Path: utzoo!utgpu!watmath!uunet!bionet!nihcu.bitnet!CZJ From: CZJ@nihcu.bitnet Newsgroups: bionet.sci-resources Subject: (none) Message-ID: <8901161401.AA01071@net.bio.net> Date: 16 Jan 89 13:55:06 GMT Sender: daemon@NET.BIO.NET Lines: 598 Attached is the Table of Contents and Items of Interest from the NIH Guide to Grants and Contracts Jan 20, 1989. Jim Cassatt -------------------------------------------------------------- Vol. 18, No. 2, January 20, 1989 NOTICES EXTRAMURAL RESEARCHERS' FINANCIAL CONFLICTS OF INTEREST ...(84/126)......... 1 National Institutes of Health Index: NATIONAL INSTITUTES OF HEALTH DATED ANNOUNCEMENTS (RFPs AND RFAs) ANALYTICAL CHEMISTRY OF CHEMICALS AND PHARMACEUTICAL PRODUCTS FOR TREATMENT OF INFECTIOUS DISEASES (RFP) ................(132/175)........ 1 National Institute of Allergy and Infectious Diseases Index: ALLERGY, INFECTIOUS DISEASES DEVELOPMENT AND MANUFACTURE OF DOSAGE FORMS OF COMPOUNDS WITH POTENTIAL FOR TREATING INFECTIOUS DISEASES (RFP) ..........(178/221)........ 2 National Institute of Allergy and Infectious Diseases Index: ALLERGY, INFECTIOUS DISEASES NOTICE - SURVEILLANCE EPIDEMIOLOGY AND END RESULTS (SEER) (RFP) ..(224/264). 2 National Cancer Institute Index: CANCER ACADEMIC RESEARCH ENHANCEMENT AWARD ........................(267/370)....... 3 National Institutes of Health Index: NATIONAL INSTITUTES OF HEALTH CORE GRANTS FOR CLINICAL NUTRITION RESEARCH UNITS (CNRUs) (RFA) ..(373/473). 4 National Institute of Diabetes and Digestive and Kidney Diseases (804/913) National Institute on Aging Index: DIABETES, DIGESTIVE AND KIDNEY DISEASES, AGING MENTAL HEALTH SERVICES RESEARCH DEMONSTRATION GRANTS (RFA) ...(481/519)..... 6 National Institute of Mental Health Index: MENTAL HEALTH NEW APPROACHES TO STUDYING EPSTEIN-BARR VIRUS ONCOGENESIS (RFA) ..(522/655). 6 National Cancer Institute (916/1248) Index: CANCER DEVELOPMENT OF SOMATIC CELL GENE THERAPY APPROACHES FOR SPECIFIC INBORN METABOLIC DISEASES (RFA) ....................(658/789, 1251/1473).... 8 National Institute of Diabetes and Digestive and Kidney Diseases Index: DIABETES, DIGESTIVE AND KIDNEY DISEASES NOTICES EXTRAMURAL RESEARCHERS' FINANCIAL CONFLICTS OF INTEREST P.T. 34; K.W. 1014004, 1014006 National Institutes of Health Growing expressions of public concerns suggest that NIH act to limit possibilities for actual or apparent financial conflicts of interest by investigators in research and development projects funded by NIH extramural awards. Of particular concern are circumstances that might affect investigators' objectivity, or where researchers might unduly influence, or might be perceived to influence, NIH-funded R&D projects in directions favorable to personal financial interests of themselves, their spouses, children, close professional associates, or organizations where they have appointments or other relationships. NIH expects that participating investigators and consultants will not have financial interests in organizations or entities that produce drugs, devices, or other interventions studied in a controlled clinical trial. NIH therefore intends to take steps to develop appropriate guidance for such relationships. Guidelines would seek to outline pertinent types of research situations and personal financial interests, in accord with the PHS Grants Policy Statement, January 1, 1987, revision, concerning Standards of Conduct for Employees for awardee organizations, and to define appropriate distributions of governance between NIH and awardee organizations. Guidelines should also recognize special conditions under which restrictions should be waived to permit investigators with unusual skills and expertise to conduct studies which might otherwise be proscribed. (These guidelines should not concern financial benefits resulting from logical steps in product research/development/testing under NIH awards, e.g., Small Business Innovation Research.) NIH encourages preliminary comments from parties wishing to suggest points to be included in this future guidance. Please address your remarks within 30 days of this publication to: Dr. Katherine L. Bick Deputy Director for Extramural Research National Institutes of Health Shannon Building, Room 144 Bethesda, Maryland 20892 Further opportunity for comments will be provided following subsequent notices in the NIH Guide for Grants and Contracts. DATED ANNOUNCEMENTS (RFPs AND RFAs) ANALYTICAL CHEMISTRY OF CHEMICALS AND PHARMACEUTICAL PRODUCTS FOR TREATMENT OF INFECTIOUS DISEASES RFP AVAILABLE: RFP-NIH-NIAID-AIDSP 89-14 P.T. 34; K.W. 1003008, 0740025 National Institute of Allergy and Infectious Diseases The purpose of the solicitation is to provide analytical chemistry support to the drug discovery effort for the treatment of infectious diseases in the areas of method development and control of chemical and pharmaceutical quality. Responsibilities of the contractor will include: characterization of the identity of the drug substance; preformulation determinations of compound solubility and stability; analysis of pharmaceutical dosage forms; and extensions of the methodologies to the detection of the drug in selected biological fluids. This announcement is a new solicitation. The issuance of the RFP will be on January 26, 1989, and proposals will be due COB on March 29, 1989. This NIAID-sponsored project will take approximately five years to complete. A cost-reimbursement contract is anticipated and the Institute expects to make one award. Vol. 18, No. 2, January 20, 1989 - Page 1 Requests for the RFP should be directed in writing to: Mr. Charles Hayes Contract Management Branch Westwood Building, 5333 Westbard Avenue, Room 707 National Institute of Allergy and Infectious Diseases National Institutes of Health Bethesda, Maryland 20892 Telephone: (301) 496-0349 To receive a copy of the RFP, please supply this office with two (2) self-addressed mailing labels. All responsible sources may submit a proposal which will be considered. This advertisement does not commit the Government to award a contract. DEVELOPMENT AND MANUFACTURE OF DOSAGE FORMS OF COMPOUNDS WITH POTENTIAL FOR TREATING INFECTIOUS DISEASES RFP AVAILABLE: RFP-NIH-NIAID-AIDSP-89-12 P.T. 34; K.W. 0740025, 0740020 National Institute of Allergy and Infectious Diseases The purpose of this solicitation is to provide a pharmaceutical research and development capability to permit further evaluation of compounds in animal models of infectious diseases, in pharmacological disposition studies in laboratory animals, in toxicological investigations and in clinical trial. Dosage form development and manufacturing capabilities will be needed for sterile small volume parenteral freeze dried and liquid dosage forms, tablets, and capsules. Quality control testing of ingredients in the formulation and of the final product will be required. Manufactured batches will be prepared in accord with FDA's current good manufacturing practice regulations. Anticipated annual requirements are one or two drugs requiring development of injectable and of oral dosage forms, one or two injectable batches of about 4000 vials each, and two of three table/capsule batches of 50,000 units/lot. This announcement is a new solicitation. The issuance of the RFP will be on January 25, 1989, and proposals will be due COB March 28, 1989. This NIAID sponsored project will take approximately five years to complete. A cost-reimbursement contract is anticipated and the Institute expects to make one award. Requests for the RFP should be directed in writing to: Ms. Mary Anne Glitz Contract Management Branch Westwood Building, 5333 Westbard Avenue, Room 707 National Institute of Allergy and Infectious Diseases National Institutes of Health Bethesda, Maryland 20892 Telephone: (301) 496-1642 To receive a copy of the RFP, please supply this office with two (2) self-addressed mailing labels. All responsible sources may submit a proposal which will be considered. This advertisement does not commit the Government to award a contract. ACADEMIC RESEARCH ENHANCEMENT AWARD P.T. 34; K.W. 0710030, 1014002, 1014006 National Institutes of Health Application Receipt Date: June 22, 1989 The National Institutes of Health (NIH) is making a special effort to stimulate research in educational institutions which provide the baccalaureate training for a significant number of our nation's research scientists but which historically have not been major recipients of NIH support. Since Fiscal Year (FY) 1985, Congressional appropriations for the NIH have included funds for this initiative, which NIH has implemented through the Academic Research Enhancement Award (AREA) Program. In FY 85, the NIH made 75 awards, totalling $5 million. In FY 86, 146 such grants were awarded, amounting to $9.57 million. In FY 87, a total of 152 AREA grants were awarded from the Congressional appropriation of $10 million. In FY 88, 173 awards were made, totalling approximately $11 million. This award is designed to enhance the research environment of educational institutions that have not been traditional recipients of NIH research funds. The AREA funds are intended to support new research projects or expand ongoing research activities proposed by faculty members of these institutions in areas related to the health sciences. Applications for FY 1989 AREA grants are currently undergoing review for scientific merit. Since it is anticipated that additional funds will be available next year, the NIH is inviting grant applications for the FY 1990 competition for AREA grants. Eligibility requirements of the AREA Program include the following: Applicant Institutions o All domestic institutions offering baccalaureate or advanced degrees in the sciences related to health are eligible, except those that have received an NIH Biomedical Research Support Grant (BRSG) of $20,000 or more per year for four or more years during the period from FY 1982 through FY 1988. o Health professional schools (e.g., schools of medicine, dentistry, nursing, osteopathy, pharmacy, veterinary medicine, public health, allied health and optometry) as well as organizationally discrete campuses of a university system are eligible if they meet the above criterion. o Multiple applications proposing different research projects may be submitted by an applicant institution. Applicant Principal Investigators o Must not have active research grant support (including an AREA) from either NIH or the Alcohol, Drug Abuse and Mental Health Administration (ADAMHA) at the applicant institution at the time of award of an AREA grant. Vol. 18, No. 2, January 20, 1989 - Page 3 o May not submit a regular NIH or ADAMHA research grant application for essentially the same project as a pending AREA application. o Are expected to conduct the majority of their research at their own institution, although limited access to special facilities or equipment at another institution is permitted. o May not be awarded more than one AREA grant at a time nor be awarded a second AREA grant to continue the research initiated under the first AREA grant. Those in doubt about eligibility should consult their institution's Office of Sponsored Research, or the Director, Special Programs and Initiatives (Building 31, Room 1B54, NIH, Bethesda, MD 20892, 301/496-1968). Funding decisions will be based on the proposed research project's scientific merit and relevance to NIH programs, and the institution's contribution to the undergraduate preparation of doctoral-level health professionals. Among projects of essentially equivalent scientific merit and program relevance, preference will be given to those submitted by institutions that have granted baccalaureate degrees to 25 or more individuals who, during the period 1978-1988, obtained academic or professional doctoral degrees in the health related sciences. AREAs are awarded on a competitive basis. Applicants may request support for up to a total of $75,000 in direct costs (plus applicable indirect costs) for a period not to exceed 36 months. Although this award is non-renewable, it will enable qualified individual scientists within the eligible institutions to receive support for feasibility studies, pilot studies and other small-scale research projects preparatory to seeking more substantial funding from the regular NIH research grant programs. Applications for this award will be accepted under the regular application submission procedures of the Division of Research Grants (DRG) of NIH. Grant applications must be prepared and submitted on Form PHS 398 (Rev. 9/86). An abbreviated format and simplified instructions will be provided upon request to the Office of Grants Inquiries (see address below) for use in preparing these applications. The receipt date is June 22, 1989. Those individuals and institutions meeting eligibility requirements and wishing to receive further information and/or application materials should write to: AREA Office of Grants Inquiries Division of Research Grants National Institutes of Health Westwood Building, Room 449 Bethesda, Maryland 20892 Telephone: (301) 496-7441 NEW APPROACHES TO STUDYING EPSTEIN-BARR VIRUS ONCOGENESIS RFA AVAILABLE: 89-CA-08 P.T. 34; K.W. 0715035, 0715125, 1002045, 1002008, 0760045 National Cancer Institute Application Receipt Date: August 3, 1989 Letter of Intent Receipt Date: June 3, 1989 I. INTRODUCTION Epstein-Barr virus (EBV) has been associated with several neoplasias, including Burkitt's lymphoma and nasopharyngeal carcinoma and with several infectious diseases, including infectious mononucleosis and severe chronic infectious mononucleosis. Recent evidence appears to link EBV with parotid gland tumors and B-cell lymphomas in immunosuppressed individuals. In vivo studies of EBV oncogenesis are complicated by the long interval between primary infection and the occurrence of neoplasia; and by the high prevalence of EBV infection in geographic areas where a high frequency of EBV-associated neoplasias occurs: e.g., in the malaria belt in Africa in the case of Burkitt's lymphoma, and in the Far East in the case of nasopharyngeal carcinoma. In vitro studies of EBV have been hampered by the lack of a lytic infection system. Studies have focused on lymphocytes which have been immortalized/transformed by EBV infection and in which a limited set of viral gene products are expressed. The application of recombinant DNA technology to this system has led to progress in elucidating the structure of the viral genome, further definition of viral gene products, and identification of several regulatory regions of the viral genome. However, the viral and host factors determining the disease manifestations and clinical outcomes for EBV infections are as yet undefined. Additionally, both B-cells and epithelial cells appear to be sites of viral latency and replication. While a number of investigators are studying specific aspects of EBV replication and tumorigenesis, delineation of viral and host factors which may determine the outcome of individual EBV infections has been difficult to approach directly. Vol. 18, No. 2, January 20, 1989 - Page 6 The present RFA is for a single competition with a deadline of August 3, 1989 for receipt of applications, and June 3, 1989 for receipt of letters of intent. Applications should be prepared and submitted in accordance with the aims and requirements described in the complete RFA document which may be obtained from the program director listed in Section IV below. II. RESEARCH GOALS AND SCOPE The overall thrust of this RFA is to stimulate research on the mechanism(s) of EBV oncogenesis by developing and using new methodological approaches to overcome the difficulties inherent in EBV research. Examples of research objectives (which are not all inclusive) would include the following: (i) use of novel methods and probes to define RNA transcripts unique to or with clinical significance for different EBV neoplasias; (ii) use of new approaches to alter (mutate) the viral genome followed by the study of the effect of altered genes on viral oncogenesis; (iii) use of cell lines expressing individual EBV gene products (both structural and regulatory) to define viral genes and assess their role in the neoplastic process; (iv) use of specific reagents such as monoclonal antibodies to viral gene products to determine the role of regulatory and structural EBV proteins in the neoplastic process; (v) measurement of host response to individual viral proteins with the goal of delineating differences in the host response in specific EBV-associated neoplasias; (vi) delineation of differences in cell-mediated responses in individuals with different EBV neoplasias; and (vii) exploitation of EBV's unique pathologic aspects, such as the use of the CR-2 receptor and the activation of B-cells during the infectious process, to develop approaches to alter these unique aspects of EBV pathogenesis with the ultimate aim of preventing or reversing neoplastic conversion. Where appropriate, collaborative arrangements to facilitate the achievement of research goals should be considered. Applications should contain as goals both methodological development and application to a specific area of EBV oncogenesis; basic and/or clinical issues are considered as appropriate subjects for this RFA. Furthermore, in studies involving differences between various EBV-associated neoplasias, investigators should consider not only the classical EBV-associated neoplasias, such as Burkitt's lymphoma and nasopharyngeal carcinoma, but also give some emphasis to newer EBV-related neoplasias such as EBV lymphomas in immunocompromised individuals, EBV tumors in other areas of the oropharynx such as the parotid gland, and other new EBV-associated diseases such as hairy leukoplakia. III. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) grant-in-aid. Responsibility for the planning, direction and execution of the proposed project will be solely that of the applicant. Except as 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) 82-50,000, revised January 1, 1987. This RFA is a one-time solicitation. Generally future unsolicited competing renewal applications will compete as research project applications with all other investigator-initiated applications and be reviewed in a standing Division of Research Grants study section. However, should the NCI determine that there is a sufficient continuing program need, NCI may announce a request for renewal applications. Approximately $ 850,000 in total costs per year for five (5) years will be committed to specifically fund applications which are submitted in response to this RFA. It is anticipated that four (4) to five (5) awards will be made. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. The total project period for applications submitted in response to the present RFA should not exceed five (5) years. The earliest feasible start date for the initial awards will be April 1, 1989. Although this program is provided for in the financial plans of the National Cancer Institute (NCI), award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. Non-profit and for-profit institutions are eligible to apply. Foreign as well as domestic institutions are eligible. IV. INQUIRIES A copy of the complete RFA describing the research goals and scope, the review criteria, and the method of applying can be obtained by contacting: Vol. 18, No. 2, January 20, 1989 - Page 7 Dr. Susan B. Spring Program Director DNA Virus Studies I Biological Carcinogenesis Branch Division of Cancer Etiology National Cancer Institute Executive Plaza North, Room 540 Bethesda, Maryland 20892 Telephone: (301) 496-4533 Written or telephone inquiries concerning the objectives and scope of this RFA or inquiries about whether or not specific proposed research would be responsive are encouraged and should be directed to Dr. Susan B. Spring at the above address. The program director welcomes the opportunity to clarify any issues or questions from potential applicants. DEVELOPMENT OF SOMATIC CELL GENE THERAPY APPROACHES FOR SPECIFIC INBORN METABOLIC DISEASES RFA AVAILABLE: 89-DK-04 P.T. 34; K.W. 0715135, 1002058, 0780015, 0755020 National Institute of Diabetes and Digestive and Kidney Diseases Application Receipt Date: July 15, 1989 INTRODUCTION AND BACKGROUND The Metabolic Diseases and the Cystic Fibrosis Research Programs, Division of Diabetes, Endocrinology and Metabolic Diseases, support basic and clinical research and research training related to the etiology, diagnosis, prevention and treatment of inborn metabolic diseases such as: cystic fibrosis (CF), other diseases of transport, aminoacidemias, organic acidurias, lysosomal storage diseases, diseases of purine and pyrimidine metabolism, glycogen storage diseases, diseases of copper metabolism, hereditary amyloidosis, etc. This initiative is an important component of a broad program for the development or improvement of therapies for orphan diseases. This initiative is intended to encourage qualified scientists to submit regular research project grant (R01) or program project grant (P01) applications which propose novel studies to facilitate development of approaches to somatic cell gene therapy. For the purposes of this program gene therapy is defined as a molecular genetic therapeutic approach that utilizes somatic cell gene transfer to correct or ameliorate the inborn error. OBJECTIVES AND SCOPE This program is intended to encourage submission of proposals to develop approaches to human gene therapy for inborn metabolic diseases. Areas of research include but are not limited to the following: development of more efficient and more rapid approaches to chromosomal localization of relevant genes; identification and characterization of retroviral and other vectors suitable for gene transfection; development of efficient gene transfection techniques; development of techniques for homologous recombination of transfected gene/s and the host chromosome in cells, or mice or other animals that serve as models for specific metabolic diseases; development of cell lines and/or mouse models suitable for gene therapy studies; development of techniques for isolation and maintenance of host cells suitable for gene therapy; and introduction of the transfected cell into the relevant target organs of an animal model and the study of in vivo expression of the functional protein. This program is intended to stimulate basic research and development of techniques focused on achieving successful human gene therapy. In this regard, studies on the general mechanisms of recombination and transfection are not suitable. MECHANISM OF SUPPORT The mechanism of support for this program will be the grant-in-aid (R01) and the program project grant (P01). Although this solicitation is included in the funding plans for Fiscal Year 1990 for NIDDK, support is contingent upon actual availability of appropriated funds. The NIDDK plans to designate a total of $2.0 million (direct and indirect costs) for the support of applications submitted in response to this solicitation; however, the amounts to be awarded will depend upon the overall merit, budget, and scope of the Vol. 18, No. 2, January 20, 1989 - Page 8 applications received. It is anticipated that approximately 5 to 10 grants will be awarded under this solicitation. APPLICATION AND REVIEW PROCEDURES Applications must be submitted on Form PHS 398 (revised 9/86), available at most institutional business offices or from the Division of Research Grants, NIH. To identify the application as a response to this RFA, please check "Yes" on item two of page one of the application and enter "NIDDK-RFA-89-DK-04 on "Somatic Cell Gene Therapy Approaches". The RFA label (found in the 9/86 revision of application form PHS 398) must be affixed to the bottom of the face page of the orginal copy of the application. Applications received in response to this solicitation will be reviewed in accord with the usual NIH peer review procedures. It is expected that site visits will not be conducted and therefore the submitted applications should be complete and stand alone for purposes of review. If an application submitted in reponse to this RFA is identical to a research grant application already submitted to the NIH for review, the applicant will be asked to withdraw the pending application before the new one is accepted. Simultaneous submission of identical applications will not be allowed. Both a P01 application and the projects which are components of this P01 may not be submitted simultaneously in response to this RFA. A single reply date of July 15, 1989, will be strictly enforced. An anticipated schedule for review and award is detailed below: APPLICATION INITIAL COUNCIL EARLIEST RECEIPT REVIEW REVIEW START DATE July 15, 1989 Oct/Nov 1989 Feb. 1990 April 1990 The original and four copies of the application should be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, Maryland 20892** Two additional copies of the application are to be sent to: Review Branch National Institute of Diabetes and Digestive and Kidney Diseases, NIH Westwood Building, Room 406 Bethesda, Maryland 20892 CONSULTATION WITH PROGRAM STAFF Prospective applicants are encouraged to request a copy of the complete RFA and to discuss their ideas with Program staff (see below) to determine whether they fit guidelines of this RFA. Applicants who intend to submit P01 applications should request a copy of NIDDK's guidelines for program project grants. Robert Katz, Ph.D. Nancy Lamontagne, Ph.D. Director, Metabolic Diseases Director, Cystic Fibrosis Research Program, NIDDK Program, NIDDK Westwood Building, Room 607A Westwood Building, Room 607 Bethesda, Maryland 20892 Bethesda, Maryland 20892 Telephone: (301) 496-7997 Telephone: (301) 496-4980 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 Part 52 and CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.