In fiscal year 2007, it is estimated that there will be 109 and in FY 2008, 120 grants. It is estimated that there will be 71 Clinical Research Resource Center awards in FY 2007 and 64 in FY 08. It is estimated that there will be 14 Clinical and Translational Science awards in FY 2007 and 18 in FY 2008. It is estimated there will be 56 Biomedical Technology Resource Centers awards in FY 2007 and FY 2008. It is estimted that there will be 94 Special Comprehensive Centers in FY 2007 and 93 in FY 2008. It is estimated that there will be 49 Comparative Medicine Centers in FY 2007 and FY 2008. It is estimated that there will be 28 Research Centers in Research Infrastructure in FY 2007 and FY 2008. It is estimated that there will be 554 Other Research Grants in FY 2007 and 45 in FY 2008. It is estimated that there will be 132 Full Time Training Positions in FY 2007 and FY 2008. It is estimated that there will be 69 Development Contracts in FY 2007 and FY 2008.

Uses and Use Restrictions

The Division of Biomedical Technology supports research, development and access to sophisticated technologies at resource centers nationwide which assist academic, nonprofit organizations in the development, use, and dissemination of innovative technologies useful for the advancement of biomedical science.

Awards are provided under a variety of funding mechanisms composed of Biomedical Technology Resource(BTR) grants, Research Project Grants, Shared Instrumentation Grants (SIG), High End Instrumentation (HEI) Program and other mechanisms, such as Exploratory Grants to develop new technologies for biomedical research, Small Business Innovation Research (SBIR) grants, and Small Business Technology Transfer (STTR) grants.

The Division for Clinical Research Resources makes it possible to apply knowledge gained through basic research to the development of lifesaving drugs, devices, and therapies that protect the health of our nation's citizens by providing research infrastructure for clinical investigators.

These specialized institutional resources are equipped to be flexible and responsive to changing scientific and economic environments and to unforeseen research challenges.

The Division for Clinical Research Resources helps translate scientific knowledge into effective patient care through General Clinical Research Centers (GCRC), Research Career Development (K23, K24), Clinical Research Curriculum Award (CRCA, K30), Mentored Clinical Research Scholar (CRS) Program (K12), National Gene Vector Laboratories (NGVL), Clinical Research-related activities, Small Business Innovation Research (SBIR) grants and Small Business Technology Transfer (STTR) grants; and improves pre-college science education and the public's understanding of science through the Science Education Partnership Award (SEPA) Program.

Additionally, a new consortium, funded through Clinical and Translational Science Awards (CTSAs), will transform how clinical and translational research is conducted, ultimately enabling researchers to provide new treatments more efficiently and quickly to patients.

The Division of Comparative Medicine supports research and resource projects, as well as centers that enable biomedical scientists to use high quality, disease-free animals effectively in research on human health problems.

Support is also available for the development of a wide range of other research models, particularly marine invertebrates and lower vertebrates, and access to an array of important biological materials.

These objectives are accomplished through activities of National Primate Research Centers (NPRC), Laboratory Animal Science (LAS), and Biological Models and Materials Research (BMMR).

The Division of Research Infrastructure addresses the under representation of minority investigators; enhances the research environment at minority colleges and universities in the health sciences; broadens the geographic distribution of research grant funding to states with historically low NIH success rates; and improves biomedical research facilities through matching grants for construction and renovation.

These objectives are accomplished through activities of the Research Centers in Minority Institutions (RCMI) program, the RCMI Clinical Research Infrastructure Initiative (RCRII), the Institutional Developmental Award (IDeA), the Research Facilities Improvement Program (RFIP), and the Animal Facilities Improvement program.

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Eligibility Requirements

Applicant Eligibility

BTR Grants: Nonprofit health professional schools; other academic institutions; hospitals; State and local health agencies; and research organizations with programs in biomedical technology research located in the United States and its territories.

SIG and HEI awards will be made to institutions only, not to individuals.

GCRC and CTSA grants: 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.

Research Career Development: Applications may be submitted on behalf of candidates by domestic, nonfederal organizations, public or private institutions of higher education.

Clinical Research Scholar Program Award: Applications will be accepted from domestic, nonprofit organizations, public and private institutions of higher education that have strong, well-established clinical research and training program.

SEPA: Public and private for-profit and nonprofit institutions and museums.

DCM: Institutions of higher education, hospitals, and other institutions and organizations, both nonprofit and for-profit, seeking to establish, continue, or enlarge programs consistent with the objectives of the program.

Applicants for NRSA must be citizens of the United States or be admitted to the United States for permanent residency.

Applicants must be nominated and sponsored by a public or private nonprofit institution with staff and facilities suitable for the proposed research training.

Nonprofit domestic organizations may apply for the institutional NRSA.

RCMI: Institutions with more than 50 percent minority enrollment that award an M.D., D.D.S., D.V.M., or other doctoral degree in the health professions and/or a Ph.D.

in the health-related sciences.

This program is open only to institutions within the United States and its territories.

RCRII: RCMI eligible institutions affiliated with medical schools.

IDeA: Domestic public and private for profit and nonprofit institutions in States in which the success rate for applications to the NIH has been historically low.

RFIP and Animal Facilities Improvement: Except where otherwise prohibited by law, any nonprofit organization competent to carry out biomedical research.

Beneficiary Eligibility

Biomedical investigators at any nonprofit or for-profit organization, company, or institution engaged in biomedical research.

Credentials/Documentation

SIG, HEI: A major user group of three or more investigators should be identified. Each major user must have NIH peer-reviewed research support at the time of the award. The application must show a clear need for the instrumentation by projects supported by multiple NIH research awards and demonstrate that these projects will require at least 75 percent of the total usage of the instrument. Applications for NRSA must be citizens of the United States or be admitted to the United States for permanent residency. Applicants must be nominated and sponsored by a public or private nonprofit institution with staff and facilities suitable for the proposed research training. Nonprofit domestic organizations may apply for the institution NRSA. RCMI, RCRII, and CCRE: Applicants must certify eligibility (see Applicant Eligibility requirements). IDeA, and Animal Facilities Improvement: None. RFIP: Application should include a complete research program description (with staff curricula vitae), space requirements for projected program, an environmental summary of the impact of the proposed facility as detailed in Public Law 90-190, The National Environmental Policy Act, and listing of all relevant licenses, permits or other approvals required by State and local authorities. Costs will be determined in accordance with OMB Circular Nos. A-122, "Cost Principles for Nonprofit Organizations," and in the case of SIG & HEI No. A-87 for State and local governments or A-21 for Educational Institutions, and HHS Regulations 45 CFR, Part 74, Subpart Q.

Aplication and Award Process

Preapplication Coordination

All programs not applicable, except RFIP.

Program staff is available for consultation.

Programs are excluded from coverage under E.O.

12372.

RFIP: The standard application forms, as furnished by PHS and required by 45 CFR 92 for State and local governments, must be used for this program.

An environmental impact statement and assessment is required for this program.

This program is eligible for coverage under E.O.

l2372, "Intergovernmental Review of Federal Programs." An applicant should consult the office or official designated as the single point of contact in his or her State for more information on the process the State requires when applying for assistance, if the State has selected the program for review.

Application Procedures

Application forms may be obtained from the Division of Extramural Outreach and Information, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910. Telephone (301) 435-0714, e-mail: ASKNIH@odrockml.od.nih.gov . Completed applications should be submitted to the Center for Scientific Review, 6701 Rockledge Drive, MSC 7710, Bethesda, MD 20892-7710. The standard application forms PHS 398, (Rev. November 1998), as furnished by PHS and required by 45 CFR, Part 92, and OMB Circular No. A-110 must be used for all programs. For filing NRSA individual fellowship award applications, Form 416-1 (Rev. October 1991) is needed. GCRC: Special instructions for preparing applications should be requested from the Division for Clinical Research Resources, One Democracy Plaza, 6701 Democracy Blvd., National Center for Research Resources, National Institutes of Health, Bethesda, MD 20892-4874. RFIP: Construction applications are to be submitted on a Standard Form 424, Application for Federal Assistance.

Award Procedures

The initial review of applications from eligible investigators and institutions is reviewed by committees comprised of authorities in various fields of biomedical research and science education, as appropriate. Each application is given a peer evaluation for merit, and recommendations are forwarded to the National Advisory Research Resources Council for final review and recommendation.

Deadlines

New applications and Resource Center renewals: February 1, June 1, and October 1. Other Competing Renewals: March 1, July 1, and November 1. NRSA Applications: Individual Fellowships - April 5, August 5, and December 5. All others: See current RFA or PA or Contact.

Authorization

Public Health Service Act, Titles III and IV, Sections 301, 479, 480, and 487 as amended, Public Laws 78-410 and 99-158, 42 U.S.C. 241, 287, 287a, and 288, as amended; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.

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 the NCRR staff. A description of the NIH Peer Review Appeal procedures is available on the NIH home page www.nih.gov/grants/guide/1997/97.11.21/n2.html .

Renewals

K23, K24, SIG, HEI, Animal Facilities Improvement, and RFIP: None. All others may be renewed upon successful reapplication.

Assistance Considerations

Formula and Matching Requirements

RFIP and Animal Facilities Improvement: NCRR will award up to 50 percent of the eligible costs, except for National Primate Research Centers for which the Federal share is 80 percent. Up to 25 percent of appropriated funds are targeted to Centers of Excellence. Matching funds from nonfederal sources are required. Even though matching funds are required, in unusual and compelling circumstances the NCRR Director may waive some or all of the requirement for nonfederal matching funds. All other programs: None.

Length and Time Phasing of Assistance

All programs except for RFIP: 1 to 5 years. An Electronic Transfer System is used for transferring funds. RFIP: Construction must be completed within the time specified in grant award. The initial budget period is usually 2 years in length, although extensions may be requested. All funds must be obligated within 5 years from the date of award.

Post Assistance Requirements

Reports

Annual progress and financial status reports are required for all grants.

Final performance and financial reports are required 90 days following the end of the project period.

Reports are required after termination of NRSA to ascertain compliance with the service and payback provisions.

RFIP: The grantee is responsible for performance of the contractor.

The contractor must be covered by performance and payment bonds.

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 expend 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.

Financial Information

Account Identification

75-0848-0-1-552.

Obigations

(Grants) Research Projects: FY 07 $64,879,000; FY 08 est $68,621,000; and FY 09 est not reported. Clinical Research Resources Centers: FY 07 $200,893,000; FY 08 est $160,626,000; and FY 09 est not reported. Clinical and Translational Science Awards: FY 07 $112,351,000; FY 08 est $157,672,000; and FY 09 est not reported. Special Comprehensive Centers: FY 07 $217,879,000; FY 08 $210,701,000; and FY 09 est not reported. Biomedical Technology Research Centers: FY 07 $74,261,000; FY 08 est $71,097,000; and FY 09 est not reported. Comparative Medicine Centers: FY 07 $113,315,000; FY 08 est $109,148,000; and FY 09 est not reported. Research Centers in Minority Institutions: FY 07 $52,241,000; FY 08 est $50,519,000; and FY 09 est not reported. Other Research: FY 07 $227,497,000; FY 08 $185,690,000; and FY 09 est not reported. Research Training: FY 07 $5,411,000; FY 08 est $5,411,000; and FY 09 est not reported. Research and Development Contracts: FY 07 $47,157,000; FY 08 est $50,142,000; and FY 09 est not reported. Construction: FY 07 $0; FY 08 est $0; and FY 09 est not reported.

Range and Average of Financial Assistance

Research Project Grants: $14,000 to $1,558,000; Research Centers: $7,000 to $12,218,000; Other Research: $4,000 to $2,505,000; Research Training Grants: $69,000 to $389,000; Research and Development Contracts: $4,000 to $4,103,000; Construction: $250,000 to $4,278,000.

Regulations, Guidelines, and Literature

BT: 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." OMB Circular No. A-128, "Audits of State and Local Governments"; Reference: Public Law 98-502, the Single Audit Act of 1984. OMB Circular No. A-87, "Cost Principles Applicable to Grants and Contracts with State and Local Governments"; Reference: 34 CFR 255. 45 CFR 92. Reference: 42 FR 45828. 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. Department Staff Manual "Grants Administration"; Indirect Cost Register, DHHS; PHS Grants Policy Statement, DHHS Publications 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"; and miscellaneous program literature from Headquarters Office.

Information Contacts

Regional or Local Office

Not applicable.

Headquarters Office

Program Contacts: Director, Division of Biomedical Technology, Telephone: (301) 435-0755; Director, Division for Clinical Research Resources, Telephone (301) 435-0790; Director, Division of Comparative Medicine. Telephone: (301) 435-0744; Director, Research Infrastructure, Telephone: (301) 435-0788, National Center for Research Resources, National Institutes of Health, Department of Health and Human Services, Bethesda, MD 20892. Grants Management Contact: Grants Management Officer, Office of Grants Management, National Center for Research Resources, National Institutes of Health, Department of Health and Human Services, Bethesda, MD 20892. Telephone: (301) 435-0844.

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 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. RFIP: Factors considered in making awards include the merit of the proposal, the needs of the institution, with special consideration for institutions designated as centers of excellence, the commitment of the institution, the availability of funds, and the overall program priorities.