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Grant Community.com Catalog of Federal Domestic Assistance Program Descriptions |
CATALOG OF FEDERAL DOMESTIC
ASSISTANCE
93.333: Clinical Research
|
| PROGRAM AND AWARD | FINANCIAL AND INFORMATION CONTACTS |
| ELIGIBILITY REQUIREMENTS | FINANCIAL AND ADMINISTRATIVE INFO. |
| APPLICATION AND AWARD PROCESS | INFORMATION CONTACTS |
| RELATED PROGRAMS | ASSISTANCE CONSIDERATIONS |
| PROGRAM ACCOMPLISHMENTS | POST ASSISTANCE REQUIREMENTS |
Applicant Eligibility: Medical schools, research hospitals, and other institutions capable of carrying out well-designed studies in any preclinical or clinical science involving human beings as research subjects in conjunction with investigators funded through the National Institutes of Health (NIH) and other Federal agencies. To become eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.
Beneficiary Eligibility: Biomedical investigators at any nonprofit or for-profit organization, company, or institution engaged in biomedical research.
Credentials/Documentation: Institutions must demonstrate potential research productivity, quality of the proposed physical facility, and soundness of the administrative plan. Costs will be determined in accordance with OMB Circular No. A-122, "Cost Principles for Nonprofit Organizations," or OMB Circular A-21 for Educational Institutions, and HHS Regulations 45 CFR, Part 74, Subpart Q.
Preapplication Coordination: Not applicable. Program staff is available for consultation. This program is eligible for coverage under E.O. 12372, "Intergovernmental Review of Federal Programs." An applicant should consult the office or officials designated as the single point of contact in his or her State for more information on the process the State requires to be followed in applying for assistance, if the State has selected the program for review.
Application Procedure: Special instructions for preparing applications should be requested from Clinical Research, One Rockledge Center, Room 6120, National Center for Research Resources, National Institutes of Health, Bethesda, MD 20892. This program is subject to the provisions of OMB Circular No. A-110.
Award Procedure: Applications from eligible investigators and institutions are initially reviewed by committees composed of authorities in various fields of medical research. Each application is given a peer evaluation for scientific merit and need for center resources. Recommendations are forwarded to the National Advisory Research Resources Council for review and final recommendation. Upon recommendation of approval of an application by the Council, an award can be made.
Deadlines: February 1, June 1, and October 1.
Range of Approval/Disapproval Time: From 6 to 9 months.
Appeals: A principal investigator (P.I) may question the substantive or procedural aspects of the review of their application by communicating with NCRR staff. A description of the NIH Peer Review Appeal procedures is available on the NIH home page grants.nih.gov/grants/peer/peer.htm.
Renewals: The GCRC center grants are eligible for support for up to 5 years and may be renewed upon successful reapplication. The CAP, MCAP, and CRS awards are not renewable.
Criteria for Selecting Proposals: The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency and primary research funding of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives.
Examples of Funded Projects: A typical center supports multiple projects from many disciplines, such as internal medicine, pediatrics, surgery, and obstetrics and gynecology. Projects may relate to all aspects of disease mechanisms and may include projects in nutrition, diabetes, growth and development, genetics, immunology, AIDS and other areas.
Range and Average of Financial Assistance: GCRC: $122,048 to $6,079,507; $2,389,976. NGVL: $398,432 to $1,491,324; $967,964.
None.
Investigators across the country use the clinical research centers for the study of virtually all aspects of human disease and health care. In fiscal year 1999, support was provided to 77 General Clinical Research Centers, three National Gene Vector Laboratories, 104 Clinical Associate Physician (CAP) awards and eight Minority Clinical Associate Physician awards (MCAP). It is estimated that 77 General Clinical Research Centers and 3 National Gene Vector Laboratories will be funded in 2000 and 2001. It is estimated that 94 K23/CAP and seven MCAP awards will be supported in fiscal year 2000 and 95 K23/CAP, seven MCAP and 10 Mentored Medical Student Clinical Research Program (MMSCRP)in 2001.
Federal Agency: NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Type of Assistance: Project Grants.
Obligations: (Grants) GCRC: FY 99 $200,758,000; FY 00 est $210,794,000; and FY 01 est $226,561,000. NGVL: FY 99 $3,148,000; FY 00 est $3,000,000; and FY 01 est $3,200,000.
Budget Account Number: 75-0848-0-1-552.
Authorization: Public Health Service Act, Titles III and IV, Sections 301, 479, and 480, as amended, Public Laws 78-410 and 99-158, 42 U.S.C. 241, 287, and 287a, as amended; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.
Regulations, Guidelines, and Literature: OMB Circular No. A-21, "Cost Principles for Educational Institutions." Reference: 44 FR 12368, March 6, 1979; Rev. No. 1, 47 FR 33658, August 3, 1982; Rev. No. 2, 51 FR 20908, June 9,1986. OMB Circular No. A-110, "Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Nonprofit Organizations"; Reference: 41 FR 32016, July 30, 1976. OMB Circular No. A-122, "Cost Principles for Nonprofit Organizations." Reference: 45 FR 46022, July 8, 1980. 45 CFR 74; 42 CFR 52h. Grants will be available under the authority of and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 USC 241; "Grants Administration"; Indirect Cost Register, DHHS; PHS Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000, (Rev.) April 1, 1994; "NIH Grants Policy Guide" Office for Protection from Research Risks, NIH; "A Guide to Grant and Award Programs of the NIH"; "Clinical Research Guidelines"; and miscellaneous program literature from Headquarters Office.
Regional or Local Office: Not applicable.
Headquarters Office: Contact: Director, Clinical Research, National Center for Research Resources, National Institutes of Health, Department of Health and Human Services, Bethesda, MD 20892-7965. Phone: (301) 435-0790. Grants Management Contact: Grants Management Officer, Office of Grants and Contract Management, National Center for Research Resources, National Institutes of Health, Department of Health and Human Services, Bethesda, MD 20892. Phone: (301) 435-0844. Use the same numbers for FTS.
(See Appendix IV for more contact info.)
Formula and Matching Requirements: None.
Length and Time Phasing of Assistance: From 2 to 5 years. An Electronic Transfer System is used for transferring funds.
Uses and Use Restrictions: The General Clinical Research Centers comprise a national network of about 75 centers, usually located in units within hospitals of academic medical centers. The GCRCs provide a research infrastructure for clinical investigators who receive their primary support from other NIH components, other Federal agencies, and peer-reviewed sources of support in the private sector. The GCRCs support combinations of inpatient and outpatient facilities, core laboratories to carry out non-routine, sophisticated procedures, computerized database management and analyses facilities, and the necessary supporting personnel (administrative manager, biostatisticians, specialized research nurses, dieticians, and computer systems manager, etc.). The GCRCs provide an environment for studies of normal and abnormal body function and for investigations into the cause, progression, prevention, and cure of disease in children and adults. In addition, the centers are intended to provide an optimal setting for controlled studies by basic and clinical investigators; to encourage collaborations among basic and clinical scientists; to encourage, develop, and maintain a national corps of expert clinical investigators; to serve as an environment for training other health professionals in clinical research, and to provide resources in which advances in basic scientific knowledge may be translated into new or improved methods of health care. As competitive supplements to GCRCs, the Clinical Associate Physician (CAP) Program is available as a development program. The CAP program provides up to 5 years of mentored support to physicians or dentists to promote their development as independent clinical investigators. To be eligible, candidates must have earned the M.D. or D.D.S. degree or equivalent, have completed their clinical training-including specialty and, if applicable, subspecialty (nonresearch) training-prior to receiving this award. Candidates must identify a mentor with extensive clinical research experience in the expressed area of interest, and be willing to spend a minimum of 75 percent of their time in conducting clinical research during the award period. The Mid-career Investigator Award in Patient-Oriented Research is to provide support for clinicians to allow them protected time to devote to patient-oriented research and to act as mentors for beginning clinical investigators. The target candidates are outstanding clinical scientists engaged in patient-oriented research who are within 15 years of their specialty training, who can demonstrate the need for a period of intensive research focus as a means of enhancing their clinical research careers, and who are committed to mentoring the next generation of clinical investigators focusing on patient-oriented research. Three National Gene vector Laboratories are supported through a cooperative agreement between the national Center for Research Resources, the National Cancer Institute, the National Heart, Lung, and Blood Institute and the National Institute of Diabetes, Digestive and Kidney Diseases. These shared resources will facilitate optimal production of clinical grade vectors for human gene therapy research. Other shared resources arrange for distribution of human cells and tissues. The goals of the Small Business Innovation Research (SBIR) program are to increase private sector commercialization of innovations derived from Federal research and development; to increase small business participation in Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation. The goals of the Small Business Technology Transfer (STTR) program are to stimulate and foster scientific and technological innovation through cooperative research and development carried out between small business concerns and research institutions; to foster technology transfer between small business concerns and research institutions; to increase private sector commercialization of innovations derived from Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.
Reports: Progress reports and financial status reports are required annually.
Audits: In accordance with the provisions of OMB Circular No. A-133 (Revised, June 24, 1997), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that receive financial assistance of $300,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $300,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal government officials.
Records: Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the final financial status report for the report period.
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Last Updated, November, 2000
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