Full Text DK-93-06 EXPLORATORY GRANTS FOR CENTERS OF EXCELLENCE IN MOLECULAR HEMATOLOGY NIH GUIDE, Volume 21, Number 41, November 13, 1992 RFA: DK-93-06 P.T. 34 Keywords: Hematology Molecular Genetics Cell Lines Viral Studies (Virology) Growth Factors Technology Planning/Policy National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: January 31, 1993 Application Receipt Date: March 15, 1993 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Exploratory Grants for Centers of Excellence in Molecular Hematology, to be awarded competitively in Fiscal Year 1993. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Exploratory Grants for Centers of Excellence in Molecular Hematology, is related to the priority areas of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted from domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, or medical centers. Applications from foreign institutions are ineligible for the center program mechanism. Applicant institutions must demonstrate an established research base in areas related to the RFA. Minority individuals and women are encouraged to submit as Principal Investigators. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included with the application. MECHANISM OF SUPPORT Support of this program will be through the NIH grant-in-aid Exploratory Grant (P20) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement and in this announcement. Requests for support must be limited to no more than $20,000 in direct costs. Any application exceeding this amount will be returned to the applicant. Under certain circumstances, a no-cost extension of up to another 12 months can be requested. FUNDS AVAILABLE The NIDDK anticipates awarding five Exploratory Grants in Fiscal Year 1993 on a competitive basis, the awards will be for one year duration and contingent upon the availability of appropriated funds. It is anticipated that approximately $150,000 in FY 93 funds will be available for funding these awards. RESEARCH OBJECTIVE The objective of Exploratory Grants (P20) is to provide partial funding for the cost of planning and developing meritorious Centers of Excellence in Molecular Hematology. The anticipated awards for full scale Centers of Excellence in Molecular Hematology (P50) will be made in Fiscal Year 1994 or Fiscal Year 1995, contingent upon authorization and appropriation of funds, and will involve a separate nation-wide competition. It is important to note that the award of an Exploratory Grant does not imply a commitment by the National Institute of Diabetes and Digestive and Kidney Diseases to future funding of a Center of Excellence in Molecular Hematology planned with the support of an Exploratory Grant. Center applications will be reviewed on the basis of their own merit. A future announcement will be made for applications for Centers of Excellence in Molecular Hematology. At that time, any eligible institution may apply; funding decisions will not be based on previous award of an Exploratory Grant. Guidelines are available from the NIDDK that describe the Centers of Excellence in Molecular Hematology (P50), and the anticipated application process for the Centers. These guidelines should be requested from the program administrator identified in INQUIRIES before applying for an Exploratory Grant. Background Exploratory Grants are intended to provide partial support for the planning phase of a Center of Excellence in Molecular Hematology. Successful applicants thus would be better prepared to formulate appropriate programs in response to a later announcement by the NIDDK of a full-scale Centers (P50) announcement. The planning phase may consist of, but is not limited to: a. departmental and interdepartmental planning to integrate a broad spectrum of molecular hematology related activities; b. planning the establishment of specialized resources and facilities; c. feasibility surveys to identify special problems and opportunities; d. use of consultants to assist in developing plans for Center activities and core resources. Centers of Excellence in Molecular Hematology will allow development of the broad range of technologies involved in the investigation of genetic diseases and genetic therapy to be brought together in a unified effort. These technologies will draw on knowledge of viruses, cell culture, bone marrow cells, growth factors, animal models, and the molecular basis of genetic diseases. During the past two decades, major advances have been made in understanding the molecular basis for inherited diseases. The clinical and biochemical effects of diseases have been clarified, and, in an ever-increasing number of genetic disorders, the molecular defects have been described. Notable examples of this new knowledge are the genes for Cooley's anemia, sickle cell disease, and hemophilia. Application of sensitive biochemical and molecular techniques has made molecular diagnosis of these disorders a reality. Now, with these important diagnostic achievements in hand, even greater efforts must be directed toward development of technologies to formulate specific therapies for these debilitating disorders. The development of Centers as an organizational mechanism will promote the joint efforts both of basic scientists and clinical researchers toward the study of gene structure and function, the structural biology of proteins and the complex biochemistry of protein interaction, the cell and molecular regulation of blood cell formation, and clinical research to test the efficacy and safety of therapeutic strategies derived from basic investigation. These studies will have as their ultimate goal the development of somatic gene therapy or other means of treatment of genetic diseases. Concentration of efforts into the Center format will allow economies of scale and will generate technologies that can be applied by other investigators. The capability to design and implement strategies for clinical application of molecular genetic knowledge will be essential for the Centers. However, Center funds will not be available for full-scale clinical trials, and investigators will be encouraged to apply for support of clinical trials by alternative mechanisms. Due to the breadth of expertise in a variety of disciplines needed for successful application of molecular genetic technologies to genetic diseases, it is anticipated that such expertise may not be available at any one institution. Therefore, applicants are encouraged to propose consortium arrangements with other suitable institutions with needed expertise. Such consortia may include geographic separation, if acceptable plans for effective collaboration are proposed. Where appropriate, applicant institutions are strongly encouraged to develop relationships with traditionally minority institutions and investigators. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 09/91) in Item 4 (Research Design and Methods) of the Research Plan AND summarized in Item 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations; i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, and Hispanics. The rationale for studies on single-minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention [and preventive strategies], diagnosis, or treatment of diseases, disorders, or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned without review. LETTER OF INTENT Potential applicants are strongly encouraged to submit a letter of intent no later than January 31, 1993. The letter of intent is to include: (1) name of the Principal Investigator/program director and principal collaborators, (2) descriptive title of the potential application, (3) identification of the organization(s) involved, and (4) reference to RFA DK-93-06. The letter of intent is to be sent to the Chief, Review Branch, NIDDK, at the address noted below. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid conflict of interest in the review. APPLICATION PROCEDURES Applications are to be submitted on the form PHS 398 (rev. 09/91) available at most institutional offices of sponsored research and from the Division of Research Grants, National Institute of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, (301) 496-7441. For item 2a of the face page of the application, applicants should enter RFA: Hematology Exploratory Grants, RFA number DK-93-06. The RFA label available in the form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application to the extent that it may not reach the review committee in time for review. Applications must be received by close of business March 15, 1993. If an application is received after this date, it will be returned to the applicant. The original and three copies of the application must be sent or delivered to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Robert D. Hammond, Ph.D. Chief, Review Branch, DEA National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 5333 Westbard Avenue Bethesda, MD 20892 The Division Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. Nor will the DRG accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Special Application Instructions The written application is the basis for the merit review. Particular attention should be given to the format of the application. The standard instructions provided with the PHS 398 are designed primarily for applications for single research projects. Exploratory Grant applications require additional information as outlined below. Page limitations presented in the PHS 398 instructions should be followed closely unless otherwise noted. Program Narrative (PHS 398, Continuation Pages) The narrative must provide a description and plan of the Exploratory Grant program, and how the applicant intends to prepare for developing a Center program. The narrative must include an overall description of the envisioned Center as well as a description of each of the Center components. Appendices Follow instructions on page 24 of PHS Form 398. Budgetary Considerations - Allowable Costs Unless otherwise indicated, allowable costs and policies governing the research grant programs of the NIH will prevail. Overlapping support between the Exploratory Grant and other NIH grants and contracts to the applicant institution will be administratively reviewed and, if appropriate, will be adjusted to avoid duplication of funding. Support may be requested for salaries of professional, technical, and support personnel who contribute to allowable activities under the Exploratory Grant. The salaries derived from the Exploratory Grant will depend on the effort provided and institutional salary policies. Salaries of personnel engaged in administrative and planning activities are allowable cost items. Stipends for research fellows/trainees are not allowable. No overlap of time or effort between the Exploratory Grant and other, separately funded projects is permitted. Support for secretarial and administrative staff may be provided to the extent that their activities relate to administrative management of the Exploratory Grant activities, providing these costs have not been included in the institution's indirect cost pool. Expenditures for major equipment under this RFA will not be considered. General purpose equipment needs may be included and justified only after surveying the availability of such items within the institution. Consumable supplies directly related to the operation of the Exploratory Grant are allowed. These supplies principally will include office materials (if not included in the indirect cost pool). Research patient care costs are not required for Exploratory Grant purposes, and will not be provided. Domestic travel costs of Exploratory Grant personnel directly related to administrative and planning activities is allowable. Foreign travel will not be allowed except under unusual and compelling circumstances, and will require prior approval by the awarding agency. Costs for consultant services (consultation fees, per diem, travel) may be included. Costs associated with consultation or scientific or technical assistance, evaluation of planning activities, and development of new organizational arrangements and consortia are allowable. Costs for telephone, photocopying, and computer time are permitted. REVIEW CONSIDERATIONS Upon receipt, applications will be examined initially by the DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation of responsiveness to the program requirements and criteria stated in this RFA is an NIDDK staff function. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below and in the Centers of Excellence in Molecular Hematology Guidelines for Scientific/Technical Merit by an appropriate peer review group convened by the NIDDK. It is essential that the written application be in a form that can be reviewed on its own merit, since no site visit is anticipated. If the number of applications is large compared to the number of awards to be made, the NIDDK may conduct a preliminary scientific peer review to eliminate those applications that are clearly not competitive. The NIDDK will withdraw administratively from competition those applications judged to be noncompetitive, and will so notify the applicant and the institutional business official. Those applications judged to be both competitive and responsive to the RFA will be evaluated further, according to the review criteria stated below. Following initial merit review, the applications will be given a second-level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. The review of the Exploratory Grant applications will focus on scientific merit. Additionally, the component parts of the Exploratory Grant will be reviewed for their synergism and contribution to the future development of a Center. The evaluation will include the following review criteria: 1. Overall Program o The scientific merit of the program as a whole. The significance of the overall program goals and the development of a well-defined central focus. o The potential of the identified participants to develop interdisciplinary research programs of high merit as evidenced by previous accomplishments. o The balance of administrative and planning expenses. 2. Administration and Planning o The scientific and administrative leadership ability and experience of the Exploratory Grant Principal Investigator and his/her commitment and ability to devote adequate time to the effective management of the Center planning. o Maintenance of internal communication and cooperation among the investigators involved in planning for a Center. o Adequacy of the Advisory Committee to assess the scientific merit of the proposed Center plans. o Inclusion of an adequate mechanism for reviewing the proposed uses of Center funds. o Appropriateness and adequacy of plans for collaboration among the members of the proposed Center. o Appropriateness of the budget for the various components of the Exploratory Grant. 3. Scientific Expertise of Participants o Quality and appropriateness of expertise available at the applicant institution. o Nature and degree of interdisciplinary approach proposed to promote the collaboration of scientists with expertise in hematology with scientists in other disciplines. o Qualifications, experience, and evidence of commitment of the investigators within the applicant institution, and their willingness to interrelate with other elements proposed for the proposed Center. o Quality and appropriateness of collaborating institutions and research staff. o Proposed plans to recruit new expertise to the proposed Center. 4. Institutional Commitment o The institutional commitment to the program, including lines of responsibility for a Center and the institution's contribution to the management capabilities of a Center. o The degree of institutional contributions for administrative and planning activities. o The academic research environment and resources in which the activities would be conducted, including the availability of space, equipment, and facilities, and the potential for interaction with scientists from other departments and institutions. o The institutional commitment to any newly-recruited individuals responsible for conducting essential planning functions and activities. AWARD CRITERIA Applications will compete for available funds with all other applications submitted in response to this RFA and recommended by peer review. The following will be considered in making funding decisions: o Quality of the application as determined by peer review o Availability of funds o Overall program balance represented by the applications recommended by peer review Schedule Letter of Intent: January 31, 1993 Application Receipt: March 15, 1993 Initial Review: June-July 1993 Second Level Review: September 1993 Anticipated Award: September 30, 1993 INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: David G. Badman, Ph.D. Hematology Program Director Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A-05 Bethesda, MD 20892 Telephone: (301) 496-7458 Direct inquiries regarding fiscal matters to: Ms. Nancy Dixon Grants Management Officer National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 637 Bethesda, MD 20892 Telephone: (301) 496-7467 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849 for DKUHD. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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