From owner-sci-resources@net.bio.net Sun May 02 23:00:00 1993 Path: biosci!agate!usenet.ins.cwru.edu!cleveland.Freenet.Edu!da650 From: da650@cleveland.Freenet.Edu (Keri L. Karnbad) Newsgroups: bionet.sci-resources Subject: reasearch Message-ID: <1s3n80$qfg@usenet.INS.CWRU.Edu> Date: 3 May 93 18:11:12 GMT Organization: Case Western Reserve University, Cleveland, Ohio (USA) Lines: 7 NNTP-Posting-Host: hela.ins.cwru.edu Hello my name is Keri Karnbad, and I am a student at Stockton College in NJ. I am am doing a project for a computer class and I need all the if[D sorry informatiot ioon I can on Biology and or Genetics. I need FTP sights, listservs, or any otheh er places to find information in this area. I am sorry this is so sloppy, this is my first message. my address is STK1694@vax003.stockton.edu From owner-sci-resources@net.bio.net Sun May 02 23:00:00 1993 Path: biosci!agate!howland.reston.ans.net!zaphod.mps.ohio-state.edu!malgudi.oar.net!zeus.franklin.edu!blair From: blair@zeus.franklin.edu (John Blair) Newsgroups: bionet.sci-resources Subject: ftp sites Message-ID: <1993May3.190113.17751@zeus.franklin.edu> Date: 3 May 93 19:01:13 GMT Organization: Franklin University Lines: 27 I need to find an ftp site or sites where I can find a software graphics package to allow the interactive placement of dots and lines for my senior project in computer science (chaotic systems and iterative function theory. I would also like to find any source code I can for graphically generating chaotic and fractal images. All I've found so far is a BASIC program which produces the Mandlebrot set but I'm unable to print out or zoom in on the graph produced. My primary interest is in the equations used in atmospheric modeling. I would appreciate any help anyone can provide me. Please e-mail your replies as I'm posting to several groups I don't subscribe too. Thank you in advance jb address: blair@zeus.franklin.edu From owner-sci-resources@net.bio.net Mon May 03 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 - 2 May 1993 Message-ID: Date: 4 May 93 05:04:15 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 134 ** NEW DOCUMENTS ON STIS ** Document Type: EPS Title: NSF Electronic Proposal Submission Project - Frequently Asked Questions File size (bytes): 1396 STIS Filename: epsfaq Document Type: Letter Title: Research in All-Optical Network and Communications File size (bytes): 6433 STIS Filename: lcise930 Title: Research in All-Optical Network and Communications File size (bytes): 6432 STIS Filename: leng9301 Title: Program Announcement-Human Brain Project File size (bytes): 38085 STIS Filename: lmps9301 Document Type: Program Guideline Title: NSF 93-46 - EHR Activities in Science, Engineering, and Mathematics for Persons with Disabilities File size (bytes): 77718 STIS Filename: nsf9346 Title: The US Tropical Ocean Global Atmosphere Program Coupled Ocean-Atmoshpere response Experiment (NSF 93-57) File size (bytes): 10966 STIS Filename: nsf9357 Title: Management of Technological Innovation 1993 Focus on Management of Innovation for Environmentally Conscious Manufacturing File size (bytes): 17344 STIS Filename: nsf9363 Document Type: Recruit Title: Assistant Inspector General for Audit File size (bytes): 6437 STIS Filename: vep9305 Title: Decision Science Administrator (Program Director) File size (bytes): 4514 STIS Filename: vex9317 Title: Physicist (Program Director) File size (bytes): 3499 STIS Filename: vex9318 Document Type: Report Title: OIG Review of NSFNET File size (bytes): 177211 STIS Filename: oig9301 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alphabetical Listing File size (bytes): 90518 STIS Filename: phnalpha Title: NSF Alphabetical Listing File size (bytes): 90518 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 95397 STIS Filename: phnorg Title: NSF Organizational Directory File size (bytes): 95397 STIS Filename: phnorg Document Type: Program Guideline Title: NSF 93-40 -- Young Scholars File size (bytes): 65991 STIS Filename: nsf9340 Title: NSF 93-54 - Research Fellowship in Marine Biotechnology and the Ocean Sciences File size (bytes): 19000 STIS Filename: nsf9345 ------------------------------------------------------------------------ ** 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 nsf9345, the text of your message should be as follows: get nsf9345 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9345, you would enter: ftp> get nsf9345 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 Thu May 06 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. 18, pt. 1, 7 May 1993 Message-ID: Date: 7 May 93 18:11:21 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1506 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. ---------------------------------------------------------------------- $$XID NIHGUIDE 19930507 V22N18 P1O2 ************************************ X-comment: RFAS described: CA-93-021, DK-93-023, CA-93-025, CA-93-026, NR-93- 005, DK-93-007, DK-93-008 NIH GUIDE - Vol. 22, No. 18 - May 7, 1993 $$INDEX BEGIN ******************************************************* NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** NATIONAL CENTER FOR THE ADVANCEMENT OF PREVENTION (RFP 277-93-1013) Center for Substance Abuse Prevention INDEX: SUBSTANCE ABUSE PREVENTION $$INDEX R2 08/12/93 ************************************************* PREVENTION CLINICAL TRIALS UTILIZING INTERMEDIATE ENDPOINTS AND THEIR MODULATION BY CHEMOPREVENTIVE AGENTS (RFA CA-93-021) National Cancer Institute INDEX: CANCER $$INDEX R3 08/20/93 ************************************************* INTERVENTIONS IN DIABETES AMONG MINORITY POPULATIONS (RFA DK-93-023) National Institute of Diabetes and Digestive and Kidney Diseases National Center for Nursing Research INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES; NURSING RESEARCH $$INDEX R4 08/24/93 ************************************************* COMMUNITY CLINICAL ONCOLOGY PROGRAM (RFA CA-93-025) National Cancer Institute INDEX: CANCER $$INDEX R5 08/24/93 ************************************************* MINORITY-BASED COMMUNITY CLINICAL ONCOLOGY PROGRAM (RFA CA-93-026) National Cancer Institute INDEX: CANCER $$INDEX R6 09/22/93 ************************************************* SMALL GRANTS PROGRAM FOR NURSING AND BIOLOGY INTERFACE (RFA NR-93-005) National Center for Nursing Research INDEX: NURSING RESEARCH $$INDEX R7 10/19/93 ************************************************* NON-INSULIN DEPENDENT DIABETES PRIMARY PREVENTION TRIAL (RFA DK-93-007) National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Child Health and Human Development Office of Research on Minority Health INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT; MINORITY HEALTH $$INDEX R8 10/19/98 ************************************************* NIDDM PRIMARY PREVENTION TRIAL: DATA COORDINATING CENTER (RFA DK-93-008) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES This publication is also available electronically to institutions via BITNET or INTERNET. 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, or send an E-mail message to ZNS@NIHCU. $$INDEX END ********************************************************* NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN 277-93-1013 ********************************************** NATIONAL CENTER FOR THE ADVANCEMENT OF PREVENTION NIH Guide, Volume 22, Number 18, May 7, 1993 RFP AVAILABLE: 277-93-1013 P.T. 34; K.W. 0404009, 0745027 Center for Substance Abuse Prevention The Center for Substance Abuse Prevention (CSAP) proposes to award a three year cost-reimbursement, level-of-effort type contract to establish a National Center for the Advancement of Prevention, which will assist CSAP in achieving its mission by developing and providing knowledge synthesis and transfer mechanisms, providing proactive technical assistance to States and through the States to the field, and by developing and providing state-of-the-art evaluation methodologies and tools. The Center is expected to be composed of a core, which would handle coordination and administrative responsibilities, and three components, one for each of the areas previously stated. The Center will require a group of highly skilled experts in the areas of substance abuse prevention services, evaluation and research, cost/benefit analysis, needs assessment, instrument development, statistics, computer programming, database and communications systems, other social sciences and training. These experts will support CSAP's mission by providing state-of-the-art knowledge to enhance the effectiveness of substance abuse prevention programs in the State and in communities. Additionally, three options are proposed within the contract. Option I concerns expanding and elaborating effective prevention strategy models, guidelines, and protocols. Option II concerns the development of a prototype for a possible regional system for dissemination, technical assistance, and training and Option III concerns performing developmental work for the future national prevention database and potential community based surveillance systems to monitor alcohol and other drug abuse incidence, prevalence, and related sequelae. It is estimated that 36 months will be required for this project. However, two separate one-year extension options are also included. INQUIRIES This is an announcement for an anticipated Request For Proposal (RFP). RFP No. 277-93-1013 will be available approximately May 14, 1993, with a closing date tentatively set for June 17, 1993. Requests for the RFP along with two self-addressed labels must be submitted in writing to: Catherine Kellington Contract Management Branch Center for Substance Abuse Prevention 5600 Fishers Lane Rockwall II Building, Room 670 Rockville, MD 20857 $$R1 END ************************************************************ $$R2 BEGIN CA-93-021 FULL-TEXT ************************************** PREVENTION CLINICAL TRIALS UTILIZING INTERMEDIATE ENDPOINTS AND THEIR MODULATION BY CHEMOPREVENTIVE AGENTS NIH Guide, Volume 22, Number 18, May 7, 1993 RFA AVAILABLE: CA-93-021 P.T. 34; K.W. 0715035, 0755015, 0710095, 0740018 National Cancer Institute Letter of Intent Receipt Date: May 28, 1993 Application Receipt Date: August 12, 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 Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites applications for cooperative agreements to support clinical trials that are directed toward examining the role of various chemopreventive agents and/or diet in the prevention of cancer. This is a follow-up to earlier RFAs which had requested grants, and then later cooperative agreement proposals in this area. 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, Prevention Clinical Trials Utilizing Intermediate Endpoints and Their Modulation by Chemopreventive Agents, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00476-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Applicants funded under this RFA will be supported through the cooperative agreement (U10) mechanism for which substantial NIH programmatic staff involvement is expected. An assistance relationship will exist between NCI and the awardees to accomplish the purpose of the activity. The recipients will have primary responsibility for the development and performance of the activity. However, there will be government involvement with regard to (1) assistance securing an Investigational New Drug (IND) approval from the Food and Drug Administration (FDA), (2) monitoring of safety and toxicity and, (3) coordination and assistance in obtaining the chemopreventive agent, (4) quality assurance with regard to the clinical chemistry aspects of the study. Responsibility for planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed five years. This RFA will be issued annually for three years. Future unsolicited continuation applications will compete with all other investigator-initiated applications and be reviewed by a study section in the Division of Research Grants. However, if the NCI determines that there is sufficient continuing program need, NCI may invite all funded recipients to submit competing continuation applications. Competing continuation applications will not compete with new applications for funding. FUNDS AVAILABLE Approximately $1.5 million in total costs for the first year will be committed to fund applications submitted in response to this RFA. The project period may not exceed five years. It is anticipated that three to five awards will be funded. This level of support is dependent on the receipt of sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, awards pursuant to this RFA are also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The major objective of this solicitation is to encourage cancer chemoprevention clinical trials that utilize biochemical and/or biological markers to identify populations at risk and/or to provide intermediate endpoints that may predict later reduction in cancer incidence rates. These studies may be developed in phases, including a pilot phase, which could later proceed to a full scale intervention. The main emphasis should be on small, efficient studies aimed at improving future research designs of chemoprevention trials, providing biologic understanding of what is happening in the trials, or providing better, more quantitative and more efficient endpoints for these trials. After successful completion of the pilot phase (i.e., demonstrated modulation of marker endpoints by the intervention), subsequent studies could include a definitive clinical trial monitoring the test system, a cancer incidence or mortality endpoint, and a designated agent. Investigators may apply at this time for the pilot phase, or submit an application for both the pilot and definitive trial studies. However, if the application is for the pilot phase only, the proposed study must describe its relevance to a clinical application and utilize a chemopreventive agent, marker test system, and study population that could later be the subject of a full scale, double-blind, randomized, risk reduction clinical trial. Intermediate marker trials of breast cancer chemoprevention are especially encouraged. STUDY POPULATION SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants 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 May 28, 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 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. Marjorie Perloff at the address listed under INQUIRIES. APPLICATION PROCEDURES The receipt date for applications is August 12, 1993. The research grant application form PHS 398 (rev - 9/91) is to be used in applying for these cooperative agreements. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, 5333, Room 449 Bethesda, MD 20892, telephone 301/594-7248; and from the NCI Program Director named below. 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 title of the application, "Prevention Clinical Trials Utilizing Intermediate Endpoints and Their Modulation by Chemopreventive Agents", and the RFA number, CA-93-021, must be typed in block 2a of the face page of the application form. 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, two additional copies of the application must also be sent to: Ms. Toby Friedberg, Referral Officer Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 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. Applications will be judged to determine if they meet the goals and objectives of the program as described in the RFA. Applications that are judged non-responsive will be returned, but may be submitted as investigator initiated grants at the next receipt date. Those applications judged to be both competitive and responsive will be further evaluated, using the review criteria shown 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 considers the special needs of the Institute and the priorities of the National Cancer Program. 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: Marjorie Perloff, M.D. Chemoprevention Branch National Cancer Institute Executive Plaza North, Suite 201 Bethesda, MD 20892 Telephone: (301) 496-8563 Direct inquiries regarding fiscal matters to: Ms. Eileen Natoli Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-7800 Ext. 56 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.399, Cancer Control.Awards will be made under the authority of the Public Health Service Act, Title IV, Section 301 (Public Law 78-410,; 42 U.S.C. 241, and Section 412, as amended by Public Law 99-158, 42 U.S.C. 258a-1); and administered under PHS grant policies and Federal regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R2 END ************************************************************ $$R3 BEGIN DK-93-023 FULL-TEXT ************************************** INTERVENTIONS IN DIABETES AMONG MINORITY POPULATIONS NIH Guide, Volume 22, Number 18, May 7, 1993 RFA AVAILABLE: DK-93-023 P.T. 34, FF; K.W. 0715075, 0785035, 0745027 National Institute of Diabetes and Digestive and Kidney Diseases National Center for Nursing Research Letter of Intent Receipt Date: July 20, 1993 Application Receipt Date: August 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 This RFA invites new and experienced investigators to submit clinical research applications designed to develop and validate intervention approaches for the amelioration or prevention of diabetes mellitus and/or its complications among minority populations, including African, Asian, and Hispanic Americans, Native Hawaiians, and Pacific Islanders. This RFA is a follow-up to the RFA DK-91-09 "Research Planning Grant: Diabetes in Minority Populations." However, respondents to this RFA are not restricted to those having previously received a planning grant under the prior RFA. Applications are encouraged from any interested investigators regardless of their prior record of grant support. Although this RFA is designed to develop and validate interventions for preventing diabetes mellitus and/or its complications, the National Institute of Diabetes and Digestive Kidney Diseases is announcing another RFA (DK-93-007) specifically for clinical centers to design and implement a full-scale, multi-center clinical trial to evaluate the efficacy of interventions designed to delay or prevent onset of non- insulin dependent diabetes mellitus in individuals at increased risk for the disease. The present RFA focuses on the specific minority populations as indicated above. An earlier RFA (DK-92- 17) was designed for studies with Native Americans and Alaskan Natives. While studies involving these populations are not responsive to the present RFA, investigators interested in working with these groups are advised to submit applications through the normal NIH investigator-initiated review process. The NIDDK and the National Center for Nursing Research seek to encourage research on all minority populations. 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, Intervention Studies in Diabetes Among Minority Populations, is specifically targeted at diabetes mellitus and its complications as a major public health problem. 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 non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments and eligible agencies of the Federal government. Teams of applicants are encouraged which could include universities, public health departments, voluntary organizations, and health clinics. Among a team of applicants, one institution must be proposed as the lead organization to serve as the Grantee Institution and assume responsibility for the fiscal and programmatic conduct of the project. Other members of the team should be proposed based on individual consortium agreements (subcontracts) with those organizations. The grantee organization and any proposed consortium must have the staff and facilities required for the proposed program. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support of this program will be through the NIH research project grant (R01) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The total requested project period for applications submitted in response to this RFA may not exceed five years. A maximum of three years can be requested for foreign awards. The earliest possible award date will be April 1, 1994. Applicants must limit their request to not more than $160,000 direct costs for the initial budget period. The average size of a grant is expected to be approximately $190,000 total costs. FUNDS AVAILABLE For fiscal year 1994, $2.2 million will be committed to fund applications submitted in response to this RFA. The NIDDK and the NCNR plan to support approximately 10 to 12 applications submitted in response to this solicitation. However, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIDDK and the NCNR, the award of grants pursuant to this RFA is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Diabetes mellitus and its complications are major public health problems in the United States today. The National Institutes of Health has encouraged research into the cause, cure and prevention of diabetes and its related endocrine and metabolic disorders. The overall objective of this RFA is to stimulate original and innovative studies directed at the elucidation of practical methods for the reduction of the public health burden of diabetes in African, Asian and Hispanic Americans, Pacific Islanders, and Native Hawaiians. Examples of research topics relevant to this solicitation are listed below, they should not be construed as required or limiting. Responsive applications to this RFA include: o Development and validation of efficacious strategies for changing health behaviors of people with or at high risk for diabetes with specific emphasis on high risk populations. o Development and validation of interventions designed to prevent NIDDK or its major risk factors, such as obesity, on a community wide basis for high risk populations. o Development and validation of interventions designed to prevent NIDDM in targeted high risk subgroups (e.g., documented impaired glucose tolerance, history of gestational diabetes, obese children or young adults,) within the population. o Development and validation of interventions designed to improve the care of minority patients with NIDDM. o Development and validation of interventions designed to reduce or prevent the long-term complications of diabetes among minority populations. o Clinical studies of the physiologic effects of alternative pharmacologic and non-pharmacologic interventions for the treatment of NIDDM in minority populations. SPECIAL REQUIREMENTS The research team, composed of the Principal Investigator and/or collaborators, must include individual(s) who are experienced in clinical research. Involvement of individuals who have demonstrated experience working with or delivering health services to minority populations is highly desirable. The application should include a succinct discussion of previous relevant investigational and health care activities. Letters of collaboration should be included for all proposed consultants/collaborators. The applicant must demonstrate that the research team has an understanding of and sensitivity to the target population. Where specific language or cultural barriers are important, the applicant must provide a plan for addressing these barriers. 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 July 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. If allows NIDDK 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: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 594-7515 APPLICATION PROCEDURES Applications are to be submitted using form PHS-398 (rev. 9/91), available in the office of sponsored research of most academic or research institutions and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. Detailed instructions on submission procedures are described in the RFA. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated by an appropriate peer review group convened by the NIDDK in accordance with the usual NIH peer review procedures. Following review, the applications will be given a secondary review by the NIDDK Advisory Council unless not recommended for further consideration by the initial review group. Applications that are incomplete or unresponsive to the RFA will be returned to the applicant or held until the next regular receipt date and reviewed by the Division of Research Grants. INQUIRES Written and telephone inquiries concerning this RFA are encouraged. Requests for the RFA and inquiries regarding programmatic issues may be directed to: Charles A. Wells, Ph.D. Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 622 Bethesda, MD 20892 Telephone: (301) 594-7505 June R. Lunney, Ph.D., R.N. Acute and Chronic Illness Branch National Center for Nursing Research Westwood Building, Room 754 Bethesda, MD 20892 Telephone: (301) 594-7397 Inquiries regarding fiscal matters may be directed to: Ms. Betty Bailey Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649 Bethesda, MD 20892 Telephone: (301) 594-7543 Sally A. Nichols Grant Management Officer National Center for Nursing Research Westwood Building, Room 748 Bethesda, MD 20892 Telephone: (301) 594-7498 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.848. 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. $$R3 END ************************************************************ $$R4 BEGIN CA-93-025 FULL-TEXT ************************************** COMMUNITY CLINICAL ONCOLOGY PROGRAM NIH Guide, Volume 22, Number 18, May 7, 1993 RFA AVAILABLE: CA-93-025 P.T. 34; K.W. 0715035, 0755015, 0745027, 0403004 National Cancer Institute Letter of Intent Receipt Date: June 25, 1993 Application Receipt Date: August 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 INQUIRIES, BELOW. PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites applications from domestic institutions for cooperative agreements to the Community Clinical Oncology Program (CCOP). New community and research base applicants and currently funded programs are invited to respond to this RFA. This issuance of the CCOP RFA seeks to build on the strength and demonstrated success of the CCOP over the past ten years by continuing the program to support community participation in cancer treatment and cancer prevention and control clinical trials through research bases (clinical cooperative groups and cancer centers supported by NCI) and utilizing the CCOP network for conducting NCI-assisted cancer prevention and control research. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Community Clinical Oncology Program, 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 New applicants and currently funded programs are eligible as described below. Two types of grantees are eligible to apply: community programs and research bases. Community applicants may be a hospital, a clinic, a group of practicing physicians, a health maintenance organization (HMO) or a consortium of these. Community programs (CCOPs) will be required to enter patients onto NCI-approved treatment and cancer prevention and control clinical trials through the research base(s) with which each CCOP is affiliated. Research base applicants must be either an NCI-funded clinical trials cooperative group or cancer center. Research bases will be required to provide clinical research treatment and cancer prevention and control protocols, monitor the quality research and follow CCOP accrual. MECHANISM OF SUPPORT Support of this program will be through the Cooperative Agreement (U10) an assistance mechanism in which substantial NCI programmatic involvement with the recipient during performance of the planned activity is anticipated, to assist awardees in the planning, direction, and execution of the proposed project. The total project period for applications submitted in response to this RFA may not exceed three years for new applicants and five years for applicants currently supported under this program. Currently supported applicants will be funded for three, four, or five years depending upon priority score/percentile, review committee recommendations, and programmatic considerations. FUNDS AVAILABLE It is anticipated that up to $4.2 million in total costs per year for five years will be committed to specifically fund applications which are submitted in response to this RFA. Of the total, approximately $1.8 million will be committed to research bases and approximately $2.4 million to CCOPs. It is anticipated that up to three research base awards and up to 15 CCOP 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 NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Over 80 percent of patients with cancer are treated in the community. The CCOP was initiated in 1983 to bring the benefits of clinical research to cancer patients in their own communities by providing support for physicians to enter patients onto treatment research protocols. The second RFA, issued in 1986, expanded the focus to include cancer prevention and control research. In 1992, there were 51 programs in 27 states involving over 300 hospitals and over 2,800 physicians. Approximately 5,000 patients were entered onto treatment trials and 4,000 subjects per year on cancer prevention and control studies. Cancer prevention and control research in the CCOPs is aimed at reducing cancer incidence, morbidity, and mortality through the identification, testing, and evaluation of interventions in controlled clinical trials. The 80 protocols activated to date cover the full spectrum of cancer prevention and control research, including chemoprevention and marker studies for future prevention interventions, smoking cessation studies, screening and early detection, and pain control and other symptom management interventions. Goals and Scope The CCOP initiative is designed to bring the advantages of state-of-the-art treatment and cancer prevention and control research to individuals in their own communities by having practicing physicians and their patients/subjects participate in NCI-approved treatment and cancer prevention and control clinical trials. The CCOP also provides a mechanism to increase the involvement of primary health care providers and other health care specialists in treatment and cancer prevention and control research and provides an opportunity for education and exchange of information on new technologies. 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 June 25, 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 NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. Letters of intent are to be sent to Dr. Leslie G. Ford 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 cooperative agreements. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NCI program official listed under INQUIRIES. A suggested format will be sent to all applicants requesting the RFA or submitting a letter of intent. Applicants are strongly encouraged to use the suggested format instructions in completing the PHS 398. 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 also be sent to: Ms. Toby Friedberg Review Logistics Branch National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Rockville, MD 20852 Applications must be received by August 24, 1993. If an application is received after that date, it will be returned to the applicant. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by Division of Research Grants staff or completeness and NCI staff for responsiveness. Incomplete or non-responsive applications will be returned to the applicant without further consideration. If the number of applications is large compared to the number of awards to be made, applications may receive a preliminary scientific peer review (triage) to determine their relative competitiveness. The NCI will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review will be provided by the National Cancer Advisory Board. Review Criteria Review Criteria for CCOP applicants include the ability to accrue a minimum of 50 credits per year to cancer prevention and control clinical trials and at least 50 credits to cancer treatment clinical trials. Review criteria for Research Bases include the ability to design appropriate treatment and/or prevention and control clinical trials. For both CCOPs and Research Bases the qualifications and experience of personnel and the stability and past performances of the functional unit applying will also be considered. The review group will critically examine submitted budgets and recommend an appropriate budget and period of support. AWARD CRITERIA The anticipated date of award is June 1, 1994. NCI program staff will take into account demographic and geographic distribution of applicants in the final funding selection process to assure inclusion of minority and undeserved populations. Multiple CCOP applicants for funding who are competing for the same patient population will be considered, but all may not be awarded unless warranted by the population density. INQUIRIES Written and telephone requests for the RFA, inquiries concerning the objectives and scope of this RFA, or whether or not specific proposed research are responsive are encouraged and may be directed to: Leslie G. Ford, M.D. Community Oncology and Rehabilitation Branch National Cancer Institute Executive Plaza North, Room 300-D Bethesda, MD 20892 Telephone: (301) 496-8541 Direct inquiries regarding fiscal matters to: Ms. Crystal Elliott Grants Administration Branch 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. 13.399, Cancer Control. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410 as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations 42 CFR 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. $$R4 END ************************************************************ $$R5 BEGIN CA-93-026 FULL-TEXT ************************************** MINORITY-BASED COMMUNITY CLINICAL ONCOLOGY PROGRAM NIH Guide, Volume 22, Number 18, May 7, 1993 RFA AVAILABLE: CA-93-026 P.T. 34, FF; K.W. 0715035, 0755015, 0745027, 0403004 National Cancer Institute Letter of Intent Receipt Date: June 25, 1993 Application Receipt Date: August 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 INQUIRIES BELOW. PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), is interested in continuing the established cancer control effort which involves practicing oncologists who serve large minority populations in the NCI clinical trials program. DCPC invites applications from domestic institutions with greater than 50 percent of new cancer patients from minority populations for cooperative agreements in response to this Minority-Based Community Clinical Oncology Program (MBCCOP) RFA. This issuance of the MBCCOP RFA seeks to build on the strength and demonstrated success of the MBCCOP over the past three years by: (1) continuing the program as a vehicle for supporting community participation in treatment and cancer prevention and control clinical trials through research bases (clinical cooperative groups and cancer centers supported by NCI); (2) expanding and strengthening the cancer prevention and control research effort; (3) utilizing the MBCCOP network for conducting NCI-assisted cancer prevention and control research; and (4) evaluating on a continuing basis MBCCOP performance and its impact in the community. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Minority - based Community Clinical Oncology Program, 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 New applicants and currently funded programs are eligible as described below. Community applicants may be a hospital, a clinic, a group of practicing physicians, a health maintenance organization (HMO) or a consortium of these. Applicants must have greater than 50 percent of new cancer patient population from minority ethnic groups. MBCCOPs will be required to enter patients onto NCI-approved treatment and cancer prevention and control clinical trials through the research base(s) with which each MBCCOP is affiliated. MECHANISM OF SUPPORT Support of this program will be through the Cooperative Agreement (410) an assistance mechanism in which substantial NCI programmatic involvement with the recipient during performance of the planned activity is anticipated, to assist awardees in the planning, direction, and execution of the proposed project. The anticipated amount of the direct cost awards will range from $100,000 to $200,000. The total project period for applications submitted in response to this RFA may not exceed three years for new applicants and four years for applicants currently supported under this program. Currently supported applicants will be funded for three or four years depending upon priority score/percentile, review committee recommendations, and program considerations. FUNDS AVAILABLE It is anticipated that up to $2.7 million in total costs per year for four years will be committed to specifically fund applications which are submitted in response to this RFA. It is anticipated that up to 12 MBCCOP 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 NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Overall, cancer incidence and mortality rates for many cancer sites in minority populations are higher compared to whites. Survival rates from cancer in minority populations are also less than in whites. One way to develop and implement effective cancer treatment, prevention and control strategies in minority populations, and thereby reduce disparities in cancer incidence, morbidity, and survival rates between whites and minority populations, is to provide broader access to benefits of clinical research and greater involvement of minority populations in the clinical trials process. NCI's clinical trials network has evolved over the past 30 years. The major NCI program initiatives supporting this network are the Clinical Cooperative Group Program, the Cancer Centers Program, the Cooperative Group Outreach Program, and the Community Clinical Oncology Program (CCOP). Treatment and cancer prevention and control clinical trials research funded through these programs provides patients and their physicians with access to state-of-the-art cancer care management opportunities, and provides oncologists with a source of continuing education on innovations in cancer therapy, diagnostic techniques, and treatment applications. The MBCCOP is an extension of the clinical trials network with the intent of including populations that have traditionally been unable to access the advantages of state of the art cancer care. Goals and Scope The MBCCOP, while designed to increase accrual of minority patients to clinical trials is also an opportunity to identify barriers to minority participation in clinical research and to test intervention strategies in cancer treatment, prevention and control. 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 June 25, 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 NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. Letters of intent are to be sent to Dr. Otis W. Brawley, 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 cooperative agreements. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NCI program official listed under INQUIRIES. A suggested format will be sent to all applicants requesting the RFA or submitting a letter of intent. Applicants are strongly encouraged to use the suggested format instructions for completing the PHS 398. 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 also be sent to: Ms. Toby Friedberg Review Logistics Branch National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Rockville, MD 20852 Applications must be received by August 24, 1993. If an application is received after that date, it will be returned to the applicant. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by Division of Research ad Grants staff for completeness and NCI staff for responsiveness. Incomplete or non-responsive applications will be returned to the applicant without further consideration. If the number of applications is large compared to the number of awards to be made, applications may receive a preliminary scientific peer review (triaged) to determine their relative competitiveness. The NCI will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review will be provided by the National Cancer Advisory Board. Review Criteria Review Criteria for MBCCOP applicants include the ability to accrue a minimum of 50 credits per year to cancer treatment clinical trials and a minimum of 30 credits in the first year of funding, 40 credits in the second year, and 50 credits in the third and fourth years to cancer prevention and control clinical trials. For MBCCOPs qualifications and experience of personnel and the stability and past performances of the functional unit applying will also be considered. The review group will critically examine submitted budgets and recommend an appropriate budget and period of support. AWARD CRITERIA The anticipated date of award is June 1, 1994. NCI program staff will take into account demographic and geographic distribution of applicants in the final funding selection process to assure inclusion of minority and undeserved populations. Multiple MBCCOP applicants for funding who are competing for the same patient population will be considered, but all may not be awarded unless warranted by the population density. INQUIRIES Written and telephone requests for the RFA, inquiries concerning the objectives and scope of this RFA, or about whether or not specific proposed research are responsive are encouraged and may be directed to: Otis W. Brawley M.D. Community Oncology and Rehabilitation Branch National Cancer Institute Executive Plaza North, Room 300 Bethesda, MD 20892 Telephone: (301) 496-8541 Direct inquiries regarding fiscal matters to: Ms. Crystal Elliott Grants Administration Branch 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. 13.399, Cancer Control. 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 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. $$R5 END ************************************************************ $$R6 BEGIN NR-93-005 FULL-TEXT ************************************** SMALL GRANTS PROGRAM FOR NURSING AND BIOLOGY INTERFACE NIH Guide, Volume 22, Number 18, May 7, 1993 RFA AVAILABLE: NR-93-005 P.T. 34; K.W. 0785130, 1002000, 1002008 National Center for Nursing Research Letter of Intent Receipt Date: July 1, 1993 Application Receipt Date: September 22, 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 CONTACTS NAMED IN INQUIRES, BELOW. PURPOSE The Small Grants Program (R03) will provide limited support for meritorious research that develops and tests innovative biological or molecular techniques for solving nursing problems or answering nursing clinical questions. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Small Grants Program for Nursing and Biology Interface, is related to the priority areas of physical activity, nutrition, and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00473-1) 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 The research proposed must utilize state-of-the-science biotechnology and be an integral part of on-going research by a nurse scientist. The ongoing research must address a clinical issue relevant to the advancement of the practice of nursing. The applicant Principal Investigator must have a Ph.D. or the equivalent and an R.N. license. If the applicant PI is not actively involved in a biological science or molecular biology laboratory, collaboration with a biological or molecular biology scientist is required. The purpose of these requirements is to increase the numbers of beginning, mid-career and senior nurse researchers using state-of-the-science biological and molecular biology technology to answer clinical nursing questions. Nurse scientists funded with Fiscal Year 1993 monies in response to RFA: NR-92-04 are ineligible. 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 women and minority individuals are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institute of Health's (NIH) Small Grants (R03) Program mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (October 1, 1990). Each grant is limited to $50,000 in total costs for the entire project period. The Small Grants Program is a nonrenewable award. FUNDS AVAILABLE Approximately $200,000 in total costs will be committed to specifically fund applications submitted in response to this RFA. It is anticipated that four applications will be funded up to two 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 NCNR, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES This RFA has two distinct aims: (1) To stimulate nurse investigators to explore innovative, state-of-the-science research using biological or molecular technology in order to answer clinical questions and nursing problems, and (2) To facilitate use of state-of-the-science biomolecular techniques by nurse researchers. The validation of nursing practice by the application of biological sciences and molecular biology into nursing research requires investigators to have the ability to use new techniques of structural and integrative biology, genetics, biophysics, and immunology. Example of Appropriate Biotechnology and Research Topics Biotechnology: recombinant DNA, gene mapping and/or sequencing, signal transduction, crystallographic analysis, peptide/protein modeling and molecular dynamics simulation, in vitro or in vivo nuclear magnetic resonance spectroscopy or imaging, positron emission tomography, isotopic scanning, monoclonal antibodies, high pressure liquid/gas chromatography, and spectrophotometry. Topics o A nurse scientist who investigates interventions to treat pain might be interested in measuring gene expression in the dorsal root ganglia, the site that changes amounts of messenger RNA after tissue and nerve injury. o A nurse scientist who investigates interventions to treat and prevent lead poisoning in school age children, might be interested in identifying blood cell markers as an immunological component of the health assessment in this population. The biotechnology might include biological and biochemical cellular markers to identify lead poisoning. o A nurse scientist whose basic science research involves identifying homeostatic mechanisms for regulating calcium ion concentration in cardiac cells might choose to study ionic flux and control as mechanisms in the degenerative process of cell function. o A nurse scientist whose clinical research is symptom management of complications arising from type II diabetes and obesity might be interested in the biochemical characterization of insulin resistance seen in these disorders. The R03 application might propose a study, in collaboration with a molecular biologist, of insulin function at the molecular level. o A nurse scientist whose clinical research is the quality of life after organ transplantation might be interested in evaluating immunologic indices of patient outcomes after bone marrow transplants. The R03 application might propose as study, in collaboration with an immunologist, of monoclonal antibodies produced by hybridomas in bone marrow transplants. 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 July 1, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the PI, 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 NCNR 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: Ethel B. Jackson, DDS Office of Scientific Review National Center for Nursing Research Building 31, Room 5B19 Bethesda, MD 20892 Telephone: (301) 496-0472 FAX: (301) 480-4969 APPLICATION PROCEDURES The RFA contains important information for applicants and may be obtained from the contacts listed under INQUIRIES. The application receipt date is September 22, 1993. The research grant application form PHS 398 (rev. 9/91) is to be used. These forms are available at most institutional offices of sponsored research and the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248. Applications must be submitted to the NIH Division of Research Grants. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NCNR staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. Those applications that are complete and responsive will be evaluated in accordance with stated criteria for scientific/technical merit by an appropriate special review group organized by NCNR. The second level of review will be provided by the National Advisory Council for Nursing Research. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct inquiries regarding programmatic issues to: Hilary D. Sigmon, Ph.D., R.N. Acute and Chronic Illness Branch National Center for Nursing Research Westwood Building, Room 754 Bethesda, MD 20892 Telephone: (301) 594-7397 FAX: (301) 594-7603 Direct inquiries regarding fiscal matters to: Sally A. Nichols Grants Management Officer National Center for Nursing Research Westwood Building, Room 748 Bethesda, MD 20892 Telephone: (301) 594-7498 FAX: (301) 594-7603 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361, Nursing Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R6 END ************************************************************ $$R7 BEGIN DK-93-007 FULL-TEXT ************************************** NON-INSULIN DEPENDENT DIABETES PRIMARY PREVENTION TRIAL NIH Guide, Volume 22, Number 18, May 7, 1993 RFA AVAILABLE: DK-93-007 P.T. 34; K.W. 0715075, 0755015, 0745027 National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Child Health and Human Development Office of Research on Minority Health Letter of Intent Receipt Date: September 17, 1993 Application Receipt Date: October 19, 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 Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Child Health and Human Development (NICHD), and the Office for Research on Minority Health (ORMH) invite cooperative agreement applications for investigators to design and implement a full-scale, multicenter, randomized clinical trial to evaluate the efficacy of interventions designed to delay or prevent onset of non-insulin dependent diabetes mellitus (NIDDM) in individuals at increased risk for NIDDM. Within the broad range of this NIDDK and NICHD-sponsored initiative, ORMH is providing specific support for research focussing on the sub-population of obese minority women with a history of gestational diabetes. 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, NIDDM Primary Prevention Trial, is related to the priority area of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock Number 017-001-00474-0 or Summary Report: Stock Number 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 for-profit and non-profit domestic organizations public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit as Principal Investigators. Applications from minority institutions are especially encouraged. Applications from foreign institutions will not be considered. The expertise appropriate for this research program includes a knowledge of the clinical and epidemiological aspects of diabetes. Institutions wishing to collaborate and function as a single Clinical Center are required to submit one application. In this regard applicants are encouraged to form collaborative arrangements with investigators at minority institutions and/or minority investigators at other institutions. However international collaborations are unacceptable. MECHANISM OF SUPPORT The administrative and funding mechanism will be the cooperative agreement (U01). The cooperative agreement is an award instrument establishing an assistance relationship between the NIH and the recipients in which substantial programmatic involvement is anticipated between NIH and the recipients during performance of the contemplated activity. FUNDS AVAILABLE Support during the planning phase (Phase 1) of this trial for FY 1994 is expected to be approximately seven million dollars with total costs per center of approximately $350,000. It is anticipated that awards for 15 to 20 Clinical Centers will be made. During Phase 2 (full scale trial period) it is expected that funding levels for each center will increase to approximately $500,000 reflecting the start of the full scale trial. During Phase 3 (close-out period) costs are expected to decrease to approximately $100,000 in keeping with the reduction in clinical personnel effort and the shift to close-out, analysis of data, and reporting. Costs for outcome measures should not be included individually for each center. These costs will be covered under the Data Coordinating Center funding. From owner-sci-resources@net.bio.net Thu May 06 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. 18, pt. 2, 7 May 1993 Message-ID: Date: 7 May 93 18:16:53 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1247 $$XID NIHGUIDE 19930507 V22N18 P2O2 ************************************ Although this program is provided for in the financial plans of the NIDDK, the award of grants in response to the RFA is contingent on the availability of funds for this purpose. The total project period for applications submitted in response to the present RFA will be seven years due, in part, to the necessity to screen large numbers of potential participants to identify individuals with sufficient risk to answer the study question discussed under "RESEARCH OBJECTIVES". The anticipated award date is July 1994. RESEARCH OBJECTIVES The purpose of this RFA is to initiate a collaborative study of interventions to prevent NIDDM in people with IGT or a history of GDM and to prevent the worsening of glucose tolerance in people with newly diagnosed NIDDM. The study will determine whether onset of NIDDM can be delayed and whether interventions in newly diagnosed NIDDM can favorably influence glucose tolerance and progression to fasting hyperglycemia. 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 17, 1993, a letter of intent that includes the title of the proposed research, the name, telephone number and mailing address of the Principal Investigator, the identities of other key personnel and participating institutions, and the name of the applicant institution, 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 it contains is helpful in planning for the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid possible conflicts of interest in the review. The letter of intent is to be sent to: Robert D. Hammond, Ph.D. Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 594-7515 FAX: (301) 594-7503 APPLICATION PROCEDURES Submit applications on form PHS 398 (rev. 9/91), the application form for NIH research project grant. This form is available in the applicant institution's office of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7250. Applications must be received by October 19, 1993. An application not received by this date will be returned to the applicant. INQUIRIES Requests for copies of the RFA and inquiries regarding programmatic issues related to this announcement may be directed to: Sanford Garfield, Ph.D. Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of diabetes and Digestive and Kidney Diseases Westwood Building, Room 626 Bethesda, MD 20892 Telephone: (301) 594-7535 FAX: (301) 594-9011 Inquiries regarding fiscal matters may be directed to: Linda Stecklein Division of Extramural Activities National Institute of diabetes and Digestive and Kidney Diseases Westwood Building, Room 649B Bethesda, MD 20892 Telephone: (301) 594-7543 FAX: (301) 594-7594 Schedule Letter of Intent Receipt Date: September 17, 1993 Application Receipt Date: October 19, 1993 Initial Review: February/March 1994 Review by the NIDDK Council: May/June 1994 Anticipated Award Date: July 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS Grants Policies and Federal Regulations 42 CFR Part 52 and 45 CFR parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R7 END ************************************************************ $$R8 BEGIN DK-93-008 FULL-TEXT ************************************** NIDDM PRIMARY PREVENTION TRIAL: DATA COORDINATING CENTER NIH Guide, Volume 22, Number 18, May 7, 1993 RFA AVAILABLE: DK-93-008 P.T. 34; K.W. 0755015, 0745027, 0755018 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: September 17, 1993 Application Receipt Date: October 19, 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 Division of Diabetes, Endocrinology and Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites cooperative agreement applications for the Data Coordinating Center in a multicenter, randomized clinical trial to evaluate the efficacy of interventions designed to delay or prevent onset of non-insulin dependent diabetes mellitus (NIDDM) in individuals at increased risk for NIDDM. The Data Coordinating Center will participate with the NIDDK and fifteen to twenty Clinical Centers in all phases of this trial. A separate request for the Clinical Centers has been issued (RFA DK-93-007). The Data Coordinating Center and a participating Clinical Center may be located in the same institution; however, each must be administratively and fiscally distinct from the other. 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, NIDDM Primary Prevention Trial, is related to the priority area of diabetes and chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock Number 017-001-00474-0 or Summary Report: Stock Number 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 for-profit and non-profit domestic organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit as Principal Investigators. Applications from minority institutions are especially encouraged. Applications from foreign institutions will not be considered. The expertise appropriate for this research program includes statistical knowledge of the clinical and epidemiological aspects of diabetes and expertise in data coordination for clinical trials. MECHANISM OF SUPPORT The administrative and funding mechanism will be the cooperative agreement (U01). The cooperative agreement is an award instrument establishing an assistance relationship between the NIH and the recipients in which substantial programmatic involvement is anticipated between NIH and the recipients during performance of the contemplated activity. FUNDS AVAILABLE Support for the Data Coordinating Center during the planning phase (Phase 1) of this trial in FY 94 is expected to be approximately $1,000,000 (direct and indirect costs). During Phase 2 and 3 it is expected that the funding level for the Coordinating Center's direct operations will remain at this level corrected for inflation. However, funding will be provided by the NIDDK to support the Data Coordinating Center recruited and managed subcontracts for centralized laboratory and clinical resources reflecting the start of the full scale trial. Funds for the subcontract will be approximately five million dollars (total costs) during Phase 2 to support adherence and end point analyses. Additional funds in the first year of Phase 2 will be provided to cover the costs of screening. The nature and extent of the screening will be established by the outcome of the protocol development. Funds to support the subcontract aspects of the Trial will largely cease during Phase 3 reflecting the final period of data analysis and reporting. Although this program is provided for in the financial plans of the NIDDK, an award in response to the RFA is contingent on the availability of funds for this purpose. The total project period for applications submitted in response to the present RFA will be seven years due, in part, to the necessity to screen large numbers of potential participants to identify individuals with sufficient risk to answer the study question discussed under RESEARCH OBJECTIVES. The anticipated award date is July 1994. RESEARCH OBJECTIVES The purpose of this RFA is to initiate a collaborative study of interventions to prevent NIDDM in people with IGT and to prevent the worsening of glucose tolerance in people with newly diagnosed NIDDM. The study will determine whether onset of NIDDM can be delayed and whether interventions in newly diagnosed NIDDM can favorably influence glucose tolerance and progression to fasting hyperglycemia. The objectives of this RFA are to select a Data Coordinating Center to participate in a full-scale trial with the Clinical Centers and the NIDDK. 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 17, 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 application, the information that it contains is helpful in planning for the review of application. It allows ICD 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: Robert D. Hammond, Ph.D. Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 594-7515 FAX: (301) 594-7503 APPLICATION PROCEDURES Submit applications on form PHS 398 (rev, 9/91), the application form for NIH research project grants. This form is available in the applicant institution's office of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7250. INQUIRIES Requests for copies of the RFA and inquiries regarding programmatic issues related to this announcement may be directed to: Sanford Garfield, Ph.D. Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of diabetes and Digestive and Kidney Diseases Westwood Building, Room 626 Bethesda, MD 20892 Telephone: (301) 594-7535 FAX: (301) 594-9011 Inquiries regarding fiscal matters may be directed to: Linda Stecklein Division of Extramural Activities National Institute of diabetes and Digestive and Kidney Diseases Westwood Building, Room 649B Bethesda, MD 20892 Telephone: (301) 594-7543 FAX: (301) 594-7594 SCHEDULE Letter of Intent Receipt Date: September 17, 1993 Application Receipt Date: October 19, 1993 Initial Review: February/March 1994 Review by the NIDDK Council: May/June 1994 Anticipated Award Date: July 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99- 158, 42 USC 241 and 285) and administered under PHS Grants Policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R8 END ************************************************************ $$XID RFA NR93005 NR-93-005 P1O1 *************************************** SMALL GRANTS PROGRAM FOR NURSING AND BIOLOGY INTERFACE NIH Guide, Volume 22, Number 18, May 7, 1993 RFA: NR-93-005 P.T. 34; K.W. 0785130, 1002000, 1002008 National Center for Nursing Research Letter of Intent Receipt Date: July 1, 1993 Application Receipt Date: September 22, 1993 PURPOSE The National Center for Nursing Research (NCNR) invites applications to develop or test innovative biological and molecular biological techniques for solving nursing problems and answering nursing clinical questions. This small grants program will provide limited support for meritorious research. The goal of this Request for Applications (RFA) is to generate significant findings so that nurse scientists can launch into investigator-initiated nursing research using biological or molecular technology. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Small Grants Program for Nursing and Biology Interface, is related to the priority area of physical activity, nutrition, and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00473-1) 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 The research proposed must utilize state-of-the-science biotechnology and be an integral part of on-going research by a nurse scientist. The ongoing research must address a clinical issue relevant to the advancement of the practice of nursing. The applicant Principal Investigator must have a Ph.D., or the equivalent, and an R.N. license. If the applicant Principal Investigator is not actively involved in a biological science or molecular biology laboratory, collaboration with a biological or molecular biology scientist is required. The purpose of these requirements is to increase the number of beginning, mid-career, and senior nurse researchers using state-of-the-science biological and molecular technology to answer clinical nursing questions. Nurse scientists funded with Fiscal Year 1993 monies in response to RFA NR-92-004 are ineligible. 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 women and minority individuals are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institute of Health (NIH) small grants (R03) Program mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (October 1, 1990). FUNDS AVAILABLE Approximately $200,000 in total costs will be committed to specifically fund applications submitted in response to this RFA. It is anticipated that four applications will be funded for up to two years. Each grant is limited to $50,000 in total costs for the entire project period. The Small Grants Program is a non-renewable award. 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 NCNR, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background An important focus of nursing research in the improvement of patient care is the interaction of biological/molecular factors associated with acute and chronic illness, health promotion, and disease prevention. This small grants program is designed to assist the integration of advanced biological/molecular technology into nursing research and clinical practice. Recognizing the rapid changes that are taking place in the biological and molecular sciences and the effect these changes will have on nursing research and practice, the biological content of NCNR's portfolio was analyzed. A Nursing Biological Task Force recommended strategies to integrate nursing research with state-of-the-art biological science. These recommendations were approved by the National Advisory Council for Nursing Research (NACNR). A long-range plan for implementing the Task Force's recommendations includes research, career development, and training initiatives to increase the interface of biological sciences and molecular biology with nursing research as a basis for clinical practice. The first step of this plan was to increase opportunities for research training and career development in the biological sciences (PA-92-35, Training & Development: Nursing and Biology Interface). The second step of this plan targets research initiatives and its purpose is three-fold: (1) to facilitate the use of innovative biological and molecular biology technology in nursing research; (2) to link the biological and molecular underpinnings of nursing research and clinical practice in specified areas of biomolecular clinical research; and (3) to interweave nursing research and behavioral research with new areas of biomolecular science, such as structural and molecular biology, genetics, and immunology. Subsequent to the announcement of RFA NR-92-04, Small Grants Program for Nursing and Biology Interface, the Molecular Biology Nursing Task Force convened to identify NCNR participation in the first objective of the trans-NIH Strategic Plan, Critical Science and Technology. Its components include molecular medicine, biotechnology, molecular immunology and vaccine development, structural biology, and cellular and integrative biology. Focusing on solving nursing problems and answering clinical questions by using biological and molecular science, task force members recommended NCNR participation in the Critical Science and Technology objective: cellular and integrative biology, molecular medicine (molecular biology), molecular immunology and vaccine development, and bioengineering. The Task Force and the NACNR supported the opportunities available through NCNR to increase training, career development, and research opportunities in the interface between molecular biology and nursing research. Targeted Aims This RFA has two distinct aims: 1. To stimulate nurse investigators to explore innovative, state-of-the-science biological or molecular technology in order to answer clinical questions and nursing problems. 2. To facilitate use of state-of-the-science biomolecular techniques by nurse researchers. The validation of nursing practice by the application of biological sciences and molecular biology to nursing research requires investigators to have the ability to use new techniques of structural and integrative biology, genetics, biophysics, and immunology. Example of Appropriate Biotechnology and Research Topics Examples of biotechnology and topics appropriate to the objectives of this solicitation include: Biotechnology: recombinant DNA, gene mapping and/or sequencing, signal transduction, crystallographic analysis, peptide/protein modeling and molecular dynamics simulation, in vitro or in vivo nuclear magnetic resonance spectroscopy or imaging, positron emission tomography, isotopic scanning, monoclonal antibodies, high pressure liquid/gas chromatography, and spectrophotometry. Topics: o A nurse scientist who investigates interventions to treat pain might be interested in measuring gene expression in the dorsal root ganglia, in which the amount of messenger RNA changes after tissue and nerve injury. o A nurse scientist who investigates interventions to treat and prevent lead poisoning in school age children might be interested in identifying blood cell markers as an immunological component of the health assessment in this population. The biotechnology might include biological and biochemical cellular markers to identify lead poisoning. o A nurse scientist whose basic science research involves identifying homeostatic mechanisms for regulating calcium ion concentration in cardiac cells might choose to study the control of ionic flux in the degeneration of cell function. o A nurse scientist whose clinical research is symptom management of complications arising from type II diabetes and obesity might be interested in the biochemical characterization of insulin resistance seen in these disorders. The R03 application might propose a study, in collaboration with a molecular biologist, of insulin function at the molecular level. o A nurse scientist whose clinical research is the quality of life after organ transplantation might be interested in evaluating immunologic indices of patient outcomes after bone marrow transplants. The R03 application might propose as study, in collaboration with an immunologist, of monoclonal antibodies produced by hybridomas in bone marrow transplants. Methodological Issues A wide spectrum of research designs and analyses are acceptable under this solicitation. In preparing the application, the nurse investigator must develop specific hypotheses or research questions that apply biological or molecular technology to clinical nursing research questions. 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 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 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 disease, 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. 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 July 1, 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 NCNR 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: Ethel B. Jackson, D.D.S. Office of Scientific Review National Center for Nursing Research Building 31, Room 5B25 Bethesda, MD 20892 Telephone: (301) 496-0472 FAX: (301) 480-4969 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 Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page 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 following supplemental instructions are given: 1. Background and Significance: The applicant must be explicit in describing the interface of the chosen biological or molecular technique with clinical nursing research questions. 2. Progress Report/Preliminary Studies: Since this award mechanism intends to fund innovative technology, preliminary data are not required. 3. Sections 1, 2, and 4 of the Research Plan (Specific Aims, Background and Significance, and Research Design and Methods) are limited to a total of 10 pages. 4. Do not submit an Appendix. 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. Ethel B. Jackson at the address listed under LETTER OF INTENT. If the applicant has an approved assurance covering the research, the applicant should provide it with the application. Certification of Institutional Review Board (IRB) approval is required, if humans are involved. These reviews and approvals should occur prior to submission of the application for award and the certifications should be submitted with the application. There is no 60 day grace period for RFAs. 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 25-28 of PHS 398 (rev. 9/91). Applications must be received by September 22, 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 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 NCNR staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. Applications may be triaged by an NCNR peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NCNR. The second level of review will be provided by the NACNR. Review criteria for this RFA are generally the same as those for unsolicited research grant applications. o scientific and technical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o the potential impact of the biological/molecular technique on nursing research and its ability to strengthen a subsequent R01 application. AWARD CRITERIA The anticipated date of award is April 1994. Decisions to make awards are based on the scientific merit of the application reflected in the priority score, availability of funds within the NCNR for this purpose, and NCNR research program priorities. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged and should be directed to the following individuals. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic and scientific issues to: Hilary D. Sigmon, Ph.D., R.N. Acute and Chronic Illness Branch National Center for Nursing Research Westwood Building, Room 754 Bethesda, MD 20892 Telephone: (301) 594-7397 FAX: (301) 594-7603 Direct inquiries regarding budgetary and administrative matters to: Sally A. Nichols Grants Management Officer National Center for Nursing Research Westwood Building, Room 748 Bethesda, MD 20892 Telephone: (301) 594-7498 FAX: (301) 594-7603 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361, Nursing Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA DK93023 DK-93-023 P1O1 *************************************** INTERVENTIONS IN DIABETES AMONG MINORITY POPULATIONS NIH Guide, Volume 22, Number 18, May 7, 1993 RFA: DK-93-023 P.T. 34, FF; K.W. 0715075, 0785035, 0745027 National Institute of Diabetes and Digestive and Kidney Diseases National Center for Nursing Research Letter of Intent Receipt Date: July 20, 1993 Application Receipt Date: August 20, 1993 PURPOSE This Request for Applications (RFA) invites new and experienced investigators to submit clinical research applications designed to develop and validate intervention approaches for the amelioration or prevention of diabetes mellitus and/or its complications among minority populations, including African, Asian, and Hispanic Americans, Native Hawaiians, and Pacific Islanders. This RFA is a follow-up to the RFA DK-91-09 "Research Planning Grant: Diabetes in Minority Populations." However, respondents to this RFA are not restricted to those having previously received a planning grant under the prior RFA. Applications are encouraged from any interested investigators regardless of their prior record of grant support. Although this RFA is designed to develop and validate interventions for preventing diabetes mellitus and/or its complications, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is announcing another RFA (DK-93-007) specifically for clinical centers to design and implement a full-scale, multi-center clinical trial to evaluate the efficacy of interventions designed to delay or prevent onset of NIDDM in individuals at increased risk for the disease. The present RFA focuses on the specific minority populations as indicated above. An earlier RFA (DK-92- 17) was designed for studies with Native Americans and Alaskan Natives. While studies involving these populations are not responsive to the present RFA, investigators interested in working with these groups are advised to submit applications through the normal NIH investigator-initiated review process. The NIDDK and the National Center for Nursing Research (NCNR) seek to encourage research on all minority populations. 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, Interventions in Diabetes Among Minority Populations, is specifically targeted at diabetes mellitus and its complications as a major public health problem. 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 non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments and eligible agencies of the Federal government. Teams of applicants are encouraged that could include universities, public health departments, voluntary organizations, and health clinics. Among a team of applicants, one institution must be proposed as the lead organization to serve as the Grantee Institution and assume responsibility for the fiscal and programmatic conduct of the project. Other members of the team should be proposed based on individual consortium agreements (subcontracts) with those organizations. The grantee organization and any proposed consortium must have the staff and facilities required for the proposed program. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support of this program will be through the NIH research project grant (R01) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The total requested project period for applications submitted in response to this RFA may not exceed five years. A maximum of three years can be requested for foreign awards. The earliest possible award date will be April 1, 1994. Applicants must limit their request to not more than $160,000 direct costs for the initial budget period. The average size of an award is expected to be approximately $190,000. FUNDS AVAILABLE For fiscal year 1994, $2.2 million will be committed to fund applications submitted in response to this RFA. The NIDDK and the NCNR plan to support approximately 10 to 12 applications submitted in response to this solicitation. However, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIDDK and the NCNR, the award of grants pursuant to this RFA is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Diabetes mellitus and its complications are major public health problems in the United States today. The National Institutes of Health has encouraged research into the cause, cure and prevention of diabetes and its related endocrine and metabolic disorders. The Report of the Secretary of Health and Human Services Task Force on Black and Minority Health (1) identified non-insulin dependent diabetes mellitus (NIDDM) and its complications as major public health problems in several minority populations. This task force cited diabetes as one of six health problems responsible for excess mortality among United States minority populations. The rate of diabetes rises with age and reaches 15 to 20 percent among those 65 years of age and older. Rates in men and women are virtually equal. Until 1940, diabetes was less common in the African American population than in the general population. Today, the prevalence of NIDDM is 60 percent higher in African Americans than in the caucasian population. Diabetes is the fourth leading cause of death from disease in African American women and the seventh leading cause in African American men. Hispanic-Americans also suffer from diabetes to a degree disproportionate to their representation in the United States population as a whole. In the United States, approximately half of the people with NIDDM do not know they have the disease. Among African, Asian and Hispanic Americans, Native Hawaiians and Pacific Islanders, as in other populations, the symptoms of NIDDM can be very subtle and remain undetected for a long time. When diagnosed, NIDDM is usually treated with diet and exercise to control blood glucose levels. Oral hypoglycemic agents or insulin injections are employed if necessary. A variety of other interventions are also employed to help prevent or delay the chronic complications of diabetes that affect organs and tissues throughout the body. Obesity is a well-established risk factor for diabetes. For Hispanics, the rate of diabetes increases with each higher level of percent desirable weight (PDW). At obesity levels of PDW over 100, rates of diabetes are higher in the Hispanic population than in the African American population, and rates are higher in the African Americans than in the Caucasians. Most adults with diabetes in both Hispanic and African American populations are overweight, and women are particularly obese (20 percent or more above desirable weight). Obesity in children is a major concern. One in five American children is obese. Younger children weigh more and have more body fat than children the same age did 20 years ago. While the role of genes in predisposing people to diabetes is important, almost all obesity studies have found family influences are significant. The NIDDK sponsored two National Conferences in 1988 and 1989 to examine the problems of diabetes in African and Hispanic Americans and to define issues and priority areas for programs to reduce the impact of diabetes on these populations (2,3). During fiscal year 1992, NIDDK awarded Collaborative Research Planning Grants to support the development of collaborative research projects that address critical questions related specifically to the etiology, pathogenesis, diagnosis, treatment, cure and prevention of diabetes mellitus and its complications in African, Asian and Hispanic Americans, Native Hawaiians and Pacific Islanders. Scope The overall objective of this RFA is to stimulate original and innovative studies directed at the elucidation of practical methods for the reduction of the public health burden of diabetes in African, Asian and Hispanic Americans, Pacific Islanders, and Native Hawaiians. Applicants must demonstrate that their research teams have an understanding of and are sensitive to the target populations. Any proposed intervention must be culturally relevant and acceptable. Special consideration will be given to investigators with demonstrated access, knowledge, and cultural sensitivity to Native Hawaiians, Pacific Islanders and African, Asian and Hispanic Americans. Examples of research topics relevant to this solicitation are listed below, they should not be construed as required or limiting. Responsive applications to this RFA include: o Development and validation of efficacious strategies for changing health behaviors of people with or at high risk for diabetes, with specific emphasis on high risk populations. o Development and validation of interventions designed to prevent NIDDM or its major risk factors, such as obesity, on a community wide basis for high risk populations. o Development and validation of interventions designed to prevent NIDDM in targeted high risk subgroups (e.g., documented impaired glucose tolerance, history of gestational diabetes, obese children or young adults) within the population. o Development and validation of interventions designed to improve the care of minority patients with NIDDM. o Development and validation of interventions designed to reduce or prevent the long-term complications of diabetes among minority populations. o Clinical studies of the physiologic effects of alternative pharmacologic and non-pharmacologic interventions for the treatment of NIDDM in minority populations. SPECIAL REQUIREMENTS The research team, composed of the Principal Investigator and/or collaborators, must include individual(s) who are experienced in clinical research. Involvement of individuals who have demonstrated experience working with or delivering health services to minority populations is highly desirable. The application should include a succinct discussion of previous relevant investigational and health care activities. Letters of collaboration should be included for all proposed consultants/collaborators. The applicant must demonstrate that the research team has an understanding of and sensitivity to the target population. Where specific language or cultural barriers are important, the applicant must provide a plan for addressing these barriers. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF MINORITIES AND WOMEN 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 person 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 Item 4 (Research Design and Methods) of the Research Plan AND summarized in Item 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, African Americans and 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 behavioral studies or 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 or 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 without review. 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 a letter of intent by July 20, 1993. The letter of intent should include a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of 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, the information that it contains is helpful in planning for the review of applications. It allows NIDDK 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: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 594-7515 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. The form is available from most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7250. The RFA label available in the 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 title of the RFA and the number must be typed on line 2a of the face page on the application form and check the yes box. Submit a signed, original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application must also be sent under separate cover to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Applications must be received by August 20, 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. However, it is allowable to submit the same project as both an R01 and as a component project of a program project. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications previously reviewed. Such applications must not only include an introduction addressing the previous critique but also be responsive to this RFA. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed 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 program requirements and criteria stated in the RFA is an NIDDK staff function. If the application is not responsive to the RFA, NIDDK staff will contact the applicant to determine whether it should be returned to the applicant, or whether it should be held until the next regular receipt date and reviewed in competition with all other applications. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIDDK. If the number of applications is large compared to the number of awards to be made, a preliminary scientific peer review may be conducted and applications withdrawn from further competition if they are not competitive for the award. The NIDDK will notify the applicant and institutional official of this action. Those applications judged to be competitive will be reviewed for scientific and technical merit in accordance with the usual NIH peer review procedures by an initial review group within the NIDDK specifically convened for this RFA. Following this review, the applications will be given a secondary review by the National Advisory Councils unless not recommended for further consideration by the initial review group. Review criteria for RFAs are generally the same as those for unsolicited research grant applications. o scientific/technical merit criteria specific to the objectives of the RFA; o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach, methodology and staff, particularly but not exclusively in the area of the proposed research; o availability of resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o if an application involves activities that could have an adverse effect upon humans, animals, or the environment, the adequacy of the proposed-means for protecting against or minimizing such effects; and o for foreign applications, the uniqueness of research such that it can only be performed outside of the United States. AWARD CRITERIA Applications will compete for available funds with all other recommended applications submitted in response to this RFA. 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. The anticipated date of award is April 1, 1994. INQUIRES Written and telephone inquiries concerning this RFA are encouraged. Inquires regarding programmatic issues may be directed to: Charles A. Wells, Ph.D. Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 622 Bethesda, MD 20892 Telephone: (301) 594-7505 June R. Lunney, Ph.D., R.N. Acute and Chronic Illness Branch National Center for Nursing Research Westwood Building, Room 754 Bethesda, MD 20892 Telephone: (301) 594-7397 Inquiries regarding fiscal matters may be directed to: Mrs. Betty Bailey Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649 Bethesda, MD 20892 Telephone: (301) 594-7543 Sally A. Nichols Grants Management Officer National Center for Nursing Research Westwood Building, Room 748 Bethesda, MD 208932 Telephone: (301) 594-7498 Schedule Letter of Intent Receipt Date: July 20, 1993 Application Receipt Date: August 20, 1993 Initial Review: October/November 1993 Anticipated Date of Award: April 1, 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.848. 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. REFERENCES 1. United States Department of Health and Human Services. Report of the Secretary's Task Force on Black and Minority Health. Vol. VII, United States Government Printing Office, Washington, D.C., January 1986. 2. Proceeding of the Symposium on Diabetes in African Americans: Diabetes Care, Volume 13, No. 11, Supplement 4, November 1990. 3. Proceeding of the Symposium on Diabetes in Blacks: Diabetes Care, Volume 14, No. 17, Supplement 3, July 1991. From owner-sci-resources@net.bio.net Thu May 06 23:00:00 1993 Path: biosci!kristoff From: kristoff@net.bio.net (David Kristofferson) Newsgroups: bionet.sci-resources Subject: This newsgroup is now moderated Message-ID: Date: 7 May 93 23:39:18 GMT Organization: BIOSCI International Newsgroups for Biology Lines: 16 Approved: biosci-moderator@net.bio.net This newsgroup is now moderated and will be used only for posting funding agency announcements unless an issue arises crucial to the operation of this newsgroup. Discussions can be held on BIOFORUM/bionet.general. Our apologies for the duplicate messages of the NIH Guide this afternoon. This was a consequence of one USENET site slightly jumping the gun on this newsgroup change. Sincerely, Dave Kristofferson BIOSCI/bionet Manager kristoff@net.bio.net From owner-sci-resources@net.bio.net Thu May 06 23:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: test message, please ignore Message-ID: Date: 7 May 93 21:52:55 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 3 checking the mailing list. From owner-sci-resources@net.bio.net Thu May 06 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. 18, pt. 7, 7 May 1993 Message-ID: Date: 7 May 93 18:23:57 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 815 $$XID RFA DK93008 DK-93-008 P1O1 *************************************** NIDDM PRIMARY PREVENTION TRIAL: DATA COORDINATING CENTER NIH Guide, Volume 22, Number 18, May 7, 1993 RFA: DK-93-008 P.T. 34; K.W. 0755015, 0745027, 0755018 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: September 17, 1993 Application Receipt Date: October 19, 1993 PURPOSE The Division of Diabetes, Endocrinology and Metabolic Diseases (DDEMD), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), invites cooperative agreement applications for the Data Coordinating Center in a multicenter, randomized clinical trial to evaluate the efficacy of interventions designed to delay or prevent onset of non-insulin dependent diabetes mellitus (NIDDM) in individuals at increased risk for NIDDM. The Data Coordinating Center will participate with the NIDDK and fifteen to twenty Clinical Centers in all phases of this trial. A separate request for the Clinical Centers has been issued (RFA DK-93-007). The Data Coordinating Center and a participating Clinical Center may be located in the same institution; however, each must be administratively and fiscally distinct from the other. 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), NIDDM Primary Prevention Trial, is related to the priority area of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock Number 017-001-00474-0 or Summary Report: Stock Number 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 for-profit and non-profit domestic organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit as Principal Investigators. Applications from minority institutions are especially encouraged. Applications from foreign institutions will not be considered. The expertise appropriate for this research program includes statistical knowledge of the clinical and epidemiological aspects of diabetes and expertise in data coordination for clinical trials. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be a cooperative agreement (U01), which is an assistance mechanism, rather than an acquisition mechanism. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by collaborating and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of a study funded under a cooperative agreement are discussed later in this document under the section "Terms and Conditions of Award." FUNDS AVAILABLE It is anticipated that an award for one new Data Coordinating Center will be made under this RFA. Support during the planning phase (Phase 1) of this trial in FY 1994 is expected to be approximately $1,000,000 (direct and indirect costs). The levels of effort are expected to remain at this amount during the remainder of the study. However, funding will be provided by the NIDDK to support subcontracts for centralized laboratory and clinical resources reflecting the start of the full scale trial and described in greater detail under SPECIAL REQUIREMENTS. Funds for the subcontract(s) will be approximately five million dollars (total costs) during Phase 2 to support adherence and end point analyses. Additional funds in the first year of Phase 2 will be provided to cover the costs of screening. The nature and extent of the screening will be established by the outcome of the protocol development. Funds to support the subcontract aspects of the Trial will largely cease during Phase 3 reflecting the final period of data analysis and reporting. Although this program is provided for in the financial plans of the NIDDK, an award in response to the RFA is contingent on the availability of funds for this purpose. The total project period for applications submitted in response to the present RFA will be seven years. This is due, in part, to the necessity to screen large numbers of potential participants to identify individuals with sufficient risk to answer the study question discussed under RESEARCH OBJECTIVES. The anticipated award date is July 1994. At this time the NIDDK anticipates that there will not be a renewed competition after seven years. If the NIDDK does not continue the program, awardees may submit grant applications through the usual investigator-initiated grants program. RESEARCH OBJECTIVES Background A family history of diabetes, obesity, insulin resistance, hyperinsulinemia, a history of gestational diabetes, and impaired glucose tolerance (IGT) are risk factors for NIDDM (1). Based on the NHANES II survey data, IGT is present in 16 percent of adults aged 40 to 74 in the US and in 23 percent of this age group who have a family history of diabetes and body weight greater than 120 percent of desirable weight (2). Minority populations have even higher rates of IGT (3). For high risk individuals the rate of progression to NIDDM is 5 to 10 percent per year (4). Importantly, screening for IGT can identify individuals at increased risk for development of NIDDM (5,7,7). In addition, obesity and gestational diabetes (GDM), an apparently temporary condition of pregnancy, are important independent risk factors for the subsequent development of NIDDM. African, Hispanic and Native American women have significantly increased prevalence of both of these conditions. It appears that excessive weight gain during pregnancy may play a role in the appearance of GDM and the documented lack of weight loss to pre-pregnancy levels following delivery may conspire to magnify the risk of future NIDDM in these groups of minority women. There is currently no accepted standard of care for patients with IGT or a history of GDM. Screening for IGT, which is undiagnosed in most affected individuals, is not widely recommended or practiced, nor are there accepted interventions for patients with IGT. No large scale, randomized, prospective, controlled clinical trials have determined whether or not progression of IGT to NIDDM can be prevented. Insulin resistance is the earliest abnormality detected in individuals who will develop NIDDM and appears to have a genetic component (8). However, it is not known whether reversing insulin resistance will prevent or delay onset of NIDDM. Insulin resistance can be reduced through weight reduction and exercise (9). Corresponding to these findings, epidemiological data indicate an association between exercise frequency and significant lowering of risk for NIDDM (10,11). Results of another study performed in Sweden suggest that moderate weight reduction of two to four percent of initial weight and increased maximal oxygen uptake of 10 to 14 percent could be maintained for a period of five years. This was associated with improvement in glucose tolerance, blood pressure, lipids, and hyperinsulinemia, and reduced mortality (12). Sustained intervention appears to be necessary to achieve these lifestyle changes (13) but importantly, such changes have the potential to slow the deterioration of glucose tolerance in IGT, thereby delaying the onset of diabetes. Pharmacologic agents also can potentially prevent or delay onset of NIDDM. Biguanides are suggested to reduce insulin resistance and improve glycemia and hyperinsulinemia, while sulfonylurea agents appear to improve glycemia by increasing insulin secretion and through extra-pancreatic effects. Data in the literature are inconclusive with respect to the ability of these agents to prevent or delay onset of NIDDM. One study using the biguanide metformin showed no effect on prevention or delay of onset (14). In contrast, studies with sulfonylureas have shown decreased rates of diabetes and of mortality in patients treated with modest doses for IGT (15,16) but are inconclusive. Nonetheless, these interventions could slow the deterioration of glucose tolerance in patients with IGT. In so doing, diabetic complications, including atherosclerosis, may also be delayed reducing morbidity and mortality due to diabetes. Methods are available for potentially reducing insulin resistance and improving glucose tolerance. Based on this and the high rates of IGT in the United States, the NIDDK has determined that a randomized controlled clinical trial is necessary. Such a trial would define the effectiveness of interventions for delaying or preventing NIDDM in high risk persons with glucose intolerance. Since the estimated population prevalence of undiagnosed NIDDM is six percent, screening for IGT will detect individuals with previously undiagnosed NIDDM, most of whom do not have fasting hyperglycemia (2). The NIDDK also believes that those with newly diagnosed NIDDM should be treated in a randomized, prospective fashion to determine whether early detection and treatment of NIDDM can reverse the disease process or have favorable effects on the deterioration of glucose tolerance that is characteristic of NIDDM. Goal of the Activity The purpose of this RFA is to invite applications for the Data Coordinating Center in a multicenter collaborative study of interventions to prevent NIDDM in people with IGT or a history of GDM and to prevent the worsening of glucose tolerance in people with newly diagnosed NIDDM. The study will determine whether onset of NIDDM can be delayed and whether interventions in newly diagnosed NIDDM can favorably influence glucose tolerance and progression to fasting hyperglycemia. The objectives of this RFA are to select a Data Coordinating Center to participate in the following: o A full-scale trial with the Clinical Centers and the NIDDK o Design of the study protocol and writing of the manual of operations o Development of the operational plans for the trial in close collaboration with the communities they serve. These plans must include racially and ethnically sensitive strategies for recruitment, screening, enrollment and adherence to the study protocol. o The establishment of clinical and laboratory subcontracts to serve as centrally supported resources for the Clinical Centers. Additional clinical centers will be recruited through a follow-up RFA if necessary to achieve adequate numbers of subjects. The collaborative protocol will be developed by a Steering Committee composed of the awardees, a Chairperson appointed by the voting members of the Steering Committee from among the Committee members or from experts in the field of diabetes and clinical trials not participating directly in the study, the Principal Investigator of the Data Coordinating Center, and the NIDDK Project Coordinator. The protocol and manual of operations will be subject to review by an uninvolved expert group (Policy and Data Monitoring Committee), and the NIDDK. The study will move into its operational phase only with the concurrence of the awardees, the Policy and Data Monitoring Committee, and the Institute. Scope of the Activity It is expected that the study will take place in fifteen to twenty Clinical Centers over a period of seven years. Each clinical center will randomize an average of 200 study participants over a 12 month period of recruitment. The entire collaborative clinical trial will consist of the following three phases: Phase 1 (12 months): Planning phase, collaborative development of the protocol and manual of operations which includes procedures for data collection and pretesting of these procedures. There must also be included in the manual well-defined procedures for the training and certification of clinic personnel in study procedures. Phase 2 (60 months): Conduct of the full-scale collaborative clinical trial including patient recruitment and followup. Phase 3 (12 months): Close out, analysis of data, and reporting of results. The Data Coordinating Center will participate during Phase 1 in the planning phase of the Trial including protocol development, preparation of the manuals of operations, sample size determination, estimates of event rates and full statistical oversight. Centralized laboratories and centralized clinical support facilities will also be developed during this period for use during Phase 2 supported through subcontracts. During Phases 2 and 3 the Data Coordinating Center will analyze the cumulative data from the study with appropriate participation of the Clinical Centers and the NIDDK. Participation in Phase 1 will require staff of the Data Coordinating Center to travel to meetings in a location such as Bethesda where the protocols, manuals, and forms will be developed. Phase 2 will require, in addition to data processing and analysis, qualified personnel to travel to the Clinical Centers to monitor quality control procedures, to attend meetings with Clinical Center personnel and NIDDK staff, and to conduct training programs for clinic staff. Phase 3 will require staff qualified to analyze data from large-scale clinical trials. Additionally, the Data Coordinating Center will be required to assist in managing the logistics of committee and sub-committee meetings during the course of the trial and be responsible for taking minutes of the various meetings. It will also provide the support and guidance necessary to maintain the scientific integrity of the trial through Coordinating Center staff or procurement of consultants. The Data Coordinating Center will be responsible for acquiring and administering subcontracts for central laboratory and clinical resources. The applicant for the Coordinating Center must identify and prepare budgets for the central laboratories and facilities proposed to carry out the centralized activities dictated by the trial protocol. The specific centralized facilities and the budgets to be supported through subcontracts will depend on the final protocol developed cooperatively by the Steering Committee. The applicant should address the requirements of the Trial with a description of the tasks to be performed and provide corresponding budgets as presented later under "Budget Preparation by Study Phase." It should, however, be understood that the final budgets will be determined following the design of the study protocol and writing of the manual of operations. Examples of the types of centralized laboratory functions that may be required include analyses such as blood glucose determinations, blood lipid and lipoprotein subtypes, and determination of drug treatment levels. Endpoint analyses may include measures conducted at centralized reading centers for electrocardiograms, reading of fundus photography, non invasive vascular determinations and renal and cardiovascular biochemistry. For a central laboratory supported by a subcontract from the Data Coordinating Center, all NIH policies and procedures governing consortium grants must be adhered to. The Data Coordinating Center will process and review all data transmitted on standard forms and prepare periodic reports to participating clinics on outstanding, incomplete, and delinquent forms or other missing information. The Coordinating Center will also prepare reports to the NIDDK and the Steering and the Policy and Data Monitoring Committees at regular intervals and as dictated by the study needs. The NIDDK Project Director will serve as a liaison between the Data Coordinating Center and the Clinical Centers. During Phase 3, the Data Coordinating Center will complete all analyses of the data from the clinical trial. Final reports will be submitted to the Steering Committee and the Policy and Data Monitoring Committee. The Coordinating Center, after final analyses, will collaborate with the investigators and the NIDDK to prepare reports of the study for publication. SPECIAL REQUIREMENTS The Data Coordinating Center will be closely involved with all facets of the trial from the initiation of Phase 1 to Phase 3 final data analysis and reporting. The following minimum number of issues should accordingly be addressed: o The participation of the Coordinating Center in the design and refinement of all protocols and the Coordinating Center's function as central point for assembling the Manuals of Operation and Forms Manuals; o The Data Coordinating Center's primary responsibility in developing and implementing systems necessary for intra-study communications. o The primary responsibility of the Data Coordinating Center for data collection, editing, processing, analysis and reporting. o The responsibility for monitoring both the quality of the data and the performance of each clinical center in the performance of the protocols. o Documentation for experience in utilizing procedures that insure the safety and confidentiality of all records. Personnel A Director and Deputy Director for the Data Coordinating Center must be designated. The Director of the Data Coordinating Center should be an experienced biostatistician, epidemiologist, physician, or other professional with experience in directing a coordinating center for a large scale collaborative clinical trial or other large scale epidemiological research project. A physician with professional interests in diabetes as part of the management team is highly desirable. Staff needs may be modified as the trial progresses; however, statisticians, systems analysts, programmers, statistical assistants, clerks, and administrative assistants must be available. It is appropriate that funds for adequate support staff to manage routine tasks be requested. It is expected that senior statistical staff devote time to developing data analysis methods for use in the trial. Budget Preparation by Study Phase Applicants for the Data Coordinating Center should submit adequately justified budgets for the entire anticipated project period of 84 months. The budgets for each phase of the study should be clearly delineated. Final budgets, however, will be generated following the design of the study protocol and writing the manual of operations during Phase 1. The Phase 1 budget period will be for establishment of the Data Coordinating Center staff such as the PI, senior statistical advisor, biostatistician, senior data controller, and others as required to carry out the Coordinating Center's functions. During this phase the collaborating centralized laboratory functions and facilities and individuals to perform clinical determinations of outcome measures will be identified. These centralized functions will be supported by subcontracts provided through the Data Coordinating Center and are to be included in the overall Coordinating Center budget for Phase 2. The Phase 2 period will be for 60 months. Separate budgets for each 12-month budget period in Phase 2 should be submitted. Activities in this second period will include all data handling costs, reporting functions, meetings and the cost of the subcontracts necessary to carry out laboratory and other central functions. The Phase 3 budget period will be for 12 months. This budget period will be concerned with study close-out, analysis of study data, and reporting of results in collaboration with the centers. Budgets for both Phases 2 and 3 will be modified based on the final protocol developed collaboratively during Phase 1. Terms and Conditions of Award 1. Cooperative Activities. The administrative and funding mechanism to be used to undertake this project will be cooperative agreements (U01), which is an "assistance" mechanism, rather than and "acquisition" mechanism. Under the cooperative agreement, the NIDDK purpose is to support and/or stimulate the recipient's activity by collaborating and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity., Consistent with this concept, the tasks and activities in carrying out the studies will be shared among the awardees and the NIDDK Project Coordinator. 2. Awardees Activities. Awardees will have substantial and lead responsibilities in all tasks and activities. These include protocol development, patient recruitment and follow-up, data collection, quality control, final data analysis and interpretation, preparation of publications. The awardee agrees to work cooperatively with the Clinical Centers and agrees to follow the common protocol and manual of operations developed in Phase 1 of the study by the Steering Committee. Awardees will retain custody of and have primary rights to their data developed under these awards, subject to Government, e.g., NIDDK, NIH, or PHS, rights or access consistent with current HHS, PHS, and NIH policies. 3. NIDDK Activities. It is the intention of the NIDDK that the central resource units for the standardized assessment of key laboratory and clinical parameters will be established and utilized by all participating Clinical Centers. These central resources will function and be supported under the Data Coordinating Center award. The NIDDK will name the Director, Special Programs from within the Division of Diabetes, Endocrinology, and Metabolic Diseases to be the Project Coordinator whose function will be to assist the Steering Committee and Policy and Data Monitoring Committee in carrying out the study. The Project Coordinator will be a voting member of all key study group committees. The Project Coordinator will serve as executive secretary of the independent Policy and Data Monitoring Committee. The NIDDK Project Coordinator will assist in quality control, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and coordination and performance monitoring. The NIDDK Project Coordinator will have voting membership on the Steering Committee, and as appropriate, its subcommittees. The NIDDK reserves the right to terminate or curtail the study (or an individual award) in the event of (a) a major breach in the protocol or substantial changes in the agreed-upon protocol with which the Institute does not agree or (b) human subject ethical issues that may dictate a premature termination. 4. Governance. The primary governing body of the study will be the Steering Committee comprised of each of the Principal Investigators of the Clinical Centers and the Data Coordinating Center and the NIDDK Project Coordinator. The Steering Committee will have primary responsibility for developing common clinical protocols, facilitating the conduct and monitoring of the studies, and reporting the study results. Topics for the protocols will be proposed and prioritized by the steering Committee. Each member of the Steering Committee will have one vote. A chairperson will be appointed by the voting members of the Steering Committee from among the Steering Committee members but not including the Project Coordinator, or alternatively, from among experts in the field of diabetes and clinical trials who are not participating directly in the study. It is anticipated that the Steering Committee will meet on a monthly basis during protocol development (Phase 1), three times a year in Phase 2, and two times in Phase 3. Subcommittees of the Steering Committee may be established as necessary and will meet as necessary. The NIDDK Project Coordinator or designee and the Data Coordinating Center will be represented on each subcommittee. An independent Policy and Data Monitoring Committee supported by the NIDDK and composed of experts in relevant medical, psychological, statistical, operational, and bioethical fields who are not otherwise involved in the study will be established to review periodically the progress of the study. The committee will oversee participant safety, evaluate results, monitor data quality, and provide operational and policy advice to the Steering Committee and the NIDDK regarding the status of the study. The Principal Investigator of the Data Coordinating Center, the NIDDK Project Coordinator, and the Director of the Division of Diabetes, Endocrinology and Metabolism may participate as ex-officio, non-voting members of this Committee. Committee members will be appointed by the Director, NIDDK in consultation with members of the Steering Committee. The NIDDK named Project Coordinator will serve as executive secretary of the Policy and Data Monitoring Committee. 5. Arbitration. Any disagreement that may arise in scientific-programmatic matters between award recipients and NIDDK may be brought to arbitration. An arbitration panel will be composed of three members - one selected by the Steering Committee (with NIDDK member not voting) or by the individual awardees in the event of an individual disagreement, a second member selected by NIDDK and the third member selected by the preceding two members. This special arbitration procedure in no way affects the awardees' right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR part 50, subpart D and HHS regulations at 45 CFR part 16. These special terms of award described above are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR parts 74 and 92, and other HHS, PHS, and NIH grant administration policy statements. 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 Item 4 (Research Design and Methods) of the Research Plan AND summarized in Item 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. If the required information is not contained within the application, the application will be returned without review. 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, but not required, to submit a letter of intent. This letter is to include the name, telephone number and mailing address of the Principal Investigator, the names of other key personnel, the name of the applicant institution, and the number and title of this RFA. Such a letter of intent is not binding and it will not enter into the review of any application subsequently submitted nor is it a necessary requirement for application. Letters of intent are requested solely for planning purposes. The information contained in these letters is helpful in planning for the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid possible conflicts of interest in the review. The NIDDK staff will not provide responses to such letters. Letters of intent are to be received no later than September 17, 1993, and are to be addressed to: Robert D. Hammond, Ph.D. Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 594-7515 FAX: (301) 594-7503 APPLICATION PROCEDURES Submit applications on form PHS 398 (rev. 9/91), the application form for NIH research project grants. This form is available in the applicant institution's office of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7250. Use the conventional format for research project grant applications and ensure that the points identified in the SPECIAL REQUIREMENTS section above and in the "Review Criteria" section below are fulfilled. To identify the application as a response to the RFA, Check "YES" on item 2a of page 1 of the application and enter the title "NIDDM Primary Prevention Trial: Data Coordinating Center" and enter the RFA number DK-93-008 in the space provided. The RFA label found in the form PHS 398 application kit must be affixed to the bottom of the face page of the original completed application form. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Send or deliver the completed, signed application and three complete photocopies to the following office, making sure that the original application with the RFA label attached is on top: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Send two additional copies of the application to Dr. Hammond at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants, otherwise the NIDDK cannot guarantee that the application will be reviewed in competition for the RFA. Applications must be received by October 19, 1993. An application not received by this date will be returned to the applicant. REVIEW CONSIDERATIONS Upon receipt, the Division of Research Grants (DRG) will review applications for completeness. Applications will be reviewed by NIDDK staff for responsiveness to the objectives of this RFA. If an application is judged unresponsive or incomplete, the application will be returned. If the number of applications is large compared to the number of awards to be made, the NIDDK will conduct a preliminary scientific peer review and will withdraw from further competition those applications that are not competitive for award. The NIDDK will notify the applicant and institutional official of this action. Those applications judged to be both competitive and responsive will be evaluated further 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, NIDDK. Subsequently, they will be reviewed by the National Advisory Diabetes and Digestive and Kidney Diseases Council. Review Criteria Specific criteria for review of applications will be as follows: o The scientific merit of the proposed approach to study design, data collection and management for interventions as outlined in the RFA o Documentation of the specific competence and previous experience of professional, technical, and administrative staff pertinent to the operation of a Data Coordinating Center for a collaborative clinical trial. Prior experience in the collection of data from multiple clinical sites, as well as experience in monitoring the quality of such data must be demonstrated. o The approach to developing a cooperative relationship among the participating clinical centers and exercising appropriate leadership in matters of study design, data acquisition, data management, and data analysis, o Suitability of the proposed data management and data analysis plans as well as the specific plans for central laboratories and clinical facilities, o Appropriateness of the proposed budget, o Ability to identify and enlist the cooperation of central laboratories and clinical facilities to carry out centralized biochemical and clinical support functions for the Clinical Centers. o The adequacy of the proposed facility, technical hardware, and space; o The organizational and administrative structure of the proposed Coordinating Center, o Evidence of the degree of commitment and support of the organization/institution for the proposed Coordinating Center including documentation of available space. Seminar for Prospective Applicants A special technical assistance workshop will be offered to assist potential applicants. The purpose of this seminar is to give background information and respond to any questions about the preparation of an application in response to this RFA. The workshop will be held in the Washington, DC metropolitan area approximately one month after the publication of this announcement. The NIH cannot support individuals who wish to attend the conference, but the conference will be open to any individual who wishes to attend. Interested persons may contact Dr. Sanford A. Garfield, at the address listed under INQUIRIES, for further information. AWARD CRITERIA The anticipated date of award is July 1994. Applications will compete for available funds with all other approved applications submitted in response to this RFA. The following will be considered in making funding decisions: o Quality of the proposed work as determined by peer review, o Availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Sanford Garfield, Ph.D. Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 626 Bethesda, MD 20892 Telephone: (301) 594-7535 FAX: (301) 594-9011 Inquiries regarding fiscal matters may be directed to: Linda Stecklein Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649B Bethesda, MD 20892 Telephone: (301) 594-7543 FAX: (301) 594-7594 Schedule Letter of Intent Receipt Date: September 17, 1993 Application Receipt Date: October 19, 1993 Initial Review: February/March 1994 Review by the NIDDK Council: May/June 1994 Anticipated Award Date: July 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99- 158, 42 USC 241 and 285) and administered under PHS Grants Policies and Federal Regulations 42 CFR Part 52 and 45 CFR parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. References: 1. National Diabetes Data Group: Classification and diagnosis of diabetes mellitus and other categories of glucose intolerance. Diabetes 28:1039-57, 1979 2. Harris MI, Hadden WC, Knowler WC, Bennett PH. Prevalence of diabetes and impaired glucose tolerance and plasma glucose levels in U.S. population aged 20-74 yr. Diabetes 36:523-534;1987 3. Harris MI Epidemiological correlates of NIDDM in Hispanics, Whites, and Blacks in the U.S. population. Diabetes Care 14:639-648:1991 4. Saad MF, Knowler WC, Pettitt DJ, Nelson RG, Mott DM, Bennett PH. The natural history of impaired glucose tolerance in the Pima Indians. New Engl J Med 319:1500- 1506;1988 5. Yudkin JS, Alberti KGMM, Mclarty DG, Swai ABM Impaired glucose tolerance. Brit Med J 301:397-402;1990 6. Eriksson KF, Lindgarde F, Impaired glucose tolerance in a middle-aged male urban population: a new approach for identifying high risk cases. Diabetologia 33:526- 531;1990 7. Harris MI, Hadden WC, Knowler WC, Bennett PH: International criteria for the diagnosis of diabetes and impaired glucose tolerance. Diabetes Care 8:562-67, 1985 8. Lillioja S, Mott DM, Zawadzki JK, Young AA, Abbott WGH, Knowler WC, Bennett PH, Moll P, Bogardus C. In vivo insulin action is a familial characteristic in nondiabetic Pima Indians. Diabetes 36:1329;1987 9. Horton ES. Exercise and decreased risk of NIDDM. N Engl J Med 325:197;1991 (editorial) 10. Helmrich SP, Ragland DR, Leung RW, Paffenbarger RS. Physical activity and reduced occurrence of non-insulin- dependent diabetes mellitus. N Engl J Med 325:147;1991 11. Manson JE, Nathan DM, Krowlewski AS, Stampfer MJ, Willett WC, Hennekens CH. A prospective study of exercise and incidence of diabetes among US male physicians. JAMA 268:63;1992 12. Eriksson KF, Lindgarde F. Prevention of Type 2 (non-insulin-dependent) diabetes mellitus by diet and physical exercise: The 6-year Malmo feasibility study. Diabetologia 34:891-898;1991 13. Page RCL, Harnden KE, Cook JTE, Turner RC. Can life-styles of subjects with impaired glucose tolerance be changed? A feasibility study. Diabetic Medicine 9:562-566;1992 14. Jarrett RJ, Keen H, Fuller H, McCartney M. Worsening to diabetes in men with impaired glucose tolerance ("Borderline Diabetes"). Diabetologia 16:25- 30;1979 15. Sartor G, Schersten B, Carlstrom S, Melander A, Norden A, Persson G. Ten-year follow-up of subjects with impaired glucose tolerance. Diabetes 29:41;1980 16. Melander A, Bitzen P-O, Sartor G, Schersten B, Wahlin-Boll E. Will sulfonylurea treatment of impaired glucose tolerance delay development and complications of NIDDM? Diabetes Care 13:53-58;1990 From owner-sci-resources@net.bio.net Thu May 06 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. 18, pt. 6, 7 May 1993 Message-ID: Date: 7 May 93 18:22:59 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 938 $$XID RFA DK93007 DK-93-007 P1O1 *************************************** NON-INSULIN DEPENDENT DIABETES PRIMARY PREVENTION TRIAL NIH Guide, Volume 22, Number 18, May 7, 1993 RFA: DK-93-007 P.T. 34; K.W. 0715075, 0755015, 0745027 National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Child Health and Human Development Office of Research on Minority Health Letter of Intent Receipt Date: September 17, 1993 Application Receipt Date: October 19, 1993 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Child Health and Human Development (NICHD), and the Office of Research on Minority Health (ORMH) invite cooperative agreement applications for investigators to design and implement a full-scale, multicenter, randomized clinical trial to evaluate the efficacy of interventions designed to delay or prevent onset of non-insulin dependent diabetes mellitus (NIDDM) in individuals at increased risk for NIDDM. Within the broad range of this NIDDK and NICHD-sponsored initiative, ORMH is providing specific support for research focussing on the sub-population of obese minority women with a history of gestational diabetes. 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, NIDDM Primary Prevention Trial, is related to the priority area of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock Number 017-001-00474-0 or Summary Report: Stock Number 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 for-profit and non-profit domestic organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit as Principal Investigators. Applications from minority institutions are especially encouraged. Applications from foreign institutions will not be considered. The expertise appropriate for this research program includes a knowledge of the clinical and epidemiological aspects of diabetes. Institutions wishing to collaborate and function as a single Clinical Center are required to submit one application. In this regard, applicants are encouraged to form collaborative arrangements with investigators at minority institutions and/or minority investigators at other institutions. However, international collaborations are unacceptable. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be a cooperative agreement (U01), which is an assistance mechanism, rather than an acquisition mechanism. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by collaborating and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of this study funded under a cooperative agreement are discussed under the section "Terms and Conditions of Award." FUNDS AVAILABLE Support during the planning phase (Phase 1) of this trial for FY 1994 is expected to be approximately seven million dollars with total costs per center of approximately $350,000. It is anticipated that awards for 15 to 20 new Clinical Centers will be made. Additional centers will be recruited through a follow-up RFA if necessary to achieve adequate numbers of subjects. During Phase 2 (full scale trial period) it is expected that funding levels for each center will increase to approximately $500,000 reflecting the start of the full scale trial. During Phase 3 (close-out period) costs are expected to decrease to approximately $100,000 in keeping with the reduction in clinical personnel effort and the shift to close-out, analysis of data, and reporting. Cost for outcome measures should not be included individually for each center. These costs will be covered under the Data Coordinating Center funding. Although this program is provided for in the financial plans of the NIDDK and the NICHD, awards in response to this RFA are contingent on the availability of funds for this purpose. The total project period for applications submitted in response to the present RFA will be seven years due, in part, to the necessity to screen large numbers of potential participants to identify individuals with sufficient risk to answer the study question discussed below under "RESEARCH OBJECTIVES". The anticipated award date is July 1994. At this time, the NIDDK anticipates that there will not be a renewed competition after seven years. If the NIDDK does not continue the program, awardees may submit grant applications through the usual investigator-initiated grants program. RESEARCH OBJECTIVES Background A family history of diabetes, obesity, insulin resistance, hyperinsulinemia, a history of gestational diabetes, and impaired glucose tolerance (IGT) are risk factors for NIDDM (1). Based on the NHANES II survey data, IGT is present in 16 percent of adults aged 40 to 74 in the U.S. and in 23 percent of this age group who have a family history of diabetes and body weight greater than 120 percent of desirable weight (2). Minority populations have even higher rates of IGT (3). For high risk individuals the rate of progression to NIDDM is 5 to 10 per cent per year (4). Importantly, screening for IGT can identify individuals at increased risk for development of NIDDM (5,6,7). There is currently no accepted standard of care for patients with IGT. Screening for IGT, which is undiagnosed in most affected individuals, is not widely recommended or practiced, nor are there accepted interventions for patients with IGT. No large scale, randomized, prospective, controlled clinical trials have determined whether or not progression of IGT to NIDDM can be prevented. In addition, obesity and gestational diabetes (GDM), an apparently temporary condition of pregnancy, are important independent risk factors for the subsequent development of NIDDM. African, Hispanic, and Native American women have significantly increased prevalence of both of these conditions. It appears that excessive weight gain during pregnancy may play a role in the appearance of GDM and the documented lack of weight loss to pre-pregnancy levels following delivery may conspire to magnify the risk of future NIDDM in these groups of minority women. Insulin resistance is the earliest abnormality detected in individuals who will develop NIDDM and appears to be genetically determined (8). However, it is not known whether reversing insulin resistance will prevent or delay onset of NIDDM. Insulin resistance can be reduced through weight reduction and exercise (9). Corresponding to these findings, epidemiologic data indicate an association between exercise frequency and significant lowering of risk for NIDDM (10,11). Results of a study performed in Sweden suggest that moderate weight reduction of two to four percent of initial weight and increased maximal oxygen uptake of 10 to 14 percent can be maintained for a period of five years. This was found to be associated with improvement in glucose tolerance, blood pressure, lipids, hyperinsulinemia, and reduced mortality (12). Sustained intervention appears to be necessary to achieve these lifestyle changes (13), but importantly, such changes have the potential to slow the deterioration of glucose tolerance in IGT, thereby delaying the onset of diabetes. Pharmacologic agents also can potentially prevent or delay onset of NIDDM. Biguanides are suggested to reduce insulin resistance and improve glycemia and hyperinsulinemia, while sulfonylurea agents appear to improve glycemia by increasing insulin secretion and through extra-pancreatic effects. Data in the literature are inconclusive with respect to the ability of these agents to prevent or delay onset of NIDDM. One study using the biguanide metformin showed no effect on prevention or delay of onset (14). In contrast, studies with sulfonylureas have shown decreased rates of diabetes and of mortality in patients treated with modest doses for IGT (15,16) but are inconclusive. Nonetheless, these interventions could slow the deterioration of glucose tolerance in patients with IGT. In so doing, diabetic complications, including atherosclerosis, may also be delayed reducing morbidity and mortality due to diabetes. Methods are available for potentially reducing insulin resistance and improving glucose tolerance. Based on this and the high rates of IGT in the United States, the NIDDK has determined that a randomized controlled clinical trial is necessary. Such a trial would define the effectiveness of interventions for delaying or preventing NIDDM in high risk persons with impaired glucose tolerance. Since the estimated population prevalence of undiagnosed NIDDM is six percent screening for IGT will detect individuals with previously undiagnosed NIDDM, most of whom do not have fasting hyperglycemia (2). In addition, the NIDDK considers that those with newly diagnosed NIDDM should be treated in a randomized, prospective fashion to determine whether early detection and treatment of NIDDM can reverse the disease process or have favorable effects on the deterioration of glucose tolerance that is characteristic of NIDDM. The NIDDK also believes that obese minority women with a history of GDM constitute an excellent interventional target to establish whether the expected high rate of NIDDM in this population can be altered. Goal of the Activity The purpose of this RFA is to initiate a collaborative study of interventions to prevent NIDDM in people with IGT or a history of GDM and to prevent the worsening of glucose tolerance in people with newly diagnosed NIDDM. The study will determine whether onset of NIDDM can be delayed and whether interventions in newly diagnosed NIDDM can favorably influence glucose tolerance and progression to fasting hyperglycemia. The objectives of this RFA are to select centers to: o Participate in a full-scale trial. o Design the study protocol and write the manual of operations. o Develop operational plans for the trial in close collaboration with the communities they serve. These plans must include racially and ethnically sensitive strategies for recruitment, screening, enrollment and adherence to the study protocol. The collaborative protocol will be developed by a Steering Committee composed of the awardees, the Chairperson, the Principal Investigator of the Data Coordinating Center, and the NIDDK Project Coordinator. The protocol and manual of operations will be subject to review by an uninvolved expert group (Policy and Data Monitoring Committee), and the NIDDK. The study will move into its operational phase only with the concurrence of the awardees, the Policy and Data Monitoring Committee, and the Institute. Scope of the Activity It is expected that the study will take place in fifteen to twenty Clinical Centers over a period of seven years. The clinical centers will randomize an approximate average of 200 study participants per center over a 12 month period of recruitment. The entire collaborative clinical trial will consist of the following three phases: Phase 1 (12 months): Planning phase, collaborative development of the protocol and manual of operations which includes procedures for data collection and pretesting of these procedures. There must also be included in the manual well-defined procedures for the training and certification of clinic personnel in study procedures. Phase 2 (60 months): Conduct of the full-scale collaborative clinical trial including patient recruitment and followup. Phase 3 (12 months): Close out, analysis of data, and reporting of results. Each applicant should propose the study design he or she believes best addresses the objectives of this project and is most appropriate for their patient population. The goal of the NIDDK and the NICHD is to have approximately 50 per cent of the subject population comprised of minorities. The study population mix at any one center may vary from this overall goal based on local demography. The overall study population may include, but is not limited to, Caucasians, Native Americans and Alaskan Natives, Blacks, Hispanics, and Asian/Pacific Islanders. In addition, applicants are encouraged, if a suitable population base exists, to include a cohort of obese women with a history of GDM. Applicants should provide a detailed justification for whatever strategy is proposed for subject selection as well as an estimate of the number of subjects in the source population and an estimate of the necessary time and effort needed for recruitment. Issues of racial and subgroup analysis will be dealt with by the Steering Committee. It is not the intent of this RFA to solicit elaborately detailed research plans for the conduct of the trial since the final protocols will be collaboratively developed by the investigators and the NIDDK during the planning phase (Phase 1) of the study described later under "Study Phases". SPECIAL REQUIREMENTS To promote the development of a collaborative program among the award recipients, the following minimum number of issues should be addressed: o The rationale and criteria for subject selection, as well as plans for and documentation of the ability to recruit sufficient numbers of study participants; o Documentation of specific competence and previous experience of the professional, technical, and administrative staff in the operation of a Clinical Center in the proposed study; o Documentation of experience in the treatment of persons with diabetes; o The willingness of the applicant to work cooperatively with the other Clinical and Data Coordinating Centers; and o The willingness to follow the common protocols that will be collaboratively developed in Phase 1. Personnel The participating members of the study team should include or have access to: o Diabetologists to enroll and maintain the patients in this study and coordinate the activities of the medical team. The diabetologists used in this study must have faculty appointments. o Nurse/Clinic Coordinator who can provide full-time attention to clinic administration and management, including logistical aspects of patient follow-up and data transmittal in addition to participating in management of patients; o Behavioral scientists to conduct standardized neuropsychological testing and psychological evaluations and to provide consultation to other clinic staff in the selection and management of the study subjects; o Exercise trainer\therapist to conduct the exercise related aspects of this trial o Nutritionists-dieticians and nurse educators to perform the educational aspects of the Protocol and provide diabetes care; and o clerical and technical support. Study Organization 1. Study Outline. The applicant's study design should include a detailed proposal of eligibility requirements including patient age, gender, and racial/ethnic background for study participation. In addition, exclusion criteria should be specified. Consideration should be given to screening individuals in the population at higher risk for NIDDM, such as those with obesity and a family history of diabetes. The procedure for screening for IGT should be provided in the application. The screening procedure should be designed to identify individuals at highest risk for progression to NIDDM and to minimize inclusion of individuals with transient IGT. It has been documented that women with a history of GDM are also at particularly high risk for the subsequent development of NIDDM. Thus, in addition to the NIDDK, the OMP is particularly interested in addressing this minority women's health issue. Applicants are therefore encouraged to include a GDM cohort in their study population where a suitable population base exists. Interventions may include diet, exercise, and pharmacologic agents in a randomized, placebo controlled, factorial design. Individuals with newly diagnosed NIDDM identified in the screening process should be included in the randomization scheme. Methods to monitor patient adherence to the trial protocol must be clearly defined. Proposed methods for management of cardiovascular risk factors, including hypertension, dyslipidemia, and smoking cessation in all subjects should be included. For IGT or for women with a history of GDM, outcome measures should be chosen to address the efficacy and adverse effects of interventions on deterioration of glucose tolerance and progression to NIDDM. For newly diagnosed diabetes, outcome measures should address the efficacy and adverse effects of interventions to prevent deterioration of glucose tolerance and progression of hyperglycemia. Outcome measures should include sequential evaluation of metabolic status. All centers must agree to implement the protocol and manual of operations that will be developed cooperatively by the Steering Committee during Phase 1 and agree to transmit all study data to a central Data Coordinating Center for combination and analysis. The recruitment of a Data Coordinating Center will be accomplished by means of a separate RFA (DK-93-008). 2. Study Components a. Clinical Centers. A Clinical Center is an institution that is actively involved in the recruitment, evaluation, treatment, and follow-up of study participants. It should consist of a core team of researchers, including Principal Investigator, full-time study coordinator, nutritionist, behaviorist, exercise therapist\trainer and clerical staff. Applications for Clinical Centers should provide evidence that the center will be capable of screening for IGT and NIDDM and, if applicable, have access to a patient base of women with a history of GDM. It will be the goal of each center to randomize approximately 200 participants into the study during the 12 month period of recruitment. Clinical Centers should describe their experience in recruiting and studying patients with diabetes including those with a history of GDM or other conditions, and in minimizing losses of patients to follow-up during long-term clinical studies. There should be evidence of strong institutional support for the Clinical Center, including documentation of adequate space in which to conduct clinic activities and office space for staff. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources are strongly encouraged to use this facility and to identify the GCRC as a resource for conducting the proposed study. If so, a letter of agreement from either the GCRC Program Director or Principal Investigator should be included with the application. An organizational structure for the Clinical Center should be provided in the application delineating lines of authority and responsibility for dealing with problems in all general areas. In addition, a statement of agreement to follow the common protocol agreed upon in Phase 1 should be included. The applicant should include a succinct discussion of previous relevant investigational efforts. The applicant also should discuss in detail the important design considerations for a clinical trial to investigate primary prevention of NIDDM, intervention in newly diagnosed NIDDM, and treatment of cardiovascular risk factors in study participants, and suggest solutions to likely problems. Clinical Centers will be required to submit protocol data expeditiously to a central Data Coordinating Center. The Principal Investigator and treatment team in each Clinical Center should be skilled in diabetes management and collaborative clinical investigation. b. Steering Committee. The primary governing body of the study will be the Steering Committee comprised of each of the Principal Investigators of the Clinical Centers and the Data Coordinating Center and The NIDDK Project Coordinator (described in detail under Terms and Conditions). c. Data Coordinating Center. A Data Coordinating Center recruited through a separate RFA (DK-93-008) will participate with the Clinical Centers and Institute staff during the entire clinical trial. The Data Coordinating Center will have primary responsibility for the biostatistical analyses and data management aspects of the trial. It will also manage through subcontracts the central laboratory and clinical support aspects of this trial. The Data Coordinating Center will perform interim analyses as needed to monitor the course of the trial as well as analyses needed for final reporting. Preparation of interim and final reports, however, will be collaborative undertakings by all participating Centers, the Data Coordinating Center, and the NIDDK. d. Policy and Data Monitoring Committee. An independent committee supported by the NIDDK and composed of experts in relevant medical, psychological, statistical, operational, and bioethical fields who are not otherwise involved in the study will be established to review periodically the progress of the study (described in detail under Terms and Conditions). e. Project Coordinator. The NIDDK will name the Director, Special Programs from within the Division of Diabetes, Endocrinology, and Metabolic Diseases to be the Project Coordinator. The Project Coordinator's function will be to assist the Steering Committee and Policy and Data Monitoring Committee in carrying out the study (described in detail under Terms and Conditions). Study Phases After the protocol is completed by the study group during the planning phase (Phase 1), it will be reviewed by the Policy and Data Monitoring Committee and the NIDDK. Progression to Phase 2 is dependent on the favorable recommendation of the protocol by the Policy and Data Monitoring Committee and the concurrence of the NIDDK. The protocol for the study will be implemented in Phase 2. It is anticipated that the Clinical Centers will recruit and randomize participants, implement the protocol according to the manual of operations, collect the outcome data specified in the protocol, and provide all study data to the Data Coordinating Center. Twelve months will be allowed for subject recruitment and randomization. Clinical Centers will be responsible for collecting and shipping patient specimens and other study data to designated Central Resource Units. The final phase (Phase 3) of the study will be for close-out of Clinical Center activities, final data analysis, and reporting of results. Phase 3 will be for a period of 12 months. Budget Preparation by Study Phase Each applicant for a Clinical Center should submit adequately justified budgets for the entire anticipated project period of 84 months. The budgets for each phase of the study should be clearly delineated. Detailed budgets will vary according to policies of the applicant institution and specific needs identified in the response to this announcement. Applicants should prepare individual budgets for each of the three planned phases of the study. The Phase 1 budget period will be for development of the protocol and manual of operations, staff training and certification. The Phase 2 period will be for 60 months. Separate budgets for each 12-month budget period in Phase 2 should be submitted. Activities in this second phase will include subject recruitment, randomization, treatment, and clinical assessment of randomized study participants. The Phase 3 period will be for 12 months. This budget period will be concerned with study close-out, analysis of study data, and reporting of results. Phase 1 activities will require phasing-in of staff within six-months prior to initiating recruitment. Budgets should allow for approximately three persons, including the Principal Investigator, to attend Steering Committee and Subcommittee meetings. The detailed budget for this phase should be estimated on the basis of monthly meetings during Phase 1. Phase 2 budgets should include travel funds for three evenly spaced meetings per year during Phase 2. Phase 3 will involve two meetings over the twelve-month interval. Each meeting should be assumed to be for two days at a cost of $1000 per person. Detailed budget estimates for Phase 2 and 3 should be based on the applicant's proposed plan. Budgets for both Phases 2 and 3 will be modified based on the final protocol developed collaboratively during Phase 1. Terms and Conditions of Award 1. Cooperative Activities. The administrative and funding mechanism to be used to undertake this project will be cooperative agreements (U01), which is an assistance mechanism, rather than and acquisition mechanism. Under the cooperative agreement, the NIDDK and NICHD purpose is to support and/or stimulate the recipient's activity by collaborating and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the tasks and activities in carrying out the studies will be shared among the awardees and the NIDDK Project Coordinator. 2. Awardee Activities. Awardees will have substantial and lead responsibilities in all tasks and activities. These include protocol development, patient recruitment and follow-up, data collection, quality control, final data analysis and interpretation, preparation of publications. The awardee agrees to work cooperatively with the other Clinical and Data Coordinating Centers and agrees to follow the common protocol and manual of operations developed in Phase 1 of the study by the Steering Committee. The awardee also agrees to transmit all study data to a central Data Coordinating Center for combination and analysis. Awardees will retain custody of and have primary rights to their data developed under these awards, subject to Government, e.g., NIDDK, NIH, or PHS, rights or access consistent with current HHS, PHS, and NIH policies. 3. NIDDK Activities. It is the intention of the NIDDK that central resource units for the standardized assessment of key laboratory and clinical parameters will be established and utilized by all participating Clinical Centers. These central resources will function and be supported under the Data Coordinating Center award. The NIDDK will name a Project Coordinator from within the Division of Diabetes, Endocrinology, and Metabolic Diseases whose function will be to assist the Steering Committee and Policy and Data Monitoring Committee in carrying out the study. The Project Coordinator will be a voting member of all key study group committees. The Project Coordinator will serve as executive secretary of the independent Policy and Data Monitoring Committee. The NIDDK Project Coordinator will assist in quality control, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and coordination and performance monitoring. The NIDDK Project Coordinator will have voting membership on the Steering Committee, and as appropriate, its subcommittees. The NIDDK and NICHD reserves the right to terminate or curtail the study (or an individual award) in the event of (a) a major breach in the protocol or substantial changes in the agreed-upon protocol with which the Institute does not agree or (b) human subject ethical issues that may dictate a premature termination. 4. Governance. The primary governing body of the study will be the Steering Committee comprised of each of the Principal Investigators of the Clinical Centers and the Data Coordinating Center and the NIDDK Project Coordinator. The Steering Committee has primary responsibility for developing common clinical protocols, facilitating the conduct and monitoring of the studies, and reporting the study results. Topics for the protocols will be proposed and prioritized by the steering Committee. Each member of the Steering Committee will have one vote. A chairperson will be appointed by the voting members of the Steering Committee from among the Steering Committee members but not the Project Coordinator, or alternatively, from among experts in the field of diabetes and clinical trials who are not participating directly in the study. It is anticipated that the Steering Committee will meet on a monthly basis during protocol development (Phase 1), three times a year in Phase 2, and two times in Phase 3. Subcommittees of the Steering Committee may be established as necessary and will meet as necessary. The NIDDK Project Coordinator or designee and the Data Coordinating Center will be represented on each subcommittee. An independent Policy and Data Monitoring Committee supported by the NIDDK and composed of experts in relevant medical, psychological, statistical, operational, and bioethical fields who are not otherwise involved in the study will be established to review periodically the progress of the study. The committee will oversee participant safety, evaluate results, monitor data quality, and provide operational and policy advice to the Steering Committee and the NIDDK regarding the status of the study. The Principal Investigator of the Data Coordinating Center, the NIDDK Project Coordinator, and the Director of the Division of Diabetes, Endocrinology and Metabolism may participate as ex-officio, non-voting members of this Committee. Committee members will be appointed by the Director, NIDDK in consultation with members of the Steering Committee. The NIDDK named Project Coordinator will serve as executive secretary of the Policy and Data Monitoring Committee. 5. Arbitration. Any disagreement that may arise in scientific-programmatic matters between award recipients and NIDDK may be brought to arbitration. An arbitration panel will be composed of three members - one selected by the Steering Committee (with NIDDK member not voting) or by the individual awardees in the event of an individual disagreement, a second member selected by NIDDK and the third member selected by the preceding two members. This special arbitration procedure in no way affects the awardees' right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR part 50, subpart D and HHS regulations at 45 CFR part 16. The special terms of award (1-5) described above are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR parts 74 and 92, and other HHS, PHS, and NIH grant administration policy statements. 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 Item 4 (Research Design and Methods) of the Research Plan AND summarized in Item 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. If the required information is not contained within the application, the application will be returned without review. 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, but not required, to submit a letter of intent. This letter is to include the name, telephone number and mailing address of the Principal Investigator, the names of other key personnel, the name of the applicant institution, and the number and title of this RFA. Such a letter of intent is not binding and it will not enter into the review of any application subsequently submitted nor is it a requirement for application. Letters of intent are requested solely for planning purposes. The information contained in these letters is helpful in planning for the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid possible conflicts of interest in the review. The NIDDK staff will not provide responses to such letters. Letters of intent are to be received no later than September 17, 1993, and are to be addressed to: Robert D. Hammond, Ph.D. Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 594-7515 FAX: (301) 594-7503 APPLICATION PROCEDURES Submit applications on form PHS 398 (rev. 9/91), the application form for NIH research project grants. This form is available in the applicant institution's office of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7250. Use the conventional format for research project grant applications and ensure that the points identified in the SPECIAL REQUIREMENTS section above and in "Review Criteria" section below are fulfilled. To identify the application as a response to the RFA, Check "YES" on item 2a of page 1 of the application and enter the title "NIDDM Primary Prevention Trial" and enter the RFA number DK-93-007 in the space provided. The RFA label available in the form PHS 398 application kit must be affixed to the bottom of the face page of the original completed application form. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Send or deliver the completed, signed application and three complete photocopies to the following office, making sure that the original application with the RFA label attached is on top to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Send two additional copies of the application to Dr. Hammond at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants, otherwise the NIDDK cannot guarantee that the application will be reviewed in competition for the RFA. Applications must be received by October 19, 1993. An application not received by this date will be returned to the applicant. REVIEW CONSIDERATIONS Upon receipt, the Division of Research Grants (DRG) will review the application for completeness. Applications will be reviewed by NIDDK staff for responsiveness to the objectives of this RFA. If an application is judged incomplete or unresponsive, it will be returned to the applicant. If the number of applications is large compared to the number of awards to be made, the NIDDK will conduct a preliminary scientific peer review and will withdraw from further competition those applications that are not competitive for award. The NIDDK will notify the applicant and institutional official of this action. Those applications judged to be both competitive and responsive will be evaluated further 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, NIDDK. Subsequently, they will be reviewed by the National Diabetes and Digestive and Kidney Diseases Advisory Council and the National Advisory Child Health and Human Development Council. Review Criteria Specific criteria for review of applications will be as follows: o The scientific merit of the proposed study design to address the objectives of the RFA. This includes criteria for subject selection, plans for recruitment of subjects, proposed follow-up assessments and schedule for data collection during follow-up (in tabular form), proposed diagnostic and therapeutic modalities, and techniques for monitoring and maintaining continued contact with subjects during the course of the study. o Documentation of the specific competence and previous experience of professional, technical, and administrative staff pertinent to the operation of a Clinical Center in the proposed study. Evaluation criteria will include the following: familiarity with and experience in recruiting research subjects, especially, the ability to access, enroll and maintain minority subjects in a randomized trial or other clinical studies; working in collaboration with other investigators under a common protocol; and experience with careful and expeditious handling of study data. o Documentation of experience in the treatment of persons with diabetes. This includes documentation of a sufficient patient population from which to recruit in order to meet the individual Clinical Center goal for number of randomized study participants (guidelines including examples of appropriate format for presenting this information should be requested from the NIDDK project coordinator indicated below). o Understanding and awareness of the scientific, ethical, and practical issues underlying the proposed study and appropriateness of plans to address them. o Appropriateness of the budget for the work proposed. o Adequacy of the proposed facility and space, including floor plans of proposed space. o Evidence of substantive institutional commitment and support for the proposed program. o A willingness to work cooperatively with other centers in a manner summarized in the RFA. Seminar for Prospective Applicants A special technical assistance workshop will be offered to assist potential applicants, especially those with limited experience with the NIH application process. The purpose of this seminar is to give background information and respond to any questions about the preparation of an application in response to this RFA. The workshop will be held in the Washington, DC metropolitan area approximately one month after the publication of this announcement. The NIH cannot support individuals who wish to attend the conference, but the conference will be open to any individual or organization who wishes to attend. Interested persons may contact Dr. Sanford A. Garfield, at the address listed under INQUIRIES, for further information. AWARD CRITERIA The anticipated date of award is July 1, 1994. Applications will compete for available funds with all other approved applications submitted in response to this RFA. The following will be considered in making funding decisions: o Quality of the proposed work as determined by peer review. o Availability of funds o Geographical balance among all applications considered for funding under this RFA. o Racial and ethnic balance among the populations to be accessed by the potential awardees. 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 intent to: Sanford Garfield, Ph.D. Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 626 Bethesda, MD 20892 Telephone: (301) 594-7535 FAX: (301) 594-9011 Dr. Gilman D. Grave Endocrinology, Nutrition and Growth Branch National Institute of Child Health and Human Development 6100 Building, Room 4B11 Bethesda, MD 20892 Telephone: (301) 496-5593 FAX: (301) 402-2085 Inquiries regarding fiscal matters should be directed to: Ms. Linda Stecklein Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649B Bethesda, MD 20892 Telephone: (301) 594-7543 FAX: (301) 594-7594 Schedule Letter of Intent Receipt Date: September 17 ,1993 Application Receipt Date: October 19, 1993 Initial Review: February/March 1994 NIDDK/NICHD Council Review: May/June 1994 Anticipated Award Date: July 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99- 158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. References 1. National Diabetes Data Group: Classification and diagnosis of diabetes mellitus and other categories of glucose intolerance. Diabetes 28:1039-57, 1979 2. Harris MI, Hadden WC, Knowler WC, Bennett PH. Prevalence of diabetes and impaired glucose tolerance and plasma glucose levels in U.S. population aged 20-74 yr. Diabetes 36:523-534;1987 3. Harris MI Epidemiological correlates of NIDDM in Hispanics, Whites, and Blacks in the U.S. population. Diabetes Care 14:639-648:1991 4. Saad MF, Knowler WC, Pettitt DJ, Nelson RG, Mott DM, Bennett PH. The natural history of impaired glucose tolerance in the Pima Indians. New Engl J Med 319:1500- 1506;1988 5. Yudkin JS, Alberti KGMM, Mclarty DG, Swai ABM Impaired glucose tolerance. Brit Med J 301:397-402;1990 6. Eriksson KF, Lindgarde F, Impaired glucose tolerance in a middle-aged male urban population: a new approach for identifying high risk cases. Diabetologia 33:526- 531;1990 7. Harris MI, Hadden WC, Knowler WC, Bennett PH: International criteria for the diagnosis of diabetes and impaired glucose tolerance. Diabetes Care 8:562-67, 1985 8. Lillioja S, Mott DM, Zawadzki JK, Young AA, Abbott WGH, Knowler WC, Bennett PH, Moll P, Bogardus C. In vivo insulin action is a familial characteristic in nondiabetic Pima Indians. Diabetes 36:1329;1987 9. Horton ES. Exercise and decreased risk of NIDDM. N Engl J Med 325:197;1991 (editorial) 10. Helmrich SP, Ragland DR, Leung RW, Paffenbarger RS. Physical activity and reduced occurrence of non-insulin- dependent diabetes mellitus. N Engl J Med 325:147;1991 11. Manson JE, Nathan DM, Krowlewski AS, Stampfer MJ, Willett WC, Hennekens CH. A prospective study of exercise and incidence of diabetes among US male physicians. JAMA 268:63;1992 12. Eriksson KF, Lindgarde F. Prevention of Type 2 (non-insulin-dependent) diabetes mellitus by diet and physical exercise: The 6-year Malmo feasibility study. Diabetologia 34:891-898;1991 13. Page RCL, Harnden KE, Cook JTE, Turner RC. Can life-styles of subjects with impaired glucose tolerance be changed? A feasibility study. Diabetic Medicine 9:562-566;1992 14. Jarrett RJ, Keen H, Fuller H, McCartney M. Worsening to diabetes in men with impaired glucose tolerance ("Borderline Diabetes"). Diabetologia 16:25- 30;1979 15. Sartor G, Schersten B, Carlstrom S, Melander A, Norden A, Persson G. Ten-year follow-up of subjects with impaired glucose tolerance. Diabetes 29:41;1980 16. Melander A, Bitzen P-O, Sartor G, Schersten B, Wahlin-Boll E. Will sulfonylurea treatment of impaired glucose tolerance delay development and complications of NIDDM? Diabetes Care 13:53-58;1990 From owner-sci-resources@net.bio.net Thu May 06 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. 18, pt. 5, 7 May 1993 Message-ID: Date: 7 May 93 18:22:17 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 811 $$XID RFA CA93021 CA-93-021 P1O1 *************************************** PREVENTION CLINICAL TRIALS UTILIZING INTERMEDIATE ENDPOINTS AND THEIR MODULATION BY CHEMOPREVENTIVE AGENTS NIH Guide, Volume 22, Number 18, May 7, 1993 RFA: CA-93-021 P.T. 34; K.W. 0715035, 0755015, 0710095, 0740018 National Cancer Institute Letter of Intent Receipt Date: May 28, 1993 Application Receipt Date: August 12, 1993 PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites applications for cooperative agreements to support clinical trials that are directed toward examining the role of various chemopreventive agents and/or diet in the prevention of cancer. This is a follow-up to earlier Requests for Applications (RFAs) that had requested grants, and then later, cooperative agreement applications in this area. 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, Prevention Clinical Trials Utilizing Intermediate Endpoints and Their Modulation by Chemopreventive Agents, 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 and foreign for-profit and non-profit organizations, public and private, such as universities, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT This RFA will use the cooperative agreement mechanism (U01). The cooperative agreement is an assistance mechanism in which substantial NIH programmatic involvement with the recipient during performance of the planned activity is anticipated. The nature of the Program Director's involvement is described in the section on SPECIAL REQUIREMENTS, A.1. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant/awardee. 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. This RFA will be issued annually for three years. Future unsolicited continuation applications will compete with all other investigator-initiated research applications and be peer reviewed by a study section in the Division of Research Grants. However, if the NCI determines that there is a sufficient continuing program need, the NCI may invite all funded recipients to submit competing continuation applications. Applicants funded under this RFA will be supported through the cooperative agreement mechanism (U01). An assistance relationship will exist between the NCI and the awardees to accomplish the purpose of the activity. As more fully described later in this announcement, the recipients will have primary responsibility for the development and performance of the activity. However, there will be government involvement with regard to (1) assistance in securing an Investigational New Drug (IND) approval from the Food and Drug Administration (FDA), (2) coordination and assistance in obtaining the chemopreventive agent, (3) monitoring of safety and toxicity and, (4) quality assurance of the clinical chemistry aspects of the study. Awards will not be made until all arrangements for obtaining the IND and the agent are completed. Final awards will also consider not only the cost of the clinical trial but also the cost of the agent and, if necessary, its formulation. The anticipated direct costs per award will be in the range of $300,000 to $500,000 for the first year. FUNDS AVAILABLE Approximately $1.5 million in total costs for the first year will be committed to specifically fund applications which are submitted in response to this RFA. It is anticipated that three to five awards will be made annually. This number of awards is dependent on the receipt of a sufficient number of applications of high scientific merit. The total project period for applications submitted in response to the present RFA may not exceed five years. The earliest feasible start date for the initial awards will be April 1, 1994. Although this program is provided for in the financial plans of the NCI, awards made pursuant to this RFA will be contingent upon the continued availability of funds for this purpose. RESEARCH OBJECTIVES Background The primary objective of this solicitation is to encourage cancer chemoprevention clinical trials that utilize biochemical and biological markers to identify populations at risk and/or to provide intermediate endpoints that may predict later reduction in cancer incidence rates. These studies may be developed in phases, including a pilot phase, which could later proceed to a full scale intervention. The main emphasis should be on small, efficient intervention studies aimed at improving future research designs of chemoprevention trials, providing further biologic understanding of the trial results, or providing better, more quantitative and more efficient endpoints for these trials. After successful completion of the pilot phase (i.e. demonstrated modulation of marker endpoints by the intervention), subsequent studies could include a definitive clinical trial monitoring the test system, a cancer incidence or mortality endpoint, and a designated agent. Investigators may apply at this time for the pilot phase, or submit an application for both the pilot and definitive trial studies. However, if the application is for the pilot phase only, it must include a description of its relevance to a broad clinical application including the chemopreventive agent, marker test system, and study population that would be the subject of a full scale, randomized, cancer risk reduction clinical trial. Applications must be prepared and submitted in accordance with the aims and requirements described in the following sections: A number of compounds and/or dietary components have been associated with the inhibition of carcinogenesis in animal models, in vitro systems, and/or epidemiologic investigations. Results from these studies suggest that chemopreventive agents, including dietary components, affect the later stages of carcinogenesis. The best approach to confidently address the efficacy and safety as well as the applicability and effectiveness for these agents is through the conduct of clinical trials. A variety of parameters have become available and may be used to identify or evaluate risk modulation in selected target populations by chemopreventive agents. Examples include reversal of abnormal cytology, prevention or reversal of nuclear aberrations (micronuclei), ornithine decarboxylase and/or prostaglandin synthetase inhibition, DNA ploidy alterations, changes in colonic mucosal proliferation (histology, tritiated thymidine labelling indices), decreases in fecal mutagens, and oncogene suppression tests. Markers of precancerous lesions may also be useful to define populations that may benefit from chemoprevention trials; however, more information is required concerning the ability of such markers to predict and/or modulate cancer incidence. The development of sensitive and accurate intermediate endpoints should greatly enhance the ability to design effective cancer risk reduction trials. Chemoprevention clinical trials involve a spectrum of subjects in various categories of risk. These might involve normal human subjects, subjects at high risk due to prior exposure to carcinogens, subjects with precancerous lesions, patients having been treated for a primary cancer now free of disease, and patients treated for primary cancer with alkylating agents or radiation who are at high risk for developing second cancers. Methods for identification of populations at risk and assessment of their risk of developing cancer is therefore a major goal of the chemoprevention program. These studies are expected to augment the efficient experimental design of clinical trials leading to lesser number of subjects required to achieve adequate statistical power. The tests used for risk identification are also of value because of the multi-step nature of cancer induction and the different mechanisms by which chemopreventive agents are known to inhibit the carcinogenic process. Thus, it is useful to have tests that measure genotoxic exposure as well as tests which indicate that subjects are in the later (e.g. promotional, progressional) phase of the carcinogenic process. It should be emphasized that protocols that propose use of assays/methods for risk identification must also include assays that measure biochemical or biological intermediate markers of cancer endpoints (in the pilot phase) or measurement of the intermediate endpoints themselves (in the later definitive trials). Studies of Special Interest Short term chemoprevention clinical trials that evaluate the effect of innovative biomedical monitoring tests in high risk populations are sought. These tests might be useful to determine an intermediate endpoint, serve as a basis to assess cancer risk status or to assess response to a chemopreventive agent. The modulation of effects by a chemopreventive agent on tests that are indicative of neoplastic progression may be an early indicator of its efficacy. Examples of such tests might include classical cytological techniques, suppression of oncogene protein products, etc. Modulation of a biological marker by a chemopreventive agent might be highly significant in relation to ultimate cancer prevention. A series of one or more tests would be included in the chemoprevention intervention clinical trial, initially to determine baseline parameters and later as a follow-up after administration of the chemopreventive agent. Biological fluids including urine, blood, sputum, etc., would have to be obtained from participants for analysis. Priority would be given for studies with biological monitoring procedures that do not overlap or duplicate currently funded projects. The pilot phase should attempt to detect the clinical activity of the chemopreventive agent rapidly, efficiently, and in reasonably accurate fashion with a relatively small number of subjects. In vivo or in vitro assays are acceptable if of particular and direct relevance to clinical trials. The pilot phase is not expected to give a definite answer to the ultimate value of the chemopreventive agent, which is the purpose of a larger Phase III study. It is expected, however, that upon completion of a pilot study, it should be possible to make a judgement regarding the effectiveness of the agent to modulate the marker test system (which will be correlated with modulation of the cancer endpoint in the definitive trials). Additionally, the pilot phase is expected to give an indication of the nature of any short term adverse effects related to the particular dose schedule, information on patient compliance, ability to measure the agent in body fluids and any other factors related to the subsequent clinical trial. These factors may provide further clarification on the need for a large, full scale study. Intervention populations of interest might include: individuals at high risk at selected cancer sites, individuals with precancerous lesions, or individuals presently free of cancer but at risk for second cancers. Intermediate marker studies of breast cancer chemoprevention are especially encouraged. SPECIAL REQUIREMENTS A. Terms and Conditions of Award The special terms and conditions as described in section 1 and 2 below will be incorporated in the Notice of Grant Award and are in addition to, and not in lieu of otherwise applicable HHS Administrative Regulations at 45 CFR 74; other DHHS, PHS, and NIH Grant Administration Policy Statements and other NCI administrative terms of award. 1. Program Staff Involvement a. Study/Protocol Plan The NCI Program Director (listed under LETTER OF INTENT) will assist the awardee in the study and protocol design by providing information regarding (a) the nature of concurrent studies in the area of research, pointing out possible duplication of effort, (b) safety and toxicity of proposed regimens, and (c) availability of necessary drugs. The NCI Program Director may also offer advice regarding the scientific rationale, priority, design and implementation of the proposed studies. A safety and protocol review will be undertaken by the NCI Program Director on all clinical trials from proposals that are ultimately funded. Such a review is legally required by the FDA to assure that all safety, toxicity, monitoring, and reporting issues are in conformance with IND guidelines. The awardee institution and Principal Investigator must agree to comply with the recommendations of the review. b. Data Access The NCI Program Director will have access to the data to review toxicity and safety aspects of the project, prepare IND applications and monitor any trial aspects required by other federal agencies. This information is necessary to satisfy FDA regulations with regard to Code of Federal Regulations (CFR) 21. The awardees, however, will retain custody of and primary rights to their data. The NCI Program Director may encourage and facilitate sharing of data between investigators when this is in the mutual interest of the investigators and the NCI. c. Investigational New Drug (IND) The NCI will have the option to cross file or independently file an IND on investigational drugs evaluated in trials supported under the cooperative agreements. The NCI will advise investigators of specific requirements and changes in requirements concerning investigational drug management for compliance with NCI and the FDA guidelines and regulations. Investigators conducting trials under cooperative agreements will be expected, in cooperation with the NCI, to comply with all FDA monitoring and reporting requirements for investigational agents, for reporting adverse reactions, and for maintaining necessary records of drug receipt and distribution. d. Assistance with Obtaining or Purchasing Investigational Drugs The NCI Program Director will assist the investigator to obtain the agent to be used in the proposed study. Once the application is recommended for funding by the peer review committee, the NCI, and the National Cancer Advisory Board, the NCI Program Director may begin discussions with the principal investigator and pharmaceutical industry with regard to obtaining the drug. In the event a suitable agent is not available at no cost, the NCI may proceed to purchase the agent through normal procurement mechanisms. Purchase of the agents is only undertaken after measures to obtain the drug at no cost have been exhausted. Awards will not be made until all arrangements for obtaining the agent are complete. Final awards by the NCI will also consider not only the cost of the trial but also the cost of the agent, including its formulation, encapsulation and packaging, if these costs are to be borne by the Government. e. Protocol Modification No protocol modifications may be implemented without approval from the NCI Program Director, and also from the FDA, if indicated. f. Protocol Termination The NCI Program Director may request that a protocol study be terminated. Reasons for this request may be (a) insufficient accrual, (b) further accrual will not add information of scientific value, and/or (c) consideration of patient safety. The NCI will not provide drugs or IND sponsorship for a study after requesting termination. Investigators who wish to challenge protocol termination may do so according to the arbitration process described in g below. If the request to terminate a study is upheld by the arbitration panel, but the awardee chooses to continue the study, the results of that study will be subject to careful monitoring through progress reports. In addition, the NCI may withdraw funding for such a protocol if the grounds for termination are patient safety and toxicity. g. Description of Arbitration Mechanism When mutually acceptable agreements on the safety of research protocols, protocol disapproval or protocol termination cannot be obtained between investigators and the NCI Program Director, as described above, an arbitration panel will be formed composed of one award recipient designee, one NCI designee, and a third designee with appropriate expertise chosen by the other two members of the panel. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. h. Clinical Trials Progress Review Progress will be evaluated semi-annually by the Program Director from material presented in the awardee's semi-annual report (as described in Section V.B.4.A. below). Recommendations of the Program Director will be communicated by letter to the investigator to which he/she is expected to respond. Insufficient numbers of patients accrued to attain the stated delta value (d=difference between treatments to be detected divided by standard deviation), unsatisfactory progress, or non-compliance with terms of award may result in a reduction of the budget, withholding of support, suspension or termination of the award. i. Quality Assurance (1) The NCI has established a clinical chemistry quality assurance program with the National Institutes of Standards and Technology, Gaithersburg, Maryland which will provide chemical standards for some of the agents that will be used and assayed for in the clinical trials. These standards will contribute to the quality control of selected laboratory determinations. The awardee will participate in the laboratory quality control activity when so notified. (2) Periodically, the NCI Program Director will review the mechanisms established by each awardee for quality control of clinical studies. These mechanism must conform with FDA regulations. j. Other Terms Patient enrollment may not begin without the prior written approval of the NCI Program Director for this cooperative agreement including submission to and approval by the FDA of an IND application and satisfactory response to the recommendations of the safety and protocol review. 2. Responsibilities of Awardees a. Safety and Toxicity Review Each awardee institution and Principal Investigator agree to comply with the recommendations of the safety and protocol review to ensure that all FDA requirements are satisfied. b. Quality Control and Adverse Reaction Reporting (1) The awardee will be required by the NCI Program Director to set up mechanisms for quality control. Some or all of the following may be relevant: compliance with protocol requirements for eligibility; treatment and follow-up; laboratory data; dietary data; pathological materials; and operative reports. (2) The awardee agrees to perform the study according to the approved protocol. Any proposed changes in the protocol must receive the advance permission of the NCI Program Director for this award. (3) The awardee is required to conform to NCI guidelines for the use of investigational drugs, including investigator registration (form FDA 1573), maintaining a record of drug receipt, and reporting of adverse drug reactions. Life threatening or unexpected toxicity MUST be reported by the investigator IMMEDIATELY by telephone to the NCI Program Director shown on the Notice of Grant Award and confirmed with details in writing within two weeks. The investigator will be responsible for amending protocols and consent forms based on new toxicity information sent to the investigators by NCI staff. c. Informed Consent; IRB Approval Approval by the Institutional Review Board (IRB) must be obtained by awardees on all protocols because of the involvement of human subjects. d. Data Management and Reporting Requirements Data acquisition and analysis is the responsibility of the investigator. Investigators will be required to submit reports to NCI using the following schedule and format: (1) Semi-annual Reports Semi-annual scientific reports should report on the progress of the project during the previous six months and the cumulative progress of the study. (a) Individual Study Information. The summary is required to include the following information for each study: o The title of the study (with any appropriate study identifiers such as protocol number), its purpose, a brief statement identifying the patient population and the inclusion of women and minorities, and a statement as to whether the study is completed. o The total number of subjects initially planned for inclusion in the study, the number entered into the study to date, the number whose participation in the study was completed as planned, and the number who dropped out of the study for any reason. o If the study has been completed, or if interim results are known, a brief description of the study results. (b) Summary Information. Information obtained during the previous six months' clinical and nonclinical investigations, including: o A narrative or tabular summary showing the most frequent and most serious adverse experiences by body system. o A list of subjects who died during participation in the investigation, with the cause of death for each subject. o A list of subjects who dropped out during the course of the investigation in association with any adverse experience, whether or not thought to be drug related. o A brief description of what, if anything, was obtained that is pertinent to an understanding of the drug's actions, including for example, information about dose response, information from controlled trials, and information about bioavailability. o A list of the preclinical studies (including animal studies) completed or in progress during the past year and a summary of the major preclinical findings. (c) A description of the general investigational plan for the coming year to replace that submitted one year earlier. (d) A description of any significant pilot trial protocol modifications made during the previous year and not previously reported to the IND in a protocol amendment. (e) A brief summary of significant foreign marketing developments with the drug during the past year, such as approval of marketing in any country or withdrawal or suspension from marketing in any country. Due Dates for Reports January 1 and July 1 for the semiannual report. (2) Final Study Report The final report of a completed study shall consist of detailed analyses of results and toxicity, plans for publications, a comprehensive list of all previous publications related to the project, and plans for archiving and storing the study records. 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 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 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 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. LETTER OF INTENT Prospective applicants are asked to submit, by May 28, 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. The letter of intent is to be sent to Dr. Marjorie Perloff at the address listed under INQUIRIES. APPLICATION PROCEDURES The receipt date for applications is August 12, 1993. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these cooperative agreements. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 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 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 title of the application, "Prevention Clinical Trials Utilizing Intermediate Endpoints and Their Modulation by Chemopreventive Agents", and the RFA number, CA-93-021, must be typed in block 2a of the face page of the application form. 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, two additional copies of the application must also be sent to: Ms. Toby Friedberg, Referral Officer Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, and has been or 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. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. Preparation of the Application The general instructions provided for the preparation of applications contained in the grant application form PHS 398 (rev. 9/91) are to be used in preparing cooperative agreement applications. Because of the award terms and conditions included in the Section under SPECIAL REQUIREMENTS, A. Terms and Conditions of Award, it is important that applicants indicate in the Research Plan how they will meet the requirements stated in the RFA for staff involvement. To ensure that the cooperative agreement remains the appropriate instrument, awardees who are invited by the NCI to submit competing continuation and supplemental applications must describe how they have met the established terms and conditions. The following items apply to new and competing continuation applications: 1. The study must clearly address a pilot trial and optionally a definitive trial. The pilot trial must involve the application of a biological and/or biochemical marker and its modulation by the study agent. The definitive trial involves the implementation of a full scale randomized, double-blind, risk reduction, prevention clinical trial. For applicants seeking to conduct only a pilot trial, the study must describe relevance to a clinical trial application including a marker, agent and target group that might be appropriate for a full scale intervention after completion of the pilot study. 2. The applicant should provide a rationale for selection of the biological or biochemical marker, its relevance to risk identification or modulation, and its relevance to the intervention agent and the target population. 3. The applicant should provide the rationale for selection of the proposed intervention agent. This should include relevant epidemiologic and laboratory data. Preclinical and clinical data on any potential untoward effects of the intervention agent should also be presented. In circumstances where there might be some doubt as to the availability or the safety of the agent, the applicant may wish to consult with the pharmaceutical company and the NCI Program Director prior to preparing the application. The applicant should thus present a reasonable case for the "readiness" of the proposed intervention agent for a clinical trial. 4. The applicant should provide a rationale for selection of a specific target group and provide an estimate of the number of participants required for the completion of the study. Criteria and calculations used to estimate sample size should be included. The applicant should provide a description of the target population or group chosen and should justify the selection of this group. The group should be defined, as appropriate, by age, sex, race, dietary customs, education, geographic location, occupational or life style risk factors, and relevancy to a specific cancer problem or to its possible prevention by the designated inhibitor(s). The accrual rate should be estimated. If multiple institutions are involved, the application should include verification of the coinvestigators' willingness to participate, and pertinent additional information regarding the cooperating institutions' staff qualifications, resources, research plans, including patient availability and data flow, as well as corresponding budget requirements. 5. The applicant should clearly indicate the clinical chemistry and biologic aspects of the study to include collection, storage, handling, analysis, and quality control of biological or biochemical samples. The methods and equipment to be used and the technical qualifications and experience of the personnel involved must be addressed. If these aspects of the study are to be conducted by groups other than at the applicant's institution, a letter from the cooperating institutions indicating their willingness to participate should be included. 6. The applicant should elucidate any known or potential safety or toxicity considerations, the techniques and procedures to monitor and report any adverse health effects and appropriate dose modifications based on toxicity monitoring. 7. The applicant should specify the methods to be used to document nutrient intake, if indicated, and adherence to the prescribed intervention during the course of the trial. 8. The applicant must indicate a willingness to work cooperatively with the assistance of the Program Director in the implementation and conduct of the study. 9. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator could be included with the application. 10. The applicant should indicate the availability of the chemopreventive agents or dietary factors. REVIEW CONSIDERATIONS A. Review Procedure 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. Applications will be judged to determine if they meet the goals and objectives of the program as described in the RFA. Applications that are judged non-responsive will be returned, but may be submitted for investigator initiated grant competition at the next receipt date. Questions concerning the relevance of proposed research to the RFA may be directed to the NCI 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 identify those which are clearly not competitive for awards. Those applications judged to be both competitive and responsive will be further evaluated, using the review criteria shown 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 considers the special needs of the Institute and the priorities of the National Cancer Program. B. Review Criteria The following factors will be considered in evaluating the scientific merit of each response to the RFA: 1. Scientific merit of the study objective(s), design, and methodology to include considerations of toxicity, safety and quality assurance. 2. Basic and clinical scientific significance as well as originality of the proposed research. 3. Research experience and/or competence of the Principal Investigator and other key personnel to conduct the proposed studies. 4. Adequacy of time (effort) which the Principal Investigator and staff would devote to conduct the proposed studies. 5. Relevancy and appropriateness of the specific target population along with assurance as to its accessibility. 6. Identity of sources of data, tissues, fluids, etc., procedures for their collection and analysis, and assurances as to their accessibility. 7. Adequacy of plans for NCI program staff involvement with the proposed studies. 8. Adequacy of plan for inclusion of women and minorities. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each meritorious application. AWARD CRITERIA The earliest feasible start date for the initial awards will be April 1, 1994. Priority would be given for studies with biological monitoring procedures that do not overlap or duplicate projects currently funded by the NCI. Awards will not be made until all arrangements for obtaining the agent are complete. Final awards by the NCI will consider not only the cost of the clinical trial, but also the cost of the agent, including its formulation, encapsulation and packaging, if these costs are to be borne by the Government. In making funding decisions the National Cancer Advisory Board considers the special needs of the Institute and the priorities of the National Cancer Program. 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 intent to: Marjorie Perloff, M.D. Chemoprevention Branch National Cancer Institute Executive Plaza North, Suite 201 Bethesda, MD 20892-4200 Telephone: (301)496-8563 FAX: (301) 402-0553 Direct inquiries regarding fiscal matters to: Ms. Eileen Natoli Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-7800 Ext. 56 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.399, Cancer Control. Awards will be made under the authority of the Public Health Service Act, Title IV, Section 301 (Public Law 78-410,; 42 U.S.C. 241, and Section 412, as amended by Public Law 99-158, 42 U.S.C. 258a-1); 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. From owner-sci-resources@net.bio.net Thu May 06 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. 18, pt. 4, 7 May 1993 Message-ID: Date: 7 May 93 18:21:16 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1083 $$XID RFA CA93026 CA-93-026 P1O1 *************************************** MINORITY-BASED COMMUNITY CLINICAL ONCOLOGY PROGRAM NIH Guide, Volume 22, Number 18, May 7, 1993 RFA: CA-93-026 P.T. 34, FF; K.W. 0715035, 0755015, 0745027, 0403004 National Cancer Institute Letter of Intent Receipt Date: July 25, 1993 Application Receipt Date: August 24, 1993 PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), is interested in continuing the established cancer control effort which involves practicing oncologists who serve large minority populations in the NCI clinical trials program. DCPC invites applications from domestic institutions with greater than 50 percent of new cancer patients from minority populations for cooperative agreements in response to this Minority-Based Community Clinical Oncology Program (Minority-Based CCOP) Request for Applications (RFA). The NCI clinical trials network provides support for clinical research in cancer centers, major university centers, and community programs. The purpose of this program is to utilize as a national resource those physicians involved in the care of minority cancer patients who are available for treatment and cancer prevention and control clinical trials research. The linkage of minority cancer patients to the current clinical trials network will facilitate the transfer of new technology in treatment and cancer prevention and control practices to minority communities and their physicians. The Minority-Based CCOP should: (1) provide support for expanding clinical research in minority community settings; (2) bring the advantages of state-of-the-art treatment and cancer prevention and control research to minority individuals in their own communities; (3) increase the involvement of primary health care providers and other specialists in cancer prevention and control studies; (4) establish an operational base for extending cancer prevention and control, and reducing cancer incidence, morbidity, and mortality in minority populations; and (5) examine selected issues in Minority-Based CCOP performance (e.g., patient recruitment, accrual, eligibility). This issuance of the Minority-Based CCOP RFA seeks to build on the strength and demonstrated success of the Minority-Based CCOP over the past three years by: (1) continuing the program as a vehicle for supporting community participation in treatment and cancer prevention and control clinical trials through research bases (clinical cooperative groups and cancer centers supported by NCI); (2) expanding and strengthening the cancer prevention and control research effort; (3) utilizing the Minority-Based CCOP network for conducting NCI-assisted cancer prevention and control research; and (4) evaluating on a continuing basis Minority-Based CCOP performance and its impact in the community. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Minority-Based Community Clinical Oncology Program, 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 from domestic institutions for cooperative agreements to continue the Minority-Based CCOP. New applicants and currently funded programs are eligible as described below. Institutions, organizations and/or physician group applicants for the Minority-Based CCOP must have greater than 50% of new cancer patients from minority populations AND, as a group, the participating physicians listed in the application must have greater than 50 percent of new cancer patients from minority ethnic groups. The following eligibility requirements then apply. o An applicant may be a hospital, a clinic, a group of practicing physicians, a health maintenance organization (HMO), or a consortium of hospitals and/or clinics and/or physicians and/or HMOs, that agree to work together with a Principal Investigator and a single administrative focus. o A university hospital that is the major teaching institution for that university AND that has greater than 50 percent of new cancer patients from minority populations is eligible to apply. o A military or Veterans Administration hospital may be included in an application as a nondominant member of a consortium led by a community institution. An unfunded nonuniversity clinical trials cooperative group member is eligible to apply. o Funded Cooperative Group Outreach Program (CGOP) participants are eligible to apply, but should state in the application that CGOP support will be relinquished if a Minority-Based CCOP award is received. o Funded Minority Satellite Supplement Program (MSSP) participants are eligible to apply, but should state in the application that MSSP support will be relinquished if a Minority-Based CCOP award is received. Institutions and organizations NOT eligible to apply as a Minority-Based CCOP are: o A comprehensive, consortial, or clinical cancer center holding an NCI Cancer Center Support (CORE) grant; o A university hospital clinical trials cooperative group member funded by DCT, NCI; and o Currently funded Community Clinical Oncology Programs (CCOPs). MECHANISM OF SUPPORT Support of this program will be through the Cooperative Agreement (U10). The Cooperative Agreement is an assistance mechanism in which substantial NCI programmatic involvement with the recipient during performance of the planned activity is anticipated to assist awardees in the planning, direction, and execution of the proposed project. The anticipated amount of the direct cost awards will range from $100,000 to $200,000. The total project period for applications submitted in response to this RFA may not exceed three years for new applicants and four years for applicants currently supported under this program. FUNDS AVAILABLE This RFA is a one-time issuance. It is anticipated that up to $2.7 million in total costs per year will be committed to specifically fund applications which are submitted in response to this RFA. It is anticipated that up to 12 awards will be made. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. The earliest feasible start date for the initial awards will be June 1, 1994. NCI program staff will take into account demographic and geographic distributions of peer-reviewed and approved Minority-Based CCOPs in the final funding selection process. Multiple Minority-Based CCOP applicants approved for funding but who are competing for the same patient population will be considered, but all may not be awarded unless warranted by the population density. Although this program is provided for in the financial plans of NCI, the issuance of awards pursuant to this RFA is also contingent upon the availability of funds for this purpose. Awards for research bases affiliated with Minority-Based CCOPs will be through Cooperative Agreements under the Community Clinical Oncology Program RFA. RESEARCH OBJECTIVES A. Background When compared to the general population, African-Americans have an increased incidence of a number of malignancies and worse overall survival rates. Greater involvement in clinical trials research by Black, Hispanic, Asian-American, American Indian, and other minority patients is needed if the advances in clinical research are to be extended to all ethnic groups, and the results of clinical trials generalizable to the entire population. In general, there has been limited participation in clinical trials research by minority cancer patients. In the past, institutions and physicians with access to large minority populations have not been r research, and few minority cancer patients and their physicians were impacted by research funded through the clinical trials network. NCI's clinical trials network has evolved over the past 30 years. The major NCI program initiatives supporting this network are the Clinical Cooperative Group Program, the Cancer Centers Program, the Cooperative Group Outreach Program, and the Community Clinical Oncology Program (CCOP). Treatment and cancer prevention and control clinical trials research funded through these programs provides patients and their physicians with access to state-of-the-art cancer care management opportunities, and provides oncologists with a source of continuing education on innovations in cancer therapy, diagnostic techniques, and treatment applications. One of the major efforts of the NCI has been to design and implement program interventions to assure that patients treated in their own communities have access to the same quality of cancer care and the same technological advances available to patients treated in major centers. The CCOP, which was first initiated in 1983, has proven to be a successful model for bringing the benefits of clinical research to cancer patients in their communities by providing support for community physicians to enter patients on treatment research protocols. In addition to increasing patient accrual to treatment clinical trials, the CCOP stimulated many communities to organize their cancer activities and expedited the development of a local-regional cancer program. Increased numbers of physicians, hospitals, and other health care professionals became involved in CCOP, and quality control standards of the cooperative groups were maintained. In 1987 the CCOP expanded the cancer prevention and control effort to include support for research in prevention, health promotion, smoking cessation, chemoprevention, treatment applications, continuing care and rehabilitation. With the development and implementation of cancer control research through the clinical trials network, opportunities exist for the implementation of effective preventive strategies for reducing cancer incidence, morbidity and mortality. Broader access to clinical research protocols is needed in order to develop and implement effective treatment and cancer prevention and control strategies in minority populations. Areas of research where minority involvement is especially needed include: cancer prevention and control intervention strategies to improve screening and early detection practices; methodological research on ways to increase the educational awareness of individuals at risk for cancer and studies of barriers to prevention and treatment applications. The Minority-Based CCOP has become an important part of these efforts. It links physicians caring for large numbers of minority patients to the NCI clinical trials network. The CCOP model has been an effective mechanism for facilitating the linkage of investigators and their institutions with the clinical trials network. The Minority-Based CCOP was initially approved by the NCI, Division of Cancer Prevention and Control Board of Scientific Counselors in January 1989. Implementation began in the fall of 1990. By 1992 the program was beginning to succeed in its goal of providing minority populations access to clinical trials. While components of each of the current ten programs were accruing patients to clinical trials prior to funding, the grant and the Minority-Based CCOP structure has enabled these groups of physicians to double and, in some cases, triple previous accrual to treatment trials. In fiscal 1992, ten Minority-Based CCOP's accrued nearly 500 patients onto treatment trials and over 400 patients/subjects onto cancer prevention and control trials. Greater than 70 percent of Minority-Based CCOP patients entered on study during that period are from minority populations. In a recent study, 14.1 percent of all patients entered onto NCI sponsored treatment trials were ethnic minorities. These ten programs contributed more than 10 percent of all minority accrual to NCI sponsored cancer treatment trials. Minority-Based CCOP accrual will likely increase as the organizational structures solidify. B. Goals and Scope The Minority-Based CCOP initiative is designed to: o Bring the advantages of state-of-the-art treatment and cancer prevention and control research to minority individuals in their own communities by having practicing physicians and their patients/subjects participate in NCI-approved treatment and cancer prevention and control clinical trials; o Provide a basis for involving a wider segment of the community in clinical research by increasing the involvement of primary health care providers and other specialists (e.g., surgeons, urologists, gynecologists) with the Minority-Based CCOP investigators in treatment and cancer control research, thus providing an opportunity for education and exchange of information; o Provide an operational base for extending cancer control, and reducing cancer incidence, morbidity, and mortality in minority populations by accelerating the transfer of newly developed cancer prevention, detection, treatment, and continuing care technology to widespread community application; o Facilitate wider community participation in future treatment and cancer control research approved by NCI; and o Examine selected issues in Minority-Based CCOP performance (e.g., patient recruitment, accrual, eligibility) and evaluate its impact in the community. The initiative will be developed and supported by DCPC, NCI. Participating programs will be required to enter patients/subjects onto NCI-approved cancer treatment and cancer prevention and control clinical trials through research bases with which the Minority-Based CCOP is affiliated. Minority-Based CCOP performance will be evaluated on a continuing basis by NCI program staff for its impact on community cancer treatment and control practices. Research bases approved for CCOP participation will provide clinical research protocols in cancer treatment and cancer prevention and control to Minority-Based CCOPs. Minority-Based CCOP applicants must demonstrate the potential for accessing appropriate cancer patients/subjects within their communities for participation in cancer treatment and cancer prevention and control protocols provided by their research bases. SPECIAL REQUIREMENTS A. Terms and Conditions of Award Under the Cooperative Agreement, a partnership will exist between the recipient of the award and NCI, with assistance from NCI in carrying out the planned activity. This assistance will include: clarification of Minority-Based CCOP requirements; review of accrual to clinical trials; monitoring of community efforts to increase minority participation in clinical research; participation in protocol review; and discussions on the continuing needs of the program for enhancing Minority-Based CCOP performance. The following terms and conditions pertaining to the scope and nature of the interaction between NCI and the investigators will be incorporated in the Notice of Grant Award. These terms will be in addition to the customary programmatic and financial negotiations which occur in the administration of grants. The "Terms and Conditions of Award: Nature of NCI Staff Involvement" and "Terms and Conditions of Award: Responsibilities of Awardees" described in this section are in addition to, and not in lieu of, otherwise applicable administrative guidelines; DHHS grant administration regulations 45 CFR 74; other DHHS, PHS, and NIH grant administration policy statements; and other NCI administrative terms and conditions of award. 1. Nature of NCI Staff Involvement a. Protocol Review All research base protocols utilized by the Minority-Based CCOPs must be reviewed and approved for CCOP use by the Cancer Control Protocol Review Committee (CCPRC), Division of Cancer Prevention and Control (DCPC) and/or the Protocol Review Committee (PRC), Division of Cancer Treatment (DCT), NCI, prior to implementation. NCI will not provide investigational drugs, permit expenditure of NCI funds, or allow accrual credit for a protocol that has not been approved, or that has been closed (except for patients already on study). b. Monitoring There will be periodic on-site audits of each Minority-Based CCOP by representatives of its research base(s), NCI, or an NCI-designee, such as DCT's current Clinical Trials Monitoring Service contractor. Such on-site audits may include review of the following: use of investigational drugs; compliance with regulations for Institutional Review Board (IRB) approval and informed consent (compliance with 45 CFR 46); compliance with protocol specifications; quality control and accuracy of data recording; and completeness of reporting adverse drug reactions. Reports of such on-site audits will be reviewed by the Quality Assurance and Compliance Section (QACS), Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), DCT, and by the DCPC Program Director. In addition, NCI program and grants management staff will review protocol accrual, fiscal and administrative procedures. c. Data Management The DCPC Program Director will have access to all data generated under this award and will periodically review the data management procedures of the Minority-Based CCOPs. Data must also be available for external monitoring if required by NCI's agreement with other Federal agencies, such as the Food and Drug Administration (FDA). d. Investigational Drug Management The Drug Management and Authorization Section, Investigational Drug Branch (IDB), CTEP, DCT and Chemoprevention Branch (CB), DCPC staff will advise investigators of specific requirements and changes in requirements about investigational drug management that the FDA and NCI may mandate, either directly or through the research bases. e. Organizational Changes Minority-Based CCOPs must obtain prior written approval of the DCPC Program Director for certain organizational changes. These changes include the addition/deletion of a participating physician or a health professional other than a physician (entering patients/subjects in cancer prevention and control research in the Minority-Based CCOP), an affiliate, component, or research base. A change in the Principal Investigator, or in any key personnel identified on the "Notice of Grant Award," must have the prior written approval of the NCI Grants Management Specialist, with the advice of the DCPC Program Director. f. Program Review Annual progress reports must be submitted to DCPC. A suggested format developed by the DCPC Program Director for this purpose will be provided. The DCPC Program Director will review the progress of each Minority-Based CCOP through consideration of the Minority-Based CCOP annual report, program site visits, patient log, and reports from affiliated research base(s). This review may include, but not be limited to, overall accrual credits, number of new cancer patients available to the participating Minority-Based CCOP physicians and the percentage of new cancer patients from minority populations placed on study, eligibility and evaluability of individuals entered on study, and timeliness and quality of data reporting. The Minority-Based CCOP's performance in accruing cancer patients from minority populations will be assessed. The inability of a Minority-Based CCOP to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. g. Strategy Sessions The DCPC Program Director or designee will sponsor strategy sessions as needed to review the status, progress, and evolving needs of the Minority-Based CCOP. These meetings may include discussions of overall Minority-Based CCOP performance, minority cancer patient recruitment and retention in clinical research trials, barriers to effective treatment and cancer prevention and control implementation, and scientific research required to address specific issues in minority populations. The DCPC Program Director will also assist the Minority-Based CCOP investigators in exploring mutual interests in cancer prevention and control research and in establishing and prioritizing goals for evolving cancer programs. h. Federally Mandated Regulatory Requirements The DCPC Program Director or designee and DCT staff will review mechanisms established by each Minority-Based CCOP to meet the Department of Health and Human Service (DHHS)/Public Health Service (PHS) regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents. At a minimum, these include: o methods for assuring that each institution at which Minority-Based CCOP investigators are conducting clinical trials has a current, approved assurance on file with the Office for Protection from Research Risks (OPRR); that each protocol is reviewed by the responsible IRB prior to patient entry; and that each protocol is reviewed annually by the IRB so long as the protocol is active; o methods for assuring or documenting that each patient (or patient's parent/legal guardian) gives fully informed consent to participation in a research protocol prior to the initiation of the experimental intervention; o a system for assuring timely reporting of all serious and unexpected toxicities to the IDB, CTEP, DCT, according to DCT guidelines and/or to DCPC according to DCPC guidelines; and o implementation of DCPC/DCT requirements for storage and accounting for investigational agents provided under DCPC/DCT sponsorship. i. Arbitration Process The Terms and Conditions of Award require that the DCPC Program Director make post-award administrative decisions related to program performance, programmatic decisions on scientific-technical matters, and funding adjustments. NCI will establish an arbitration process when a mutually acceptable agreement cannot be obtained between the awardee and the DCPC Program Director. An arbitration panel (with appropriate expertise) composed of one member of the recipient group, one NCI nominee, and a third member chosen by the other two will be formed to review the NCI decision and recommend a course of action to the Director, DCPC. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS regulations 45 CFR Part 16. 2. Responsibilities of Awardees a. Protocols All research base protocols utilized by Minority-Based CCOPs must have been reviewed and approved for CCOP use by the CCPRC, DCPC and/or the PRC, DCT, NCI, prior to implementation. The Research base is responsible for the development and implementation of high quality treatment and cancer prevention and control clinical trials, and for evaluation of the results of such studies. To be eligible to receive credit for accrual to a research base protocol, the Minority-Based CCOP must have an affiliation agreement with the research base responsible to NCI for that protocol. b. Research Base Affiliation(s) Each Minority-Based CCOP must affiliate with a national multi-specialty cooperative group (research base) having a spectrum of treatment and cancer prevention and control clinical trial protocols available. Each Minority-Based CCOP may affiliate with up to four additional NCI approved research bases. A Minority-Based CCOP cannot affiliate with more than one national multi-specialty cooperative group. Note: A list of currently eligible research bases may be obtained from the program official listed under INQUIRIES. If participation in the protocols of one group competes with that of another group with which the Minority-Based CCOP is affiliated (e.g., two adjuvant protocols for the same eligible Stage II node positive patient), the Minority-Based CCOP must prioritize the protocols in order to avoid bias in the allocation of patients to competing protocols. Initial affiliations should be maintained during the funding cycle. When circumstances require changes in research base affiliations, prior written approval from the DCPC Program Director is required. c. Accrual Patient accrual to clinical trials is expected to be reflective of the new cancer patient distribution of the participating physicians, that is, greater than 50 percent of new cancer patients from minority populations. Each Minority-Based CCOP is required to accrue a minimum of 50 credits* per year in treatment clinical trials that are approved by the PRC, DCT, NCI. The 50 credit minimum requirement may be waived for applicants whose specialty is pediatrics and who are able to place a majority of their eligible patients on protocols.) As one measure of performance, it is expected that at least 10 percent of all new cancer patients for whom protocols are available will be placed on study by Minority-Based CCOP physicians. Each Minority-Based CCOP is required to accrue to cancer prevention and control protocols that have been approved by the CCPRC, DCPC. Cancer prevention and control research should be intervention-oriented and may include such areas as cancer prevention, early detection, patient management, rehabilitation, and continuing care. Minority-Based CCOPS are required to accrue a minimum of 30 credits* in the first year of funding, 40 credits in the second year, and 50 credits in the third and fourth years. The Minority-Based CCOP's ability to meet projected accrual goals to both cancer treatment and cancer prevention and control clinical trials will also be assessed. * Each protocol approved for CCOP use will be assigned a credit value. Credits will be based on the complexity of the intervention, the amount of data management required, and the duration of follow-up. For example, each patient accrued to an average Phase II or Phase III protocol will count 1 credit; an NCI-designated high-priority protocol 1.5 credits; and a childhood acute lymphocytic leukemia protocol 2 credits. Cancer control protocols will be assessed for credit using a similar approach. For example, a randomized Phase III chemoprevention protocol will be assigned a value of 1 credit per subject entered on cancer control protocols involving administration of questionnaires receive an average assignment of 0.3 credits/subject. d. Quality Control The Minority-Based CCOP will follow the procedures required by each of its research bases and the QACS, RAB, CTEP, DCT/DCPC Program Director. 2.e. Data Management The Minority-Based CCOP must provide the DCPC Program Director with access to all data generated under this award for periodic review of data management procedures of the Minority-Based CCOP. Data must also be available for external monitoring if required by NCI's agreement with other Federal agencies, such as the FDA and with NCI's agreements with pharmaceutical companies for the co-development of investigational agents. The awardees will retain custody of and primary rights to their data. 2.f. Investigational Drug Management Investigators performing trials under Cooperative Agreements will be expected, in cooperation with NCI, to comply with all FDA monitoring and reporting requirements for investigational agents. 2.g. Organizational Changes Certain Minority-Based CCOP organizational changes must have the prior written approval of the DCPC Program Director. These include the addition/deletion of a participating physician, a health care professionals other than a physician (who actively enters patients to cancer prevention and control trials), an affiliate, component, or research base. A change in the Principal Investigator, or in any institution or key personnel identified on the "Notice of Grant Award," must have the prior written approval of the NCI Grants Management Specialist, with the advice of the DCPC Program Director. h. Radiotherapy Equipment Radiotherapy equipment must have its calibration verified according to standards set by the Radiologic Physics Center (RPC) in order for institutions to participate in protocols requiring radiation therapy, as required by the affiliated research base(s). i. Monitoring Each Minority-Based CCOP agrees to periodic on-site audits by representatives of its research base(s), NCI, or an NCI-designee (Refer to 1.b. above). j. Reporting Requirements Annual progress reports must be submitted to DCPC. A suggested format developed by the DCPC Program Director for this purpose will be provided. The DCPC Program Director will review the progress of the Minority-Based CCOP. The inability of a Minority-Based CCOP to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award (refer to 1.f. above). k. Network Participation Minority-Based CCOPs are part of a national network for conducting treatment and cancer prevention and control clinical trials. As such, each Minority-Based CCOP may be asked to participate in strategy sessions or workshops and in the continuing evaluation of the Minority-Based CCOP and its impact in the community. l. Patient Log Each Minority-Based CCOP agrees to maintain a new patient log or minimal registry to include age, sex, race, primary site of cancer, stage of disease, and treatment disposition for the potentially eligible patient pool (patients with a protocol available for site and stage) seen by the Minority-Based CCOP investigators. m. Federally Mandated Regulatory Requirements Each Minority-Based CCOP must establish mechanisms to meet DHHS/PHS regulations for the protection of human subjects (Refer to 1.h. above). n. Publications and Presentations Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement requires acknowledgement of NCI support. 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 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 must be included in the form PHS 398 in the Research Plan 1- 4, AND summarized in 5, Human Subjects. If the required information is not contained within the application, the application will be returned. 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). To address the informational request, it is recommended that a breakdown by percentage of the gender and minority composition of the study population be provided. This information may be based on the institutional records and/or prior experience. 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 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. 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. LETTER OF INTENT Prospective applicants are asked to submit by June 25, 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, 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 subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to Dr. Otis W. Brawley at the address listed under INQUIRIES. APPLICATION PROCEDURES A. Preparation of Applications General instructions for the preparation of the cooperative agreement application are contained in the grant application form PHS 398 (rev. 9/91). Responses to the instructions concerning Human Subjects verification must be provided when the application is initially submitted. Because the Terms and Conditions of Award (discussed in the Special Requirements Section above) will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to these terms. Plans should describe how the applicant will comply with NCI staff involvement as well as how all the responsibilities of awardees will be fulfilled. An application from a currently funded program will be a competitive continuation and must include a progress report, which at a minimum consists of: (1) a summary of prior Minority-Based CCOP activities/accomplishments, including a clear presentation of yearly accrual over the funding period; (2) an evaluation of Minority-Based CCOP performance by affiliated research base(s); and (3) a complete description of how the applicant has met the special cooperative agreement terms and conditions of the award. 1. Each applicant must demonstrate access to a population with greater than 50 percent of new cancer patients from minority groups. Data from hospital registries, admission, discharge, clinic, and billing records may be utilized to document the minority new cancer patient population available to the applicant organization AND its physician participants. 2. Each applicant must delineate its patient catchment area. A map of the service area, designating counties or zip codes from which approximately 80 percent of the patients will be drawn, should be provided. A description of other cancer care resources in the catchment area (i.e., hospitals, clinics, physicians, cancer centers) that are not part of the application should be included. A detailed demographic description, including a distribution of all new cancer patients (including minorities) available for participation in clinical research, should be provided. The applicant must clearly indicate the percentage of new cancer patients from minority populations available to institutions (i.e., hospitals) included in the application AND the percentage of new cancer patients from minority populations seen by the participating physicians included in the application. 3. Each applicant must demonstrate the potential and stated commitment to accrue a minimum of 50 credits per year to treatment clinical trials (except if waived for applicants whose specialty is pediatrics). Documentation must include any prior participation in treatment research clinical trials with a clear presentation of the number of patients and credits accrued to NCI approved treatment clinical trials. A list of the NCI-approved treatment protocols in which the applicant expects to participate and projected accrual to each must be provided. 4. Each applicant must demonstrate the potential and stated commitment to accrue a minimum of 30 credits in the first year of funding, 40 credits in the second year, and 50 credits in the third and fourth years to cancer prevention and control clinical trials. Documentation must include any prior participation in cancer prevention and control research clinical trials with a clear presentation of the number of patients and credits accrued to NCI-approved cancer prevention and control clinical trials. A list of the NCI-approved cancer prevention and control protocols in which the applicant expects to participate and projected accrual to each must be provided. 5. The ability of Minority-Based CCOPs and research bases to collaborate in cancer prevention and control research must be demonstrated by each applicant. Working with affiliated research bases, the applicant must provide at least two examples of DCPC approved intervention cancer prevention and control protocols appropriate for the Minority-Based CCOP's participation, and should describe their implementation, including specifics on patient/subject recruitment, compliance and follow-up. 6. A designated Principal Investigator is required. An associate Principal Investigator should also be named to assure continuity in the event of resignation of the Principal Investigator. The qualifications and experience of both, in terms of ability to organize and manage a community oncology program that includes treatment and cancer prevention and control research and related activities, must be described. 7. Each applicant is expected to have a committed multidisciplinary professional group appropriate for its expected protocol participation. This team may include medical oncologists, surgeons, radiation oncologists, pathologists, oncology nurses, data managers, health educators, and other disciplines (e.g., gynecology, urology, pediatrics, internal medicine, family practice) as appropriate. The training and experience of participating physicians must be provided, along with a description of working relationships. Any experience working together as a group, particularly in implementing clinical treatment and cancer prevention and control research and related activities, should be included. An organizational chart showing how the group will function must also be included. 8. Each applicant must provide the qualifications and experience of all proposed support personnel as well as a description of the proposed duties for each position. 9. Through formal affiliations with a maximum of five CCOP approved research bases, only one of which can be a national multi-specialty cooperative group, each applicant must demonstrate access to both treatment and cancer prevention and control research protocols. Evidence must be provided that an affiliation has been established with at least one NCI-funded research base which has the capacity to provide both clinical treatment and cancer prevention and control protocols. In addition, affiliations with research bases offering only cancer prevention and control protocols are appropriate. The conditions of affiliation must be provided in the Minority-Based CCOP-research base affiliation agreement(s). Initial affiliations should be maintained during the funding cycle. Multiple research base affiliations are permitted provided they are not conflicting. The affiliation agreements must state specifically how the problem of competing protocols will be resolved. To be eligible to receive accrual credit for entry to an NCI- approved protocol, the Minority-Based CCOP must have an affiliation agreement with the research base responsible to NCI for that protocol. Note: A list of currently eligible Research Bases may be obtained from the program official listed under INQUIRIES. 11. Quality control procedures must be described in detail. Assurance of quality is the joint responsibility of the Minority-Based CCOP and its research base(s). Quality control procedures of the research base will be applied to the Minority-Based CCOPs and should be specified in the affiliation agreement between the Minority-Based CCOP and the research base. Procedures for investigational drug monitoring and data management must also be described. 12. The availability of facilities, including laboratories, inpatient and outpatient resources, cancer registries, etc., must be described. A statement of commitment from each participating institution or organization and/or documentation of consortium arrangements must be provided. Evidence of involvement with community-based voluntary organizations must be provided. Evidence of involvement with community-based voluntary organizations may be submitted. In addition, each applicant must have a defined space for administrative activities and administrative personnel that will serve as a focus for data management, quality control, and communication. 13. Allocation of funds to support community costs for receipt, handling, and quality control of patient data must be specified. Allowable items in the budget are requests for full or part-time administrative personnel, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); and appropriate travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel). Funding is not allowed for clinical care provided to patients (e.g., reimbursement of patient care expenses; transportation costs). Physician compensation is only an allowable cost for the Principal Investigator (PI) and Co-PI, specifically for time spent on Minority-Based CCOP organizational/administrative tasks. Justification must be provided for personnel time, effort and funds requested. Special personnel resource needs to support the recruitment and retention of eligible minority patients on clinical trials may be requested. Method of Applying The research grant application form PHS 398 (rev. 9/91) is to be used in applying for cooperative agreements. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NCI program official listed under INQUIRIES. A suggested format will be sent to all applicants requesting the RFA or submitting a letter of intent. All applicants are encouraged to obtain and use the suggested format instructions for organizing the specific information concerning the RFA programmatic requirements in the PHS 398. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA 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, 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 also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Rockville, MD 20852 Applications must be received by August 24, 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 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 and NCI staff for responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff will return it. If the number of applications is large compared to the number of awards to be made, applications may receive a preliminary scientific peer review (triaged) to determine their relative competitiveness. The NCI will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review will be provided by the National Cancer Advisory Board. Review Criteria o Ability to access through participating Minority-Based CCOP physicians a population with greater than 50% of new cancer patients from minorities. o Ability to accrue a minimum of 50 credits per year to treatment clinical trials and a minimum of 30 credits per year to cancer prevention and control clinical trials in the first year, 40 credits in the second year, 50 credits in the third and fourth years. The NCI Program Director may waive the accrual requirement for applicants whose specialty is pediatrics. Each applicant's ability to access the appropriate populations, professional disciplines, and facilities to participate with affiliated research bases in at least two DCPC approved cancer prevention and control intervention protocols will be appraised. Any prior participation in treatment and cancer prevention and control research will be considered. o Qualifications and experience of the Principal Investigator/associate Principal Investigator, in terms of ability to organize and manage a community oncology program that includes both treatment and cancer prevention and control research and related activities. o Training, experience, and commitment of participating physicians for accruing individuals to protocols in which the applicant has agreed to participate. The experience of proposed investigators in the entry and treatment of cancer patients on research trials (gained from residency, fellowships, postdoctoral training and/or subsequent practice) will be appraised. For multidisciplinary studies, evidence of the availability of appropriate professional resources (e.g., radiotherapy, pediatrics, surgery, gynecology, urology, pathology, internal medicine, family practice, nursing, and nutrition) will be required. Experience or special skills in cancer prevention and control research and related activities will be considered, together with availability of other community resources and personnel for such clinical trials. Previous involvement by participating physicians and the applicant organization in cancer care management, clinical research, and related activities in minority populations will be assessed. o Stability of the functional unit or group applying to become a Minority-Based CCOP. Preexisting organizational affiliations of at least a core of the group applying, and evidence of stable working relationships, will be appraised. Examples of established consortium arrangements, and committee structure which demonstrates the participation of appropriate physicians and administrators, may be submitted. Evidence of previous success as a group in implementing clinical treatment and cancer prevention and control research and related activities will be considered. o Qualifications and experience of all proposed support personnel relative to their position descriptions. The relevant credentials and expected contributions to the program of personnel resources not fiscally supported by the award will be considered. o Adequacy of quality assurance mechanisms for both treatment and cancer prevention and control interventions, and adequacy of procedures for investigational drug monitoring and data management. o Adequacy of available facilities, including laboratories, in-patient and outpatient resources, cancer registries, etc., and adequacy of space for administrative activities and personnel. o Appropriateness of research base affiliations and of the treatment cancer prevention and control research protocols chosen. Affiliation agreements must be provided in the application. o For competitive continuations, adequacy of progress during the funding period, including ability to meet the minimum accrual credits in cancer treatment and cancer prevention and control, progress made as a Minority-Based CCOP, and evaluation of Minority-Based CCOP performance by affiliated research bases(s). Consideration will be given to previous accrual and the ability to meet the previous accrual projections for which the CCOP was funded. The research base evaluation report(s) must be provided in the application. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each favorably recommended application. Allowable items in the budget are requests for full or part-time administrative personnel, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); and appropriate travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel). Special personnel resource needs to support the recruitment and retention of eligible minority patients on clinical trials will be considered. Funding is not allowed for clinical care provided to patients. (e.g., reimbursement of patient care expenses; transportation costs). Physician compensation is allowable only for time spent on Minority-Based CCOP organizational/administrative tasks. Justification must be provided for personnel time and effort and funds requested. AWARD CRITERIA The anticipated date of award is June 1, 1994. NCI program staff will take into account demographic and geographic distribution of applicants in the final funding selection process to assure inclusion of minority and underserved populations. Multiple Minority-Based CCOP applicants for funding who are competing for the same patient population will be considered, but all may not be awarded unless warranted by the population density. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA or 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: Otis W. Brawley, M.D. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 300 Bethesda, MD 20892 Telephone: (301) 496-8541 Direct inquiries regarding fiscal matters to: Ms. Crystal Elliott Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 13.399, Cancer Control. 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 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. From owner-sci-resources@net.bio.net Thu May 06 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. 18, pt. 3, 7 May 1993 Message-ID: Date: 7 May 93 18:19:03 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1559 $$XID RFA CA93025 CA-93-025 P1O2 *************************************** COMMUNITY CLINICAL ONCOLOGY PROGRAM NIH Guide, Volume 22, Number 18, May 7, 1993 RFA: CA-93-025 P.T. 34; K.W. 0715035, 0755015, 0745027, 0403004 National Cancer Institute Letter of Intent Receipt Date: June 25, 1993 Application Receipt Date: August 24, 1993 PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites applications from domestic institutions for cooperative agreements to the Community Clinical Oncology Program (CCOP). New community and research base applicants and currently funded programs are invited to respond to this Request For Applications (RFA). Utilizing the national resource of highly trained oncologists in community practice, the CCOP: (1) provides support for expanding the clinical research effort in the community setting; (2) stimulates quality care in the community through participation in protocol studies; (3) fosters the growth and development of a scientifically viable community cancer network able to work closely with NCI-supported clinical cooperative groups and cancer centers; (4) supports development of and community participation in cancer prevention and control intervention research, which includes chemoprevention, early detection, patient management, rehabilitation, and continuing care research; (5) involves primary care providers and other specialists in cancer prevention and control clinical trials; and (6) increases the involvement of minority and underserved populations in clinical research. Combining the expertise of community physicians and other health care professionals with NCI-approved treatment and cancer prevention and control clinical trials provides the opportunity for the transfer of the latest research findings to the community level. This issuance of the CCOP RFA seeks to build on the strength and demonstrated success of the CCOP over the past ten years by: (1) continuing the program as a vehicle for supporting community participation in treatment and cancer prevention and control clinical trials through research bases (clinical cooperative groups and cancer centers supported by NCI); (2) expanding and strengthening the cancer prevention and control research effort; (3) utilizing the CCOP network for conducting NCI-assisted cancer prevention and control research; and (4) evaluating on a continuing basis CCOP performance and its impact in the community. 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, Community Clinical Oncology Program, 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 from domestic institutions for cooperative agreements to continue the Community Clinical Oncology Program (CCOP). New applicants and currently funded programs are eligible as described below. A. CCOP Applicants 1. An applicant may be a hospital, a clinic, a group of practicing physicians, a health maintenance organization (HMO), or a consortium of hospitals and/or clinics and/or physicians and/or HMOs that agree to work together with a principal investigator and a single administrative focus. 2. A university, military, or Veterans Administration hospital may be included in an application as a member of a consortium led by a community institution, but may not be the applicant organization or the major contributor to accrual. An unfunded, non-university clinical trials cooperative group member is eligible to apply. 3. Funded Cooperative Group Outreach Program (CGOP) participants are eligible to apply, but should state in the application that CGOP support will be relinquished if a CCOP award is received. 4. Institutions not eligible to apply as a CCOP include: a. A comprehensive, consortial, or clinical cancer center holding an NCI Cancer Center Support (CORE) grant; b. A university hospital that is the major teaching institution for that university; or c. A university hospital clinical trials cooperative group member funded by DCT, NCI. B. Research Base Applicants An applicant may be: 1. An NCI-funded clinical trials cooperative group; 2. An NCI-funded clinical, consortia, or comprehensive cancer center. Cooperative groups must participate in both treatment and cancer prevention and control clinical trials; cancer centers may participate in treatment and cancer prevention and control studies or cancer prevention and control research only. MECHANISM OF SUPPORT Support of this program will be through the clinical cooperative agreement (U10). The Cooperative Agreement is an assistance mechanism in which substantial NCI programmatic involvement with the recipient during performance of the planned activity is anticipated to assist awardees in the planning, direction, and execution of the proposed project. The total project period for applications submitted in response to this RFA may not exceed three years for new applicants, and five years for applicants currently supported under this program. Currently supported applicants will be funded for three, four, or five years depending upon priority score/percentile, review committee recommendations, and programmatic considerations. FUNDS AVAILABLE The NCI has determined that there is a continuing program need for community participation in cancer clinical research trials, both treatment and cancer prevention and control. While this RFA is a one-time issuance, it is expected that a CCOP RFA will be published in the NIH Guide for Grants and Contracts annually in the future provided that funds are available. It is anticipated that up to $4.2 million in total costs per year for five years will be committed to specifically fund applications which are submitted in response to this RFA. Of the total, approximately $1.8 million will be committed to research bases and approximately $2.4 million to CCOPs. It is anticipated that up to three research base awards and up to 15 CCOP 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 NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES A. Background Over 80 percent of patients with cancer are treated in the community. The CCOP was initiated in 1983 to bring the benefits of clinical research to cancer patients in their own communities by providing support for physicians to enter patients onto treatment research protocols. In the first three years of the CCOP, 62 community programs in 34 states were funded. During this time, approximately 14,000 patients were entered onto NCI-approved treatment clinical trials through the CCOP. The data from CCOP participants met or exceeded all the quality control standards of the cooperative groups. The CCOP evaluation indicated that patients on protocol and patients treated by CCOP participating physicians received more appropriate patterns of care than patients seen by physicians who never used protocols. The CCOPs also had an increase in the number of physicians using protocols, the number of protocols used, and the number of patient registrations. It was further documented that CCOPs with higher accruals were often associated with more appropriate patterns of care. All of these factors contribute to establishing a framework that is critical to the diffusion process and the widespread dissemination of state-of-the-art practices. The CCOPs clearly were very effective in accruing patients to treatment clinical trials. The second CCOP RFA, issued in 1986, expanded the focus to include cancer prevention and control research based on the rationale that the multi-institutional clinical trials model essential for testing new treatment regimens is also required for conducting large-scale cancer prevention and early detection trials. In 1992, there were 51 programs in 27 states involving over 300 hospitals and over 2,800 physicians. Approximately 5,000 patients per year were entered onto treatment trials and 4,000 subjects per year on cancer prevention and control trials. Cancer prevention and control research in the CCOPs is aimed at reducing cancer incidence, morbidity, and mortality through the identification, testing, and evaluation of interventions in controlled clinical trials. The development of cancer prevention and control research in the CCOP network has been increasing steadily since funding started in 1987. Since that time over 100 protocols have been reviewed and 80 have been activated. Protocols reviewed to date cover the full spectrum of cancer prevention and control research, including chemoprevention, marker studies for future prevention interventions, smoking cessation studies, screening and early detection, and pain control and other symptom management interventions. Several large chemoprevention trials have been implemented through the CCOP network, including the breast cancer prevention trial with tamoxifen and the head and neck chemoprevention trial with 13-cis retinoic acid (13-cRA). The CCOPs are a vital resource for conducting NCI cancer prevention and control research because they provide access to: (1) a national network for cancer prevention and control trials which require large sample sizes for completion; (2) geographic areas which include cross sections of the population, providing mixes of patients/subjects not always available in university or urban settings; (3) large populations of cancer patients free of disease which provide a unique resource for chemoprevention clinical trials; and (4) cancer patients' family members and others who may be at increased risk of developing cancer and thus be candidates for prevention and detection studies. Participation in cancer prevention and control research by CCOPs also further expands the network of community physicians, increasing the potential for diffusion of state-of-the-art cancer prevention and control practices. B. Goals and Scope The CCOP initiative is designed to: o bring the advantages of state-of-the-art treatment and cancer prevention and control research to individuals in their own communities by having practicing physicians and their patients/subjects participate in NCI-approved treatment and cancer prevention and control clinical trials; o provide a basis for involving a wider segment of the community in cancer prevention and control research and investigate the impact of cancer therapy and control advances in community medical practices; o increase the involvement of primary health care providers and other specialists (e.g., surgeons, family practitioners, urologists, gynecologists) with the CCOP investigators in treatment and cancer prevention and control research, providing an opportunity for education and exchange of information; o facilitate wider community participation, including minorities, women, and other underserved populations, in treatment and cancer prevention and control research approved by NCI; and o reduce cancer incidence, morbidity, and mortality by accelerating the transfer of newly developed cancer prevention, early detection, treatment, patient management, rehabilitation, and continuing care technology to widespread community application. Participating community programs (CCOPs) will be required to enter patients onto NCI-approved treatment and cancer prevention and control clinical trials through the research base(s) with which each CCOP is affiliated. CCOPs may relate directly to NCI for assistance and participation in selected cancer prevention and control protocols. CCOP performance will be evaluated on a continuing basis by the NCI program director for its impact on community cancer treatment and control practices. Participating research bases will be required to continue providing clinical research treatment and/or cancer prevention and control protocols, as applicable, and as studies progress and findings indicate, to develop new protocols. Cancer prevention and control research should be intervention-oriented and may include such areas as cancer prevention, early detection, patient management, rehabilitation, and continuing care. Research bases will be expected to monitor the quality of protocol conduct, follow CCOP accrual, and participate in the continuing program evaluation. SPECIAL REQUIREMENTS A. Terms and Conditions of Award Under the cooperative agreement, a partnership will exist between the recipient of the award and NCI, with assistance from NCI in carrying out the planned activity. The following terms and conditions pertaining to the scope and nature of the interaction between NCI and the investigators will be incorporated in the Notice of Award. These terms will be in addition to the customary programmatic and financial negotiations which occur in the administration of grants. The "Terms and Conditions of Award: Nature of NCI Staff Involvement" and "Terms and Conditions: Responsibilities of Awardees" described in this section are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines; DHHS grant administration regulations 45 CFR 74; other DHHS, PHS, and NIH grant administration policy statements; and other NCI administrative terms of award. 1. Community (CCOP) Awardees a. Nature of NCI Staff Involvement (1) Protocol Review All protocols utilized by the CCOPs must be reviewed and approved for CCOP use by the Cancer Control Protocol Review Committee (CCPRC), Division of Cancer Prevention and Control (DCPC), and/or the Protocol Review Committee (PRC), Division of Cancer Treatment (DCT), NCI, prior to implementation. The NCI will not provide investigational drugs, permit expenditure of NCI funds, or allow accrual credit for a protocol that has not been approved, or that has been closed (except for patients already on study). (2) Monitoring There will be periodic on-site audits of each CCOP by representatives of its research base(s), NCI, or an NCI-designee, such as DCT's current Clinical Trials Monitoring Service contractor. Such on-site audits may include review of the following: use of investigational drugs; compliance with regulations for Institutional Review Board (IRB) approval and informed consent (compliance with 45 CFR 46); compliance with protocol specifications; quality control and accuracy of data recording; and completeness of reporting adverse drug reactions. Reports of such on-site audits will be reviewed by the Quality Assurance and Compliance Section (QACS), Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), DCT, and by the DCPC Program Director. In addition, NCI program and grants management staff will review protocol accrual, fiscal and administrative procedures. (3) Data Management The DCPC Program Director will have access to all data generated under this award and will periodically review the data management procedures of the CCOP. Data must also be available for external monitoring if required by NCI's agreement with other federal agencies, such as the Food and Drug Administration (FDA). (4) Investigational Drug Management The Drug Management and Authorization Section, Investigational Drug Branch (IDB), CTEP, DCT and Chemoprevention Branch (CB), DCPC staff will advise investigators of specific requirements and changes in requirements about investigational drug management that the FDA and NCI may mandate, either directly or through the research bases. (5) Organizational Changes CCOPs must obtain prior written approval from the DCPC Program Director for certain organizational changes. These changes include the addition/deletion of a participating physician or a health professional other than a physician (entering patients/subjects in cancer prevention and control research in the CCOP), an affiliate, component, or research base. A change in the Principal Investigator, or in any key personnel identified on the "Notice of Grant Award," must have the prior written approval of the NCI Grants Management Specialist, with the advice of the DCPC Program Director. (6) Program Review Annual progress reports must be submitted to DCPC. A suggested format developed by the DCPC Program Director for this purpose will be provided. The DCPC Program Director will review the progress of each CCOP through consideration of the CCOP annual report, program site visits, and reports from affiliated research bases. This review may include, but not be limited to, overall accrual credits, percent of available patients/subjects placed on study, eligibility and evaluability of individuals entered on study, and timeliness and quality of data reporting. The inability of a CCOP to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. (7) Strategy Sessions The DCPC Program Director or designee will sponsor strategy sessions when indicated, attended by Principal Investigators from the CCOPs and appropriate DCPC/DCT staff. At these meetings, information relevant to the CCOPs will be reviewed and discussed, including such issues as overall CCOP performance and the science of current or proposed clinical trials. Data will be analyzed and the outstanding research questions established and prioritized into national research goals by CCOP investigators and the DCPC/DCT attendees. The Principal Investigators will have the primary responsibility for analyzing and prioritizing the research questions to be developed into clinical trials. The DCPC Program Director will also assist the CCOP investigators in exploring mutual interests in cancer prevention and control research. (8) Federally Mandated Regulatory Requirements The DCPC Program Director or designee and DCT staff will review mechanisms established by each CCOP to meet the Department of Health and Human Services (DHHS)/Public Health Service (PHS) regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents. At a minimum, these include: o methods for assuring that each institution at which CCOP investigators are conducting clinical trials has a current, approved assurance on file with the Office for Protection from Research Risks (OPRR); that each protocol is reviewed by the responsible IRB prior to patient entry; and that each protocol is reviewed annually by the IRB so long as the protocol is active; o methods for assuring or documenting that each patient (or patient's parent/legal guardian) gives fully informed written consent to participation in a research protocol prior to the initiation of the experimental intervention; o a system for assuring timely reporting of all serious and unexpected toxicities to the IDB, CTEP, DCT, according to DCT guidelines and/or to DCPC according to DCPC guidelines; and o implementation of DCPC/DCT requirements for storage and accounting for investigational agents provided under DCPC/DCT sponsorship. (9) Arbitration Process The Terms and Conditions of Award require that the DCPC Program Director make post-award administrative decisions related to program performance, programmatic decisions on scientific-technical matters, and funding adjustments. The NCI will establish an arbitration process when a mutually acceptable agreement cannot be obtained between the awardee and the DCPC Program Director. An arbitration panel (with appropriate expertise) composed of one member of the recipient group, one NCI nominee, and a third member chosen by the other two will be formed to review the NCI decision and recommend a course of action to the Director, DCPC. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS regulations 45 CFR Part 16. b. Responsibilities of Awardees (1) Protocols All protocols utilized by the CCOPs must have been reviewed and approved for CCOP use by the CCPRC, DCPC, and/or the PRC, DCT, NCI, prior to implementation. The research base is responsible for the development and implementation of high quality treatment and cancer prevention and control clinical trials, and for evaluation of the results of such studies. To be eligible to receive credit for accrual to a research base protocol, the CCOP must have an affiliation agreement with the research base responsible to NCI for that protocol. (2) Research Base Affiliation(s) Each CCOP must affiliate with a national multi-specialty cooperative group having a spectrum of treatment and cancer prevention and control clinical trials. Each CCOP can affiliate with four or fewer additional research bases. Note: A list of currently eligible research bases may be obtained from the program official listed under INQUIRIES. If participation in the protocols of one group competes with that of another group with which the CCOP is affiliated, the CCOP must prioritize the protocols in order to avoid bias in the allocation of patients to competing protocols. Initial affiliations should be maintained during the funding cycle. When circumstances require changes in research base affiliations, prior written approval from the DCPC Program Director is required. (3) Accrual Each CCOP is required to accrue a minimum of 50 credits* per year to treatment clinical trials that have been approved by the PRC, DCT, NCI. (For applicants whose specialty is pediatrics, the 50 credit minimum requirement may be waived for those applicants who are able to place a majority of their eligible patients on protocols.) As one measure of performance, it is expected that at least 10 percent of patients for whom protocols are available will be placed on clinical trials by CCOP physicians. Each CCOP is required to accrue a minimum of 50 credits* per year to cancer prevention and control clinical trials that have been approved by the CCPRC, DCPC. The CCOPs ability to meet projected accrual goals to both cancer treatment and cancer prevention and control clinical trials will also be assessed. * Each protocol approved for CCOP use will be assigned a credit value. Credits will be based on the complexity of the intervention, the amount of data management required, and the duration of follow-up. For example, each patient accrued to an average Phase II or Phase III protocol will count 1 credit; an NCI-designated high-priority protocol 1.5 credits; and a childhood acute lymphocytic leukemia protocol 2 credits. Cancer control protocols will be assessed for credit using a similar approach. For example, a randomized Phase III chemoprevention protocol will be assigned a value of 1 credit per subject entered. Cancer control protocols involving administration of questionnaires receive an average assignment of 0.3 credits/subject. (4) Quality Control The CCOP must follow the procedures required by each of its research bases and the QACS, RAB, CTEP, DCT/DCPC Program Director. (5) Data Management The CCOP must provide the DCPC Program Director with access to all data generated under this award for periodic review of data management procedures of the CCOP. Data must also be available for external monitoring if required by NCI's agreement with other federal agencies, such as the FDA and with NCI's agreements with pharmaceutical companies for the co-development of investigational agents. The awardees will retain custody of and primary rights to their data. (6) Investigational Drug Management Investigators performing trials under cooperative agreements will be expected, in cooperation with NCI, to comply with all FDA monitoring and reporting requirements for investigational agents. (7) Organizational Changes Certain CCOP organizational changes must have the prior written approval of the DCPC Program Director. These include the addition/deletion of a participating physician, a health professional other than a physician (who actively enters patients to cancer prevention and control trials), an affiliate, component, or research base. A change in the Principal Investigator, or in any key personnel identified on the "Notice of Grant Award," must have the prior written approval of the NCI Grants Management Specialist, with the advice of the DCPC Program Director. (8) Radiotherapy Equipment Radiotherapy equipment must have its calibration verified according to standards set by the Radiologic Physics Center (RPC) in order for institutions to participate in protocols requiring radiation therapy, as required by the affiliated research base(s). (9) Monitoring Each CCOP must agree to periodic on-site audits by representatives of its research base(s), NCI, or an NCI-designee. (10) Reporting Requirements Annual progress reports must be submitted to DCPC. A suggested format developed by the DCPC Program Director for this purpose will be provided. The DCPC Program Director will review the progress of each CCOP. The inability of a CCOP to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. (11) Network Participation CCOPs are part of a national network for conducting treatment and cancer prevention and control clinical trials. As such, each CCOP may be asked to participate in strategy sessions or workshops and in the continuing evaluation of the program and its impact in the community. (12) Patient Log Each CCOP may be asked to periodically maintain a new patient log or minimal registry to include age, sex, race, insurance status, primary site of cancer, stage of disease, and treatment disposition for the potentially eligible patient pool seen by the CCOP investigators. (13) Federally Mandated Regulatory Requirements Each CCOP must establish mechanisms to meet DHHS/PHS regulations for the protection of human subjects. (14) Publications Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement requires acknowledgement of NCI support. B. Terms and Conditions of Award 1. Research Base Awardees a. Nature of NCI Staff Involvement (1) Scientific Resource The Division of Cancer Prevention and Control (DCPC) and Division of Cancer Treatment (DCT) staff will serve as a resource for specific scientific information on cancer prevention and control clinical trials, treatment regimens, and clinical trial design. The DCPC Program Director will assist the research base as appropriate in developing information concerning the scientific basis for specific trials and will also be responsible for advising the research base of the nature and results of relevant trials being carried out nationally or internationally. The DCPC Program Director will sponsor strategy sessions when indicated, attended by leading investigators from the research bases, other extramural scientists, and appropriate experts to discuss specific research initiatives. The Investigational Drug Branch (IDB), Cancer Therapy Evaluation Program (CTEP), DCT, Chemoprevention Branch (CB), DCPC, staff, through the DCPC Program Director, will provide updated information on the efficacy, toxicity and availability of all Investigational New Drugs (INDs) supplied by NCI to the research base. The Principal Investigators will have primary control over making decisions derived from meetings with the additional staff named above. (2) Protocol Development The protocol should be a document mutually acceptable to the research base and to DCPC/DCT. Communication at the various stages of development is encouraged. DCPC/DCT will assist the research base in protocol design as appropriate by providing information regarding: (a) the existence and nature of concurrent clinical trials in the area of research, with an emphasis on preventing duplication of effort; (b) relevant pharmacokinetic and pharmacodynamic data on investigational agents; (c) availability of investigational agents, including biologic response modifiers; (d) feasibility and appropriateness of the research for use by the CCOPs and/or in a community setting; and (e) basic research in cancer centers and other NCI-funded programs which may be ready for clinical trials. DCPC/DCT will also comment on the scientific rationale, programmatic relevance, priority, design, statistical requirements, and implementation of the proposed study. All cancer prevention and control protocols proposed for use by the CCOPs must be preceded by a concept for review by DCPC. All cancer prevention and control concepts and protocols should be submitted to the Protocol Information Office (PIO), CTEP, DCT, for review by the Cancer Control Protocol Review Committee, DCPC. DCT may require a letter of intent for cancer treatment trials. All treatment protocols should be submitted to the PIO, CTEP, DCT. (3) Protocol Review All research base protocols utilized by the CCOPs must be reviewed and approved for CCOP use by the Cancer Control Protocol Review Committee (CCPRC), DCPC, and/or the Protocol Review Committee (PRC), DCT, NCI, prior to implementation. The major considerations in protocol review by DCPC/DCT include: (a) strength of the scientific rationale supporting the study; (b) importance of the question being posed; (c) avoidance of undesirable duplication with ongoing clinical trials; (d) appropriateness and feasibility of study design; (e) satisfactory projected accrual rate and follow-up period; (f) patient/subject safety; (g) compliance with NIH and other federal regulatory requirements; (h) adequacy of data management; and (i) appropriateness of patient/subject selection, evaluation, assessment of toxicity, response to intervention, and follow-up. The DCPC/DCT review committee chairperson will provide the research base with a consensus review that describes recommended modifications and other suggestions as appropriate. If a protocol is disapproved, the specific reasons for lack of approval will be communicated to the research base principal investigator as a consensus review within a reasonable time. The DCPC Program Director will work with the research base, where appropriate, to develop a mutually acceptable protocol compatible with the research interests, abilities, and needs of the base, its affiliates, and NCI. Credit will be assigned following final approval of the protocol. The NCI will not provide investigational drugs, permit expenditure of NCI funds, or allow accrual credit for a protocol that has not been approved. (4) Data Management and Analysis The awardees will retain custody of and primary rights to their data; however, DCPC/DCT will have access to all data generated under this award. The DCPC Program Director or a DCT representative may review data management and analysis procedures of the research base, under mutually agreeable circumstances, for consistency with policies and procedures established by DCPC/DCT for awardees conducting treatment and cancer prevention and control clinical trials. Data must also be available for external monitoring if required by NCI's agreement with other federal agencies, such as the Food and Drug Administration (FDA) and by NCI's agreements with pharmaceutical companies for the co-development of investigational agents. (5) Quality Control and Monitoring The Quality Assurance and Compliance Section (QACS), Regulatory Affairs Branch (RAB), CTEP, DCT/DCPC Program Director may review quality control and monitoring procedures of the research base for consistency with policies and procedures established by DCT/DCPC for awardees conducting treatment and cancer prevention and control clinical trials. (6) Investigational Drug Management The Drug Management and Authorization Section, IDB, CTEP, DCT, and CB, CPRP, DCPC, staff will advise investigators of specific requirements and changes in requirements concerning investigational drug management that the FDA may mandate. (7) Organizational Changes A change in the research base Principal Investigator, or in any key personnel identified in the "Notice of Grant Award," must have the prior written approval of the NCI Grants Management Specialist, with the advice of the DCPC Program Director. (8) Program Review Annual progress reports, including an annual performance report on each affiliated CCOP, must be submitted to DCPC. A suggested format developed by the DCPC Program Director for this purpose will be provided. The DCPC Program Director will review the progress of each research base through consideration of the research base annual report and program site visits. The annual report will include, as a minimum, information on: overall case accrual credits; cancer prevention and control research, existing or planned; eligibility and evaluability of patients/subjects entered on study; timeliness and quality of data reporting; and results of quality control review and audits if performed during that year. Research base funding is contingent on accrual from affiliated CCOPs/Minority-Based CCOPs and annual adjustments in funding may be made. The inability of a research base to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. (9) Protocol Closure DCPC/DCT will review research base mechanisms for interim monitoring of results and will monitor protocol progress. DCPC/DCT may request that a protocol study be closed for reasons including: (a) insufficient accrual rate; (b) accrual goal met; (c) poor protocol performance; (d) patient/subject safety; (e) already conclusive study results; and (f) emergence of new information which diminishes the scientific importance of the study question. The NCI will not provide investigational drugs, permit expenditure of NCI funds, or allow accrual credit for a study after requesting closure (except for patients already on study). If a research base wishes to close accrual to a study prior to meeting the initially established accrual goal, the interim results and other documentation should be made available to NCI for review and concurrence prior to implementation of the decision by the research base. It is recommended that statistical guidelines for early closure be presented as explicitly as possible in the protocol in order to facilitate these decisions. (10) Federally Mandated Regulatory Requirements The DCPC Program Director and a DCT representative will review mechanisms established by each research base to meet Department of Health and Human Services (DHHS)/Public Health Service (PHS) regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents. At a minimum, these include: o a method for assuring that local IRB approval has been obtained before patients are registered on each study. o an on-site audit program for periodic data verification and review of regulatory responsibilities at each CCOP, cooperative group member, and Cooperative Group Outreach/cancer center affiliate institution. o a method of providing, upon DCPC/DCT request, summary efficacy and toxicity data to be included in DCPC/DCT's annual reports to the FDA for each investigational agent. o a method for the timely reporting of serious adverse reactions. (11) CCOPs/Minority-Based CCOPs The DCPC Program Director will notify research bases when CCOPs/Minority-Based CCOPs are funded. (12) Arbitration Process The Terms and Conditions of Award require that the DCPC Program Director make post-award decisions related to protocol review, program performance and adjustments in funding. The NCI will establish an arbitration process when a mutually acceptable agreement cannot be obtained between the awardee and NCI staff. An arbitration panel (with appropriate expertise) composed of one member of the recipient group, one NCI nominee, and a third member chosen by the other two will be formed to review the NCI decision and recommend an appropriate course of action to the Director, DCPC. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS regulations 45 CFR Part 16. b. Responsibilities of Awardees (1) Protocol Development The research base is responsible for the development and implementation of high quality treatment and cancer prevention and control clinical trials, and for evaluation of the results of such clinical trials. (2) Protocol Review All research base protocols utilized by the CCOPs must have been reviewed and approved for CCOP use by the CCPRC, DCPC, and/or the PRC, DCT, NCI, prior to implementation. Treatment and cancer prevention and control protocols must be submitted to the PIO, CTEP, DCT, for review by the appropriate committee. DCT may require a letter of intent for treatment protocols. All cancer prevention and control protocols must be preceded by a concept review by DCPC. (3) Accrual A research base for treatment research is required to accrue a minimum of 50 credits* per year from affiliated CCOPs to treatment clinical trials that have been approved by the PRC, DCT, NCI. A research base for cancer prevention and control research is required to accrue a minimum of 50 credits* per year from affiliated CCOPs to cancer prevention and control clinical trials that have been approved by the CCPRC, DCPC. * The NCI Program Director will assign a patient/subject credit value to each NCI approved protocol. Credits will be based on the complexity of the intervention, the amount of data management required, and the duration of follow-up. For example, each patient accrued to an average Phase II or Phase III protocol will count 1 credit; an NCI-designated high-priority protocol 1.5 credits; and a childhood acute lymphocytic leukemia protocol 2 credits. Cancer control protocols will be assessed for credit using a similar approach. (4) Data Management and Analysis Data generated is the property of the awardee; however, the research base must provide DCPC/DCT with access to all data generated under this award. The DCPC Program Director or a DCT representative may review data management and analysis procedures of the research base under mutually agreeable circumstances. Data must also be available for external monitoring if required by NCI's agreement with other Federal agencies, such as the FDA and by NCI's agreements with pharmaceutical companies for the co-development of investigational agents. (5) Quality Control A DCPC/DCT-funded research base must follow all the policies and procedures for quality control established by NCI. Similar policies and procedures for quality control will be expected from cancer centers. (6) Investigational Drug Management Investigators performing trials under cooperative agreements will be expected, in cooperation with DCPC/DCT to comply with all FDA distribution, monitoring, and reporting requirements for investigational agents. (7) Organizational Changes A change in the research base Principal Investigator, or in any key personnel identified in the "Notice of Grant Award," must have the prior written approval of the NCI Grants Management Specialist, with the advice of the DCPC Program Director. (8) Audits Each research base will be responsible for auditing its affiliated CCOPs/Minority-Based CCOPs. Cooperative group research bases will be responsible for on-site audits of affiliated CCOPs according to the established guidelines for monitoring its other members and/or affiliates. Cancer center research bases may initiate their own audit programs following guidelines established by the QACS, RAB, CTEP, DCT. As an alternative, they may choose to include CCOP records in the audits of center studies conducted by CTEP. If this latter option is chosen, the center must prospectively assure that medical charts and other records from the affiliated CCOPs will be brought to the center for audit when they are requested. Results of CCOP audits will be reported to the QACS, RAB, CTEP, DCT, and the DCPC Program Director. Cancer centers approved as research bases for only cancer prevention and control research must have audit procedures for affiliated CCOPs. Results of these CCOP audits will be reported to the DCPC Program Director. (9) Reporting Requirements Annual progress reports, including an annual performance report on each affiliated CCOP, must be submitted to DCPC. A suggested format developed by the DCPC Program Director for this purpose will be provided. The DCPC Program Director will review the performance of each research base. Research base funding is contingent on accrual from affiliated CCOPs/Minority-Based CCOPs and annual adjustments may be made. The inability of a research base to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. (10) Network Participation Research bases are part of a national network for conducting treatment and cancer prevention and control clinical trials. As such, each research base may be asked to participate in strategy sessions or workshops and the continuing evaluation of the program and its impact in the community. (11) Federally Mandated Regulatory Requirements Each research base must establish mechanisms to meet FDA regulatory requirements for clinical trials involving DCPC/DCT-sponsored investigational agents and DHHS/PHS regulations for the protection of human subjects. (12) CCOPS/Minority-Based CCOPs Research bases must agree to affiliate with CCOPs/Minority-Based CCOPs when they are funded, according to guidelines established by each research base for its affiliates, and as appropriate. (13) Publications Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement requires acknowledgement of NCI support. 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 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 must be included in the form PHS 398 in the Research Plan 1-4, AND summarized in 5, Human Subjects. If the required information is not contained within the application, the application will be returned. 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). To address the informational request, it is recommended that a breakdown by percentage of the gender and minority composition of the study population be provided. This information may be based on the institutional records and/or prior experience. 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 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. 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. LETTER OF INTENT Prospective applicants are asked to submit, by June 25, 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 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. Leslie G. Ford at the address listed under INQUIRIES. APPLICATION PROCEDURES A. Preparation of Application General instructions for the preparation of the cooperative agreement application are contained in the grant application form PHS 398 (rev. 9/91). Responses to the instructions concerning Human Subjects verification must be provided when the application is initially submitted. 1. CCOP Applicants Because the Terms and Conditions of Award (discussed in the SPECIAL REQUIREMENTS Section above) will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to these terms. Plans must describe how the applicant will comply with NCI staff involvement as well as how all the responsibilities of awardees will be fulfilled. An application from a currently funded program will be a competitive continuation and must include a progress report, which at a minimum consists of: (1) a summary of prior CCOP activities/accomplishments, including a clear presentation of annual accrual over the funding period such as accrual tables from previous annual progress reports; (2) an evaluation of CCOP performance by affiliated research base(s); and (3) a complete description of how the applicant has met the special cooperative agreement terms and conditions of the award. a. Each applicant must delineate its catchment area. A map of the service area, designating counties or zip codes from which approximately 80 percent of the patients will be drawn, should be provided. A description of other cancer care resources in the catchment area (i.e., hospitals, clinics, physicians, cancer centers) that are not part of the application should be included. b. Each applicant must demonstrate the potential and stated commitment to accrue a minimum of 50 credits per year to treatment clinical trials (except if waived for applicants whose specialty is pediatrics). Documentation must include any prior participation in treatment research clinical trials with a clear presentation of the number of patients and credits accrued to NCI approved treatment clinical trials. A list of the NCI approved treatment protocols in which the applicant expects to participate and projected accrual to each must be provided. c. Each applicant must demonstrate the potential and stated commitment to accrue a minimum of 50 credits per year to cancer prevention and control protocols. Documentation must include any prior participation in cancer prevention and control research clinical trials with a clear presentation of the number of patients and credits accrued to NCI approved cancer prevention and control clinical trials. The CCOP applicant must document experience in cancer prevention and control activities and research, ability to access the appropriate physicians and patient/subject populations, and adequate facilities to participate in the proposed clinical trials. The ability of CCOPs and research bases to collaborate in cancer prevention and control research must be demonstrated by each applicant. Working with affiliated research bases, the applicant must provide at least two examples of DCPC approved intervention cancer prevention and control protocols appropriate for the CCOP's participation, and should describe their implementation, including specifics on patient/subject recruitment, compliance and follow-up. A list of the NCI approved cancer prevention and control protocols in which the applicant expects to participate and projected accrual to each must be provided. d. A designated Principal Investigator is required. An associate Principal Investigator should also be named to assure continuity in the event of resignation of the principal investigator. The qualifications and experience of both, in terms of ability to organize and manage a community oncology program that includes treatment and cancer prevention and control research and related activities, must be described. e. Each applicant is expected to have a committed multidisciplinary professional group appropriate for its expected protocol participation. This team may include medical oncologists, surgeons, radiation oncologists, pathologists, oncology nurses, data managers, health educators, and other disciplines (e.g., gynecology, urology, pediatrics, internal medicine, family practice) as appropriate. The training and experience of participating physicians must be provided, along with a description of working relationships. Any experience working together as a group, particularly in implementing clinical treatment and cancer prevention and control research and related activities, should be included. An organizational chart showing how the group will function must also be included. f. Each applicant must provide the qualifications and experience of all proposed support personnel as well as a description of the proposed duties for each position. g. Through formal affiliations with a maximum of five research bases, only one of which may be a national multi-specialty cooperative group, each applicant must demonstrate access to both treatment and cancer prevention and control research protocols. Evidence must be provided that an affiliation has been established with at least one NCI-funded research base which has the capacity to provide both clinical treatment and cancer prevention and control protocols. In addition, affiliations with research bases offering only cancer prevention and control protocols are appropriate. The conditions of affiliation must be provided in the CCOP-research base affiliation agreement(s). Initial affiliations should be maintained during the funding cycle. Multiple research base affiliations are permitted provided they are not conflicting. The affiliation agreements must state specifically how the problem of competing protocols will be resolved. Note: A list of currently eligible research bases may be obtained from the program official listed under INQUIRIES. h. Quality control procedures must be described in detail. Assurance of quality is the joint responsibility of the CCOP and its research base(s). Quality control procedures of the research base will be applied to the CCOPs and should be specified in the CCOP-research base affiliation agreement. Procedures for investigational drug monitoring and data management must also be described. i. The availability of facilities, including laboratories, inpatient and outpatient resources, cancer registries, etc., must be described. A statement of commitment from each participating institution or organization and/or documentation of consortium arrangements must be provided. Evidence of involvement with community-based voluntary organizations may be submitted. In addition, each applicant must have a defined space for administrative activities and administrative personnel that will serve as a focus for data management, quality control, and communication. j. Allocation of funds to support community costs for receipt, handling, and quality control of patient data must be specified. Allowable items in the budget are requests for full or part-time administrative personnel, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); and appropriate travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel). Funding is not allowed for clinical care provided to patients (e.g., reimbursement of patient care expenses; transportation costs). Physician compensation is only an allowable cost for the Principal Investigator (PI) and Co-PI, specifically for time spent on CCOP organizational/administrative tasks. Justification must be provided for personnel time, effort and funds requested. 2. Research Base Applicants Because the Terms and Conditions of Award (discussed in the SPECIAL REQUIREMENTS Section above) will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to these terms. Plans must describe how the applicant will comply with NCI staff involvement as well as how all the responsibilities of awardees will be fulfilled. An application from a currently funded program will be a competitive continuation and must include a progress report, which at a minimum consists of: (1) a summary of prior research base activities/accomplishments, including a clear presentation of annual accrual from affiliated CCOPs over the funding period; (2) progress in developing and implementing DCPC-approved cancer prevention and control clinical trials; (3) a description of how the applicant has met the special cooperative agreement terms and conditions of the award; and (4) a summary of participation of members and affiliates in cancer prevention and control research. Cooperative groups must participate in both treatment and cancer prevention and control clinical trials; cancer centers may participate in treatment and cancer prevention and control clinical trials or cancer prevention and control research only. a. Each applicant must demonstrate the ability to design and implement multi-institutional treatment clinical trials, if applicable as stated above. A list of treatment protocols available for CCOP participation must be provided. b. Each applicant must demonstrate the ability to design and implement multi-institutional cancer prevention and control clinical trials. A list of cancer prevention and control protocols available for CCOP participation must be provided. The research base applicant must also provide at least two examples of NCI-approved cancer prevention and control protocols and describe plans for study design, intervention(s), and statistical considerations; access to potential patients/subjects to be studied; and procedures for data management, quality control, and follow-up. The availability of appropriate expertise to design, implement, and analyze the results of the proposed clinical trials must be documented. New applicants must provide at least two detailed examples of proposed cancer prevention and control intervention clinical trials. c. Each applicant must have an organizational structure for involving appropriate personnel in the design and implementation of treatment and/or cancer prevention and control research. An organizational chart and a description of the research base operations showing the relationship(s) between the scientific and administrative functional units of the research base, vis-a-vis the conduct of treatment and/or cancer prevention and control clinical trials, must be provided. The organizational focus within the research base for cancer prevention and control research must be described, including the composition and activities of the research base cancer prevention and control committee, or equivalent, and its relationship to other clinical trial committees and activities. d. Collaboration with affiliated CCOPs/Minority-Based CCOPs in treatment and/or cancer prevention and control research, as applicable, is required. CCOP-research base affiliation agreements must be included in the application. For treatment research, each applicant must demonstrate the ability to accrue a minimum of 50 credits per year from affiliated CCOPs/Minority-Based CCOPs to treatment clinical trials. For cancer prevention and control research, each applicant must demonstrate the ability to accrue a minimum of 50 credits per year from affiliated CCOPs/Minority-Based CCOPs to cancer prevention and control clinical trials. It is expected that selected cooperative group members and/or Cooperative Group Outreach/cancer center affiliates other than the CCOPs will participate in cancer prevention and control research. The applicant must indicate the participants and their expected level of participation, and describe their ability to participate. e. A designated Principal Investigator is required and his/her qualifications and experience must be described. An individual must be designated to coordinate cancer prevention and control research. His or her qualifications and experience within the research base structure should also be described. Each applicant must also demonstrate the ability to access professionals with the appropriate expertise to design and implement the proposed treatment and/or cancer prevention and control clinical trials. Basic scientists, medical, surgical, radiation and other oncology specialists, nurse oncologists, epidemiologists, health educators and/or other public health professionals may be included. f. Each applicant's ability to manage the data from multi-institutional treatment and/or cancer prevention and control clinical trials must be described. Data management includes development of data collection forms, procedures for data transmittal, procedures for data entry, data editing, compilation, and analysis, as well as procedures for quality control and verification of submitted data. Standards should exist for determining eligibility and evaluability of patients/subjects entered on protocols. Statistical capability must exist to develop protocol statistical parameters, analyze the data, and report results. g. Each applicant must demonstrate the ability to initiate procedures for training and maintaining the proficiency of personnel from affiliated CCOPs/Minority-Based CCOPs on techniques for successful management of treatment and/or cancer prevention and control clinical trials research. Depending on the clinical trials initiated and the interventions involved, this will include training for data managers/nurses and any other individuals responsible for data collection, monitoring, or carrying out the intervention(s). h. Each applicant's ability to provide mechanisms for periodic review of the performance of affiliated CCOPs/Minority-Based CCOPs, including on-site monitoring (auditing) and written procedures and criteria for continued affiliations, must be described. Similar measures must be described for other member/affiliates participating in cancer prevention and control research. i. Requests for funds must reflect headquarters operational, quality control and data management add-on costs for CCOP participation in protocols, based on the expected accrual credits of affiliated CCOPs/Minority-Based CCOPs and for member/affiliate accrual credits in cancer prevention and control. CCOP-research base affiliation agreements must be included. Funding can be requested for scientific development and pilot testing of new cancer prevention and control research initiatives (including support of a cancer prevention and control committee for the research base), and funds can also be requested for appropriate travel to meetings directly related to study activities (such as NCI-sponsored strategy sessions/workshops). Specific justification must be provided. B. Method of Applying The research grant application form PHS 398 (rev. 9/91) is to be used in applying for cooperative agreements. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NCI program official listed under INQUIRIES. A suggested format will be sent to all applicants requesting an RFA or submitting a letter of intent. All applicants are encouraged to obtain and use the suggested format instructions for organizing the specific information concerning the RFA programmatic requirements in the PHS 398. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA 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, 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 also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Rockville, MD 20852 Applications must be received by August 24, 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 substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS A. Review Procedures Upon receipt, applications will be reviewed by DRG staff for completeness and NCI staff for responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff will return it. If the number of applications is large compared to the number of awards to be made, applications may receive a preliminary scientific peer review (triaged) to determine their relative competitiveness. The NCI will withdraw from further competition those applications judged to be non- competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review will be provided by the National Cancer Advisory Board. B. Review Criteria 1. CCOP Applicants a. Ability to accrue a minimum of 50 credits per year to treatment clinical trials and a minimum of 50 credits per year to cancer prevention and control clinical trials. The accrual requirement may be waived for applicants whose specialty is pediatrics. Each applicant's ability to access the appropriate populations, professional disciplines, and facilities to participate with affiliated research bases in at least two DCPC approved cancer prevention and control intervention protocols will be appraised. Any prior participation in treatment and cancer prevention and control research will be considered. b. Qualifications and experience of the Principal Investigator/associate Principal Investigator, in terms of ability to organize and manage a community oncology program that includes both treatment and cancer prevention and control research and related activities. c. Training, experience, and commitment of participating physicians for accruing individuals to protocols in which the applicant has agreed to participate. The experience of proposed investigators in the entry and treatment of cancer patients on research trials (gained from residency, fellowships, postdoctoral training and/or subsequent practice) will be appraised. For multidisciplinary studies, evidence of the availability of appropriate professional resources (e.g., radiotherapy, pediatrics, surgery, gynecology, urology, pathology, internal medicine, family practice, nursing, and nutrition) will be required. Experience or special skills in cancer prevention and control research and related activities will be considered, together with availability of other community resources and personnel for such clinical trials. d. Stability of the functional unit or group applying to become a CCOP. Preexisting organizational affiliations of at least a core of the group applying, and evidence of stable working relationships, will be appraised. Examples of established consortium arrangements, and committee structure which demonstrates the participation of appropriate physicians and administrators, may be submitted. Evidence of previous success as a group in implementing clinical treatment and cancer prevention and control research and related activities will be considered. e. Qualifications and experience of all proposed support personnel relative to their position descriptions. The relevant credentials and expected contributions to the program of personnel resources not fiscally supported by the award will be considered. f. Adequacy of quality assurance mechanisms for both treatment and cancer prevention and control interventions, and adequacy of procedures for investigational drug monitoring and data management. g. Adequacy of available facilities, including laboratories, in-patient and outpatient resources, cancer registries, etc., and adequacy of space for administrative activities and personnel. h. Appropriateness of research base affiliations and of the treatment and cancer prevention and control research protocols chosen. Affiliation agreements must be provided in the application. i. For competitive continuations, adequacy of progress during the funding period, including ability to meet the minimum accrual credits in cancer treatment and cancer prevention and control, progress made as a CCOP, and evaluation of CCOP performance by affiliated research bases(s). Consideration will be given to previous accrual and the ability to meet the previous accrual projections for which the CCOP was funded. The research base evaluation report(s) must be provided in the application. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each favorably recommended application. Allowable items in the budget are requests for full or part-time administrative personnel, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); and appropriate travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel). Funding is not allowed for clinical care provided to patients (e.g., patient care reimbursement, transportation costs). Physician compensation is only an allowable cost for the Principal Investigator (PI) and Co-PI, specifically for time spent on CCOP organizational/administrative tasks. Justification must be provided for personnel time and effort and funds requested. 2. Research Base Applicants a. Experience in conducting multi-institutional clinical trials; demonstrated ability to develop such studies and act as a coordinating and statistical center; and adequate facilities to conduct the clinical trials. b. Quality and availability of treatment and/or cancer prevention and control protocols, as applicable, that are appropriate for CCOP participation, or the potential for developing such clinical trials. Documentation of DCPC cancer prevention and control protocols, including a detailed description of at least two examples of NCI-approved cancer prevention and control protocols, will be evaluated as part of the application along with professional expertise to assure the quality of the proposed intervention clinical trials. Two detailed examples of proposed cancer prevention and control intervention clinical trials will be evaluated for new applicants. c. For treatment research, ability to accrue a minimum of 50 credits per year from affiliated CCOPs/Minority-Based CCOPs to treatment clinical trials. For cancer prevention and control research, ability to accrue a minimum of 50 credits per year from affiliated CCOPs/Minority-Based CCOPs to cancer prevention and control clinical trials. Experience as well as the potential for developing future clinical trials will be considered. Documentation must include CCOP-research base affiliation agreements. Prior CCOP assessments must be included. d. Organizational structure for involving appropriate personnel in the design and implementation of treatment and/or cancer prevention and control research. The organizational focus within the research base for cancer prevention and control research, including the composition and activities of the cancer prevention and control committee, and its relationship to other clinical trial committees and activities will be assessed. e. Qualifications and experience of the Principal Investigator and/or the individual responsible for directly relating to the CCOPs. The availability and experience of multidisciplinary health professionals and allied professionals with skills needed to develop, utilize, and analyze treatment and/or cancer prevention and control clinical trials will also be evaluated. f. Experience in working with community oncologists, orienting community data personnel to protocol requirements, organizing scientific and educational meetings for those participating in the clinical trials, and participating in intergroup clinical trials. g. Ability to establish quality control, quality assurance, and data management procedures. Experience in data management and analysis of multi-institutional clinical trials and adequacy of data management staff will be appraised. The availability of mechanisms for periodic review of quality control, quality assurance, and data management procedures will be assessed. h. For competitive continuations, adequacy of progress during the funding period, including cancer prevention and control protocol development, implementation and current status of each to meet minimum accrual credits from affiliated CCOPs, and progress in meeting the requirements of a research base for CCOP. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each favorably recommended application. Requests for funds must reflect headquarters operational, quality control and data management add-on costs for CCOP participation in protocols, based on the expected accrual credits of affiliated CCOPs/Minority-Based CCOPs and for member/affiliate accrual credits in cancer prevention and control. Funding may be requested for scientific development and pilot testing of new cancer prevention and control research initiatives (including a cancer prevention and control committee for the research base), or for appropriate travel to meetings directly related to study activities (such as NCI-sponsored strategy sessions/workshops). Specific justification must be provided. AWARD CRITERIA The anticipated date of award is June 1, 1994. NCI program staff will take into account demographic and geographic distribution of applicants in the final funding selection process to assure inclusion of minority and underserved populations. Multiple CCOP applicants for funding who are competing for the same patient population will be considered, but all may not be awarded unless warranted by the population density. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA or inquiries about whether or not specific proposed research would be responsive are encouraged. The program official welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues and address the letter of intent to: Leslie G. Ford, M.D. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 300-D Bethesda, MD 20892 Telephone: (301) 496-8541 Direct inquiries regarding fiscal matters to: Ms. Crystal Elliott Grants Administration Branch 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. 13.399, Cancer Control. 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 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. From owner-sci-resources@net.bio.net Sun May 09 23:00:00 1993 Path: biosci!kristoff From: kristoff@net.bio.net (David Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 9 May 1993 Message-ID: Date: 10 May 93 18:56:46 GMT Organization: BIOSCI International Newsgroups for Biology Lines: 54 Approved: biosci-moderator@net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Program Guideline Title: The US Tropical Ocean Global Atmosphere Program Coupled Ocean-Atmoshpere response Experiment (NSF 93-57) File size (bytes): 10966 STIS Filename: nsf9357 ------------------------------------------------------------------------ ** 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 nsf9357, the text of your message should be as follows: get nsf9357 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9357, you would enter: ftp> get nsf9357 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 May 16 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 - 16 May 1993 Message-ID: Date: 17 May 93 17:02:41 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 87 Approved: sci-resources-moderator@net.bio.net ** NEW DOCUMENTS ON STIS ** Document Type: Dir of Awards Title: NSF 93-65 Engineering Directorate Directory of Awards File size (bytes): 876852 STIS Filename: nsf9365 Also available: nsf9365.ps nsf9365.wp5 Document Type: Letter Title: NSF 93-61 EAR Dear Colleague Letter File size (bytes): 5196 STIS Filename: nsf9361 Document Type: Press Release Title: OCEANOGRAPHER SELECTED FOR WATERMAN AWARD, NSF'S MOST PRESTIGIOUS HONOR FOR YOUNG RESEARCHERS File size (bytes): 8154 STIS Filename: pr9334 Document Type: Program Guideline Title: NSF 93-45 - Graduate Research Traineeships Fiscal Year 1993 File size (bytes): 26679 STIS Filename: nsf9345 Title: NSF 93-52 - NETWORK ACCESS POINT MANAGER, ROUTING ARBITER, REGIONAL NETWORK PROVIDERS, AND VERY HIGH SPEED BACKBONE NETWORK SERVICES PROVIDER FOR NSFNET AND THE NREN(SM) PROGRAM File size (bytes): 56445 STIS Filename: nsf9352 Title: NSF 93-54 - Research Fellowship in Marine Biotechnology and the Ocean Sciences File size (bytes): 19001 STIS Filename: nsf9354 Document Type: Report Title: Draft on Ocean Sciences HPCC report File size (bytes): 27258 STIS Filename: geo9301 ------------------------------------------------------------------------ ** 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 geo9301, the text of your message should be as follows: get geo9301 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve geo9301, you would enter: ftp> get geo9301 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 May 17 23:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: No NIH Guide for 5/14 & 5/28 Message-ID: Date: 18 May 93 17:11:00 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 9 Approved: sci-resources-moderator@net.bio.net $$MAIL BEGIN *********************************************************** There was no E-Guide for 5/14/93. There will be one for 5/21, but none for 5/28. Sorry for the delayed notice, but the office that prepares it is in the process of moving and the notice was overlooked. Bill Jones $$MAIL END************************************************************** From owner-sci-resources@net.bio.net Tue May 18 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 19, pt. 1, 21 May 1993 Message-ID: Date: 19 May 93 22:12:42 GMT Sender: kristoff@net.bio.net Lines: 1505 Approved: biosci-moderator@net.bio.net NOTE: The NIH Guide may be split into more than one mail message to avoid truncation during e-mail distribution. The first message always begins with the RFP/RFA summary sections followed by the appended texts of the full RFP/RFAs. ---------------------------------------------------------------------- $$XID NIHGUIDE 19930521 V22N19 P1O2 ************************************ X-comment: RFAs described: MH-93-009 NIH GUIDE - Vol. 22, No. 19 - May 21, 1993 $$INDEX BEGIN ******************************************************* THE NIH GUIDE WILL NOT BE PUBLISHED ON MAY 28, 1993. THE NEXT ISSUE WILL BE JUNE 4, 1993. NOTICE OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 07/21/93 ************************************************* MINORITY RESEARCH FELLOWSHIP PROGRAM IN SOCIOLOGY MINORITY RESEARCH FELLOWSHIP PROGRAM IN SOCIAL WORK (MH-93-009) National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX R2 ********************************************************** STORING, MONITORING, AND DISTRIBUTING CENTER FOR COLLABORATIVE PERINATAL PROJECT SERUM SAMPLES (RFP NICHD-DESPR-93-09) National Institute of Child Health and Human Development INDEX: CHILD HEALTH AND HUMAN DEVELOPMENT ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** STUDIES ON THE PREVENTION, ETIOLOGY, CONTROL, BIOLOGY, DIAGNOSIS, OR TREATMENT OF BREAST CANCER (PA-93-083) National Cancer Institute INDEX: CANCER $$INDEX P2 ********************************************************** HEALTH CARE QUALITY IMPROVEMENT AND QUALITY ASSURANCE RESEARCH (PA-93- 084) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH $$INDEX P3 ********************************************************** BIOLOGICAL FACTORS INFLUENCING SEXUAL TRANSMISSION OF HUMAN IMMUNODEFICIENCY VIRUS (PA-93-085) National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute of Diabetes and Digestive and Kidney Diseases INDEX: ALLERGY, INFECTIOUS DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT; DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX P4 ********************************************************** GENETIC STUDIES IN ALCOHOL RESEARCH (PA-93-086) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX P5 ********************************************************** NRSA INSTITUTIONAL TRAINING GRANTS FOR ACQUIRED IMMUNODEFICIENCY SYNDROME (PA-93-087) National Institute of Allergy and Infectious Diseases National Institute of Mental Health INDEX: ALLERGY, INFECTIOUS DISEASES; MENTAL HEALTH $$INDEX P6 ********************************************************** RESEARCH ON INTEGRATING MENTAL HEALTH AND RELATED SERVICES FOR PERSONS WITH SEVERE MENTAL HEALTH DISORDERS (PA-93-088) National Institute of Mental Health INDEX: MENTAL HEALTH This publication is also available electronically to institutions via BITNET or INTERNET. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details, or send an E-mail message to ZNS@NIHCU. $$INDEX END ********************************************************* NOTICE OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN MH-93-009 FULL-TEXT ************************************** MINORITY RESEARCH FELLOWSHIP PROGRAM IN SOCIOLOGY MINORITY RESEARCH FELLOWSHIP PROGRAM IN SOCIAL WORK NIH GUIDE, Volume 22, Number 19, May 21, 1993 RFA AVAILABLE: MH-93-009 P.T. 22, FF; K.W. 0720005, 0417000, 0715095 National Institute of Mental Health Application Receipt Date: July 21, 1993 THE REQUESTS 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 This dual announcement of a Minority Research Fellowship Program (MRFP) in Sociology and an MRFP in Social Work is to encourage applications designed to support the development and training of individuals in doctoral programs in sociology and social work to enable them to undertake active, productive careers in scientific investigations related to mental health and mental illness. While it is expected that these future researchers will also become prominent within their professions at large, the MRFP is not designed simply to support graduate study for its own sake. Rather, mastery of sound research skills, commitment to future research activity, and future achievement in research endeavors in the mental health field should be the outcome of successful fellowship training. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, MRFP in Sociology and MRFP in Social Work, is related to the priority areas of mental health and mental disorders and educational and community-based programs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Domestic public and private non profit institutions and professional and scientific organizations and associations may apply. Applicants must have staff and facilities suitable for implementing a national program to recruit, select, and place minority students in doctoral programs in sociology or social work with environments appropriate for performing high-quality mental health research training and with strong research programs in one or more of the areas of interest to NIMH indicated in the Extramural Research Support Program, June 1992, announcement. Trainee Eligibility Requirements: Individuals selected by the program director to participate in the MRFP must be citizens or noncitizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence and have in their possession an Alien Registration Receipt Card (I-151 or I-551) at the time of entering the MRFP. Noncitizen nationals are persons born in lands which are not States but which are under U.S. sovereignty, jurisdiction, or administration (e.g., American Samoa). Individuals on temporary or student visas are not eligible. For the purpose of this announcement, minority trainees are defined as individuals who are determined by the grantee institution to be underrepresented in biomedical or behavioral research. The predoctoral trainees must have received a baccalaureate degree, (domestic or equivalent foreign), from an accredited institution as of the date of appointment to the MRFP, and be enrolled in a doctoral degree program. These National Research Service Award(NRSA) fellowships are not made for study leading to an M.D., D.O., D.D.S., or other similar professional degrees, or for study which is part of residency training leading to a medical specialty. However, this fellowship may support a specified period of full-time research training for a health professional who intends to pursue a research career, even if that period of training may be credited toward a specialty board certification. MECHANISM OF SUPPORT Support of these programs will be by the Institutional Training Grant (T32). This RFA is a one-time solicitation. Period of Support: An MRFP grant may be made for a period of up to five years. By law, an individual trainee may receive no more than five years of support in the aggregate at the predoctoral level. Any exception to this limitation requires a waiver from the Director, NIMH, based on a review of the justification provided by the awardee. Annual Stipends: The annual stipend for predoctoral individual at all levels is $8,800 for 12 months of training. Supplementation of the MRFP stipend from non-Federal funds is permitted, however stipend splitting is not permitted. Taxability of Stipends: The Tax Reform Act of 1986, Public Law 99-514, affects the tax liability of all individuals supported under the NRSA program. NIH is not in a position to advise students or institutions about tax liability. Stipends are subject to Federal income tax. Other Allowable Costs: In addition to stipends, the applicant organization may request funds for tuition, fees, and certain types of travel for trainees; actual indirect costs or eight percent of allowable direct costs (whichever is less) to cover related organizational overhead (applications from State and local government agencies may request full indirect cost reimbursement). The applicant organization may also request funds for other related costs. Ordinarily, up to $1,500 per predoctoral individual is provided for those "other related costs" which are deemed essential to carry out the training program for the National Research Service awardees appointed under the grant. FUNDS AVAILABLE The funds available for this announcement are $700,000. It is anticipated that one award of up to $350,000, will be granted in each of these disciplines; selection for funding will be made after competitive peer review. TRAINING OBJECTIVES The applicant should provide a plan for the proposed MRFP, including the following components: Program Plan The applicant should describe the program plan for an MRFP in Sociology or an MRFP in Social Work, including the overall goals, specific objectives, and number of trainees to be supported. The plan should clearly indicate how the program will recruit, select, and place minority students in appropriate doctoral level programs with strong mental health research and how it will anticipate and deal with potential problems which may be encountered in program implementation. The plan should also indicate how the applicant will provide ongoing monitoring and career counseling to help ensure that MRFP fellows complete their doctoral training; special emphasis should be given to how the training will prepare them for careers in mental health research. Finally, the plan should indicate how the program will establish networks and linkages with other mental health researchers. The application also should include a plan for evaluating the program, including follow up of trainees supported. Finally, the application must provide assurance that the MRFP award will increase the number of minority persons trained to conduct research and will not be used to substitute for existing Federal funding for research training. Program Leadership The program director of the applicant organization will be responsible, with the assistance of a MRFP Advisory Committee, for the recruitment and selection of minority trainees, and for their placement in doctoral training programs which have strong research and research training in mental health. HUMAN SUBJECTS AND VERTEBRATE ANIMALS REQUIREMENTS While the MRFP applicant will not itself provide research training, the applicant organization must retain overall responsibility for compliance with all applicable regulations and must assure that all organizations which do provide the training have complied with the Human Subjects and Vertebrate Animals regulations. APPLICATION PROCEDURES Applicants must use and follow the instructions for the Institutional NRSA, section of the PHS 398 (rev. 9/91). Item 2a on the face page of the application must read: "RFA MH 93-009 NIMH MRFP in Sociology" or "RFA MH 93-009 NIMH MRFP in Social Work." Applications must be complete, providing all information called for by the instructions. Completed application forms (original and 5 copies) must be submitted to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD, 20892** The Division of Research Grants is the central receipt point for applications to all PHS programs. Applications are assigned on the basis of established PHS referral guidelines. The applicant must describe the administrative structure of the program, indicating the distribution of responsibilities and the relationship of the MRFP to the overall program of the sponsoring organization. The applicant must present a plan for establishing an MRFP Advisory Committee of outstanding mental health researchers, which includes substantial minority representation, to assist the program director in the recruitment and selection of fellows and to advise students concerning appropriate doctoral programs with strong mental health research. The application should also contain a list of proposed committee members who are active mental health researchers and provide the rationale for their selection, including a description of their current mental health research, its source and amount of funding. A Biographical Sketch and Other Support Form (Pages 6 & 7) must be included for each. Applicants should indicate how they have or will acquire, maintain, and make use of important information about appropriate university programs for fellows supported by the award. The applicant must list proposed training faculty members, his/her primary department and university affiliation, role and percent of effort in the proposed program, and include a Biographical Sketch and Other Support Form (Pages 6 & 7) for each current or proposed faculty member. Responsible Conduct of Research: The applicant must describe plans to provide trainees with instruction on scientific integrity and ethical principles in research, and include a description of both formal (courses, seminars, etc.) and informal training that will be provided. Progress Reports (Competing Continuation Applications Only): General directions are on pages 5 and 6 of the application kit. Application Receipt and Review Schedule Receipt Initial Review Council Earliest Date Group Meeting Meeting Start Date July 21, 1993 Oct/Nov 1993 Jan/Feb 1994 July 1, 1994 Applications received after July 21, 1993 will not be reviewed and will be returned to the applicant. REVIEW CONSIDERATIONS Training grant applications are reviewed for scientific and educational merit by NIMH initial review groups comprised primarily of nongovernment scientists and are also subject to the review and recommendations of the National Advisory Mental Health Council. Major considerations in the review are the breadth, depth, and quality of the plan for implementing the MRFP; qualifications, capability, and experience of the program director and the organization to implement the plan; qualifications of the MRFP Advisory Committee; plans for recruiting, selecting, and placing trainees in appropriate graduate departments and programs; and adequacy of the facilities and resources. Detailed review criteria are listed in the full announcement. AWARD CRITERIA An application will be selected for funding primarily on the basis of scientific merit review results, ability to meet program priorities and balance, and the availability of funds. Applicants will receive a copy of the summary statement of the review of their application and will be notified of final action on the application by letter. INQUIRIES Applicants are encouraged to contact NIMH staff for information and the RFA before applying for an award. The information and application kits are available from: Dr. Kenneth G. Lutterman Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10-C-05 Rockville, MD 20857 Telephone: (301) 443-3373 For information on grants management issues, applicants may contact: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-15 Rockville, MD 20857 Telephone: (301) 443-3065 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.282. 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 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. $$R1 END ************************************************************ $$R2 BEGIN NICHD-DESPR-93-09 **************************************** STORING, MONITORING, AND DISTRIBUTING CENTER FOR COLLABORATIVE PERINATAL PROJECT SERUM SAMPLES NIH GUIDE, Volume 22, Number 19, May 21, 1993 RFP AVAILABLE: NICHD-DESPR-93-09 P.T. 34; K.W. 0775020, 0775025, 0780005 National Institute of Child Health and Human Development The National Institute of Child Health and Human Development (NICHD) is seeking organizations that have the capacity as a center to store, monitor, and distribute samples of serum collected from the Collaborative Perinatal project (CPP). CPP was a multi-center, prospective cohort study of pregnancy and child development administered by the National Institute of Neurological Disorders and Stroke (NINDS). The original purpose of the Project was to study factors responsible for the development of cerebral palsy, epilepsy, mental retardation, and related neurological disorders of childhood. As part of the CPP study protocol, serum was collected from the women several times during pregnancy, at delivery, and at one to two months postpartum. Serum was also collected from the umbilical cord of newborns. Computer records indicate that a total of 833,756 samples of serum stored in 4 ml. screw-capped vials were collected. Fewer vials remain, although the exact number is not known. (They are currently being inventoried.) For the past 25 or more years, these vials have been stored by the NINDS at -20 degrees C. in two walk-in cold rooms on the NIH campus. Custody of this resource has now been transferred to NICHD. They are presently being maintained under contract in Rockville, Maryland. Frequent on-site monitoring by the Project and Contracting Officers will be necessary. Therefore, the proposed storage facility must be located within easy access to the NIH campus. This announcement for a holding center is a new solicitation. The Request For Proposal was issued on May 12, 1993, and proposals are due by 4:00 p.m. (Local Time) July 14, 1993. INQUIRIES All requests must cite the RFP number and include two self-addressed mailing labels. All sources who consider themselves qualified are encouraged to submit proposals. This advertisement does not commit the Government to award a contract. Organizations desiring a copy of the above announced RFP may send a written request to: Mrs. Lynn Salo National Institute of Child Health and Human Development Contracts Management Branch, OGC 6100 Building, Room 7A07 Bethesda, MD 20892 Telephone: (301) 496-4611 FAX: (301) 402-3676 $$R2 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-93-083 ************************************************ STUDIES ON THE PREVENTION, ETIOLOGY, CONTROL, BIOLOGY, DIAGNOSIS, OR TREATMENT OF BREAST CANCER NIH GUIDE, Volume 22, Number 19, May 21, 1993 PA NUMBER: PA-93-083 P.T. 34; K.W. 0715035, 0755030, 0795003, 0745027, 0745070 National Cancer Institute PURPOSE Despite significant strides in prevention, diagnosis, and treatment, breast cancer continues to be a leading cause of death in the United States. It has been estimated that approximately 46,000 women will die of breast cancer in the United States in 1993 and that about 18 percent of all female cancer deaths in the U.S. will be due to malignancies of the breast. The average U.S. mortality rate for breast cancer is 27.5 per hundred thousand. Of particular concern are recent data that point to an unexplained increase in breast cancer incidence and mortality rates. The long-term threat to women's health cannot be understated, since the incidence of breast cancer rises with age. Without vigorous efforts to develop improved cancer prevention, detection and treatment strategies, as advances in other areas of medicine extend average lifespan, the nation faces a continuing breast cancer crisis of increasing magnitude as the baby boom population cohort ages. The United States Congress has expressed continued concern about the growing epidemic of breast cancer in the United States. In the most recent appropriation, the Conferees have urged, in the strongest way, that the National Cancer Institute (NCI) make breast cancer one of its highest priorities. This disease is expected to be a continuing priority and focus of the Congress for the foreseeable future. The NCI has devoted, and will continue to devote, significant resources to studies of breast cancer. However, not only does a great deal remain to be accomplished so that more effective preventive, diagnostic, and therapeutic modalities can be established, but much more emphasis on pertinent basic research is also necessary. This program announcement (PA) is one of several ongoing or planned initiatives that should, in the strongest way possible, serve to notify and reaffirm to the scientific community the continuing commitment of the NCI to expanding research support in basic and applied studies of the etiology, biology and immunology, genetic regulation, diagnosis, treatment, assessment of demographics, patterns of care, and strategies for control and prevention of breast cancer. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Studies on the Prevention, Etiology, Control, Biology, Diagnosis, or Treatment of 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 "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Research grant 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. Further, the institute is especially interested in receiving applications from women and from minority investigators. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) award (R29). MECHANISMS OF SUPPORT Support of this program will be through the research project grant (either single or interactive R01), program project grant (P01), FIRST award (R29), as well as through competing supplemental awards to currently active research project grants (R01, P01), Cooperative Agreements (U01) or Method to Extend Research in Time (MERIT) Awards (R37). Unless otherwise noted, all PHS grants policies apply. RESEARCH OBJECTIVES The purpose of this program is to provide support for investigators to pursue promising avenues of research addressed to all areas of basic, clinical and applied research relevant to breast cancer. Applications will be accepted within all of NCIs extramural program areas relevant to breast cancer as outlined below. In addition to basic research projeres, the NCI strongly urges the submission of competing applications proposing novel projects that represent laboratory-to-clinic transitions in breast cancer or that offer the opportunity for participation of women or under-represented minority individuals. Interdisciplinary collaborations between geneticists, molecular biologists, epidemiologist, environmental health scientists, public health officials and others are especially encouraged, either through the program project mechanism, or through the interactive research project grant (NIH Guide for Grants and Contracts, Vol. 21, No. 1, January 10, 1992; Announcement PA-92-29). The NCI is composed of four programmatic Divisions that support extramural research relevant to this program announcement. The spectrum of research relevant to breast cancer encouraged by these Divisions is as follows: The Division of Cancer Etiology plans and directs a national program of basic and applied research, including laboratory, field, epidemiologic and biometric research on the cause and natural history of breast cancer and the means for preventing such cancer, and evaluates mechanisms of cancer induction and promotion by chemicals, radiation, viruses and environmental agents. Epidemiologic research activities appropriate to this Program Announcement include assessment of the relative contributions and interactions of lifestyle, diet, environment, occupation, genetic factors, viruses, radiation, and/or metabolism on breast cancer risk; identification, validation and epidemiological assessment of markers/indicators of environmental, occupational, dietary, radiation, chemical and/or hormonal exposures likely to play a role in the etiology of breast cancer. Appropriate studies in biological carcinogenesis include: elucidation of the potential role of viruses and/or other biological agents in human breast cancer, including initiation of animal model systems, investigations of the changes in the structure or regulation of viral oncogenies, tumor suppressor genes, and other cellular genes relevant to the development of breast cancer, and development of microbial vectors such as bacteria and viruses that target breast tissues. Studies in chemical and physical carcinogenesis include integrated multidisciplinary laboratory investigations in carcinogenesis and its prevention using human tissues, whole animal, or in vitro systems; identification, quantitation and validation of biological, chemical, cellular and molecular markers for temporal stages of preneoplasia and neoplasia and their inhibition; synthesis, identification, characterization and mechanism of action of inhibitors of breast carcinogenesis, including natural inhibitors in the human environment; determination of the role of changes in the structure/regulation of oncogenies, tumor suppressor genes, and other cellular genes to the development, progression and biologic behavior of breast cancer induced by chemical and physical agents; and studies on the roles of protein, peptide and steroid hormones, and growth factors, in the development and progression of breast cancer. The Division of Cancer Biology, Diagnosis, and Centers supports research on the cellular and molecular biology of malignant cells, the role of the immune system in tumor growth and progression, and on the transfer of basic research findings to clinical application for improved diagnosis/prognosis of cancer. In breast cancer biology, areas of emphasis include, but are not limited to: the various growth factors and their receptors that contribute to the growth and progression of human breast cancer, the target genes in malignant and normal breast epithelium whose expression is regulated by the estrogen or progesterone receptor, the cellular mechanisms responsible for the action of tamoxifen on breast cells, the interplay of stromal and extracellular matrix components with breast epithelium in facilitating breast cancer growth and progression, and the identification of genetic modifications associated with the progression from early stage cancer to more malignant tumors and the related functional changes that occur in the affected cells. Of special interest are applications that utilize human breast tumors and tumor cells to pursue these research goals. In the area of cancer immunology, specific interests include, but are not limited to: identification and characterization of breast cancer antigens recognized by T lymphocytes, functional significance of leukocyte infiltrates in breast cancer, cytokine influences on immune responsiveness to tumor, neuroendocrineimmune interactions, immune mechanisms in tumor dormancy, immune control of tumor metastasis and tumor modulation of host immune function. Studies are specifically solicited for further research in these areas of immunology aimed at the eventual development of vaccines for the primary or secondary prevention of breast cancer. Cancer diagnosis emphasizes evaluation of predictive markers for breast tumors to aid therapeutic decision making, of markers for monitoring the response to therapy and the earlier detection of recurrent tumors, and identification of individuals at risk for developing breast cancer. The Division of Cancer Prevention and Control plans, develops, directs, and coordinates research on prevention, control, and community oncology. Representative studies involve the identification and evaluation of agents that may inhibit carcinogenesis (initiation, promotion, transformation, and/or progression). These studies could include identification of appropriate agents through literature searches or laboratory methods, efficacy and toxicology studies in animals to aid in selection of materials for human studies, and phase I and II clinical trials of potential preventive agents. Initiation, validation and clinical testing of biomarkers, and their modulation for prevention and early detection also are appropriate. Other research could focus on reduction of cancer morbidity and mortality through early detection including identification of biological markers of risk, exposure, and pre-malignant events of progression. Research on the roles of nutrients, food groups, and other dietary components in cancer incidence is appropriate including the influence of dietary factors on the modulation of cancer risk markers or intermediate endpoints. Cancer control includes research on the development and testing of intervention strategies to modify personal, social, and lifestyle factors known to contribute to the development and/or increased risk of cancer, and multidisciplinary intervention research aimed at addressing minority, undeserved, and other special populations. Research under the program announcement also may include data collection, statistical analysis and mathematical modeling, health services research, and information database linkage studies to monitor progress toward cancer control, particularly pertaining to the PHS "Healthy People 2000" National Goals. The Division of Cancer Treatment plans, directs, and coordinates an integrated program of preclinical and clinical cancer treatment research with the objective of curing or controlling cancer in humans by utilizing single or combination treatment modalities. Breast cancer requires multi-modal treatment for optimal management of all stages and presentations of disease, but these treatment methods cause serious morbidity and fail to cure most patients with advanced disease. In preclinical breast cancer treatment research, there is an urgent need to translate recent developments in the molecular biology of cancer into the discovery of new anticancer treatments whose actions will be highly specific for particular genes or gene products. Exciting areas that may be exploited include oncogenies such as the HER-2/neu oncogene in breast cancer, suppressor genes, signal transduction, cell cycle regulation, growth factors/receptors, metastasis, and angiogenesis. Several approaches will be necessary to take advantage of these new opportunities. Additional topics include, but are not limited to, drug discovery of new anticancer agents, biochemical and molecular mechanisms of antitumor drug action, and pharmacology and toxicology of antitumor agents. Studies to circumvent individual and multiple drug resistance and prevent metastasis of these cancers to other organs are included. Clinical research opportunities exist in the areas of high-dose chemotherapy followed by autologous bone marrow rescue, multidrug resistance, radiosensitizers, adjuvant chemotherapy, innovative surgical or multi-modal approaches, particle beam irradiation, novel immune therapies and genetic manipulations of host or malignant tissues, therapy with biological products, such as interleukins, monoclonal antibodies, and/or retinoic acid. Studies of microbial vectors such as vaccinia virus, retroviruses, adenoviruses and salmonellae as potential targeting and delivery vehicles in experimental therapeutics also are appropriate. Applications that address these opportunities for breast cancer are specifically solicited. 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 that 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 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 purposes of this PA, it is expected that females will be the major focus of the proposed research project. 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 the purposes of this announcement, females are expected to be major gender under study. 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. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The title and number of this program announcement must be typed in line 2a on the face page of the application. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator could be included with the application. 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 CONSIDERATION Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit either by study sections of the Division of Research Grants (DRG), NIH, or by initial review committees convened by the Division of Extramural Activities, NCI, in accordance with the standard NIH peer review criteria and procedures for specific award mechanisms. Applications for supplements to ongoing awards will be assigned for review on the basis of current NIH referral guidelines, and reviewed according to criteria applicable to the mechanism of the ongoing award. Following scientific-technical review, the applications will receive a second-level review by an appropriate national advisory council. AWARD CRITERIA Although there is no specified set-aside of funds for these awards, all meritorious applications submitted in response to this announcement, if assigned to the NCI, will receive consideration for a designation of high program relevance in the funding plans of the Institute. The President's proposed FY 1994 budget for the NCI specifically allocates substantial funds for breast cancer. Should future funding appropriations contain language designating funds specifically for breast cancer, it is anticipated that competing applications submitted in response to this announcement would be eligible for payment with such funds. Award decisions will be based on quality of the proposed project as determined by peer review, availability of funds, and program balance among research areas of the announcement. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this program announcement are encouraged and may be directed to the NCI Referral Office at the address below. The opportunity to clarify any issues or questions from potential applicants is welcome. NCI Referral Office Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636 Bethesda, MD 20892 Telephone: (301) 496-3428 FAX: (301) 402-0275 Inquiries will be referred to the appropriate NCI Program Director in one of the program Divisions listed under RESEARCH OBJECTIVES. Direct inquiries regarding fiscal matters to: Ms. Susan Cook Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 27 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance under one or more of the applicable sections: No. 93.393, No. 93.394, No. 93.395, No. 93.396, and No. 93.399. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P1 END ************************************************************ $$P2 BEGIN PA-93-084 ************************************************ HEALTH CARE QUALITY IMPROVEMENT AND QUALITY ASSURANCE RESEARCH NIH GUIDE, Volume 22, Number 19, May 21, 1993 PA NUMBER: PA-93-084 P.T. 34; K.W. 0730020, 0730050 Agency for Health Care Policy and Research PURPOSE The purpose of this program announcement (PA) is to stimulate research and evaluation projects addressing health care quality improvement and quality assurance. Important in its own right, this area of research takes on added prominence in the context of health care reform. As efforts are made to increase the efficiency with which health care is provided and to curtail unnecessary expenditures, measuring and assessing the adequacy of care is critical to assure that quality is not sacrificed. The Agency for Health Care Policy and Research (AHCPR) is particularly interested in research and evaluation projects that will produce results within one to two years, although projects of longer duration will also be considered. HEALTH PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. Applications responding to this PA could be related to many priority areas. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign non-profit organizations, public and private, including universities, clinics, units of State and local governments, non-profit firms, and non-profit foundations. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT This PA will use the research project grant (RO1). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Most projects are expected to vary from one to two years in length. This PA is in effect through July 1, 1995. RESEARCH OBJECTIVES Background. The Omnibus Budget Reconciliation Act of 1989, P.L. 101-239, established AHCPR for the purpose of enhancing the quality, appropriateness, and effectiveness of health care services; and access to such services. The AHCPR accomplishes this through the establishment of a broad base of scientific research; and the promotion of improvements in clinical practice and in the organization, financing, and delivery of health care services. Continuing support of research on quality improvement and quality assurance is essential to AHCPR's efforts to integrate knowledge about the effectiveness of health care into clinical practice. Moreover, focused research on quality improvement and quality assurance is particularly important at this time of health care reform. To refine a research agenda responsive to current needs, the AHCPR convened a conference in March 1992 to examine research priorities in quality improvement and quality assurance. The conference provided a forum for discussion among health care providers, researchers, policy makers, and quality improvement and quality assurance professionals working in both public and private delivery settings. Although there are a variety of definitions of quality review terms, the working definitions that emerged over the course of the conference are used here. Quality improvement refers to a set of specific approaches to improving performance, as indicated by objective measures, and using techniques such as organizational redesign, cross-functional management, and/or processes of continuous improvement, such as quality improvement teams and a focus on customer-oriented objectives. Quality assurance refers to a wide range of internal and external methods used to assess the incidence or levels of quality problems and assure that quality is achieved. Several common themes were articulated at the agenda setting conference. First, information technologies are both a driving force behind and a major source of concern in evolving quality improvement and quality assurance systems. Second, the field of quality improvement holds promise for major changes in organization and practice. But there is currently little sound evidence of its effects on either health care outcomes or delivery system efficiency. Finally, there is a strong interest across the practice, research, and payer communities in evaluating models of quality improvement to identify: the aspects of the methods and processes that work best in different organizational environments, and the factors that facilitate or hinder their effectiveness. A full report of the March conference including comprehensive background papers and summaries of identified research issues "Putting Research to Work in Quality Improvement," AHCPR Pub No. 93-0001, is scheduled for publication in Spring 1993. Applicants may also refer to the NIH Guide Announcement, Volume 21, No. 10, March 13, 1992, on "Effective Dissemination of Health and Clinical Information and Research Issues" (also available as AHCPR Publication No. 92-0045). Issues addressed in that announcement continue to be of interest, but are not repeated here. Applicants may request copies of these documents from the AHCPR Hotline, 800-358-9295. Objectives The objective of this PA is to stimulate new grant applications in the four priority areas described below: 1. Methods and Measures: Improving methods and measures is essential to facilitate the translation of state-of-the-art information about medical effectiveness into better medical management, including measures relevant to consumers' engagement in decisions about quality health care. Research issues center on medical review criteria, performance standards, and improving the science of quality assessment and improvement. Illustrative questions include: o What are the best methods for developing, implementing, and evaluating explicit medical review criteria? Where expert panels are the source of criteria, how do composition of the panels and the methods by which they operate affect acceptability and utility of panel recommendations? What are the differences in content and usefulness of nationally versus locally developed criteria? o What data are needed on the process and outcome of care to help improve quality? How can patient care episodes be framed to permit measurement of quality of care longitudinally across the complete range of care settings? How can the contribution to outcome of patient characteristics and other non-clinical factors be measured? How can they be controlled for, to improve clarity of attribution of outcomes to the care process? What aspects of provider-patient communication should be addressed in quality assurance and quality improvement systems? o What methods of feedback regarding quality of care for practitioners, patients/consumers, and systems are most likely to lead to change in practice patterns? What elements of practice are most amenable to change? o How can the reliability and validity of commonly used quality measures be evaluated or improved, or substitutes provided? Is the incorporation of these measures into quality assurance or quality improvement systems cost effective? How do approaches such as screening, auditing, profiling, and implementing clinical practice guidelines change measurement requirements? How do such strategies compare in effectiveness and cost? 2. Information Technologies: Research priorities for information technologies focus on availability, quality, and specificity of data for quality assessment and on specific ways to address the social and behavioral barriers to using new information technologies such as automated medical records and decision support systems, or to development and availability of comprehensive data. Illustrative questions include: o How effective are automated information systems as tools for improving the quality of patient care? How are the data in existing information systems used, and what elements should be added to improve the systems, quality measurement, and quality of care? Do they allow for more efficient delivery of care? o How can patient-specific and provider-specific probabilities and utilities be optimally incorporated into decision support systems? o What are the factors that influence the adoption of information systems technology in quality assurance and improvement programs? What innovations of technology, or initiatives in policy or legislation have the potential to resolve the problems of privacy and confidentiality of patient-based electronic records? What are the barriers to their implementation? 3. The Organization of Quality Improvement and Assurance: Research on organization and system issues is necessary if new methods and measures are to be incorporated effectively into ongoing health care programs. Relevant issues include organizational readiness and capacity to accept and use new methods and technologies, institutional and professional culture, and public demands and expectations. Research is needed on: how different approaches to designing and implementing quality improvement can be structured to work in and across different health care delivery settings, including institutional and noninstitutional long-term care; how responsibility for monitoring quality is allocated among internal and external review entities; and what resources are needed to assure and improve health care quality. There is a continuing need for descriptive and comparative information on what is happening in quality review systems throughout the country, as well as a need for more information on State and Federal regulation, accreditation programs, and certification systems. Illustrative questions include: o What factors affect organizational readiness to adopt quality improvement methods and programs? How do management variables influence the process of care and decision making, and how do these, in turn, influence care outcomes? o What have been the measurable effects on the cost, quality, and effectiveness of the health care provided by organizations using quality improvement? How have improvements been achieved? Can characteristics of effective versus less effective quality improvement be measured? o What are the effects of oversight? Can an optimal relationship be identified between an external and internal review of quality of care in a delivery setting? How does external review stimulate, support, or subvert internal quality improvement or quality assurance? o What common measures or tools of quality improvement are needed/used to link participants in integrated community systems? How can the use of common measures be facilitated? 4. Using Quality-related Information: Information on quality of care is of increasing interest to patients, purchasers of insurance, and providers alike; and is crucial to managed competition approaches to health care reform. Illustrative questions include: o Does providing information about quality of care to patients, or information about patient experiences and expectations to clinicians and provider organizations, improve care? At what stage or stages in the quality improvement process should this exchange of information take place? o How do patients and purchasers make judgments about quality and effectiveness of health care? What are the effects of data about quality on patient health-related behaviors, health care seeking behavior, or satisfaction with care? o What information about quality of care do patients and purchasers perceive as useful in making informed decisions when they choose among providers? How can they be assisted in interpreting and using quality improvement and quality assurance data? Does the availability of this information improve their decisions in some measurable way? o What can be learned from existing partnerships between health care providers and purchasers regarding quality improvement and quality assurance goals? Can their approaches to using information about quality be evaluated objectively and related to success in achieving quality improvement and quality assurance goals? o Does provision of quality-related information encourage development of common measures across modes of care and facilities so that longitudinal and population-based evaluation of quality of care becomes possible? 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 is intended to apply 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. 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 assigning the priority score to the application. 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. State and local governments may use Form PHS 5161 and submit an original and two copies of the application. Application kits are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the Office of Scientific Review, Agency for Health Care Policy and Research, Suite 602, 2101 East Jefferson Street, Rockville MD 20852, telephone 301-227-8449. The title and number of the PA must be typed in section 2a on the face page of the application. 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** 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. Applicants are encouraged to apply by the earliest possible submission date. The first due date is June 1, 1993. Thereafter, through July 1995, the due dates for new applications are October 1, February 1, and June 1. Applications for R01 grants must be received by the Division of Research Grants, NIH. An application received after the deadline may be acceptable if it carries a legible proof- of-mailing date assigned by the carrier and the proof-of-mailing date is not later than 1 week prior to the deadline date. REVIEW CONSIDERATION Upon receipt, applications will be reviewed for completeness and responsiveness. Incomplete applications will be returned to applicants without further consideration. Review criteria for grant applications are significance and originality from a scientific and technical viewpoint; adequacy of the method to carry out the project; availability of the data or the 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 by an appropriate peer review group. Applications assigned to the AHCPR and requesting total direct costs in excess of $50,000 may be reviewed by the National Advisory Council for Health Care Policy, Research, and Evaluation. Funding will be based on recommendations from the peer review and AHCPR's Council. AWARD CRITERIA Applications will compete for available funds with all other applications. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program balance among research areas of the announcement. The anticipated dates of award for applications are 10 months from the date of submission. The AHCPR is particularly interested in funding policy relevant proposals that can be completed within one to two years. INQUIRIES Those considering applying in response to this PA are strongly encouraged to discuss their project with AHCPR program administrators before formal submission. The AHCPR welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues to: Bertha D. Atelsek Center for General Health Services Extramural Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 502 Rockville, MD 20852 Telephone: (301) 227-8352, Ext. 111 Direct inquiries regarding fiscal matters to: Ralph Sloat Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 227-8447 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.180 and 93.226. Awards are made under authorization of the Public Health Service Act, Title IX, as amended (Public Laws 101-239 and 102-410) and administered under PHS grants policies 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. $$P2 END ************************************************************ $$P3 BEGIN PA-93-085 ************************************************ BIOLOGICAL FACTORS INFLUENCING SEXUAL TRANSMISSION OF HUMAN IMMUNODEFICIENCY VIRUS NIH GUIDE, Volume 22, Number 19, May 21, 1993 PA NUMBER: PA-93-085 P.T. 34; K.W. 0715182, 1002000 National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE Knowledge of the biological factors that influence the sexual transmission of HIV is critical to prevention efforts, including vaccine and topical virucide development. Although some progress has been made in identifying behavioral risk factors for sexual transmission of human immunodeficiency virus (HIV), little is known about the biologic determinants of infectivity and susceptibility. The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Child Health and Human Development (NICHD), and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite investigator-initiated research applications focused on the studies directed at elucidation of the biology of sexual transmission of HIV. Prior to preparing an application, prospective applicants are strongly encouraged to consult with the NIH staff. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Biological Factors Influencing Sexual Transmission of HIV, includes the priority areas of immunization and infectious diseases, sexually transmitted diseases, and HIV infection. Potential applicants may obtain a copy of a "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 or local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) award. MECHANISMS OF SUPPORT Applications considered appropriate responses to this announcement are the research project grant (R01) and the FIRST award (R29). Although no funds are specifically set aside for funding grants submitted in response to this program announcement, the NIAID, NICHD, and NIDDK regard research in this area as a high priority, and of great significance. RESEARCH OBJECTIVE Background Currently, the Division of AIDS, NIAID, is supporting epidemiological studies on sexual transmission, e.g., the Heterosexual AIDS Transmission Study, Multicenter AIDS Cohort Study, and the San Francisco Young Men's Health Study for understanding conditions or behaviors that promote sexual transmission. Studies on strategies for eliciting protective regional mucosal immunity in the female or male reproductive tracts, and in the rectum to block the transmission of HIV will be supported by a recently issued RFA, Collaborative Mucosal Immunology Groups for AIDS Vaccines (AI-93-008). Because there is very limited information on biological/cellular aspects that affect sexual transmission, there is a need to stimulate research in this area. The objective of this program announcement is to stimulate research on the biological factors influencing HIV sexual transmission. It is anticipated that the investigators may collaborate to test hypotheses in animal models and to evaluate human studies including clinical samples. The NIH staff will assist investigators in identifying potential collaborators and resources including cohorts for the study. Examples of research studies encouraged include, but are not limited to, the following: o Biological mechanism of cell-free versus cell- associated viral entry across the genital mucosal barrier, including such aspects as virus variability, tropism, and stability. o Cell types and location of HIV infected cells in the reproductive tract and in vaginal, seminal, and rectal fluids. o Cells initially infected by HIV during sexual transmission and how the virus is disseminated into circulation. o Changes in HIV transmissibility that correlate with disease progression by comparing HIV in vaginal, seminal, and rectal fluids by comparison with HIV from blood/serum or lymphoid tissue, the number of CD4 positive cells and/or other surrogate markers of HIV progression. o Biological factors in vaginal and cervical mucosal tissues that may affect host susceptibility to HIV; e.g., infection with other pathogens, irritation or inflammation from any cause, and confection with other sexually transmitted pathogens; menstrual cycle, pregnancy, menopause, or hormones. o Biological factors that may affect the level and transmissibility of cell-free HIV and/or cell-associated virus in vaginal, seminal and rectal fluids i.e., infection with other pathogens including those that are sexually transmitted, irritation and inflammation from any cause; menstrual cycle, pregnancy, menopause, or hormones. o Effect of anti-retroviral or other therapeutic interventions on the level and transmissibility of HIV in vaginal, seminal, and rectal fluids or tissues. o Potential role of immunosuppressive/immunomodulating factors in the reproductive tract, including studies of neutralization/facilitation of HIV transmission by antibodies to HIV in semen and vaginal secretions. o Role of antiviral defense mechanisms in HIV transmission, e.g., the effect of low pH, lysozyme, hydrogen peroxide, and lactoferrin in vaginal fluids. o Sexual transmission of SIV/HIV in monkey animal models; e.g., determination of how virus gets through the reproductive tract into the blood stream; to identify target cells infected in vaginal and rectal mucosa; delineation of mechanisms of SIV/HIV spread from mucosal to systemic lymphoid systems in the male and female reproductive tracts; study of the effects of menstrual cycle including menopause, pregnancy, oral or injectable steroid contraceptives, and assessment of the role of irritation and inflammation due to any cause including infection with other pathogens in increasing susceptibility following SIV/HIV exposure. The effect of anti-HIV/SIV antibody coated virus on transmission would also be of interest. Applications should each focus on a central theme. Because issues of molecular biology, immunology, virology, reproductive physiology and pathology, sexually transmitted diseases, clinical care, epidemiology, biostatistics and SIV/HIV animal models may need to be addressed in a coordinated manner, collaboration among investigators having expertise in these and other appropriate disciplines is strongly encouraged. Applicants are encouraged to coordinate, through the use of consortium arrangements or subcontracts, integrated approaches with investigators or institutions with demonstrated ability in a particular area of research, or who have access to relevant, already enrolled, patient populations or are conducting studies on animal models in AIDS research. Involvement of such institutions to obtain specimens at little or no extra cost to the grant is encouraged. Listings of institutions and PIs conducting such studies and/or resources will be provided. 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 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 that 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 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 receipt dates for applications for AIDS-related research: January 2, May 1, and September 1. Application kits are available at most institutional offices for sponsored research and may be obtained from the Office of Grants Inquiries, 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 and the "YES" box marked. The completed original and five legible copies must be sent or delivered to: From owner-sci-resources@net.bio.net Tue May 18 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. 19, pt. 2, 21 May 1993 Message-ID: Date: 19 May 93 22:13:22 GMT Sender: kristoff@net.bio.net Lines: 1042 Approved: biosci-moderator@net.bio.net $$XID NIHGUIDE 19930521 V22N19 P2O2 ************************************ Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** FIRST (R29) applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center of Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS Applications in response to this announcement will be assigned on the basis of established Public Health Service Referral Guidelines. Each application must be complete in itself and must be able to stand on its own merit. Applications will be reviewed independently for scientific and technical merit by study sections of the Division of Research Grants, NIH, and in accordance with the standard NIH peer review criteria for traditional research grant applications. A second-level of review will be provided by the appropriate national advisory council. AWARD CRITERIA Applications will compete for available funds with all other applications of significant and substantial merit assigned to that institute. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among research areas of the announcement, and availability of funds. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this PA and inquiries about whether or not specific proposed research would be appropriate for this mechanism are encouraged. Direct inquiries regarding programmatic issues to: Dr. Opendra K. Sharma, or Dr. Gregory Milman Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2B-35 Bethesda, MD 20892 Telephone: (301) 496-8378 FAX: (301) 480-5703 Dr. Nancy J. Alexander Center for Population Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B-13 Bethesda, MD 20892 Telephone: (301) 496-1661 FAX: (301) 496-0962 Dr. Leroy M. Nyberg Division of Kidney, Urologic, and Hematologic Disorders National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A-05A Bethesda, MD 20892 Telephone: (301) 594-7522 FAX: (301) 594-7501 Direct inquiries regarding fiscal matters may be directed to: Ms. Jane Unsworth AIDS Grants Management Section National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B-25 Bethesda, MD 20892 Telephone: (301) 496-6177 FAX: (301) 402-1506 AUTHORITY AND REGULATIONS This program is described in Catalogue of Federal Domestic Assistance, Nos. 93.855, Immunology, Allergy and Immunology Diseases Research; 93.856, Microbiology and Infectious Diseases Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. $$P3 END ************************************************************ $$P4 BEGIN PA-93-086 ************************************************ GENETIC STUDIES IN ALCOHOL RESEARCH NIH GUIDE, Volume 22, Number 19, May 21, 1993 PA AVAILABLE: PA-93-086 P.T. 34; K.W. 0404003, 1002019, 1002008 National Institute on Alcohol Abuse and Alcoholism THE PROGRAM ANNOUNCEMENT (PA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE PA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research grant applications to study the genetic basis of alcoholism and the medical consequences of excessive alcohol consumption. Alcoholism has been recognized for over a century as a familial condition, and considerable evidence has accumulated in support of important roles for both genes and environment in its etiology. The specific genetic factors underlying susceptibility to alcoholism and its complications remain, however, largely unknown. The NIAAA encourages the submission of grant applications proposing use of current genetic methods to elucidate these factors, either in humans or in animal models. Characterization and isolation of genes underlying susceptibility to alcoholism and its complications will allow early identification of individuals at risk, will help improve the design of studies of environmental factors conducive to alcoholism and its complications, and may ultimately improve pharmacotherapy for alcoholism and its complications by facilitating the design of drugs that interact with the products of these genes. Insofar as a capacity to prevent and remediate excessive consumption of alcohol will naturally lead to a reduction in the occurrence of its attendant medical complications, the NIAAA's primary interest is in factors predisposing to excessive alcohol consumption. 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, Genetic Studies in Alcohol Research, is related to the priority area of alcohol abuse reduction. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0, or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: 202-783-3238). ELIGIBILITY Applications may be submitted by domestic and foreign, public and private, non-profit and for-profit organizations, such as universities, colleges, hospitals, research institutes and organizations, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign applicants are not eligible for First Independent Research Support and Transition (FIRST) awards (R29). MECHANISMS OF SUPPORT Research support may be obtained through applications for a research project grant (R01), small grant (R03), exploratory/developmental grant (R21), or FIRST (R29) award. Potential applicants for small grants (R03), exploratory/developmental grants (R21), and FIRST (R29) awards may obtain copies of the specific announcements for these programs from the National Clearinghouse for Alcohol and Drug Information, P.O. Box 2345, Rockville, MD 20847-2345, telephone 301-468-2600 or 1-800-729-6686. Although program project grants (P01) will be considered for funding, due to budget constraints and NIAAA requirements for program balance, applications are not generally encouraged. Applications for program projects may not be submitted without presubmission clearance by NIAAA program staff. FUNDS AVAILABLE Although the NIAAA desires to stimulate research in this area, no specific funds are being allocated for this program at this time. The amount of funding available will depend on appropriated funds, quality of research proposals, and program priorities at the time of the award. In FY 1992, six new and competing renewal grants related to this program area were funded for approximately $1,213,000 in total costs. RESEARCH OBJECTIVES The following list of topics is intended only to illustrate NIAAA interests; topics not mentioned are not necessarily excluded from consideration. Twin and adoption studies as a means of defining more precisely which aspects of the alcoholic phenotype are most strongly heritable. Studies to find genetic markers that cosegregate with alcoholism and its complications in pedigrees of alcoholic families, or that are associated with these disorders in populations. Case-controlled allelic association studies are considered responsive to this program announcement only when the investigator expresses a clear intent to confirm any positive findings with evidence from other sorts of studies (e.g., linkage analysis). NIAAA would particularly like to encourage investigators wishing to test newly developed methods of pedigree analysis that have the potential to detect linkage in the presence of genetic heterogeneity. Studies to elucidate specific genetic factors predisposing to medical complications of alcoholism (e.g., liver cirrhosis, cardiomyopathy, pancreatitis, Wernicke-Korsakoff's Syndrome), and fetal alcohol syndrome (FAS). QTL mapping of genes influencing ethanol-related behaviors (e.g., ethanol sensitivity, preference, tolerance, locomotor stimulation, and withdrawal) in rodents. Targeted disruption of mouse genes encoding products known to play a role in the ontogeny and function of the nervous and endocrine systems and that might serve as possible targets for the actions of ethanol. Genetic analyses of less well-studied aspects of ethanol related animal behavior (e.g., consumption of ethanol after stress, ethanol effects on aggression and anxiety, ability of ethanol to serve as a behavioral reinforcer, animal behaviors thought to model aspects of human emotionality and personality) that might be informative about human ethanol related behavior. Genetic analysis (especially by mutagenesis screens) of ethanol-related behavior, as well as effects on CNS function and development in the fruit fly Drosophila melanogaster and the soil nematode Caenorhabditis elegans. Tests of the effects of ethanol on the expression of genes believed to play a role in specification of the embryonic body plan, especially those involved in development of the CNS. Tests of the roles of such genes in ethanol-induced teratogenesis by targeted disruption in mice. Both types of proposal will be considered responsive to this program announcement only if they articulate explicit mechanistic hypotheses about how changes in the function of the genes proposed for study could lead to observed patterns of ethanol-induced teratology. Mapping (either by single-gene or QTL approaches) genes responsible for interstrain differences in susceptibility to ethanol-induced teratogenesis. Attempts to induce teratogenesis by ethanol treatment in the zebra fish Brachydanio rerio, and, if these attempts are successful, intensive genetic analysis of this process. SPECIAL REQUIREMENTS In accordance with the PHS policy relating to distribution of unique research resources produced with PHS funding (NIH Guide for Grants and Contracts, Vol. 21, No. 33, pgs 4-5, September 11, 1992), investigators proposing the development of certain specialized genetic lines of animals (see RESEARCH OBJECTIVES, Animal Genetics, QTL Mapping, above) will be required to submit an explicit plan for making them available to other researchers desiring to use them before an award will be made. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS 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. NIH funding components will not award grants that do not comply with these policies. APPLICATION PROCEDURES Applicants are to use the grant application form PHS 398 (rev. 9/91). Applications will be accepted at the standard deadlines as indicated in the application kit. Application kits containing the necessary forms and instructions (PHS 398) may be obtained from institutional offices of sponsored research at most universities, colleges, medical schools, and other major research facilities, and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248. Applicants for FIRST Awards (R29) must include three letters of reference. Non-conforming applications will be returned without being reviewed. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator should be included in the application material. The signed original and five permanent, legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications received under this announcement will be assigned to an Initial Review Group (IRG) in accordance with established PHS Referral Guidelines. The IRG, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit. Applications will receive a second-level review by an appropriate National Advisory Council, whose review may be based on policy as well as considerations of scientific merit. Small Grants (R03s) do not require a second level review. REVIEW CRITERIA Research grant applications will be reviewed based on standard criteria for scientific and technical merit. The review criteria for Small Grants (R03), Exploratory/Developmental Grants (R21), FIRST Awards (R29), and Program Projects (P01) are contained in their respective program announcements. AWARD CRITERIA Applications recommended for approval will be considered for funding on the basis of the overall scientific and technical merit of the proposal as determined by peer review, programmatic needs and balance, and the availability of funds. INQUIRIES Potential applicants are encouraged to seek preapplication consultation and may contact the individuals listed below for consultation in preparing an application under this announcement. Direct inquiries regarding genetic studies and requests for the PA to: Robert W. Karp, Ph.D. Genetics Program National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16C-05 Rockville, MD 20857 Telephone: (301) 443-4223 FAX: (301) 227-8673 Inquiries related to fiscal matters may be directed to: Joseph Weeda Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16-86 Rockville, MD 20857 Telephone: (301) 443-4703 FAX: (301) 443-3891 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, "Administration of Grants and 45 CFR Part 46, "Protections of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P4 END ************************************************************ $$P5 BEGIN PA-93-087 ************************************************ NRSA INSTITUTIONAL TRAINING GRANTS FOR ACQUIRED IMMUNODEFICIENCY SYNDROME NIH GUIDE, Volume 22, Number 19, May 21, 1993 PA NUMBER: PA-93-087 P.T. 44; K.W. 0715008, 0720005 National Institute of Allergy and Infectious Diseases National Institute of Mental Health PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Mental Health (NIMH) invite applications from institutions to develop or enhance research training for pre-doctoral students and postdoctoral fellows in specific targeted areas of HIV and AIDS research. Prior to preparing an application, prospective applicants are strongly encouraged to consult with the NIH staff. 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, NRSA Institutional Training Grants for Acquired Immunodeficiency Syndrome, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit private and public institutions to support research training programs. The applicant institution must have the staff and facilities required for the proposed program. The training program director at the institution will be responsible for the selection and appointment of trainees to receive support and for the overall direction of the program. The individuals to be trained on a National Research Service Awards (NRSA) training grant must be citizens or non-citizen nationals of the United States, or have been lawfully admitted for permanent residence (i.e., in possession of the Alien Registration Receipt Card 1-551 or 1-151) at the time of appointment. Individuals on temporary or student visas are not eligible. NRSA research training grants may not be used to support studies leading to the M.D., D.O., D.D.S., D.V.M., or other similar health-professional degree. Programs able to provide predoctoral and concomitant postdoctoral training to Ph.D.s, M.D.s, and D.V.M.s are encouraged. MECHANISM OF SUPPORT The mechanism of support for this program announcement will be the National Research Service Award institutional training grant (T32) and institutions are subject to the eligibility and evaluation criteria developed for that award. Institutions may request support for pre-doctoral students, postdoctoral trainees, and short-term research training. Institutions are encouraged to develop strong multi-year research training plans. Stipends will be awarded at levels in accordance with NIH policy at the time of award and may be supplemented from non-Federal sources. Training related expenses, tuition and fees, and travel expenses may also be requested for trainees, although the levels vary depending on the type of training to be supported. It is anticipated that the size of awards will vary. RESEARCH OBJECTIVES The NIAID and the NIMH are committed to increasing the number of well-trained health professionals and basic scientists capable of conducting high quality research in areas of HIV infection and AIDS. The objective of this Program Announcement is to promote basic and clinical research training of Ph.D. candidates and postdoctoral training in HIV and AIDS research. An applicant institution should describe a program within the following guidelines: o Training may be for predoctoral students, postdoctoral fellows (e.g., Ph.D., D.V.M. or M.D.), or both. Predoctoral trainees should be appointed to a minimum of two and a maximum of five years, postdoctoral trainees to a minimum of two and a maximum of three years. o Training should take place in an environment committed to focused interdisciplinary collaboration among investigators active in the fields of HIV and AIDS research. The training program should include a range of disciplines requisite for the development of multidisciplinary research skills. o Training programs are encouraged that include research scientists who collaborate with clinicians treating HIV- infected patients. It is important that trainees recognize that an important goal of their research efforts is to cure and/or prevent AIDS. It is expected that pre-doctoral students will be provided with prerequisite basic science training in HIV and AIDS research including didactic courses in such disciplines as molecular biology, microbiology, immunology, and other related fields. Areas of research training include, but are not limited to, the following: o Molecular biology of HIV, viral entry, replication, role of viral and cellular genes in integration and virus activation, and virus assembly o Mechanisms by which HIV causes defects or dysregulated lymphocyte/thymocyte differentiation, including effects on T cell signalling and T cell receptors o Mechanisms by which HIV causes immune dysfunction, CD4+ cell depletion, functional alteration of CD4+ and CD8+ cells, or disruption of normal immune mechanisms at regional mucosal sites o Studies on the effects of HIV variants on tropism, drug resistance, and vaccine strategies o Host factors, including genetic factors, that may either impede or enhance immune deficiency o Humoral and cellular immune responses to HIV infection, and potential strategies for enhanced and/or selective immune protection o Novel recombinant vectors and/or AIDS vaccine formulations designed to induce protective mucosal immunity o Correlates of protection of HIV infected individuals from progressing to AIDS and causes of disease progression o Mechanisms of HIV neuropathogenesis o Biological and cellular factors influencing HIV sexual transmission o The biology, virology, and immunology of mother-to-infant HIV transmission; strategies to prevent viral transmission o Strategies for effective structure based drug discovery to HIV and opportunistic agents; mechanisms of drug resistance; biochemistry and pharmacology of novel therapeutic agents o Development of research skills in clinical studies on HIV and AIDS. These include: epidemiology, surveillance, natural history and transmission studies, biostatistics, theoretical fundamentals of clinical research design, protocol development, regulatory requirements, clinical research execution, data collection, quality assurance and data management. The intent is not to support clinical trials, although a trainee may participate in the conduct of such studies. o Development and use of animal models for the study of HIV-mediated pathogenesis SPECIAL REQUIREMENTS All pre- and postdoctoral trainees supported by the NIAID training grants are required to attend "The Annual AIDS Fellows Meeting" sponsored by the NIAID. An annual Progress Report on the achievements attributable to the research training program must include an update on the success in recruiting trainees, including under-represented minorities in AIDS research (i.e., Native Americans including Americans Indians and Alaskan Natives, Asian/Pacific Islanders, Blacks, Hispanics), specifically addressing their degree status and extent of participation. Institutions should provide assurance that they will track the careers of all trainees supported by this program for 10 years post-completion of their training. Additional special reporting requirements may be necessary from time to time to document fulfillment of the stated objectives under this PA. APPLICATION PROCEDURES Additional instructions for preparing the application for an NRSA institutional training grant are found at the end of form PHS 398 (rev. 9/91) under the tab: "Institutional National Research Service Award". These instructions should be carefully followed in preparing an application. For any clarification of these instructions, consult staff listed under INQUIRIES, below. In addition to following the specific instructions provided under "Research Training Program Plan", applicants are particularly reminded about the requirement for active recruitment of minorities as trainees, as well as the requirement to describe plans for instructions on the responsible conduct of research. Minority Recruitment Plan: in addition to the specific instructions in item 3, page 5 of form PHS 398 (Recruitment of Individuals from Underrepresented Racial/Ethnic Groups) and the NIH Guide for Grants and Contracts, Vol. 18, No. 20, June 9, 1989, the following information may be helpful in preparing this section of the application. Potential mechanisms for minority recruitment may include, but are not limited to: advertisements actively recruiting minorities to the program; posters and flyers actively recruiting minorities; visits by the program to minority institutions; cooperative programs with minority institutions; procedures to identify minority applicants; mailings to minorities on various lists; invitations to prospective minority applicants using institutional funds. Applications without such specific plans will be deferred until such plans are provided. Responsible Conduct of Research: applicants as announced in the NIH Guide for Grants and Contracts, Vol. 21, No. 43, November 27, 1992, are strongly encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Applications without plans for instruction on the responsible conduct of research will be considered incomplete and returned without review. Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Application kits are available from most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Institutional Research Training Grant Applications may be submitted for the NIAID on January 10, May 10, and September 10; and for the NIMH on May 10 of each year. Applications submitted in response to this announcement must be identified by typing the title and number of the announcement in Section 2a of the face page, and the "YES" boxed marked. The budget should include a request for travel funds for trainees in the application for both "The Annual AIDS Fellows Meeting" sponsored by the NIAID and an optional AIDS-related scientific meeting of the applicants' choice. The request for funds for both meetings should include an itemized breakdown of costs and must not exceed $2500 per trainee a year. The typed original application and five signed exact single-sided photocopies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS Referral Guidelines. Applications will be reviewed for scientific and technical merit by the review committee of the institute to which the application is assigned, followed by a second level review by the appropriate advisory council. The following review criteria used by initial review groups in reviewing NRSA Institutional Training applications are given in the booklet "National Research Service Award for Institutional Training Grants (T32)," dated March 20, 1992, available from the Office of Grants Inquiries at the address listed under APPLICATION PROCEDURES. In addition, the applications will be judged on the following criteria: o The proposed or ongoing research programs and the role of the trainees in these programs o Multi-disciplinary nature of proposed program o Scientific environment and active resources of the participating faculty and the applicant institution, including current AIDS research support o Cohesiveness of training program, including mechanisms for promoting interdisciplinary exchange of information such as seminar series, journal clubs, laboratory rotations, and research presentations o The applicant's ability to attract high-caliber trainees o Qualifications of the training faculty, the relevance of their current research activities to AIDS research, and their previous research training experience o Relation of the proposed program goals to the need for research personnel AWARD CRITERIA Applications will compete for available funds with other NRSA institutional research training applications of substantial and significant merit. The following will be considered in making funding decisions: scientific and technical merit of the application as determined by peer review; availability of funds; program balance among research areas of the announcement. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this announcement are encouraged and may be directed to: Opendra K. Sharma, Ph.D., or Gregory Milman, Ph.D. Pathogenesis Branch/DAIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2B-35 Bethesda, MD 20892 Telephone: (301) 496-8378 FAX: (301) 480-5703 Leonard Mitnick, Ph.D. Office on AIDS National Institute of Mental Health 5600 Fishers Lane, Room 15-99 Rockville, MD 20857 Telephone: (301) 443-7281 FAX: (301) 443-9719 Direct inquiries regarding fiscal matters to: Ms. Jane Unsworth AIDS Grants Management Section National Institute of Allergy and Infectious Diseases Solar Building, Room 4B-25 Bethesda, MD 20892 Telephone: (301) 496-6177 Ms. Diana Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-15 Rockville, MD 20857 Telephone: (301) 443-3065 FAX: (301) 443-9719 AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance Nos. 93.282, 93.855, and 93.856. 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 at 42 CFR Part 66. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P5 END ************************************************************ $$P6 BEGIN PA-93-088 ************************************************ RESEARCH ON INTEGRATING MENTAL HEALTH AND RELATED SERVICES FOR PERSONS WITH SEVERE MENTAL HEALTH DISORDERS NIH GUIDE, Volume 22, Number 19, May 21, 1993 PA NUMBER: PA-93-088 P.T. 34; K.W. 0730050, 0715129 National Institute of Mental Health PURPOSE The purpose of this announcement is to encourage research grant applications for studies that extend current knowledge about the effects on the service system, providers, consumers, and family members and the effectiveness of alternative approaches of integrating mental health, rehabilitation, substance abuse, general health, income support, and/or housing services for children, adolescents, adults, and/or elderly persons who suffer from severe mental disorders. The goal of this initiative is to increase the quality, appropriateness, cost-effectiveness, sensitivity, and accessibility of mental health services. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Research on Integrating Mental Health and Related Services for Persons with Severe Mental Disorders, is related to the priority areas of mental health and mental disorders and diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by any domestic and foreign public and private non-profit organization and by for-profit organizations, including universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) awards (R29). MECHANISM OF SUPPORT Research support may be requested through applications for a regular research grant (R01), a small grant (R03), the FIRST award (R29), and the Multi-Institutional Collaborative Research Project (R10). Since the R03, R29, and R10 mechanisms have special requirements regarding eligibility, application format, and review criteria, applicants are strongly encouraged to consult with program staff listed under INQUIRIES and obtain specialized announcements. The small grant (R03) is especially suited for initial research by junior investigators and pilot research prior to large-scale field trials. Because the nature and scope of the research proposed in response to this announcement will vary, it is anticipated that the size of the awards will also vary. RESEARCH OBJECTIVES Children, adolescents, adults, and elderly persons with severe mental disorders living in the community require many types of services. However, most service agencies are specialized, provide a limited range of services, and do not coordinate their services with those of other service agencies. Agencies providing services may also have requirements and eligibility rules that make it difficult for people with severe mental disorders to obtain needed services. The fragmentation and lack of accountability make existing services far less effective than they should be. There is a growing consensus that what is needed is an integrated system of care for people with severe mental disorders. This requires integrating basic life supports, such as food and shelter, with specialized services, such as medical and mental health services; linking services at the client and systems levels; coordinating Federal, State, and local resources; and providing a clear delineation of authority and of clinical, fiscal, and administrative responsibility. A first test of the effects and effectiveness of integrated systems of care was begun in 1986 by the Robert Wood Johnson Foundation (RWJF), in conjunction with NIMH. RWJF selected nine cities to participate in a five-year program to develop community-wide systems of care that would integrate all levels of the service system--client, local, State, and Federal--for people with severe mental disorders. In addition to integrating services and establishing the administrative, fiscal, and clinical responsibility for providing services to individuals with severe mental disorders, housing integration was promoted through the contribution of Section 8 housing certificates to the program participants by the Department of Housing and Urban Development (HUD). The NIMH-sponsored evaluation shows that much more information is needed about the process of integrating systems and the effectiveness and utility of various components of integrated systems. Another opportunity to study the effect and effectiveness of comprehensive services integration is being provided by the Access to Community Care and Effective Services and Supports (ACCESS) grants, which are administered and will be evaluated by the Center for Mental Health Services (CMHS). The Department of Health and Human Services, in collaboration with HUD and the Departments of Labor, Education, Veterans Affairs, and Agriculture, is making grants available to States to help communities explore ways to make services integration possible for people who have severe mental disorders and are also homeless. This announcement invites research applications to study the effect and/or cost-effectiveness of these and other examples of integrated service systems for children, adolescents, adults, and elderly persons with severe mental disorders. Listed below are examples of research topic areas focusing on the effectiveness of integrating mental health services for children, adolescents, adults, and elderly persons with severe mental disorders with other types of services. The list of examples is illustrative, not exhaustive; it is expected that additional important research topics will be identified by researchers who respond to this announcement. o Research on the effect and effectiveness of efforts to integrate services under the ACCESS and other preexisting service integration programs o Studies of the effectiveness of different levels of service intensity, within integrated service programs, for individuals with severe mental disorders who have different diagnoses, functional abilities, and sociodemographic characteristics o Research on the effects of different structural relationships among components of integrated service systems on providers, consumers, families and organizational functioning o Studies of the relative cost-effectiveness of integrated programs and systems of care o Research on the effects of alternate approaches to consumer and family involvement in integrated care o Studies of the effectiveness and cost-effectiveness of integrating substance abuse treatment with mental health treatment o Research on the effects of integrated mental health and substance abuse services in jails, prisons, and parole systems o Research on factors that are barriers to and facilitators of the service integration process o Development of improved methods for measuring and analyzing service integration, and within integrated systems, for measuring service intensity and service outcomes STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF FEMALES AND MINORITIES IN RESEARCH STUDY POPULATIONS Applications for grants and cooperative agreements that involve human subjects are required to include minorities and both genders 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 applies to all research involving human subjects and human materials, and applies to males and females of all ages. If one gender and/or minorities are excluded or are inadequately represented in this research, particularly in proposed population-based studies, clear compelling rationale for exclusion or inadequate representation should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. 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. 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., American Indians or Alaskan Natives, Asians or Pacific Islanders, African Americans, Hispanics). Investigators must provide the rationale for studies on single minority population groups. Applications for support of research involving human subjects must employ a study design with minority and/or gender representation (by age distribution, risk factors, incidence/prevalence, etc.) appropriate to the scientific objectives of the research. It is not an automatic requirement for the study design to provide statistical power to answer the questions posed for men and women and racial/ethnic groups separately; however, whenever there are scientific reasons to anticipate differences between men and women, and racial/ethnic groups, with regard to the hypothesis under investigation, applicants should include an evaluation of these gender and minority group differences in the proposed study. If adequate inclusion of one gender and/or minorities is impossible or inappropriate with respect to the purpose of the research, because of the health of the subjects, or other reasons, or if in the only study population available, there is a disproportionate representation of one gender or minority/majority group, the rationale for the study population must be well explained and justified. NIH funding components will not make awards of grants, cooperative agreements, or contracts that do not comply with this policy. For research awards that are covered by this policy, awardees will report annually on enrollment of women and men, and on the race and ethnicity of subjects. APPLICATION PROCEDURES Applicants are to use the research grant application form PHS 398 (rev. 9/91). The number (PA-93-XX) and the title of this announcement, Research on Integrating Mental Health and Related Services for Persons with Severe Mental Health Disorders, must be typed in item 2a on the face page of the PHS 398 application form. Applicants must also specify which support mechanism they are applying under, e.g., R29, R03, R10. Application kits containing the necessary forms may be obtained from IHS Area offices and business offices or offices of sponsored research at most universities, colleges, medical schools, and other major research facilities. If such a source is not available, the forms may be obtained from the Grants Management Branch, National Institute of Mental Health, 5600 Fishers Lane, Room 7C-05, Rockville, MD 20857, telephone 301/443-4414. The signed original and five legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892 REVIEW CONSIDERATIONS Applications will be reviewed for scientific and technical merit by an initial review group (IRG) composed primarily of non-Federal scientific experts. Final review is by the appropriate National Advisory Council; review by Council may be based on policy considerations as well as scientific merit. By law, only applications recommended for consideration for funding by the Council may be supported. Summaries of IRG recommendations are sent to applicants as soon as possible following IRG review. Criteria to be considered in evaluating applications for scientific/technical merit include: o Scientific, technical, or medical significance and originality of the proposed research o Appropriateness and adequacy of the research approach and methodology proposed to carry out the research o Qualifications and research experience of the principal investigators and staff, particularly but not exclusively in the area of the proposed research o Availability of resources necessary to the research o Appropriateness of the proposed budget and duration in relation to the proposed research o Adequacy of the proposed means for protecting against or minimizing adverse effects to human and/or animal subjects AWARD CRITERIA As part of the NIMH Public-Academic Liaison (PAL) initiative, special encouragement is given to applications that involve active collaborations between academic researchers and public sector agencies in planning, undertaking, analyzing, and publishing research pertaining to persons with severe mental illness. The PAL initiative is based on the premise that important new advances in understanding and treatment of severe mental illness can result from improved linkages between the Nation's scientific resources and the public sector agencies and programs in which many persons with severe mental illness receive their care. The scope of the PAL initiative encompasses public sector agencies of all types that deal with children, adolescents, adults, and elderly persons with severe mental disorders. In addition, preference in funding will be given to projects that include, but do not necessarily focus on, American Indian, Alaska Native, and Native Hawaiians living in urban settings and projects that include females in study populations. Factors considered in determining which applications will be funded include IRG and Council recommendations, PHS program needs and priorities, and availability of funds. INQUIRIES NIMH staff are available for consultation concerning application development before or during the process of preparing an application. Potential applicants should contact the NIMH as early as possible for information and assistance in initiating the application process and developing an application. The NIMH program staff member listed below may be contacted for further information and assistance. Charles Windle, Ph.D. Services Research Program National Institute of Mental Health 5600 Fishers Lane, Room 10C-06 Rockville, MD 20857 Telephone: (301) 443-4233 For further information on grants management issues, applicants may contact: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-15 Rockville, MD 20857 Telephone: (301) 443-3065 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance 93.242, Mental health Research Grants. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This announcement is not subject to the intergovernmental review requirements of Executive Order 12372, as implemented through DHHS regulations at 45 CFR Part 100, or Health Systems Agency Review. $$P6 END ************************************************************ From owner-sci-resources@net.bio.net Tue May 18 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 19, pt. 3, 21 May 1993 Message-ID: Date: 19 May 93 22:13:58 GMT Sender: kristoff@net.bio.net Lines: 665 Approved: biosci-moderator@net.bio.net $$XID RFA MH93009 MH-93-009 P1O1 *************************************** MINORITY RESEARCH FELLOWSHIP PROGRAM IN SOCIOLOGY MINORITY RESEARCH FELLOWSHIP PROGRAM IN SOCIAL WORK NIH Guide, Volume 22, Number 19, May 21, 1993 RFA: MH-93-009 P.T. 22, FF; K.W. 0720005, 0417000, 0715095 National Institute of Mental Health Application Receipt Date: July 21, 1993 PURPOSE The goal of research training programs at the National Institute of Mental Health (NIMH) is to help educate the leaders of the Nation's next generation of mental health researchers. The specific purpose of the Minority Research Fellowship Program (MRFP) is to ensure that minority investigators assume a prominent position among these researchers. This dual announcement of an MRFP in Sociology and an MRFP in Social Work is to encourage applications designed to support the development and training of individuals in doctoral programs in sociology and social work to enable them to undertake active, productive careers in scientific investigations related to mental health and mental illness. While it is expected that these future researchers will also become prominent within their professions at large, the MRFP is not designed simply to support graduate study for its own sake. Rather, mastery of sound research skills, commitment to future research activity, and future achievement in research endeavors in the mental health field should be the outcome of successful fellowship training. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), MRFP in Sociology and MRFP in Social Work, is related to the priority areas of mental health and mental disorders and educational and community-based programs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Domestic public and private non-profit institutions and professional and scientific organizations and associations may apply. Applicants must have staff and facilities suitable for implementing a national program to recruit, select, and place minority students in doctoral programs in sociology or social work with environments appropriate for performing high-quality mental health research training and with strong research programs in one or more of the areas of interest to NIMH indicated in the Extramural Research Support Program, June 1992, announcement. Trainee Eligibility Requirements: Individuals selected by the program director to participate in the MRFP must be citizens or noncitizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence and have in their possession an Alien Registration Receipt Card (I-151 or I-551) or other legal verification of admission of permanent residence at the time of entering the MRFP. Noncitizen nationals are persons born in lands which are not States but which are under U.S. sovereignty, jurisdiction, or administration (e.g., American Samoa). Individuals on temporary or student visas are not eligible. For the purpose of this announcement, minority trainees are defined as individuals which are determined by the grantee institution to be underrepresented in biomedical or behavioral research. The predoctoral trainees must have received a baccalaureate degree, (domestic or equivalent foreign), from an accredited institution as of the date of appointment to the MRFP, and must be enrolled in a doctoral degree program. These National Research Service Award (NRSA) fellowships are not made for study leading to an M.D., D.O., D.D.S., or other similar professional degrees, or for study which is part of residency training leading to a medical specialty. However, this fellowship may support a specified period of full-time research training for a health professional who intends to pursue a research career, even if that period of training may be credited toward a specialty board certification. MECHANISM OF SUPPORT These grants will be made using the Institutional National Research Service Award (NRSA) (T32) mechanism. Applications may be submitted for either new or competing continuation awards. This RFA is a one-time solicitation. Period of Support: An MRFP grant may be made for a period of up to five years. By law, an individual trainee may receive no more than five years of support in the aggregate at the predoctoral level. Any exception to this limitation requires a waiver from the Director, NIMH, based on a review of the justification provided by the awardee. Special Terms and Conditions of Support Payback Requirements: Recipients of stipends under the MRFP must agree to engage in health-related research and/or teaching for a period equal to the length of support in excess of 12 months. The Training Program Director must assure that potential trainees understand the payback requirement. An individual's initial 12 months of post-baccalaureate MRFP or other NRSA support are excluded from payback obligation. All subsequent MRFP (or other NRSA) support is fully obligated. Activities carried out while supported by MRFP or other NRSAs may not be used to fulfill the payback requirements. Conditions of Award: Grants must be administered in accordance with the PHS Grants Policy Statement. Title 42 of the Code of Federal Regulations, Part 66, is applicable to these awards. Before a trainee can be appointed to an MRFP Award and receive an MRFP Award under the grant, he or she must meet MRFP eligibility requirements and sign a Payback Agreement indicating his or her intent to meet the payback provision required under the law. Organizations must notify prospective trainees of these provisions prior to or at the time an appointment is offered. The applicant organization must submit to NIH a Statement of Appointment form (PHS 2271) along with the signed Payback Agreement and Statement of Non-Delinquency on Federal Debt (PHS-T-600) at the time a trainee is appointed. No funds may be provided to a trainee until such documents are submitted. At the end of the total support period for each individual trainee, the applicant must submit a Termination Notice (PHS 416-7) to NIH. Failure to submit the required forms in a timely fashion may result in an expenditure disallowance. All grants awarded under MRFP are made for full-time research training. Awardees may use some of their time in course studies and clinical duties if such work is closely related to and necessary for the research training experience. No appointment for less than 12 months may be made without prior approval. An MRFP award may not be held concurrently with another federally sponsored fellowship or similar Federal award which provides a stipend or otherwise duplicates provisions of the MRFP award. An awardee may, however, accept concurrent educational remuneration from the Veterans Administration and loans from Federal funds. Trainees in academic institutions are not entitled to vacations as such. They are, however ent