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 inte