kristoff@GENBANK.BIO.NET (Dave Kristofferson) (08/16/90)
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. ---------------------------------------------------------------------- NIH GUIDE - Vol. 19, No. 30, August 17, 1990 NOTICES REMINDER AND UPDATE: REQUIREMENT FOR PROGRAMS ON THE RESPONSIBLE CONDUCT OF RESEARCH IN NATIONAL RESEARCH SERVICE AWARD INSTITUTIONAL TRAINING PROGRAMS .....................................(84/144).............. 1 National Institutes of Health Alcohol, Drug Abuse, and Mental Health Administration Index: NATIONAL INSTITUTES OF HEALTH ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION NOTICES OF AVAILABILITY (RFPs AND RFAs) ACQUISITION AND CHARACTERIZATION OF ALLOANTISERA AND MOLECULAR PROBES RECOGNIZING PUBLIC SPECIFICITIES OF THE MHC (RFP) .....(164/201)............. 2 National Institute of Allergy and Infectious Diseases Index: ALLERGY, INFECTIOUS DISEASES PRECLINICAL PHARMACOLOGY STUDIES OF ANTI-AIDS AGENTS (RFP) ..(204/253)....... 2 National Cancer Institute Index: CANCER TOXICITY STUDIES IN ANIMALS (RFP) ...........................(256/305)....... 3 National Institute of Environmental Health Sciences Index: ENVIRONMENTAL HEALTH SCIENCES SPECIALIZED RESEARCH CENTER PROGRAMS OR CENTER CORE GRANTS TO SUPPORT RESEARCH IN REPRODUCTION (RFA HD-91-01) ...(321/416, 884/1177)....... 4 National Institute of Child Health and Human Development Index: CHILD HEALTH, HUMAN DEVELOPMENT CHILD AND ADOLESCENT TRIAL FOR CARDIOVASCULAR HEALTH: COORDINATING CENTER (RFA HL-90-13-P) ...........................(419/458, 1180/1842)...... 5 National Heart, Lung, and Blood Institute Index: HEART, LUNG, BLOOD NATIONAL RESEARCH SERVICE AWARD - INSTITUTIONAL GRANTS (RFA HS-90-01) ....... 5 Agency for Health Care Policy and Research (461/525, 1845/2296) Index: AGENCY FOR HEALTH CARE POLICY AND RESEARCH ONGOING PROGRAM ANNOUNCEMENTS MULTIPURPOSE ARTHRITIS AND MUSCULOSKELETAL DISEASES CENTERS (PA-90-24) ...... 6 National Institute of Arthritis and Musculoskeletal and Skin Diseases Index: ARTHRITIS, MUSCULOSKELETAL DISEASES, SKIN DISEASES (531/619) STUDIES OF STRUCTURAL BIOLOGY AND PROTEIN STRUCTURE-FUNCTION RELEVANT TO DIABETES, ENDOCRINOLOGY, AND GENETIC METABOLIC DISEASES (PA-90-25) ....... 7 National Institute of Diabetes and Digestive and Kidney Diseases Index: DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES (622/842) NOTICES REMINDER AND UPDATE: REQUIREMENT FOR PROGRAMS ON THE RESPONSIBLE CONDUCT OF RESEARCH IN NATIONAL RESEARCH SERVICE AWARD INSTITUTIONAL TRAINING PROGRAMS P.T. 44; K.W. 1014004, 1014006 National Institutes of Health Alcohol, Drug Abuse, and Mental Health Administration As stated in the NIH Guide for Grants and Contracts, Vol. 18, No. 45, December 22, 1989, administrative guidelines for the National Research Service Award (NRSA) institutional training grant applications submitted to the National Institutes of Health (NIH) and Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) have been revised "to require that a program in the principles of scientific integrity be an integral part of the proposed research training effort". This requirement applies to all competing training grant applications received after July 1, 1990. The principal goal of the NRSA grant mechanisms is to train scientists for future careers in biomedical and behavioral research. An important factor in biomedical and behavioral research is the need to maintain the highest levels of integrity in the conduct of research. The research training environment in the university setting provides a powerful context in which to promote responsible research practices. NIH and ADAMHA recognize that the scientific community is at an early stage of developing information and methods that pertain specifically to training in research ethics for trainees. Not all methods will work in all training situations given the heterogeneity among disciplines and professions. There are no single models or paradigms. Appreciation of the heterogeneity among the biomedical and behavioral research components within the institutions calls for flexibility in approaches to effective education and training models. Institutions must accept primary responsibility and be allowed to develop their own ways of promoting responsible conduct of research in conjunction with their training programs. Scientific and administrative leaders of the university or from outside (as consultants or speakers) could be a visible part of this effort. Applicants are urged to discuss the development of methods on this important topic with their colleagues and also look to the professional associations for guidance as well as discussions with NIH and ADAMHA staff. An array of methods might be used at various training levels. It was stated in the NIH Guide for Grants and Contracts, December 22, 1989 notice: "Most universities and academic institutions have practices and procedures to ensure the responsible conduct of research. These may include informal seminars and presentations on conflict of interest, data recording and retention, professional standards and codes of conduct, responsible authorship, institutional policies and procedures for handling allegations of misconduct, policies regarding the use of human and animal subjects, etc. or formal courses on bioethics, research conduct, the ideals of science, etc." For the first 18 months of implementation of this requirement, it is expected that institutions will be given considerable flexibility in order to encourage innovation in the development of methods for providing training in scientific integrity. However, descriptions of formal or informal activities related to incorporation of efforts relevant to the responsible conduct of research (i.e., "the plan") should be explicit as possible (e.g., topics to be covered; faculty that may be involved; format; schedule, etc.). No application will be awarded until a description of the institution's plan to provide instruction on ethics in research training is furnished. NIH GUIDE - Vol. 19, No. 30, August 17, 1990 - Page 1 NOTICES OF AVAILABILITY (RFPs AND RFAs) ACQUISITION AND CHARACTERIZATION OF ALLOANTISERA AND MOLECULAR PROBES RECOGNIZING PUBLIC SPECIFICITIES OF THE MHC RFP AVAILABLE: RFP-NIH-NIAID-DAIT-91-22 P.T. 34; K.W. 0710065, 1002008, 1002058, 0760053 National Institute of Allergy and Infectious Diseases The Division of Allergy and Immunology and Transplantation of the National Institute of Allergy and Infectious Diseases has a requirement for the acquisition and characterization of alloantisera and molecular probes recognizing complex public specificities of the major histocompatability (MHC). The acquisition will require knowledge of immunogenetics, nucleic acid molecular biological techniques, as well as, acquisition and characterization of alloantisera recognizing the public specifities of the MHC. One or more contracts may be awarded as a result of this solicitation. It is expected that the contract will have a five-year period of performance. Any responsible offeror may submit a proposal which shall be considered by the Government. RFP-NIH-NIAID-DAIT-91-22 will be issued on or about August 22, 1990. Proposals will be due forty-five days thereafter. To receive a copy of this RFP, please supply this office with a request in writing and two self-addressed mailing labels addressed to the office listed below: Ms. Grace A. Bruce Contract Specialist Contract Management Branch, NIAID National Institute of Allergy and Infectious Diseases Westwood Building/Room 707 5333 Westbard Avenue Bethesda, MD 20892 This advertisement does not commit the Government to make an award. PRECLINICAL PHARMACOLOGY STUDIES OF ANTI-AIDS AGENTS RFP AVAILABLE: NCI-CM-27701-27 P.T. 34; K.W. 0710100, 0740020, 0715008, 0755010 National Cancer Institute The Developmental Therapeutics Program (DTP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), is seeking organizations having the necessary experience, scientific and technical personnel, and facilities to conduct a series of preclinical pharmacokinetic and other pharmacology studies in non-disease bearing animals on compounds having demonstrated ANTI-HIV activity and considered by DCT to merit further development. The studies to be performed will include: The development of methodology for the quantitative measurement of the compound and/or metabolites in animal body fluids and tissues; stability studies of the compound in biological fluids; determination of the plasma concentration-time profile and calculation of relevant pharmacokinetic parameters; determination of the most effective mode of compound administration to achieve and maintain viral inhibitory concentrations in body fluids and tissues; bioavailability studies following administration of an agent by various routes; tissue distribution and urinary excretion studies; and structural determination of metabolites and transformation products of the parent compound. The Government will supply all animals (mice, rats, dogs), test agents, and radiolabeled test agents. Contractors will be expected to provide all equipment, solvents, reagents, and animal facilities needed to conduct this type of work. It is anticipated that three awards will be made as result of this Request for Proposal (RFP), each for a three year, incrementally-funded level of effort contract beginning on or about October 1, 1991. Only one award will be made to an institution. This project is a recompetition of the work being done under contract numbers: N01-CM-87284 A.D. Little, INC., Massachusetts; N01-CM-87285 Southern Research Institute, Alabama; N01-CM-87286 Vermont Regional Cancer Center, Vermont. NIH GUIDE - Vol. 19, No. 30, August 17, 1990 - Page 2 RFP No. NCI-CM-27701-27 will be issued on or about August 13, 1990, with a due date for receipt of proposals on October 13, 1990. Requests for the RFP should be sent to: Johnny Jordan Contract Specialist Treatment Contract Section Research Contracts Branch National Cancer Institute Executive Plaza South, Room 6031 9000 Rockville Pike Bethesda, MD 20892 TOXICITY STUDIES IN ANIMALS RFP AVAILABLE: NIH-ES-90-25 P.T. 34; K.W. 1007009, 0780017 National Institute of Environmental Health Sciences The purpose of this contract is to conduct short-term, in vivo studies that will assist the National Toxicology Program (NTP) in the toxicologic characterization of chemicals. The NTP will provide a chemical-specific protocol outline for each chemical to be studied under this contract. The contracts obtained under this solicitation shall provide the capability to perform specified procedures for assessing the toxicity of approximately 5 chemicals per contract per year for five years. The basic contract award shall provide for the conduct of approximately eight studies per contract per year. The Government may, pending the availability of funds, exercise one option in each year of each contract for the conduct of four additional studies. Study designs will generally involve daily (gavage or skin paint) or continuous (dosed fee or water) dosing periods. The types of chemicals to be studied may include, but shall not be limited to, industrial solvents, plasticizers, food preservatives and colorants, drugs, pesticides, and heavy metals. Most studies will involve rats and mice; however, some studies may include rabbits, guinea pigs, and dogs. This work shall be performed in accordance with the Good Laboratory Practice Regulations established by the FDA for Nonclinical Laboratory Studies (FDA Good Laboratory Practice Regulations for Nonclinical Laboratory Studies; Final Report (Fed. Register, Vol. 52, #172, Friday, September 4, 1987, pp. 33768-33782; 21 CFR Part 58). At least two cost-reimbursement, term form, level of effort, task order type contracts with an estimated period of performance of five years each are contemplated as a result of this solicitation. One award is set-aside for a small business concern. One or more award(s) will be made on an open competition basis. The Government estimates that approximately 1.79 senior professional person years, 1.75 professional person years, and 7.02 technical person years will be required on an annual basis for each basic contract award. An additional .98 senior professional person year, .90 professional person year, and 3.81 technical person years will be required on an annual basis for each contract award for optional studies. All responsible sources may submit a proposal which shall be considered by the Agency. Expected release date of the RFP is August 21, 1990, with proposals due October 30, 1990. Requests should reference RFP NIH-ES-90-25 and should be forwarded to: National Institute of Environmental Health Sciences Contracts and Procurement Management Branch, OM ATTN: Marilyn B. Whaley, Contract Specialist 79 T.W. Alexander Drive, 4401 Building P. O. Box 12874 Research Triangle Park, NC 27709 NIH GUIDE - Vol. 19, No. 30, August 17, 1990 - Page 3 SPECIALIZED RESEARCH CENTER PROGRAMS OR CENTER CORE GRANTS TO SUPPORT RESEARCH IN REPRODUCTION RFA AVAILABLE: HD-91-01 P.T. 04; K.W. 0413002, 0710030 National Institute of Child Health and Human Development Letter of Intent Receipt Date: January 1, 1991 Application Receipt Date: May 6, 1991 The Reproductive Sciences Branch (RSB), Center for Population Research (CPR), National Institute of Child Health and Human Development (NICHD), supports research on reproduction that relies on a variety of approaches in biomedical sciences. Among the grant mechanisms used to provide research support, the RSB uses: 1) Specialized Research Centers (P50s) which are integrated groups of research projects and supporting core service facilities. The research activities included in such project grants must comprise, by definition, a multidisciplinary approach to biomedical problems in reproduction. Although these research programs may have more than one theme, focus, or emphasis, all of the projects must be responsive to one or more of the specific areas of reproductive research which constitute the purview of the RSB, CPR, NICHD. 2) Center Core Grants (P30s) that support Center Core facilities designed to enhance existing federally supported research projects within the purview of the RSB, CPR, NICHD. Such Center awards require a critical mass of individual, reproductive-oriented awards whose productivity and quality would be increased by support from central technical facilities. At present, the RSB supports a fixed number of centers with a commitment of five years of support that is competitively renewable for additional five-year periods. Support for one P50 Center and three P30 Centers ends in FY 1992, and it is anticipated that these Centers will submit renewal applications. While there are no new Center positions available at this time, new groups of investigators, in addition to the current awardees, are invited to compete for the existing four (4) positions. Potential applicants should contact the RSB staff for further information regarding reproductive sciences center grants (P50s and P30s). It is strongly recommended, but not mandatory, that potential applicants send a letter of intent to the RSB staff at the address listed below by January 1, 1991. This letter should outline the organizational structure of the proposed center, list the title of the relevant research projects to be associated with it, and the names of the relevant principal investigators. The letter of intent should be received by the RSB no later than January 1, 1991, but applicants are encouraged to send it as soon as they decide to apply for the grant so that the RSB staff can be of maximum assistance in the application process. Although this solicitation is included in the plans for FY 1992, support for these center grants is contingent upon the receipt of funds for these purposes by the NICHD. The number of grants to be awarded is also contingent upon a sufficient number of applications receiving a high enough level of merit to be considered for an award. It is expected that up to four (4) awards will be made as a result of this announcement. Applications for grants involving clinical studies should include members of minority groups and women in the study populations. Otherwise, a clear rationale for their exclusion must be provided in the application. For further information and a copy of the fully described RFA, please contact: Julia Lobotsky, M.S. Reproductive Sciences Branch Center for Population Research National Institute of Child Health and Human Development National Institutes of Health Executive Plaza North, Suite 603 Bethesda, MD 20892 Telephone: (301) 496-6515 NIH GUIDE - Vol. 19, No. 30, August 17, 1990 - Page 4 To obtain copies of the NICHD Policy and Formatting Guidelines for P30 and P50 center grant applications, please contact: Laurance Johnston, Ph.D. Scientific Review Program National Institute of Child Health and Human Development National Institutes of Health Executive Plaza North, Suite 520 Bethesda, MD 20892 Telephone: (301) 496-1696 This program is described in the Catalog of Federal Domestic Assistance No. 13.864, Population Research. Awards will be made under the authority of the Public Health Service Act 301 (42 USC 241) and 441 (USC 289d) and administered under PHS Grant Policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to A-95 or Health Systems Agency review. CHILD AND ADOLESCENT TRIAL FOR CARDIOVASCULAR HEALTH: COORDINATNG CENTER RFA AVAILABLE: HL-90-13-P P.T. 34; K.W. 0715040, 0745035, 0755015, 0755018, 0403001 National Heart, Lung, and Blood Institute Application Receipt Date: November 13, 1990 The Division of Epidemiology and Clinical Applications (DECA), National Heart, Lung, and Blood Institute (NHLBI), announces the availability of a Request for Applications (RFA) on the above subject. Copies of the RFA are available from staff of the NHLBI. Competition will be limited to domestic institutions. This award will support a coordinating center to participate with field centers and the NHLBI in a collaborative study entitled "Child and Adolescent Trial for Cardiovascular Health" (CATCH). The overall objective of the trial is to assess the effects of a school-based intervention for promoting healthful behavior in elementary school children to reduce their subsequent cardiovascular disease risk. CATCH is currently in the last year of a 3.5 year feasibility study that involves protocol writing and developmental work and testing in elementary schools at four Field Centers across the country. The assistance mechanism used to support the current feasibility study and the proposed main trial for the CATCH Study is the cooperative agreement which is similar to the traditional NIH research grant. The administrative and funding mechanism for this trial will continue to be a cooperative agreement. It differs from a research grant principally in the extent and nature of NHLBI staff involvement. Requests for copies of the RFA may be addressed to: Elaine J. Stone, Ph.D. Prevention and Demonstration Research Branch Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute Federal Building, Room 604A Bethesda, MD 20892 Telephone: (30l) 496-3503 FAX : (30l) 402-05l7 NATIONAL RESEARCH SERVICE AWARD-INSTITUTIONAL GRANTS RFA AVAILABLE: HS-90-01 P.T. 44; K.W. 0720005, 0730050 Agency for Health Care Policy and Research Application Receipt Date: October 15, 1990 AUTHORITY AND PURPOSE Under authority of Section 487 of the Public Health Service (PHS) Act as amended (42 USC 288), the Agency for Health Care Policy and Research (AHCPR) is awarding National Research Service Award (NRSA) institutional grants (T32) to eligible institutions to develop or enhance research training opportunities for qualified individuals of the institution's selection who seek to prepare for careers in health services research. This Request for Applications (RFA) NIH GUIDE - Vol. 19, No. 30, August 17, 1990 - Page 5 announces the application receipt date for this program (October 1, 1990) and identifies the training areas of special interest. The purpose of the NRSA program is to help ensure that highly trained scientific personnel will be available in adequate numbers and in the appropriate research areas and fields to maintain the nation's health services research agenda. Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program as is the following Catalog of Federal Domestic Assistance number: 13.226. APPLICANT ELIGIBILITY REQUIREMENTS Domestic nonprofit private or public institutions may apply for grants to support research training programs. The applicant institution must have the staff and facilities required for the proposed program. The training program director at the institution will be responsible for the selection and appointment of trainees and for the overall direction of the program. REVIEW SCHEDULE The schedule (indicated below) is designed to allow Program Directors time to recruit candidates during the fall/winter of the academic year (1991) for appointments to begin the following summer. Application Initial Review Council Earliest Receipt Date Meeting Meeting Award October 15 February May/June July 1990 1991 1991 1991 ADDITIONAL INFORMATION The AHCPR supports training in all areas of health services research. The AHCPR expects to fund approximately five new and/or renewal institutional training awards in response to this RFA. Complete details on the policy and guidelines, the mechanism of the award, application procedure, review criteria, and copies of the RFA may be obtained from: Mr. Hoke S. Glover Parklawn Building, Room 18-12 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3091 ONGOING PROGRAM ANNOUNCEMENTS MULTIPURPOSE ARTHRITIS AND MUSCULOSKELETAL DISEASES CENTERS PA: PA-90-24 P.T. 04; K.W. 0715010, 0715136, 0785055, 0710030, 0730050 National Institute of Arthritis and Musculoskeletal and Skin Diseases The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) uses a variety of award mechanisms to accomplish its research mission. Among these mechanisms is the P60 award for a multipurpose arthritis and musculoskeletal diseases center. The application guidelines for the multipurpose arthritis and musculoskeletal diseases centers have been revised and are in effect for all applications received on or after June 1, 1990. Fourteen centers are currently funded by NIAMS. Organizations not currently funded are encouraged to consider applying for this program. Eligible organizational entities are major medical complexes in the United States with a base of meritorious biomedical research related to arthritis and musculoskeletal diseases. Institutional programs in education, epidemiology, and/or health services that can be related to arthritis and musculoskeletal diseases should also be present. The center fosters a multidisciplinary research approach to the manifold problems of arthritis and musculoskeletal diseases. The center grant is not intended to provide total funding for all of these activities, but to provide funds for development of new capabilities for research and related activities. NIH GUIDE - Vol. 19, No. 30, August 17, 1990 - Page 6 A multipurpose arthritis and musculoskeletal diseases center has two major research coordinating components: biomedical research and research in education, epidemiology, and health services. An administrative unit provides oversight. The interactions afforded by the administrative unit and two research components provide opportunities to promote new research directions through developmental and feasibility projects and through core units. In addition, research projects in education, epidemiology, and/or health services are supported. The NIH urges applicants for grants to give added attention (where feasible and appropriate) to the inclusion of minority groups and women in the study populations for research. APPLICATION AND REVIEW PROCEDURES Applications in response to this announcement will be reviewed in accordance with standard NIH peer review procedures for research center grants. Review criteria include significance and originality of the research goals and approaches; feasibility of the research and adequacy of the experimental design; training, research competence, and dedication of the investigators; adequacy of available facilities; and provision for the humane care of animals and appropriate use of human subjects. Funding decisions will be based on peer review group and National Advisory Council recommendations. Applications should be submitted on form PHS-398 (rev. 10/88), available in the business or grants office at most academic research institutions, or from the NIH Division of Research Grants. Applications will be accepted in accordance with the submission dates for new and competing center grant applications on a continuing basis: February 1, June 1, October 1 The phrase "RESPONSE TO NIAMS PROGRAM ANNOUNCEMENT: MULTIPURPOSE ARTHRITIS AND MUSCULOSKELETAL DISEASES CENTER, PA-90-24" should be typed on line 2 of the face page of the application. The original and six copies should be sent or delivered to: Grant Application Receipt Office Division of Research Grants Westwood Building, Room 240 National Institutes of Health Bethesda, MD 20892-4500** Because of the limitations and the special nature of the program, potential applicants are strongly encouraged to contact NIAMS staff to discuss the scope, content, size, and timing of any applications for this program. Initial inquiries and requests for the revised guidelines and additional information should be directed to: Julia B. Freeman, Ph.D. Centers Program Director National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 403 Bethesda, MD 20892 Telephone: (301) 496-7495 This program is described in the Catalog of Federal Domestic Assistance No. 13.846, Arthritis, Musculoskeletal and Skin Diseases Research. Awards will be made under the authority of the Public Health Service Act, administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency. STUDIES OF STRUCTURAL BIOLOGY AND PROTEIN STRUCTURE-FUNCTION RELEVANT TO DIABETES, ENDOCRINOLOGY, AND GENETIC METABOLIC DISEASES PA: PA-90-25 P.T. 34; K.W. 0790000, 0760060, 0760070, 1002004, 1002008, 1002019, 0710070 National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE This announcement is intended to encourage the submission of applications proposing research relevant to understanding the relationships between structure and function of peptides and/or proteins and the role they play in normal and disease-related processes. Such understanding should also lead to the design, synthesis, or engineering of new, biologically active NIH GUIDE - Vol. 19, No. 30, August 17, 1990 - Page 7 peptides/proteins with therapeutic potential in diabetes, endocrine disorders, and genetic metabolic diseases. DISCIPLINES AND EXPERTISE Interdisciplinary approaches may be needed for the proposed studies. Expertise required could span the following research areas: biophysics, computer-based structural analysis, biochemistry, cell and molecular biology, immunology, genetics, and genetic or protein engineering. Integration of basic research approaches and development of techniques is encouraged. BACKGROUND The Division of Diabetes, Endocrinology and Metabolic Diseases (DDEM) supports basic and clinical research and research training related to diabetes mellitus and its complications, to endocrinology and a variety of endocrine diseases, and to metabolism and various genetic metabolic diseases. Studies on structural biology, especially peptide/protein structure-function, are of significant relevance to the DDEM. Recent notable advances in this area include: development of area detectors that facilitate macromolecular X-ray crystal diffraction data collection and analysis; availability of neutron scattering facilities and other new biophysical approaches to macromolecular structural analysis; development of new approaches to computerized representation, manipulation, and analysis of three-dimensional structures; and development of novel gene manipulation techniques including site-directed mutagenesis. These techniques allow the initiation of a broad variety of new studies relevant to understanding peptide/protein structure-function. OBJECTIVE AND SCOPE The research project grant (R01) and FIRST grant (R29) applications submitted in response to this announcement could propose studies on: o Development of manual, semiautomated, and automated techniques for the purification and crystallization of soluble, membrane-associated, or integral membrane peptides and/or proteins. o Analysis of crystallized peptide or protein structures by X-ray and neutron diffraction, image reconstruction, and other state-of-the-art technologies. o Development of new approaches for the prediction of three-dimensional structures of peptides and proteins in solution, lipid-bilayers, and membranes, including the prediction of surface probability profiles and protein backbone structures. o Development of new software algorithms and improvement of existing methods that will accelerate progress in the field of macromolecular simulations in structural biology. o Enhancement of transcriptional and translational efficiency for over-expression of proteins from genes of interest, both endogenous and foreign, in eukaryotic or model prokaryotic systems. o Elucidation of mechanisms for peptide/protein insertion and/or translocation across membranes. o Design, synthesis, and engineering of new pharmacologically-active peptides and/or proteins. o Structure-activity studies of peptides and/or proteins that integrate several of the above approaches. The research areas exemplified above are not intended to be all inclusive. There are, however, some specific limitations to the scope of this announcement. Thus: 1. Peptides and/or proteins selected for study should be of mammalian or other vertebrate origin. Peptides and/or proteins of prokaryotic origin, or of lower eukaryotic origin such as drosophila or yeast, should be proposed only as models for mammalian systems when information on the latter is not available. Studies proposed in these model systems should facilitate understanding of peptide/protein structure-function in mammalian systems. NIH GUIDE - Vol. 19, No. 30, August 17, 1990 - Page 8 2. The peptides or proteins to be studied should have specific relevance to one of the following programmatic areas: carbohydrate metabolism and its hormonal control; diabetes mellitus; peptide hormones, hormone receptors, and signal transmission; endocrine disorders; normal and abnormal processes of lipid, protein, amino acid, urea, purine, pyrimidine, metal ion, and steroid metabolism; genetic metabolic disorders, e.g., lysosomal storage diseases, diseases of peroxisomal metabolism, diseases of transport, diseases of amino and other organic acid metabolism, diseases of carbohydrate metabolism (other than diabetes mellitus), diseases of purine and pyrimidine metabolism, etc. MECHANISM OF SUPPORT The mechanism of support for this program will be the regular research project and FIRST grants (R01 and R29). The regulations (Code of Federal Regulation, Title 42, Part 52 and, as applicable to the state and local governments, Title 45, Part 74) and policies which govern the research grants programs of the National Institutes of Health will prevail. Since a variety of approaches would represent valid responses to this solicitation, it is anticipated that there will be a range of costs among individual grants awarded. With respect to post award administration, the current policies and requirements that govern the regular research grant programs of the NIH will prevail. REVIEW PROCEDURES AND CRITERIA Assignment of Application Applications will be received by the NIH, Division of Research Grants (DRG), referred to an appropriate Initial Review Group (IRG) for scientific merit review, and the usual DRG referral guidelines will be followed in assignment of applications. Referral decisions will be governed by normal programmatic considerations as specified in the Referral Guidelines of the NIH, DRG. Some applications may receive a dual assignment. Review Procedures Applications submitted in response to this solicitation will be reviewed on a nationwide basis in accord with the usual NIH peer review procedures. Applications will first be reviewed for scientific and technical merit by an IRG composed primarily of non-federal scientific consultants, and then by the National Advisory Council of the appropriate Institute(s). The review criteria customarily employed by the NIH will prevail. Review Criteria The factors to be considered in the evaluation of the scientific merit of each application will be those used in the review of traditional research project grant applications, including the novelty, originality, and feasibility of the approach; the training experience and research competence of the investigator(s); the adequacy of the experimental design; and the suitability of the facilities. The appropriateness of the requested budget to the work proposed will also be assessed. METHOD OF APPLYING: Format for Application Applications should be submitted on form PHS 398 (rev. 10/88), which is available from the applicant institution's Office of Sponsored Research or from the NIH Division of Research Grants. Use the conventional format for research project grant applications and ensure that the points identified in this Program Announcement (PA), in the section on "Review Procedures and Criteria", are fulfilled. To identify the application as a response to this PA, check "Yes" on item two of page one of the application and enter the title "NIDDK: Structural Biology in DEMD, PA-90-25." Deadline Applications will be accepted in accordance with the announced receipt dates for new applications (see receipt dates and review schedule in application kits). This is an open-ended program which intends to provide interested applicants the maximum flexibility they need to develop appropriate research applications. NIH GUIDE - Vol. 19, No. 30, August 17, 1990 - Page 9 Application Procedure The original and six copies of the application should be sent or delivered to: Application Receipt Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Inquiries Before submitting an application, and for further information, investigators are strongly encouraged to contact the appropriate program staff listed below: For the Endocrinology, Metabolic Diseases, and Cystic Fibrosis Research Programs: Robert Katz, Ph.D. Deputy Chief, Endocrinology and Metabolic Diseases Research Programs Branch, DDEM, NIDDK, NIH Westwood Building, Room 607 Bethesda, MD 20892 Telephone: (301) 496-7997 For the Diabetes Research Programs: Joan T. Harmon, Ph.D. Executive Director, Diabetes Research Program DDEM, NIDDK, NIH Westwood Building, Room 622 Bethesda, MD 20892 Telephone: (301) 496-7731 This program is described in the Catalog of Federal Domestic Assistance, No. 13.847, Diabetes, Endocrinology, and Metabolic Diseases. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301, (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grant policies and Federal Regulations, most specifically at 42 CFR and CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. **THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD BUILDING IS: 5333 Westbard Avenue Bethesda, Maryland 20816 NIH GUIDE - Vol. 19, No. 30, August 17, 1990 - Page 10 SPECIALIZED RESEARCH CENTER PROGRAMS OR CENTER CORE GRANTS TO SUPPORT RESEARCH IN REPRODUCTION RFA AVAILABLE: HD-91-01 P.T. 04; K.W. 0413002, 0710030 NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT Letter of Intent Receipt Date: January 1, 1991 Application Receipt Date: May 6, 1991 The National Institute of Child Health and Human Development (NICHD) provides funding for a limited number of research centers in the area of reproductive sciences research. These centers are broadly based investigative endeavors encompassing research of a biomedical nature. They are supported through either Center Core Grants (P30) or Specialized Research Center Grants (P50). These centers form a national network that fosters communication, innovation, and high quality research. Reproductive Sciences Research Centers provide a stimulating, multidisciplinary environment that attracts and nurtures both established and promising young investigators. Each Center works closely with the NICHD staff in participating in a Center Network and in carrying out its objectives in a manner consistent with the goals and mission of the NICHD. BACKGROUND The Reproductive Sciences Branch (RSB) of the Center for Population Research (CPR) of the National Institute of Child Health and Human Development (NICHD) supports basic and clinical research on reproduction that relies on a variety of approaches in biomedical sciences. Among the grant mechanisms used to provide research support, the RSB uses: 1) Specialized Research Center Grants (P50s) that support integrated groups of research projects and supporting core service facilities. The research activities included in such project grants must comprise, by definition, a multidisciplinary approach to biomedical problems in reproduction. These research programs may have more than one theme, focus, or emphasis but all of the projects involved must be responsive to one or more specific research areas of reproduction promulgated by the RSB. 2) Center Core Grants (P30s) that support Center Core facilities designed to enhance existing federally supported research projects within the purview of the RSB, CPR, NICHD. Such center awards require a critical mass of individual awards where coordinated technical support would be cost- effective to the NIH. Core Grants provide no funds for the direct support of research projects other than for new program development; however, by making cost-effective resources and facilities available, they enhance the productivity of existing projects that are either integrated in a specialized research area or organized within a central theme of research. At present, the RSB supports a fixed number of centers with a commitment of five years of support that is competitively renewable for additional five-year periods. Committed support for one P50 Center and three P30 Centers ends in FY 1992, and it is anticipated that these Centers will submit renewal applications. While there are no new Center positions available at this time, new groups of investigators, in addition to the current awardees, are invited to compete for the existing four (4) positions in FY 1992. RESEARCH GOALS AND SCOPE The ultimate goals of biomedical research in the reproductive sciences are to develop new knowledge leading to clinical applications that will enable men and women to control their fertility with methods that are safe, effective, inexpensive, reversible, and acceptable to various population groups, and to overcome problems of infertility and reproductive disorders. The Reproductive Sciences centers designated as "Specialized Reproductive Sciences Research Centers" (P50s) and as "Reproductive Sciences Research Centers" (P30s) are awarded funds for the support of comprehensive reproductive research programs of high quality that focus on topics deemed to be of high priority and significance because of their critically important relationship to the mission of the RSB, CPR. In order to receive funding, a grant for a specialized reproductive research center (P50) must have three (3) or more related, integrated, and high quality research projects that provide a multidisciplinary, yet thematic, approach to the problems to be investigated. These research projects may be accompanied by an appropriate number and type of core facilities providing cost-effective technical support. A grant for a reproductive sciences research Center Core facility (P30) must be predicated on the existence of a substantial number of eligible, funded research grants which will be active on April 1, 1992. A minimal number of three (3) relevant NIH or other federally funded grants are required for eligibility of a core in a P30 Center. These grants must support active users of the core facilities and services proposed in the center grant application and represent scientific research relevant to the mission of the RSB, CPR. Because reproductive sciences research center grants are complex entities, interested applicants should contact the RSB staff for a consultation regarding the submission of an application. This Request for Applications (RFA) is specifically designed to stimulate the reproductive sciences research community to organize or to maintain reproductive sciences research centers of outstanding quality which, serving as national research resources, form a network that fosters communication, innovation, and high quality research. Applications are encouraged on, but not limited to, the biomedical topics listed below: 1. Reproductive medicine: Fertility and infertility aspects 2. Mechanism(s) of follicular selection, atresia and ovulation 3. Neuroendocrinology of reproduction: Clarification of the regulatory mechanisms of the hypothalamo-pituitary- gonadal axis 4. Regulatory mechanism(s) of gametogenesis 5. Mechanism of action of reproductive hormones, particularly at the cellular and genetic level; modification of action by growth factors 6. Mechanisms regulating gonadal or genital tract functions 7. Studies on fertilization, preimplantation development of embryos, or blastocyst implantation 8. Immunological mechanisms regulating fertility MECHANISM OF SUPPORT The support mechanisms for these programs are the P50 Specialized Reproductive Sciences Research Center Grant and the P30 Reproductive Sciences Research Center Core Grant. Although this solicitation is included in the plans for FY 1992, support for these center grants is contingent upon the receipt of funds for these purposes. The number of grants to be awarded is also contingent upon a sufficient number of applications receiving high enough levels of merit to be considered for an award. It is expected that up to four (4) awards will be made as a result of this announcement. The applications should be prepared in a manner consistent with the guidelines presented in the publications entitled either P50 SPECIALIZED RESEARCH CENTER GRANT GUIDELINES or P30 CENTER CORE GRANT GUIDELINES which are available from the NICHD offices listed below. The current policies and requirements that govern the research grant programs of NIH will prevail (Code of Federal Regulations, Title 42, Part 52 and Title 45, Part 75). Applications for grants involving clinical studies should include members of minority groups and women in the study populations. Otherwise, a clear rationale for their exclusion must be provided in the application. REVIEW PROCEDURES AND CRITERIA An administrative review of the application will be performed by the Review, Program, and Grants Management staff for conformance to NIH policy and NICHD guidelines, as well as for relevance to the program purview of the RSB. Applications that fail to comply with NIH policy and/or NICHD guidelines will be formally returned to the applicant. Applications may be subjected to a triage by a peer review group to determine their potential competitiveness relative to other applications submitted. The Institute will withdraw from competition those applications judged by the triage procedure to be noncompetitive and notify the applicants and institutional business officials. Those applications judged to be competitive will be further evaluated by peer review for scientific/technical merit. The Executive Secretary of the Population Research Committee (PRC), NICHD, may forward the application to selected members of the PRC for their evaluation to determine if a site visit is needed. A site visit, however, is not a prerequisite for consideration of an application by the PRC. If a site visit is required, the Executive Secretary will communicate with the applicant for the visit arrangements as described in the guidelines. All competitive applications received in response to this RFA will be reviewed on a nationwide competitive basis. The initial review for scientific merit will be carried out by the PRC. The second-level review will be made by the National Advisory Child Health and Human Development Council. The earliest possible funding date is April 1, 1992. Review procedures and criteria are detailed in the P50 SPECIALIZED RESEARCH CENTER GRANT GUIDELINES and P30 CENTER CORE GRANT GUIDELINES (available from the NICHD offices listed below). The concurrent submission of an R01 or R29 research project application to do essentially the same research as that proposed in a subproject of a P50 Center (or a P01 Program Project) application is permissible within the context of extant NIH policy. As a general policy, preference in selection for funding by NICHD will be given to the subprojects of the P50 Center (or P01 Program Project) in order to maintain the integrity of the program and the validity of its merit assessment. The coincident R01 or R29 application(s) will usually be expected to be withdrawn or relinquished. METHOD OF APPLYING Interested applicants should contact the RSB staff for an advisory consultation regarding reproductive sciences center grants (P50s and P30s). If an applicant intends to apply, it is strongly recommended, but not mandatory, that applicants send a letter of intent to the RSB staff at the address listed below by January 1, 1991. This letter should outline the organizational structure of the proposed center, list the titles of relevant research projects to be associated with it, and the names of relevant principal investigators. The letter of intent should be received by the RSB no later than January 1, 1991, but applicants are encouraged to send it as soon as they decide to apply for the grant so that the RSB staff can be of maximum assistance in the application process. The standard grant application form PHS-398 (rev. 10/88) is used to prepare these applications. The RFA number and the type of center grant request (P50 or P30) should be indicated on the face page of the application in item #2. The RFA label available in the 10/88 version of PHS Form 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. The PHS-398 form is available from most business offices or grant/contract offices at most institutions and can also be obtained from NIH by calling (301) 496-7441. It is especially important that applicants obtain and follow the supplemental NICHD guidelines, which require certain tabulations in addition to the usual instructions. Applications must be submitted by May 6, 1991. Send or deliver the original, completed, signed application and four (4) complete copies to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 533 Westbard Avenue Bethesda, Maryland 20892** In addition to those applications mailed to the Division of Research Grants, two (2) copies of the application should be sent under separate cover directly to: Laurance Johnston, Ph.D. Scientific Review Program National Institute of Child Health and Human Development National Institutes of Health Executive Plaza North, Suite 520 Bethesda, Maryland 20892 Late applications will not be accepted and will be returned to the applicants. For further information contact: Julia Lobotsky, M.S. Reproductive Sciences Branch Center for Population Research National Institute of Child Health and Human Development National Institutes of Health Executive Plaza North, Suite 603 Bethesda, Maryland 20892 Telephone: (301) 496-6515 This program is described in the Catalog of Federal Domestic Assistance No. 13.864, Population Research. Awards will be made under the authority of the Public Health Service Act 301 (42 USC 241) and 441 (USC 289d) and administered under PHS Grant Policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to A-95 or Health Systems Agency review.