FEDERAL AGENCY:

NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES

AUTHORIZATION:

Public Health Service Act, Sections 301, 461 and 487, as amended; Public Laws 78-410 and 99-158, 42 U.S.C. 241, as amended; 42 U.S.C. 285k; 42 U.S.C. 288; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.

To obtain genetic maps, physical maps, and determine the deoxyribonucleic acid (DNA) sequences of the genomes of humans and model organisms to be used as resources in biomedical research, medicine, and biotechnology. Small Business Innovation Research (SBIR) program: To expand and improve the SBIR program; 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. Small Business Technology Transfer (STTR) program: 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.

TYPES OF ASSISTANCE:

Project Grants. Place Cursor Here for Definition

USES AND USE RESTRICTIONS:

The research project grant is awarded to an eligible institution in the name of a principal investigator for a discrete project or group of related projects representing the investigator's interest and competence. Funds may be used for salaries and wages, equipment, supplies, travel and other costs required to carry out the research project. National Research Service Awards are made directly to individuals for research training in disciplines supporting the research areas. In addition, grants may be made to institutions to enable them to select individuals for National Research Service Awards. Each individual who receives a National Research Service Award is responsible for certain service and payback provisions. Responsibilities of grantees and restrictions on use of funds are set forth in the Public Health Service policy statement on grants for research projects, which is available on request from the Division of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health (NIH), 6701 Rockledge Drive, Room 6207, MSC 7910, Bethesda, MD 20892-7910. Telephone: (301) 435-0714. Fax (301) 480- 0525. E-mail: asknih.od.nih.gov. Small Business Innovation Research (SBIR) Program: SBIR Phase I grants (of approximately 6 months' duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process. Phase II grants are for the continuation of research initiated in Phase I and which are likely to result in commercial products or processes. Only Phase I awardees are eligible to apply for Phase II support. STTR Phase I grants (normally of 1-year duration) are to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort that has potential for commercial application. Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential of Phase II application.

ELIGIBILITY REQUIREMENTS:

Applicant Eligibility:   Research Projects: Awards can be made to any public or private, for-profit or nonprofit university, college, hospital, laboratory, or other institution, including State and local units of government, qualifying small businesses (through the Small Business Innovation Research/STTR Programs, and to individuals. To be eligible for funding, a proposal must be approved for scientific merit and program relevance by a scientific review committee and a national advisory council. SBIR grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed, and have no more than 500 employees). Primary employment (more than one- half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. In both Phase I and Phase II, the research must be performed in the U.S. or its territories. To be eligible for funding, an SBIR grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council. STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more than 500 employees) which "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions. To be 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. Nonfederal public and private domestic organizations may apply for an Institutional National Research Service Award. Individual National Research Service awardees must be nominated and sponsored by a public or nonprofit private institution having staff and facilities appropriate to the proposed research training program. All awardees must be citizens or have been admitted to the United States for permanent residence. Predoctoral awardees must have completed the baccalaureate degree, and postdoctoral awardees must have a professional or scientific degree (M.D., Ph.D., D.O., D.V.M., Sc.D., E.Eng., or equivalent domestic or foreign degree). Applicants to the Small Business Innovation Research/STTR Programs must meet special requirements for small businesses, as defined by the Small Business Administration.

Beneficiary Eligibility:   Any nonprofit or for-profit organization, company, or institution engaged in biomedical research.

Credentials/Documentation:   Each applicant for a research project must present a research plan and furnish evidence that scientific competence, facilities, equipment, and supplies are appropriate to carry out the plan. Use grant application form PHS-398 (Rev. May 1995) provided by, the Division of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health, Bethesda, MD 20892. For applicants for National Research Service Awards, the academic record, research experience, citizenship, institutional sponsorship, and the proposed area and plan of training must be included in the application. The applicant institution must show the objectives, methodology, and resources for the research training program, the qualifications and experience of directing staff, the criteria to be used in selecting individuals for the award, and a detailed budget and justification for the grant funds requested. Costs will be determined in accordance with OMB Circular No. A-87 for State and local governments. For-profit organizations, costs are determined in accordance with 48 CFR, Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined in accordance with HHS Regulation 45 CFR 74 Subpart Q. For SBIR and STTR grants, applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. Grant forms PHS 6246-1 and 6246-2 are used to apply for Phase I and Phase II awards, respectively, or SBIR and STTR programs.

Pre-application Coordination:   This program is excluded from coverage under E.O. 12372.

Application Procedure:   Application forms and information concerning the area of science being supported may be obtained from the Division of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, Telephone 301/435-0714, e-mail: ASKNIH@odrockml.od.nih.gov. Complete the application and return it to the Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892 for assessment by a scientific review committee. The standard application forms, as furnished by PHS and required by 45 CFR, Part 92 for State and local governments, must be used for this program. This program is subject to the provisions of 45 CFR, Part 92 for State and local governments and OMB Circular No. A-110, "Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Nonprofit Organizations", as appropriate. The SBIR and STTR Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH "Small business Funding Opportunities" homepage at www.nih.gov/grants/funding/sbir.htm on the World Wide Web. A limited number of hard copies of these publications are produced. Subject to availability, they may be obtained by contacting the NIH support services contractor: phone (301) 206-9385; fax: (301) 206-9722; e- mail: a2y@cu.nih.gov. The Solicitations include submission procedures, review considerations, and grant application or contract proposal forms. Completed SBIR and STTR grant applications should be submitted to the Center for Scientific Review, 6701 Rockledge Drive, Room 1040 - MSC 7710, Bethesda, MD 20892-7710.

Award Procedure:   All accepted applications for project grants and institutional National Research Service Awards are reviewed for scientific merit by an appropriate initial review group and by the National Advisory Council for Human Genome Research (NACHGR). (Individual NRSA applications are not reviewed by council.) All approved applications compete for available funds on the basis of scientific merit and program emphasis. Awards are issued throughout the year. All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score ranging from the best (100) to worst (500) compete for the available SBIR/STTR set-aside funds on the basis of scientific and technical merit (which includes the potential of the proposed research for commercial application), program relevance, and program balance among the areas of research.

Deadlines:   New Research Projects: February 1, June 1, and October 1. Renewals: March 1, July 1, and November 1. Individual NRSA: April 5, August 5, and December 10. Institutional NRSA: January 10, May 10, and September 10. SBIR/STTR Applications: April 1, August 1, and December 1. SIP: Contact Headquarters Office.

Range of Approval/Disapproval Time:   Project Grants: About 9 months. SBIR/STTR: About 7-1/2 months.

Appeals:   A principal investigator (P.I.) may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute. 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:   Renewal grants are competitively awarded.

ASSISTANCE CONSIDERATIONS:

Formula and Matching Requirements:   This program has no statutory formula or matching requirements.

Length and Time Phasing of Assistance:   All awards are made for at least 1 year. Additional support may be available for up to 4 more years depending upon the recommendations of the scientific review group, the National Advisory Council for Human Genome Research, successful annual performance, and availability of funds. SBIR: Normally, Phase I awards are for 6 months; normally, Phase II awards are for 2 years. STTR: Normally, Phase I awards are for 1 year; normally, Phase II awards are for 2 years.

POST ASSISTANCE REQUIREMENTS:

Reports:   Annual progress and financial status reports for continuing projects and final reports on all projects upon conclusion are required. Recipients of National Research Service Awards are required to file termination reports to ascertain compliance with the service and payback provisions.

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 officials.

Records:   Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period.

FINANCIAL INFORMATION:

Account Identification:   75-0891-0-1-552.

Obligations:   (Research Grants) FY 01 $275,980,000; FY 02 est $308,871,000; and FY 03 est $343,578,000. SBIR/STTR: FY 01 est $8,030,000; FY 02 est $8,851,000; and FY 03 est $9,231,000. NRSA: FY 01 $3,353,000; and FY 02 est $4,671,000; and FY 03 est $4,793,000.

Range and Average of Financial Assistance:   Research Project Grants, past and current: $25,000 to $7,279,315; Average: $548,376.

NHGRI manages a broad-based research program directed towards the development of a resource, consisting of genetic maps, physical maps, and DNA sequence information of the human genome and the genomes of a number of other organisms, to be used in biomedical research, medicine, and biotechnology. A component of the program also addresses the ethical, legal, and social implications of the application of new genetics technology. In fiscal year 2001, 141 research project grants were funded. Additionally, 24 research centers, 22 research careers awards, 45 other research awards and 85 full-time trainee positions were supported. In fiscal year 2002, 139 research project grants, 32 research centers, 24 research career awards, 26 other research-related awards, and 110 full-time trainee positions are estimated to be funded. In fiscal year 2003, an estimated 138 applications for competing research project grants are expected to be received. Of that number, 38 competing grants are estimated to be funded. Additionally, support is anticipated for 35 research centers, 25 research career awards, 28 other research-related awards, and 110 full-time trainee positions.

REGULATIONS, GUIDELINES, AND LITERATURE:

42 CFR 52; 42 CFR 66; 45 CFR 74; 45 CFR 92; NIH Extramural Programs brochure and other miscellaneous program literature are available from Headquarters Office. 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; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant applications.

INFORMATION CONTACTS:

Regional or Local Office:   Not applicable.

Headquarters Office:   Program Contact: National Human Genome Research Institute, National Institutes of Health, Public Health Service, Department of Health and Human Services, Bethesda, MD 20892. Program Contacts: Dr. Mark Guyer - Telephone: (301) 496-7531 or Dr. Bettie Graham - Telephone: (301) 496-7531. Research Centers contact: Dr. Jane Peterson - Telephone: (301) 496-7531. Ethical, Legal, and Social Implications Contact: Ms. Elizabeth Thomson Telephone: (301) 402- 4997. SBIR Contact: Dr. Bettie Graham. Telephone: (301) 496-7531. Grants Management Contact: Ms. Jean Cahill, Grants Management Officer, National Human Genome Research Institute, National Institutes of Health, Public Health Service, Department of Health and Human Services, Bethesda, MD 20892. Telephone: (301) 402-0733. Use the same numbers for FTS.

Web Site Address:   http://www.nih.gov

EXAMPLES OF FUNDED PROJECTS:

(1) "Establishing a Robust Multiplex SNP-scoring system"; (2) "Sequencing the Mouse Genome" (3) "Mapping and Sequencing Human Telomeres"; (4) "Thermoreversible Gels for Microchannel Sequencing DNA"; (5) "Attitudes about Hereditary Breast Cancer"; and (6) "DNA Pattern Identification and Analysis."

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 project; and (5) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation, originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget request for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.