From owner-sci-resources@net.bio.net Sun Nov 01 22:00:00 1992 Path: biosci!KARYON.BIO.NET!kristoff From: kristoff@KARYON.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 1 November 1992 Message-ID: Date: 2 Nov 92 17:45:48 GMT Sender: daemon@net.bio.net Distribution: bionet Lines: 3 ------------------------------------------------------------------------ There were no new documents on STIS this week. ------------------------------------------------------------------------ From owner-sci-resources@net.bio.net Mon Nov 02 22:00:00 1992 Path: biosci!bcm!cs.utexas.edu!swrinde!zaphod.mps.ohio-state.edu!uwm.edu!spool.mu.edu!uunet!timbuk.cray.com!hemlock.cray.com!dudley From: dudley@fir35.cray.com (Dudley Knappe) Newsgroups: bionet.sci-resources Subject: Help needed with reference material - plant growth project Message-ID: Date: 3 Nov 92 01:00:09 GMT Reply-To: dudley@fir.cray.com Distribution: bionet Organization: Cray Research, Inc. Lines: 21 Nntp-Posting-Host: fir35 My son is working on a science project involving growing plants in a gravitationally chaotic environment. I would appreciate it if someone could give us references to similar experiments or related material. It would be especially helpful if someone knew how we could obtain any abstracts or papers from NASA zero gravity growth experiments. Please e-mail me with responses as I am not a regular reader of this group. If anyone is interested, I will post a summary of the information I receive. Thanks in advance for your help. -- Dudley Knappe, Software Development Division Cray Research, Inc. Phone: (612) 683-5529 655F Lone Oak Drive E-mail: dudley@cray.com or uunet!cray!dudley Eagan, MN 55121 From owner-sci-resources@net.bio.net Tue Nov 03 22:00:00 1992 Path: biosci!RESUNIX.RI.SICKKIDS.ON.CA!jim From: jim@RESUNIX.RI.SICKKIDS.ON.CA Newsgroups: bionet.sci-resources Subject: wiring diagram Message-ID: <9211041932.AA20897@resunix.ri.sickkids.on.ca> Date: 4 Nov 92 19:32:15 GMT Sender: daemon@net.bio.net Distribution: bionet Lines: 16 Research Institute Rm 8134 Hospital for Sick Children 555 University Avenue Toronto, Ontario, M5G 1X8 Canada Phone:416-813-6429 FAX: 416-813-5085 Hi Netters I would appreciate it very much if some one could FAX me a supplemental Wiring Diagram (not supplied in the manual) for a New Brunswick Air Shaker, G-76D. Thank you. James D Friesen (FAX:416-813-5085) From owner-sci-resources@net.bio.net Wed Nov 04 22:00:00 1992 Path: biosci!agate!stanford.edu!rutgers!utcsri!torn!pulp.cs.laurentian.ca!nickel.laurentian.ca!s1400067 From: s1400067@nickel.laurentian.ca Newsgroups: bionet.sci-resources Subject: Material wanted for Ra-226 study Message-ID: <1992Nov5.125640.1@nickel.laurentian.ca> Date: 5 Nov 92 17:56:40 GMT Sender: news@ramsey.cs.laurentian.ca (USENET News System) Organization: Laurentian University Lines: 11 I have just recently been exposed to this network, so excuse me if I am using improper protocol. I have undertaken a study which examines Ra-226 uptake in Lake Herring. Anyone who has any information regarding Ra-226 in fish, alpha- or gamma- spectometry, effects of Ra-226 in aquatic macroorganisms or any other related articles would you kindly forward to my email address. Thank you in advance, Greg Pyle S1400067@NICKEL.LAURENTIAN.CA From owner-sci-resources@net.bio.net Wed Nov 04 22:00:00 1992 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 21, no. 40, pt. 1, 6 November 1992 Message-ID: Date: 5 Nov 92 18:46:28 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. ---------------------------------------------------------------------- $$XID NIHGUIDE 19921106 V21N40 P1O2 ************************************ X-comment: RFAs described: CA-93-06, HD-93-06, DK-93-12 NIH GUIDE - Vol. 21, No. 40 - November 6, 1992 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** THE ETHICS OF CLINICAL RESEARCH ON HUMAN SUBJECTS: FACING THE 21st CENTURY National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** WORKSHOP ON MINIMIZING PAIN AND DISTRESS IN LABORATORY ANIMALS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 01/25/93 ************************************************* DEVELOPMENTAL RESEARCH IN NATIVE PACIFIC POPULATIONS (RFA CA-93-06) National Cancer Institute INDEX: CANCER $$INDEX R2 04/15/93 ************************************************* NETWORK OF PEDIATRIC PHARMACOLOGY RESEARCH UNITS (RFA HD-93-06) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R3 05/18/93 ************************************************* RESEARCH USING THE UNITED STATES RENAL DATA SYSTEM (RFA DK-93-12) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** THE IMMUNOLOGY OF AGING (PA-93-014) National Institute on Aging National Institute of Allergy and Infectious Diseases INDEX: AGING; ALLERGY, INFECTIOUS DISEASES $$INDEX P2 ********************************************************** PHYSIOLOGICAL ROLE OF THE ADRENAL ANDROGEN, DHEA, IN AGING (PA-93-015) National Institute on Aging INDEX: AGING This publication is also available electronically to institutions via BITNET or INTERNET. Alternative access is through the NIH Grant Line using a personal computer. Contact Dr. John James at 301/496-7554 for details, or send an E-mail message to ZNS@NIHCU. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** THE ETHICS OF CLINICAL RESEARCH ON HUMAN SUBJECTS: FACING THE 21st CENTURY NIH GUIDE, Volume 21, Number 40, November 6, 1992 P.T. 42; K.W. 0783005 National Institutes of Health The National Institutes of Health (NIH) Office for Protection from Research Risks (OPRR) is co-sponsoring with the University of Texas Medical Branch, Galveston a conference to discuss the ethical issues associated with clinical research involving human subjects. This conference is open to anyone with an interest in research involving human subjects and may be of special significance for individuals serving on Institutional Review Boards. DATES: February 28 through March 2, 1993 LOCATION: San Luis Hotel 5222 Seawall Boulevard Galveston, TX 77551 Telephone: 1-800-392-5937 SPONSORS: The University of Texas Medical Branch at Galveston Galveston, Texas National Institutes of Health, Office for Protection from Research Risks, Bethesda, MD REGISTRATION AND INFORMATION: Ms. Sharon Goodwin Institute for the Medical Humanities 301 University Boulevard, M-11 The University of Texas Medical Branch Galveston, TX 77555-1311 Telephone: (409) 772-2376 This national/international conference will explore the ethics of clinical research on human subjects. The goals of this timely meeting include: (1) providing a forward-looking analysis of the major ethical issues now facing biomedical researchers and institutions; (2) critically examining research ethics as set forth in the Belmont Report and other position papers of the two National Commissions; (3) enabling researchers and research-oriented administrators to plan effectively for future research initiatives; and (4) providing a forum for discussion and collaboration between IRB members and ethicists. INQUIRIES Ms. Roberta Sonneborn Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B59 Bethesda, MD 20892 Telephone: (301) 496-7163 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 21, Number 40, November 6, 1992 P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human subjects. The meetings should be of special interest to those persons currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all other Public Health Service agencies. The current schedule includes the following: SOUTHWESTERN WORKSHOP DATES: November 16 and 17, 1992 LOCATION: Wyndham Warwick 5701 Main Street Houston, TX 77005 Telephone: (713) 526-1991 SPONSORS: University of Texas Health Science Center at Houston Prairie View A&M University REGISTRATION: Ms. Paula Knudson Executive Coordinator Office of Research Support Committee University of Texas Health Science Center at Houston P.O. Box 20036 Houston, TX 77225 Telephone: (713) 792-5048 TITLE: Geriatric Research as an Ethical Mandate: Politics, Policy, and Problems DESCRIPTION: Expanded life expectancies and expanding technologies are swelling the ranks of the frail and disabled elderly. Minimal research has been carried out to understand the problems this subject group and their families encounter in finding solutions to their health and social needs. The conference will identify key problems that need to be studied; isolate the risks and benefits associated with behavioral, clinical, or evaluation research designed to enroll this group as subjects; and pose solutions that will meet the needs of regulators, scientists, and the elderly. The program is designed to be of interest to physicians, nurses, pharmacists, scientific investigators, and other health care professionals, clergy, lawyers, medical, nursing, social work students, psychologists, and IRB members and administrators. Attention will be paid to Federal regulations with special emphasis on the assessment of risks---medical, legal, and psychosocial. Opportunities will be available through workshops, question periods, and informal discussions for participants to exchange ideas and interests with faculty and OPRR and FDA representatives. SOUTHEASTERN WORKSHOP DATES: January 14 and 15, 1993 LOCATION: Sheraton Sand Key Resort 1160 Gulf Boulevard Clearwater Beach, FL 33515 Telephone: (813) 595-1611 SPONSORS: University of South Florida Florida A & M University REGISTRATION: Ms. Eileen Highsmith Executive Secretary University of South Florida 4202 E. Fowler Avenue (MP.FAO-126) Tampa, FL 33620-7900 Telephone: (813) 974-2897 TITLE: Barriers to Informed Consent: Language, Age Factors, Trauma, and Women/Minority Issues DESCRIPTION: Today's researchers face numerous barriers to obtaining an informed consent. Such issues as age, language, mental capacity, and sobriety may affect the ability of subjects to give a truly informed consent. Many of these barriers oftentimes impact the pool of subjects which an investigator is willing (or able) to use in a research project. In addition, recent legislation from the Congress was designed to address the issue of inadequate numbers of women and minorities in research projects. This conference has been designed to address three main areas in which barriers to informed consent may exist: mental competence, ethnic and gender issues, and research with children and the elderly. The conference program is designed to be of value to physicians, nurses, pharmacists, scientific investigators, and other health care professionals. All IRB members, students in health care areas and administrators will also benefit from the conference. Attention will be given to Federal regulations governing research on human subjects, with special emphasis placed on the assessment of risks---medical, legal, and psychosocial. Ample opportunities will be provided to exchange ideas and interests, through question and answer sessions and informal discussions. SOUTHWESTERN WORKSHOP DATES: February 12 and 13, 1993 LOCATION: Sheraton Tempe Mission Palms Hotel 60 East 5th Street Tempe, AZ 85281 Telephone: (602) 894-1400 SPONSORS: Arizona State University Northern Arizona University REGISTRATION: Ms. Carol Jablonski IRB Coordinator Office of the Assistant Vice President for Research Arizona State University Tempe, AZ 85287-3403 Telephone: (602) 965-6788 TITLE: Contemporary Issues in Human Subject Research: Challenges for Today's IRBs DESCRIPTION: This program is designed to be a practical working session to explore contemporary issues in human subjects protection including regulations and assurances, categorization of research protocols, uses of special populations, experimental design and scientific merit, fetal tissue research, ethical/legal issues in human subjects research, and conflict of interest. As appropriate, topics will be discussed from the perspective of the clinical researcher and the behavioral/social science researcher. Issues will be discussed in a panel format with ample time for audience questions. An outstanding faculty has been assembled. This program should be of interest to researchers in clinical medicine and the behavioral and social sciences. Institutional Review Board members, university and hospital administrators, lawyers, ethicists, health care practitioners, students, and other persons with interests in human subject protection issues. SOUTHWESTERN WORKSHOP DATES: February 28 through March 2, 1993 LOCATION: San Luis Hotel 5222 Seawall Boulevard Galveston, TX 77551 Telephone: (800) 392-5937 SPONSORS: The University of Texas Medical Branch at Galveston REGISTRATION: E. Ray Stinson, Ph.D. Office of Sponsored Programs-Academic The University of Texas Medical Branch at Galveston Galveston, TX 77555-1311 Telephone: (409)-772-3482 TITLE: The Ethics of Clinical Research on Human Subjects: Facing the 21st Century For further information regarding these workshop and future NIH/FDA National Human Subject Protections Workshops, please contact: Ms. Darlene Marie Ross Division of Human Subject Protections Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B59 Bethesda, MD 20892 Telephone: (301) 496-8101 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** WORKSHOP ON MINIMIZING PAIN AND DISTRESS IN LABORATORY ANIMALS NIH GUIDE, Volume 21, Number 40, November 6, 1992 P.T. 42; K.W. 0201011, 1014003 National Institutes of Health The National Institutes of Health (NIH), Office for Protection from Research Risks (OPRR), is continuing to sponsor workshops on implementing the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Each of the workshops scheduled for FY 1993 will focus on a specific theme. The workshops are open to institutional administrators, members of Institutional Animal Care and Use Committees, laboratory animal veterinarians, investigators and other institutional staff who have responsibility for high-quality management of sound institutional animal care and use programs. Opportunities will be available through workshops, question periods, and informal discussions for participants to exchange ideas and interests with faculty and OPRR representatives. DATE: DECEMBER 3-4, 1992 TOPIC: MINIMIZING PAIN AND DISTRESS IN LABORATORY ANIMALS LOCATION: Loews Vanderbilt Plaza 2100 West End Avenue Nashville, TN 37203 Telephone: (615) 320-1700 FAX: (615) 320-5019 SPONSORS: Vanderbilt University Meharry Medical College REGISTRATION: Ms. Marilyn Dasaro Division of Continuing Medical Education Vanderbilt University D-8211 Medical Center North Nashville, TN 37232-2337 Telephone: (615) 322-4030 FAX: (615) 343-0809 DATE: JANUARY 21-22, 1993 TOPIC: TO BE ANNOUNCED LOCATION: Sheraton Grande Torrey Pines 10950 N. Torrey Pines Road La Jolla, CA 92037 Telephone: (619) 558-1500 FAX: (619) 558-1131 SPONSORS: Scripps Clinic and Research Foundation Salk Institute REGISTRATION: Janie Partridge Scripps Clinic and Research Foundation/MB 10666 North Torrey Pines Road La Jolla, CA 92037-000 Telephone: (619) 554-8048 FAX: (619) 554-8841 DATE: June 10-11, 1992 TOPIC: TO BE ANNOUNCED LOCATION: Oklahoma City Marriott 3233 Northwest Expressway Oklahoma City, OK 73112 Telephone: (405) 842-6633 FAX: (405) 842-3152 SPONSOR: University of Oklahoma Health Sciences Center REGISTRATION: Ms. Marilyn Perry, Assistant to Director for Compliance Division of Animal Resources BMSB/Room 203 University of Oklahoma Health Sciences Center Telephone: (405) 271-5185 FAX: (405) 271-3032 $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN CA-93-06 FULL-TEXT *************************************** DEVELOPMENTAL RESEARCH IN NATIVE PACIFIC POPULATIONS NIH GUIDE, Volume 21, Number 40, November 6, 1992 RFA AVAILABLE: CA-93-06 P.T. 34, FB; K.W. 0715035, 0795003, 0745027 National Cancer Institute Letter of Intent Receipt Date: December 4, 1992 Application Receipt Date: January 25, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICATIONS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The National Cancer Program is mandated to address the unique cancer prevention, early detection, and treatment needs of all populations within the U.S. and its territories. Therefore, the Special Populations Studies Branch (SPSB) of the Division of Cancer Prevention and Control (DCPC) of the National Cancer Institute (NCI) invites applications from various organizations for developmental studies that: (1) assess cancer control need, (2) determine barriers to cancer control, and/or (3) validate intervention methods and assessment instruments in native Pacific populations; i.e., American Samoans, Guamanians (Chamorros), Palauians, and Northern Marianians. This initiative will define the cancer prevention and control needs of native Pacific populations and those of similar ancestry located in the Pacific as well as the U.S. mainland. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Developmental Research in Native Pacific Populations, is related to the priority area of cancer. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000 (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic (including U.S. Territorial possessions) public and private, for-profit and non-profit organizations serving native Pacific populations such as universities, public health departments, voluntary organizations, research centers, hospitals, consortia of health providers, units of State and local governments and eligible agencies of the Federal government. Teams of applicants are encouraged. Among a team of applicants, one institution must be proposed as the lead institution to serve as the applicant and to assume responsibility for the conduct and administration of the project. Note that awards will not be made to foreign institutions and that applications from domestic organizations may not include international components. MECHANISM OF SUPPORT The mechanism of support for this RFA will be the National Institutes of Health (NIH) research project grant (R01). Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. In addition to the requirements stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1991. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. It is anticipated that four awards will be made at approximately $300,000 total costs per year. FUNDS AVAILABLE Approximately $1.2 million in total costs per year for three years will be set-aside to specifically fund applications that are submitted in response to this RFA. It is anticipated that up to four awards will be made. The total project period of these awards may not exceed three years. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of a grant pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Studies conducted under this RFA will seek to define cancer prevention and control needs/services of the native Pacific population segments (Phase I). Studies to test ways in which existing intervention methods can be used or adapted for the target populations (Phase II); or studies of new methods designed to be sensitive to the needs of the target populations (Phase II); or methodologic research on validation of assessment instruments in target populations (Phase II) are eligible for consideration under the RFA. This "developmental cancer control research" (Phase I and Phase II) is absolutely essential to future development of cancer prevention and control research for native Pacific populations. The following definitions apply for this RFA: Cancer Control -- Cancer control is defined as the reduction of cancer incidence, morbidity, and mortality through an orderly sequence from research on interventions and their impact in defined populations to the broad, systematic application of the research results. Phases of Cancer Control -- Cancer control research studies are classified in the five phases that represent the orderly progression noted in the above definition: (I) Hypothesis development; (II) Intervention methods development and testing; (III) Controlled intervention trials to establish cause and effect relationships; (IV) Research in defined human populations; and (V) Demonstration and implementation studies. The research of interest in this RFA falls into either Phase I or Phase II studies. Hypothesis development (Phase I) studies should focus on the assessment of cancer prevention and control needs in communities or organizations within native Pacific populations or studies that identify barriers to cancer prevention and control within these indigenous populations. Methods development and testing studies, Phase II, should focus on: (1) validating the use of existing intervention methods (e.g., dietary modification, health services, tobacco cessation) applied in the target populations described above; (2) developing and pilot testing unique methods that are sensitive to the needs of the target populations described above; or (3) developing and validating assessment instruments to measure the cancer control related needs of the target populations or for use in evaluating the effectiveness of intervention methods in the target populations. STUDY POPULATIONS The targeted population of this RFA is the native Pacific populations and those of similar ancestry located in the Pacific as well as the U.S. mainland; i.e., American Samoans, Guamanians (Chamorros), Palauians, and North Marianians. Applicants responding to this RFA are expected to successfully access a significant portion of this population to decrease cancer incidence and mortality, increase cancer survival, and increase the diagnosis of cancers at earlier stages. SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by December 4, 1992, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the Principal Investigator (PI); the identity of other key personnel and participating institutions; and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to Dr. George A. Alexander at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). These forms are available at most institutional offices of sponsored research and the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/496-7447. Applications must be received by January 25, 1993. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed (initially) by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the RFA is an NCI program staff function. If an application is judged to be non-responsive, the applicant will be contacted and given an opportunity to withdraw the application or to have it considered with other unsolicited applications received by NIH in the next review cycle. Questions concerning responsiveness to the RFA may be directed to NCI program staff identified under INQUIRIES. Those applications that are complete and responsive will be initially evaluated in accordance with the review criteria stated within the RFA for scientific/technical merit by an ad hoc review committee convened by the Division of Extramural Activities, NCI. The second level of review will be provided by the National Cancer Advisory Board. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: George A. Alexander, M.D. Chief, Special Populations Studies Branch Cancer Control Science Program Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 240 Bethesda, MD 20892-4200 Telephone: (301) 496-8589 FAX: (301) 496-8675 Direct inquiries regarding fiscal issues to: Crystal Elliott Grants Management Specialist National Cancer Institute Grants Administration Branch Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800 Ext. 19 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control Science Program. Awards are made under authorization of the Public Health Service Act, Title IV, Part A. (Public Law 78-410, as amended by Public Law 99-158, 42 USC 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R1 END ************************************************************ $$R2 BEGIN HD-93-06 FULL-TEXT *************************************** NETWORK OF PEDIATRIC PHARMACOLOGY RESEARCH UNITS NIH GUIDE, Volume 21, Number 40, November 6, 1992 RFA AVAILABLE: HD-93-06 P.T. 34, AA; K.W. 0710100, 0770005, 0403020, 0715006 National Institute of Child Health and Human Development Letter of Intent Receipt Date: February 15, 1993 Application Receipt Date: April 13, 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 BELOW. PURPOSE The National Institute of Child Health and Human Development (NICHD) will support a cooperative network of Pediatric Pharmacology Research Units (PPRU) to facilitate clinical studies of drug action and disposition in infants and children. These studies are to be conducted by qualified pediatric clinical pharmacologists, either cooperatively with investigators at other Units in the network, collaboratively with pharmaceutical companies, or independently with other support. The major goal of studies conducted by the PPRU Network is to provide the clinical data on drugs necessary for U.S. Food and Drug Administration (FDA) approval for use in children. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention goals of "Healthy People 2000," a PHS-led national activity for setting priorities. This RFA, Network of Pediatric Pharmacology Research Units, is related to the priority areas of food and drug safety and maternal and infant health. Copies of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0, or Summary Report: Stock No. 017-001-00473-1) are available through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY PPRU cooperative clinical agreement (U10) awards will be made to children's hospitals or the equivalent, or to educational institutions with accredited medical schools, within the United States. The applicant institution must also meet the standard eligibility requirements for research grants established in the Public Health Service Grants Policy Statement #(OASH) 90-50,000, rev. 10/1/90. There must be at the applicant institution an ongoing program of excellence in clinical pharmacology, with an emphasis on pediatric applications. The quality of this program must be evident from the receipt by its staff of research support in peer-reviewed competition or from their consistent record of publication in peer-reviewed research journals. In addition, the applicant institution must have available a sufficient number of eligible research subjects in the pediatric age groups: newborns, infants, children, pre- adolescents, and adolescents. MECHANISM OF SUPPORT The funding mechanism to be used to assist the scientific community in undertaking this program of clinical pharmacologic investigation will be a cooperative clinical agreement (U10) between the participating units and the NICHD. The U10 award provides support for laboratory and administrative resources to assist the research community in carrying out clinical therapeutic research. The major difference between a cooperative agreement and a traditional research grant is the substantial scientific involvement of NICHD staff beyond the levels normally required for program stewardship of grants. FUNDS AVAILABLE It is expected that up to four applications will be funded, within the total direct cost limit of $1,000,000 available for the first year. Therefore, the maximum direct cost request (first year) for individual applications should not exceed $250,000. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NICHD, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Federal law and the regulations of the FDA require that drugs be tested for safety and efficacy before they are approved for clinical use. This testing must take place with all populations with which the drug will be employed. Studies must therefore be conducted with infants and children before a drug can be approved for use with them. Several practical problems discourage the testing of drugs and medical devices in children. These include the unpredictable nature of some of the clinical responses; the possibility of catastrophic unanticipated reactions; the threat of adverse effects on growth; the ethical problems of conducting nontherapeutic research in children; and the absence of a financial incentive for pharmaceutical companies when children are a minority of the population for whom the drug might be prescribed. The result of these practical problems and the regulatory requirements is that more than three-quarters of the drugs marketed in the United States, including many of the most useful agents in modern therapy, are not approved as safe and effective for use in children. Since the provision of pediatric care without the use of these agents would be unacceptable, they are often administered "off-label," meaning without specific FDA approval. This dilemma must be resolved if children are to escape the status of therapeutic orphans and to receive the full benefits of contemporary therapeutics. Modern pediatric pharmacology is a sophisticated clinical discipline capable of carrying out the studies necessary for the safe and ethical evaluation of drugs in children. Pursuit of such studies, however, is limited by the scarcity of available facilities in which to perform them and the small number of qualified clinical investigators interested in this problem. The objective of the PPRU Program is to increase the number and variety of medications that are FDA-approved for use in children, with the ultimate goal that all drugs prescribed for children be labeled for such usage. This is to be accomplished by providing resources for pediatric pharmacokinetic and pharmacodynamic research through the establishment of a network of pediatric pharmacology research units. Each PPRU will have four specific aims: (1) To participate with other units in the network and with NICHD staff assistance in collaborative clinical trials of drugs in children through protocols determined by consensus; (2) To provide a locus for the conduct of pre-marketing and post-marketing clinical trials in children by qualified clinical pharmacologists working in collaboration with proprietary pharmaceutical firms; (3) To conduct independent, investigator-initiated studies on the pharmacodynamics and pharmacokinetics of drugs in children; and (4) To provide an environment in which pediatricians and others can gain supervised experience in pediatric clinical pharmacology. The PPRU group will be organized through a Network Steering Committee (NSC), comprising the Principal Investigators (PI) of the funded units, one NICHD staff member, and appropriate outside advisers. This committee will meet at least quarterly to review and select protocols to be performed collaboratively by the network and to exchange information on progress. The NSC will be chaired by a non-NICHD scientist not affiliated with any of the units. 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 females and minorities in study populations. If minorities are not included in the study populations, a specific justification for this exclusion must be provided. Applications without such inclusion or justification will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by February 15, 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 NICHD 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: Ephraim Y. Levin, M.D. Endocrinology, Nutrition and Growth Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development Executive Plaza North, Room 637 Bethesda, MD 20892 Telephone: (301) 496-5593 APPLICATION PROCEDURES Applications are to be submitted on form PHS 398, and must be received by April 13, 1993. Potential applicants must request the detailed information included in the complete RFA before preparing an application. REVIEW CONSIDERATIONS Applications will be reviewed by NICHD staff for responsiveness to the RFA. A non-responsive application will be returned to the applicants. Responsive applications may be subjected to a triage by a peer-review group to determine the scientific merit relative to the other applications received in response to this RFA. The NICHD will withdraw from competition those applications judged to be noncompetitive and notify the applicants and institutional business officials. Applications considered responsive to this RFA will be reviewed for technical merit by an Initial Review Group convened by the scientific review staff of the NICHD solely to evaluate these applications. Criteria for the initial review are described in the RFA. Following review by the Initial Review Group, applications will be evaluated by the National Advisory Child Health and Human Development (NACHHD) Council for program relevance and policy issues before awards are made. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: Ephraim Y. Levin, M.D. Endocrinology, Nutrition and Growth Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development Executive Plaza North, Room 637 Bethesda, MD 20892 Telephone: (301) 496-5593 Direct inquiries regarding fiscal matters to: E. Douglas Shawver Office of Grants and Contracts National Institute of Child Health and Human Development Executive Plaza North, Room 505 Bethesda, MD 20892 Telephone: (301) 496-1303 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865, Research for Mothers and Children. Awards are made under authorization of the Public Health Service Act, Section 301 (42 USC 421), 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 Health Systems Agency review. $$R2 END ************************************************************ $$R3 BEGIN DK-93-12 FULL-TEXT *************************************** RESEARCH USING THE UNITED STATES RENAL DATA SYSTEM NIH GUIDE, Volume 21, Number 40, November 6, 1992 RFA AVAILABLE: DK-93-12 P.T. 34; K.W. 0785095, 0755018 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: April 19, 1993 Application Receipt Date: May 18, 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 initiative invites grant applications for biomedical research utilizing the United States Renal Data System (USRDS) database. 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, Research Using the United States Renal Data System, 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 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 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. MECHANISM OF SUPPORT Support of this program will be through the investigator initiated research project grant (R01) mechanism. Each grant award will not be more than $50,000 total cost (including direct and indirect costs). 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. Generally, 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 each application submitted in response to this RFA may not exceed two years. The earliest possible award date will be January 1994. FUNDS AVAILABLE It is anticipated that approximately 10 awards will be made. 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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the award of grants pursuant to this RFA is also contingent upon the availability of funds designated for this purpose. RESEARCH OBJECTIVES The USRDS database contains information on 420,000 Medicare patients who have had end-stage renal disease (ESRD) therapy at any time since 1976. For each patient, the database includes information on basic demographics, the primary medical diagnosis that led to renal failure, dialysis records, hospital records, transplant information. In addition, the database contains details on the 2,492 institutions that provide ESRD treatment services. Limited information is available on non-Medicare funded ESRD patients who are treated by the Department of Veterans Affairs (no billing record data or social security information). The USRDS database is supplemented by data from the U.S. Census Bureau. Specific questions that would be considered responsive to this RFA include but are not limited to the following examples: the relative incidence, prevalence, mortality and survival associated with various comorbid conditions, causes of ESRD, modes of ESRD treatment, or subgroups of the treated ESRD population in the United States; examination of the relative burden of disease in various minority groups; ecologic analyses which relate prevalence of predisposing diseases to incidence and prevalence of treated and untreated ESRD in various subgroups of the population. Creativity in using the data to develop descriptive, analytic, and hypothesis generating studies is encouraged. Questions primarily of an economic focus would not be considered responsive to this RFA, although such issues may be included as secondary aims. The investigator is encouraged to contact the USRDS Project Officer, Dr. Lawrence Agodoa, (KUH/NIDDK, Westwood Building, Room 3A-06, 5333 Westbard Avenue, Bethesda, Maryland 20892, telephone 301/496-7571), to discuss the data request and to request a copy of the USRDS Data Release Policy and the USRDS Agreement for Data Release Form. The USRDS database may be contacted at any time. The USRDS process of reviewing a written request for data, generating the data, and releasing the data takes approximately three months. 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 April 19, 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 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) 496-7083 APPLICATION PROCEDURES Applications are to be submitted using form PHS 398 (rev. 9/91), available in 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 301-496- 7441. 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 initial review, the applications will be given a secondary review 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. Review criteria are given in the RFA. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Inquiries regarding programmatic issues, and requests for the RFA may be directed to: Camille A. Jones, M.D., M.P.H. Director, Epidemiology Program Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A-06 5333 Westbard Avenue Bethesda, MD 20892 Telephone: (301) 496-7571 Inquiries regarding fiscal matters may be directed to: Ms. Trude McCain Grants Management Specialist Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649 5333 Westbard Avenue Bethesda, MD 20892 Telephone: (301) 496-7467 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R3 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-93-014 ************************************************ THE IMMUNOLOGY OF AGING NIH GUIDE, Volume 21, Number 40, November 6, 1992 PA NUMBER: PA-93-014 P.T. 34; K.W. 0710010, 0710070, 0705040, 0765035 National Institute on Aging National Institute of Allergy and Infectious Diseases PURPOSE It has been well established that overall immune function declines with advancing age. However, because the immune system is highly complex, it is essential to understand the multi-faceted nature of this age-related loss of immune function and to identify the primary changes in immune mechanisms leading to this decline in the immune responses. It has been proposed that the decline and/or dysregulation of the immune system may be a primary cause of aging or perhaps a pace-setter of the aging process. The possibility that changes in the immune system may be a fundamental predisposing factor in the aging process is also an appropriate field of scientific inquiry. Research is also indicated into the pathological consequences of age-related changes in the immune system, such as decreased resistance to infection with pathogens and an increased tendency toward autoimmunity and immunopathology. The Biology of Aging Program (BAP) of the National Institute on Aging (NIA) has responsibility for supporting extramural research and training in the fundamental studies of immunology as related to aging. The Geriatrics Program (GP) has responsibility for supporting clinical studies of the immune competence of aging humans, the transfer of promising immunological interventions, and the delivery of effective vaccines to geriatric populations. The Division of Allergy, Immunology, and Transplantation (DAIT) of the National Institute of Allergy and Infectious Diseases (NIAID) is responsible for promoting research into the basic mechanisms of the immune system and the changes that occur in the immune system that initiate or contribute to disease. The two institutes share the goal of achieving a better understanding of the behavior of the immune system and the specific deficits of various components of the immune system that occur during aging to permit intervention and prevent or reverse the immunologic deficits of aging. ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit, public and private organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Applicants for K and F awards must be U.S. citizens, non citizen nationals, or have been lawfully admitted for permanent residence at the time of award. Applications related to the health of women and minorities are particularly encouraged. MECHANISMS OF SUPPORT o Research grant (R01) o Program Project grant (P01) o First Independent Research Support and Transition (FIRST) award (R29) o Career grants, which include: Research Career Development Award (K04); Clinical Investigator Award (K08); Physician Scientist Award (individual K11) o Training grants (T32) o Fellowships (F32, F33) Deadlines for applications are as follows: F-series and T-series grants: Jan 10, May 10, Sep 10 New R, K, and P-series: Feb 1, Jun 1, Oct 1 Competing continuation and revised: Mar 1, Jul 1, Nov 1 Foreign institutions are not eligible to apply for T32 Awards, Program Project (P01) Awards, or FIRST Awards (R29). RESEARCH OBJECTIVES The NIA and the NIAID invite investigators to submit applications for research and research training in all areas of immunology that relate to fundamental processes of aging. Applications to study the aging of the immune system in humans, animals, or cell culture systems are welcome. Applications that might lead to successful interventions in the aging of the immune system are particularly encouraged. The following topics are illustrative of appropriate research areas covered by this Program Announcement. However, applications need not be limited to the issues listed below. o Age related changes in the functions of lymphoid organs (thymus, spleen, lymph nodes, gut-associated lymphoid tissue) o The roles of changes in bone marrow cell production and thymic involution in the aging immune response. The possible role, source and mechanism of extrathymic T cell repopulation o Age-related changes in the genetic and ontogenic control of T and B cell production. Selection and deletion of involved cell types. The nature and function of different T and B cell subtypes (naive, memory, helper, and cytotoxic T cells) o Age-related changes in the mechanisms of antigen sequestration, transport, processing, and presentation, including the accessory cells involved (Langerhans cells, macrophages, dendritic cells, B cells) o Age-related changes in molecules involved in specific antigen recognition (B-cell and T-cell receptors, MHC-encoded molecules) and in lymphocyte and macrophage activation o Age-related changes in biochemical processes leading to lymphocyte and macrophage activation o Age-related changes in the production of lymphokines and other cytokines (and their receptors) involved in the immune response o The role of hormones and neuroendocrine factors in the regulation of T and B cell activity and in age-related changes in immune function. o Age-related changes in the regulation of the immune response (e.g., regulatory cells, immunoglobulin isotypes, the idiotypic network). Changes in the nature of the antibody repertoire with aging. o Immune responses to infectious agents and to vaccines in senescence; development of vaccine delivery systems. o Immunologic tolerance, autoimmunity, and immunopathology in senescence o The interrelationship between disease and immune function in the aging process o The role of nutrition and caloric restriction in the potentiation or prevention of age-associated deficits in immune function o Immune surveillance in aged individuals o Generalized immunosuppression due to viral, protozoal, and bacterial infections in aged individuals o Attempts to prevent or reverse the immunologic deficits of aging by immunotherapy (e.g., development of techniques for immune augmentation, biological response modifiers, hormonal treatment) o Attempts to prevent or reverse the immunologic deficits of aging through cellular or genetic engineering o Effects of drugs on the immune system of older individuals o Gender-related differences in any of the above areas of research. The Geriatrics Program of the NIA also supports research in the clinical aspects of several of the preceding topics, particularly those regarding immune responses to infectious agents in senescence and the development and delivery of effective vaccines. Inquiries considered more appropriate for the Geriatrics Program will be referred to them. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 3, Recruitment of Individuals from Underrepresented Racial/Ethnic Groups, and Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in ALL research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are found in the PHS 398 instructions. National Research Service Award (NRSA) (F32, F33) applications must be submitted on grant application Form PHS 416 (rev. 10/91). 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 301/496-7441. The title and number of the announcement must be typed in Section 2a on the face page of the application. Applications 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. In such a case, 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 PROCEDURES Other institutes may also have interest in several of the topics mentioned here. All applications in response to this Program Announcement will be assigned to an Initial Review Group and reviewed by the usual Public Health Service Peer Review (Study Section) procedures. They will also be given appropriate primary and secondary Institute assignments in accordance with established PHS Referral Guidelines. The review criteria are the traditional criteria appropriate to each mechanism. In accordance with the standard NIH peer review procedures, research project grant (R01 and R29) applications, fellowships (F32, F33) and research career development awards (K04) will be reviewed for scientific and technical merit by an appropriate study section in the Division of Research Grants. All other applications will be reviewed by review groups of the appropriate funding component. Following the Study Section review, the applications will receive a second-level review by the appropriate advisory council. Funding decisions will be based on the above evaluations and on the availability of funds. AWARD CRITERIA Applications compete for available funds on the basis of scientific merit. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Researchers considering an application in response to this announcement are strongly encouraged to discuss their project, and the range of grant mechanisms available with NIA and/or NIAID staff. This can be done either through a telephone conversation or a brief letter. Correspondence and inquiries may be directed to: Dr. David Lavrin, Immunology Program Administrator Biology of Aging Program National Institute on Aging Gateway Building, Room 2C231 7201 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-6402 FAX: (301) 402-0010 Dr. Joseph Albright Program Administrator, Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A20 Bethesda, MD 20892 Telephone: (301) 496-7985 FAX: (301) 402-0175 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.866 and 93.855. 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-93-015 ************************************************ PHYSIOLOGICAL ROLE OF THE ADRENAL ANDROGEN, DHEA, IN AGING NIH GUIDE, Volume 21, Number 40, November 6, 1992 PA NUMBER: PA-93-015 P.T. 34; K.W. 0710010, 0705030, 0705040, 0760025 National Institute On Aging PURPOSE The National Institute on Aging (NIA) has responsibility for extramural programs of research and training in immunology and endocrinology related to aging. This support has resulted in a better understanding of the behavior of, and specific changes in, various components of the immune and endocrine systems in aging. It is well recognized that changes in the immune and endocrine systems during aging have profound influences on homeostatic mechanisms of the body. Some of these changes may be a result of "normal aging;" others may be due to environmental factors, such as stress and disease. Steroid, peptide, and eicosenoid hormones secreted from endocrine tissues are known to influence the immune system. Conversely, some cytokines, interferons and interleukins, modulators of immune system function, have profound regulatory effects on the endocrine system. Since both the immune and some components of the endocrine systems decline with advancing age, it is of interest to explore and delineate regulatory interactions between the immune and endocrine systems in the aging mammal. The purpose of this program announcement is to focus on the physiological role of the adrenal steroidal androgen precursor, dehydroepiandrosterone (DHEA), in aging. DHEA, and its sulfated form, DHEAS, decrease steadily with age in both animals and humans. This decline may represent a biomarker of biological aging. DHEA/DHEAS levels have also been found to be depressed in a number of disease states (eg., systemic lupus erythematosis (SLE), AIDS, cancer, diabetes, cardiovascular disease) and during stress and trauma (e.g., burns, surgery). Administration of DHEA has been shown to inhibit the development of obesity and to protect against carcinogenesis in mice. Recent research has demonstrated that the administration of physiologic doses of DHEA/DHEAS to aged mice may reverse the age-related immunological anergy by permitting the production of antibody and cellular responses at levels comparable to those of fully immunocompetent mature adult mice. The pattern of the lymphokine production was also restored to that of normal mature mice. DHEAS administration also has been shown to counteract the inflammatory From owner-sci-resources@net.bio.net Wed Nov 04 22:00:00 1992 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 21, no. 40, pt. 2, 6 November 1992 Message-ID: Date: 5 Nov 92 18:50:48 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1207 $$XID NIHGUIDE 19921106 V21N40 P2O2 ************************************ production of Interleukin-6 and the effects of corticosteroids following stress and trauma. ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Applicants for K- and F-series awards must be U.S. citizens, non- citizen nationals, or have been lawfully admitted for permanent residence at the time of award. MECHANISMS OF SUPPORT o Research grant (R01) o Program Project grant (P01) o First Independent Research Support and Transition (FIRST) award (R29) o Career grants, which include: Research Career Development Award (K04); Clinical Investigator Award (K08); Physician Scientist Award (individual K11) o Fellowships (F32, F33) Deadlines for applications are as follows: F-series grants: Jan 10, May 10, Sep 10 New R, K, and P-series: Feb 1, Jun 1, Oct 1 Competing continuation and revised: Mar 1, Jul 1, Nov 1 Foreign institutions are not eligible to apply for Program Project (P01) awards, or FIRST awards (R29). RESEARCH OBJECTIVES The NIA invites researchers to submit applications for research grants, career development awards, and postdoctoral fellowships for studies on the role of DHEA/DHEAS and their metabolic products as they interface with fundamental aging. Of particular interest is the pathway of action and its possible role as a biomarker of aging, including the decline of the immune system and the propensity for increased disease in aging. Of interest also are potential intervention methods to delay and control the aging process with respect to the susceptibility to diseases of the immune, endocrine, and other physiologic systems. Although the interaction of DHEA/DHEAS and their metabolic products and analogs with components of the immune system and various pathophysiologic processes is of primary interest in this Program Announcement, other relevant areas of investigation exploring the communication between the immune and endocrine systems in aging mammals are also of interest and are included within the scope of this Program Announcement. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 3, Recruitment of Individuals from Underrepresented Racial/Ethnic Groups, and Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in ALL research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are found in the PHS 398 instructions. National Research Service Award (NRSA) (F32, F33) applications are to be submitted on grant application Form PHS 416 (rev. 10/91). 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 301/496-7441. The title and number of this announcement must be typed in Section 2a on the face page of the application. Applications 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. In such a case, 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 PROCEDURES All applications in response to this Program Announcement will be assigned to Initial Review Groups on the basis of the PHS Referral Guidelines and reviewed by the usual Public Health Service Peer Review (Study Section) procedures. They will also be given appropriate primary and secondary Institute assignments in accordance with established PHS Referral Guidelines. The review criteria are the traditional criteria appropriate to each mechanism. In accordance with the standard NIH peer review procedures, research project grant (R01 and R29) applications, fellowships (F32, F33) and research career development awards (K04) will be reviewed for scientific and technical merit by appropriate study sections in the Division of Research Grants. All other applications will be reviewed by review groups of the appropriate Institute. Following the Study Section review, the applications will receive a second-level review by appropriate advisory councils. Funding decisions will be based on the above evaluations and on the availability of funds. AWARD CRITERIA Applications compete for available funds on the basis of scientific merit with other applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Researchers considering an application in response to this announcement are strongly encouraged to discuss the projects and the range of grant mechanisms available, with NIA staff. This can be done either through a telephone conversation or a brief letter. Applications related to the health of women and minorities are particularly encouraged. Correspondence and inquiries may be directed to: Dr. David Lavrin Immunology Program Administrator Biology of Aging Program National Institute on Aging Gateway Building, Room 2C231 Bethesda, MD 20892 Telephone: (301) 496-6402 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.855. 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. $$P2 END ************************************************************ $$XID RFA DK9312 DK-93-12 P1O1 ***************************************** RESEARCH USING THE UNITED STATES RENAL DATA SYSTEM NIH GUIDE, Volume 21, Number 40, November 6, 1992 RFA: DK-93-12 P.T. 34; K.W. 0785095, 0755018 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: April 19, 1993 Application Receipt Date: May 18, 1993 PURPOSE The purpose of this initiative is to invite grant applications for biomedical research questions that can be answered using the United States Renal Data System (USRDS) database. Awarded funds will be used to generate the data file through the USRDS Coordinating Center and to support the investigator's analysis of the data. 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), Research Using the United States Renal Data System, 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 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 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. MECHANISM OF SUPPORT Support of this program will be through the investigator initiated research project grant (R01) mechanism. Each grant award will not be more than $50,000 total cost (including direct and indirect costs). 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. Generally, 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 each applications submitted in response to this RFA may not exceed two years. The earliest possible award date will be January 1994. FUNDS AVAILABLE It is anticipated that approximately ten awards will be made; 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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the award of grants pursuant to this RFA is also contingent upon the availability of funds designated for this purpose. RESEARCH OBJECTIVES End-stage renal disease (ESRD) treatment is costly, and the number of patients being treated has been increasing steadily in this country since 1977. The total number of patients with treated ESRD in 1989 was 190,862. The 1989 estimated federal Medicare payments for ESRD patients averaged $30,900 per patient. The estimated total 1989 direct medical payments for ESRD by public and private payers is $5.99 billion. The USRDS database, designed to serve as a resource to the academic and clinical medicine communities, has been operational since 1988. The USRDS database contains information on approximately 420,000 Medicare patients who have had ESRD therapy at any time since 1976. For each patient, the database includes information on basic demographics, the primary medical diagnosis that led to renal failure, dialysis records, hospital records, and transplant information. In addition, the database contains details on the 2,492 institutions that provide ESRD treatment services. Limited information is available on non-Medicare funded ESRD patients who are treated by the Department of Veterans Affairs (excluding billing data and social security information). The USRDS database is supplemented by data from the U.S. Census Bureau. Since 1989, the USRDS Coordinating Center has produced an annual data report containing descriptive and analytic epidemiologic data on ESRD patients. However, as yet, few investigators outside of the USRDS Coordinating Center have utilized the database to answer biomedical research questions. It is the purpose of this RFA to solicit applications that will pose and answer questions relevant to ESRD in the United States. Specific questions that would be considered responsive to this RFA include, but are not limited to, the following examples: o the relative incidence, prevalence, mortality and survival associated with various comorbid conditions, causes of ESRD, modes of ESRD treatment, or subgroups of the treated ESRD population in the United States; o examination of the relative burden of disease in various minority groups; o ecologic analyses that relate prevalence of predisposing diseases to incidence and prevalence of treated and untreated ESRD in various subgroups of the population. Creativity in using the data to develop descriptive, analytic, and hypothesis generating studies is encouraged. Questions primarily of an economic focus would not be considered responsive to this RFA, although such issues may be included as secondary aims. The USRDS data release policy includes the following provisions: The sole purpose of providing the data is the conduct of legitimate biomedical research by the Principle Investigator (PI). The investigator will not use the data to identify individuals on the file. The investigator will not combine or link the data provided with any other collection or source of information that may contain information specific to individuals on the file, except specific, written authorization has been obtained through the approval process. The investigator will not use the data for purposes that are not related to biomedical research. The investigator will not publish or otherwise disclose the data in the file to any person unless the data have been aggregated (that is, combined into groupings of data such that the data are no longer specific to any individual within each grouping) and no cells (aggregates of data) contain information on fewer than 10 individuals. A copy of any aggregation of data intended for publication will be submitted to the USRDS Project Officer for review prior to publication; if the publication is not in conformity with the Privacy Act, it will not be published until revised to adhere to the Privacy Act provisions. Appropriate administrative, technical, procedural, and physical safeguards shall be established by the investigator to protect the confidentiality of the data and to prevent unauthorized access to it. The safeguards will provide a level of security outlined in OMB Circular No. A-130, Appendix III-- "Security of Federal Automated Information Systems," which sets forth guidelines for security plans for automated information systems in Federal agencies. The investigator is encouraged to contact the USRDS Project Officer, Dr. Lawrence Agodoa, (KUH/NIDDK, Westwood Building, Room 3A-06, 5333 Westbard Avenue, Bethesda, MD 20892, telephone 301/496-7571), to discuss the data request and to request a copy of the USRDS Data Release Policy and the USRDS Agreement for Data Release Form. The USRDS database may be contacted at any time. The USRDS process of reviewing a written request for data, generating the data, and releasing the data takes approximately three months. STUDY POPULATIONS It is NIH policy that women and minorities must be included in clinical study populations unless there is a good reason to exclude them. The study design must seek to identify any pertinent gender or minority population differences. 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. 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, by April 19, 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 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 the Chief, Review Branch, Division of Extramural Activities at the address provided below. 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 301/496-7441. 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 check the YES box. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** 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 5333 Westbard Avenue Bethesda, MD 20892 Applications must be received by May 18, 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 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 return it to the applicant. 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. Applications may be subjected to triage by an NIDDK peer review group to determine their scientific merit relative to other applications received in response to this RFA. 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 when 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 specifically convened for this RFA. Following this review, the applications may be given a second level review by the NIDDK Advisory Council unless not recommended for further consideration by the initial review group. Review criteria for this RFA are as follows: o Scientific/medical significance of the proposed research. o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. o Requested data elements are already contained in the database. (New data collection and purchase of equipment will not be covered by this RFA.) o Realistic cost estimates for generating and analyzing the data. o Availability of resources necessary to perform the research. o Appropriateness of the proposed budget and duration in relation to the proposed research. o Qualifications and research experience of the Principal Investigator and staff in doing epidemiologic analyses. o If the researcher is from a foreign country, the uniqueness of research such that it can only be performed outside of the United States must be demonstrated. AWARD CRITERIA The anticipated date of award is January 1994. Applications will compete for available funds with all other applications recommended by the initial review group. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review. o Availability of funds. o Programmatic balance among the studies recommended for funding. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Direct inquiries regarding programmatic issues to: Camille A. Jones, M.D., M.P.H. Director, Epidemiology Program Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A-06 5333 Westbard Avenue Bethesda, MD 20892 Telephone: (301) 496-7571 Inquiries regarding fiscal matters may be directed to: Ms. Trude McCain Grants Management Specialist Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649 5333 Westbard Avenue Bethesda, MD 20892 Telephone: (301) 496-7467 Schedule Letter of Intent: April 19, 1993 Application Receipt: May 18, 1993 Initial Review: October - November 1993 Second Level Review: January 1994 Anticipated Award: January 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA CA9306 CA-93-06 P1O1 ***************************************** DEVELOPMENTAL RESEARCH IN NATIVE PACIFIC POPULATIONS NIH GUIDE, Volume 21, Number 40, November 6, 1992 RFA: CA-93-06 P.T. 34, FB; K.W. 0715035, 0795003, 0745027 National Cancer Institute Letter of Intent Receipt Date: December 4, 1992 Application Receipt Date: January 25, 1993 PURPOSE The National Cancer Program is mandated to address the unique cancer prevention, early detection, and treatment needs of all populations within the U.S. and its territories. An excerpt from the FY 1992 Committee on Appropriations to the U.S. Department of Health and Human Services stated: "The Committee also urges NCI to expand its efforts to develop an appropriate response to the needs of American Samoans. Access to timely treatment intervention is especially important for this native American population...." (Senate Report No. 102-104, page 86) Therefore, the Division of Cancer Prevention and Control (DCPC) of the National Cancer Institute (NCI) invites applications from various organizations for developmental studies that: (1) assess cancer control need, (2) determine barriers to cancer control, and/or (3) validate intervention methods and assessment instruments in native Pacific populations; i.e., American Samoans, Guamanians (Chamorros), Palauians, and Northern Marianians. This initiative will define the cancer prevention and control needs of native Pacific populations and those of similar ancestry located in the Pacific as well as the U.S. mainland. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Developmental Research in Native Pacific Populations, is related to the priority area of cancer. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000 (Summary Report: Stock No. 017-001- 00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic (including U.S. Territorial possessions) public and private, for-profit and non-profit organizations serving native Pacific populations such as universities, public health departments, voluntary organizations, research centers, hospitals, consortia of health providers, units of State and local governments and eligible agencies of the Federal government. Teams of applicants are encouraged. Among a team of applicants, one institution must be proposed as the lead institution to serve as the applicant and to assume responsibility for the conduct and administration of the project. Note that awards will not be made to foreign institutions and that applications from domestic organizations may not include international components. MECHANISM OF SUPPORT The mechanism of support for this RFA will be the National Institutes of Health (NIH) research project grant (R01). Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. In addition to the requirements stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1991. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. It is anticipated that four awards will be made at approximately $300,000 total costs per year. FUNDS AVAILABLE Approximately $1.2 million in total costs per year for three years will be set-aside to specifically fund applications that are submitted in response to this RFA. It is anticipated that up to four awards will be made. The total project period of these awards may not exceed three years. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of a grant pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background The National Cancer Program is mandated to address the unique cancer prevention, early detection, and treatment needs of all populations within the U.S. and its territories. The cancer control objectives for the nation are aimed at (1) reducing the cancer death rates for all Americans and (2) eliminating differentials in cancer rates between population segments. The means to obtain these objectives include the development and implementation of cancer control and prevention strategies directed at the general U.S. population and targeted initiatives directed at minority and medically underserved populations that are differentially affected by cancer. These populations include those who experience high cancer incidence/mortality rates or low survival rates, or who are underserved in terms of cancer prevention and control programs that include the native Pacific populations. The paucity of data on effective cancer prevention and control intervention methods in the target populations reflect both a dearth of such programs and of validated instruments to evaluate their effectiveness. The need for the development of sensitive intervention methods and assessment instruments has to be established in many areas of health (e.g., mental health, cardiovascular diseases) and other sectors (e.g., education). In recent years, the Division of Cancer Prevention and Control (DCPC) has carried out intervention research initiatives directed at the American Indian/Alaska Native, Black, Native Hawaiian, and Hispanic populations. These experiences, combined with information gathered through external working groups and experts in the cancer prevention and control needs of minority and medically underserved populations and extensive conversations with experienced investigators, has clarified the need for Phase I and Phase II cancer control studies for native Pacific populations. It is clear that the concepts of health and healing vary significantly, and this diversity is not captured by a single design, method, or instrument. Studies conducted under this RFA will seek to define cancer prevention and control needs/services of the native Pacific population segments (Phase I). Studies to test ways in which existing intervention methods can be used or adapted for the target populations (Phase II); studies of new methods designed to be sensitive to the needs of the target populations (Phase II); and methodologic research on validation of assessment instruments in target populations (Phase II) are eligible for consideration under the RFA. This "developmental cancer control research" (Phase I and Phase II) is absolutely essential to future development of cancer prevention and control research for native Pacific populations. The following definitions apply to this RFA: 1. Native Pacific Populations -- The term "native Pacific populations" refers to those population segments indigenous to the Pacific region and/or populations of similar ancestry located within the U.S. mainland, such as American Samoan populations. 2. Cancer Control -- Cancer control is defined as the reduction of cancer incidence, morbidity, and mortality through an orderly sequence from research on interventions and their impact in defined populations to the broad, systematic application of the research results. 3. Phases of Cancer Control -- Cancer control research studies are classified in the five phases that represent the orderly progression noted in the above definition: (I) Hypothesis development; (II) Intervention methods development and testing; (III) Controlled intervention trials to establish cause and effect relationships; (IV) Research in defined human populations; and (V) Demonstration and implementation studies. The research of interest in this RFA falls into either Phase I or Phase II studies. Hypothesis development (Phase I) studies should focus on the assessment of cancer prevention and control needs in communities or organizations within native Pacific populations, or studies that identify barriers to cancer prevention and control within these indigenous populations. Methods development and testing studies, Phase II, should focus on: (1) validating the use of existing intervention methods (e.g., dietary modification, health services, tobacco cessation) as applied in the target populations described above; (2) developing and pilot testing unique methods that are sensitive to the needs of the target populations described above, or (3) developing and validating assessment instruments to measure the cancer control related needs of the target populations or for use in evaluating the effectiveness of intervention methods in the target populations. It is the interest of this RFA that the projects should be multidisciplinary in design. Applicable disciplines may include epidemiology, oncology, public health, pathology, health services research, behavioral, and social sciences. The research team should include individuals with knowledge of the culture and language of the native Pacific populations. Because validation and intervention studies may depend on the review of case records, investigators should assure in the application that a mechanism to access pertinent records has been identified. A. Goals and Objectives The goals of this program initiative are to identify cancer control needs, to determine barriers to cancer control, and to validate intervention methods and assessment instruments. The objectives relating to Phases I and II are described below: Phase I Studies 1. Assess cancer prevention and control needs/services in communities with native Pacific populations. 2. Identify barriers to cancer prevention and control in native Pacific population communities. Phase II Studies 1. Validate the use of existing intervention methods (e.g., dietary modification, health services, tobacco cessation) applied in the target populations. 2. Develop and pilot test unique intervention methods sensitive to the needs of the target populations. 3. Develop and validate assessment instruments (e.g., dietary intake, risk factor surveys) to measure the cancer control related needs of the target populations and to evaluate the effectiveness of intervention methods in the target populations. B. Project Approach It is important that applicants describe fully and in detail all aspects of the proposed project in the application, including cancer sites to be studied, the target population for which the research is being conducted, available population data bases, hypotheses to be considered, the planned intervention approaches, methods of assessment and validation, and the overall research design approach to the proposed study. It is essential to select and justify in the application, cancer sites on the basis of the significance in the target population and the potential for reduction of mortality rates. It is also essential that the population for which the study(ies) will be carried out be specified and characterized using population-based estimates of the demographic characteristics of the target population. All collaborative arrangements that are planned should be described in detail, including areas of responsibility, coordinating, decision- making authority, and financial relationships. Letters of commitment from each participating organization should be included in the application. C. Research Plan The applicant should include a detailed protocol outlining the proposed project methods for determining outcome effects. The protocol should detail the research project as conceived and should provide the complete methodological approach to the problem under investigation. The design for the project should provide enough information to determine an adequate "test" of the concepts, whether validation or intervention outcomes. It is important that the design permits statistically valid results to be achieved within the period of award. D. Options in Project Design Applicants must choose from the three types of projects described below: o Type One - Validation study of an existing intervention method for use in a native Pacific population group. o Type Two - Develop and pilot test a "unique" intervention method that is sensitive to the needs of the target population. o Type Three - Develop and validate needs assessment instruments or assessment instruments that could be used to measure effectiveness of cancer control methods in the target population. Applicants must specify which type they have selected in the first line of section 2(a), "Specific Aims", in the application. E. Time Schedule A detailed time schedule should be presented in the application. This schedule is important because it will provide the milestones against which progress will be validated. SPECIAL REQUIREMENTS Awardees should include in the proposed budgets travel to the NCI for up to two persons to attend two meetings of Principal Investigators and NCI program staff to discuss such issues as the validation of stated hypotheses, determination of population characteristics/size relative to the intervention specified, research progress, and results. These meetings will be held approximately three months prior to the scheduled completion of years 01 and 03, respectively. Awardees should anticipate that NCI staff may conduct a site visit as a part of program management in order to assure that projects are proceeding according to the plans specified in the application. This anticipated site visit is not intended to reduce the requirements for the customary detailed progress report in accordance with the instructions appearing in form PHS 2590. STUDY POPULATIONS The targeted population intended under this RFA is the native Pacific populations and those of similar ancestry located in the Pacific as well as the U.S. mainland; i.e., American Samoans, Guamanians (Chamorros), Palauians, and North Marianians. Applicants responding to this RFA are expected to successfully access a significant portion of this population to decrease cancer incidence and mortality, increase cancer survival, and increase the diagnosis of cancers at earlier stages. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaska Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by December 4, 1992, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is extremely helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. In addition, if it appears that the potential applicant has misunderstood the objectives of the RFA or opted for an inappropriate funding mechanism, NCI staff will respond to such letters. The NCI would like to emphasize the benefits to the applicant and to staff of having a Principal Investigator submit a letter of intent. The letter establishes communication between the potential applicant and program staff initiating the RFA. Program staff may be able to assist prospective applicants in several areas, i.e., scientific content and objectives of an application, size and focus of a research program, organization of an application, and appropriate use of core components and consultants. The letter of intent is to be sent to: George A. Alexander, M.D. Chief, Special Populations Studies Branch Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 240 Bethesda, MD 20892-4200 Telephone: (301) 496-8589 FAX: (301) 496-8675 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892; telephone 301/496-7441. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number should be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies in one package to the Division of Research Grants at the address below. The photocopies must be clear and single-sided. Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg, Referral Officer Division of Extramural Activities National Cancer Institute Westwood Building, Room 838 5333 Westbard Avenue Bethesda, MD 20892 Applications must be received by January 25, 1993. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but the revised application must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Review Procedures Upon receipt, applications will be reviewed (initially) by the DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the RFA is an NCI program staff function. If an application is judged to be non-responsive, the applicant will be contacted and given an opportunity to withdraw the application or have it considered with other unsolicited applications received by NIH in the next review cycle. Questions concerning responsiveness to the RFA may be directed to NCI program staff listed under INQUIRIES. If the number of applications submitted is large compared to the number of awards to be made, the NCI may conduct a preliminary scientific peer review to eliminate those that are clearly not competitive. The NCI will remove from competition those applications judged to be noncompetitive for award and notify the applicant and institutional business official. Those applications that are complete and responsive will be initially evaluated in accordance with the review criteria stated below for scientific/technical merit by an ad hoc review committee convened by the Division of Extramural Activities, NCI. The second level of review will be provided by the National Cancer Advisory Board. Responsiveness Criteria Applicants must be responsive to this RFA in the sense of being directed towards the attainment of the stated programmatic goals. Five considerations are of paramount importance to this RFA: 1. Descriptions of the cancer problem with justification for the selection of specific cancer site(s) in terms of potential for reduction of mortality rates, cancer control intervention strategy, research method, procedures, analysis plans, and time schedule must be clearly delineated. 2. Studies must be limited to Phase I and/or Phase II only. 3. Assurance of access to a community with characteristics appropriate for the proposed intervention: written documentation must be included. 4. The target population must be a native Pacific population indigenous to the U.S. Pacific territorial region, i.e., American Samoa, Guam, Palau, Northern Marianas; or of similar ancestry located in Hawaii and the U.S. mainland, i.e., American Samoans. 5. Agreements with communities, organizations, agencies, or institutions that are critical to ensure access to appropriate records and to the implementation of the research plan must be included. Review Criteria Each application will be reviewed on its own merit. All applicants must clearly define the target population and geographic location where the program efforts will be demonstrated as well as the project team's ability to access the target population. All applicants should include in the application a succinct discussion of previous relevant efforts and plans to meet the terms of award. Applicants are encouraged to submit and describe the approach that they think would best meet the goals of this RFA and to identify in-kind contributions and/or co-sponsors for specific personnel, activities, and facilities. Each application will be reviewed according to the following criteria: 1. Scientific merit of the research approach, design, and methodology. 2. Scientific and technical significance and originality of the proposed research. 3. Experience (research or clinical or service) and/or competence of the Principal Investigator and staff. 4. Adequacy of time (effort) that the Principal Investigator and staff would devote to the proposed project. 5. Characterization of the native Pacific population to be used (cultural, spiritual or language considerations) in the proposed project. 6. Adequacy of the approaches to produce valid assessment instruments for use in larger community intervention studies for cancer control. 7. Likelihood of intervention (Phase II studies) to be readily accepted and feasible in terms of cost. 8. Potential for generalizability of the findings and adaptability of the intervention approaches and assessment instruments in other communities with similar cancer control problems. 9. Adequacy of the plans for inclusion of women. The ad hoc review group will recommend an appropriate budget for each approved application. AWARD CRITERIA The anticipated date of award is July 1, 1993. Applicants will compete for funding based on the quality and merit of the proposed research study as determined by peer review, availability of funds, and programmatic priorities, as well as geographic location. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: George A. Alexander, M.D. Chief, Special Populations Studies Branch Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 240 Bethesda, MD 20892-4200 Telephone: (301) 496-8589 Direct inquiries regarding fiscal issues to: Crystal Elliott 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. 93.399, Cancer Control Science Program. Awards are made under authorization of the Public Health Service Act, Title IV, Part A. (Public Law 78-410, as amended by Public Law 99-158, 42 USC 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Wed Nov 04 22:00:00 1992 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 21, no. 40, pt. 3, 6 November 1992 Message-ID: Date: 5 Nov 92 18:52:05 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 784 $$XID RFA HD9306 HD-93-06 P1O1 ***************************************** NETWORK OF PEDIATRIC PHARMACOLOGY RESEARCH UNITS NIH GUIDE, Volume 21, Number 40, November 6, 1992 RFA: HD-93-06 P.T. 34, AA; K.W. 0710100, 0770005, 0403020, 0715006 National Institute of Child Health and Human Development Letter of Intent Receipt Date: February 15, 1993 Application Receipt Date: April 13, 1993 PURPOSE The National Institute of Child Health and Human Development (NICHD) plans to support a cooperative Network of Pediatric Pharmacology Research Units (PPRU) to serve as a resource for studies of drug action and disposition in infants and children. These studies will be conducted by pediatric clinical pharmacologists, either cooperatively with investigators at other units in the network, collaboratively with pharmaceutical companies, or independently with other support. The ultimate goal of studies conducted by the network is to provide the clinical data on drugs necessary for U.S. Food and Drug Administration (FDA) approval for use in children. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention goals of "Healthy People 2000," a PHS-led national activity for setting priorities. This Request for Applications (RFA), Network of Pediatric Pharmacology Research Units, is related to the priority areas of food and drug safety and maternal and infant health. Copies of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0, or Summary Report: Stock No. 017-001-00473-1) are available through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS PPRU cooperative clinical agreement (U01) awards will be made to children's hospitals or their equivalent or to educational institutions with accredited medical schools, within the United States. Each PPRU must become an identifiable unit within its institution, its Principal Investigator reporting to the chief of pediatrics or the chairperson of the pediatrics department. The applicant institution must also meet the standard eligibility requirements for research grants established in the Public Health Service Grants Policy Statement #(OASH) 90-50,000, Rev. 10/1/90. There must be at the applicant institution an ongoing program of excellence in clinical pharmacology, with an emphasis on pediatric applications. The quality of this program must be evident from the receipt by its staff of research support in peer-reviewed competition, or from their consistent record of publication in peer-reviewed research journals. In addition, the applicant institution must have available a sufficient number of eligible research subjects in the pediatric age groups: newborns, infants, children, pre-adolescents, and adolescents. This is an essential component of the network and must be spelled out in detail in the application. MECHANISM OF SUPPORT The funding mechanism to be used to assist the scientific community in undertaking this program of research in clinical pharmacology will be a cooperative clinical agreement (U10) between the participating units and the NICHD. The U10 award will provide support for laboratory and administrative resources to assist the research community in carrying out clinical therapeutic research protocols. The major difference between a cooperative agreement and a traditional research grant is the substantial scientific involvement of NICHD staff beyond the levels normally required for program stewardship of grants. Cooperative clinical agreements (U01) are assistance mechanisms and are subject to the same administrative requirements as grants. FUNDS AVAILABLE It is expected that up to four applications will be funded, within the total direct cost limit of $1,000,000 available for the first year. Therefore, the maximum direct cost request (first year) for individual applications should not exceed $250,000. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NICHD, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Federal law and the regulations of the FDA require that drugs be tested for safety and efficacy before they are approved for clinical use. This testing must take place in all populations in which the drug will be employed. Since both the qualitative and quantitative aspects of pharmacodynamics and pharmacokinetics are different in immature individuals, studies must be conducted in infants and children before a drug can be approved for use with them. For the purposes of this RFA, the term children is used to mean human beings during their prenatal and postnatal stages of development, from fetal life through adolescence. Several practical problems discourage the testing of drugs in children. These include the unforeseeable nature of some clinical responses in immature individuals; the possibility of catastrophic unanticipated reactions; the threat of effects on growth or health long after completion of the drug administration; the difficulty in predicting efficacious blood levels by extrapolation from data obtained in adults; the ethical problems of conducting nontherapeutic research in children; the awkwardness of procedures for obtaining informed consent or assent in older children; the lack of a suitable infrastructure for the conduct of pediatric pharmacology research; the high cost of pediatric studies; and the absence of a financial incentive for the pharmaceutical industry to conduct pediatric pharmaceutical trials if children are a minority of the population for which the drug might be prescribed. The result of these practical problems and the regulatory requirements is that more than three-quarters of the drugs marketed in the United States, including many of the most useful agents in modern therapy, are not approved as safe and effective for use in children. Since the provision of pediatric care without the use of these agents would be unacceptable, they are commonly administered "off-label" (without specific FDA approval) by pediatricians, anesthesiologists, general practitioners, surgeons, and others. Under these conditions the child is at risk of an inadequate therapeutic response or some unanticipated adverse reaction. Physicians can face medicolegal actions as a result of such accidents, but they can also risk suit for failure to utilize an effective drug for a child's illness, even if that drug does not have specific FDA approval for use in children. This dilemma must be resolved if children are to receive the full benefits of contemporary therapeutics. Modern pediatric pharmacology is a sophisticated clinical discipline capable of carrying out the studies necessary for the safe and ethical evaluation of drugs in children. Pursuit of such studies, however, is limited by the scarcity of available facilities in which to follow children receiving drugs and collect data in a systematic way, as well as the small number of qualified clinical investigators interested in this problem. In order to assist the pediatric community in carrying out these needed studies, the NICHD is issuing this RFA. Objectives and Scope The objective of the PPRU Program is to increase the number and variety of medications that are FDA-approved for use in children, with the ultimate goal that all drugs prescribed for children be labeled for such usage. This is to be accomplished by providing resources for pediatric pharmacokinetic and pharmacodynamic research through the establishment of a Network of Pediatric Pharmacology Research Units (PPRU). Each PPRU will have four specific aims: (1) To participate with other units in the network and with NICHD staff assistance in collaborative clinical trials of drugs in children through protocols determined by consensus; (2) To provide a locus for the conduct of pre-marketing and post-marketing clinical trials in children by qualified clinical pharmacologists working in collaboration with proprietary pharmaceutical firms; (3) To conduct independent, investigator-initiated studies on the pharmacodynamics and pharmacokinetics of drugs in children; and (4) To provide an environment in which pediatricians and others can gain supervised experience in pediatric clinical pharmacology. It is expected that most of the studies conducted in the PPRU network will be clinical and pediatric. Nevertheless, pre-clinical studies may sometimes be conducted (with other support) in a Unit's core laboratory if these are important as preliminaries or adjuncts to clinical projects. Similarly, limited clinical studies in adults may sometimes justify PPRU support if they are necessary for adapting existing protocols to children. Components of a PPRU A. Principal Investigator and Administrative Staff The Principal Investigator (PI) of a PPRU must be an established pediatric clinical pharmacologist, preferably holding independent peer-reviewed grant or contract support, actively publishing in the field, and familiar with academic and proprietary research in pharmacology and pharmacokinetics. The PI is responsible for developing and maintaining the PPRU as an institutional and national resource and for general oversight, appointing the members of the institutional advisory committee (see below) and (with advisory committee advice) the associate clinical pharmacologist and other members of the Unit staff. It is expected that the PI will be active in conducting research within the Unit and in negotiating support from proprietary pharmaceutical organizations. The PI will assist other investigators in conducting PPRU research protocols. The PI will attend the meetings of the Network Steering Committee (see below) and participate in its deliberations. The PI may be supported for up to 25 percent time and effort in the program, and may be assisted by a part-time secretary (25 percent time and effort). The PI is expected to hold final authority and responsibility for the care of PPRU patients, reporting only to the chief of pediatrics or the chairperson of the pediatrics department, even though the regular care of the patients may be in the hands of other investigators or house officers. The PI must therefore be state-licensed as a physician and board-certified in pediatrics. B. Local Advisory Committee This group will play an important part in the operations of the PPRU program. It should comprise from three to five members of the host institution faculty in addition to the PI, either users or non-users of the Unit, appointed for defined terms. Members should all be sensitive from experience or training to the special needs of children participating in research. They should all be qualified for the committee's principal activities, evaluating protocols to be conducted on the Unit for scientific merit and recommending to the PI priorities for the use of unit resources. The committee also has the responsibility of examining the qualifications of candidates for the associate clinical pharmacologist and other PPRU positions and reporting their recommendations to the PI. C. Clinical Facility A designated physical site where the clinical research is to be performed is required. To allow optimal opportunities for collaboration among units in the network, it is desirable that each PPRU have both an inpatient and an outpatient capability. These could be provided by a pediatric metabolic ward and outpatient clinic, a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources and suitable for admitting children and caring for them as outpatients, or some other unit similarly equipped for conducting pediatric clinical research. Applicant institutions that wish to identify the GCRC as a site for conducting PPRU research should include with the application a letter of agreement from the GCRC program director or PI. D. Core Laboratory A funded PPRU may include a core laboratory dedicated to performing specialized analyses and/or data management functions for studies conducted in the Unit. This should not include procedures routinely performed for a fee in institutional laboratories or available in the laboratories of the investigators utilizing the unit. Each proposed protocol should end with an estimate of staff time and required hospital ancillary costs that will be made necessary by pursuit of the protocol. (These costs should not be included in the overall requested Unit budget, since they will be distributed over all the network participants in that protocol.) For studies performed in collaboration with pharmaceutical firms, those firms should pay the fees for research-related clinical determinations. For investigator-initiated studies in which pharmaceutical firms do not participate, these costs must be supported from sources other than the PPRU funding. The core laboratory may be staffed by a PPRU-supported doctoral-level core laboratory director (maximum 25 percent time and effort) and a core laboratory technician (maximum 50 percent time and effort), if the science proposed so warrants. Core laboratory consumable expenses and equipment maintenance costs, up to a maximum of $20,000 annually, may be supported if justified. The core laboratory director, who reports to the PI, should have responsibility for quality control in that laboratory. The time and effort of the PI may also be devoted to developing new methods for protocols being conducted with PPRU support and to standardizing procedures to be carried out for PPRU network collaborative protocols. In addition, the core laboratory director is responsible for the care and maintenance of the laboratory equipment, and will cooperate with the PI in assisting other investigators in their use of the Unit. The equipment used in the core laboratory should be primarily that available to the investigators or obtainable from institutional resources. Nevertheless, new equipment up to a maximum cost of $50,000 over the first four years of the award may be requested in a PPRU cooperative agreement application, with appropriate justification. As an occasional courtesy, determinations that are available in the core laboratory may be performed for non-PPRU protocols, at the discretion of the PI and core laboratory director. For consistent or recurrent non-PPRU usage, or for drug company-initiated protocols being pursued on the units, there should be appropriate reimbursements from non-PPRU sources for core laboratory equipment maintenance, supplies, and personnel time, as well as for data management costs. These reimbursements, which must be used to offset unit costs, should be reported as grant-related income. E. Investigators Any person with pediatric privileges at the grantee institution is eligible to utilize the PPRU resources for studies of drug efficacy or metabolism, supported from independent research funds, if the protocols have been approved and prioritized by the local PPRU Advisory Committee. These individual investigator protocols must not delay or interfere with pursuit of the collaborative studies that are the Units primary responsibility. For investigators inexperienced in clinical pharmacology, the PI is expected to provide advice and guidance. Clinical pharmacists are encouraged to participate in PPRU research in collaboration with physicians who bear the responsibility for patient care. F. Research Plan The scientific program at each PPRU should comprise three areas of investigation. The first priority will be the collaborative protocols agreed upon by the Network Steering Committee (see below); the second will be protocols performed for and with pharmaceutical companies; and the third will be the Unit's own investigator-initiated research protocols. For the inter-PPRU collaborative work, applicant institutions are asked to provide one or two examples of drug evaluation studies that they would propose to the Network Steering Committee (see below). These examples should be drafts (up to 1,500 words) for consideration by other participants in the program, but should include enough detail (proposal, rationale, significance, procedures, resources required, end points, power calculations, and discussion of feasibility) to allow reviewers of the application to evaluate them for scientific merit. For the collaborative work with industry, each applicant may include one or two examples of previous studies conducted with pharmaceutical organizations on the development of drugs for use in children. Alternatively, a protocol proposed for pursuit with industry participation may be presented, if a letter of interest from the proprietary organization is included. For the independent investigator work, each PPRU application should include one or two examples of research protocols on pharmacokinetics or pharmacodynamics in children that participating investigators intend to pursue if the PPRU is funded. These protocols should be presented in fewer than 1,500 words. Each should include a clearly identified hypothesis, brief background information, and a narrative of the procedures to be employed. They should include details of statistical design and enough additional specific material as necessary for a fair scientific review. In addition, each protocol should provide a brief justification of its need for PPRU resources. G. Nurse Coordinator A qualified nurse coordinator is one of the most important assets of a PPRU. The nurse coordinator reports to and takes direction from the PI, whether or not he or she is a member of the institution's nursing service. The nurse coordinator (in cooperation with the associate clinical pharmacologist) carries out as many parts of the research protocols as possible, dovetailing schedules for maximum efficiency and instructing and supervising the other nursing staff in those operations or procedures for which he or she is unavailable. He or she is responsible for data collection and organization, unless the latter responsibility is assigned to a data coordinator (see below). One or more individuals may be supported in the nurse coordinator position, at a total of one full-time equivalent (100 percent time and effort). H. Associate Clinical Pharmacologist Units may request support for salaries and fringe benefits for this position (maximum 50 percent time and effort). The associate clinical pharmacologist may be a physician who is fully trained in pediatrics, has completed subspecialty training, and wishes to gain experience in the conduct of pediatric pharmacology research under the guidance and supervision of the PI or some other appropriate person. Alternatively, the associate clinical pharmacologist may be a non-physician holding the Pharm.D. degree who has had special training in pediatric pharmacology and wishes to obtain additional supervised clinical experience. Support for the associate clinical pharmacologist from the PPRU is for research time and effort only, except that if this person is a licensed physician he or she may assist the PI in supervising patient care in the Unit. A qualified individual may be supported for up to two years as an associate clinical pharmacologist at a PPRU. I. Data Coordinator Each PPRU application should include information about the data management system to be used in the unit. The system must be satisfactory not only for support of local PPRU activities, but also for participation in collaborative studies being performed by the network, since each PPRU will serve in turn as the data coordinating center for collaborative protocols. If justified by the volume of work expected, a data coordinator may be supported (up to 25 percent time and effort) by a PPRU grant. This person will organize the data in preparation for transmission to other PPRUs when appropriate. These functions are critical to the success of the network. SPECIAL REQUIREMENTS Terms and Conditions of Awards The following terms and conditions of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Part 74, and other HHS, PHS, and NIH grant administration policies and procedures. The specific terms and conditions pertaining to the nature and scope of the interaction between NICHD staff and the participating PPRUs will be incorporated into the Notice of Grant Award and will be in addition to the customary programmatic and financial negotiations that occur in the administration of grants. Awardee Responsibilities Each PI will have primary responsibility to define objectives and approaches and to plan, conduct, analyze, and publish results, interpretations, and conclusions of his/her studies. For network collaborative protocols, this responsibility will be shared with other network members and the project coordinator. The awardees retain custody of and primary rights to the data developed under those awards, subject to government rights of access, consistent with current HHS, PHS, and NIH policies. Awardees must be willing to participate and collaborate with other awardees and with NICHD staff. NICHD Responsibilities The Project Coordinator (Medical Officer, Endocrinology, Nutrition and Growth Branch, NICHD) will assist in the identification of important areas for study; in the development of collaborative protocols; in the review and evaluation of each stage of study protocols before subsequent stages are started; and in the reporting of results to the scientific community. Network Steering Committee Responsibilities The Network Steering Committee (NSC) will consist of the PIs of the funded units and the Project Coordinator, NICHD, and will be chaired by an (non-voting) outside chairperson selected by the members. The committee will meet at least quarterly to review and select protocols to be performed collaboratively by the network and to exchange information on progress. The Steering Committee will collaboratively establish rules governing publication, analysis and inter-unit sharing of data. Arbitration Procedures Whenever agreement between an awardee and NICHD staff cannot be reached on programmatic and scientific issues that arise after the award, an arbitration panel will be formed. The panel will consist of one person selected by the PI, one person selected by the NICHD Project Coordinator, and a third person selected by these two members. The decision of the arbitration panel, by majority vote, will be binding. 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. Other Application Requirements A Safety Monitoring Committee will monitor the data from each ongoing collaborative clinical trial and advise on the safety of its continuation. This committee, to be selected by the Steering Committee, will include expertise in clinical trial design, pharmacology, epidemiology, statistics, and medical ethics. The availability of a pharmacy capable of supporting clinical research activities and experienced in the preparation of materials for randomized clinical trials should be documented. An explicit statement of the applicants' preparedness to participate in PPRU network clinical trials according to the terms of the RFA should be in the application, and evidence of a long-term institutional commitment to the needs of the PPRU is required. This may take various forms, including (but not limited to) the waiver of facility fees or bed costs for use of an outpatient clinic or research ward for patients on protocol; equipment and space for a core laboratory; released time for faculty to perform clinical pharmacology research in children; and/or funding for support personnel. Allowable Budgetary Items and Supportable Activities Allowable costs in NIH cooperative agreements are governed by rules set forth in the Public Health Service Grants Policy Statement and as stated on the Notice of Grant Award. Under these rules the PI may exercise flexibility to meet unexpected requirements by rebudgeting or requesting approval to rebudget among categories within the total direct cost budget of the PPRU (as shown on the Notice of Grant Award), within the ceilings set in these guidelines. PPU grants are for five years, at a maximum level of $250,000 in direct costs for the first year, with annual increments of 4 percent thereafter. They are renewable through competing continuation applications, provided funds are available. Items supportable through a PPRU cooperative agreement award may include: 1. Administration. Personnel: Principal investigator (maximum 25 percent time and effort); secretary (maximum 25 percent time and effort). Administrative Support Services: supplies, duplication costs, telephone. Travel: PI to meetings of the NSC. 2. Core Laboratory. Personnel: Core laboratory director (maximum 25 percent time and effort); core laboratory technician (maximum 50 percent time and effort). Equipment: Maximum of $50,000 total cost, distributed over the first four years of the award. Supplies: Appropriate for unit participation in collaborative protocols and for support of specialized analyses for investigator-initiated studies on the Unit Other: Maintenance costs on equipment purchased by the award or otherwise dedicated to Unit use. The maximum allowable total annual amount for supplies plus other in the core laboratory is $20,000. 3. Research Services Core. Personnel: Nurse Coordinator (maximum 100 percent time and effort); Associate Clinical Pharmacologist (maximum 50 percent time and effort); Data Coordinator (maximum 25 percent time and effort). The following items are not fundable through a PPRU grant: Costs of clinical care, such as patient bed costs, outpatient visit fees, and clinical laboratory determinations. These costs must be paid by the pharmaceutical companies for protocols performed on their initiative or by third-party carriers or other sources for investigator-initiated protocols. For Network protocols for which necessary ancillary costs cannot be paid from other sources, the NICHD will provide administrative supplements. Travel to scientific meetings or for any other purpose except for the PI to attend meetings of the NSC. Laboratory costs (outside the core laboratory) for projects being performed by investigators using the Unit. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF FEMALES 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 females 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 females 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 females 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 or racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in Sections 1-4 of the Research Plan and summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. 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 females 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 support submitted to NIH are required to address these policies. NIH funding components will not award cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by February 15, 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 NICHD 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: Ephraim Y. Levin, M.D. Endocrinology, Nutrition and Growth Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development Executive Plaza North, Room 637 Bethesda, MD 20892 Telephone: (301) 496-5593 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, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. 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. Applicants should follow the instructions included with PHS Form 398 except where these are at variance with instructions in this RFA. Since the generic guidelines were not prepared specifically to be used for PPRU cooperative agreement applications, considerable flexibility in application format will be tolerated. Applicants should take care, however, that adequate information is provided to allow reviewers to evaluate the application on the basis of the review criteria listed below. Since applicants will be proposing at least two research plans, the individual and the collaborative, the standard 25-page limit will not apply. For questions related to application format, applicants may contact one of the individuals under INQUIRIES. 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 Room 240, Westwood Building Bethesda, MD 20892** In addition to the application and copies mailed to the Division of Research Grants, two copies of the application must also be sent to: Susan Streufert, Ph.D. National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E01 Bethesda, MD 20892 Applications must be received by April 13, 1993. If an application is received after that date, it will be returned to the applicant. REVIEW CONSIDERATIONS Applications will be reviewed by the Division of Research Grants for completeness and by NICHD staff for responsiveness to the RFA. An incomplete or non-responsive application will be returned to the applicant. Responsive applications may be subjected to a triage by a peer-review group to determine the scientific merit relative to the other applications received in response to this RFA. The NICHD will withdraw from competition those applications judged to be noncompetitive and notify the applicants and institutional business officials. Applications considered responsive to this RFA will be reviewed for technical merit by an Initial Review Group convened by the scientific review staff of the NICHD solely to evaluate these applications. Criteria for the initial review are described below. Following review by the Initial Review Group, applications will be evaluated by the National Advisory Child Health and Human Development (NACHHD) Council for program relevance and policy issues before awards are made. REVIEW CRITERIA The following are the review criteria for the evaluation of PPRU applications: Qualifications of the core of experienced investigators in clinical pharmacology who have independent competitively-earned research support, a record of research productivity, and a demonstrated interest in pharmacological research in children. An explicitly stated willingness by these investigators to generate protocols to perform on the unit, propose protocols to the NSC for collaborative pursuit, and collaborate with pharmaceutical firms in testing useful drugs in children is required. Suitability of the proposed clinical locus for the Unit in the applicant institution or its affiliated hospital, such as a pediatric metabolic ward and outpatient clinic, a GCRC with staff accustomed to conducting studies in children, or some unit similarly staffed and equipped. Availability of a suitable population to participate as research subjects in PPRU studies. Qualifications of the PI for the duties described in this RFA. Scientific quality and relevance of the sample protocols proposed for pursuit in the Network and in the local PPRU. Evidence of previous successful research collaborations with industry or of efforts to arrange future collaborations. Nature, facilities, functions, and probable value to the research of any proposed core laboratory. Adequacy of data management resources available to support PPRU protocols. Evidence of institutional commitment to the long-term activities of the PPRU network. Composition of the proposed local advisory committee and its proposed procedures for evaluating protocols, monitoring ongoing research on the Unit, and recommending candidates for the associate clinical pharmacologist and other PPRU positions. Qualifications of the nurse coordinator proposed for support from the Unit and/or the criteria to be used in selecting a person for this position. Qualifications of the associate clinical pharmacologist (if any) proposed for support from the Unit and/or the criteria to be used in selecting a person for this position. AWARD CRITERIA The anticipated date of award is September 30, 1993. Awards will be made on scientific merit as determined by peer review. The availability of appropriate study populations, the extent of investigator experience, adequacy of equipment and facilities, and program balance will also be taken into account. Timetable Letter of Intent Receipt Date: February 15, 1993 Application Receipt Date: April 13, 1993 Initial Review Date: July 1993 Review by NACHHD Council: September 1993 Earliest Possible Award Date: September 30, 1993 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: Ephraim Y. Levin, M.D. Endocrinology, Nutrition and Growth Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 637 Bethesda, MD 20892 Telephone: (301) 496-5593 Direct inquiries regarding fiscal matters to: E. Douglas Shawver Supervisory Grants Management Specialist Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 505 Bethesda, MD 20892 Telephone: (301) 496-1303 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865, Research for Mothers and Children. Awards are made under authorization of the Public Health Service Act, Section 301 (42 USC 421), 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 Health Systems Agency review. From owner-sci-resources@net.bio.net Thu Nov 05 22:00:00 1992 Path: biosci!agate!ames!saimiri.primate.wisc.edu!usenet.coe.montana.edu!news.u.washington.edu!ogicse!das-news.harvard.edu!husc-news.harvard.edu!husc8.harvard.edu!mlevin From: mlevin@husc8.harvard.edu (Michael Levin) Newsgroups: sci.bio,bionet.sci-resources Subject: looking for a supplier of bio-related posters Message-ID: <1992Nov6.154326.17169@husc3.harvard.edu> Date: 6 Nov 92 20:43:26 GMT Distribution: usa Organization: Harvard University Science Center Lines: 10 Xref: biosci sci.bio:674 bionet.sci-resources:532 Nntp-Posting-Host: husc8.harvard.edu Does anyone know of a mail-order place to get posters of bio-related stuff? For example, I saw a poster someone had of a electron-micrograph of a drosophila head. I amm looking for posters of weird creatures, embryos, cells dividing, microphotographs, labelled neurons (like they have on the covers of develompental bio books), etc. If anyone knows of a place that sells posters of this sort of thing, please email to mlevin@husc8.harvard.edu. Mike Levin From owner-sci-resources@net.bio.net Mon Nov 09 22:00:00 1992 Path: biosci!uwm.edu!caen!destroyer!cs.ubc.ca!utcsri!torn!csd.unb.ca!mikemac From: mikemac@jupiter.sun.csd.unb.ca (Mike MacDonald) Newsgroups: sci.chem,sci.bio,sci.engr.biomed,bionet.sci-resources Subject: Looking for info on aldehydes Message-ID: <1992Nov10.021344.5627@jupiter.sun.csd.unb.ca> Date: 10 Nov 92 02:13:44 GMT Sender: Michael MacDonald Followup-To: mikemac@unb.ca Organization: University of New Brunswick Lines: 20 Xref: biosci sci.chem:784 sci.bio:716 sci.engr.biomed:61 bionet.sci-resources:533 I have a close friend who has been quite ill lately, it appears that it may be related to a low level exposure to one or more of the following aldehydes. 1) propionaldehydes 2) acetaldehydes 3) 2-methylbuteraldehydes 4) 2-methylpentaldehydes She is keenly interested in talking to someone (telephone style) who knows anything about the long term low level exposure to any and/or all of the above. Michael J. MacDonald Senior Systems Specialist Faculty of Computer Science University of New Brunswick P.O. Box 4400 Fredericton NB Canada E3B 5A3 Phone (506) 453 4566 Fax (506) 453 3466 From owner-sci-resources@net.bio.net Mon Nov 09 22:00:00 1992 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 - 8 November 1992 Message-ID: Date: 10 Nov 92 22:27:55 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 80 ** NEW DOCUMENTS ON STIS ** Document Type: General Publication Title: NSF92-99 - Gateway to Diversity in the Scientific and Technological Workforce File size (bytes): 266693 STIS Filename: nsf9299 Document Type: Program Guideline Title: NSF 92-111 - Human Resource Development for Minorities in Science and Engineering File size (bytes): 179276 STIS Filename: nsf92111 Title: NSF 92-120 - CISE Postdoctoral Research Associates in Computational Science and Engineering CISE Postdoctoral Research Associates in Experimental Science File size (bytes): 13914 STIS Filename: nsf92120 Document Type: Recruit Title: Director, Division of Polar Programs File size (bytes): 6947 STIS Filename: vep9216a Title: Dep. Dir., Div of International Programs File size (bytes): 6670 STIS Filename: vep931 Title: Physicist EX92-60 File size (bytes): 3437 STIS Filename: vex9260 Document Type: Report Title: NSF 92-112 - The Multinational Coordinated Arabidopsis thaliana Genome Research Project File size (bytes): 107051 STIS Filename: nsf92112 ------------------------------------------------------------------------ ** 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 nsf92112, the text of your message should be as follows: get nsf92112 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf92112, you would enter: ftp> get nsf92112 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet) or "pubs@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 Wed Nov 11 22:00:00 1992 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 21, no. 41, pt. 2a, 13 November 1992 Message-ID: Date: 12 Nov 92 18:17:13 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 875 $$XID NIHGUIDE 19921113 V21N41 P3O3 ************************************ Investigator or program director, as well as any participating investigators, will plan, direct, and perform the research. Applicants for program project grants should contact the NINDS representative listed below as early as possible in the planning stages. RESEARCH OBJECTIVES Background Millions of Americans suffer from recurrent headaches. For many, the headaches are of such severity that they are disabling. In addition to the profound effects on the quality of life for these people, the economic consequences are enormous. Some estimates are that headache sufferers seek medical care through over eight million visits to physicians or emergency rooms each year. Other estimates of the impact of this condition are that migraineurs alone lose over sixty million workdays a year. A major research goal of the NINDS, which is the responsible agency for neurological research in the Federal Government, is to understand the basic pathophysiology of headaches and to use this understanding to improve methods for treatment and prevention of recurrence. Headaches can be classified as vascular headaches, muscle contraction headaches, tension headaches, or inflammatory headaches, to mention but a few. Vascular headaches are thought to involve abnormal function of the brain's blood vessels or vascular system. The most common type of vascular headache is migraine headache, the cause of which is still not known. Migraine headaches are frequently characterized by severe pain on one or both sides of the head, nausea, and extreme sensitivity to light and noises. The two most prevalent types of migraine headache are the classic migraine and the common migraine. The major difference between these two types of migraine is that the victim of a classic migraine experiences an aura about 10 to 30 minutes before the onset of headache. This aura is the major prodromal neurological symptom and warning of the imminent onset of the classic migraine. The pain of a migraine headache is described as an intense, throbbing, or pounding pain in the forehead, temple, ear, jaw, or around the eye; these pains may continue for several days. The common migraine is not preceded by an aura; however, some people who are subject to the common migraine exhibit a variety of vague symptoms before the onset of the headache, such as mood shifts, fatigue, and abnormal retention of fluids. The pain of common migraine can also last several days, during which the victim may have nausea or vomiting. Research Goals and Scope Examples of investigator-initiated research grant applications for basic and clinical studies related, in the broadest sense, to the etiology, prevention, and treatment of recurrent headache, especially migraine headache, may include, but should not necessarily be limited to: o precise elucidation of the cellular and molecular events that cause or lead to headaches; o development of more specific clinical interventions for both prevention and treatment of migraine headaches, such as anti-platelet clumping drugs; more efficacious anti-serotonin drugs or other means of preventing or reducing the constriction of arteries; and site-specific anti-prostaglandins; o development of methods for precisely identifying the sequence of alterations in blood flow or vascular reactivity that may be an initiating factor for migraine; o identification of risk factors, or events, that predispose the migraineur to an attack, such as stress, allergies, diet, sleeping patterns, neuroses, personality type, and behavioral characteristics such as excitability and compulsiveness; o control of risk factors in relation to the prevention of a migraine headache; o longitudinal epidemiology of the distribution and inter-relation between risk factors and the predisposition to an attack of migraine headache; o determination of whether or not genetic factors predispose to migraines, and, if so, identification of the genetic locus with a view toward understanding the causative or contributory mechanisms and developing a means of preventing migraine headache; and o determination of the relation between hormones and migraine. 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 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 should be provided. The composition of the proposed study population must be described in terms of gender and racial or ethnic group. In addition, gender and racial or ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups; however, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of Unites States racial or ethnic minority populations: Native Americans (including American Indians or Alaska Natives), Asian or Pacific Islanders, Blacks, and 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 prevention 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 or ethnic minorities when it is important to apply the results of the study broadly. This directive 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' population, 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 the NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION AND REVIEW PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) according to the instructions included in the application package. These application packages are available at the offices of sponsored research of most institutions eligible to receive Federal grants and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. Applicants for program project grants should request, from the address below, a copy of the NINDS Guidelines: Program Project and Research Center Grants (rev. June 1992). Receipt dates for new research project grant applications and FIRST Awards (R01 and R29, respectively) and for program project and center grant applications (P01 and P50, respectively) are February 1, June 1, and October 1. FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. On page 1 of form PHS 398, check "yes" in Item 2a, enter the number of this Program Announcement in the space provided, and provide the name of this Program Announcement (Neurological Basis of Recurrent Headaches, Especially Migraine) in the blank space labeled "Title." Use the mailing label provided in the application package to mail the signed original and five exact copies to the Division of Research Grants. If the application is for a program project or center grant, please send the original and three copies to the Division of Research Grants. An additional two copies of the program project or center grant application sent to the address below would be useful for expediting the processing of these applications for multidisciplinary efforts. REVIEW CONSIDERATIONS Research project grant applications and FIRST award applications (R01 and R29, respectively) will be reviewed for scientific and technical merit by an appropriate study section in the Division of Research Grants. Program project grant and center grant applications (P01 and P50, respectively) will be reviewed according to the practice of the Institute to which the application is assigned. The second level of review will be by the appropriate National Advisory Council. The standard review criteria will be used to assess the scientific merit of applications. AWARD CRITERIA Applications will compete for available funds with all other applications. The following will be considered when making funding decisions: o quality of the proposed projects as determined by peer review o availability of funds o program balance among research areas INQUIRIES Questions concerning scientific aspects of this PA may be addressed to: Dr. George N. Eaves Division of Stroke and Trauma National Institute of Neurological Disorders and Stroke Federal Building, Room 8A13 Bethesda, MD 20892 Telephone: (301) 496-4226 FAX: (301) 480-1080 Questions concerning fiscal aspects of this PA may be addressed to: Ms. Kathleen Howe Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 Bethesda, MD 20892 Telephone: (301) 496-9231 FAX: (301) 402-0219 AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance, No. 93.853, Clinical Research Related to Neurological Disorders, and 93.854, Biological Basis Research in the Neurosciences. Grants will be awarded under the authority of the Public Health Service Act, Title IV, Section 301 (Public Law 78-410, as amended: 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR 74. This program is not subject to Health Services Agency review of the intergovernmental review requirements of Executive Order 12372. $$P5 END ************************************************************ $$P6 BEGIN PA-93-020 ************************************************ SMALL INSTRUMENTATION GRANTS PROGRAM NIH GUIDE, Volume 21, Number 41, November 13, 1992 PA: PA-93-020 P.T. 34; K.W. 0735000, 1002024, 0735015, 1014001 National Institutes of Health Application Receipt Date: February 10, 1993 PURPOSE The National Institutes of Health (NIH) has supported a Small Instrumentation Grants Program (SIP) since FY 1987 in response to several studies indicating that the state of biomedical research instrumentation had seriously eroded over the recent past and that this situation is retarding the progress of biomedical research. The most significant need identified in these studies is for the relatively low- cost pieces of equipment in the price range of approximately $5,000 to $60,000. Approximately $6 million will be available from the NIH in FY 1993 for the SIP. (As of October 1, 1992, the NIH was expanded to include the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse, and the National Institute of Mental Health and these three institutes will participate in this program.) ELIGIBILITY REQUIREMENTS Eligible organizations or organizational components are those domestic, non-profit organizations that: (1) received at least three NIH (including the three Institutes indicated above) research grants in the research grants base (defined below) totaling between $200,000 and $2,924,000 in FY 1992, and (2) have active NIH research grant support. The "research grants base" is defined as those grants awarded with the following activity codes: K01, K02, K04, K05, K06, K08, K11, K12, K14, K15, K16, K20, K21, P01, P40, P41, P42, P50, P60, R01, R03, R10, R21, R22, R23, R24, R29, R35, R37, R55, S06, S14, U01, U10, U24, U41, U42, and U54. MECHANISM OF SUPPORT The mechanism of support for this program will the small instrumentation program (S15). Applicants will be responsible for identifying and purchasing the equipment requested for use on active NIH research grants. APPLICATION PROCEDURES Only those organizations or organizational components receiving a LETTER OF INVITATION TO APPLY are eligible for a SIP award. These letters, which will contain application instructions, will be mailed on or about November 25, 1992. Only one application may be submitted from each eligible organization or organizational component, which may establish its own procedures for identifying equipment requests. Investigators interested in participating in their organization's or organizational component's application should contact the official responsible for completing the application. Those officials who expect to be involved in preparing an application should publicize the availability of SIP funds, so that investigators in need of small research instruments are provided the opportunity to indicate their needs for such equipment. The SIP award will be restricted to the purchase of equipment costing between $5,000 and $60,000. Awards will be made on or before September 1, 1993. The amount of the award will be based on a percentage of the organization's or organizational component's research grants base for FY 1992 or $5,000, whichever is greater. Organizations or organizational components will be notified of the maximum amount for which they may apply. Completed applications must be received by February 10, 1993. REVIEW CONSIDERATIONS Applications will be assigned to individual NIH Institutes and Centers for administrative review of the completeness of the application in accordance with the application instructions. Incomplete applications will be returned to the applicant without further consideration. Specific funding decisions will depend on available funds and the appropriateness of the request in relation to active NIH research grant support. INQUIRIES Issues NOT ADDRESSED in the application instructions may be addressed to: Research Training and Special Programs Office Office of Extramural Research National Institutes of Health Building 31, Room 5B44 Bethesda, MD 20892 Telephone: (301) 496-1968 FAX: (301) 496-0166 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.337, Biomedical Research Support. Grants will be available under the authority of and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 USC 241. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P6 END ************************************************************ ERRATUM $$E1 BEGIN P3 19921016 APPEND PAR-93-008 BOTH ************************** ACADEMIC AWARD IN VASCULAR DISEASE NIH GUIDE, Volume 21, Number 41, November 13, 1992 PAR NUMBER: PAR-93-008 P.T. 34; K.W. 0715040 National Heart, Lung, and Blood Institute This change is issued for PAR-93-008, Academic Awards in Vascular Disease which was published in the NIH Guide for Grants and Contracts, Vol. 21, No. 37, October 16, 1992). The fifth sentence under the section ELIGIBILITY REQUIREMENTS should read: "An individual institution may submit an application for a systemic vascular program OR an application for a pulmonary vascular program for a given receipt date." The NHLBI will accept only one application per institution, and will make only one award per institution. $$E1 END ************************************************************ $$XID RFA HL9310 HL-93-10 P1O1 ***************************************** ASTHMA ACADEMIC AWARD NIH GUIDE, Volume 21, Number 41, November 13, 1992 RFA: HL-93-10-L P.T. 34; K.W. 0715013, 0502024, 0785035 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 15, 1992 Application Receipt Date: February 17, 1993 PURPOSE The primary objective of this program is to stimulate the development and/or improvement of the quality of medical curricula, physician/patient/and community education, and clinical practice for the prevention, management, and control of asthma in the United States. 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), Asthma Academic Award, is related to the priority areas of diabetes and chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: 202-783-3238). ELIGIBILITY REQUIREMENTS Institutions Applications may be submitted by domestic universities or schools of medicine. Minority institutions and urban institutions from areas with high rates of morbidity of asthma that have the necessary resources and facilities and a commitment to providing the awardee with the time to develop and implement plans consistent with the goals of this announcement are encouraged to sponsor candidates for these awards. Candidates A candidate for an award must: o be an established physician and medical faculty member in an accredited school of medicine or osteopathy in the United States, its territories or possessions, and have competence in the management of asthma, and; o be employed by a school of medicine or osteopathy that is located in an area with high asthma morbidity, such as an institution located in an inner city; o have sufficient clinical training, research, and teaching experience in pulmonary medicine to develop and implement a high quality curriculum in asthma encompassing current knowledge and methods applicable to the control of asthma in individuals of all ages and to provide leadership in applied research in control of asthma; o be a citizen or non-citizen national of the United States or have been lawfully admitted to the United States for permanent residence at the time of application; Individuals who have held another National Institutes of Health (NIH) career development award (K series) are eligible to apply for the Asthma Academic Award. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA is part of the Academic Award Program (K07) of the National Heart, Lung, and Blood Institute (NHLBI). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years and is non-renewable. It is anticipated that support for this program will begin September 1993. A maximum of $50,000 for the salary of the awardee, plus applicable fringe benefits, a maximum of $20,000 for technical support, and indirect costs not to exceed eight percent may be requested. FUNDS AVAILABLE The estimated funds (total costs) for the first year of support for the entire program will be $300,000. It is anticipated that three to four grants will be awarded each year for five years under this program. The specific number, however, will depend upon the merit and scope of the applications received and the availability of funds. RESEARCH OBJECTIVES Background Asthma is a serious chronic condition, affecting approximately 10 million Americans. People with asthma experience over 100 million days of restricted activity annually, and costs for asthma care exceed $4 billion a year. Asthma morbidity and mortality rates are increasing. >From 1980 to 1987, the prevalence of asthma in the U.S. increased 29 percent, and the number of asthma deaths increased by 31 percent. Recent reports indicate that mortality from asthma has been rising since about 1968 in all age groups. In 1987, the overall death rate from asthma was 1.9/100,000 people with females slightly higher than males. Many of these deaths were considered to be largely preventable. The largest increase in asthma-related mortality has been among blacks, women, and persons over 65 years of age. Additionally, since about 1950 there has been a widening gap in the death rate from asthma between blacks and whites. The asthma mortality rate has been three times higher in black compared to white males and twice as high in black than in white females. Reduction of asthma morbidity has been identified as a new objective in the U.S. Health Objectives for the Year 2000. Considerable national attention is being directed at this problem, including the following major efforts. Considerable behavioral and education research has been conducted in the area of patient/family self management to complement and enhance medical treatment regimens, and these have yielded several effective educational programs for patients and their families. With representation from 30 governmental, professional, and voluntary health organizations, a National Asthma Education Program has been initiated to educate patients, the public, and health care providers about the disease. A major early accomplishment of this Program was the preparation and dissemination of the Guidelines for the Diagnosis and Management of Asthma. Yet, although asthma is a disease that generally can be controlled with expert medical treatment and self-management, many patients are not receiving state-of-the-art medical care and/or are not following the prescribed treatment plans. Special programs are needed to reach health care providers in areas remote from major medical centers and to reach minority and lower socioeconomic level patients in both inner city and rural areas. Multidimensional research conducted by multidisciplinary teams will be required to improve clinical practice and patient evaluation. Therefore, the aim of this program is to stimulate the development and/or improvement of the quality of medical education, patient and community education, research programs, and clinical practice focused on the control of asthma. Objectives The objectives of the Asthma Academic Award are to: o encourage the development of high quality curricula in schools of medicine that will significantly increase the opportunities for students, house staff, and others, to learn the principles and practice of preventing, managing, and controlling asthma; o develop and implement interdepartmental programs with common goals and standardize diagnostic and therapeutic approaches; o promote communication among specialists in primary care, allergy, and obstetrics and gynecology to ensure appropriate treatment of pregnant women with asthma; o encourage applied research in the control of asthma; o promote the development of a faculty capable of providing appropriate instruction in asthma; o provide for outreach programs from medical centers to health practitioners in the community to enhance optimal care, especially in areas of high asthma morbidity, such as inner city minority communities; o promote an institutional environment that facilitates an interchange of information and educational evaluation techniques about new diagnostic, therapeutic and prevention measures in asthma in both children and adult populations; o investigate coordinated clinical approaches to the care of patients of various ages and ethnic groups who have asthma, such as minorities, young children, and the elderly; o facilitate an interchange of ideas among awardees and institutions; and o contribute to the public health efforts to control asthma in the United States. Of particular interest are programs targeted to inner city populations and to rural areas that may be in need of education about asthma and among physicians who are or who will be caring for medically underserved populations. SPECIAL REQUIREMENTS Awardee Salary The salary requested for the awardee must not exceed the actual institutional salary rates, and must not exceed $50,000 plus fringe benefits. A candidate must spend at least 30 percent time on this award. An awardee may devote up to a total of 100 percent effort as an Academic Awardee and as Principal or participating Investigator on any other NIH-supported grant(s) or contract(s) and may receive remuneration from such grant(s) or contract(s) accordingly. Technical Support Technical support will be provided up to a maximum of $20,000 per year for the following: o personnel other than the awardee if required for the development of the program. Salaries will be allowable for technical and support staff and consultants. Student stipends are allowable for students conducting projects directly related to the award; o equipment costs are not allowable; o consumable supplies essential to the proposed program; o funds for educational development to enable the awardee to develop educational skills and to meet with other awardees to exchange ideas, methods, and program evaluations. Awardees may be requested to meet as a group up to two times a year. These meetings will promote collaborative efforts, provide for some needed technical support, and encourage an exchange of ideas among the awardees. Funds should be allocated for travel for the Principal Investigator to a midpoint in the country and the principal investigator must agree to participate in these meetings. Indirect Costs Awards will be provided for the reimbursement of actual indirect costs at a rate up to, but not exceeding, eight percent of the total direct costs of each award, exclusive of tuition, fees, and expenditures of equipment. Conditions of the Award Institutions may apply for awards on behalf of named individuals meeting the criteria for this award. Awards will be limited to one from each eligible school over the life of the award. After the first year, grants will be renewed for a maximum of four years on a non-competitive basis depending upon progress being made in meeting the program's objectives. An annual report will be required that summarizes activities relevant to curriculum development at the institution and other elements of the program plan and outlines future plans. This report will serve as the principal basis for renewal of the grant. The grant will be made annually for each of the five annual budget periods. Awards may not be transferred from one institution to another. If an awardee moves to another institution, the award will continue at the original institution only upon approval by the Division of Lung Diseases of a suitable replacement proposed by the grantee institution. Such a replacement will not lengthen the overall term of the award. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS Although the Asthma Academic Award is not primarily a mechanism to support research, some awardees may implement some research as a part of the overall Academic Award program. If any clinical research is proposed under this program, the policies of the NIH regarding inclusion of women and minority apply. NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. 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 December 15, 1992, a letter of intent that includes 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 NHLBI 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: James C. Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 548B Bethesda, MD 20892 Telephone: (301) 496-7383 APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Application kits are available at most institutional offices of sponsored research and may be 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) 496-7441. The title and number of the request for grant application must be typed on Line 2a of the face page of the application form and the "YES" box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: James C. Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 548B Bethesda, MD 20892 Applications must be received by February 17, 1993. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of 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 NIH staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NHLBI staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. The review includes an assessment of the written application and the letters of reference, and may be followed by an interview with the candidate in Bethesda, MD. Travel expenses for this interview must be paid by the applicant institution. The initial review will be conducted by a Special Review Committee, managed by the Division of Extramural Affairs, National Heart, Lung, and Blood Institute. The secondary review will be by the National Heart, Lung, and Blood Advisory Council. Applications for this Asthma Academic Award will be evaluated in terms of the following criteria: o the overall merit of the proposed five-year plan for improving the institution's interdepartmental curricula in asthma control; o access to a population with high incidence of asthma; o the qualifications and background of the candidate, including experience in teaching, curriculum development, and research; o the institution's commitment to implement the proposed curriculum and to continue a program in education about asthma control after the termination of the award; o the involvement of appropriate disciplines in the development, implementation, and evaluation of the program; o design and evaluation of educational interventions for health care providers and for patients with asthma, especially in areas with high morbidity from asthma, such as inner city minority communities; o plans for communication and cooperation between specialists in adult and pediatric pulmonary medicine, family practice, internal medicine, community medicine, and other specialties; o plans for collaborative projects with other organizations that have responsibility for and interest in asthma control, for example, health departments, medical and nursing associations, and voluntary health agencies; o the potential for the program making an impact on the control of asthma among populations served; o the potential for replication or adaptation of the program at other sites. AWARD CRITERIA The anticipated date of award is September 30, 1993. Factors that will be taken into consideration in making awards include the scientific merit of the proposed program, as evidenced by the priority score, and the availability of funds. Subject to the availability of necessary funds and consonant with the objectives of the Asthma Academic Award, the Division of Lung Diseases will provide funds for a project period up to five years. 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: Joan M. Wolle, Ph.D., M.P.H. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640 Bethesda, MD 20892 Telephone: (301) 496-7668 Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 496-4970 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants are made under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99-158, 42 US 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Wed Nov 11 22:00:00 1992 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 21, no. 41, pt. 5, 13 November 1992 Message-ID: Date: 12 Nov 92 18:18:19 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 985 $$XID RFA HL9309 HL-93-09 P1O1 ***************************************** TUBERCULOSIS ACADEMIC AWARD NIH GUIDE, Volume 21, Number 41, November 13, 1992 RFA: HL-93-09-L P.T. 34; K.W. 0715165, 0502024, 0785035 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 15, 1992 Application Receipt Date: February 17, 1993 PURPOSE The primary objective of this program is to stimulate the development and/or improvement of the quality of medical curricula, physician/patient/and community education, and clinical practice for the prevention, management, and control of Mycobacterial tuberculosis (TB) in the United States. 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), Tuberculosis Academic Award, is related to the priority areas of immunization and infectious diseases and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: 202-783-3238). ELIGIBILITY REQUIREMENTS Institutions Applications may be submitted by domestic universities or schools of medicine. Minority institutions and urban institutions from areas with high rates of incidence of TB that have the necessary resources and facilities and a commitment to providing the awardee with the time to develop and implement plans consistent with the goals of this announcement are encouraged to sponsor candidates for these awards. Candidates A candidate for an award must: o be an established physician and a medical faculty member in an accredited school of medicine or osteopathy in the United States, its territories or possessions, and have competence in tuberculosis and; o be employed by a school of medicine or osteopathy that is located in an area with high TB rates; o have sufficient clinical training, research, and teaching experience in the control of TB to develop and implement a high quality curriculum in TB encompassing current knowledge and methods applicable to the control of tuberculosis in individuals of all ages and to provide leadership in applied research in control of TB; o be a citizen or non-citizen national of the United States or have been lawfully admitted to the United States for permanent residence at the time of application; Individuals who have held another NIH career development award (K series) are eligible to apply for the Tuberculosis Academic Award. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA is part of the Academic Award Program (K07) of the National Heart, Lung, and Blood Institute (NHLBI). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years and is non-renewable. It is anticipated that support for this program will begin September 1993. FUNDS AVAILABLE The estimated funds (total costs) for the first year of support for the entire program will be $300,000. It is anticipated that three to four grants will be awarded each year for five years under this program. The specific number, however, will depend upon the merit and scope of the applications received and the availability of funds. A maximum of $50,000 for the salary of the awardee, plus applicable fringe benefits, a maximum of $20,000 for technical support, and indirect costs not to exceed eight percent may be requested. RESEARCH OBJECTIVES Background Despite major advances in our understanding of the pathogenesis, detection and treatment of tuberculosis, nearly 28,000 cases have been reported in the United States since 1984, the year when the lowest number of cases were reported. Currently, TB is spreading rapidly, especially in some population groups. From 1985 through 1990, the number of TB cases increased by 44 percent in the 25-44 year old age group. There was a 12 percent increase among Asians, a 25 percent increase among non-Hispanic whites, a 55 percent increase among blacks, and a 77 percent increase among Hispanics. There is also a high prevalence of TB among HIV infected patients. It is estimated that about 12 percent of all AIDS cases develop TB. HIV-associated TB has occurred in virtually all age groups, both men and women, all race/ethnic groups, and in all HIV-transmission categories, although the largest numbers of cases have occurred in intravenous drug users and homosexual/bisexual men. Other groups at high risk for TB include persons living or working in group or institutional settings such as hospitals and correctional facilities. More recently, there have been outbreaks of multi-drug resistant TB. These outbreaks are a dramatic manifestation of serious underlying problems in public and private efforts to control TB. Although considered "curable" since the development of effective chemotherapy in 1950, the TB problem has not been dealt with adequately. This has been attributed to a lack of sufficient awareness of the problem and inadequate resources, as well as clinical management errors and patient non-adherence to treatment regimens. The management errors include failing to diagnose and treat the cases in a timely manner, relying heavily on Isoniazide (INH) therapy even in patients likely to have INH-resistant organisms, using a single drug therapy, prescribing inappropriate drug dosages, and failing to isolate patients appropriately with infectious TB, thereby missing opportunities to prevent the spread of the disease. Surveillance has often been slow or incomplete. Noncompliance with treatment regimens for chronic diseases has been a major problem with approximately 50 percent not taking their medicine. A study in 1988 in New York City reported 89 percent of the patients at one hospital failed to complete therapy, more than half failed to keep their first clinic appointment, and within twelve months of discharge 27 percent of the patients had been readmitted at least once with confirmed active TB. The concept for this initiative originated with the Tuberculosis Education Planning Committee convened by the NHLBI in December 1991, which emphasized the need for increased efforts to educate health care workers, patients, and the public on tuberculosis, and recommended that public health officials identify populations and geographic areas in the community where tuberculosis screening programs should be intensified and conduct public education campaigns targeted to high risk populations to encourage symptomatic patients to seek prompt treatment. In addition, in 1987 the Department of Health and Human Services established an Advisory Committee (Council) for the Elimination of TB (ACET), and in 1992 a "National Action Plan to Combat Multidrug Resistant Tuberculosis" was published to complement and supplement the "Strategic Plan for the Elimination of Tuberculosis." These plans indicate the urgency to improve the control of TB in the United States. In summary, TB is spreading in the U.S., despite major advances in our ability to diagnose, treat, and prevent this disease, largely due to inadequate education of health professionals, patients and their families, and the community. Objectives The objectives of the Tuberculosis Academic Award are to: o encourage the development of high quality curricula in schools of medicine that will significantly increase the opportunities for students, house staff, and others, including practicing physicians, to learn the principles and practice of preventing, managing, and controlling TB; o encourage applied research in the control of TB; o encourage the development of a faculty capable of providing appropriate instruction in TB; o contribute to updating the knowledge and skills of practicing physicians and other health care providers in the community; o enhance the awareness of health care providers of the unique ethnic, cultural, socioeconomic, and medical dimensions of TB; o coordinate and collaborate with other community organizations to control TB in areas with high incidence of TB; o facilitate an interchange of ideas and methods among awardees and institutions; and o contribute to public health efforts to control TB in the United States. SPECIAL REQUIREMENTS Awardee Salary The salary requested for the awardee must not exceed the actual institutional salary rates, and must not exceed $50,000 plus fringe benefits. An awardee may devote up to a total of 100 percent effort as an Academic Awardee and as principal or participating investigator on any other NIH supported grant(s) or contract(s) and may receive remuneration from such grant(s) or contract(s) accordingly. Technical Support Technical support will be provided up to a maximum of $20,000 per year for the following: o personnel other than the awardee when required for the development of program. Salaries will be allowable for technical and support staff and consultants. Students stipends are allowable for students conducting projects directly related to the award; o equipment costs are not allowable; o consumable supplies essential to the proposed program; o funds for educational development to enable the awardee to develop educational skills and to meet with other awardees to exchange ideas, methods, and program evaluations. Awardees may be requested to meet as a group up to two times a year. These meetings will promote collaborative efforts, provide for some needed technical support, and encourage an exchange of ideas among the awardees. Funds should be allocated for travel for the Principal Investigator to a midpoint in the country and the Principal Investigator must agree to participate in these meetings. Indirect Costs Awards will be provided for the reimbursement of actual indirect costs at a rate up to, but not exceeding, eight percent of the total direct costs of each award, exclusive of tuition, fees, and expenditures of equipment. Conditions of the Award Institutions may apply for awards on behalf of named individuals meeting the criteria for this award. Awards will be limited to one from each eligible school over the life of the award. After the first year, grants will be renewed for a maximum of four years on a non-competitive basis depending upon progress being made in meeting the program's objectives. An annual report will be required that summarizes activities relevant to curriculum development at the institution and other elements of the program plan and outlines future plans. This report will serve as the principal basis for renewal of the grant. The grant will be made annually for each of the five annual budget periods. Awards may not be transferred from one institution to another. If an awardee moves to another institution, the award will continue at the original institution only upon approval by the Division of Lung Diseases of a suitable replacement proposed by the grantee institution. Such a replacement will not lengthen the overall term of the award. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS Although the TB Academic Award is not primarily a mechanism to support research, some awardees may implement research as part of the overall Academic Award Program. If any clinical research is proposed under the program, the policies of the NIH regarding inclusion of women and minorities apply. NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. 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 December 15, 1992, a letter of intent that includes 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 the Institute 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: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 548B Bethesda, MD 20892 Telephone: (301) 496-7363 APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Application kits are available at most institutional offices of sponsored research and may be 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) 496-7441. The title and number of the request for grant application must be typed on Line 2a of the face page of the application form and the "YES" box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 548B Bethesda, MD 20892 Applications must be received by February 17, 1993. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of 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 NIH staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NHLBI staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. The review includes an assessment of the written application and the letters of reference, and may be followed by an interview with the candidate in Bethesda, MD. Travel expenses for this interview must be paid by the applicant institution. The initial review will be conducted by a Special Review Committee, managed by the Division of Extramural Affairs, National Heart, Lung, and Blood Institute. The secondary review will be by the National Heart, Lung, and Blood Advisory Council. Applications for this Tuberculosis Academic Award will be evaluated in terms of the following criteria: o the overall merit of the proposed five-year plan for improving the institution's interdepartmental curricula in tuberculosis control; o the qualifications and background of the candidate, including experience in teaching, curriculum development, and research; o the institution's commitment to implement the proposed curriculum and to continue a program in education about tuberculosis control after the termination of the award; o the involvement of appropriate disciplines in the development, implementation, and evaluation of the program; o design and evaluation of educational interventions for health care providers and for patients with tuberculosis in areas with high incidence of TB; o plans for communication and cooperation between specialists in adult and pediatric pulmonary medicine, infections, and community medicine to ensure optimal treatment; o plans for collaborative projects with other organizations that have responsibility for and interest in tuberculosis control, for example, health departments, medical and nursing associations, and voluntary health agencies; o the potential of the program for making an impact on the control of tuberculosis among populations served; and o the potential for replication or adaptation of the program at other sites. AWARD CRITERIA The anticipated date of award is September 30, 1993. Factors that will be taken into consideration in making awards include the scientific merit of the proposed program as evidenced by the priority score and the availability of funds. Subject to the availability of necessary funds and consonant with the objectives of the Tuberculosis Academic Award, the Division of Lung Diseases will provide funds for a project period up to five years. 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: Joan M. Wolle, Ph.D., M.P.H. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640 Bethesda, MD 20892 Telephone: (301) 496-7668 Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 496-4970 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants are made under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99- 158, 42 US 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 DK9306 DK-93-06 P1O1 ***************************************** EXPLORATORY GRANTS FOR CENTERS OF EXCELLENCE IN MOLECULAR HEMATOLOGY NIH GUIDE, Volume 21, Number 41, November 13, 1992 RFA: DK-93-06 P.T. 34; K.W. 0785070, 1002058, 0780015, 1002045, 0760020, 1016003 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: January 31, 1993 Application Receipt Date: March 15, 1993 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Exploratory Grants for Centers of Excellence in Molecular Hematology, to be awarded competitively in Fiscal Year 1993. 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), Exploratory Grants for Centers of Excellence in Molecular Hematology, is related to the priority areas of 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 from domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, or medical centers. Applications from foreign institutions are ineligible for the center program mechanism. Applicant institutions must demonstrate an established research base in areas related to the RFA. Minority individuals and women are encouraged to submit as Principal Investigators. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included with the application. MECHANISM OF SUPPORT Support of this program will be through the NIH grant-in-aid Exploratory Grant (P20) 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 and in this announcement. Requests for support must be limited to no more than $20,000 in direct costs. Any application exceeding this amount will be returned to the applicant. Under certain circumstances, a no-cost extension of up to another 12 months can be requested. FUNDS AVAILABLE The NIDDK anticipates awarding five Exploratory Grants in Fiscal Year 1993 on a competitive basis, the awards will be for one year duration and contingent upon the availability of appropriated funds. It is anticipated that approximately $150,000 in FY 93 funds will be available for funding these awards. RESEARCH OBJECTIVE The objective of Exploratory Grants (P20) is to provide partial funding for the cost of planning and developing meritorious Centers of Excellence in Molecular Hematology. The anticipated awards for full scale Centers of Excellence in Molecular Hematology (P50) will be made in Fiscal Year 1994 or Fiscal Year 1995, contingent upon authorization and appropriation of funds, and will involve a separate nation-wide competition. It is important to note that the award of an Exploratory Grant does not imply a commitment by the National Institute of Diabetes and Digestive and Kidney Diseases to future funding of a Center of Excellence in Molecular Hematology planned with the support of an Exploratory Grant. Center applications will be reviewed on the basis of their own merit. A future announcement will be made for applications for Centers of Excellence in Molecular Hematology. At that time, any eligible institution may apply; funding decisions will not be based on previous award of an Exploratory Grant. Guidelines are available from the NIDDK that describe the Centers of Excellence in Molecular Hematology (P50), and the anticipated application process for the Centers. These guidelines should be requested from the program administrator identified in INQUIRIES before applying for an Exploratory Grant. Background Exploratory Grants are intended to provide partial support for the planning phase of a Center of Excellence in Molecular Hematology. Successful applicants thus would be better prepared to formulate appropriate programs in response to a later announcement by the NIDDK of a full-scale Centers (P50) announcement. The planning phase may consist of, but is not limited to: a. departmental and interdepartmental planning to integrate a broad spectrum of molecular hematology related activities; b. planning the establishment of specialized resources and facilities; c. feasibility surveys to identify special problems and opportunities; d. use of consultants to assist in developing plans for Center activities and core resources. Centers of Excellence in Molecular Hematology will allow development of the broad range of technologies involved in the investigation of genetic diseases and genetic therapy to be brought together in a unified effort. These technologies will draw on knowledge of viruses, cell culture, bone marrow cells, growth factors, animal models, and the molecular basis of genetic diseases. During the past two decades, major advances have been made in understanding the molecular basis for inherited diseases. The clinical and biochemical effects of diseases have been clarified, and, in an ever-increasing number of genetic disorders, the molecular defects have been described. Notable examples of this new knowledge are the genes for Cooley's anemia, sickle cell disease, and hemophilia. Application of sensitive biochemical and molecular techniques has made molecular diagnosis of these disorders a reality. Now, with these important diagnostic achievements in hand, even greater efforts must be directed toward development of technologies to formulate specific therapies for these debilitating disorders. The development of Centers as an organizational mechanism will promote the joint efforts both of basic scientists and clinical researchers toward the study of gene structure and function, the structural biology of proteins and the complex biochemistry of protein interaction, the cell and molecular regulation of blood cell formation, and clinical research to test the efficacy and safety of therapeutic strategies derived from basic investigation. These studies will have as their ultimate goal the development of somatic gene therapy or other means of treatment of genetic diseases. Concentration of efforts into the Center format will allow economies of scale and will generate technologies that can be applied by other investigators. The capability to design and implement strategies for clinical application of molecular genetic knowledge will be essential for the Centers. However, Center funds will not be available for full-scale clinical trials, and investigators will be encouraged to apply for support of clinical trials by alternative mechanisms. Due to the breadth of expertise in a variety of disciplines needed for successful application of molecular genetic technologies to genetic diseases, it is anticipated that such expertise may not be available at any one institution. Therefore, applicants are encouraged to propose consortium arrangements with other suitable institutions with needed expertise. Such consortia may include geographic separation, if acceptable plans for effective collaboration are proposed. Where appropriate, applicant institutions are strongly encouraged to develop relationships with traditionally minority institutions and investigators. 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 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. 09/91) 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, 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 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. LETTER OF INTENT Potential applicants are strongly encouraged to submit a letter of intent no later than January 31, 1993. The letter of intent is to include: (1) name of the Principal Investigator/program director and principal collaborators, (2) descriptive title of the potential application, (3) identification of the organization(s) involved, and (4) reference to RFA DK-93-06. The letter of intent is to be sent to the Chief, Review Branch, NIDDK, at the address noted below. 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 the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid conflict of interest in the review. APPLICATION PROCEDURES Applications are to be submitted on the form PHS 398 (rev. 09/91) available at most institutional offices of sponsored research and from the Division of Research Grants, National Institute of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, (301) 496-7441. For item 2a of the face page of the application, applicants should enter RFA: Hematology Exploratory Grants, RFA number DK-93-06. 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 to the extent that it may not reach the review committee in time for review. Applications must be received by close of business March 15, 1993. If an application is received after this date, it will be returned to the applicant. The original and three copies of the application must be sent or delivered to: Application Receipt Office 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: Robert D. Hammond, Ph.D. Chief, Review Branch, DEA National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 5333 Westbard Avenue Bethesda, MD 20892 The Division 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. Nor will the DRG 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. Special Application Instructions The written application is the basis for the merit review. Particular attention should be given to the format of the application. The standard instructions provided with the PHS 398 are designed primarily for applications for single research projects. Exploratory Grant applications require additional information as outlined below. Page limitations presented in the PHS 398 instructions should be followed closely unless otherwise noted. Program Narrative (PHS 398, Continuation Pages) The narrative must provide a description and plan of the Exploratory Grant program, and how the applicant intends to prepare for developing a Center program. The narrative must include an overall description of the envisioned Center as well as a description of each of the Center components. Appendices Follow instructions on page 24 of PHS Form 398. Budgetary Considerations - Allowable Costs Unless otherwise indicated, allowable costs and policies governing the research grant programs of the NIH will prevail. Overlapping support between the Exploratory Grant and other NIH grants and contracts to the applicant institution will be administratively reviewed and, if appropriate, will be adjusted to avoid duplication of funding. Support may be requested for salaries of professional, technical, and support personnel who contribute to allowable activities under the Exploratory Grant. The salaries derived from the Exploratory Grant will depend on the effort provided and institutional salary policies. Salaries of personnel engaged in administrative and planning activities are allowable cost items. Stipends for research fellows/trainees are not allowable. No overlap of time or effort between the Exploratory Grant and other, separately funded projects is permitted. Support for secretarial and administrative staff may be provided to the extent that their activities relate to administrative management of the Exploratory Grant activities, providing these costs have not been included in the institution's indirect cost pool. Expenditures for major equipment under this RFA will not be considered. General purpose equipment needs may be included and justified only after surveying the availability of such items within the institution. Consumable supplies directly related to the operation of the Exploratory Grant are allowed. These supplies principally will include office materials (if not included in the indirect cost pool). Research patient care costs are not required for Exploratory Grant purposes, and will not be provided. Domestic travel costs of Exploratory Grant personnel directly related to administrative and planning activities is allowable. Foreign travel will not be allowed except under unusual and compelling circumstances, and will require prior approval by the awarding agency. Costs for consultant services (consultation fees, per diem, travel) may be included. Costs associated with consultation or scientific or technical assistance, evaluation of planning activities, and development of new organizational arrangements and consortia are allowable. Costs for telephone, photocopying, and computer time are permitted. REVIEW CONSIDERATIONS Upon receipt, applications will be examined initially by the DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation of responsiveness to the program requirements and criteria stated in this RFA is an NIDDK staff function. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below and in the Centers of Excellence in Molecular Hematology Guidelines for Scientific/Technical Merit by an appropriate peer review group convened by the NIDDK. It is essential that the written application be in a form that can be reviewed on its own merit, since no site visit is anticipated. If the number of applications is large compared to the number of awards to be made, the NIDDK may conduct a preliminary scientific peer review to eliminate those applications that are clearly not competitive. The NIDDK will withdraw administratively from competition those applications judged to be noncompetitive, and will so notify the applicant and the institutional business official. Those applications judged to be both competitive and responsive to the RFA will be evaluated further, according to the review criteria stated below. Following initial merit review, the applications will be given a second-level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. The review of the Exploratory Grant applications will focus on scientific merit. Additionally, the component parts of the Exploratory Grant will be reviewed for their synergism and contribution to the future development of a Center. The evaluation will include the following review criteria: 1. Overall Program o The scientific merit of the program as a whole. The significance of the overall program goals and the development of a well-defined central focus. o The potential of the identified participants to develop interdisciplinary research programs of high merit as evidenced by previous accomplishments. o The balance of administrative and planning expenses. 2. Administration and Planning o The scientific and administrative leadership ability and experience of the Exploratory Grant Principal Investigator and his/her commitment and ability to devote adequate time to the effective management of the Center planning. o Maintenance of internal communication and cooperation among the investigators involved in planning for a Center. o Adequacy of the Advisory Committee to assess the scientific merit of the proposed Center plans. o Inclusion of an adequate mechanism for reviewing the proposed uses of Center funds. o Appropriateness and adequacy of plans for collaboration among the members of the proposed Center. o Appropriateness of the budget for the various components of the Exploratory Grant. 3. Scientific Expertise of Participants o Quality and appropriateness of expertise available at the applicant institution. o Nature and degree of interdisciplinary approach proposed to promote the collaboration of scientists with expertise in hematology with scientists in other disciplines. o Qualifications, experience, and evidence of commitment of the investigators within the applicant institution, and their willingness to interrelate with other elements proposed for the proposed Center. o Quality and appropriateness of collaborating institutions and research staff. o Proposed plans to recruit new expertise to the proposed Center. 4. Institutional Commitment o The institutional commitment to the program, including lines of responsibility for a Center and the institution's contribution to the management capabilities of a Center. o The degree of institutional contributions for administrative and planning activities. o The academic research environment and resources in which the activities would be conducted, including the availability of space, equipment, and facilities, and the potential for interaction with scientists from other departments and institutions. o The institutional commitment to any newly-recruited individuals responsible for conducting essential planning functions and activities. AWARD CRITERIA Applications will compete for available funds with all other applications submitted in response to this RFA and recommended by peer review. The following will be considered in making funding decisions: o Quality of the application as determined by peer review o Availability of funds o Overall program balance represented by the applications recommended by peer review Schedule Letter of Intent: January 31, 1993 Application Receipt: March 15, 1993 Initial Review: June-July 1993 Second Level Review: September 1993 Anticipated Award: September 30, 1993 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: David G. Badman, Ph.D. Hematology Program Director Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A-05 Bethesda, MD 20892 Telephone: (301) 496-7458 Direct inquiries regarding fiscal matters to: Ms. Nancy Dixon Grants Management Officer National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 637 Bethesda, MD 20892 Telephone: (301) 496-7467 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849 for DKUHD. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Wed Nov 11 22:00:00 1992 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 21, no. 41, pt. 3, 13 November 1992 Message-ID: Date: 12 Nov 92 18:14:29 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1080 $$XID RFA AI9212 AI-92-12 P1O1 ***************************************** WOMEN'S INTERAGENCY HIV STUDY NIH GUIDE, Volume 21, Number 41, November 13, 1992 RFA: AI-92-12 P.T. 34, II; K.W. 0715008, 0740075, 0411005, 0403004, 0785035 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: January 11, 1993 Application Receipt Date: February 18, 1993 PURPOSE The Vaccine Trials and Epidemiology Branch (VTEB) of the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for cooperative agreements for the establishment of a Women's Interagency HIV Study (WIHS) to investigate the clinical, laboratory, and psychosocial impact of human immunodeficiency virus (HIV) infection in women. The WIHS will use a multi-site, prospective study design to gather data on the clinical, immunological and behavioral aspects of HIV infection and disease in women. This study will investigate the full spectrum of clinical disease caused by HIV infection in women. It also will seek to determine the immunological factors and the cofactors which may be associated with HIV disease progression in women. 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), Women's Interagency HIV Study, 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. 017-001-10473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit research institutions; public and private organizations such as universities, colleges, hospitals or laboratories; units of State and local governments; and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Applicants must demonstrate the capability to recruit and maintain a minimum of 300 HIV-infected women and 75 HIV seronegative women with high risk behaviors for HIV; the proposed study cohort should reflect the socioeconomic, racial, and ethnic female populations infected with HIV in the US. MECHANISM OF SUPPORT Successful applicants funded under this RFA will be supported through Cooperative Agreements (U01). This type of funding mechanism is used when it is desired to encourage investigator-initiated research projects in areas of special importance to the NIAID and when programmatic assistance and involvement of NIAID staff would be beneficial to attain the desired research goals. This RFA represents a single competition with a specified deadline for receipt of applications. Reissuance of this RFA will be dependent on the state of science and findings at the completion of this cooperative agreement as well as the availability of funds. It is estimated that the total annual cost for an awardee with a study population of 300 HIV-seropositive women and 75 HIV-seronegative women could approach $1,000,000. It may be advantageous for applicants (including institutional consortia) to recruit significantly more than the minimum number of women when it would be cost effective. Awards will be made annually for a period of up to four years. Continuation of funding for each new annual budget period will be contingent on availability of funds, and will be based on satisfactory performance in recruitment and retention, success in protocol performance, and scientific productivity. Annual progress reports will be required and will include reports on recruitment, retention, and scientific productivity. Funding adjustments may be made based on study performance and changing NIAID research priorities. FUNDS AVAILABLE Approximately $5,000,000 will be available for funding the total costs of the WIHS during its initial year. The earliest possible award date is July 1993. The NIAID anticipates making two to five awards as a result of this RFA. The final number of awards to be made is dependent upon receipt of a sufficient number of applications of high scientific merit and the continuing availability of funds. RESEARCH OBJECTIVES Background The number of cases of Acquired Immunodeficiency Syndrome (AIDS) diagnosed in women has increased rapidly since 1985. As of December 1991, more than 21,000 cases of AIDS in women had been reported to the Centers for Disease Control (CDC) in sharp contrast to the approximately 1,100 women reported by the end of 1985. Approximately 100,000 American women are estimated to be infected with HIV-1. These numbers are expected to continue to increase throughout the 1990s. Major deficiencies remain in understanding the clinical, immunological, and virological spectrum of HIV disease and AIDS in women. Gynecological manifestations of HIV infection have not been sufficiently studied despite early results indicating their importance. There is also a growing body of evidence that other female genital and reproductive tract infections, such as vaginal candidiasis, pelvic inflammatory disease (PID), syphilis, herpes simplex virus-2 (HSV-2), and other sexually transmitted infections, are more severe and/or more common in women with HIV-induced immune dysfunction than in comparable groups of HIV-negative women. The rate and pattern of decline of CD4+ cells and factors which affect immune function in HIV-infected women have not been well-characterized. On the basis of these early reports, women-specific disease outcomes have been identified suggesting the need for a large-scale prospective study of HIV infection and disease in women to address the multiplicity of research questions within a single research design. Such information is critically important in designing and interpreting medical intervention research including trials of therapeutic interventions and vaccines. These data will be important in designing programs to improve access to and use of medical services by HIV-infected women. The primary purpose of this RFA is to develop a cooperative multi-site prospective epidemiologic study of the clinical, immunologic, virologic and behavioral aspects of HIV disease progression in women. The NIAID and CDC have jointly developed an organizational working arrangement for the HERS and for the transition phase incorporating the NIAID-funded WIHS sites. This organizational structure of an Executive Committee and Working Groups is intended to enable the NIAID WIHS sites expedite implementation of their cooperative agreements, while protecting the autonomy implicit in an assistance mechanism. The NIAID continues to play an active role in facilitating the HERS. The CDC and the NIAID have initiated the initial phase of this interagency prospective study of HIV-infected and uninfected women through the CDC's 1991 program announcement #115 (Federal Register, vol. 56, no. 65, Thursday, April 4, 1991), the HIV Epidemiology Research Study (HERS). Cooperative agreements have been awarded by the CDC to four clinical sites. For purposes of clarity in this RFA AI-92-12, the HERS sites will be referred to as the "CDC HERS sites", though it should be understood that they are part of the WIHS initiative. Accordingly, awardees of this RFA will be referred to as the "NIAID WIHS sites," and will be named by the WIHS Principal Investigators themselves after the cooperative agreements are awarded. A pilot study manual for this phase of the study has been developed by the CDC, NIAID, the four currently funded clinical sites, and an interim data center. Pilot studies of draft data collection instruments and procedures have been initiated including: (1) study subject identification and enrollment; (2) patient sociodemographic and health history; (3) physical examination; and (4) laboratory specimen collection and procedures. The current version of these materials will be provided to potential applicants upon written request to Dr. Sandra Melnick, Division of AIDS, NIAID (see INQUIRIES for address and FAX numbers). A Request for Proposals (RFP) for a Statistical and Clinical Coordinating Center (SACCC), which will support WIHS and other NIAID prospective studies, has recently been announced. So that applicants for cooperative agreements under this WIHS RFA are aware of the services to be provided by the SACCC, each prospective applicant will also be provided with a copy of the statement of work from the SACCC RFP. When new sites are awarded under this RFA, the awardees will review the study protocols to arrive at data collection procedures and instruments compatible with those of the HERS sites, and contribute to the development of new studies and procedures. The final study design could be a modular study design that may include both standardized modules (separate study protocols on a particular topic, consisting of standardized physical exam procedures and a questionnaire) to be used at all CDC HERS sites and NIAID WIHS sites, as well as separate modules for CDC HERS sites that differ from those modules used by the NIAID WIHS sites. During the course of the four-year study period, there may also be modules carried out at a single site. Plans for such site-specific modules are encouraged in this application (see Site-Specific Research Studies). Sample Size Goal The goal of the entire WIHS research effort is 2,500 HIV-seropositive women and a comparison group of 775 HIV-seronegative women who engage in activities that place them at high risk of acquiring HIV. The following table shows the sample size goals for the NIAID WIHS sites and the CDC HERS sites. NIAID WIHS sites CDC HERS sites Total 1,700 HIV(+) women 800 HIV(+) women 2,500 375 HIV(-) 400 HIV(-) 775 high risk women high risk women 2,075 women 1,200 women 3,275 RESEARCH OBJECTIVES The overall objectives of WIHS are to: o Determine the spectrum and course of the clinical manifestations of HIV infection in women, including those affecting the genital tract and oral cavity. o Determine the pattern and rate of decline of CD4+ cells in women and the relationship of CD4+ changes to other immunologic and virologic parameter, and to the clinical manifestations of HIV. o Investigate factors (e.g., infectious, treatment-related, nutritional, socioeconomic, drug-use related) that may delay or accelerate HIV-induced immune dysfunction and specific manifestations of HIV-associated clinical disease. o Study the factors influencing the length of survival and quality of life of women with HIV infection. Although the emphasis of this study is not on HIV transmission, follow-up of the initially seronegative group of women will be important to: o Determine the rate of incident HIV seroconversion and identify the factors that may increase the risk of incident HIV infection among a smaller cohort of high-risk women who are HIV-antibody negative at the time of study enrollment. o Access the feasibility of HIV vaccine trial initiation in high-risk HIV-seronegative women by assessing willingness to participate in vaccine efficacy trials. All applicants should provide plans and other evidence describing their capability to participate in this multicenter collaborative study. The Research Plan should be based on the approaches the applicant would take to participate in the WIHS including recommendations to refine the draft HERS procedures being provided to applicants. The Research Plan should address separately three components of WIHS: 1. Cohort Studies including o Recruitment, Retention, and Service Linkages. o Study Visits and Data Collection Including Interviews, Medical Histories, and Physical Examinations. o Laboratory Specimen Collection, Testing, and Storage. 2. WIHS Organization, Management, and Communications 3. Site-Specific Research Studies Each WIHS component is discussed separately in the following paragraphs. Cohort studies o Recruitment, Retention, and Service Linkages The applicant should provide a recruitment and retention plan with information regarding their access to, and ability to enroll and retain, a minimum of 300 HIV-infected women and 75 HIV-uninfected but high risk women into a prospective study of HIV-related disease outcomes. Adolescents (ages 15 to 18) may be recruited depending on local Institutional Review Board (IRB) requirements and applicable State laws. The suggested enrollment ratio of HIV-infected women to uninfected high risk women is five to one. Uninfected women should meet criteria for high-risk of acquiring HIV infection including current or recent injection drug or crack cocaine use and/or engaging in high risk sex (e.g., as a commercial sex worker, as a sexual partner to an injection drug user, and/or engaging in frequent heterosexual encounters that are not for money). Applicants should demonstrate their capability to enroll at least 300 HIV infected women and 75 uninfected high risk women by 18 months. At least 50 percent of the HIV infected women should be in later stages of HIV disease. The applicant's recruitment and retention plan should address the following elements: o Plans for community outreach, screening for cohort enrollment, HIV testing and counseling, and informed consent. o Evidence of capability to work with women who have substance abuse problems. o Identification of sources of study subjects, e.g., inpatient or outpatient units providing primary care or substance abuse treatment, HIV clinics and testing sites, referrals from community-based physicians or agencies, sexually transmitted disease clinics, and community-based clinics. o Description of procedures for assistance with and referral for non-protocol-related care. A strategy for interaction with community health care providers or agencies to handle referral of HIV-infected women in this study should be incorporated into the application. The cultural, ethnic, and language expertise of the staff to interact with community-based organizations and with women in their communities, or alternatively, the ability of the staff to interact with community-based organizations and with women in a culturally sensitive manner, should be described. o Provision of a detailed and specific plan for retention of study subjects, including, for example, a patient advocate or study nurse who provides continuity of care at visits, a small cash award, or reimbursement/vouchers for transportation expenses, on-site child care arrangements, culturally sensitive research staff, etc. Collaboration with community-based organizations is strongly encouraged to facilitate retention of women, particularly from socioeconomically disadvantaged backgrounds. All applicants should describe how clinical care will be provided to study participants, and describe the amount of primary care, if any, that will be provided by the research study staff to the study population. Clinical care costs directly associated with the WIHS protocols can be paid for under this award, when these are not covered by other sources. Proposed clinical facilities should have demonstrated experience in providing services to, or effective referral services for low-income cultural and ethnic minority groups and chemically dependent women. Applicants are encouraged to form linkages with other AIDS-related studies and services. Applications should include letters of agreement in the application that should be co-signed by the Principal Investigator of the applicant institution and each cooperating site. All letters should be explicit as to the intended purpose and role of the collaborating site or organization. See Appendices 5-13 for listings of contacts for AIDS-related services and studies, including: Contact List Appendix AIDS Clinical Trial Units (ACTUs), which comprise the AIDS Clinical Trials Group (ACTG) 5 Community Programs for Clinical Research on AIDS (CPCRA) 6 General Clinical Research Centers (GCRCs) 7 Research Centers at Minority Institutions (RCMIs) 8 Centers for AIDS Research (CFAR) 9 National Institute on Drug Abuse (NIDA) Cooperative Agreement Awardees 10 American Foundation for AIDS Research (AmFAR) Community-based Clinical Trials Network 11 AIDS Vaccine Evaluation Units (AVEUs) which comprise the AIDS Vaccine Evaluation Group (AVEG) 12 Health Resource and Services Administration (HRSA) Ryan White CARE Act Titles I & II Grantees 13 Applicants should describe plans for establishing, within two months of award, a Community Advisory Board (CAB). The purpose of the CAB is to foster interaction between the WIHS staff and HIV-infected women in the community, health care and other service providers, and other related community-based groups. (If an appropriate CAB is already in place, it is not necessary to establish a separated CAB for this project). Applications should describe the role and relationship of the CAB to the applicant institution. Applications should also specify the composition of the CAB, functions it will perform for the WIHS, and a proposed meeting schedule. Inclusion on the CAB of women, particularly those representing minority populations, to reflect the demographics of HIV-infected women in the catchment area may ensure representation of concerns of community members and patient advocates. o Study Visits and Data Collection including Interviews, Medical Histories, and Physical Examinations The applicant should submit a plan for initial and follow-up study visits. As stated above, the enrollment goal is at least 300 HIV-infected women and 75 uninfected women in the first 18 months of the study. The applicant should assume that the final WIHS procedures and data collection forms will be completed by the WIHS Executive Committee and Working Groups (see "2. WIHS Organization, Management, and Communication" below) within the first nine months after award of the WIHS cooperative agreements. The applicant's plan should be based on (1) the six WIHS objectives stated above and the associated suggested areas for study-wide data collection stated in Appendix 2 to this RFA and (2) a review the HERS study visit procedures and data collection instruments. The applicant's plan should address each of the six objectives and should include the applicant's recommendations for refinement of these HERS procedures and data collection instruments. Based on the HERS pilot study materials and possible refinements, a typical initial study visit could entail: (1) an interview; (2) a physical examination; (3) laboratory specimen collection; and (4) medical record extraction. The applicant should address their plans for conducting these initial visits as efficiently as possible. The applicants should base their plans for follow-up visits on the following considerations: (1) follow-up visits should be conducted every six months for all study participants; and (2) additional contacts (which may be short visits or phone calls) should be made to collect data on major clinical events between the regular 6-month visits for women who (a) have fewer than 350 CD4+ cells/ul at their last 6-month visit, (b) have AIDS-related clinical conditions, and/or (c) are pregnant. The applicant should discuss potential approaches to obtaining data between the regular six month visits. In preparing their plans and budgets for study visits, the applicants should consider possible attrition rates, reasons for attrition, and the implications for the study and study budgets. The applicant should assume that no study visits will be conducted during the final six months of the four year award period; that six month period will be devoted to ensuring that all study data have been completed, validated, and submitted to the SACCC. o Laboratory Specimen Collection, Testing, and Storage Applicants should submit a plan and budget for the collection and processing of WIHS study specimens. Certain specimens may be analyzed at the clinical research site and funded through this cooperative agreement. Other specimens may be obtained and shipped to central laboratories to establish consistency across sites. Applicants should review the draft HERS Laboratory Procedures and Data Collection Instruments and two appendices to this RFA: Appendix 3 for suggested components of the Laboratory Protocol and Appendix 4 for local and central processing of specimens (Appendix 4 is a summary of information from Appendix 3). Awardee laboratories will be required to participate in a quality assurance (QA) program. Funds are not available in this RFA for new laboratory equipment or for the expansion of facilities. Applicants are encouraged to make arrangements with other institutions if necessary to have adequate laboratory capabilities. The laboratory studies plan should provide documentation of the following: (1) prior experience with each proposed laboratory procedure; (2) facilities available for performance of laboratory procedures; (3) current quality assurance programs; (4) experience with multi-institutional prospective studies; and (5) facilities and processes for the storage and shipment of study specimens. The applicant's budget should be based on the information in RFA Appendices 3 and 4 and in the HERS draft procedures and data collection instruments. The applicant should address possible changes or improvements in the laboratory efforts that could be incorporated into WIHS with the approval of the WIHS Executive Committee. Site-specific research studies Access to significant numbers of clinical specimens from well-characterized study subjects will be a important resource for the support of research studies of HIV and AIDS-related issues. Applicants should propose site-specific research studies that will investigate issues associated with one or more of the major objectives of WIHS (stated above) and the associated suggested areas for study-wide data collection presented in Appendix 2 of this RFA. These proposed research studies should take advantage of samples and data generated under the WIHS protocols. Research that does not require the use of WIHS samples, WIHS data, or WIHS study subjects will not be supported by this RFA; applicants for such research are encouraged to seek funding through other funding sources and mechanisms. SPECIAL REQUIREMENTS Terms and conditions Special Requirements Under the Cooperative Agreement Successful applicant(s) funded under this RFA will be supported through Cooperative Agreements. Within a cooperative agreement, a partnership relationship exists between the recipient of the award and the NIAID. Each party to this partnership within the WIHS will have rights and responsibilities as well as a defined working relationship. Awardee Rights and Responsibilities The WIHS Principal Investigators will be responsible for directing the research efforts of the WIHS, as well as the conduct of the studies performed at their respective clinical sites. As a group (the Executive Committee), WIHS investigators will identify scientific objectives and research hypotheses, arrive at mutually-agreed upon data collection instruments and physical exam protocols, and verify that the data collection instruments will meet the objectives and produce high quality data. Investigators will implement the protocols and the data collection instruments, and be responsible for ensuring patient accrual. WIHS investigators will hold leadership positions in the Executive Committee, on the Working Groups, and ad hoc committees, thereby providing the direction for the study. These responsibilities will also include overseeing study design, data analyses, and presentation of results according to Executive Committee policies. WIHS site performance during each budget period will determine the subsequent budget awards. Applicant institutions are reminded that adequate protection for human subjects in research is an essential requirement for the NIH. Awardee institutions, each subordinate entity to the Awardee, and each performance site, whether institutions or independent investigators, should agree that the rights and welfare of human subjects involved in research under this cooperative agreement shall be protected in accordance with 45 CFR 46. As a condition of award, not as a condition of application, applicants and affiliated performance sites are required to designate an Institutional Review Board (IRB) and possess an applicable assurance of compliance which has been approved by the Office for Protection from Research Risks (OPRR) of the NIH. Applicants will be notified if additional information is required on this matter. NIAID Rights and Responsibilities The NIAID staff will assist the WIHS Principal Investigators through a Program Official who will be designated by the Chief of the Vaccine Trials and Epidemiology Branch of NIAID's Division of AIDS. The NIAID Program Official will have overall responsibility to assure the scientific and technical integrity of the project on behalf of the Institute. It is again emphasized that the role of NIAID will be to act as a facilitator and not to direct the activities of the WIHS investigators. It is anticipated that decisions aimed towards achieving the research objectives of the WIHS project will be made by the Executive Committee. NIAID staff will assist the WIHS awardees by o Providing scientific and technical assistance in the development of research plans, data collection methods, analyses and reporting. o Providing technical support in areas including statistical and data collection, analysis, and publication through the SACCC. o Providing logistical and other support services for meetings of the Executive Committee and Working Groups. o Preventing duplication of efforts among WIHS sites, other WIHS grantees, and other related NIAID projects by overseeing efforts of all the sites, and other NIAID projects. o Coordinating research reagents and technologies used by WIHS sites to achieve standardization. The NIAID will establish an arbitration process to resolve any difference of opinion between the awardee and the NIAID with regard to programmatic decisions on scientific-technical matters. An arbitration panel, composed of one WIHS awardee designee, one NIAID designee, and a third designee with expertise in the relevant area and chosen by the other two, will be formed to review any scientific or programmatic issue that is significantly restricting progress. While the decisions of the Arbitration Panel are binding, these special arbitration procedures will 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. Cooperative Agreements are subject to the administrative requirements outlined in OMB circulars. All pertinent HHS, PHS, and NIH grant regulations, policies and procedures, with particular emphasis on PHS regulations at 42 CFR Part 52 and HHS regulations at 45 CFR Parts 74 and 92, are applicable. These special terms and conditions pertaining to the scope and nature of the interaction between NIAID and the investigators will be incorporated in the Notice of Grant Award. However, these terms will be in addition to, not in lieu of, the customary programmatic and financial negotiations which occur in the administration of cooperative agreements. WIHS Organization, Management, and Communication The planned organizational structure for WIHS and the current organizational structure for HERS are presented in Appendix 1 to this RFA. In that appendix, the roles of the Executive Committees and Working Groups for both WIHS and HERS are outlined. Executive Committee. To ensure that the WIHS addresses questions of the highest scientific priority and to provide leadership and direction for the study, WIHS Principal Investigators, and the NIAID WIHS Program Official will be members of the Executive Committee with voting privileges. The Principal Investigator from the SACCC and one program official from each Federal agency contributing funds to the project will participate as ex officio members of the Executive Committee. This organizational structure of an Executive Committee and Working Groups is intended to enable the NIAID WIHS sites to expedite implementation of their cooperative agreements while protecting the autonomy implicit in an assistance mechanism. The Executive Committee will develop general WIHS policies concerning: subcommittee or Working Group structure and membership; publications; access to data; interim data monitoring; agendas for group meetings; protocol and questionnaire development; evaluation of WIHS performance; and schedule and content of WIHS meetings. Most importantly, the Executive Committee will be charged with the establishment of overall scientific priorities. Working Groups. Within this cooperative framework, clinical staff may participate in study-wide Working Groups and contribute to the broader study goals outside of the sphere of their own clinical center. These Working Groups will have responsibility for the development of a research agenda for specific topic areas, for developing and modifying modules (specific clinical physical examination and laboratory specimen collection procedures) to address that agenda, assess the progress in specific topic areas, and publish the results of collaborative study findings. These activities will be conducted according to procedures and standards developed and/or overseen by the Executive Committee. While the CDC HERS sites and NIAID WIHS sites will each have their own Executive Committee, it is the intention of NIAID and CDC Program Officials to encourage the merger of the two Executive Committees, or develop other collaborative arrangements, as soon as is practical and desirable. Applicants should review the material in Appendix 1 with particular reference to the Working Groups which have been established for the HERS study. Given the objectives and scope of WIHS, applicants are requested to recommend Working Groups for WIHS, to state why these specific Working Groups will be needed, and to identify which proposed staff would be recommended as members of each Working Group. Applicants are also asked to recommend an approach which could be taken during the first nine months after the award of WIHS to use the Executive Committee and Working Groups structure to develop final data collection procedures and instruments. Study-wide data management issues Data Management and Study Coordination The WIHS will be assisted by the SACCC, contracted by the NIAID, to provide extensive technical and logistical support. This contract will: 1) provide statistical expertise and data analysis, in conjunction with the Executive Committee; 2) establish and administer an effective and responsive data management system; and 3) assist with the design and implementation of educational and training activities involving data quality assurance, including clinical training for the staff performing physical examinations at the WIHS clinical sites. Each applicant will be sent a copy of the work statement from the Request for Proposals (RFP) for the SACCC so that the applicant can be aware of the full range of services to be provided by the SACCC. Applicants may plan for either: o On-site data entry, using a data entry module that will be developed by the SACCC. Computer tapes or diskettes containing files of the data entered on site will be sent to the SACCC. OR o Central data entry by photocopying and retaining copies of completed data collection instruments on site, and sending the originals to the SACCC for data entry. Inconsistencies discovered by the SACCC and reported to the sites will be the responsibility of the sites to resolve regardless of whether they elect on-site or central data entry. Selection of either option does not preclude the participation of the site investigators in any of the above activities, including statistical analyses of their own data. At a minimum, applicants should have equipment available for computer-to- computer electronic mail communications and report generation. This equipment should be dedicated for WIHS-related operations, and should include: o IBM compatible 386/33 microcomputer. o Monochrome or color VGA display. o Minimum of 40 megabyte hard disk, 2 megabyte memory, (dual 3.5" and 5" drives are recommended). o Hayes compatible 9600 baud modem. o Hewlett-Packard IIIP or comparable laser printer. o WordPerfect word processing software, version 5.1. o ProComm Plus or compatible communications software. Reporting Requirements, Access to Data, and Publication of Research Findings In addition to the reporting requirements currently in existence for awardees of traditional NIH research project grants, the following apply: o Site-Specific Data WIHS awardee institutions will generate data that will be submitted to the SACCC as explained above. In most cases, these institutional data will represent a subset of the total database for a given protocol. These data may have limited value or may have substantial independent scientific value for specific research questions. The WIHS Executive Committee may establish policies encouraging or limiting publication of such site-specific institutional data as appropriate for a given circumstance. These institutional data will remain the property of the awardee. o Study-Wide Data The total database for the WIHS core protocol will come from all funded sites, including the HERS sites. While physically located at the SACCC, the use and publication of the data will be governed by policies established by the Executive Committee. Working groups will be established to define research questions of interest, coordinate data analyses, and determine publication policies and dissemination of findings. NIAID Program staff, in collaboration with the EC, (or Program staff from other Federal funding agencies) may have access to data generated under this cooperative agreement. Information obtained from the data may be used by NIAID for the preparation of internal reports on WIHS activities. However, the awardees will retain rights to the data. Publication policies will be established by the Executive Committee. Publication of major findings is the responsibility of the Executive Committee in accordance with these policies. Publication or oral presentation of work performed under this agreement will require appropriate acknowledgement of NIAID support. Specific instructions This section supplements the instructions for preparing a grant application, form PHS 398 (rev. 9/91). Additional information is provided on the organization of the application to accommodate a multi-component studies. The cooperative agreement application should be assembled and paginated as one complete application. Research Plans Separate research plans are required for each of the three WIHS components: (1) Cohort Studies; (2) WIHS Organization, Management, and Communications; and (3) Site-Specific Research Studies. o Component 1 - Cohort Studies. As part of items 1-4 of the Research Plan section of the PHS 398 form, applicants should present their plans for the required cohort studies including: (a) recruitment, retention, and service linkages; (b) study visits and data collection; and (c) laboratory specimen collection, testing, and storage (see pages 14-18 of the RFA). This section may not exceed 20 pages in length. A separate PHS 398 page 2, titled "Component 1 - Cohort Studies", should precede this section. o Component 2 - WIHS Organization, Management, and Communications. In place of items 1-4 of the Research Plan section of the PHS form 398, applicants should present their plans for participation in central WIHS activities (see RFA pages 21-22. This section may not exceed five pages in length. A separate PHS 398 page 2, titled "Component 2 - WIHS Organization, Management, and Communications" should precede this section. o Site-Specific Research Studies. For each proposed research study, the applicant should complete the Research Plan section of the PHS 398 (see RFA page 18). Items 1-4 of the Research Plan should be limited to 10 pages with emphasis on "1. Specific Aims" and "4. Research Design and Methods" since much of the background and significance will be discussed in the cohort studies section of the application. A separate PHS 398 page 2, with the title of each proposed research study, should precede each proposed study. Budgets An overall composite budget for all components of WIHS must be submitted by the applicant on pages 4 and 5 of the PHS 398 form. The composite budget must be the sum of separate itemized budgets for each component of WIHS; the itemized budgets for each component should immediately follow the composite budget. A separate itemized budget (PHS 398 form pages 4 and 5, renumber appropriately) must be completed for the following components of WIHS: o Cohort Studies. The budget for the cohort studies should be based on (a) the applicants proposed number of study subjects including estimated retention rates; (b) the visits, exams, and laboratory studies presented in the draft HERS protocols; (c) supplies to carry out the study activities; and (d) computer equipment. NOTE: Budget justification should include a breakdown of laboratory costs (i.e., cost per test). On-site laboratory costs charged to this grant must be the actual cost of the test. Applicants must include cost of shipping those tests that will be processed at a central laboratory (see Appendix 4). NOTE: Although applicants are encouraged to recommend refinements in the HERS protocols, the budget should be based on the current HERS design. o WIHS Organization, Management, and Communications. The budget for this component should address personnel involved in carrying out study activities, and travel/meeting information should be based on the assumptions presented on pages 26 and 27 of the RFA. Travel costs for meetings other than those related to the conduct of the WIHS will not be covered by this award. o Site-Specific Research Studies. A separate budget must be prepared for each proposed research study, using pages 4 and 5 of the PHS 398 kit (renumbered appropriately). For budget purposes, applicants should assume the following: Executive Committee. While the actual number and scheduling of the Executive Committee will be determined by the Principal Investigators, for budgetary purposes, assume there will be two one-day meetings per year of the Executive Committee during the first nine months of WIHS to develop, review, and make final WIHS policies and procedures prior to, or during the initial phase of, enrollment of the study subjects. Assume that there will be a third one-day meeting of the Executive Committee at the end of the first year of WIHS. Assume that three of the meetings will be held in Bethesda, MD and two will be held in Atlanta, GA. Assume that participants from each awardee will include the Principal Investigator and one other senior staff member. For the second through fourth years of WIHS study, assume there will be three one-day Executive Committee meetings per year. Assume that two of the meetings will be held in Bethesda, MD and one in Atlanta, GA. These meetings are intended to provide a forum for the Executive Committee(s) and working groups (see below) to review research findings, define research activities, and discuss and resolve issues. Meetings will include the Principal Investigator and one other senior staff member from each funded site. Assume that the Executive Committee will also hold conference calls twice monthly for the duration of the project. Working Groups. While the actual number and content of the Working Groups will be decided by the Executive Committee, assume there will be seven Working Groups. Assume that each awardee will have one staff member from his/her clinical sites on each Working Group. During the first nine months of the WIHS awards, assume that each Working Group will meet two times for two-day meetings; one meeting to be held in Bethesda, MD and one meeting to be held in Atlanta, GA. Although the purposes of these meetings will be specifically determined by the Executive Committee, the general goal will be to provide a forum to review and discuss refinements and changes to the protocols for approval by the Executive Committee. Assume an additional two-day meeting will take place at the end of the first year of the WIHS in Bethesda, MD. During the second through fourth years of the WIHS study, assume there will be three two-day meetings annually of each Working Group. In addition, assume all working groups will hold conference calls twice monthly. 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 adult males and females. 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 should be described in terms of racial/ethnic group. In addition, racial/ethnic issues should be addressed developing a research design and sample sizes appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Asian and Pacific Islanders, African Americans/Blacks, Hispanics/Latinos, and Native Americans, which includes American Indians and Alaskan Natives). 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 tissues from 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 further review or consideration by the NIH. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of 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 elements will not award grants or cooperative agreements that do not comply with these policies. NOTE: This study fully meets the requirements for inclusion of women because it is exclusively comprised of female subjects. LETTER OF INTENT Prospective applicants are asked to submit, by January 11, 1993, a letter of intent that includes a descriptive title of the proposed research and 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. The letter of intent is requested in order to provide an indication of the number and scope of applications to be reviewed. The letter of intent does not commit the sender to submit an application, nor is it a requirement for submission of an application. The letter of intent is to be sent to: Dr. Sandra L. Melnick Vaccine Trials and Epidemiology Branch Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building Room 2A28 6003 Executive Boulevard Bethesda, MD 20892 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these cooperative agreements. These forms are available from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland, 20892, telephone 301/496-7441. 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, WOMEN'S INTERAGENCY HIV STUDY, RFA AI-92-12 should be typed on line 2a of the face page of the application form and the "YES" box should be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed, identical single-sided photocopies, in one package, to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 5333 Westbard Avenue Bethesda, MD 20892** At the time of submission, two additional copies must also be sent directly to: Dr. Dianne Tingley Division of AIDS Division of Extramural Activities National Institutes of Allergy and Infectious Diseases Solar Building, Room 4C16 6003 Executive Boulevard Bethesda, MD 20892 Applications must be received by both the Division of Research Grants (DRG) and Dr. Tingley by February 18, 1993. Applications received after February 18, 1993 will be returned to the applicant without review. The DRG will not accept any application in response to this announcement that is virtually identical to 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, however, the submission of substantial revisions of previously reviewed applications which are suitably tailored to the guidelines and requirements expressed in this RFA. Applications that are not received as a single package from the principal investigator will be judged non-responsive and will be returned to the applicant. Applications must also conform to the instructions contained in PHS 398 (rev. 9/91), with the exceptions that the research plan and page length limitations for the usual grant applications are modified as stated in the RFA. Applications that do not follow the prescribed font sizes outlined in form 398 will be judged non-responsive and will be returned to the applicant. Applicants should use standard, easily readable printer/typewriter fonts; it is not in the self-interest of an applicant to submit an application that is hard to read or that exceeds the above page length limitations. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed DRG for completeness and by NIAID review staff for responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is complete, but is judged not responsive to the RFA, it will be returned to the applicant without further consideration, though the applicant may then submit a revision, within page length limitations of PHS 398 (rev. 9/91), for review as unsolicited, investigator-initiated research at the next DRG review cycle. A triage may be performed by a peer review group to determine relative competitiveness of applications responding to this RFA. 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 for award will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Disease Council in June 1993. The earliest possible award date is July 1993. The following criteria will be considered in the review of the applications: o Demonstration of the applicant's willingness and capability to participate in this multicenter study. o Adequacy of applicant's plan for achieving the recruitment and retention goals. o Adequacy of the plans for linkages with and utilization of other AIDS-related studies and services, including the requisite plans for establishing or utilizing a Community Advisory Board. o Adequacy of applicant's plan for refining and implementing HERS study visit procedures and data collection forms. o Adequacy of applicant's plan for collecting and distributing or analyzing laboratory specimens. o Adequacy of applicant's plan for participation in central WIHS activities (Executive Committee and Working Groups). o Adequacy of applicant's plan for any site-specific studies. Applicant must demonstrate that each proposed site-specific research study will use WIHS study participants, specimens, or data, alone or in some combination. o The professional qualifications and the scientific experience of the Principal Investigator and key personnel responsible for various aspects of the clinical and research investigations proposed. o Adequacy of the administrative and organizational structure that facilitates attainment of the objectives of the program, including arrangements for internal quality control, allocation of funds, day-to-day management, internal communications, and cooperation among the investigators, contractual agreements, and replacement of the Principal Investigator on an interim or permanent basis. INQUIRIES Direct inquiries pertaining to programmatic issues and for copies of HERS materials and the statement of work from the SACCC RFP, and the Appendices of the RFA to: Dr. Sandra Melnick Vaccine Trials and Epidemiology Branch Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2A28 6003 Executive Boulevard Bethesda, MD 20892 FAX: (301) 402-1506 Direct inquiries pertaining to fiscal and policy matters to Ms. Jane Unsworth Chief, AIDS Grants Management Section/GMB/DEA National Institutes of Allergy and Infectious Diseases Solar Building, Room 4B25 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7075 FAX: (301) 480-3780 Direct inquiries pertaining to the review process and review requirements to Dr. Dianne Tingley Division of AIDS Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C16 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-0818 FAX: (301) 402-2638 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856, Microbiology and Infectious Disease Research and No. 93.855 Immunology, Allergic and Immunologic Diseases Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52, 45 CFR Part 74, and 45 CFR Part 92. 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 Wed Nov 11 22:00:00 1992 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 21, no. 41, pt. 2, 13 November 1992 Message-ID: Date: 12 Nov 92 18:13:46 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1500 $$XID NIHGUIDE 19921113 V21N41 P2O3 ************************************ 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 is a one-time solicitation. However, if it is determined that there is a sufficient continuing program need, the NCI will invite recipients of awards under this RFA to submit competitive continuation cooperative agreement applications for review according to the procedures described in Review Considerations, Part A. FUNDS AVAILABLE Approximately $1,500,000 in total costs per year for four years will be committed to specifically fund applications submitted in response to this RFA. It is anticipated that six to nine individual awards will be made to one to three consortia. This funding level 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 four years. Although this program is provided for in the financial plans of the NCI, the award of cooperative agreements pursuant to this RFA is also contingent upon the continuing availability of funds for this purpose. RESEARCH OBJECTIVES The primary goal of this initiative is to stimulate clinical research in the treatment of primary CNS malignancies in adult patients by providing support for consortia of institutions to perform Phase I and II clinical evaluations of promising new chemotherapeutic or biologic agents. A secondary goal is to utilize the consortia as a mechanism for sharing human brain tumor specimens among investigators conducting laboratory studies relevant to the biology, clinical behavior, or therapy of CNS tumors, particularly malignant gliomas. Clinical trials will take advantage of new developments in drug and radiation resistance, radiation sensitization, biological response modification, immune modulation, induction of apoptosis, differentiation induction, therapeutic irradiation techniques, induction or suppression of specific gene function, or other innovative approaches. Each CNSC will be formed for the purpose of: (1) sharing expertise of researchers in multiple disciplines; (2) conducting joint phase I and II clinical trials to provide adequate patient populations and timely completion; and (3) sharing of tumor specimens and data useful in the conduct of clinical pharmacologic and correlative laboratory studies. Participant institutions in the proposed consortium may be involved in clinical trials and/or laboratory studies. It is anticipated that one to three consortia will be established, comprising three to nine institutions. Each CNSC will select the specific agents to be tested in accord with their scientific interest and expertise and will develop a series of appropriate Phase II or Phase I trials with supporting protocol documents. Each applicant CNSC should submit as examples one or more draft clinical protocols as supplements to the Central Operations Office/Coordinating Center (Project Leader) and the participant institution applications. The CNSC, along with the assistance of the NCI Program Director, will develop a plan for prioritization of investigational trials. The NCI may provide NCI-sponsored IND agents or provide assistance to the awardee(s) by sponsoring or cross-referencing INDs for selected agents. Each CNSC must have documented numbers of patients with CNS tumors and a history of accrual of patients to clinical trials adequate for two-six phase I or II trials (60-180 patients) per year. It is expected that all of the CNSC institutions together will be able to complete approximately six phase I or phase II trials (180 patients) per year. In addition, proposed consortia must have: (1) adequate radiotherapy support for clinical trials utilizing radiation in combination with other modalities; (2) adequate central data collection and processing capabilities as well as biostatistical expertise; (3) adequate pathology support for both institutional tumor classification and central neuropathology review and for banking and distribution of tumor tissues for concurrent and future laboratory studies; (4) mechanisms to collect and store patient specimens for laboratory studies being conducted by institutions in the CNSC; (5) expertise in antineoplastic drug pharmacology/pharmacokinetics. The correlative laboratory research program in a CNSC should address at least one field of research into the biology of human malignant gliomas with some potential for future clinical relevance. Examples of research fields for laboratory studies include: molecular genetics and cytogenetics, gene function and expression, signal transduction pathways, radiobiology, growth regulation, metabolism, differentiation and gene modulation by investigational agents, intracellular metabolism, mechanisms of drug resistance in tumor cells, CNS pharmacokinetics, invasion and spread, cytokine production or interactions, immune function and antigen expression, or other aspects that may have clinical implications or lead to new therapeutic approaches. Investigators are not limited to the above areas of laboratory experimentation. Correlative laboratory studies need not be directly related to individual clinical Phase I/II trials but should attempt to utilize the large clinical database that will be generated by the consortium to identify potential correlates of tumor behavior, and laboratory studies should be based on strong and testable hypotheses. A clear rationale should be given for the experimental design and technological methodologies selected. Preliminary data from appropriate tumor models or analysis of patient specimens should be provided to support the feasibility of each study. The laboratory assays must utilize tumor specimens from patients and there should be an established plan for prioritization of specimen distribution to collaborating laboratories. Participating institutions primarily involved in laboratory studies may accrue patients on CNSC clinical trials if the minimum clinical resources are in place (See ELIGIBILITY REQUIREMENTS). The cooperative approach outlined in this RFA allows for interactions among successful applicants, with the assistance of NCI extramural staff, to perform Phase I and Phase II trials of anticancer agents and ancillary laboratory studies. This mechanism retains the decision-making prerogatives of the Principal Investigator and his/her colleagues, but at the same time, permits the active participation of NCI in research activities. (See TERMS OF COOPERATION) 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. Applications without such documentation will not be accepted for 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 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 January 15, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Project Leader, 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 is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Richard Kaplan 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, Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda, MD 20892, telephone (301) 496-7441; and from the NCI Program Director named below. The Central Operations Office/Coordinating Center as lead institution should submit a research grant application in which they should list the anticipated participant institutions, and include proposed clinical protocols in the Appendix. (The Central Operations Office/Coordinating Center application must be a separate document from any application from a participant institution; if a single institution will be applying for both participation in clinical and/or laboratory studies and as the Central Operations Office/Coordinating Center, two applications will be necessary.) Each participant institution should submit an individual research grant application and should indicate the Central Operations Office/Coordinating Center of the CNSC consortium in which they intend to participate. Participant institutions conducting clinical trials should include copies of the proposed CNSC clinical protocols in the Appendix. The grant application should describe the nature of their participation and justify budget requests for the protocols. Applications must be received by March 10, 1993. If an application is received after that date, it will be returned. 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 Review Procedures Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. Applications that are judged non-responsive will be returned by the NCI. An application judged to be non-responsive to this RFA may be submitted as an investigator initiated regular research grant (R01) or program project grant (P01) at the next receipt date. The application would require modification in accordance with either the R01 or P01 guidelines. The new application would not be considered an application for a Cooperative Agreement, nor would it be considered a response to an RFA. Questions concerning the relevance of proposed research to the RFA may be directed to program staff as described in the INQUIRIES section below. Applications may be triaged by an NCI peer review group on the basis of relative competitiveness. The NCI will withdraw from further competition those applications judged to be noncompetitive for award and notify the applicant and institutional business official. Those applications judged to be both competitive and responsive will be further evaluated, using the review criteria stated below, for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review will be provided by the National Cancer Advisory Board. AWARD CRITERIA The anticipated date of award is September 1993. In addition to the technical merit of the application, NCI will consider how well the CNSC and participant institutions met the goals and objectives of the program as described in the RFA. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not specific proposed research would be responsive are strongly encouraged and may be directed to program staff listed below. The program staff welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues and requests for the RFA to: Dr. Richard Kaplan, Senior Investigator Cancer Therapy Evaluation Program National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 Direct inquiries regarding fiscal matters to: Ms. Katharine Schulze National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 16 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.395, Cancer Treatment Research. Awards are made under the authorization of the Public Health Service Act, Title IV Sections 301, 410, and 411, Part A (Public Law 78-410, 42 USC 241 as amended, Public Law 99-158, 42 USC 285a) 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 Agency review. $$R8 END ************************************************************ $$R9 BEGIN DK-93-06 FULL-TEXT *************************************** EXPLORATORY GRANTS FOR CENTERS OF EXCELLENCE IN MOLECULAR HEMATOLOGY NIH GUIDE, Volume 21, Number 41, November 13, 1992 RFA AVAILABLE: DK-93-06 P.T. 34; K.W. 0785070, 1002058, 0780015, 1002045, 0760020, 1016003 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: January 31, 1993 Application Receipt Date: March 15, 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) invites applications for Exploratory Grants for Centers of Excellence in Molecular Hematology, to be awarded competitively in Fiscal Year 1993. 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, Exploratory Grants for Centers of Excellence in Molecular Hematology, is related to the priority areas of 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 from domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, or medical centers. Minority individuals and women are encouraged to submit as Principal Investigators. Applications from foreign institutions are ineligible to apply. MECHANISM OF SUPPORT Support of this program will be through the NIH grant-in-aid Exploratory Grant (P20) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Except as otherwise stated in this announcement, awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. The anticipated awards will be for one year duration. Requests for support must be limited to no more than $20,000 in direct costs. Any application exceeding this amount will be returned to the applicant. FUNDS AVAILABLE The NIDDK anticipates awarding five Exploratory Grants in Fiscal Year 1993 on a competitive basis, contingent upon the availability of appropriated funds. It is anticipated that approximately $150,000 in FY 93 funds will be available for funding these awards. RESEARCH OBJECTIVES The objective of Exploratory Grants (P20) is to provide partial funding for the cost of planning and developing meritorious future Centers of Excellence in Molecular Hematology. Centers of Excellence in Molecular Hematology will allow development of the broad range of technologies involved in investigation of genetic diseases and genetic therapy to be brought together in a unified effort. These technologies will draw on knowledge of viruses, cell culture, bone marrow cells, growth factors, animal models, and the molecular basis of genetic diseases. During the past two decades, major advances have been made in understanding the molecular basis for inherited diseases. Application of sensitive biochemical and molecular techniques has made molecular diagnosis of a significant number of genetic disorders a reality. Now, with these important diagnostic achievements in hand, even greater efforts must be directed toward development of technologies to formulate specific therapies for these debilitating disorders. The development of Centers as an organizational mechanism will promote the joint efforts both of basic scientists and clinical researchers toward the study of gene structure and function, the structural biology of proteins and the complex biochemistry of protein interaction, the cell and molecular regulation of blood cell formation, and clinical research to test the efficacy and safety of therapeutic strategies derived from basic investigation. These studies will have as their ultimate goal the development of somatic gene therapy or other means of treatment of genetic diseases. STUDY POPULATIONS It is NIH policy that women and minorities must be included in clinical study populations unless there is a good reason to exclude them, and the study design must seek to identify any pertinent gender or minority population differences. 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 Potential applicants are strongly encouraged to submit a letter of intent no later than January 31, 1993. The letter of intent is to include: (1) name of the Principal Investigator/program director and principal collaborators, (2) descriptive title of the potential application, (3) identification of the organization(s) involved, and (4) reference to RFA DK-93-06. 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 the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Disease Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 496-7083 APPLICATION PROCEDURES Applications are to submitted using form PHS 398 (rev. 9/91), available in the business or grants offices 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 301-496-7441. 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 of 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. AWARD CRITERIA The anticipated date of award is September 30, 1993. The criteria to be used in the review of applications and the award of grants are discussed in the RFA. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Direct inquiries about programmatic issues and request for copies of the RFA to: David G. Badman, Ph.D. Hematology Program Director Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A-05 Bethesda, MD 20892 Telephone: (301) 496-7458 Direct inquiries regarding fiscal matters to: Ms. Nancy Dixon Grants Management Officer National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 637 Bethesda, MD 20892 Telephone: (301) 496-7467 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849 for DKUHD. 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. $$R9 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-92-111 ************************************************ MINORITY HIGH SCHOOL STUDENT RESEARCH APPRENTICE PROGRAM NIH GUIDE, Volume 21, Number 41, November 13, 1992 PA NUMBER: PA-92-111 P.T. 34, FF; K.W. 0710030, 0720005 National Center for Research Resources Application Receipt Date: December 1, 1992 PURPOSE The National Center for Research Resources (NCRR), National Institutes of Health (NIH), currently plans to continue and expand the Minority High School Student Research Apprentice Program (MHSSRAP) in 1993. The purpose of the program is to provide minority high school students with a meaningful experience in various aspects of health-related research in order to stimulate their interest in careers in science. In FY 1993, the program is expanding the science teacher initiative to include not only in-service elementary, middle, junior, and senior high school teachers, but also potential K-12 science teachers in pre-service education programs. Eligible teachers will still be those who are members of a minority group or who teach a significant number of minority students. Teachers may participate in the program for a second year. The hands-on summer research project must be structured to update the teachers' knowledge and skills in modern research tools and techniques as well as to strengthen their teaching skills. The experience should provide teachers the opportunity to bring back to the classroom a sense of the excitement of research that would stimulate students to pursue scientific careers. A longer range goal is to establish year round linkages between pre-service and in-service science teachers, elementary and secondary school students, and biomedical researchers. Please note, however, that expansion of the program in FY 1993 is contingent on the availability of appropriated funds. Thus, allocations may be reduced below the amount requested in the application. Upon recommendation of the National Advisory Research Resources Council, the NCRR will give preference in making awards to those institutions that can support a summer program having a "critical mass" of at least five or six students. ELIGIBILITY REQUIREMENTS Eligible institutions are those that were eligible for a Biomedical Research Support Grant award in FY 1992 or are awardees of the Minority Biomedical Research Support (MBRS) Program. ALL ELIGIBLE INSTITUTIONS, INCLUDING THOSE NOT CURRENTLY OR PREVIOUSLY FUNDED UNDER THE MHSSRAP, ARE STRONGLY ENCOURAGED TO APPLY. Only one application for the Apprentice Program may be submitted by a component of an institution that is BRSG-eligible in FY 1992 and the recipient of an MBRS award. Under-represented minority students and teachers are defined as individuals who identify themselves as Black, Hispanic, Native American, Pacific Islander, or any particular ethnic or racial group which has been determined by the grantee institution to be under-represented in biomedical or behavioral research. Participants eligible for support must be U.S. citizens or have a permanent visa. Eligible students are those who are enrolled in high school during the 1992-1993 academic year. (Students who will graduate from high school in 1993 are eligible, as is a student who participated in a previous year provided he/she is still enrolled at the high school level.) MECHANISM OF SUPPORT The mechanism of support for this program will be the NIH grant-in-aid (S03). Awards will be for one year beginning March 1, 1993, contingent upon availability of appropriated funds. Support will be provided at a level of $2,000 for each student apprentice, $3,000 for each pre-service teacher, and $5,000 for each in-service science teacher. Applications may request both students and teachers or students only. No indirect costs will be paid. Direct support must be as salary; stipends are not allowed. Funds allocated may also be utilized for supplies, extending the research experience, or if adequate funds exist, for the addition of a student apprentice. However, funds from these grants may only be used for the costs of the apprentice program. The Program Director is responsible for the recruitment and selection of the apprentices and science teachers and assignment of each to an appropriate investigator. Students. Recruitment and selection of students must emphasize factors including the student's motivation, ability, scholastic aptitude, and accomplishments. In addition, consideration must be given to science teachers' recommendations and, whenever possible, the degree of parental commitment. Assignments must be made to investigators involved in health-related research who are committed to increasing the high school student's understanding of research and the technical skills needed. Teachers. Recruitment and selection criteria for in-service teachers must include: experience and teaching responsibilities, level of interest in participating in a research program, expected impact on their teaching programs, ability to stimulate minority students to pursue scientific careers, and future plans for continued interaction with the research institution. Potential teachers should be enrolled in pre-service programs and have an expressed interest in teaching life sciences at the K-12 level. APPLICATION PROCEDURES The application consists of (a) a letter stating the justification for the number of student and teacher positions requested (preference will be given to those institutions with a demonstrated commitment and a documented history of encouraging students to pursue scientific careers) and (b) the original and one signed and completed copy of the face page, page 4 "Detailed Budget for First 12-Month Budget Period Direct Costs Only," and checklist page of the grant application form PHS 398 (rev. 9/91). The required pages of the PHS 398 application form must be completed according to instructions provided in the PHS 398 (rev. 9/91) kit except for the following: Face Page Item 1 - Leave blank. Items 2a and 2b - Check the box marked "YES" and type in the number and title of this Program Announcement. Items 4 and 5 - Not applicable; do not complete. Item 6, Dates of entire proposed project period - Enter 03-01-93 through 02-28-94. Item 7 and 8 - Insert the total dollar amount of the request, which is the sum, from application page 4, of the number of student positions requested times $2,000 per student; the number of pre-service teachers requested times $3,000; and the number of in-service teachers times $5,000. No indirect costs will be provided; thus the direct and total costs will be the same. Item 14, Organizational component to receive credit towards a Biomedical Research Support Grant - Use this space to enter the code on which eligibility for this MHSSRAP application is based (no credit will be given for the S03 application). Also use this space to enter the BRSG and/or MBRS grant number(s) if available. Page 4, "Detailed Budget for First 12-Month Budget Period Direct Costs Only" - Using ONLY the Other Expenses category, enter on separate lines the number of students requested at $2,000 per student; the number of pre-service teachers requested at $3,000 per teacher; and the number of in-service science teachers requested at $5,000 per teacher. Enter the sum of the amounts requested for each under the "TOTALS" column for the Other Expenses category and under "Total Direct Costs for First 12-Month Budget Period" at the bottom of the page. The original and one copy of the student and teacher report(s), signed by the Program Director, must be submitted with the renewal application by December 1 so that the data contained in these reports can be used by NCRR to decide about policies and future funding for the MHSSRAP. These reports must also be submitted at the same time even if renewal support is not requested. All reports, including the Financial Status Report, must be submitted to the NIH by the grantee institution no later than May 31, 1993, unless an extension of the budget period end date has been authorized in writing. Applications must be received by December 1, 1992 by: Office of Grants and Contracts Management National Center for Research Resources Westwood Building, Room 849 5333 Westbard Avenue Bethesda, MD 20892 (Do NOT mail the application to the Division of Research Grants, NIH.) INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Marjorie A. Tingle, Ph.D. Director, Biomedical Research Support Program National Center for Research Resources Westwood Building, Room 10A-11 5333 Westbard Avenue Bethesda, MD 20982 Telephone: (301) 496-6743. Direct inquiries regarding fiscal matters to: Ms. Mary V. Niemiec Office of Grants and Contracts Management National Center for Research Resources Westwood Building, Room 849 5333 Westbard Avenue Bethesda, MD 20982 Telephone: (301) 496-9840 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.337, Biomedical Research Support. Grants will be awarded under the authority of the Public Health Service Act, Section 301 (a)(3); Public Law 78-410 (42 USC 241) as amended, and administered under PHS grants policies and Federal Regulations 45 CFR 74 and the Guidelines for Minority High School Student Research Apprentice Program. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P1 END ************************************************************ $$P2 BEGIN PA-93-016 ************************************************ MOLECULAR AND CELLULAR BIOLOGY OF METASTATIC TUMOR CELLS NIH GUIDE, Volume 21, Number 41, November 13, 1992 PA: PA-93-016 P.T. 34; K.W. 0715035, 1002004, 1002008 National Cancer Institute PURPOSE The National Cancer Institute (NCI) invites exploratory/developmental grant applications to study the molecular and cellular biology of metastatic tumor cells. This special initiative is designed to promote collaborations and facilitate scientific interchange between investigators, one with experience in the biology of metastasis and the other in a more basic scientific discipline such as molecular or cellular biology, or biochemistry. Therefore, prospective Principal Investigators need to identify a research collaborator. 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), Molecular and Cellular Biology of Metastatic Tumor Cells, 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 foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) exploratory/development research grant (R21). Applicants will be responsible for the planning, direction, and execution of the proposed project. Awards will be administered under PHS policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990 and in this PA. The Exploratory/Developmental Research Grants program (R21) provides limited funds for short-term research projects. These grants provide an opportunity for initiating studies that may be preliminary in nature. Research investigators in relevant fields are invited to apply for these grants in order to develop preliminary data that could form the basis of future research project grant (R01) applications. The Principal Investigator must be accountable to the recipient organization officials for the proper conduct of the project. The research collaborator must be named and time and effort listed on the budget page. The recipient organization is legally responsible and accountable to the PHS for performance and financial aspects of the grant-supported activity. FUNDS AVAILABLE The direct costs per year for each application funded by the NCI must not exceed $50,000. The total project period for applications submitted in response to this PA may not exceed two years and is not renewable. Applicants are advised to contact other relevant funding components regarding their funding policies. RESEARCH OBJECTIVES The goal of this initiative is to provide funds for preliminary research projects that will form the basis of future R01 applications to investigate metastasis. The intent is to (1) foster collaborative research between investigators with basic molecular and cellular biological and biochemical research experience, and those with experience in metastasis research, and (2) increase the number of laboratories and investigators addressing issues of metastasis. The scope of the research may encompass the application of any aspect of molecular and cellular biology and biochemistry to the investigation of metastasis biology. Applications should be for preliminary data gathering or pilot feasibility studies, and should be founded on the combined research experience of the Principal Investigator and his/her collaborator. The application should specifically address how the application meets the intent of the initiative, e.g., the development of a new collaboration between an investigator with basic molecular and cellular biological and biochemical research experience and one with experience in metastasis research. Furthermore, the research collaborator should address how the proposed research will relate to and integrate with other ongoing research in his/her laboratory. Just as the initiative is intended to foster a research collaboration, the application itself should clearly be the product of in-depth discussions and input from both the research collaborator and the Principal Investigator. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. Applications will be accepted at the three regular application deadlines as indicated in the application kit. These forms are available at most institutional offices of sponsored research; from the Office of Grant Inquiries, Division of Research Grants (DRG), National Institutes of Health, Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda, MD 20892, telephone 301/496-7441; from the NCI Program Director named below. 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 exact copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892 REVIEW PROCEDURE Upon receipt, applications will be reviewed by the DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Those applications judged to be complete will be further evaluated for scientific and technical merit by study sections of the DRG. Following the scientific and technical review, the applications will receive a second level of review by the appropriate national advisory council. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following factors will be considered when 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 PA. The following additional factors will be considered for applications assigned to the NCI: o In order to increase the number of laboratories and investigators with potential for a long-term commitment to metastasis research, preference in funding will be given to those investigators that are early in their research careers o The extent to which the proposed research develops collaborations that address the purpose of the initiative o How the proposed research relates to and integrates with other ongoing research in the research collaborator's laboratory INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Suresh Mohla Chief, Cancer Biology Branch National Cancer Institute Executive Plaza South, Room 630 Bethesda, MD 20892 Telephone: (301) 496-7028 FAX: (301) 402-1037 Direct inquiries regarding fiscal and administrative issues to: Robert Hawkins Grants Management Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800 ext. 13 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No.93.396, Cancer Biology. Awards are under authorization of the Public Health Service Act, Title, IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive order 12372 or Health Systems Agency review. $$P2 END ************************************************************ $$P3 BEGIN PA-93-017 ************************************************ OXIDATIVE DAMAGE, ANTIOXIDANT DEFENSE, AND AGING NIH GUIDE, Volume 21, Number 41, November 13, 1992 PA: PA-93-017 P.T. 34; K.W. 0710010, 0765035, 0760070, 0765025 National Institute on Aging PURPOSE Free radical damage has long been believed to be a risk factor for the degenerative processes that accompany aging in a variety of animal species ranging from insects to humans. The free radical theory of aging was proposed by Denham Harman in 1956, and much research since then has been directed towards establishing correlations among oxidative damage, antioxidant defense systems, aging and life span. Although a few modest correlations have been observed, efforts to move beyond correlative evidence, e.g., using antioxidant manipulations in animal and cell culture models to attempt to extend maximum life spans, have yielded few definitive results. Nevertheless, evidence continues to accumulate about the ubiquity of free radicals and their considerable destructive potential in living tissues. It is plausible that an improved understanding of free radical processes will lead to the discovery of interventions (dietary, pharmacological or genetic) to improve health and increase life spans. Research is needed to establish the critical relationships among free radical sources, protective systems and aging phenomena that may be amenable to intervention. ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit, public and private organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Foreign institutions are not eligible to apply for career awards (K04, K08, K11) or First Independent Research Support and Transition (FIRST) (R29) awards, and can apply for National Research Service Training Awards (F32, F33) only if the applicant is a U.S. citizen. Applicants for F32, F33, K04, K08, and K11 awards must be U.S. citizens or resident aliens. MECHANISMS OF SUPPORT The primary mechanisms for support of this program are: o Research grant (RO1) o FIRST award (R29) o Career grants, which include: Research Career Development Award (K04); Clinical Investigator Award (K08); Physician Scientist Award, individual (K11) o Fellowships (F32, F33) Deadlines for applications are as follows: F-series grants: Jan 10, May 10, and Sep 10 New R and K-series grants: Feb 1, Jun 1, and Oct 1 Competing continuation and revised grants: Mar 1, Jul 1, and Nov 1 RESEARCH OBJECTIVES The National Institute on Aging (NIA) invites investigators to submit applications for research on oxidative damage and pathobiology as related to aging and the aging process. Priority will be given to research projects that are likely to provide critical insights into these relationships other than correlative data. Also, it is recognized that the National Cancer Institute (NCI) has an interest in the role of oxidative damage in cancer and the carcinogenesis process, the National Institute of Environmental Health Sciences (NIEHS) has an interest in toxic environmental agents, and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has an interest in the role of oxidative damage due to saturated and unsaturated lipids on normal and abnormal metabolic processes in high eukaryotes and humans. Applications will be given an institute assignment based on the Referral Guidelines for Funding Components of PHS. The following areas of research are of particular interest to the NIA, but applications need not be limited to the areas listed below. 1. Improved methods for measuring any of the following in biological tissues suitable for aging studies: levels of antioxidants in both the oxidized and reduced state; rate of production of superoxide, hydrogen peroxide and hydroxyl radical; levels and/or identification of oxidized products in macromolecules, such as DNA, protein and lipids; rate of repair of oxidized macromolecules in vivo. 2. Identification of which enzyme activities involved in antioxidant defense are rate-limiting, with particular emphasis on age-related changes. 3. The role of heavy metal ions, whether bound or free, in age-related accumulation of oxidative damage in vivo. 4. Development of interventions that reduce oxidative damage through either neutralization of oxygen free radicals, reduction of the rate of production of oxygen free radicals, repair of oxidative damage, or improvement of antioxidant defense systems, coupled with a demonstration that this reduced oxidative stress is associated with a change in age-associated biological processes and/or diseases. 5. The role of mitochondrial dysfunction in cellular oxidative damage due to normal metabolism, and how this changes with age. 6. Elucidation of how genes involved in antioxidant defense systems are regulated in vivo, with particular emphasis on how the regulation is altered during aging. 7. The mechanism of attenuation of oxidative damage by spin trapping compounds and other chemical and dietary interventions. 8. Determination of whether and/or how caloric restriction reduces oxidative damage, and whether or not this is related to life span extension. 9. The relationship between oxidative damage and the eventual development of age-related disease states. 10. Development of animal model systems, particularly transgenic animals, to test the effect of altering oxidative damage or antioxidant defense systems on aging and/or life span. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 3, Recruitment of Individuals from Under represented Racial/ethnic Groups, and Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in ALL research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans including American Indians or Alaskan Natives, Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention and preventive strategies, diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications for R01, R29, and K Awards are to be submitted on the grant application form PHS 398 (rev.9/91) and will be accepted at the standard application deadlines indicated in the application kit. Applications for F32 and F33 awards are to be submitted on form PHS 416 (rev. 10/91). 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) 496-7441. The title and number of the announcement must be typed in Section 2a on the face page of the application. The completed original application and five legible copies of PHS 398 or two copies of PHS 416 must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** To expedite the application's routing within the NIH, please check the box on the face page of the application indicating that the application is in response to this announcement and type (next to the checked box) "Oxidative Damage and Aging." Applications for F32, F33 and R29 awards must include at least three letters of reference attached to the face page of the original application. Applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. REVIEW CONSIDERATIONS The review criteria are the traditional considerations underlying scientific merit. Applications will be assigned on the basis of established Public Health Service referral guidelines. For information on the special review criteria for the FIRST (R29) award, research career awards (K series), and fellowships (F32, F33) contact the program staff listed under INQUIRIES. Applications will be assigned on the basis of established PHS referral guidelines. In accordance with the standard NIH peer review procedures, research project grant (RO1 and R29) applications, fellowships (F32, F33) and research career development awards (K04) will be reviewed for scientific and technical merit by an appropriate study section in the Division of Research Grants. Other applications (K08 and K11) will be reviewed by an appropriate institute review group. Following scientific/technical review, the applications will receive a second-level review by the appropriate advisory council. AWARD CRITERIA There are no set-aside funds for funding these applications. Applications compete for available funds on the basis of scientific merit with all other applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Researchers considering an application in response to this announcement may discuss their project and the range of grant mechanisms available with NIA staff in advance of formal submission. This can be done either through a telephone conversation or a brief letter giving the descriptive title of the proposed project and identifying the Principal Investigator and, when known, other key participants. Applications related to the health of women and minorities are particularly encouraged. Correspondence and inquiries may be directed to: Huber R. Warner, Ph.D. Biology of Aging Program National Institute on Aging Gateway Building, Room 2C231 7201 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-6402 FAX: (301) 402-0010 or Pamela Starke-Reed, Ph.D. Geriatrics Program National Institute on Aging Gateway Building, Room 3E327 7201 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-6761 FAX: (301) 402-1784 Direct inquiries regarding fiscal matters to: Joseph Ellis Grants and Contracts Management Officer National Institute on Aging Gateway Building, Room 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866. 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. $$P3 END ************************************************************ $$P4 BEGIN PA-93-018 ************************************************ NEURAL REGENERATION AND PLASTICITY AFTER SPINAL CORD INJURY NIH GUIDE, Volume 21, Number 41, November 13, 1992 PA: PA-93-018 P.T. 34; K.W. 0715027, 0705055, 1002030, 0760015 National Institute of Neurological Disorders and Stroke PURPOSE The Division of Stroke and Trauma (DST), National Institute of Neurological Disorders and Stroke (NINDS), invites applications for support of research that will increase our knowledge of the mechanisms underlying the neuronal regeneration and plasticity that can follow spinal cord injury. 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), Neural Regeneration and Plasticity after Spinal Cord Trauma, is related to the priority area of unintentional injuries: spinal cord injury. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic institutions, 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 institutions, minority individuals, and women are particularly encouraged. MECHANISMS OF SUPPORT The support mechanism for grants in this area will be the traditional investigator-initiated research project grant (R01). The Principal Investigator will plan, direct, and, along with any co-investigators, perform the research. Applicants are encouraged to contact the NINDS representative listed below as early as possible in the planning stages. RESEARCH OBJECTIVES Background Injury to the spinal cord tragically affects hundreds of thousands of victims in the United States, with approximately 10,000 new traumatic injuries each year. Early treatment and improved hospital care have increased survival, but at great cost. The estimated yearly cost of long term, specialized care for paralyzed patients exceeds $2 billion. The personal costs to patients and their families is beyond calculation: planned education, career, marriage, and independence are interrupted and often never regained. The spinal cord, as part of the central nervous system (CNS), coordinates movement and sensation for the entire body below the head. Specialized cell populations within the cord are the substrates for these functions. Large motoneurons extend long axons peripherally to innervate skeletal muscle. Extensive arborizations of these motoneurons receive information via descending tracts from the brain. The long fibers of dorsal root ganglion cells connect peripheral sensory receptors to spinal interneurons, to motoneurons, and to brain centers. This complex neuronal circuitry of the spinal cord is supported by the glia of the CNS. Radial glia enclose the cord like the rim and spokes of a wheel, defining compartments for ascending and descending fiber systems. Astrocytes contribute to the blood-spinal cord barrier and provide a wide variety of support functions. Oligodendrocytes myelinate axons. Traumatic injury disrupts all of these cell types and changes their functions. Axons degenerate, neurons die, astrocytes proliferate and become reactive, radial glia enclose large cysts, and oligodendrocytes cannot remyelinate damaged areas. The anatomy of an injured spinal cord shows profound pathology, but also reveals the sprouting of uninjured fibers, the regeneration of damaged populations, the reorganization of glia, and clearing away of debris. Enhancement of these beginnings of regeneration and reorganization is necessary. Several trophic factors are known to affect survival of neurons and extension of neurites. Likewise, naturally occurring substances may enhance supportive glial functions. Components of the extracellular matrix can support the growth of axons. The growing knowledge of cellular mechanisms of repair within the injured spinal cord offers the hope of treatment for this devastating disorder. Research Goals and Scope Examples of investigator-initiated research grant applications for basic, applied, and clinical studies related to the understanding and enhancement of regeneration in the injured spinal cord may include, but should not necessarily be limited to: o identification of the tissues, cells, and substrates critical to the regenerative process; o behavioral, chemical, functional, and structural correlates of restored or remodeled neural circuits; o gene and protein expression in neurons and support cells during regeneration; o development of cellular transplants to augment or support regeneration, restore lost function, or replace damaged cells; o immune responses to implants of neural tissues, cell lines, or cellular products; and o pharmacological or biochemical approaches to prolong or enhance regeneration. Applicants are encouraged to develop and use new or refined methodologies, instrumentation, and procedures that will reveal mechanistic details of the regenerative process. Basic, applied, or clinical studies on interventions or manipulations to improve regrowth of fibers, prevent pathophysiological changes, or aid in functional recovery are welcome. 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 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 should be provided. The composition of the proposed study population must be described in terms of gender and racial or ethnic group. In addition, gender and racial or ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups; however, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of Unites States racial or ethnic minority populations: Native Americans (including American Indians or Alaska Natives), Asian or Pacific Islanders, Blacks, and 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 prevention 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 or ethnic minorities when it is important to apply the results of the study broadly. This directive 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 the NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) according to the instructions included in the application package. These application packages are available at the business offices of most institutions eligible to receive Federal grants and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. Receipt dates for new research project grant applications (R01) are February 1, June 1, and October 1. On page 1 of form PHS 398, check "yes" in Item 2a, enter the number of this Program Announcement in the space provided, and provide the name of this Program Announcement, Neural Regeneration and Plasticity after Spinal Cord Injury in the blank space labeled "Title." Use the mailing label provided in the application package to mail the signed original and five exact copies of it 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 appropriate study section in the Division of Research Grants. The second level of review will be by the appropriate national advisory council. The standard review criteria will be used to assess the scientific merit of applications. AWARD CRITERIA Applications will compete for available funds with other applications assigned to an Institute or Center. The following will be considered when making funding decisions: o quality of the proposed projects as determined by peer review o availability of funds o program balance among research areas. INQUIRIES Questions concerning scientific aspects of this Program Announcement may be addressed to: Dr. Mary Ellen Michel Division of Stroke and Trauma National Institute of Neurological Disorders and Stroke Federal Building, Room 8A13 Bethesda, MD 20892 Telephone: (301) 496-4226 FAX: (301) 480-1080 Questions concerning fiscal aspects of this Program Announcement may be addressed to: Mr. King P. Bond, Jr. Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 Bethesda, MD 20892 Telephone: (301) 496-9231 FAX: (301) 402-0219 AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance No. 93.853, Clinical Research Related to Neurological Disorders, and No. 93.854, Biological Basis Research in the Neurosciences. Grants will be awarded under the authority of the Public Health Service Act, Title IV, Section 301 (Public Law 78-410, as amended: 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR 74. This program is not subject to Health Services Agency Review of the intergovernmental review requirements of Executive Order 12372. $$P4 END ************************************************************ $$P5 BEGIN PA-93-019 ************************************************ NEUROLOGICAL BASIS OF RECURRENT HEADACHE, ESPECIALLY MIGRAINE NIH GUIDE, Volume 21, Number 41, November 13, 1992 PA: PA-93-019 P.T. 34; K.W. 0715138, 0765035, 0760025, 0755030, 0745027, 0411005 National Institute of Neurological Disorders and Stroke PURPOSE The Division of Stroke and Trauma (DST), National Institute of Neurological Disorders and Stroke (NINDS), invites applications for support of research that will increase our understanding of the causes of, and add to our ability to treat and prevent, recurrent headache, especially migraine. ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic institutions, for-profit and non-profit organizations, public or private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign institutions are eligible to apply for research project grants (R01) only. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applications from minority institutions, minority individuals, and women are particularly encouraged. MECHANISMS OF SUPPORT The support mechanisms for grants in this area will be the traditional investigator-initiated research project grant (R01), the FIRST award (R29), the program project grant (P01), and the center grant (P50). As consistent with the aforementioned mechanisms, the Principal From owner-sci-resources@net.bio.net Wed Nov 11 22:00:00 1992 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 21, no. 41, pt. 1, 13 November 1992 Message-ID: Date: 12 Nov 92 18:12:42 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. ---------------------------------------------------------------------- $$XID NIHGUIDE 19921113 V21N41 P1O3 ************************************ X-comment: RFAs described: HL-93-09, HL-93-10, AI-92-12, CA-93-03, DK-93-06 NIH GUIDE - Vol. 21, No. 41, November 13, 1992 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** LABORATORY FOR ASSESSMENT OF MUCOSAL IMMUNE RESPONSES INDUCED BY AIDS VACCINES IN CLINICAL TRIAL VOLUNTEERS (RFP NIAID-DAIDS-93-18) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R2 ********************************************************** BIOCHEMICAL SCREENS FOR AGENTS EFFECTIVE AGAINST AIDS-RELATED OPPORTUNISTIC INFECTION (RFP NIAID-DAIDS-93-19) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R3 ********************************************************** GENETIC SEQUENCE VARIABILITY OF HIV-1 AND RELATED LENTIVIRUSES (RFP NIAID-DAIDS-93-22) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R4 ********************************************************** CLINICAL TRIALS CENTER FOR ANTIHYPERTENSIVE AND LIPID-LOWERING TREATMENT TO PREVENT HEART ATTACK TRIAL (RFP NHLBI-HC-93-44) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R5 02/17/93 ************************************************* TUBERCULOSIS ACADEMIC AWARD (RFA HL-93-09-L) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R6 02/17/93 ************************************************* ASTHMA ACADEMIC AWARD (RFA HL-93-10-L) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R7 02/18/93 ************************************************* WOMEN'S INTERAGENCY HIV STUDY (RFA AI-92-12) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R8 03/10/93 ************************************************* THERAPEUTIC STUDIES OF PRIMARY CENTRAL NERVOUS SYSTEM MALIGNANCIES IN ADULTS (RFA CA-93-03) National Cancer Institute INDEX: CANCER $$INDEX R9 03/15/93 ************************************************* EXPLORATORY GRANTS FOR CENTERS OF EXCELLENCE IN MOLECULAR HEMATOLOGY (RFA DK-93-06) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** MINORITY HIGH SCHOOL STUDENT RESEARCH APPRENTICE PROGRAM (PA-92-111) National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX P2 ********************************************************** MOLECULAR AND CELLULAR BIOLOGY OF METASTATIC TUMOR CELLS (PA-93-016) National Cancer Institute INDEX: CANCER $$INDEX P3 ********************************************************** OXIDATIVE DAMAGE, ANTIOXIDANT DEFENSE, AND AGING (PA-93-017) National Institute on Aging INDEX: AGING $$INDEX P4 ********************************************************** NEURAL REGENERATION AND PLASTICITY AFTER SPINAL CORD INJURY (PA-93-018) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX P5 ********************************************************** NEUROLOGICAL BASIS OF RECURRENT HEADACHE, ESPECIALLY MIGRAINE (PA-93-019) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX P6 ********************************************************** SMALL INSTRUMENTATION GRANTS PROGRAM (PA-93-020) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH ERRATUM $$INDEX E1 ********************************************************** ACADEMIC AWARD IN VASCULAR DISEASE (PAR-93-008) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD This publication is also available electronically to institutions via BITNET or INTERNET. Alternative access is through the NIH Grant Line using a personal computer. Contact Dr. John James at 301/496-7554 for details, or send an E-mail message to ZNS@NIHCU. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 21, Number 41, November 13, 1992 P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human subjects. The meetings should be of special interest to those persons currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all other Public Health Service agencies. The current schedule includes the following: SOUTHWESTERN WORKSHOP DATES: November 16 & 17, 1992 LOCATION: Wyndham Warwick 5701 Main Street Houston, TX 77005 Telephone: (713) 526-1991 SPONSORS: University of Texas Health Science Center at Houston Prairie View A&M University REGISTRATION: Ms. Paula Knudson Executive Coordinator Office of Research Support Committee University of Texas Health Science Center at Houston P.O. Box 20036 Houston, TX 77225 Telephone: (713) 792-5048 TITLE: Geriatric Research as an Ethical Mandate: Politics, Policy, and Problems DESCRIPTION: Expanded life expectancies and expanding technologies are swelling the ranks of the frail and disabled elderly. Minimal research has been carried out to understand the problems this subject group and their families encounter in finding solutions to their health and social needs. The conference will identify key problems that need to be studied; isolate the risks and benefits associated with behavioral, clinical, or evaluation research designed to enroll this group as subjects; and pose solutions that will meet the needs of regulators, scientists, and the elderly. The program is designed to be of interest to physicians, nurses, pharmacists, scientific investigators, and other health care professionals, clergy, lawyers, medical, nursing, social work students, psychologists, and IRB members and administrators. Attention will be paid to Federal regulations with special emphasis on the assessment of risks---medical, legal, and psychosocial. Opportunities will be available through workshops, question periods, and informal discussions for participants to exchange ideas and interests with faculty and OPRR and FDA representatives. SOUTHEASTERN WORKSHOP DATES: January 14 & 15, 1993 LOCATION: Sheraton Sand Key Resort 1160 Gulf Boulevard Clearwater Beach, FL 33515 Telephone: (813) 595-1611 SPONSORS: University of South Florida Florida A & M University REGISTRATION: Ms. Eileen Highsmith Executive Secretary University of South Florida 4202 E. Fowler Avenue (MP.FAO-126) Tampa, FL 33620-7900 Telephone: (813) 974-2897 TITLE: Barriers to Informed Consent: Language, Age Factors, Trauma, and Women/Minority Issues DESCRIPTION: Today's researchers face numerous barriers to obtaining an informed consent. Such issues as age, language, mental capacity, and sobriety may affect the ability of subjects to give a truly informed consent. Many of these barriers oftentimes impact the pool of subjects which an investigator is willing (or able) to use in a research project. In addition, recent legislation from the Congress was designed to address the issue of inadequate numbers of women and minorities in research projects. This conference has been designed to address three main areas in which barriers to informed consent may exist: mental competence, ethnic and gender issues, and research with children and the elderly. The conference program is designed to be of value to physicians, nurses, pharmacists, scientific investigators, and other health care professionals. All IRB members, students in health care areas and administrators will also benefit from the conference. Attention will be given to Federal regulations governing research on human subjects, with special emphasis placed on the assessment of risks---medical, legal, and psychosocial. Ample opportunities will be provided to exchange ideas and interests, through question and answer sessions and informal discussions. For further information regarding these workshop and future NIH/FDA National Human Subject Protections Workshops, please contact: Ms. Darlene Marie Ross Division of Human Subject Protections Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B59 Bethesda, MD 20892 Telephone: (301) 496-8101 $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN RFP NIAID-DAIDS-93-18 ************************************ LABORATORY FOR ASSESSMENT OF MUCOSAL IMMUNE RESPONSES INDUCED BY AIDS VACCINES IN CLINICAL TRIAL VOLUNTEERS NIH GUIDE, Volume 21, Number 41, November 13, 1992 RFP AVAILABLE: NIAID-DAIDS-93-18 P.T. 34; K.W. 0715008, 0740075, 0755010, 0710070 National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID), NIH, has a requirement to provide for the centralized performance of immunological assays to evaluate HIV-specific humoral and cellular mucosal immune responses in support of clinical trials of prototype AIDS vaccines. The purpose of this contract is to support the NIAID in its mission to stimulate research towards discovery and testing of prototype vaccines for the acquired immunodeficiency syndrome (AIDS). The NIAID requires a Mucosal Immunology Laboratory to evaluate reproductive tract, gut, blood, and other mucosal specimens from vaccine clinical trial volunteers for humoral and cellular mucosal immune responses induced by immunization with prototype AIDS vaccines. This effort will support the research of AIDS investigators, including the AIDS Vaccine Evaluation Group (AVEG), the National Cooperative Vaccine Evaluation Groups (NCVDG), and other programs initiated by NIAID. Specifically, the selected Contractor shall be responsible for: (1) performing specific immunological assays for detection of HIV-specific antibody and cellular responses in mucosal site and blood specimens from AIDS vaccine recipients; (2) developing standard protocols for the collection, processing, and storage of mucosal specimens at the vaccine trial sites; (3) receiving, cataloging, tracking, coding, storing, and maintaining an inventory of vaccinee specimens arriving for evaluation; and (4) maintaining a test result database and transferring data electronically to the AIDS Vaccine Clinical Trials Network (AVCTN) Data Coordinating and Analysis Center (DCAC). This is an announcement for an anticipated Request for Proposals (RFP). RFP: NIH-NIAID-DAIDS-93-18 will be issued on or about November 13, 1992 with a closing date tentatively set for January 5, 1993. It is expected that one (1) contract will be awarded as a result of this solicitation. It is expected that the contract will have a five-year period of performance, and a completion type cost-reimbursement contract is anticipated. INQUIRIES Requests for the RFP may be directed in writing to: Lawrence Butler, Contracting Officer Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C-07 6003 Executive Boulevard Bethesda, MD 20892 Please provide this office with three self-addressed mailing labels. Telephone inquiries will not be honored and all inquiries must be in writing. A short-form version of the RFP will be provided first, which includes only the statement of work and the Evaluation Criteria to be used for selection of the awardee. After examining this, a full-text version of the RFP must be requested in writing by those offerors interested in responding. FAX requests are acceptable for the full-text version of the RFP only (FAX: 301-402-0972). All proposals from responsible sources will be considered by the NIAID. This advertisement does not commit the Government to award a contract. $$R1 END ************************************************************ $$R2 BEGIN RFP NIAID-DAIDS-93-19 ************************************ BIOCHEMICAL SCREENS FOR AGENTS EFFECTIVE AGAINST AIDS-RELATED OPPORTUNISTIC INFECTION NIH GUIDE, Volume 21, Number 41, November 13, 1992 RFP: NIAID-DAIDS-93-19 P.T. 34; K.W. 0755010, 0715008, 0755060, 0760013 National Institute of Allergy and Infectious Diseases The Developmental Therapeutics Branch, Basic Research and Development Program, Division of AIDS, National Institute of Allergy and Infectious Disease (NIAID), NIH has a requirement to apply established biochemically-based enzymatic or non-enzymatic assays to screen agents for inhibition of one or more steps in the metabolism of AIDS-associated opportunistic pathogens. These biochemical prescreens are considered particularly useful for rapid testing of compounds. Examples of such assays may include, but not be limited to: protein synthesis, dihydrofolate reductase, and dihydropteroate synthase. The major effort of this contract will involve the screening of a large number of compounds. A secondary focus of this contract will be development/modification of automated biochemical assays and their application to drug testing against opportunistic infections in AIDS. It is anticipated that some assays will require isolation of enzymes from relevant microorganisms or cloning to obtain the protein. However, most of the enzymes and recombinant proteins required for the development of assays in this project will be provided by the AIDS Reference and Reagent Repository. Other non-enzymatic assays may be developed /used to evaluate drug activities in vitro. At the present time, NIAID has one contract that is scheduled to end in 1993 to screen agents in enzymatic assays. This NIAID sponsored project will take approximately three years to complete. A level-of-effort, cost reimbursement contract is anticipated. It is expected that one award will be made. This is an announcement for an anticipated Request for Proposal (RFP). RFP NIH-NIAID-DAIDS-93-19 will be issued on or about November 12, 1992, with a closing date tentatively set for January 15, 1993. INQUIRIES Requests for the RFP may be directed in writing to: Cyndie Cotter Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 6003 Executive Boulevard Bethesda, MD 20892 To receive a copy of the RFP, please supply this office with three self-addressed mailing labels. Telephone inquiries will not be honored and all inquiries must be in writing. A short- form version of the RFP will be provided first, which includes only the Statement of Work and the Evaluation Criteria to be used for selection of the awardee. After examining this, a full-text version of the RFP must be requested, in writing, for those offerors interested in responding. FAX requests are acceptable for the full-text version only (FAX: 301-402-0972). All proposals from responsible sources will be considered by the NIAID. This advertisement does not commit the Government to award a contract. $$R2 END ************************************************************ $$R3 BEGIN RFP NIAID-DAIDS-93-22 ************************************ GENETIC SEQUENCE VARIABILITY OF HIV-1 AND RELATED LENTIVIRUSES NIH GUIDE, Volume 21, Number 41, November 13, 1992 RFP: NIH-NIAID-DAIDS-93-22 P.T. 34; K.W. 1215018, 0755018 National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID), NIH, has a requirement for a contractor to receive samples infected with HIV-1 or related lentiviruses, to amplify virus-specific genetic sequences from these samples, and to clone and sequence these amplified fragments. The Contractor will be required to design gene amplification primers for distinct regions of the virus genome and for diverse viral isolates. The Contractor will be required to amplify and clone sizable genomic fragments (>1500 base pairs), and carry out large-scale genetic sequencing (approximately 200,000 bases/year). Specifically, the selected contractor shall be responsible for: (1) amplifying, cloning and sequencing HIV-1 and related lentivirus-specific gene fragments from samples derived from HIV-infected individuals provided through the Project Officer; (2) compiling and analyzing genetic sequence data, and transferring data to the HIV Genetic Sequence Database and Analysis Unit at the Los Alamos National Laboratory; (3) receiving, cataloging, processing, storing samples, and distributing samples to other investigators; and (4) providing an Inventory and Database Management System. This is an announcement for an anticipated Request for Proposals (RFP). RFP NIH-NIAID-DAIDS-93-22 will be issued on or about November 9, 1992, with a closing date tentatively set for January 5, 1993. One contract will be awarded as a result of this solicitation. It is expected that the contract will have a five-year period of performance. A level-of-effort cost-reimbursement contract is anticipated. INQUIRIES Requests for the RFP are to be directed in writing to: Kristiane E. Hofacker, Contract Specialist Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 Bethesda, MD 20892 Please provide this office with three self-addressed mailing labels. Telephone inquiries will not be honored and all inquiries must be in writing. A short-form version of the RFP will be provided first, this includes only the Statement of Work and the Evaluation Criteria to be used for selection of the awardee. After examining this, a full-text version of the RFP must be requested, in writing, for those offerors interested in responding. FAX requests are acceptable for full-text versions of the RFP only (FAX: 301/402-0972). All proposals from responsible sources will be considered by the NIAID. This advertisement does not commit the Government to award a contract. $$R3 END ************************************************************ $$R4 BEGIN RFP NHLBI-HC-93-44 *************************************** CLINICAL TRIALS CENTER FOR ANTIHYPERTENSIVE AND LIPID-LOWERING TREATMENT TO PREVENT HEART ATTACK TRIAL NIH GUIDE, Volume 21, Number 41, November 13, 1992 RFP AVAILABLE: NHLBI-HC-93-44 P.T. 34; K.W. 0715115, 0755015, 0740025 National Heart, Lung, and Blood Institute The primary purpose of this program is to select a Clinical Trials Center to conduct a practice-based, randomized clinical trial of antihypertensive pharmacologic treatment and, in a specific subset, lipid-lowering, in a factorial design. The purpose of the antihypertensive trial is to determine whether or not the combined incidence of fatal coronary heart disease (CHD) and non-fatal myocardial infarction differs between diuretic-based and alternative antihypertensive pharmacologic treatment in patients broadly representative of the U.S. hypertensive population, including at least 55 percent African-Americans. The purpose of the lipid-lowering trial is to conduct, in a subset of this population and in a factorial design, a placebo-controlled randomized clinical trial to determine whether or not lowering serum cholesterol in older, moderately hypercholesterolemic men and women with a 3-hydroxymethylglutaryl coenzyme A (HMG CoA) reductase inhibitor will reduce the combined incidence of fatal CHD and non-fatal myocardial infarction. Rather than using independently funded clinics, patients will be recruited through office-based practices and hypertension clinics that will be reimbursed by the Clinical Trials Center on a per-patient basis. The study will consist of a vanguard phase and a full-scale trial phase. Six hundred patients will be entered into the vanguard phase; approximately 30,000 patients will be enrolled in the full-scale trial. This is not a Request for Proposals (RFP). RFP NHLBI-HC-93-44 will be released on or about November 6, 1992 with proposals due on or about January 15, 1993. One incrementally funded contract is anticipated to be awarded for nine years. Written requests must include three self-addressed mailing labels and must cite RFP NHLBI-HC-93-44. Requests for copies of the RFP are to be sent to: Kristee M. Camilletti, Contracting Officer HLVD Contracts Section, Contracts Operations Branch, DEA National Heart, Lung, and Blood Institute Federal Building, Room 4C04 Bethesda, MD 20892 $$R4 END ************************************************************ $$R5 BEGIN HL-93-09 FULL-TEXT *************************************** TUBERCULOSIS ACADEMIC AWARD NIH GUIDE, Volume 21, Number 41, November 13, 1992 RFA AVAILABLE: HL-93-09-L P.T. 34; K.W. 0715165, 0502024, 0785035 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 15, 1992 Application Receipt Date: February 17, 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 primary objective of this program is to stimulate the development and/or improvement of the quality of medical curricula, physician/patient/and community education, and clinical practice for the prevention, management, and control of Mycobacterial tuberculosis (TB) in the United States. 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, Tuberculosis Academic Award, is related to the priority areas of immunization and infectious diseases and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017- 001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: 202-783-3238). ELIGIBILITY REQUIREMENTS Institutions Applications may be submitted by domestic universities or schools of medicine. Minority institutions and urban institutions from areas with high rates of incidence of TB that have the necessary resources and facilities and a commitment to providing the awardee with the time to develop and implement plans consistent with the goals of this announcement are encouraged to sponsor candidates for these awards. Candidates A candidate for an award must: o be an established physician and a medical faculty member in an accredited school of medicine or osteopathy in the United States, its territories or possessions, and have competence in tuberculosis and; o be employed by a school of medicine or osteopathy that is located in an area with high TB rates; o have sufficient clinical training, research, and teaching experience in the control of TB to develop and implement a high quality curriculum in TB encompassing current knowledge and methods applicable to the control of tuberculosis in individuals of all ages and to provide leadership in research in control of TB; o be a citizen or non-citizen national of the United States or have been lawfully admitted to the United States for permanent residence at the time of application; Individuals who have held another NIH career development award (K series) are eligible to apply for the Tuberculosis Academic Award. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA is part of the Academic Award Program (K07) of the National Heart, Lung, and Blood Institute (NHLBI). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years and is non-renewable. It is anticipated that support for this program will begin September 1993. FUNDS AVAILABLE The estimated funds (total costs) for the first year of support for the entire program will be $300,000. It is anticipated that three to four grants will be awarded each year for five years under this program. The specific number, however, will depend upon the merit and scope of the applications received and the availability of funds. A maximum of $50,000 for the salary of the awardee, plus applicable fringe benefits, a maximum of $20,000 for technical support, and indirect costs not to exceed eight percent may be requested. OBJECTIVES The objectives of the Tuberculosis Academic Award are to: o encourage the development of high quality curricula in schools of medicine that will significantly increase the opportunities for students, house staff, and others, including practicing physicians, to learn the principles and practice of preventing, managing, and controlling TB; o encourage research in the control of TB; o encourage the development of a faculty capable of providing appropriate instruction in TB; o contribute to updating the knowledge and skill of practicing physicians and other health care providers in the community; o enhance awareness of health care providers of the unique ethnic, cultural, socioeconomic, and medical dimensions of TB; o coordinate and collaborate with other community organizations to control TB in areas with high incidence of TB; o facilitate an interchange of ideas and methods among awardees and institutions; o cooperate and collaborate with other organizations that have responsibility for and interest in TB control, for example, health departments, medical and nursing associations, and voluntary health agencies; and o contribute to public health efforts to control TB in the community. Of particular interest are programs targeted to inner city populations and to rural areas that may be in need of education about TB and among physicians who are or who will be caring for medically underserved populations. 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 December 15, 1992, a letter of intent that includes 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 the Institute 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: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 548B Bethesda, MD 20892 Telephone: (301) 496-7363 APPLICATION PROCEDURES Applications must be received by February 17, 1993. Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-496-7441. REVIEW CONSIDERATIONS Applications for this Tuberculosis Academic Award will be evaluated in terms of the following criteria: o the overall merit of the proposed five-year plan for improving the institution's interdepartmental curricula on tuberculosis; o the qualifications and background of the candidate, including experience in teaching, curriculum development, and research; o the institution's commitment to implement the proposed curriculum and to continue a program in education about tuberculosis control after the termination of the award; o the involvement of appropriate disciplines in the development, implementation, and evaluation of the program; o design and evaluation plans for educational interventions for health care providers and for patients with tuberculosis, especially in areas with high incidence of TB; o plans for communication and cooperation between specialists in adult and pediatric pulmonary medicine, infections, and community medicine to ensure optimal treatment; o plans for collaborative projects with other organizations that have responsibility for and interest in tuberculosis control, for example, health departments, medical and nursing associations, and voluntary health agencies; o the potential of the program for making an impact on the control of tuberculosis among populations served; o the potential for replication or adaptation of the program at other sites. Of particular interest are programs targeted to inner city populations and to rural areas that may be in need of education about TB and among physicians who are or who will be caring for medically underserved populations. INQUIRIES Guidelines for this RFA are available from the person named below. Written and telephone inquiries concerning this announcement are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Joan M. Wolle, Ph.D., M.P.H. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640 Bethesda, MD 20892 Telephone: (301) 496-7668 Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 496-4970 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants will be awarded under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99-158, 42 US 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CAR 52 and 45 CAR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to a review by a Health Systems Agency. $$R5 END ************************************************************ $$R6 BEGIN HL-93-10 FULL-TEXT *************************************** ASTHMA ACADEMIC AWARD NIH GUIDE, Volume 21, Number 41, November 13, 1992 RFA AVAILABLE: HL-93-10-L P.T. 34; K.W. 0715013, 0502024, 0785035 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 15, 1992 Application Receipt Date: February 17, 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 primary objective of this RFA is to stimulate the development and/or improvement of the quality of curricula, physician/patient/and community education, and clinical practice for the prevention, management, and control of asthma in the United States. 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, Asthma Academic Award, is related to the priority areas of diabetes and chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: 202-783-3238). ELIGIBILITY REQUIREMENTS Institutions Applications may be submitted by domestic universities or schools of medicine. Minority institutions and urban institutions from areas with high rates of morbidity of asthma that have the necessary resources and facilities and a commitment to providing the awardee with the time to develop and implement plans consistent with the goals of this announcement are encouraged to sponsor candidates for these awards. Candidates A candidate for an award must: o be an established physician and medical faculty member in an accredited school of medicine or osteopathy in the United States, its territories or possessions, and have competence in the management of asthma, and; o be employed by a school of medicine or osteopathy that is located in an area with high asthma morbidity, such as an institution located in an inner city; o have sufficient clinical training, research, and teaching experience in pulmonary medicine to develop and implement a high quality curriculum in asthma encompassing current knowledge and methods applicable to the control of asthma in individuals of all ages and to provide leadership in applied research in control of asthma; o be a citizen or non-citizen national of the United States or have been lawfully admitted to the United States for permanent residence at the time of application; Individuals who have held another NIH career development award (K series) are eligible to apply for the Asthma Academic Award. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA is part of the Academic Award Program (K07) of the National Heart, Lung, and Blood Institute (NHLBI). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years and is non-renewable. It is anticipated that support for this program will begin September 1993. A maximum of $50,000 for the salary of the awardee, plus applicable fringe benefits, a maximum of $20,000 for technical support, and indirect costs not to exceed eight percent may be requested. FUNDS AVAILABLE The estimated funds (total costs) for the first year of support for the entire program will be $300,000. It is anticipated that three to four grants will be awarded each year for five years under this program. The specific number, however, will depend upon the merit and scope of the applications received and the availability of funds. OBJECTIVES The objectives of the Asthma Academic Award are: o to encourage the development of high quality curricula in schools of medicine that will significantly increase the opportunities for students, house staff, and others to learn the principles and practice of preventing, managing, and controlling asthma; o to develop and implement interdepartmental programs with common goals and standardize diagnostic and therapeutic approaches; o to promote communication among specialists in primary care, allergy, and obstetrics and gynecology to ensure appropriate treatment of pregnant women with asthma; o to encourage research in the control of asthma; o to promote the development of a faculty capable of providing appropriate instruction in asthma; o to promote an institutional environment that facilitates an interchange of information and educational evaluation techniques about new diagnostic, therapeutic and prevention measures in asthma in both children and adult populations; o to investigate coordinated clinical approaches to the care of patients of various ages and ethnic groups who have asthma, such as minorities, young children, and the elderly; o to provide for outreach programs from medical centers to health practitioners in the community to enhance optimal care, especially in areas of high asthma morbidity, such as inner city minority communities; o to facilitate an interchange of ideas among awardees and institutions; o to contribute to public health efforts to control asthma in the United States. Of particular interest are programs targeted to inner city populations and to rural areas that may be in need of education about asthma and among physicians who are or who will be caring for medically underserved populations. 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 December 15, 1992, a letter of intent that includes 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 the Institute 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: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 548B Bethesda, MD 20892 Telephone: (301) 496-7383 APPLICATION PROCEDURES Applications must be received by February 17, 1993. Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/496-7441. REVIEW CONSIDERATIONS Applications for this Asthma Academic Award will be evaluated in terms of the following criteria: o the overall merit of the proposed five-year plan for improving the institution's interdepartmental curricula in asthma control; o the qualifications and background of the candidate, including experience in teaching, curriculum development, and research; o the institution's commitment to implement the proposed curriculum and to continue a program in education about asthma control after the termination of the award; o the involvement of appropriate disciplines in the development, implementation, and evaluation of the program; o design and evaluation plans for educational interventions for health care providers and for patients with asthma, especially in areas with high morbidity from asthma, such as inner city minority communities; o plans for communication and cooperation between specialists in adult and pediatric pulmonary medicine, family practice, internal medicine, community medicine, and other specialties; o plans for collaborative projects with other organizations that have responsibility for and interest in asthma control, for example, health departments, medical and nursing associations, and voluntary health agencies; o the potential of the program for making an impact on the control of asthma among populations served; o the potential for replication or adaptation of the program at other sites. INQUIRIES Guidelines for this RFA are available from the person named below. Written and telephone inquiries concerning this announcement are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Joan M. Wolle, Ph.D., M.P.H. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640 Bethesda, MD 20892 Telephone: (301) 496-7668 Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 496-4970 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants are made under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99-158, 42 US 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CAR 52 and 45 CAR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Heath Systems Agency review. $$R6 END ************************************************************ $$R7 BEGIN AI-92-12 FULL-TEXT *************************************** WOMEN'S INTERAGENCY HIV STUDY NIH GUIDE, Volume 21, Number 41, November 13, 1992 RFA AVAILABLE: AI-92-12 P.T. 34, II; K.W. 0715008, 0740075, 0411005, 0403004, 0785035 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: January 11, 1993 Application Receipt Date: February 18, 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 Vaccine Trials and Epidemiology Branch (VTEB) of the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for cooperative agreements for the establishment of a Women's Interagency HIV Study (WIHS) to investigate the clinical, laboratory, and psychosocial impact of human immunodeficiency virus (HIV) infection in women. The WIHS will use a multi-site, prospective study design to gather data on the clinical, immunological, virological, and behavioral aspects of HIV infection and disease in women. This study will investigate the full spectrum of clinical disease caused by HIV infection in women. It also will seek to determine other cofactors that may be associated with HIV disease progression in women. 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, for the Women's Interagency HIV Study, 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. 017-001-10473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit, and for-profit research institutions; public and private organizations such as universities, colleges, hospitals or laboratories; units of State and local governments; and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Applicants must demonstrate the capability to recruit and maintain a minimum of 300 HIV-seropositive women and 75 HIV-seronegative women who engage in activities that put them at high risk of acquiring HIV infection; the proposed study population should reflect the socioeconomic, racial, and ethnic female populations infected with HIV. MECHANISM OF SUPPORT Applications funded under this RFA will be supported through the National Institutes of Health (NIH) cooperative agreement (U01). Cooperative agreements are awarded to institutions when it is desired to encourage investigator-initiated research in areas of special importance to the NIH and where substantial programmatic involvement by NIH staff is anticipated. The interaction of NIAID staff with the investigators is expected to assist and facilitate the research. This RFA represents a single competition with a specified deadline for receipt of applications. Reissuance of this RFA will be dependent on the state of science and findings at the completion of this cooperative agreement, as well as the availability of funds. FUNDS AVAILABLE Approximately $5,000,000 will be available for funding the total costs of the WIHS during its initial year. The earliest possible award date is July, 1993. The NIAID anticipates making two to five awards as a result of this RFA. The final number of awards to be made is dependent upon receipt of a sufficient number of applications of high scientific merit and the continuing availability of funds. BACKGROUND The number of cases of Acquired Immunodeficiency Syndrome (AIDS) diagnosed in women has increased rapidly since 1985. As of June 1992, more than 24,000 cases of AIDS in women had been reported to the Centers for Disease Control (CDC); in sharp contrast to the approximately 1,100 women reported by the end of 1985. Approximately 100,000 American women are estimated to be infected with HIV-1. These numbers are expected to continue to increase throughout the 1990s. Major deficiencies remain in understanding the clinical, immunological, and virological spectrum of HIV disease and AIDS in women. Gynecological manifestations of HIV infection have not been sufficiently studied despite early results indicating their importance. On the basis of these early reports, women-specific disease outcomes have been identified, suggesting the need for a large-scale prospective study of HIV infection and disease in women to address the multiplicity of research questions within a single research design. The primary purpose of this RFA is to develop a cooperative multi-site prospective epidemiologic study of the clinical, immunologic, and virologic and behaviorally-associated aspects of HIV disease progression in women. The CDC and NIAID have initiated the initial phase of this interagency prospective study of HIV-infected and uninfected women through the CDC's 1991 program announcement No. 115 (see Federal Register, vol. 56, no. 65, Thursday, April 4, 1991), the HIV Epidemiology Research Study (HERS). The data collection instruments (medical history intake questionnaires, physical exam protocols, and laboratory specimen collection forms) for this phase of the study are being developed collaboratively between the CDC, NIAID, the four currently funded clinical sites, and an interim data center. The data collection instruments developed for the HERS are available on request by faxing your request to Dr. Sandra Melnick at (301) 402-1506. When new sites are awarded under this RFA awardees will collaborate with the investigators from the CDC HERS sites to review the study data collection instruments and physical examination protocols, to arrive at compatible data collection procedures. RESEARCH OBJECTIVES The overall objectives of this project are to: o Describe the spectrum and course of the clinical manifestations of HIV infection in women, including those which may occur in the genital tract and oral cavity. o Describe the pattern and rate of decline of CD4+ cells in women and its relationship to other immunologic and virologic parameters, and to the clinical manifestations of HIV. o Investigate factors (e.g., infectious, treatment-related, nutritional, socioeconomic, drug-use related) which may delay or may accelerate HIV-induced immune dysfunction and specific manifestations of HIV-associated clinical disease. o Study the length of survival and quality of life of women living with HIV infection. Although the emphasis of this study is not on transmission of HIV, it will still be important to follow the initially HIV-seronegative women to: o Determine the rate of incident HIV seroconversion and factors that may increase the risk of incident HIV infection among a smaller cohort of women who are HIV-antibody negative at the time of study enrollment. Such factors may include age, race, and ethnicity. o Assess the feasibility of HIV vaccine trial initiation in HIV-seronegative women by assessing willingness to participate in vaccine efficacy trials. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. NOTE: This study fully meets the requirements for inclusion of women, in that it is exclusively comprised of female subjects. LETTER OF INTENT Prospective applicants are asked to submit, by January 11,1993, 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. The letter of intent is requested to provide an indication of the number and scope of applications to be reviewed. The letter of intent does not commit the sender to submit an application, nor is it a requirement for submission of an application. The letter of intent is to sent to Dr. Sandra Melnick Vaccine Trials and Epidemiology Branch Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2A28 6003 Executive Boulevard Bethesda, MD 20892 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91)is to used in applying for these cooperative agreements. These forms are available from the institutional offices of sponsored research and Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892, telephone 301/496-7441. 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, "WOMEN'S INTERAGENCY HIV STUDY", RFA AI-92-12 should be typed on line 2a of the face page of the application form and the "YES" box should be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed, identical 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 must be sent directly to Dr. Dianne Tingley AIDS RRS/SRB/DEA National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4C16 Bethesda, MD 20892 Applications must be received by both the Division of Research Grants (DRG) and Dr. Tingley by February 18, 1993. Applications received after February 18, 1993 will be returned to the applicant without review. REVIEW CONSIDERATIONS This application must be directed toward the objectives identified in the RFA. The primary factors that will be considered in the review of the application will be the demonstrated ability or potential to achieve the recruitment and retention goals, scientific merit of the research plans, and the capability to participate in this multicenter study. The RFA contains important additional information about review procedures and criteria. AWARD CRITERIA Scientific merit and technical proficiency, based on priority scores assigned by the scientific review group, will be the predominant criteria for determining funding priorities. However, after applications have been approved by the National Advisory Allergy and Infectious Diseases Council, NIAID staff reserves the right to consider the demographic features of the nationwide HIV epidemic among women and study cost-efficiency. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed. Direct inquiries regarding programmatic issues and requests for the RFA to: Dr. Sandra Melnick Vaccine Trials and Epidemiology Branch Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building Room 2A28 6003 Executive Boulevard Bethesda, MD 20892 FAX: (301) 402-1506 Direct inquiries regarding fiscal matters to: Ms. Jane Unsworth Chief, AIDS Grants Management Section/DEA National Institute of Allergy and Infectious Diseases Solar Building Room 4B25 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7075 FAX: (301) 480-3780 Direct inquiries concerning the review process and requirements to: Dr. Dianne Tingley AIDS RRS/SRB Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building Room 4C16 Bethesda, MD 20892 Telephone: (301) 496-0818 FAX: (301) 402-2638 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856, Microbiology and Infectious Disease Research and No. 93.855, Immunology, Allergic and Immunologic Diseases Research. Awards are made under authorization of the Public Health Service Act, Title IV,Part A (Public Law 78-410, as amended by Public Law 99-158,42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52, 45 CFR Part 74,and 45 CFR Part 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R7 END ************************************************************ $$R8 BEGIN CA-93-03 FULL-TEXT *************************************** THERAPEUTIC STUDIES OF PRIMARY CENTRAL NERVOUS SYSTEM MALIGNANCIES IN ADULTS NIH GUIDE, Volume 21, Number 41, November 13, 1992 RFA AVAILABLE: CA-93-03 P.T. 34; K.W. 0715035, 0705055, 0740015, 0740020 National Cancer Institute Letter of Intent Receipt Date: January 15, 1993 Application Receipt Date: March 10, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The Cancer Therapy Evaluation Program (CTEP) and the Radiation Research Program (RRP) of the Division of Cancer Treatment (DCT) at the National Cancer Institute (NCI) invite applications for cooperative agreements (U01) from consortia of institutions to perform Phase I and II clinical evaluations of promising new chemotherapeutic or biologic agents for the treatment of primary central nervous system (CNS) malignancies and to perform ancillary laboratory studies of aspects of CNS tumor biology with potential clinical implications. Integrated packages of individual applications are encouraged, with the lead institution of a proposed consortium indicating which participating institutions will provide organizational support, scientific leadership, laboratory capabilities, and/or patient resources. Each consortium of institutions will be referred to as a CNS Consortium (CNSC) for the purpose of this RFA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Therapeutic Studies of Primary Central Nervous System Malignancies in Adults, 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 North American non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, DCT clinical cooperative groups, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. It is essential that applications be submitted as an integrated package from a team or consortium (CNSC) of medical institutions (a minimum of three) that agree to work together with a single Project Leader and a single administration, and submit applications that will be reviewed in relation to the consortium. Together, the institutions in the consortium would encompass experience in investigational drug clinical trials, access to sufficient numbers of primary CNS tumor patients to enter a minimum of 60-80 fully evaluable cases per year onto Phase I and II protocols, expertise in laboratory investigation of the biology of human gliomas, and access to a Central Operations Office for coordination of research activities and data analysis. Except under unusual circumstances, the Central Operations Office/Coordinating Center would be expected to reside at the Project Leader's institution. MECHANISM OF SUPPORT Awards will be made as cooperative agreements that create an assistance relationship with substantial NCI programmatic involvement with the recipients during the performance of the project, as outlined in this RFA. The cooperative agreement mechanism is used when the NCI wishes to stimulate investigator interest and proposes to advise or assist in an important and opportune area of research. Support of this program will be through the Cooperative Agreement (U01), an assistance mechanism in which substantial NCI programmatic involvement with the recipient during performance of the planned activity is anticipated. The nature of NCI staff involvement is described in the RFA. Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise From owner-sci-resources@net.bio.net Wed Nov 11 22:00:00 1992 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 21, no. 41, pt. 4, 13 November 1992 Message-ID: Date: 12 Nov 92 18:15:01 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1247 $$XID RFA CA9303 CA-93-03 P1O1 ***************************************** THERAPEUTIC STUDIES OF PRIMARY CENTRAL NERVOUS SYSTEM MALIGNANCIES IN ADULTS NIH GUIDE, Volume 21, Number 41, November 13, 1992 RFA: CA-93-03 P.T. 34; K.W. 0715035, 0705055, 0740015, 0740020 National Cancer Institute Letter of Intent Receipt Date: January 15, 1993 Application Receipt Date: March 10, 1993 PURPOSE The Cancer Therapy Evaluation Program (CTEP) and the Radiation Research Program (RRP) of the Division of Cancer Treatment (DCT) at the National Cancer Institute (NCI) invite applications for cooperative agreements (U01) from consortia of institutions to perform Phase I and II clinical evaluations of promising new chemotherapeutic or biologic agents for the treatment of primary central nervous system (CNS) malignancies and to perform ancillary laboratory studies of aspects of CNS tumor biology with potential clinical implications. Integrated packages of individual applications are encouraged, with the lead institution of a proposed consortium indicating which participating institutions will provide organizational support, scientific leadership, laboratory capabilities, and/or patient resources. Each consortium of institutions will be referred to as a CNS Consortium (CNSC) for the purpose of this RFA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Therapeutic Studies of Primary Central Nervous System Malignancies in Adults, 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 North American non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, DCT clinical trials cooperative groups, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. It is essential that applications be submitted as an integrated package from a team or consortium (CNSC) of medical institutions (a minimum of three) that agree to work together with a single Project Leader and a single administration, and submit applications that will be reviewed in relation to the consortium. Together, the institutions in the consortium would encompass experience in investigational drug clinical trials, access to sufficient numbers of primary CNS tumor patients to enter a minimum of 60-80 fully evaluable cases per year onto Phase I and II protocols, expertise in laboratory investigation of the biology of human gliomas, and access to a Central Operations Office for coordination of research activities and data analysis. Except under unusual circumstances, the Central Operations Office/Coordinating Center would be expected to reside at the Project Leader's institution. Detailed requirements are listed below in Terms of Cooperation, Responsibilities of Awardees. The members of each proposed consortium should together fulfill the criteria listed below. A. Requirements for the Consortium (CNSC) as a whole: 1. A commitment to participate in multi-institutional protocols and documentation of facilities and professional personnel available, committed, and expert in conducting brain tumor clinical trials. This includes assignment of appropriate specialist collaborators including, but not limited to, medical oncologists, radiation therapists, neurologists, neurosurgeons, neuroradiologists, and neuropathologists. 2. A Central Operations Office/Coordinating Center for biostatistical support, collection, analysis, reporting, and quality control of data from Phase I and II trials and related laboratory investigations. Detailed requirements will be found in RESEARCH OBJECTIVES, DEFINITIONS. 3. The applicant CNSC and each of its participating clinical institutions must have adequate central data collection and processing capabilities and the capability to meet FDA and HHS requirements for the conduct of research using investigational agents. 4. Each CNSC, a minimum of three institutions, must have the demonstrated capability of accruing a minimum of 60 fully evaluable, histologically confirmed high-grade glioma patients per year who would be appropriate candidates for Phase I or Phase II clinical trials, and who have acceptable performance status and organ function to enter such trials. In the case of a consortium (CNSC) with more than three clinical member institutions, a minimum of 20 such evaluable patients per institution per year will be required. 5. The CNSC (consortium) must demonstrate an active laboratory program at one or more of its participant institutions that utilizes human glioma specimens or cell lines and would be able to take advantage of additional clinical specimens (and accompanying clinical data) to perform correlative studies bearing on the clinical behavior of CNS tumors and/or their response to therapeutic interventions. Experience with gliomas and/or other human CNS tumors must be documented by a record of publications or peer-reviewed grant support. 6. The CNSC must demonstrate laboratory capabilities among one or more of its participant institutions sufficient to perform at least two comprehensive pharmacokinetic studies per year of selected Phase I or Phase II drugs being evaluated by the consortium. Experience with pharmacokinetic data analysis and correlation of these data with clinical drug response must be documented, as must familiarity with the latest technology for the detection and quantitation of drugs and their metabolites in physiological fluids and tissues. (see RESEARCH OBJECTIVES, RESEARCH GOALS AND SCOPE below) B. Each participant institution in the CNSC must have a mechanism to collect and ship patient specimens to other members of the CNSC and other consortia under the guidelines established for the individual studies. Institutions involved in laboratory studies must have the capability to receive and conduct research studies on patient specimens not only from within their own centers, but also from other members of the CNSC and other consortia funded by this U01. There must also be a mechanism in place for the collection and transfer of patient and laboratory data to the Central Operations Office/Coordinating Center for analysis. C. Each institution participating in the clinical trials of the consortium must meet the following requirements: 1. Experienced full-time physician investigators associated with the project who have demonstrated expertise in Phase I/II studies. 2. A multi-disciplinary neuro-oncology team with clinician members representing expertise in the disciplines of medical and radiation oncology, neurology/neurosurgery, neuropathology and neuroradiology. 3. Adequate physician, nursing and data management resources to comply with all data reporting requirements of NCI-sponsored Phase I and II trials. 4. Patient populations to support adequate patient accrual (criteria determined by the consortium) with annual monitoring to assure continued enrollment of patients on Phase I and II trials. 5. Availability of state-of-the-art instrumentation for neurologic magnetic resonance imaging and for radiation therapy. 6. Appropriate drug control procedures as required for utilization of NCI-supplied experimental agents. 7. Capability of meeting FDA requirements in A3 above. MECHANISM OF SUPPORT Awards will be made as cooperative agreements, which create an assistance relationship with substantial NCI programmatic involvement with the recipients during the performance of the project, as outlined in this RFA. The cooperative agreement mechanism is used when the NCI wishes to stimulate investigator interest and proposes to advise or assist in an important and opportune area of research. Support of this program will be through the Cooperative Agreement (U01), an assistance mechanism in which substantial NCI programmatic involvement with the recipient during performance of the planned activity is anticipated. The nature of NCI staff involvement is described in Terms of Cooperation, Nature of Participation by NCI Staff. Applicants will be responsible for the planning, direction, and execution of the proposed project. 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 is a one-time solicitation. If it is determined that there is a sufficient continuing program need, the NCI will invite recipients of awards under this RFA to submit competitive continuation cooperative agreement applications for review according to the procedures described in Review Considerations, Part A. FUNDS AVAILABLE Approximately $1,500,000 in total costs per year for four years will be committed to specifically fund applications submitted in response to this RFA. It is anticipated that six to nine individual awards will be made to the members of one to three consortia. This funding level 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 four years. Although this program is provided for in the financial plans of the NCI, the award of cooperative agreements pursuant to this RFA is also contingent upon the continuing availability of funds for this purpose. RESEARCH OBJECTIVES A. Background Primary malignant brain tumors are responsible for approximately 12,000 deaths annually in the US. Astrocytomas of various histologic grades make up 65-70 percent of all primary, central nervous system (CNS) tumors. Other malignant histologies such as medulloblastomas, ependymomas, oligodendrogliomas, and CNS lymphomas make up an additional 15-20 percent of all cases. Standard treatment with surgery, radiation therapy, and chemotherapy has been shown to improve short term survival by two- to threefold, but in spite of aggressive, multimodality therapy and despite the fact that the majority of these cancers rarely metastasize, high-grade gliomas are nearly 100 percent lethal, and average survival usually ranges between 9-18 months. Surgery, radiation therapy, chemotherapy, and immunotherapy are limited in their effectiveness by the susceptibility of adjacent, normal brain to the adverse effects of treatment and by extensively infiltrating and/or resistant nests of malignant cells, and perhaps by other phenomena such as relative incapacity of the immune effector system and the brain's poor capacity for repair. In addition, clinical trials have been hampered by the fact that tumor status, the adverse sequelae of therapy, and the effects of ancillary treatments (such as steroids) are very difficult to segregate when assessed either by clinical examination or conventional diagnostic imaging. Clinical investigations of new means to treat such tumors are needed. Collaborative interactions between clinicians and laboratory scientists and between clinicians and diagnostic imagers are essential features of these investigations. The special skills of experienced tumor neurosurgeons, neuro-oncologists, radiation therapists, and neuroradiologists with access to the latest generation of imaging equipment will be required. NCI is therefore seeking multidisciplinary and multiinstitutional teams of talented scientists from non-profit and for-profit research organizations who will interact with the Cancer Therapy Evaluation Program (CTEP) and Radiation Research Program (RRP) in a concerted way to conceive, create, and evaluate new approaches to therapy of CNS malignancies. Scientific approaches should be broad and reflect the creativity and capabilities of team participants, including surgical, medical, radiotherapeutic, diagnostic imaging, laboratory and statistical skills. New clinical research opportunities exist with the development of novel cytotoxic drugs, radiation sensitizers, differentiating agents, immune modulators, monoclonal antibodies, and new approaches to gene therapy. Among the agents and techniques currently under development that appropriately might be studied by such a consortium are: temozolomide, the topoisomerase-1 inhibitors, taxol and its analogues, inhibitors of cytokines such as suramin or the TNF-` inhibitor pentoxifylline, differentiation-inducers, newer polyamine analogs, inhibitors of O6-methylguanine-DNA methyltransferase or mdr-1/P-glycoprotein or other drug resistance inhibitors, antisense oligonucleotides, monoclonal antibodies to appropriate cellular targets such as gangliosides, the novel bioreductive agent SR-4233, which is cytotoxic to hypoxic cells preferentially, and others, alone and in potential combination with sophisticated regional approaches such as brachytherapy, radiosurgery, or other modalities. Team objectives and approaches will be investigator-originated but consistent with program aims of improving the survival and quality of life for persons with primary CNS malignancies and providing fundamental insights into the biology of these tumors. B. Definitions COOPERATIVE AGREEMENT - An assistance mechanism in which substantial NCI programmatic involvement with the recipient is anticipated during performance of the planned activity. CENTRAL NERVOUS SYSTEM CONSORTIUM (CNSC) - The consortium of institutions (minimum of three members) who are submitting research grant applications together to conduct Phase I/II clinical trials and ancillary laboratory studies. Each CNSC also contains an application for a Central Operations Office/Coordinating Center. Each consortium will consist of talented and experienced individuals in multiple disciplines (e.g. medical oncology, neurosurgery, neurology, radiotherapy, radiobiology, pharmacology, molecular biology, pathology, biostatistics). CENTRAL OPERATIONS OFFICE/COORDINATING CENTER - An administrative unit that coordinates all CNSC activities. Responsibilities include administrative management, coordination of protocol development and submission, study conduct, quality control and protocol performance monitoring, statistical analyses, adherence to requirements regarding NCI drug accountability and FDA, OPRR and HHS regulations, and protocol and institutional performance reporting. Statistical responsibilities include experimental design, participation in study planning and coordination, collection and analysis of patient and laboratory data, data management and analysis, data monitoring, and reporting of data. The Central Operations Office/Coordinating Center may consist of a consortium with the statistics center located at another institution. PROJECT LEADER - The person who submits the application for the Central Operations Office/Coordinating Center and who is responsible for the CNSC as a whole. The consortium of participant institutions must agree to work together with the Project Leader. The Project Leader is responsible for coordinating the CNSC activities scientifically and administratively. The Project Leader may be the principal investigator on a participant institution application. PARTICIPANT INSTITUTION - The individual research grant application from an institution who is participating in the CNSC. The participant institution may conduct clinical trials and/or laboratory studies. PRINCIPAL INVESTIGATOR - The person who submits the single application for the participant institution and who is responsible for performance of the key personnel of that application. The Principal Investigator provides the scientific leadership for the participant institution. PROGRAM DIRECTOR - The staff member from the Cancer Therapy Evaluations Program, Division of Cancer Treatment (cited in the INQUIRIES SECTION) who coordinates NCI interactions, interacts scientifically with the CNSC, and provides guidance for the overall program within the NCI. C. RESEARCH GOALS AND SCOPE The primary goal of this initiative is to stimulate clinical research in the treatment of primary CNS malignancies in adult patients by providing support for consortia of institutions to perform Phase I and II clinical evaluations of promising new chemotherapeutic or biologic agents. A secondary goal is to utilize the consortia as a mechanism for sharing human brain tumor specimens among investigators conducting laboratory studies relevant to the biology, clinical behavior, or therapy of CNS tumors, particularly malignant gliomas. Clinical trials will take advantage of new developments in drug and radiation resistance, radiation sensitization, biological response modification, immune modulation, induction of apoptosis, differentiation induction, therapeutic irradiation techniques, induction or suppression of specific gene function, or other innovative approaches. Each CNSC will be formed for the purpose of: (1) sharing expertise of researchers in multiple disciplines; (2) conducting joint phase I and II clinical trials to provide adequate patient populations and timely completion; and (3) sharing of tumor specimens and data useful in the conduct of clinical pharmacologic and correlative laboratory studies. Participant institutions in the proposed consortium may be involved in clinical trials and/or laboratory studies. It is anticipated that one to three consortia will be established, comprising three to nine institutions. Each CNSC will select the specific agents to be tested in accord with their scientific interest and expertise and will develop a series of appropriate Phase II or Phase I trials with supporting protocol documents. Each applicant CNSC should submit as examples one or more draft clinical protocols as supplements to the Central Operations Office/Coordinating Center (Project Leader) and the participant institution applications. The CNSC, along with the assistance of the NCI Program Director, will develop a plan for prioritization of investigational trials. The NCI may provide NCI-sponsored IND agents or provide assistance to the awardee(s) by sponsoring or cross-referencing INDs for selected agents. Each CNSC must have documented numbers of patients with CNS tumors and a history of accrual of patients to clinical trials adequate for two-six phase I or II trials (60- 180 patients) per year. It is expected that all of the CNSC institutions together will be able to complete approximately six phase I or phase II trials (180 patients) per year. In addition, proposed consortia must have: (1) adequate radiotherapy support for clinical trials utilizing radiation in combination with other modalities; (2) adequate central data collection and processing capabilities as well as biostatistical expertise; (3) adequate pathology support for both institutional tumor classification and central neuropathology review and for banking and distribution of tumor tissues for concurrent and future laboratory studies; (4) mechanisms to collect and store patient specimens for laboratory studies being conducted by institutions in the CNSC; (5) expertise in antineoplastic drug pharmacology/pharmacokinetics. The correlative laboratory research program in a CNSC should address at least one field of research into the biology of human malignant gliomas with some potential for future clinical relevance. Examples of research fields for laboratory studies include: molecular genetics and cytogenetics, gene function and expression, signal transduction pathways, radiobiology, growth regulation, metabolism, differentiation and gene modulation by investigational agents, intracellular metabolism, mechanisms of drug resistance in tumor cells, CNS pharmacokinetics, invasion and spread, cytokine production or interactions, immune function and antigen expression, or other aspects that may have clinical implications or lead to new therapeutic approaches. Investigators are not limited to the above areas of laboratory experimentation. Correlative laboratory studies need not be directly related to individual clinical Phase I/II trials but should attempt to utilize the large clinical database that will be generated by the consortium to identify potential correlates of tumor behavior, and laboratory studies should be based on strong and testable hypotheses. A clear rationale should be given for the experimental design and technological methodologies selected. Preliminary data from appropriate tumor models or analysis of patient specimens should be provided to support the feasibility of each study. The laboratory assays must utilize tumor specimens from patients and there should be an established plan for prioritization of specimen distribution to collaborating laboratories. Participating institutions primarily involved in laboratory studies may accrue patients on CNSC clinical trials if the minimum clinical resources are in place (See Eligibility Requirements). The cooperative approach outlined in this RFA allows for interactions among successful applicants, with the assistance of NCI extramural staff, to perform Phase I and Phase II trials of anticancer agents and ancillary laboratory studies. This mechanism retains the decision-making prerogatives of the Principal Investigator and his/her colleagues, but at the same time, permits the active participation of NCI in research activities. (See Terms of Cooperation) SPECIAL REQUIREMENTS A. Terms of Cooperation The cooperative agreements will require cooperation between an NCI Program Director and the Project Leader(s) of the CNSC(s). The NCI Program Director will assist in coordinating the activities of the CNSC as defined below and in facilitating exchange of information. These Terms of Cooperation are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Part 74, and other HHS, PHS and NIH grant administration policy statements. Nature of Participation by NCI Staff The role of the CTEP and RRP staff as described throughout these terms of cooperation is to assist and facilitate but not to direct research activities. This cooperative agreement is part of a larger program of investigational agent development in the NCI. Each of the CTEP staff listed below has very specific and well defined responsibilities in terms of investigational agent development and the role of DCT as a drug sponsor as defined in 21 CFR Part 312. 1. CTEP and RRP as a Scientific Resource for NCI-supported Phase I and II Clinical Trials Investigations The NCI Program Director (cited in the INQUIRIES SECTION) will serve as a resource available to the CNSC for scientific information with respect to treatment regimens and clinical trial design. The Cancer Expert, RRP, will serve as a resource for specific scientific information with respect to radiation therapy and diagnostic imaging of CNS tumors. The NCI Program Director will assist the CNSC as appropriate in developing information concerning the scientific basis for specific trials and also will be responsible for advising the CNSC of the nature and results of relevant trials being carried out nationally or internationally. The NCI Program Director will sponsor an initial strategy meeting with the awardees to review the research plans proposed to ensure that they are compatible with the overall goals of the RFA, to ensure avoidance of duplication of effort, and to ensure the most effective use of available resources, including investigational agents. The NCI Program Director will also sponsor strategy meetings semi-annually or as needed, to be attended by investigators in the CNSC and other investigators as appropriate. At these meetings relevant information will be reviewed, national research goals discussed, and the outstanding research questions established and prioritized by the CNSC investigators. The Program Director will also provide updated information on the efficacy and toxicity of investigational new agents supplied to the CNSC under an Investigational New Drug (IND) Application sponsored by the DCT. 2. CTEP Assistance in Protocol Development The protocol must be a detailed written plan of a clinical experiment mutually acceptable to the proposing CNSC and to the CTEP Protocol Review Committee (PRC). Communication at the various stages of protocol development is encouraged as necessary to promote protocol development and implementation. All protocols should be preceded by a written Letter of Intent (LOI) from the CNSC declaring interest in conducting a particular study. The LOI should be sent to the CTEP LOI Coordinator who receives, logs in and schedules LOIs for review by the PRC (see Section - Responsibilities of Awardees). The PRC will formally review the LOI. Following review, the NCI Program Director will provide a Program response to the CNSC and will address the following issues: (a) the existence and nature of concurrent clinical trials in the area of research, pointing out possible duplication of effort; (b) information including relevant pharmacokinetic and pharmacodynamic data concerning investigational agents; (c) availability of investigational agents, including biologic response modifiers; (d) the scientific rationale and value of the proposed study, the design, the statistical requirements; and (e) the implementation of the study, if indicated. The LOI mechanism is designed for preliminary review and is recommended to expedite protocol development and implementation and to facilitate agreement on study priority and design (see the DCT Investigator's Handbook, pp 32-35, available on request from Dr. Richard Kaplan at the address below, for further discussion of these mechanisms). 3. CTEP Review of Proposed Protocols CNSC protocols will be reviewed by the PRC which meets weekly. It is chaired by the Associate Director, CTEP. Ad hoc reviewers, external to NCI, will be utilized when deemed appropriate by the PRC chairperson. Following the review of the protocol by the PRC, the NCI Program Director will provide the CNSC with a consensus review that describes recommended modifications and other suggestions, as appropriate (see the DCT Investigator's Handbook, for further information regarding protocol review at CTEP). The major considerations relevant to Protocol Review by CTEP include: (a) the strength of the scientific rationale supporting the study; (b) the medical importance of the question being posed; (c) the avoidance of unnecessary duplication with other ongoing studies; (d) the appropriateness of study design; (e) consistency with development plans for particular IND agents; (f) a satisfactory projected accrual rate and follow-up period; (g) patient safety; (h) compliance with federal regulatory requirements; (i) adequacy of data management; (j) appropriateness of patient selection, evaluation, assessment of toxicity, response to therapy and follow-up; and (k) method of monitoring to be used. If a proposed protocol is disapproved, the specific reasons for lack of approval will be communicated in writing by the NCI Program Director to the CNSC as a consensus review within 30 days of protocol receipt by the NCI. NCI will not provide investigational drugs or permit expenditure of NCI funds for a protocol that it has not approved. The NCI Program Director will be available to assist the CNSC in developing a mutually acceptable protocol, consistent with the research interests, abilities and strategic plans of the CNSC and of the NCI. Disagreements arising pursuant to protocol approval will be submitted to an arbitration panel to determine the suitability of a protocol that has been disapproved. An arbitration panel composed of one CNSC nominee, one NCI nominee, and a third member with oncologic clinical trials expertise chosen by the other two nominees will be formed to review the CTEP decision and recommend an appropriate course of action to the Director, DCT. These special arbitration procedures in no way affect the awardee's right to appeal an adverse determination in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. The CNSC will not expend NCI funds to conduct any study disapproved by CTEP unless CTEP's disapproval has been modified by the arbitration process outlined above. 4. CTEP Review of Quality Control and Study Monitoring The Head, Quality Assurance and Compliance Section (QACS), Regulatory Affairs Branch (RAB), CTEP will review and provide advice, through the NCI Program Director, regarding mechanisms established by the CNSC for quality control of therapeutic and diagnostic modalities employed in its trials. (See RESPONSIBILITIES OF AWARDEES). The Head, QACS will review the CNSC procedures and policies for study monitoring including the awardees' on-site monitoring program (See 8. CTEP Review of Federally Mandated Regulatory Requirements). 5. CTEP Review of Data Management and Analysis The Chief, Biometrics Research Branch (BRB), CTEP will review CNSC mechanisms for data management and analysis. (See RESPONSIBILITIES OF AWARDEES). When deemed appropriate, The Chief, BRB will make recommendations to the CNSC, through the NCI Program Director, to ensure that data collection and management procedures are: (a) adequate for quality control and analysis; (b) as simple as appropriate in order to encourage maximum participation of physicians entering patients and to avoid unnecessary expense; and (c) sufficiently uniform across the CNSC participants. 6. CTEP Involvement in Protocol Closure The NCI Program Director will monitor protocol progress. When a study involves a DCT IND agent, the Head , QACS and the Investigational Drug Branch (IDB) Physician (Drug Monitor) who is assigned to each DCT IND agent to coordinate its development will also monitor progress. The NCI Program Director may request that a protocol study be closed to accrual for reasons including: (a) insufficient accrual rate; (b) accrual goal met; (c) poor protocol performance; (d) patient safety and regulatory concerns; (e) study results are already conclusive; and (f) emergence of new information that diminishes the scientific importance of the study question. NCI will not provide investigational agents or permit expenditures of NCI funds for a study after requesting closure (except for patients already on-study). For any study, whether involving an investigational drug or not, NCI will establish an arbitration process for investigators who wish to appeal protocol closure. This process will be identical to that described above for protocol disapproval. 7. CTEP involvement in Investigational New Drug Applications a. The NCI will have the option to cross file or independently file an IND on investigational drugs evaluated in the Phase I and II Clinical Trials. This would apply to drugs not developed in the NCI drug development program. b. The NCI Program Director assisted by the Chief, RAB, CTEP will advise investigators of specific requirements and changes in requirements concerning IND sponsorship that the FDA may mandate. Investigators performing trials under cooperative agreements will be expected, in cooperation with the NCI, to comply with all FDA monitoring and reporting requirements for investigational agents. c. Investigators performing NCI funded Phase I and II Clinical Trials will be advised by the NCI Program Director of potential studies that will be relevant to new avenues of cancer therapy. When this involves investigational agents, the NCI Program Director assisted by the Chief, RAB, CTEP will advise the investigators of the specific clinical information that will be needed from the clinical trials for that information to be acceptable to the FDA for inclusion in a new drug application (NDA). 8. CTEP Review of Federally Mandated Regulatory Requirements The Head, QACS, through the NCI Program Director, will advise the CNSC regarding mechanisms to meet FDA regulatory requirements for studies involving DCT-sponsored investigational agents and the Office for Protection from Research Risks (OPRR) requirements for the protection of human subjects by the CNSC institutions. (See RESPONSIBILITIES OF AWARDEES, below) For specific Phase I and II trials with NCI-sponsored investigational agents, the NCI has contracted for a Clinical Trials Monitoring Service (CTMS) to document regulatory compliance, to maintain a computerized data base and to produce periodic routine reports of the results, and special reports as necessary. For Phase I studies, CTEP determines that the CTMS monitoring described above is necessary using the following guidelines: (a) Introduction of drug into humans for the first time; (b) Early Phase I studies using a single agent; (c) Concern for safety of patients; (d) PRC expresses concern with excessive toxicity. Phase II studies may also be monitored as noted above if PRC expresses concern with excessive toxicity. For these trials, awardees may be visited by the CTMS contractor three times a year. Phase II studies may also be monitored if PRC expresses concern with excessive toxicity. For these Phase I and II trials, awardees may be visited by the CTMS contractor three times a year. The required biweekly data submissions to the CTMS are described under RESPONSIBILITIES OF AWARDEES Section 9.d. For Phase II trials with DCT IND agents not requiring the above described monitoring, NCI will delegate to the awardee the task of providing an independent audit of each research study. The NCI's Clinical Trials Monitoring Service (CTMS) contractor shall be used to conduct these audits. The staff of QACS will perform random audits of the awardee to assure that the awardee is performing the delegated audit duties. Audit schedules and final audit reports will be provided to QACS, CTEP. Institutional responsibilities for monitoring are described below under RESPONSIBILITIES OF AWARDEES Section 9.c. 9. Access to Data The NCI will have access to all data generated under this cooperative agreement and may periodically review the data. Data must also be available for external monitoring as required by NCI's Drug Master File Agreement with the FDA relative to the responsibility of the NCI as an IND agent sponsor. The awardee will retain custody and primary rights to the data consistent with current HHS, PHS and NIH policies. 10. CTEP Review of Progress Performance of each CNSC will be reviewed at least annually by the NCI Program Director on the basis of the information provided at the CTEP sponsored Meetings, in the annual progress reports and in the data summary reports submitted to the IDB Drug Monitor or by CTMS reports. In addition, periodic accrual information may be requested from the CNSC by the NCI Program Director for all active studies when deemed appropriate. Insufficient patient accrual or progress, or noncompliance with the terms of award, including these Terms of Cooperation, may result in a reduction of budget, withholding of support, suspension or termination of the award. RESPONSIBILITIES OF AWARDEES It is the responsibility of the CNSC to develop the details of the clinical and laboratory research design, including definition of objectives and approaches, planning, implementation, analysis, and publication of results, interpretations and conclusions of studies. The CNSC shall, with CTEP assistance, develop Phase I and II protocols for clinical cancer research in accord with the research interests of the CNSC, abilities and goals, and submit them to CTEP (either to the LOI Coordinator or to the CTEP Protocol and Information Office, the receiving office for all protocols sent to CTEP) for review as appropriate prior to their implementation. 1. Protocol Development It is anticipated that decisions in all CNSC activities will be reached by consensus of the collaborating member institutions under the leadership of the CNSC Project Leader. The Project Leader shall designate a Protocol Chairperson for each proposed study. The Project Leader along with coordinating Central Operations Office/Coordinating Center staff will be responsible for communication with the appropriate CTEP staff. 2. The CNSC Central Operations Office/Coordinating Center The CNSC Central Operations Office/Coordinating Center, under the leadership of the Project Leader and with CTEP assistance, is responsible for coordinating protocol development, protocol submission, study conduct, quality control and study monitoring, drug ordering, data management, statistical analysis, protocol amendments/status changes, adherence to requirements regarding investigational drug management and federally mandated regulations and protocol and performance reporting. All the scientific and administrative decisions related to the CNSC funded activities and made by the CNSC institutions or affiliates will be coordinated by the Project Leader with the assistance of the CNSC Central Operations Office/Coordinating Center. 3. Protocol Submission The CNSC Central Operations Office/Coordinating Center, under the leadership of the Project Leader, will submit CNSC protocols to the CTEP Protocol and Information Office in a timely fashion for review and approval by NCI. All protocols should be preceded by a written Letter of Intent (LOI) from the CNSC to the CTEP LOI Coordinator declaring interest in conducting a particular study. The LOI shall describe the hypothesis to be investigated, the general design of the contemplated trial plus relevant information on accrual capabilities to document feasibility. Protocols will be developed and submitted and studies will be conducted in accordance with the "DCT GUIDELINES FOR MULTICENTER INVESTIGATIONAL AGENT STUDIES" (available upon request from Dr. Richard Kaplan at the address below). The Project Leader, with the assistance of the Central Operations Office/Coordinating Center staff, will communicate the results of the NCI review of protocols to the CNSC participating institutions. 4. Prioritization of Studies The CNSC Project Leader and the Principal Investigators of the participant institutions will develop, together with the NCI Program Director, mutually acceptable plans for prioritization of clinical protocols, laboratory studies, and distribution of clinical specimens and tissues. 5. Quality Control The CNSC will establish mechanisms for quality control of therapeutic and diagnostic modalities employed in its trials. Quality control at a minimum must consist of: a) Pathology: Verification of pathologic diagnosis in cases where known variability in the accuracy of histologic diagnosis is a potentially serious problem and where pathology data may provide important prognostic information. b) Radiation Therapy: Review (either concurrent or retrospective) of port films and compliance with protocol-specified doses for individual patients, where relevant. Determination of adequacy of radiation delivery with the assistance of the Radiological Physics Center (RPC), whose functions usually include equipment dosimetry, periodic institutional visits and other aspects of physics review. c) Chemotherapy: Review of flow sheets with determination of protocol compliance in dose administration and dosage modification. d) Neurosurgery: Assessment of adequacy of protocol-specified surgical procedures (where relevant) through review of operative notes and study-specific surgical forms. e) Diagnostic Imaging: Central review of claimed responses and adequacy of imaging. 6. Study Monitoring The CNSC will establish mechanisms for study monitoring. The CNSC is responsible for assuring accurate and timely knowledge of the progress of each study through: a) establishing procedures for assigning dose level at the time a new patient is entered, and assuring that the required observation period has elapsed before beginning a higher dose level; b) tracking and reporting of patient accrual and adherence to defined accrual goals; c) ongoing assessment of case eligibility and evaluability; d) timely medical review and assessment of patient data; e) rapid reporting of treatment-related morbidity (adverse drug reactions) and measures to ensure communication of this information to all parties; f) interim evaluation and consideration of measures of outcome, as consistent with patient safety and good clinical trials practice; g) timely communication of results of studies; and h) an on-site monitoring program (see 9c below). i) establishing data management support capabilities which assure that data will be submitted via electronic transfer to the NCI's Clinical Trials Monitoring Service (CTMS) when required. (See 9d below) 7. Data Management and Analysis The CNSC will develop procedures to ensure that data collection and management are: (1) adequate for quality control and analysis; (2) as simple as appropriate in order to encourage maximum participation of physicians entering patients and to avoid unnecessary expense; and (3) sufficient across the participating institutions. 8. Investigational Drug Management Investigators performing trials under cooperative agreements must be NCI registered investigators (form 1572) and will be expected to implement CTEP requirements described in the DCT Investigators' Handbook for storage and accounting for investigational agents, to abide by NCI/HHS Drug Accountability Records (DAR) procedures, and to comply with all FDA requirements for investigational agents. 9. CNSC Compliance with Federally Mandated Regulatory Requirements The CNSC is responsible for establishing procedures for all participating institutions to comply with FDA regulations for studies involving investigational agents and OPRR requirements for the protection of human subjects. These procedures are: a) methods for assuring that each institution where investigators are conducting CNSC trials has a current, approved assurance on file with the OPRR; that each protocol is reviewed and approved by the responsible Institutional Review Board (IRB) prior to patient entry; that each protocol is reviewed at least annually by the IRB so long as the protocol is active; that each investigator is registered with the Drug Management and Authorization Section (DMAS), CTEP, with a current 1572 form on file; and that each patient (or legal representative) gives written informed consent prior to entry on study. b) a system for assuring timely reporting of all serious and unexpected toxicities to the IDB, CTEP according to CTEP guidelines (mailed annually to all registered investigators). This requires reporting Adverse Drug Reactions (ADRs) by telephone to the IDB Drug Monitor within 24 hours of the event and requires a written report to follow within 10 working days. c) an on-site monitoring program which assures that a sampling of records at each participating institution is audited at least two times during the cooperative agreement period. The on-site audit will address issues of data verification and compliance with regulatory requirements for the protection of human subjects and investigational agent accountability. Any serious problems with data verification or compliance with Federal regulations must be reported to the Head, QACS immediately. Otherwise, written reports must be submitted within six weeks of each audit. All audit schedules are to be provided to the Head, QACS at least four weeks prior to the date of the audit. d) For the specific Phase I and Phase II trials that require monitoring by the CTMS three times a year, information must be provided via electronic transfer to the CTMS at two week intervals and includes: notification of each patient entered onto a Phase I or II protocol within the previous two week period, and all data obtained on each registered patient within the previous two weeks as specified by the NCI/DCT Standard Case Report Form and the individual protocol. e) implementation of the CTEP requirements described in the DCT Investigators Handbook for storage and accounting for investigational agents provided under DCT sponsorship. 10. Progress Review The CNSC will establish a mechanism for assessing performance of its members, with particular attention to accrual of adequate number of eligible patients onto consortium trials, timely submission of required data, conscientious observance of protocol requirements, authorship and participation in group leadership. This mechanism will include a procedure for recommending an adjustment of institutional funds within the consortium as appropriate for the level of participation in consortium activities, including (but not limited to) accrual. 11. Attendance at Meetings The CNSC Project Leader and appropriate representative(s) of the CNSC participating institutions, shall meet twice a year with the NCI Program Director to review CNSC progress, establish priorities, and plan future activities. Additional meetings between the NCI Program Director and the Project Leader will be held if necessary. 12. Reporting Requirements Reporting requirements will be in agreement with FDA regulations and NCI procedures. Annual progress reports will be submitted to the NCI and will include at a minimum summary data on protocol performance by the awardee and each participating institution. In addition, data summary reports will be requested prior to the due date of the annual report to the FDA required of IND sponsors. The types of reports required are determined by CTEP at the time of protocol review. They are: (a) Quarterly Data Updates (QDA) for late Phase I trials not CTMS monitored; (2) Annual Data Updates (ADU) for late Phase I/Phase II combination studies sent to Protocol Chairman to summarize clinical data and progress; (3) Study summaries sent annually to summarize clinical data for Phase II studies. A system for providing such information in a timely manner must be in place. 13. Publication of Data Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement will require appropriate acknowledgement of NCI support. The NCI will have access to all data generated under this cooperative agreement and may periodically review the data. The awardee will retain custody and primary rights to the data consistent with current HHS, PHS and NIH policies. SPECIAL INSTRUCTIONS FOR PREPARATION OF COOPERATIVE AGREEMENT APPLICATIONS The grant application form PHS 398 (rev. 9/91) is to be used for the cooperative agreement application. The general instructions, e.g., for format and budget issues, included in the application packet must be followed. Because the Terms of Cooperation discussed 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 staff involvement. All costs required for these studies must be included in the application and must be fully justified. These costs include the additional costs of clinical research associated with Phase I and Phase II studies including costs for patient accrual, sample handling, laboratory studies, quality assurance, data management and data analysis, study monitoring, travel, an on-site audit program and the biweekly electronic data submissions to the NCI's Clinical Trials Monitoring Service when required. For Phase II trials with DCT IND agents for which the awardee is responsible for providing the on-site monitoring, the awardee shall contract with the NCI's Clinical Trials Monitoring Service for the performance of audits. The awardee(s) will be expected to provide two audits per institution during the cooperative period and to request funding accordingly. Funds requested for the audit program will be restricted for this purpose only. The on-site audit requirements are described in the above section entitled SPECIAL REQUIREMENTS, TERMS OF COOPERATION, RESPONSIBILITIES OF AWARDEE. Each CNSC should anticipate the need to attend two meetings per year to share data and to coordinate activities. Travel funds for two representatives from the Central Operations Office/Coordinating Center and one or two representative(s) from each participant clinical and/or laboratory member institution should be included in the budget. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Section 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants/offerors 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 policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit by January 15, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Project Leader, 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 is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Dr. Richard Kaplan Cancer Therapy Evaluation Program Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 6130 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 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, Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda, MD 20892, telephone (301) 496-7441; and from the NCI Program Director named below. The Central Operations Office/Coordinating Center as lead institution should submit a research grant application in which they should list the anticipated participant institutions, and include proposed clinical protocols in the Appendix. (The Central Operations Office/Coordinating Center application must be a separate document from any application from a participant institution; if a single institution will be applying for both participation in clinical and/or laboratory studies and as the Central Operations Office/Coordinating Center, two applications will be necessary.) Each participant institution should submit an individual research grant application and should indicate the Central Operations Office/Coordinating Center of the CNSC consortium in which they intend to participate. Participant institutions conducting clinical trials should include copies of the proposed CNSC clinical protocols in the Appendix. The grant application should describe the nature of their participation and justify budget requests for the protocols. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package: 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: Referral Officer Division of Extramural Activities National Cancer Institute Westwood Building, Room 838 5333 Westbard Avenue Bethesda, MD 20892 Applications must be received by March 10, 1993. If an application is received after that date, it will be returned. 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 for completeness by DRG and responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. Applications that are judged non-responsive will be returned by the NCI. An application judged to be non-responsive to this RFA may be submitted as an investigator initiated regular research grant (R01) or program project grant (P01) at the next receipt date. The application would require modification in accordance with either the R01 or P01 guidelines. The new application would not be considered an application for a Cooperative Agreement, nor would it be considered a response to an RFA. Questions concerning the relevance of proposed research to the RFA may be directed to program staff as described in the INQUIRIES section below. Applications may be triaged by an NCI peer review group on the basis of relative competitiveness. The NCI will withdraw from further competition those applications judged to be noncompetitive for award and notify the applicant and institutional business official. Those applications judged to be both competitive and responsive will be further evaluated, using the review criteria stated below, for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review will be provided by the National Cancer Advisory Board. B. REVIEW CRITERIA 1. Applications for the Central Operations Office/Coordinating Center will be reviewed on the basis of the following criteria: o Scientific, technical, and medical significance and originality of proposed research as reflected in the protocols, research plans and strategies that address the clinical and laboratory considerations in the CNSC as a whole. o Qualifications and research experience of the Project Leader, Principal Investigators, and the key personnel including, but not limited to, previous experience with design and administration of multi-institutional clinical trials and correlative laboratory studies. o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the CNSC objectives including: o adequacy of plans for the development, implementation and analysis of multi-institutional clinical trials o adequacy of plans for correlative laboratory studies and evaluation of the data with respect to treatment administration or treatment outcome o adequacy of statistical approach for correlating research studies with treatment outcomes in clinical trials o Adequacy of plans for effective collaboration between laboratory and clinical investigators and the Central Operations Office/Coordinating Center within the consortium. Documentation of commitment of the Program Leader and each Principal Investigator and of key personnel to the goals of the CNSC. o Adequacy of the available facilities and data management resources and personnel. Evidence of the competence of the Central Operations Office/Coordinating Center with regard to the mechanisms for CNSC administration, experimental design, quality control, study monitoring, data management and reporting, statistical analysis, and compliance with regulatory requirements. o Demonstration of access to sufficient numbers of evaluable patients for Phase I and II clinical trials and followup by the CNSC (see Eligibility Requirements) and access to adequately processed tissue samples from a proportion of these patients. o Plans for effective interaction and coordination among participant institutions within the consortium, with other consortia working on CNS tumors, and with the NCI. 2. Applications for participant institutions will be reviewed on the basis of the following criteria: o The overall qualifications of applicant institutions to meet the eligibility requirements for participant institutions (see Eligibility Requirements) o Scientific merit and feasibility of the proposed research. o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. o Demonstration of availability of and access to sufficient numbers of evaluable patients for the conduct of phase I and II clinical trials. Evidence of ability to accrue patients to clinical trials. o Clinical and/or basic research experience, training, time availability, and research competence of the investigators involved. o Adequacy of plans for pathology support for tumor classification and for banking and distribution of patient specimens for concurrent and future studies. o Availability of state-of-the-art imaging equipment, especially MRI. The availability of MRS, SPECT, PET and other imaging techniques will be considered favorable additional assets. o Adequacy of state-of-the-art radiotherapy equipment. The availability of equipment for stereotactic radiosurgery and brachytherapy is not required, but would also be considered as assets to the application. o Adequacy of the available facilities and data management resources. o Adequacy of provisions for the protection of human subjects. o Adequacy of the plans for inclusion of females and minorities. The reviewers will also judge the appropriateness of the proposed budget and duration in relation to the scientific merit and feasibility of the proposed research. AWARD CRITERIA The anticipated date of award is September 1993. In addition to the technical merit of the application, NCI will consider how well the CNSC and participant institution met the goals and objectives of the program as described in the RFA. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not specific proposed research would be responsive are strongly encouraged and should be directed to program staff listed below. The program staff welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues to: Dr. Richard Kaplan, Senior Investigator Cancer Therapy Evaluation Program Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 Direct inquiries regarding fiscal matters to: Ms. Katharine Schulze Grants Administration Branch National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 16 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.395, Cancer Treatment Research. Awards are made under the authorization of the Public Health Service Act, Title IV Sections 301, 410, and 411, Part A (Public Law 78-410, 42 USC 241 as amended, Public Law 99-158, 42 USC 285a) 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 Agency review. From owner-sci-resources@net.bio.net Sun Nov 15 22:00:00 1992 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 - 15 November 1992 Message-ID: Date: 16 Nov 92 18:23:27 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 58 ** NEW DOCUMENTS ON STIS ** Document Type: General Publication Title: NSF 92-123 - Directorate for Engineering, Program Descriptions File size (bytes): 117557 STIS Filename: nsf92123 Document Type: Program Guideline Title: NSF 90-20 - Earth Sciences Research at the National Science Foundation File size (bytes): 41941 STIS Filename: nsf9020 ------------------------------------------------------------------------ ** 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 nsf9020, the text of your message should be as follows: get nsf9020 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9020, you would enter: ftp> get nsf9020 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet) or "pubs@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 Fri Nov 20 22:00:00 1992 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: Computational Science and Engineering Posdoctoral Assoc. Message-ID: Date: 21 Nov 92 02:11:38 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 325 I'm passing along this note that I received from NSF. Sincerely, Dave Kristofferson BIOSCI/bionet Manager kristoff@net.bio.net --------------- Attached is the program announcement for the CISE Computational Science and Engineering Postdoctoral Research Associate. In the past this type of award has helped to support postdocs in the biological sciences (5 out of 18 awarded in FY92). The deadline is January 19, 1993. PLEASE distribute this to anyone who might be interested! Title : NSF 92-120 - CISE Postdoctoral Research Associates in Computational Science and Engineering CISE Postdoctoral Research Associates in Experimental Science Type : Program Guideline NSF Org: CISE Date : November 5, 1992 File : nsf92120 CISE Postdoctoral Research Associates in Computational Science and Engineering CISE Postdoctoral Research Associates in Experimental Science The Computer and Information Science and Engineering (CISE) Directorate of the National Science Foundation plans a limited number of grants for support of Postdoctoral Research Associateships contingent upon available funding. The Associates are of two types: Associateships in Computational Science and Engineering (CS&E Associates) supported by the New Technologies Program in the Division of Advanced Scientific Computing (DASC) in cooperation with other NSF CS&E disciplines (CS&E Associates). The objective of these Associateship awards is to increase expertise in the development of innovative methods and software for applying high performance, scalable parallel computing systems in solving large scale CS&E problems. Associateships in Experimental Science (ES Associates) supported by the Office of Cross Disciplinary Activities (CDA) . The objective of the ES Associateship awards is to increase expertise in CISE experimental science by providing opportunities for associates to work in established laboratories performing experimental research in one or more of the research areas supported by the CISE Directorate. These awards provide opportunities for recent Ph.D.s to broaden their knowledge and experience and to prepare them for significant research careers on the frontiers of contemporary computational science and engineering and experimental science. It is assumed that CS&E Associates will conduct their research at academic research institutions or other centers or institutions which provide access, either on site or by network, to high performance, scalable parallel computing systems and will be performing research associated with those systems. It is assumed that ES Associates will conduct their research in academic research institutions or other institutions devoted to experimental science in one or more of the research areas supported by the CISE Directorate. Who may submit Universities, colleges, and other research institutions as described in Grants for Research and Education in Science and Engineering (GRESE), (NSF 92-89) are eligible to submit proposals to this program. For CS&E Associateships the institution must have access to high performance, emerging parallel computing systems. For ES Associateships, the institution should have an established laboratory performing research in CISE experimental areas (as described in Guide to Programs (NSF 92-78)). Associateship awards will be based on proposals submitted by the sponsoring institution. The principal investigator will serve as an unreimbursed scientific advisor for the research associate. Research associates should not be listed as co-principal investigators. Each proposal must include a research and training plan for the proposed research associate in an activity of computational science and engineering in any of the fields supported by DASC, other NSF CS&E programs or experimental research supported by the CISE Directorate. To be eligible for this support, individuals must; (1) be eligible to be appointed as a research associate or research assistant professor in the institution which has submitted the proposal, (2) fulfill the requirement for the doctoral degree in computational science and engineering, computer science or a closely related discipline by September 30, 1993. Award Amounts, Stipends and Research Expense Allowances Awards will range from $36,200-$46,200 for a 24 month period. The award will include $32,000-$42,000 to support the Research Associate (to be matched equally by the sponsoring institution). There will also be an allowance of $4,200 to the sponsoring institution, in lieu of indirect costs, as partial reimbursement for expenses incurred in support of the research. The annual award to the research associate will be composed of two parts; an annual stipend (salary and benefits) that may range from $28,000-$38,000, and a $4,000 per year research expense allowance expendable at the Associate's discretion for travel, publication expenses, and other research-related costs. There is no allowance for dependents. The effective date of the award cannot be later than January 1994. Matching Funds The institution must match the NSF award on a dollar for dollar basis excluding the $4,200 granted in lieu of indirect costs. Matching funds may come from grants from other NSF programs, other agencies' programs, or from other institutional resources. Matching fund arrangements are the responsibility of the submitting institution and must be detailed in the budget request. To the extent that the sponsoring institution increases its cost sharing by providing additional stipend beyond the level of $38,000 over the 24 month award period, the CISE Postdoctoral Associates program will not provide additional funds. Evaluation and Selection Proposals will be reviewed by panel in accordance with established Foundation procedures and the general criteria described in the GRESE brochure. In particular, the review panel will consider: the candidate's ability, accomplishments, potential as evidenced by the quality and significance of past research, long range career goals, the likely impact of the proposed postdoctoral training and research on the future career goals, the likely impact of the proposed postdoctoral training and research on the future scientific development of the applicant and on the parallel computing infrastructure of the US (for CS&E Associates) or on Experimental Science in CISE disciplines (for ES Associates), and the adequacy of the sponsoring institution's access to high performance and/or experimental computational resources to support the proposed research. The selection of the Research Associates will be made by the National Science Foundation on the basis of panel reviews, with due consideration of the effect of the awards on the infrastructure of CS&E and experimental computer science research in the US. Copies of the GRESE brochure and other NSF publications are available at no cost from the NSF Forms and Publication Unit, phone (202) 357-7668, or via e-mail (Bitnet:pub@nsf or Internet:pubs@note.nsf.gov). Application Procedures and Proposal Materials To be eligible for consideration, a proposal must contain forms which can be found in the GRESE brochure. Required are a Supplementary Application Information Form (NSF Form 1225-one copy), a Current and Pending Support Form (NSF Form 1239-one copy) to be completed by the Principal Investigator (the scientific advisor), and one original and twelve copies of: (a) Cover page with institutional certificates (Form 1207). Title should indicate whether the proposal is an CS&E Postdoctoral Associate or ES Postdoctoral Associate. (b) Budget (Form 1030). (c) Statement with details regarding matching funds and their source. (d) Personal career goals statement not to exceed one single- spaced page, written by the research associate applicant, that describes the career goals of the applicant and what role the chosen research, scientific advisor and sponsoring institution will play in enhancing the realization of these long-range career goals. (e) Statement of results from prior NSF support (of the Principal Investigator) related to the proposed research. (f) Biographical sketch of the principal investigator as called for in the GRESE brochure. (g) Up-to-date curriculum vitae of the research associate applicant including a complete list of publications, but no reprints (a thesis should not be included, but a thesis abstract may be included). (h) Proposal abstract, less than 250 words, of the training and research plan. (i) Training and research plan (not to exceed three single- spaced typewritten pages). This should propose research which could be carried out during the award period. The creativity, description and essential elements of the research proposal must be those of the research associate applicant. (j) Statement from the proposed postdoctoral advisor nominating the research associate indicating the nature of the postdoctoral supervision to be given if the award is made. (k) Statement from the advisor clearly describing the computing facilities and resources that will be available to support the proposed research. (l) Three recommendations (normally including one from the doctoral advisor). Training and research plans should be provided to your references to assist their recommendations. Please note that the research description page limit is less than the research description page limit specified in GRESE. All application materials must be: (1) received by NSF no later than the deadline date January 19, 1993; (2) be postmarked no later than five (5) days prior to the deadline date; or (3) be sent via commercial overnight mail no later than two (2) days prior to the deadline date; to be considered for award. Send completed proposals with supporting application materials to: New Technologies Postdoctoral Associateships, NSF 92-120, Division of Advanced Scientific Computing, Room 417, National Science Foundation, Washington, D.C.,20550 for CS&E Associates and to CISE Experimental Science Postdoctoral Associateships,NSF 92-120, Office of Cross Disciplinary Activities, Room 436, National Science Foundation, Washington, DC, 20550 for ES Associates. Award recommendations are planned for March, 1993 with announcements in April, 1993. In FY1992 DASC made 18 such post-doc awards and CDA made 12. In FY1993, it is anticipated that DASC and CDA will make approximately 35 awards total. Additional Information If you wish additional information, please contact Dr. Robert G.Voigt, Program Director, New Technologies, DASC, at (202) 357-7727 (e-mail: rvoigt@nsf.gov) for CS&E Associates or Dr. John C. Cherniavsky, Head, CDA at (202) 357-7349 (e-mail: jchernia@nsf.gov) for ES Associates. Copies of most program announcements are available electronically using the Science and Technology Information System (STIS). The full text can be searched on-line, and copied from the system. Instructions for use of the system are in NSF 91-10 "STIS Flyer." The printed copy is available from the Forms and Publications Unit. An electronic copy may be requested by sending a message to "stis@nsf" (bitnet) or "stis@nsf.gov" (Internet). The Foundation provides awards for research in the sciences and engineering. The awardee is wholly responsible for the conduct of such research and preparation of the results for publication. The Foundation does not assume responsibility for such findings or their interpretation. The Foundation welcomes proposals on behalf of all qualified scientists and engineers and strongly encourages women, minorities, and persons with disabilities to compete fully in any of the research and research-related programs described in this document. Facilitation Awards for Scientists and Engineers with Disabilities provide funding for special assistance or equipment to enable persons with disabilities (investigators and other staff, including student research assistants) to work on an NSF project. See program announcement (NSF 91-54), or contact the program coordinator (202) 357-7456 for more information. In accordance with Federal statutes and regulations and NSF policies, no person on grounds of race, color, age, sex, national origin, or disability shall be excluded from participation in, denied the benefits of, or be subject to discrimination under any program or activity receiving financial assistance from the National Science Foundation. NSF has TDD (Telephone Device for the Deaf) capability which enables individuals with hearing impairments to communicate with the Division of Personnel and Management for information relating to NSF programs, employment, or general information. This number is (202) 357-7492. Grants awarded as a result of this announcement are administered in accordance with the terms and conditions of NSF GC-1, "Grant General Conditions," or FDP-II, "Federal Demonstration Project General Terms and Conditions," depending on the grantee organization. Copies of these documents are available at no cost from the NSF Forms and Publications Unit, phone (202) 357-7668, or via e-mail (Bitnet:pubs@nsf or Internet:pubs@note.nsf.gov). More comprehensive information is contained in the NSF Grant Policy Manual (July 1989) for sale through the Superintendent of Documents, Government Printing Office, Washington, DC 20402. "Catalog of Federal Domestic Assistance Number 47.070, Computer and Information Science and Engineering." The information requested on this application material is solicited under the authority of the National Science Foundation Act of 1950, as amended. It will be used in connection with the selection of qualified proposals and may be used and disclosed to qualified reviewers and staff assistants as part of the review process and to other government agencies. See Systems of Records, NSF-50, "Principal Investigator/ Proposal File and Associated Records" and NSF-51, "Reviewer/Proposals File and Associated Records" 56 Federal Register 54907 (October 23, 1991). Submission of the information is voluntary. Failure to provide full and complete information, however, may reduce the possibility of your receiving an award. Public reporting burden for this collection of information is estimated to average 120 hours per response, including the time for reviewing instructions. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Herman G. Fleming Reports Clearance Officer Division of Human Resource Management National Science Foundation Washington, DC 20550 And to: Office of Management and Budget Paperwork Reduction Project (3145-0058) Washington, DC 20503 NSF 92-120 (New) OMB 3145-0058 PT 34 KW 1004000, 0600000 From owner-sci-resources@net.bio.net Fri Nov 20 22:00:00 1992 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 21, no. 42, pt. 3, 20 November 1992 Message-ID: Date: 21 Nov 92 04:20:51 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 853 $$XID RFA HL9305 HL-93-05 P1O1 ***************************************** EFFECTS OF SEX HORMONES ON CORONARY ARTERY REACTIVITY NIH GUIDE, Volume 21, Number 42, November 20, 1992 RFA: HL-93-05-H P.T. 34; K.W. 0715040, 0760025, 0760085, 1002061, 0765035 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: February 1, 1993 Application Receipt Date: April 27, 1993 PURPOSE The Division of Heart and Vascular Diseases invites grant applications for up to five years of support for research into the roles of sex hormones in the physiology and pathophysiology of the coronary vasculature. The ultimate goal is to develop insights into therapeutic approaches for reducing the higher incidence of coronary diseases in men and post-menopausal women than pre-menopausal women. 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), Effects of Sex Hormones on Coronary Artery Reactivity, is related to the priority area of heart disease and stroke. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed five years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Approximately $1.5 million in total cost will be provided for the first year of support for the entire program. It is anticipated that six new grants will be awarded under this program. 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 plan of the National Heart, Lung, and Blood Institute (NHLBI), awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Administrative adjustments in project period and/or amount of support may be required at the time of the award. Since a variety of approaches would represent valid responses to this announcement, it is anticipated that there will be a range of costs among individual grants awarded. RESEARCH OBJECTIVES Background Recent studies reveal that temporary ischemia can occur, not only as a result of organic obstruction of the coronary artery, but also as a result of vasoconstriction and vasospasm. There is evidence that in many blood vessels, the endothelium as well as the vascular smooth muscle plays an active role in the control of vascular reactivity. The regulation of vascular reactivity, especially in the coronary arteries, may have a significant effect on vasospasm and the development of coronary vascular disease. Gender is one of the major risk factors for the development of coronary artery disease. Epidemiological studies show that young men are at higher risk than young women and that this prominent difference decreases in post-menopausal women. Involvement of sex hormones in vascular reactivity has been suggested frequently but clear evidence for a mechanism is lacking. Gender differences in vascular reactivity have been demonstrated by several research groups which suggest that the function of the endothelium and vascular smooth muscle are sexually differentiated and modulated by sex hormones. In these studies, a number of vessel segments from female and male animals treated with estrogen relaxed significantly more in response to both endothelium-dependent and endothelium-independent vasodilators than did ring segments from male or female animals treated with testosterone. In other studies, the tension generated by the vascular smooth muscle in response to the vasoconstrictors was greater in aortas from male than female rats. Moreover, removal of the endothelium and treatment with testosterone increases the responsiveness of the aorta of female rats. These observations suggest that the endothelium of male rats has a lesser capacity to inhibit contractions of the underlying vascular smooth muscle, possibly because it releases less endothelium-dependent relaxation factors under basal conditions. The expression of gender differences in vascular responses, however, depends on the vessel itself. Although several studies have demonstrated that coronary vessels from male animals show greater vascular reactivity, the degree to which coronary smooth muscle and the endothelium are sexually differentiated and modulated by sex hormones remains to be determined. It has been suggested that one of the protective effects of estrogens may be mediated through several systemic and local processes which include the direct and indirect effects of estrogens on structural elements of the vessel wall. Limited but significant data have identified the presence of androgen, progesterone and estrogen receptors in the coronary vasculature in experimental animals and progesterone receptors have been identified in coronary arteries of men. However, no attempt has been made to see whether there is a sex difference in the distribution and density of steroid binding sites. These results ca