where appropriate. Biological and behavioral variables should be included as appropriate to the research question. The inclusion of biological variables that can be measured directly is encouraged. This will require collaboration across disciplines and the inclusion of community care givers and primary care providers on the research team. This intervention research may incorporate a descriptive phase for collection of baseline data, or a short pilot phase for refining the proposed intervention. Applicants are expected to have a foundation of previous work so that only a minimal descriptive, exploratory phase will be required before moving to the intervention and evaluation phases. Study Evaluation A strong evaluation component is required. Existing measures of the outcome variables of interest, with established validity and reliability, must be used. The investigators will be expected to evaluate the feasibility and effectiveness of the transfer of technology from the traditional care settings to the out-patient, community or home setting. This includes assessing patient outcomes, the efficiency of the intervention with respect to use of community resources, considerations of the costs incurred, and mechanism of payment. A multidisciplinary approach to the research question and to the evaluation of the intervention is recommended. Outcomes can include measures of satisfaction with pain control, changes in level of pain reported either subjectively or by biological means; functional status (cognitive and/or physical); duration of response; changes in reported quality of life; compliance with or persistence in cancer therapy when pain management is optimal; effectiveness of the care delivery model in the target group; influences of health care provider characteristics and attitudes on adequate pain management in the target group; convenience and cost. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear and compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations [i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics]. The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the Research Plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to the NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by August 12, 1993, a letter of intent that includes a descriptive title of the proposed research; the name, address, telephone and FAX numbers of the Principal Investigator; the names of other key personnel; the participating institution(s); 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, it contains information that is helpful in planning for the review. The letter of intent allows NCI staff to estimate the potential review workload and helps to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Claudette Varricchio, at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. The application package is available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248; and from the NCI Program Director listed under INQUIRIES. The RFA label available in the application form PHS 398 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 and title must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact, clear and single-sided photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Referral Officer, Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 Bethesda, MD 20892 If the applicant has an approved assurance covering the research, the applicant must provide, with the application, certification of Institutional Review Board (IRB) approval, if humans are involved. Reviews and approval should occur prior to submission of the application for award and the certification should be submitted with the application. If humans will be subjects of the research at performance sites other than the applicant organization, the applicant must identify, in the application, the assurance status of each participant. Failure to provide required certifications in the application could result in delay of an award. Instructions regarding inclusion of human subjects are given on pages 22-23 and 25-26 of PHS 398 (rev. 9/91). Applications must be received by close of business November 16, 1993. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this announcement 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 a substantial revision to an already reviewed application, but such an application must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Review Procedure Upon receipt, applications will be reviewed initially by the DRG for completeness. An incomplete application will be returned to the applicant without further consideration. Evaluation for responsiveness to the RFA is an NCI program staff function. Applications will be judged to determine how well they meet the goals and objectives of the program as described in the RFA. Applications judged non-responsive will be returned, but may be submitted as investigator-initiated research grant applications at the next regular receipt date. Questions concerning the relevance of proposed research to the RFA may be directed to the Program Director listed under INQUIRIES. If the number of applications is large compared to the number of awards to be made, the NCI may conduct a preliminary scientific peer review to triage applications on the basis of relative competitiveness and to eliminate those applications that are clearly not competitive. The NCI will withdraw from further competition those applications judged to be noncompetitive and notify the applicant and institutional business official. Those applications judged to be both competitive and responsive will be further evaluated according to the review criteria stated below for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review by the National Cancer Advisory Board for NCI will consider the special needs and the research priorities of the Institute. Review Criteria Applications responsive to this competitive solicitation will be reviewed in accordance with the criteria stated below: o Scientific merit of the research design, clinical significance and originality of the proposed intervention. o Appropriateness and adequacy of the experimental approach and methodology proposed to the goals and objectives of the RFA, including outcome measures and the feasibility of the procedure to be used. o Appropriateness of the study population to the goals and objectives of the RFA and investigator access to the study population. o Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research. Inclusion of professionals representing diverse disciplines, as appropriate, on the leadership level. o Availability of resources necessary to perform the research. o Feasibility of applying successful interventions in community practice settings and home care settings. o Adequacy of the proposed means for protecting against hazardous or unethical research procedures. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each scored application. AWARD CRITERIA The earliest anticipated date of award is July 1, 1994. The following factors will be considered in making funding decisions: (1) the scientific merit of the proposed project as determined by peer review; (2) availability of funds; and (3) program balance among research areas of the RFA. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA, and inquiries about whether or not specific proposed research would be responsive, are encouraged. The opportunity to clarify any scientific or programmatic issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and address the letter of intent to: Claudette Varricchio, D.S.N., R.N., O.C.N., F.A.A.N. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Suite 300 Bethesda, MD 20892 Telephone: (301) 496-8541 FAX: (301) 496-8667 Inquiries regarding budgetary, administrative, and/or policy issues may be directed to: Mrs. Crystal Elliott Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 19 FAX: (301) 496-8601 Other institutes and agencies are also interested in research focused on cancer pain management. These include the National Institute for Nursing Research. Inquiries may be directed to: June R. Lunney, Ph.D., R.N. Acute and Chronic Disease Branch National Center for Nursing Research Building 31, Room 5B09 Bethesda, MD 20892 Telephone: (301) 594-7397 This RFA is in addition to the ongoing program announcement on Cancer Prevention and Control Research, published in the NIH Guide for Grants and Contracts, Vol. 21, No. 12, March 27, 1992. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control Research, and 93.361, Nursing Research. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and 45 CFR 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. References 1. Ferrel BR, Ferrel BA, Rhimer M, Grant MM. 1991, Family Factors Influencing Cancer Pain. Pst Graduate Medical Journal 67(Supple 2): S64-S69. 2. Ferrel BR, Ferrel BA. 1991, Pain Management at Home. Clinics in Geriatric Medicine 18(8): 1315- 1321. 3. Hill CS. 1990, Relationship Among Cultural, Educational, and Regulatory Agency Influences on Optimum Cancer Pain Treatment. Journal of Pain and Symptom Management 5(1) (sup): S37-S45. 4. Hill CS, Fields WS. 1989, Advances in Pain Research and Therapy Volume 11: Drug Treatment of Cancer Pain in a Drug-Oriented Society. Raven Press, New York. 5. Hill CS, Fields WS, Thorpe DM. 1989, A Call to Action to Improve Relief of Cancer Pain, in, Advances in Pain Research and Therapy Volume 11: Drug Treatment of Cancer Pain in a Drug-Oriented Society, Hill CS, Fields WS, (eds). Raven Press, New York: 353-361. 6. Foley KM, Bonica, JJ, Ventafridda V,eds. 1990, Advances in Pain Research and Therapy, Vol. 16: Proceedings of the Second International Congress on Cancer Pain. Raven Press, New York. 7. Pratt, RB. 1993, Cancer Pain. JB Lippincott, Philadelphia. 8. Portenoy, R, Foley, K. 1989, Management of Cancer Pain, in, Handbook of Psychooncology, Holland, JC, Rowland, JH, eds. Oxford University Press, New York: 369-382. 9. Schmitt, RM. 1992, Outpatient Cancer Pain Management: Issues in Research and Practice. Pain Management Issues in Research and Practice. American Cancer Society Pub. No. 50M 4503, 05 PE, Atlanta, GA. From owner-sci-resources@net.bio.net Thu Jul 29 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 27, pt. 1, 30 July 1993 Message-ID: Date: 30 Jul 93 01:13:19 GMT Sender: kristoff@net.bio.net Lines: 1505 Approved: biosci-moderator@net.bio.net NOTE: The NIH Guide may be split into more than one mail message to avoid truncation during e-mail distribution. The first message always begins with the RFP/RFA summary sections followed by the appended texts of the full RFP/RFAs. ---------------------------------------------------------------------- $$XID NIHGUIDE 19930730 V22N27 P1O2 ************************************ X-comment: RFAs described: AI-93-016, CA-93-036, MH-93-006 NIH GUIDE - Vol. 22, No. 27 - July 30, 1993 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** MODIFICATION OF THE NRSA SERVICE PAYBACK OBLIGATION National Institutes of Health Agency for Health Care Policy and Research Health Resources Services Administration INDEX: NATIONAL INSTITUTES OF HEALTH; HEALTH CARE POLICY; RESOURCE SERVICES $$INDEX N2 ********************************************************** FINAL FINDINGS OF SCIENTIFIC MISCONDUCT Public Health Service INDEX: PUBLIC HEALTH SERVICE NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 11/10/93 ************************************************* AID/NIAID PROGRAM: FUNDAMENTAL MALARIA VACCINE STUDIES (RFA AI-93-016) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R2 11/23/93 ************************************************* VIRAL INTERACTIONS WITH p53 IN HUMAN CANCER (RFA CA-93-036) National Cancer Institute INDEX: CANCER $$INDEX R3 12/01/93 ************************************************* SPACELAB LIFE SCIENCES-4, NEUROLAB (NASA/NIH-94-001) Canadian Space Agency Centre National d'Etudes Spatiales European Space Agency Headquarters German Space Agency National Institute of Neurological Disorders and Stroke National Science Foundation National Space Development Agency of Japan National Aeronautics and Space Administration National Institute on Aging National Institute on Deafness and Other Communication Disorders Office of Naval Research INDEX: SPACE; AERONAUTICS; NEUROLOGICAL DISORDERS, STROKE; AGING; DEAFNESS, OTHER COMMUNICATIONS DISORDERS; NAVAL RESEARCH $$INDEX R4 12/03/93 ************************************************* DIAGNOSTIC CENTERS FOR PSYCHIATRIC LINKAGE STUDIES (RFA MH-93-006) National Institute of Mental Health INDEX: MENTAL HEALTH ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 10/01/93 ************************************************* DEVELOPING AND IMPROVING INSTITUTIONAL ANIMAL RESOURCES (PAR-93-102) National Center for Research Resources INDEX: RESEARCH RESOURCES This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** MODIFICATION OF THE NRSA SERVICE PAYBACK OBLIGATION NIH GUIDE, Volume 22, Number 27, July 30, 1993 P.T. 22, 44; K.W. 0720005, 1014006 National Institutes of Health Agency for Health Care Policy and Research Health Resources Services Administration The National Institutes of Health (NIH) Revitalization Act of 1993, signed into law on June 10, 1993, includes provisions in Section 1602 that substantially modify the service payback requirement for individuals supported by National Research Service Awards (NRSA). These new provisions will be applicable to all new appointments or reappointments to research training grants and to all new, noncompeting continuation, and competing renewal fellowship awards beginning on or after June 10, 1993. For fellowships, the award beginning date refers to the award activation date. An individual appointed to a research training grant or who has a fellowship award activated before June 10, 1993 will continue to accrue a service payback obligation as specified in the NRSA Guidelines for Individual Awards and Institutional Grants (NIH Guide for Grants and Contracts, Vol. 13, No. 1, January 6, 1984) until the end of the current appointment. The following will apply to appointments beginning and awards activated on or after June 10, 1993: o Predoctoral trainees and fellows WILL NOT incur a service payback obligation. o Postdoctoral trainees and fellows in the first twelve months of postdoctoral NRSA support WILL incur one month of obligation for each month of support. o Postdoctoral trainees and fellows in the 13th and subsequent months of NRSA support will incur NO further obligation. The requirements established by the Revitalization Act also provide that the 13th and any subsequent month of postdoctoral NRSA supported research training will be used to discharge any PRIOR postdoctoral NRSA service payback obligation. Beginning with awards operating under the Act, service payback obligations may be discharged in the following ways: o By receiving an equal number of months of postdoctoral NRSA support beginning in the 13th month of such postdoctoral NRSA support; o By engaging in an equal number of months of health-related research and/or health related teaching averaging more than 20 hours per week of a full work year. IMPLEMENTATION o Individuals who have completed their NRSA training and have an existing NRSA service payback obligation will be required to engage in service payback or make financial repayment as described in the 1984 Guidelines cited above or other guidelines applicable to NRSA recipients appointed prior to 1984. o Individuals currently appointed to a research training grant or who have had a fellowship award activated before June 10, 1993, will continue to accrue a service payback obligation as described in the 1984 Guidelines until the end of that appointment or fellowship award period. At the end of the current appointment or award period, individuals will complete and submit a Termination Notice (form PHS 416-7) even if they expect to continue NRSA supported research training after that date. This form will serve as the basis for determining their payback obligation under the 1984 Guidelines. Individuals who then are reappointed to a training grant or receive a fellowship award will follow the new guidelines to be established by the NIH Revitalization Act of 1993. o PREDOCTORAL trainees beginning appointments and fellows activating awards on or after June 10, 1993 are NOT required to complete the Payback Agreement Form (PHS 6031). o POSTDOCTORAL trainees and fellows beginning the first twelve months of postdoctoral NRSA support on or after June 10, 1993 must complete a Payback Agreement Form (PHS 6031). At the present time, the NIH is modifying the Payback Agreement Form. Until the revised form becomes available, trainees and fellows beginning appointments or awards for the first twelve months of postdoctoral NRSA support will continue to sign the existing Payback Agreement Form (PHS 6031 (rev. 10/91). Under the 10/91 revision of the Payback Agreement Form, no payback obligation will accrue if this period of postdoctoral NRSA support is the individual's initial twelve months of NRSA support (postdoctoral or predoctoral). When the Payback Agreement Form has been revised to reflect the requirements of the NIH Revitalization Act, copies will be distributed to all NRSA institutional training grant program directors and to all individual fellows. In addition, the availability of the revised form will be announced in the NIH Guide for Grants and Contracts. All unused copies of the 10/91 revision will be replaced by the new form under which all individuals beginning the first twelve months of postdoctoral NRSA support will incur an obligation even if this is their initial period of support under the NRSA program. o Postdoctoral trainees and fellows beginning appointments or fellowship awards for the 13th or subsequent month of NRSA support on or after June 10, 1993 are NOT required to complete the Payback Agreement Form (PHS 6031). SERVICE PAYBACK Trainees and fellows beginning appointments for the 13th and subsequent month of POSTDOCTORAL NRSA support on or after June 10, 1993 will be engaging in service which will satisfy any prior postdoctoral NRSA service payback obligation. Post-award service in non-NRSA supported health-related research or teaching, as described in the 1984 Guidelines, is creditable toward any NRSA service payback obligation. INQUIRIES Questions concerning the implementation of these policies may be directed to program staff at the NIH Institute or Center that awarded your training grant or fellowship. Questions concerning general information about this policy may be directed to: Research Training and Special Programs Office National Institutes of Health Building 31, Room 5B44 Bethesda, MD 20892 Telephone: (301) 496-9743 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** FINAL FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 22, Number 27, July 30, 1993 P.T. 34; K.W. 1014004 Public Health Service Notice is hereby given that The Public Health Service's Office of Research Integrity (ORI) has issued final findings of scientific misconduct and has implemented administrative actions in the following case: Torrey Johnson, Tufts University. An inquiry and a subsequent investigation conducted by the University found that Mr. Johnson, a predoctoral graduate student in the Department of Biology, had fabricated research data on the genetic control of spermatogenesis. Mr. Johnson worked on a grant from the National Institute of Child Health and Human Development (R01 HD 11878). The university investigation concluded that Mr. Johnson's reports that he had extracted, purified, and characterized a transcription factor protein were fabricated. Mr. Johnson's notebooks provided no details on the purification procedures and he was unable to describe to his thesis committee the steps used to purify the protein. The investigation also concluded that it was likely that Mr. Johnson had used commercially- obtained human transcription factor instead of the claimed purified protein from mouse testis. The ORI concurred in the University's findings, and Mr. Johnson has been debarred from receiving Federal grant or contract funds for a three year period beginning May 14, 1993. For two years beyond the debarment period, any research institution which employs Mr. Johnson must provide the Public Health Service (PHS) a plan for the oversight of his scientific activities and certify the accuracy and integrity of information provided in PHS applications or in reports generated under a PHS award. Two abstracts containing fabricated data were withdrawn ("Footprint analysis of the promoters of mouse and rat protamine 2 genes reveals differences in protein binding" XIth North American Testis Workshop, and "Protein binding to a conserved promoter element of the male germ cell specific mouse protamine 1 and 2 genes suppresses transcription in vitro in non- expressing tissues" J. Cell Biology Abstracts, 115: 48a, 1991). INQUIRIES The Office of Research Integrity will continue to publish findings of scientific misconduct as further cases are closed. For further information, contact: Director, Division of Research Investigations Office of Research Integrity Telephone: (301) 443-5330 $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN AI-93-016 FULL-TEXT ************************************** AID/NIAID PROGRAM: FUNDAMENTAL MALARIA VACCINE STUDIES NIH GUIDE, Volume 22, Number 27, July 30, 1993 RFA AVAILABLE: AI-93-016 P.T. 34; K.W. 0740075, 0715151 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: September 1, 1993 Application Receipt Date: November 10, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) announces a new collaborative effort with the United States Agency for International Development (AID), the Joint AID/NIAID Malaria Vaccine Program (AID/NIAID Program), and invites applications to expand basic and clinical research on those aspects of malaria most relevant to vaccine candidate identification, characterization, and development. The ultimate goal of this program is to develop vaccines that will reduce malaria-associated morbidity and mortality, especially in children in endemic areas. Studies of human immune responses to malaria, studies in relevant animal models, and studies of the cellular and molecular basis of immunity to malaria are all of interest under this initiative. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, AID/NIAID Program: Fundamental Malaria Vaccine Studies, is related to the priority area of immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Foreign institutions are not eligible to submit applications. MECHANISM OF SUPPORT Support for this program will be through the Cooperative Agreement (U01) funding instrument. These are interactive assistance relationships in which an ongoing collaborative relationship exists between NIAID staff and the investigators. This type of funding mechanism is utilized when it is desired to encourage investigator-initiated research projects in areas of special importance to the government and when substantial programmatic involvement by NIH staff is anticipated. The awardee will be responsible for the planning, direction and execution of the proposed project and interrelated activities. The award will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. The total project period for applications submitted in response to this RFA may not exceed three years. The earliest possible award date is September 1, 1994. Reissuance of this RFA is uncertain at the present time. If, by the end of the second year of the award, AID's continued support of the AID/NIAID Joint Program is unclear and NIAID has therefore not announced its intent to reissue the RFA, incumbents of U01s should contact program staff before preparing a recompeting application to seek advice on the most appropriate method of application submission. FUNDS AVAILABLE The estimated level of support (total direct and indirect costs) for the entire program for the first year is $800,000. The NIAID anticipates making four awards. RESEARCH OBJECTIVES It has been increasingly recognized that the scientific basis of vaccine development is extremely complex and requires sustained scientific support of, technical assistance to, and cooperation with investigators, from the earliest stages of vaccine discovery through the later phases of vaccine design, production, and testing. The need for investigators' awareness of and efficient access to current information and resources to accelerate vaccine development is now widely accepted. In particular, rapid dissemination of information and results from all stages of vaccine development among investigators is necessary to expedite vaccine development. In appreciation of these factors and in an effort to overcome those barriers impeding investigators' progress in this area, AID and NIAID have agreed to form a new cooperative program dedicated to malaria vaccine development. The objective of this RFA is to stimulate innovative new research that will provide information critical to determining the potential value of various antigens as components of malaria vaccines. All applications should be directly related to development of vaccines against P. falciparum (this may include studies of rodent models which make use of analogous plasmodial species). Basic research projects, including studies of clinical material, are sought that emphasize investigations of the following: o pre-erythrocytic antigens, excluding the circumsporozoite protein (CSP): studies of liver-stage antigens are particularly encouraged; o blood-stage antigens, excluding the merozoite surface antigen MSP-1/gp195 and cytoadherence antigens; o parasite antigens thought to participate in the pathogenesis of the severe manifestations of the disease, especially those that occur in children (for example, antigens thought to stimulate production of cytokines such as tumor necrosis factor). All applications must clearly describe how the information obtained from the proposed research will assist in achieving the goal of reducing malaria-associated mortality and morbidity, especially in children in endemic areas. SPECIAL REQUIREMENTS Successful applicants will be invited to participate in the AID/NIAID Joint Malaria Vaccine Program. Each Principal Investigator would represent his/her program at meetings organized conjointly by AID and NIAID that will be held to share advances in malaria vaccine research among the participants of the AID/NIAID Joint Program and other NIAID- and AID-supported activities, to discuss research needs and opportunities in malaria vaccine research, and to develop collaborations and multi-center studies. Principal Investigators should include funds to attend these meetings in their budget requests. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by September 1, 1993, a letter of intent that includes a descriptive title of the proposed research, the names and affiliations of proposed key investigators, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to Dr. Olivia Preble at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91), the standard application form for research grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. Applicants must adhere to the format and requirements specified in the PHS 398 application kit. The date for receipt of applications is November 10, 1993. The signed, typewritten original of the application, including the Checklist, and three exact single-sided copies must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies must be sent to Dr. Olivia Preble at the address listed under INQUIRIES. To ensure their review, applications must be received by both the Division of Research Grants and Dr. Olivia Preble by November 10, 1993. Applications not received on the official date will be considered non-responsive and will be returned to the applicant. If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications will be reviewed by DRG staff for completeness and by NIAID staff to determine administrative and programmatic responsiveness to this RFA. Those judged to be incomplete or non-responsive will be returned to the applicant without review. Those considered complete and responsive may be subjected to a triage review by an NIAID peer review group to determine their scientific merit relative to the other applications submitted in response to this RFA. The NIAID will withdraw from competition those applications judged by the triage peer review group to be noncompetitive for award and will so notify the applicant investigator and the institutional business official. Those applications judged to be competitive for award will be reviewed for scientific and technical merit by a Review Committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. AWARD CRITERIA In selecting applications for funding, while scientific merit is of primary consideration, applications will also be evaluated for program relevance and programmatic balance. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and requests for the RFA to: B. Fenton Hall, M.D., Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-36 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7115 FAX: (301) 402-0804 E-mail: bfh@exec.niaid.pc.niaid.nih.gov Address the letter of intent and direct any questions regarding review procedures, to: Dr. Olivia Preble Microbiology and Immunology Review Section National Institute of Allergy and Infectious Diseases Solar Building, Room 4C-20 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8208 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Mr. Todd Ball Grants Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-37 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7075 FAX: (301) 480-3780 Schedule Letter of Intent Receipt Date: September 1, 1993 Application Receipt Date: November 10, 1993 Scientific Review Date: March 1994 Council Meeting Date: June 1994 Earliest Award Date: September 1, 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856, Microbiology and Infectious Disease Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R1 END ************************************************************ $$R2 BEGIN CA-93-036 FULL-TEXT ************************************** VIRAL INTERACTIONS WITH p53 IN HUMAN CANCER NIH GUIDE, Volume 22, Number 27, July 30, 1993 RFA AVAILABLE: CA-93-036 P.T. 34; K.W. 0715035, 1002045, 1002008 National Cancer Institute Letter of Intent Receipt Date: September 15, 1993 Application Receipt Date: November 23, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE COMPLETE RFA FROM THE CONTACT NAMED UNDER INQUIRIES, BELOW. PURPOSE The National Cancer Institute (NCI) invites investigator-initiated research grant applications for support of basic studies on the molecular mechanisms by which DNA tumor viruses (such as papillomavirus, SV40, adenovirus) interact with p53, thereby providing new insight into viral oncology and human tumorigenesis. 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, Viral Interactions with p53 in Human Cancer, is related to the priority areas of cancer and women's health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit 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 and organizations are not eligible for the First Independent Research Support and Transition (FIRST) Awards (R29). Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01) and the FIRST Award (R29). Responsibility for the planning, direction and execution of the proposed project will be solely that of the applicant. The total project period for application submitted in response to this RFA may not exceed five years. The anticipated award date is July 1, 1994. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Approximately $1,000,000 in total costs per year for up to five years will be committed to fund applications which are submitted in response to this RFA. It is anticipated that five to six awards will be made. RESEARCH OBJECTIVES Cancer is a multi-step process that is usually preceded by the accumulation of mutations in an assortment of genes. Until recently, the tumorigenic mutations that have been studied in detail are those that activate oncogenes. The discovery of anti-oncogenes or tumor suppressor genes, by which inactivating mutations elicit tumorigenesis, has added a new dimension to the understanding of neoplasia. The retinoblastoma susceptibility gene (RB) is the prototype tumor suppressor gene and has been shown to suppress the transformed phenotype for several different cancers. The p53 gene is a growth control gene that plays a key role in the suppression of abnormal cell proliferation and tumor development. Mutations in the p53 gene are becoming the most common genetic alterations in many human cancers. Genetic abnormalities of p53, some of which may be due to viral involvement, are functionally implicated in the development of a wide variety of human cancers, including breast, cervix, bone, colon, liver and lung. Many of the viral oncoproteins from DNA tumor viruses such as human papillomaviruses, simian virus 40 (SV40) and adenoviruses, which transform cells in culture and induce tumors in animals, act in part through the functional inactivation of p53 tumor suppressor gene products resulting in uncontrolled cell growth. On December 18, 1992, the Biological Carcinogenesis Branch, Division of Cancer Etiology (DCE), NCI sponsored a workshop entitled "Viral Interactions with p53 in Human Cancer." The purpose of this workshop was to assess the current state of knowledge on the role of viral protein interactions with p53 in human cancer and to determine whether or not there are particular research areas that need stimulation in the form of grants. This RFA is issued in accordance with the workshop recommendation that extramural research be stimulated in this area with set-aside funds. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by September 15, 1993, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested in order to provide an indication of the number and scope of applications to be reviewed. It allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. May Wong at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NCI Program Director named below. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applications must be received by November 23, 1993. Applications received after that date will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this announcement 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 Those applications judged to be both competitive and responsive will be evaluated according to the review criteria stated below for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. A second level of review will be done by the National Cancer Advisory Board which considers the special needs of the NCI and the priorities of the National Cancer Program. 1. Extent to which the proposed research addresses the goals of the RFA. 2. The scientific merit, technical and medical significance of the proposed research, including the appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. Familiarity with the proposed techniques should be demonstrated, e.g., by the presentation of preliminary data. 3. The research experience, expertise and qualifications of the Principal Investigator and proposed staff and/or collaborators to perform the proposed experiments. 4. Documentation of the adequacy of the facilities and resources necessary to perform the research. 5. Appropriateness of the proposed budget and duration in relation to the proposed research. AWARD CRITERIA The earliest anticipated date of award is July 1, 1994. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not specific proposed research would be responsive are encouraged. The Program Director welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues, requests for the RFA, and address the letter of intent to: May Wong, Ph.D. Division of Cancer Etiology National Cancer Institute Executive Plaza North, Room 540 Bethesda, MD 20892 Telephone: (301) 496-1953 Direct inquiries regarding fiscal matters to: Mr. Joseph H. FitzGerald Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, Ext. 15 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.393, Cancer Cause and Prevention Research. Awards are made under the authorization of the Public Health Service (PHS) Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 U.S.C. 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R2 END ************************************************************ $$R3 BEGIN NASA/NIH-94-001 ****************************************** SPACELAB LIFE SCIENCES-4, NEUROLAB NIH GUIDE, Volume 22, Number 27, July 30, 1993 ANNOUNCEMENT OF OPPORTUNITY AVAILABLE: NASA/NIH-94-001 P.T. 34; K.W. 0785005, 0705010, 1002030 Canadian Space Agency Centre National d'Etudes Spatiales European Space Agency Headquarters German Space Agency National Institute of Neurological Disorders and Stroke National Science Foundation National Space Development Agency of Japan National Aeronautics and Space Administration National Institute on Aging National Institute on Deafness and Other Communication Disorders Office of Naval Research Letter of Intent Receipt Date: October 1, 1993 Application Receipt Date: December 1, 1993 THE ANNOUNCEMENT OF OPPORTUNITY DESCRIBED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE ANNOUNCEMENT FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The National Aeronautics and Space Administration (NASA), in collaboration with several domestic and international partners, announces the opportunity for participation in scientific investigations in the weightless environment of the Space Shuttle. This is a Notice of Availability of an Announcement of Opportunity that solicits life sciences investigations in the neuroscience disciplines to be conducted in the Space Shuttle laboratory, Spacelab. The specific instructions and regulations governing the application format, submission, review, and award are defined in the Announcement. The President of the United States declared January 1990 as the beginning of the "Decade of the Brain." This Spacelab mission, titled "Neurolab," has been established as part of NASA's activities in the "Decade of the Brain." The primary goal is to advance scientific knowledge about the brain and the nervous system and apply that knowledge to maximize human potential. The purpose of this announcement is to offer the neuroscience community the opportunity to propose distinct and innovative research that requires the unique environment of space flight. ELIGIBILITY REQUIREMENTS All institutions, foreign and domestic, including universities, industry, NASA Centers, and other government agencies are eligible to submit applications. Applications from minority (U.S.) and women investigators are encouraged. MECHANISM OF SUPPORT For NIH applications, the administrative and funding instrument to be used for this program will be a cooperative agreement (U01), an assistance mechanism in which substantial NIH and other Federal government scientific, technical and/or programmatic involvement with the awardee is anticipated during performance of the activity; details are provided in the Announcement. For other partners, applications will be supported through appropriate mechanisms as defined by each partner. During the pre-award definition phase, NASA will facilitate and support the investigators and investigator teams in developing integrated protocols that are scientifically optimal and that will maximize the use of resources to support the goals of each investigator. FUNDS AVAILABLE It is estimated that six to eight awards will be made by the NIH, at an estimated total cost of $ 1.6 million for the first year of support, depending on receipt of a sufficient number of applications of high scientific merit and subject to the availability funds for this purpose. RESEARCH OBJECTIVES The investigations to be funded in response to this solicitation will be conducted on the Spacelab Life Sciences-4 (SLS-4) Neurolab mission planned for the first quarter of 1998. This mission will be between two to three weeks in duration. The experiments on this mission will be conducted primarily in the Spacelab module with limited use of the Shuttle Middeck. The Spacelab module will be configured to provide the resources required to conduct the selected neuroscience investigations. Implementation of investigations on this mission is limited by the Spacelab/Shuttle environment, available facilities and hardware, animal housing facilities, and utilization of crewmembers as experimental subjects or operators. These constraints are further defined in the announcement. Applications submitted in response to this announcement must address scientific questions that are related to the neuroscience theme and require the conditions of space flight. These conditions include: (1) microgravity and a changing G load during launch, flight, and reentry; (2) increased radiation; (3) altered temporal cues; (4) isolation and confinement; and (5) physiological and psychological changes associated with space flight and exposure to the space craft environment. The unique research environment provided by the Space Shuttle must be a necessary aspect of the proposed investigations. Studies are being solicited in the following research areas: o Cell and Molecular Neurobiology o Developmental Neurobiology o Sensory and Motor Systems o Central Nervous System Homeostasis and Adaptation o Behavior, Cognition, and Performance A detailed description of solicited research areas is provided in the announcement. LETTER OF INTENT Those persons interested in responding to this announcement may submit a letter of intent no later than October 1, 1993. The letter of intent should contain the name, title, affiliation, mailing address, and telephone number of the Principal Investigator; name, title, affiliation, mailing address, and telephone number of the Co- Investigators; and a descriptive title of the research. All domestic applicants may submit a letter of intent to: Neurolab Program Scientist AO No. NASA/NIH-94-001 Life and Biomedical Sciences and Applications Division Code UL NASA Headquarters Washington, DC 20546 Foreign Investigators may submit a letter of intent to the Neurolab Program Scientist and also to: International Relations Division Code IRD AO No. NASA/NIH-94-001 NASA Headquarters Washington, DC 20546 U.S.A. The letter of intent is for information and planning purposes only and is not binding. APPLICATION PROCEDURES A series of preapplication meetings will be held to provide potential applicants information to assist them in submitting an application. Presentations about previous flight experiments and information concerning the submission, review, award, and implementation of applications will be provided at these meetings. NASA officials will be available to answer questions and discuss issues raised by researchers. Attendance is open to all potential applicants. Additional information may be obtained from the staff listed in INQUIRIES. The preapplication meetings will be held at the following places and dates: North America August 23, 1993 Northwestern University, Evanston, Illinois Address further questions concerning this meeting to: Dr. David Liskowsky 300 D Street, SW, Suite 801 Washington, DC 20024 Telephone: (202) 488-5130 FAX: (202) 479-2613 Asia Held on July 21-22, 1993 Europe Held on August 3, 1993 Applications submitted in response to the announcement must be prepared in accordance with the General Instructions and Provisions provided in the Application for Public Health Service Grants, form PHS 398 (rev. 9/91). (Note: the instructions for Career Development and National Service Awards included in PHS 398 do not apply to Neurolab.) Failure to follow these instructions may preclude consideration of the application. Copies of the PHS 398 may be obtained from most institutional offices of sponsored research and the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. REVIEW CONSIDERATIONS Applications received in response to the Announcement will be evaluated in accordance with NIH review policies. The scientific peer review of the applications will be managed by the Division of Research Grants, NIH. The purpose of the initial review is to assess the scientific and technical merit of the applications in the context of the Announcement. Applications will be further reviewed by NASA and its partners for implementation feasibly and mission accommodation requirements. Based on the peer review evaluations and NASA's assessment of feasibility and accommodation requirements, applications will be selected for further definition. A team of researchers in each research area will be defined and investigator teams will be formed. The investigator teams will be responsible for developing integrated protocols to accommodate the goals of each investigator. Each investigation will be organized and conducted by an investigator team, rather than an individual investigator with an individually defined protocol. Final confirmation of selection and award will follow the completion of the experiment definition and mission feasibility studies. The fundamental goal of the investigation solicitation process is to identify unique ideas and capabilities that best suit the overall science objectives of the mission. The following criteria will be used in evaluating applications submitted in response to this announcement: o Scientific, technical, and/or medical significance and originality of the proposed research; o Appropriateness and adequacy of the experimental approach and methodology to be used; o Requirement for the space environment; o Qualifications for the Principal Investigator and staff in the area of the research and the Principal Investigator's prior research experience and record; o Adequacy of the available facilities and hardware required to carry out the investigation; o Reasonableness and adequacy of justification for the proposed budget and duration of support in relation to the proposed research; o Adequacy of the proposed means for protecting against adverse effects upon humans, vertebrate animals, and/or the environment; and o When human subjects are involved, the adequacy of plans for supporting ground-based research to involve a study population representative of the crew, which usually includes both men and women; Applications determined to be nonresponsive or noncompetitive will not receive detailed review and the applicant Principal Investigator and Institutional Official will be informed. AWARD CRITERIA Selection will be made from highly meritorious applications (as determined by the scientific evaluation) based on the following criteria: o Relevance to mission goals and objectives o Programmatic interest of the awarding agency; o Distribution of science among research areas on mission and use of resources; o Engineering feasibility as determined by separate engineering review. Schedule Letter of Intent Receipt Date: Oct 1, 1993 Application Receipt Date: Dec 1, 1993 Initial Selection of Investigators & Investigator Teams: Jun 1994 Experiment Definition: Jul 94-Jan 95 Revised Team Proposal: Jan 1995 Agency Review: Feb 1995 Final Selection Date: Jun 1995 INQUIRIES Direct requests for the Announcement and additional information about the preapplication meetings to: Andrew Monjan, Ph.D., M.P.H. National Institute on Aging Gateway Building, Suite 3C307 7102 Wisconsin Boulevard Bethesda, MD 20892 Telephone: (301) 496-9350 FAX: (301) 496-1494 Daniel A. Sklare, Ph.D. National Institutes on Deafness and Other Communication Disorders Executive Plaza South, Room 400-B 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 402-3461 FAX: (301) 402-6251 William Heetderks, M.D., Ph.D. National Institute of Neurological Disorders and Stroke Federal Building, Room 916 Bethesda, MD 20892 Telephone: (301) 496-5745 Christopher Platt, Ph.D. National Science Foundation 1800 G Street, NW, Room 321 Washington, DC 20050 Telephone: (301) 357-7428 Joel L. Davis, Ph.D. Office of Naval Research 800 North Quincy Street Arlington, VA 22217-5660 Telephone: (703) 696-4744 Dr. Alan Mortimer Chief, Space Life Sciences Canadian Space Agency P.O. Box 7275 Station Ottawa, Ontario K1L8E2 CANADA Telephone: (613) 990-0801 Dr. Heinz Oser ESA Headquarters 8-10, rue Mario-Nikis F-75738 Paris Cedex 15 FRANCE Telephone: 33-14-273-7318 FAX: 33-14-273-7560 Dr. Antonio Guell CNES 18, Avenue Edouard-Belin 31055 Toulouse Cedex FRANCE Telephone: 33-61-28-2577 FAX: 33-61-28-2228 Dr. Shunji Nagaoka National Space Development Agency of Japan Tsukuba Space Center 2-1-1, Sengen Tsukuba, 305 JAPAN Telephone: 81-298-52-2773 FAX: 81-298-52-1597 Prof. Dr. Gunter Ruyters DARA (German Space Agency) Life Sciences Section (GN-WS3) Konigswinterer StraBe 522-524 P.O.Box 30 03 64 D-5300 Bonn 3 GERMANY Telephone: 49-228-447-214 FAX: 49-228-447-700 AUTHORITY AND REGULATIONS For NIH, this program is described in the Catalog of Federal Domestic Assistance No. 93.173. 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 (and 92 when applicable for state and local governments). This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R3 END ************************************************************ $$R4 BEGIN MH-93-006 FULL-TEXT ************************************** DIAGNOSTIC CENTERS FOR PSYCHIATRIC LINKAGE STUDIES NIH GUIDE, Volume 22, Number 27, July 30, 1993 RFA AVAILABLE: MH-93-006 P.T. 34; K.W. 0785185, 0745020, 0760015, 0715177, 0715180 National Institute of Mental Health Application Receipt Date: December 3, 1993 PURPOSE The National Institute of Mental Health (NIMH) wishes to solicit applications to use the resources and experience of investigators of the NIMH-funded "Diagnostic Centers for Psychiatric Linkage Studies" to complete the objectives set forth in the original request for applications (RFA) for this program (RFA: MH-89-05) and to support the research necessary to identify genes that influence susceptibility to Alzheimer's disease, bipolar disorder, and schizophrenia. The NIMH anticipates funding three centers for Alzheimer's disease, three centers for schizophrenia, and three centers for bipolar disorder in September 1994. 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, Diagnostic Centers for Psychiatric Linkage Studies, is related to the priority area of mental disorders in adults. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Only currently funded Diagnostic Centers for Psychiatric Linkage Studies are eligible to apply for up to three years of support. The nine currently active Diagnostic Centers for Psychiatric Linkage Studies are considered uniquely structured to undertake this study for several reasons: use of a common protocol for data collection that has included uniform assessments and extension rules permitting pooling of data across sites; ability to follow subjects longitudinally and track changes in diagnoses or compare diagnoses; and existing infrastructure, scope and aims, and multidisciplinary staffing. MECHANISM OF SUPPORT Awards will be made as cooperative agreements (U01). Substantial NIMH programmatic involvement with the recipient is anticipated during the performance of the planned activity. Prior to termination of this Cooperative Agreement, NIMH will evaluate long-term plans for resource sharing to be submitted by the Principal Investigators. FUNDS AVAILABLE The NIMH expects to support nine cooperative agreements funded during fiscal year 1994. It is expected that up to $175,000 in direct costs will be available for each cooperative agreement in fiscal year 1994. RESEARCH OBJECTIVES Background The role of genetic factors in the observed familial aggregation is well supported by twin and adoption studies in schizophrenia and bipolar disorder and in twin studies of Alzheimer's disease. However, attempts to fit genetic models to family data have yielded contradictory results. In 1987, NIMH began to develop a program to study the genetic basis of vulnerability to these three disorders. The NIMH initiated its "Diagnostic Centers for Psychiatric Linkage Studies" in fiscal year 1989. Three centers were selected to coordinate the assessment and collection of data from affected sibling pairs and family members with Alzheimer's disease, three centers for probands and family members with schizophrenia, and three centers for bipolar disorder, in addition to a fourth center for bipolar disorder at the NIMH Intramural Research Program. Concomitantly, NIMH established resource contracts for a National Cell Repository (Coriell Institute for Medical Research) in addition to a repository of clinical information, the Data Management Center (SRA, Inc.). Research Goals and Scopes This extension of the Diagnostic Centers for Psychiatric Linkage Studies project is intended to allow completion of the collection of pedigree data and blood for future genetic studies and for longitudinal follow-up of subjects enrolled in the study. SPECIAL REQUIREMENTS Terms and Conditions of Award Assistance via cooperative agreements differs from the individual research project grant in that substantial technical involvement by NIMH staff is anticipated during the performance of the project. It is the right and responsibility of the awardees to control and direct the development, conduct, and publication of their studies with the assistance of NIMH. Applicants must include in the application a plan for fulfilling the terms of cooperation with other awardees with NIMH assistance. Awardees will be responsible for the planning, direction, and execution of the proposed project and each applicant will be responsive to the requirements and conditions set forth in this Letter of Solicitation. Awardees will retain custody of and primary rights to all identifiable data under these awards, subject to NIMH rights of access and consistent with current HHS, PHS, and NIH policies. The data, cell lines, and DNA produced by this program constitute valuable resources that cannot readily be replicated by other investigators. Therefore, consistent with PHS policy relating to the distribution of unique research resources produced with PHS funding, the data and DNA repositories should not only serve the needs of this study, but they should be a resource to the larger scientific research community as well. Any disagreement that may arise in scientific or technical matters, not resolved by the normal deliberations of the Steering Committee, or a disagreement regarding scientific collaboration between award recipients and the NIMH staff coordinators may be brought to mediation. These Terms and Conditions of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Part 74, and other HHS, PHS, and NIH grant administration policies. Applicants must describe plans to accommodate these requirements, including involvement of Institute staff. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. Protection of Human Subjects The Department of Health and Human Services has regulations for the protection of human subjects and has developed additional regulations (45 CFR 46, Protection of Human Subjects) and those pertaining specifically to children are available from the Office of Protection from Research Risks, National Institute of Health, Bethesda, MD 20892, telephone 301/496-7041. Specific questions concerning protection of human subjects in research may be directed to NIMH staff members listed under INQUIRIES. Allowable Costs Applicants may request funds for salary, research costs, consultants, consortium/contractual costs, travel (including travel to Steering Committee meetings), alterations and renovations, patient costs, equipment, supplies, other allowable expenses, and appropriate indirect costs. Cooperative agreements are awarded directly to the applicant institution. Funds may be used only for those expenses clearly related to and necessary to carry out the project and must be expended in conformance with the Public Health Service Grants Policy Statement (rev. 10/90). APPLICATION PROCEDURES Applications are to be prepared on the form PHS 398 (rev. 9/91). These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The RFA label available in the PHS 398 (rev.9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. A completed original application and five copies must be sent to: Division of Research Grants National Institutes of Health Westbard Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS This is a one-time-only application process with a receipt date of December 3, 1993. Applications received after that date will be returned to the applicant's institutional organization without review. Scientific/technical merit review will take place in February or March 1994; National Advisory Mental Health Council review will be in May 1994, with a start date in September 1994. Applications submitted in response to this RFA will be reviewed in accordance with the usual NIH peer review procedures for research grant applications. Review for scientific and technical merit will be by an initial review group (IRG) convened by NIMH and composed primarily of non-Federal scientific experts, and by the National Advisory Mental Health Council. Review Criteria Applications will be judged on the review criteria stated in the RFA. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Potential applicants may seek additional information and consultation from the NIMH by contacting: Kate Berg, Ph.D., Chief Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18C-14 Rockville, MD 20857 Telephone: (301) 443-3524 Inquiries pertaining to grants management, may be directed to: Bruce L. Ringler, Chief Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-15 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3065 AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance 93.242, Mental Health Research Grants. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 as implemented through DHHS Regulations at 45 CFR Part 100. $$R4 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PAR-93-102 *********************************************** DEVELOPING AND IMPROVING INSTITUTIONAL ANIMAL RESOURCES NIH GUIDE, Volume 22, Number 27, July 30, 1993 PAR NUMBER: PAR-93-102 P.T. 34; K.W. 1002002, 1014003 National Center for Research Resources Application Receipt Date: October 1, 1993 PURPOSE The National Center for Research Resources (NCRR) encourages the submission of individual animal resource improvement grant applications from biomedical research institutions. Any domestic public or private institution, organization, or association is eligible to apply for this grant if the institution has one or more research projects supported by the Public Health Service (PHS) that involve the use of laboratory animals. The major objectives of this program are to upgrade animal facilities, develop administratively centralized programs of animal care, and enable institutions to comply with the USDA Animal Welfare Act and DHHS policies related to the care and use of laboratory animals. These awards require matching funds from the awardee institution. Support is limited to alterations and renovations (A&R) to improve laboratory animal facilities, and the purchase of major equipment items for animal resource, diagnostic laboratory, transgenic animal resources, or similar associated activities. ELIGIBILITY REQUIREMENTS Any domestic public or private institution, organization, or association is eligible to apply for this grant if it meets the above requirement. Institutions and commercial firms providing only services or products and without a clearly defined animal related research component are not eligible to apply. Also, this program will not support requests for equipment used for teaching purposes and for housing non-research animals. Applications from other Federal agencies or institutions (e.g., Department of Veterans Affairs) are limited to requests for equipment only. Applicants may not submit more than one application or apply for other NCRR support for developing and improving institutional animal resources in the same Federal fiscal year. For purposes of these guidelines, an "institution" is defined as the organizational component identified in item 14, form PHS 398 (rev. 9/91) page 1, for which descriptive information is provided on page 15 in the grant application form PHS 398 kit. Separate applications may be submitted from different colleges or schools on the same campus of a university within the same Federal fiscal year if they have different organizational component codes. If this is done, documentation from an appropriate institutional official, stating that the applications are part of a coordinated, campus-wide plan to improve the animal facilities, must be provided. The applicant institution is strongly encouraged to develop a single application for a campus-wide program with a single, centralized animal care program whenever possible or feasible. A separate grant program for animal facility improvement is available for research institutions receiving less than $1,500,000 (direct costs) of PHS support for research projects during the most recently completed Federal fiscal year. These institutions may, if they desire, compete for funding under either program, but not both in a single fiscal year. MECHANISM OF SUPPORT The mechanism available for the support of improvement projects is the Grant for Repair, Renovation, and Modernization of Existing Research Facilities (G20). Requests are limited to A&R to improve existing laboratory animal facilities, allowable fees associated with the A&R project, and major resource equipment related to the improvement project, such as animal cage systems and cage washers. Requests for new construction, including the completion of shell space, and equipment intended for teaching or non-research purposes are not allowable. Requests for basic general purpose equipment items for centralized surgeries, diagnostic laboratories, transgenic animal facilities, and other similar associated activities are allowable when well justified and integral to the proposed project. However, a single item of equipment or an aggregate of identical equipment items must have a total cost of at least $1,000. The total budget request for the improvement grant application and award is limited to $700,000 (direct costs), of which not more than $500,000 may be used for alterations and renovations. Matching funds from non-Federal sources are required, equal to or exceeding one-third of the total allowable costs (equipment and A&R) of the requested project ($2 Federal to $1 non-Federal). These matching funds must be applied to the specific project described in the application and cannot be met by citing other expenditures. Improvement grants are not intended to provide general operational support for the resource (e.g., funding for personnel, consumable supplies for routine animal care, or small equipment items) or to provide specialized research equipment or facilities for use by only a few investigators. Because the nature and scope of the proposed projects submitted in response to this announcement will vary, it is From owner-sci-resources@net.bio.net Thu Jul 29 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 27, pt. 2, 30 July 1993 Message-ID: Date: 30 Jul 93 01:14:21 GMT Sender: kristoff@net.bio.net Lines: 652 Approved: biosci-moderator@net.bio.net $$XID NIHGUIDE 19930730 V22N27 P2O2 ************************************ anticipated that the size of the awards will vary also. RESEARCH OBJECTIVES Animal resource improvement grants are awarded to assist biomedical research institutions in upgrading animal facilities and developing administratively centralized and uniformly effective programs of research animal care. Another major objective is to assist institutions in complying, and maintaining compliance, with provisions of the Animal Welfare Act and PHS policies related to the care and use of laboratory animals. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91). The single annual receipt date for these applications is October 1. Application forms may be obtained from the institutions office of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Applications received by this deadline will receive February/March initial peer review, May/June review by the National Advisory Research Resources Council, and will have an earliest possible award date of July 1. Applications received after the October 1 deadline will be returned to the applicant without review. Current guidelines for this program may be requested from the Laboratory Animal Sciences Program, CMP. These guidelines must be followed in detail. Applications not adhering to these guidelines will be considered non-responsive to this program and will be returned to the applicant without review. The completed original application (signed original including appendices, if any) and three copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892-4500** Simultaneously, two additional copies (with appendices, if any) must be sent under separate cover to: Scientific Review Administrator Comparative Medicine Review Committee National Center for Research Resources Westwood Building, Room 10A16 Bethesda, MD 20892-4500 REVIEW CONSIDERATIONS All applications will be reviewed for scientific and technical merit by an appropriate review committee managed by the Office of Review, NCRR. Second level review will be provided by the National Advisory Research Resources Council (NARRC). Review of the applications will be based on scientific merit, technical soundness, and cost effectiveness. Review criteria are listed in the supplemental program guidelines. AWARD CRITERIA Applications will compete with all other applications assigned to the Comparative Medicine Program, NCRR. An institution must have current PHS funding for research involving laboratory animals to be eligible for an award. The following will also be considered when making funding decisions: o Quality of the proposed project as determined by peer review o Institutional assurance of non-federal matching funds o Availability of funds INQUIRIES Inquiries about specific improvement program guidelines and detailed instructions for application are encouraged and may be directed to: Dr. Cynthia L. Pond Comparative Medicine Program National Center for Research Resources Westwood Building, Room 857 Bethesda, MD 20892 Telephone: (301) 594-7933 FAX: (301) 594-9149 Requests for guidelines must include two self-addressed mailing labels. Questions regarding fiscal matters may be directed to: Mr. Paul Karadbil Office of Grants and Contracts Management National Center for Research Resources Westwood Building, Room 849 Bethesda, MD 20892 Telephone: (301) 594-7955 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.306, Laboratory Animal Sciences and Primate Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78.410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 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. $$P1 END ************************************************************ $$XID RFA AI93016 AI-93-016 P1O1 *************************************** AID/NIAID PROGRAM: FUNDAMENTAL MALARIA VACCINE STUDIES NIH GUIDE, Volume 22, Number 27, July 30, 1993 RFA: AI-93-016 P.T. 34; K.W. 0740075, 0715151 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: September 1, 1993 Application Receipt Date: November 10, 1993 PURPOSE This initiative seeks to expand basic and clinical research on those aspects of malaria immunology and pathogenesis most relevant to vaccine candidate identification, characterization, and development. For many years both the United States Agency for International Development (AID) and the National Institute of Allergy and Infectious Diseases (NIAID) have independently supported fundamental studies of malaria immunology in recognition that such studies serve as the scientific foundation for malaria vaccine development efforts. This initiative, which focusses on basic research investigations on the role of malaria antigens in potential protection of individuals from malaria infection or disease, represents a new collaborative program between these two government agencies to foster accelerated development of effective malaria vaccines. Studies of human immune responses to malaria, studies in relevant animal models, and studies of the cellular and molecular basis of immunity are all of interest under this initiative. The ultimate goal of this program is to develop vaccines that will reduce malaria-associated morbidity and mortality, especially in children in endemic areas. 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), AID/NIAID Program: Fundamental Malaria Vaccine Studies, is related to the priority area of immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic 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. Foreign institutions are not eligible to submit applications. MECHANISM OF SUPPORT Support for this program will be through the Cooperative Agreement (U01), which is an interactive assistance relationship of ongoing collaboration between NIAID staff and the investigators. The nature of NIAID program involvement is further described under Terms of Award; Awardee Rights and Responsibilities; Nature of Participation of NIAID Staff. The awardee will be responsible for the planning, direction and execution of the proposed project and interrelated activities. The award will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. The total project period for applications submitted in response to this RFA may not exceed three years. The earliest possible award date is September 1, 1994. Reissuance of this RFA is uncertain at the present time. If, by the end of the second year of the award, AID's continued support of the AID/NIAID Joint Program is unclear and NIAID has therefore not announced its intent to reissue the RFA, incumbents of U01s should contact program staff before preparing a recompeting application to seek advice on the most appropriate method of application submission. FUNDS AVAILABLE The estimated level of support (total direct and indirect costs) for the entire program for the first year is $800,000. The NIAID anticipates making four awards. RESEARCH OBJECTIVES Background As recently described in the Institute of Medicine (IOM) Report, Malaria: Obstacles and Opportunities, the outlook for malaria control is grim. Today 2.1 billion persons worldwide are at risk, and an estimated 270 million are infected. Each year, there are more than 100 million clinical cases and one to two million deaths. The number of malaria cases worldwide is rising, most notably those due to Plasmodium falciparum, the parasite species responsible for the most dangerous form of the disease. As a result of the rapid emergence of drug resistance of Plasmodium spp. and the widespread insecticide resistance of mosquitoes responsible for transmitting the disease, there are now fewer tools to effectively control malaria than there were even 20 years ago. Since the current means to effectively control, prevent, and treat malaria are both inadequate and in jeopardy, the IOM Committee recommended "sustained support for research to identify mechanisms and targets of protective immunity and to exploit the use of novel scientific technologies to construct vaccines that induce immunity against all relevant stages of the parasite life cycle." AID has supported malaria research for over 25 years in recognition that such studies serve as the scientific foundation of vaccine development efforts, and the current AID Malaria Vaccine Development Program has a continuing interest in support of fundamental research on this topic. The ultimate goal of AID's Malaria Vaccine Program is to develop vaccines that will reduce malaria-associated morbidity and mortality, especially in children and pregnant women in less developed countries. Likewise, NIAID has a long history of supporting research efforts on malaria immunology and cell biology. AID and NIAID have thus long shared complementary interests in malaria research, especially in the areas of malaria immunology and vaccine development. In light of these shared interests, NIAID and AID have worked cooperatively in the past in efforts aimed at production and clinical evaluation of candidate vaccines. This initiative represents a new collaborative effort between the NIAID and AID's Malaria Vaccine Development Program. It has been increasingly recognized that the scientific basis of vaccine development is extremely complex and requires sustained scientific support of technical assistance to, and cooperation with, investigators from the earliest stages of vaccine discovery through the later phases of vaccine design, production, and testing. The need for investigators' awareness of, and efficient access to, current information and resources to accelerate vaccine development is now widely accepted. In particular, rapid dissemination of information and results from all stages of vaccine development among investigators is necessary to expedite vaccine development. In appreciation of these factors and in an effort to overcome those barriers impeding investigators' progress in this area, AID and NIAID have agreed to form a new cooperative program dedicated to malaria vaccine development. Scope of Research The objective of this RFA is to stimulate innovative new research that will provide information critical to determining the potential value of various antigens as components of malaria vaccines. All applications should be directly related to development of vaccines against P. falciparum (this may include studies of rodent models which make use of analogous plasmodial species). Basic research projects, including studies of clinical material, are sought that emphasize investigations of the following: o pre-erythrocytic antigens, excluding the circumsporozoite protein (CSP): studies of liver-stage antigens are particularly encouraged; o blood-stage antigens, excluding the merozoite surface antigen MSP-1/gp195 and cytoadherence antigens; o parasite antigens thought to participate in the pathogenesis of the severe manifestations of the disease, especially those manifestations that occur in children (for example, antigens thought to stimulate the production of cytokines such as tumor necrosis factor). All applications must clearly describe how the information obtained from the proposed research will assist in achieving the goal of reducing malaria-associated mortality and morbidity, especially in children in endemic areas: applications not related to the identification and characterization of potential components of a vaccine against P. falciparum will be considered non-responsive. SPECIAL REQUIREMENTS Awardee Rights and Responsibilities; Nature of Participation of NIAID Staff Successful applicants will be invited to participate in the AID/NIAID Joint Malaria Vaccine Program. Each Principal Investigator would represent his/her program at meetings organized jointly by AID and NIAID. These meetings, which are expected to take place annually in the Washington, DC area and to last no more than three days, will be held to share advances in malaria vaccine research among the participants of the AID/NIAID Joint Program and other NIAID- and AID-supported activities, to discuss research needs and opportunities in malaria vaccine research, and to develop collaborations and multi-center studies. Principal Investigators should include funds to attend these meetings in their budget requests. Under the Cooperative Agreement, a partnership relationship exists between the recipient of the award and the NIAID according to the terms and conditions stated below. Investigators are expected to define research objectives and methods in accord with their own interests and perceptions of novel and exploitable approaches to research that ultimately are likely to contribute to the accelerated discovery and development of malaria vaccines. Terms and Conditions It is the primary responsibility of each Principal Investigator to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies. The awardee will retain custody of and primary rights to data generated under this cooperative agreement. The Government, however, shall retain rights of access to such data. Accordingly, the NIAID Program Officer and the AID Malaria Vaccine Program Officer may periodically review and generate internal reports from data and progress reports developed under this cooperative agreement. Customary NIAID programmatic and stewardship responsibilities will be assumed by the NIAID Malaria Vaccine Program Officer. In addition, the NIAID anticipates substantial scientific and programmatic involvement during the performance of a Cooperative Agreement. Awardees will be offered the opportunity to participate in the full network of AID and NIAID Programs to support malaria vaccine development, including vaccine production and testing. The NIAID Program Officer will serve as a focal point for input from AID Staff concerning programmatic objectives and will work closely with the Joint Program investigators. The role of the NIAID Program Officer, however, will be to facilitate and not to direct the activities. During performance of this award, the NIAID Program Officer, in coordination with the AID Program Officer, may work with the AID/NIAID Joint Program Principal Investigators to provide appropriate assistance and advice concerning: o the design and planning of research activities; o selection of sources or resources, including provision of biological supplies (e.g., DNA constructs, genetically engineered or recombinant proteins), or reagent production facilities (e.g., cGMP facilities) available through NIAID or AID sources; o identification, selection, and provision of appropriate clinical testing facilities; o development of collaborative research efforts with principal investigators supported by other NIAID and AID programs; o coordination, collection and/or evaluation of data; o technical and management performance of AID/NIAID Joint Program activities; o preparation of publications. NIAID will support and enhance coordination among the components of the AID/NIAID Joint Program through: o facilitation of information exchange between AID/NIAID Joint Program PI's, other members of AID's Malaria Vaccine Development Program, and the NIAID's International Center for Tropical Diseases Research (ICTDR) network, which includes the International Collaborations in Infectious Diseases (ICIDR) and Tropical Medicine Research Centers (TMRC) located in endemic areas, and Tropical Disease Research Units (TDRU), as well as other investigators and agencies engaged in tropical disease research; o provision of new research reagents and technologies or of other important resources and information that may not otherwise be available to the individual AID/NIAID Joint Program Principal Investigators; In the event that research supported by the Cooperative Agreement results in development of a prophylactic, therapeutic, or other medical intervention, the NIAID will retain the option to cross-file or independently file an application for investigational clinical trial, i.e., an Investigational New Drug Application (INDA) to the United States Food and Drug Administration. Reports of data generated by the AID/NIAID Joint Program that are required for inclusion in the INDAs and for cross-filing purposes will be submitted in final draft form by the Principal Investigator to the NIAID Malaria Vaccine Program Officer upon request. Arbitration Panel It is anticipated that decisions in all activities outlined within this RFA will be reached by consensus of the Principal Investigators and that the NIAID Program Officer will be given the opportunity to offer input during this process. The manner of reaching this consensus and the final decision-making authority will rest with the Principal Investigator. If any difference of opinion arises, an arbitration panel, composed of one person designated by NIAID, one person designated by the Principal Investigator, and a third member selected by these two, will be established to review any scientific/programmatic issue that is significantly restricting progress. This arbitration process in no way affects the right of an award recipient to appeal post award administrative decisions in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Part 74, and other HHS, PHS, and NIH grant administration policy statements. NIH reserves the right to withhold funds if any of the terms of the award not be implemented. Applicants must describe plans to accommodate these stated program requirements, criteria and staff involvement. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For studies conducted overseas, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign research groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer review groups need adequate information about the composition of proposed study populations in all applications involving human subjects. To avoid delays in review of such applications, the NIAID advises that, as a minimum, the application should contain demographic data about clinic and/or in-patient population from which study subjects will be drawn: average hospital admissions per year; percentage distribution of Black/Hispanic/other minority/non-minority populations; gender; etc. Studies using non-hospital populations, such as community-based studies, should provide similar data about populations in the area or region from which the study subjects will be drawn. In the absence of current data, historical demographic information and/or previous recruitment data for similar studies from the proposed study sites should be provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by September 1, 1993, a letter of intent that includes a descriptive title of the proposed research, the names and affiliations of proposed key investigators, and the number and title of the RFA in response to which the application may be submitted. The letter of intent is requested in order to provide an indication of the number and scope of applications to be reviewed. This does not commit the sender to submit an application, nor is it a requirement for submission of an application. The letter of intent is to be sent to Dr. Olivia Preble at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91), the standard application form for research grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7428. Applicants must adhere to the format and requirements specified in the PHS 398 application kit. For purposes of identification and processing, mark "yes" in item 2a on the face page of the application and type in the RFA number AI-93-016 and the title "AID/NIAID Program: Fundamental Malaria Vaccine Studies." The RFA label available in the form PHS 398 must be affixed to the bottom of the face page of the original application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. The signed, typewritten original of the application, including the Checklist, and three exact single-sided copies must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies must be sent to Dr. Olivia Preble at the address listed under INQUIRIES. To ensure their review, applications must be received by both the Division of Research Grants and Dr. Olivia Preble by November 10, 1993. Applications not received on the receipt date will be considered non-responsive and will be returned to the applicant. If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Review Procedures Applications will be reviewed by DRG staff for completeness and by NIAID staff to determine administrative and programmatic responsiveness to this RFA. Those judged to be incomplete or non-responsive will be returned to the applicant without review. Those considered complete and responsive may be subjected to a triage review by an NIAID peer review group to determine their scientific merit relative to the other applications submitted in response to this RFA. This triage may be conducted before or during the initial review committee meeting. The NIAID will withdraw from competition those applications judged by the triage peer review group to be noncompetitive for award and will so notify the applicant investigator and the institutional business official. Those applications judged to be competitive for award will be reviewed for scientific and technical merit by a Review Committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria The factors to be considered in scientific review of the application are: 1. Scientific merit of research approach, design, and methodology as well as the potential scientific, technical, or medical significance of the proposed research. 2. Research experience and competence of the Principal Investigator(s) and other staff to conduct the proposed studies. 3. Adequacy of the time (effort) that the Principal Investigator(s) and staff would devote to the proposed studies. 4. Adequacy of facilities, including, if relevant to the proposed research, adequacy of the clinical facilities and patient availability for clinical studies. AWARD CRITERIA In selecting applications for funding, while scientific merit is of primary consideration, applications will also be evaluated for program relevance and program balance. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: B. Fenton Hall, M.D., Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-36 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7115 FAX: (301) 402-0804 E-mail: bfh@exec.niaid.pc.niaid.nih.gov Address the letter of intent and direct any questions regarding review procedures to: Olivia Preble, Ph.D. Microbiology and Immunology Review Section National Institute of Allergy and Infectious Diseases Solar Building, Room 4C-20 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8208 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Mr. Todd Ball Grants Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 4B-35 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7075 FAX: (301) 480-3780 Schedule Letter of Intent Receipt Date: September 1, 1993 Application Receipt Date: November 10, 1993 Scientific Review Date: March 1994 Council Meeting Date: June 1994 Earliest Award Date: September 1, 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856, Microbiology and Infectious Disease Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Thu Jul 29 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 27, pt. 3, 30 July 1993 Message-ID: Date: 30 Jul 93 01:15:41 GMT Sender: kristoff@net.bio.net Lines: 881 Approved: biosci-moderator@net.bio.net $$XID RFA CA93036 CA-93-036 P1O1 *************************************** VIRAL INTERACTIONS WITH p53 IN HUMAN CANCER NIH GUIDE, Volume 22, Number 27, July 30, 1993 RFA: CA-93-036 P.T. 34; K.W. 0715035, 1002045, 1002008 National Cancer Institute Letter of Intent Receipt Date: September 15, 1993 Application Receipt Date: November 23, 1993 PURPOSE The National Cancer Institute (NCI) invites investigator-initiated research grant applications for support of basic studies on the molecular mechanisms by which DNA tumor viruses (such as papillomavirus, SV40, adenovirus) interact with p53, thereby providing new insight into viral oncology and human tumorigenesis. 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), Viral Interactions with p53 in Human Cancer, is related to the priority areas of cancer and women's health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit 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 and organizations are not eligible for the First Independent Research Support and Transition (FIRST) Awards (R29). Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) research project grant (R01) and the FIRST Award (R29). Applicants will be responsible for the planning, direction, and execution of the proposed project. The total project period for applications submitted in response to this RFA may not exceed five years. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990, and 45 CFR Part 74 and Part 92, as applicable. The anticipated award date is July 1, 1994. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all other investigator-initiated research grant applications and be peer reviewed by a chartered study section in the Division of Research Grants (DRG), NIH. If the NCI determine that there is a sufficient continuing program need, a request for competing continuation applications will be announced. Only recipients of awards under this RFA will be eligible to apply. FUNDS AVAILABLE Approximately $1,000,000 in total costs per year for up to five years will be committed to fund applications that are submitted in response to this RFA. It is anticipated that five to six awards will be made. The level of funding is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Cancer is a multi-step process that is usually preceded by the accumulation of mutations in an assortment of genes. Until recently, the tumorigenic mutations that have been studied in detail are those that activate oncogenes. The discovery of anti-oncogenes or tumor suppressor genes, by which inactivating mutations elicit tumorigenesis, has added a new dimension to the understanding of neoplasia. The retinoblastoma susceptibility gene (RB) is the prototype tumor suppressor gene and has been shown to suppress the transformed phenotype for several different cancers. The p53 gene is a growth control gene that plays a key role in the suppression of abnormal cell proliferation and tumor development. Mutations in the p53 gene are becoming the most common genetic alterations in many human cancers. Genetic abnormalities of p53, some of which may be due to viral involvement, are functionally implicated in the development of a wide variety of human cancers, including breast, cervix, bone, colon, liver and lung. Many of the viral oncoproteins from DNA tumor viruses such as human papillomaviruses, simian virus 40 (SV40) and adenoviruses, which transform cells in culture and induce tumors in animals, act in part through the functional inactivation of p53 tumor suppressor gene products resulting in uncontrolled cell growth. On December 18, 1992, the Biological Carcinogenesis Branch, Division of Cancer Etiology (DCE), NCI sponsored a workshop entitled "Viral Interactions with p53 in Human Cancer." The purpose of this workshop was to assess the current state of knowledge on the role of viral protein interactions with p53 in human cancer and to determine whether or not there are particular research areas that need stimulation in the form of grants. This RFA is issued in accordance with the workshop recommendation that extramural research be stimulated in this area with set-aside funds. Research Goals and Scope The overall goal of this RFA is to stimulate research on the molecular mechanisms by which viral oncogenes from DNA tumor viruses and p53 interact, thereby providing new insight into human tumorigenesis. Examples of studies that may be supported under this RFA include, but are not limited to: (1) determination of the role of inactivation of p53 and other tumor suppressor genes in human papillomavirus-induced cervical cancer; (2) identification and characterization of viral mechanisms for overcoming apoptosis via p53; (3) determination of the host immune response to altered p53 and how DNA tumor viral proteins affect immune recognition of p53; (4) determination of the possible viral involvement in p53 mutations associated with human breast cancer; (5) identification and characterization of other viral or cellular proteins that physically complex with p53 and whose expression may be modulated by p53; (6) utilization of DNA viruses as probes to study the interacting pathways that are involved in regulating cell growth; and (7) study the function of p53 in inducing growth arrest in response to DNA damage. SPECIAL REQUIREMENTS The Principal Investigator is expected to spend a minimum of 20 percent time and effort on this project. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender, and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by September 15, 1993, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested in order to provide an indication of the number and scope of applications to be reviewed. It allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. May Wong at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/597-7248; and from the NCI Program Director named below. The RFA label available in the PHS 398 (rev.9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2a of the face page of the application form and the YES box must be marked. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact, clear and single-sided photocopies, in one package to: Division of Research grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, send two additional copies of the application to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 Applications must be received by November 23, 1993. Applications received after that date will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by DRG staff for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the RFA is an NCI program staff function. Applications will be judged to determine responsiveness to the goals and objectives of the RFA. Applications judged non-responsive will be returned to the applicant but may be submitted as investigator-initiated research grants at the next receipt date. Questions concerning the relevance of proposed research to the RFA may be directed to program staff listed under INQUIRIES. If the number of applications is large compared to the number of awards to be made, the NCI may conduct a preliminary scientific peer review to eliminate those applications that are clearly not competitive. The NCI will withdraw from further competition those applications judged to be noncompetitive and notify the applicant and institutional business official. Those applications judged to be both competitive and responsive will be further evaluated according to the review criteria stated below for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. 1. Extent to which the proposed research addresses the goals of the RFA. 2. The scientific merit, technical and medical significance of the proposed research, including the appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. Familiarity with the proposed techniques should be demonstrated, e.g., by the presentation of preliminary data. 3. The research experience, expertise, and qualifications of the Principal Investigator and proposed staff and/or collaborators to perform the proposed experiments. 4. Documentation of the adequacy of the facilities and resources necessary to perform the research. 5. Appropriateness of the proposed budget and duration in relation to the proposed research. The second level of review by the National Cancer Advisory Board considers the special needs of the NCI and the priorities of the National Cancer Program. AWARD CRITERIA The earliest anticipated date of award is July 1994. Factors, including the scientific and technical merit reflected in the priority score, availability of funds, and relevance to selected areas of programmatic emphasis, will be used to make award decisions. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not specific proposed research would be responsive are encouraged. The Program Director welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues and address the letter of intent to: May Wong, Ph.D. Division of Cancer Etiology National Cancer Institute Executive Plaza North, Room 540 Bethesda, MD 20892 Telephone: (301) 496-1953 Direct inquiries regarding fiscal matters to: Mr. Joseph H. FitzGerald Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, Ext. 15 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.393, Cancer Cause and Prevention Research. Awards are made under the authorization of the Public Health Service (PHS) Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 U.S.C. 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA MH93006 MH-93-006 P1O1 *************************************** DIAGNOSTIC CENTERS FOR PSYCHIATRIC LINKAGE STUDIES NIH GUIDE, Volume 22, Number 27, July 30, 1993 RFA: MH-93-006 P.T. 34; K.W. 0785185, 0745020, 0760015, 0715177, 0715180 National Institute of Mental Health Application Receipt Date: December 3, 1993 PURPOSE The National Institute of Mental Health (NIMH) wishes to solicit applications to use the resources and experience of investigators of the NIMH-funded "Diagnostic Centers for Psychiatric Linkage Studies" to complete the objectives set forth in the original request for applications (RFA) for this program (RFA: MH-89-05) and to support the research necessary to identify genes that influence susceptibility to Alzheimer's disease, bipolar disorder, and schizophrenia. The NIMH anticipates funding three centers for Alzheimer's disease, three centers for schizophrenia, and three centers for bipolar disorder in September 1994. 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, Diagnostic Centers for Psychiatric Linkage Studies, is related to the priority area of mental disorders in adults. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Only currently funded Alzheimer's disease, bipolar disorder, and schizophrenia Diagnostic Centers for Psychiatric Linkage Studies are eligible to apply for up to three years of support. The nine currently active Diagnostic Centers for Psychiatric Linkage Studies are considered uniquely structured to undertake this study for several reasons: use of a common protocol for data collection that has included uniform assessments and extension rules permitting pooling of data across sites; ability to follow subjects longitudinally and track changes in diagnoses or compare diagnoses; and existing infrastructure, scope and aims, and multidisciplinary staffing. MECHANISM OF SUPPORT Awards will be made as cooperative agreements (U01). In cooperative agreements, unlike individual research project grants, substantial NIMH programmatic involvement with the recipient is anticipated during the performance of the planned activity. Prior to termination of this Cooperative Agreement, NIMH will evaluate long-term plans for resource sharing to be submitted by the Principal Investigators. A determination of the mechanism for continued support of the resource contracts will be made no later than year 08. FUNDS AVAILABLE The NIMH expects to support nine cooperative agreements funded during fiscal year 1994. It is expected that up to $175,000 in direct costs will be available for each cooperative agreement in fiscal year 1994. RESEARCH OBJECTIVES Background The role of genetic factors in the observed familial aggregation is well supported by twin and adoption studies in schizophrenia and bipolar disorder and in twin studies of Alzheimer's disease. However, attempts to fit genetic models to family data have yielded contradictory results. In 1987, NIMH began to develop a program to study the genetic basis of vulnerability to these three disorders. The primary goals of the 1987 program were to: (1) develop a set of common protocols to assess subjects; (2) develop a comprehensive set of reliable and valid assessment instruments and adopt a common protocol and criteria for diagnosing subjects across centers; (3) design and implement an ascertainment plan for collection of a large number of families with each of the three disorders in order to have sufficient power to perform genetic analyses such as linkage studies under conditions of heterogeneity; and (4) provide the scientific community with a national resource of DNA contained in immortalized cell lines as well as diagnostic information on probands and their families. The NIMH initiated its "Diagnostic Centers for Psychiatric Linkage Studies" in fiscal year 1989. After rigorous peer review, three centers were selected to coordinate the assessment and collection of data from affected sibling pairs and family members with Alzheimer's disease, three centers for probands and family members with schizophrenia, and three centers for bipolar disorder, in addition to a fourth center for bipolar disorder at the NIMH Intramural Research Program. Concomitantly, NIMH established resource contracts for a National Cell Repository (Coriell Institute for Medical Research) in addition to a repository of clinical information, the Data Management Center (SRA, Inc.). In accord with the assistance aspects of a cooperative agreement, the Principal Investigators retain primary custody of all IDENTIFIABLE data collected, while anonymous information about family structure, age, sex, and diagnosis is sent to the Data Management Center to form part of a national resource. Since their primary function is the acquisition and storage of cells and data to be used as a national resource, the repositories were funded through separate contract mechanisms. Research Goals and Scopes This extension of the Diagnostic Centers for Psychiatric Linkage Studies project is intended to allow completion of the collection of pedigree data and blood for future genetic studies and for longitudinal follow-up of subjects enrolled in the study. The collaboration of experts from a wide range of scientific disciplines is necessary for this undertaking. SPECIAL REQUIREMENTS Terms and Conditions of Award Assistance via cooperative agreements differs from the individual research project grant in that substantial technical involvement by NIMH staff is anticipated during the performance of the project. It is the right and responsibility of the awardees to control and direct the development, conduct, and publication of their studies with the assistance of NIMH. Although awards will be based on the quality of the individual applications received, awardees must demonstrate the willingness to cooperate with each other, with NIMH assistance. The intent of the NIMH is to assist the awardees in the development of common data elements, procedures, and evaluation tools to maximize the capacity of individual awardees to contribute to a combined analysis across all awards. Applicants must include in the application a plan for fulfilling the terms of cooperation with other awardees with NIMH assistance. The nature of staff involvement is described below. Awardees will be responsible for the planning, direction, and execution of the proposed project. Specifically, each applicant will be responsive to the requirements and conditions set forth in this Letter of Solicitation. A. Responsibilities of Awardees 1. Shortly after the awards are made, the Principal Investigators and their key personnel will be required to cooperate with each other, with NIMH assistance, to continue developing common data elements, evaluation instruments, and procedures which will ensure quality control. It will be the responsibility of each Principal Investigator to attend Steering Committee meetings. Principal Investigators should include in their budgets three 2-day trips per year to NIMH for themselves and personnel they deem necessary. 2. Each awardee will continue to be responsible for maintaining a data management system that meets high standards of quality control. Each Principal Investigator will be responsible for supplying computerized data, in the previously agreed upon format, to the Data Management Center to enable analyses across projects. The comparative analyses will be joint efforts of the awardees and NIMH. 3. Each awardee will continue to be responsible for drawing and sending blood to the Cell Repository for DNA extraction and cell transformation to enable analyses across projects. 4. Publications will be a high priority. Publication of data findings and procedures by each awardee are encouraged. It is the responsibility of the investigators to provide copies of publications and major presentations to the NIMH Project Coordinator. Collaborative publications among awardees and NIMH are anticipated. NIMH staff will be included as coauthors if NIMH participation in the analysis warrants it. Publications policies developed by the Steering Committee will be followed. The quality of publications will be the responsibility of the authors. No NIMH clearances will be required except for NIMH staff who may serve as coauthors. B. Responsibilities of NIMH Staff NIMH Staff Role: The NIMH staff role in this cooperative agreement will extend beyond the level usually required for stewardship of a grant because of the need for coordination of study protocols among centers, technical assistance in the analysis of data, and monitoring and possible reassessment of project objectives as the study proceeds. 1. The Program Official has overall responsibility for monitoring the conduct, progress, and fiscal management of the program. Progress of the program will be reviewed by the Program Official annually at the time of each continuation application to assure that satisfactory progress is being made in achieving the objectives of the program and that each performance site is following the program goals and procedures recommended for use by all participants in the cooperative program and approved by the Steering Committee. The Program Official performs the usual stewardship functions. 2. The Project Coordinator will coordinate the work of the three disorder-based groups with each other and with the Data Management Center and the National Cell Repository and will be a voting member of the Steering Committee. The Scientific Coordinator will contribute assistance especially with regard to psychiatric research issues and will be a voting member of the Steering Committee from NIMH Staff. 3. One Staff Coordinator for each disorder-based group will continue to have input in their area of expertise as needed, in collaboration with award recipients, in both the planning and conduct of the study, but will not be a member of the Steering Committee. C. NIMH Intramural Participation The Neurogenetics Branch of the NIMH Intramural Research Program will also continue to participate as a co-equal site for bipolar disorder (not funded under this award) in addition to the nine extramural sites. As such, the Neurogenetics Branch functions in a manner analogous to the awardees rather than to NIMH staff and is subject to the same requirements (A1 through A4) as outlined above. D. Collaborative Responsibilities The Steering Committee will be the primary decision-making body of this collaborative multi-site study. Several NIMH staff will be members of the Steering Committee but cannot hold the position of chair. Membership will be composed of: the Principal Investigator from each site including the NIMH Intramural site (one vote per site), the NIMH Scientific Coordinator (one vote), and the NIMH Project Coordinator (one vote). All decisions will be made by majority vote with an attempt for consensus when possible. The Steering Committee will meet at least three times per year in the Washington, DC Metropolitan Area. Each disorder-based group will form a disorder-based subcommittee. No subcommittees will be chaired by NIMH staff. Additional subcommittees will continue (publications, administration, ethics) or be formed on an as-needed basis. NIMH will centralize management of non-identifiable data and storage of transformed cell lines and DNA using the contract mechanism described above. E. Data Rights Awardees will retain custody of and primary rights to all identifiable data under these awards, subject to NIMH rights of access and consistent with current HHS, PHS, and NIH policies. Availability of Unique Resources to the Broader Research Community: The data, cell lines, and DNA produced by this program constitute valuable resources. Because of the expense and expertise needed to produce them, these resources cannot readily be replicated by other investigators. Therefore, consistent with PHS policy relating to the distribution of unique research resources produced with PHS funding (NIH Guide: Volume 21, Number 33, September 11, 1992, pages 4-5), the data and DNA repositories should not only serve the needs of this study, but they should be a resource to the larger scientific research community as well. Thus, applicants must formulate a statement of their data-sharing and resource-sharing policy based on the above-cited PHS policy. Investigators must include within their application a description of their plans to assure compliance with this policy. This description should include, at a minimum, procedures to ensure timely access to qualified investigators. F. Arbitration Any disagreement that may arise in scientific or technical matters, not resolved by the normal deliberations of the Steering Committee, or a disagreement regarding scientific collaboration between award recipients and the NIMH staff coordinators may be brought to mediation. A mediation panel will be composed of three members: one selected by the individual awardee in the event of an individual disagreement, a second member selected by NIMH, and the third member selected by the two prior members. Decisions of this panel will be by majority vote. Failure to comply with decisions of the panel will be considered a material failure to comply with the terms and conditions of the grant award and may result in termination of support for the awardee by NIMH. This special mediation procedure in no way affects either the Government's right to bring an adverse action or the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, subpart D and HHS, Grant Administration Regulations at 45 CFR Part 74, and HHS regulations at 45 CFR Part 16. Special Requirements: Terms and Conditions of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Part 74, and other HHS, PHS, and NIH grant administration policies. Applicants must describe plans to accommodate these requirements, including involvement of Institute staff. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. Protection of Human Subjects The Department of Health and Human Services has regulations for the protection of human subjects and has developed additional regulations (45 CFR 46, Protection of Human Subjects) and those pertaining specifically to children are available from the Office of Protection from Research Risks, National Institute of Health, Bethesda, MD 20892, telephone 301/496-7041. Specific questions concerning protection of human subjects in research may be directed to NIMH staff members listed under INQUIRIES. Allowable Costs Applicants may request funds for salary, research costs, consultants, consortium/contractual costs, travel (including travel to Steering Committee meetings), alterations and renovations, patient costs, equipment, supplies, other allowable expenses, and appropriate indirect costs. Cooperative agreements are awarded directly to the applicant institution. Funds may be used only for those expenses clearly related to and necessary to carry out the project and must be expended in conformance with the Public Health Service Grants Policy Statement (rev. 10/90). APPLICATION PROCEDURES Applications are to be prepared on the form PHS 398 (rev. 9/91). The PHS 398 application form is available at most institutional offices of sponsored research; from the Grants Management Branch, National Institute of Mental Health, 5600 Fishers Lane, Room 7C-05, Rockville, MD 20857, telephone 301/443-4414; and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301 594-7248. On line 2a of the application face page, applicants must enter the number of the Letter of Solicitation as MH-93-006; for 2b, the title, "Diagnostic Centers for Psychiatric Linkage Studies." The RFA label (found in the 10/88 revision of application form PHS 398) must be affixed to the bottom of the face page of the original copy of the application. Failure to use this label could result in delayed processing of your application such that it will not reach the review committee in time for review. A completed original application and five copies must be sent to: Division of Research Grants National Institutes of Health Westbard Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS This is a one-time-only application process with a receipt date of December 3, 1993. Applications received after that date will be returned to the applicant's institutional organization without review. Scientific/technical merit review will take place in February or March 1994; National Advisory Mental Health Council review will be in May 1994, with a start date in September 1994. Applications submitted in response to this RFA will be reviewed in accordance with the usual NIH peer review procedures for research grant applications. Review for scientific and technical merit will be by an initial review group (IRG) convened by NIMH and composed primarily of non-Federal scientific experts, and by the National Advisory Mental Health Council. Review Criteria Applications will be judged on: o Evidence of familiarity with and understanding of relevant research literature o Evidence of significant progress in the first five years of data collection o Quality of the project design and methodology o Demonstrated scientific and technical capability, experience, and level of commitment of the Principal Investigator and proposed research staff o Availability of research expertise in the area of assessment, molecular biology, and genetic epidemiology o Adequacy of facilities, general environment, core resources, and collaborative relationships for the development and implementation of the proposed research o Evidence of the institution's research and administrative support commitment o Adequacy of the plan to protect research participants o Adequacy of plans to implement the Special Requirements: Terms and Conditions of Award section including provisions for the involvement of Institute Staff o Adequacy of the plans for the inclusion of females and minorities o Appropriateness of budget requested AWARD CRITERIA In making awards, the following criteria will be used for applications that have been recommended for approval, provided the applicant has complied with all legislative, regulatory, and policy requirements of the Public Health Service: o Quality of application as documented by IRG and Council reviews o Availability of NIMH funding INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. the opportunity to clarify any issues or questions from potential applicants is welcome. Potential applicants may seek additional information and consultation from the NIMH by contacting: Kate Berg, Ph.D., Chief Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18C-14 Rockville, MD 20857 Telephone: (301) 443-3524 Inquiries pertaining to grants management, may be directed to: Bruce L. Ringler, Chief Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-15 Rockville, MD 20857 Telephone: (301) 443-3065 AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance 93.242, Mental Health Research Grants. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 as implemented through DHHS Regulations at 45 CFR Part 100. From owner-sci-resources@net.bio.net Fri Jul 30 23:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 30 July 1993 Message-ID: Date: 31 Jul 93 14:28:45 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 108 Approved: sci-resources-moderator@net.bio.net ** NEW DOCUMENTS ON STIS ** Document Type: Antarctic EAM Title: Damage to McMurdo ice pier File size (bytes): 6109 STIS Filename: opp93105 Document Type: Letter Title: NSF 93-110 Proposals Related to Comet Shoemaker-Levy-9 / Jupiter Impact File size (bytes): 4489 STIS Filename: nsf93110 Document Type: Program Guideline Title: NSF 93-106 MATERIALS RESEARCH SCIENCE AND ENGINEERING CENTERS File size (bytes): 33085 STIS Filename: nsf93106 Title: NSF 93-93, NSF Earth Sciences Postdoctoral Research Fellowships-Program Announcement and Guidelines File size (bytes): 28712 STIS Filename: nsf9393 Document Type: Recruit Title: Clerical and Administrative Support Positions File size (bytes): 4118 STIS Filename: vgs9373 Document Type: Report Title: NSF 93-75, Knowledge Dissemination and use in Science and mathematics education- A Literature Review File size (bytes): 95114 STIS Filename: nsf9375 Document Type: SRS Data Brief Title: DB 93-310 U.S. Industry R&D Expenditures Declined in 1991 File size (bytes): 6215 STIS Filename: db93310 Also available: db93310.doc ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Antarctic EAM Title: USAP environmental documents list File size (bytes): 13152 STIS Filename: opp93000 Document Type: Phone Book Title: NSF Alphabetical Listing File size (bytes): 91191 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 95623 STIS Filename: phnorg ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet) or stisinfo@NSF (BITNET). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserv@nsf.gov (Internet) or stisserv@NSF (BITNET). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg, the text of your message should be as follows: get phnorg Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg, you would enter: ftp> get phnorg WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet) or "firstop@nsf" (BITNET). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet) or "stis@NSF" (BITNET).