FEDERAL AGENCY:

NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES

AUTHORIZATION:

Public Health Service Act, Title IV, Section 301, as amended, Public Law 78-410; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.

OBJECTIVES:

PLEASE SEE PROGRAM 93.855; Allergy and Infectious Diseases Research NO FUNDING WILL BE REPORTED UNDER 93.856.

TYPES OF ASSISTANCE:

Project Grants. Place Cursor Here for Definition

USES AND USE RESTRICTIONS:

PLEASE SEE PROGRAM 93.855; Allergy and Infectious Diseases Research NO FUNDING WILL BE REPORTED UNDER 93.856.

ELIGIBILITY REQUIREMENTS:

Applicant Eligibility:   Universities, colleges, hospitals, laboratories and other public or private nonprofit domestic institutions, including State and local units of government. Individuals are eligible to make application for grant support of research by a named principal investigator or a research career development candidate. For-profit organizations are also eligible, with the exception of NRSA. Individual NRSA 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 NRSA awardees must be citizens or have been admitted to the United States for permanent residence. To be eligible, predoctoral candidates must have completed the baccalaureate degree and postdoctoral candidates must have a professional or scientific degree (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D.Eng.), or must have an equivalent domestic or foreign degree. 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 being 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 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. 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 researches 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.

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

Credentials/Documentation:   Research grant applicants must define the objectives, methodology, and facilities for the program, and must present the program director's competence and scientific interest. 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 PHS 6246-2 are used to apply for SBIR Phase I and Phase II, respectively. Grant forms PHS 6246-3 and PHS 6246-4 are used to apply for STTR Phase I and Phase II, respectively. Applicants for Individual NRSAs must include their academic record, research experience, citizenship, institutional sponsorship, and the proposed area and plan of training in their applications. The applicant for an Institutional NRSA must specify 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 award, and a detailed budget and justification for the amount of grant funds requested. Costs will be determined in accordance with OMB Circular No. A-87 for State and local government. For-profit organizations' costs are determined in accordance with Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined by HHS Regulations 45 CFR, Part 74, Subpart Q.

Pre-application Coordination:   Not applicable. This program is excluded from coverage under E.O. 12372.

Application Procedure:   Use Form PHS-398 (Rev. May 1995), (PHS- 5161-1 for State and local government units) to apply for new, renewal, and supplemental research grants. Application forms and information concerning current areas of science being supported are available from the Division of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health, 6701 Rockledge Drive, Room 6207, MSC 7910, Bethesda, MD 20892. Telephone: (301) 435- 0714. Fax (301) 480-0525. E-mail: asknih@od.nih.gov. 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 for nonprofit organizations. Completed applications should be submitted to the Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892. SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's "Small Business Funding Opportunities" home page 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. 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 are reviewed for scientific merit by an appropriate initial review group and a national advisory council. If the application is recommended for approval and a decision to make an award is made, a formal award notice will be sent to the applicant or applicant institution. 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 compete for available SBIR/STTR set-aside funds on the basis of scientific and technical merit and commercial potential of the proposed research, program relevance, and program balance among the areas of research.

Deadlines:   New Non-AIDS research applications: February 1, June 1, and October 1. For Renewal and Supplemental Non-AIDS research grant applications: March 1, July 1, and November 1. For all AIDS research grant applications: January 2, May 1, September 1. Research Career Development Award programs: February 1, June 1, October 1. Individual NRSAs: April 5, August 5, and December 5. Institutional NRSA: September 10. SBIR/STTR: April 1, August 1, and December 1.

Range of Approval/Disapproval Time:   From 8 to 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. Final decisions on unresolved appeals are made with the advice of the National Advisory Allergy and Infectious Diseases Council.

Renewals:   Renewals of research grant support are by competitive application and review. The competitive application may request support for a segmental period of up to 5 years.

ASSISTANCE CONSIDERATIONS:

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

Length and Time Phasing of Assistance:   Research grant project periods average 4 years; these may not be extended beyond 7 years. (Project periods are generally composed of 1-year budget periods.) 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 reports and financial status reports are required.

Audits:   In accordance with the provisions of OMB Circular No. A- 133 (Revised, June 24, 1997), "Audits of States, Local Governments, and Nonprofit 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 last expenditure report for the report period.

FINANCIAL INFORMATION:

Account Identification:   75-0885-0-1-552.

Obligations:   (Grants) FY 01 $1,064,523,000; FY 02 est $1,172,574,000; and FY 03 est $1,480,643,000. (SBIR) FY 01 $35,326,000; FY 02 est $40,869,000; and FY 03 est $70,361,000. (STTR) FY 01 $3,388,000; FY 02 est $3,469,000; and FY 03 est $4,221,000.

Range and Average of Financial Assistance:  
PLEASE SEE PROGRAM 93.855; Allergy and Infectious Diseases Research NO FUNDING WILL BE REPORTED UNDER 93.856.

In fiscal year 2001, a total of 3,070 awards were made to establish, expand, and promote research and research training in bacterial and mycosis diseases, viral diseases, parasitic diseases and other related areas. An estimated 3,127 and 3,533 awards will be made in fiscal years 2002 and 2003 respectively. A total of 92 SBIR Phase I, 48 SBIR Phase II, 6 STTR Phase I, and 6 STTR Phase II awards were made in fiscal year 2001.

REGULATIONS, GUIDELINES, AND LITERATURE:

42 CFR 52; 42 CFR 66; 45 CFR 74; 45 CFR 92; (SBIR) Small Business Administration Policy Directive No. 65 01 (47 Fed. Reg. 52966 et seq. (1982), as amended by Policy Directive No. 65 01.1 (48 Fed Reg. 38794 et seq. (1983)); 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:  
None. PLEASE SEE PROGRAM 93.855; Allergy and Infectious Diseases Research NO FUNDING WILL BE REPORTED UNDER 93.856.

Headquarters Office:   Donna C. Perry 5601 Fishers Lane Room 5E48, Bethesda, Maryland 20892 Email: dp94y@nih.gov Phone: 240-669-5429

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

EXAMPLES OF FUNDED PROJECTS:

Not Applicable.

CRITERIA FOR SELECTING PROPOSALS:

See relevant program announcements.