FEDERAL AGENCY:

NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES

AUTHORIZATION:

Public Health Service Act, Section 301, as amended, Public Law 78-410, 42 U.S.C. 241; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.

To develop scientific information about potentially toxic and hazardous chemicals by concentrating on toxicological research, testing and test development, and validation efforts. Specific goals of the program include the determination of the toxicological profiles of chemicals, and the development and validation of existing and emerging methodologies that can be successfully employed for predicting the human response to toxic agents. 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:

Research Grants: Research Grants and Cooperative Agreements are intended to support the direct costs of a project, in accordance with an approved budget, plus an appropriate amount for indirect costs. 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 the research initiated in Phase I and that are likely to result in commercial products or processes. Only Phase I awardees are eligible to receive 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. Independent Scientist Awards (supersede the former Career Development Awards): These awards in amounts up to $50,000 (plus fringe benefits and 8 percent indirect costs) are made to institutions to provide stable salary support for the development of newly independent scientists to enable them to expand their potential to make significant contributions to their field of research. Supplementation from nonfederal funds is allowed. Mentored Research Scientist Development Awards (encompass the previous Mid-Career Development Awards and the Minority School Faculty Development Awards): These awards in amounts up to $50,000 (plus fringe benefits, 8 percent indirect costs, and $10,000 for research support) are made to institutions to provide salary and research support for research scientists who need an additional period of sponsored research as a way to gain experience in a research area new to the candidate or in an area that would demonstrably enhance the candidate's scientific career. Mentored Clinical Scientist Development Awards (encompass the previous Clinical Investigator Awards and the Physician Scientist Awards: Awards up to $50,000 (salary), $10,000 to $20,000 for research plus 8 percent indirect costs and fringe benefits, to provide for specialized study for clinically trained professionals who are committed to a career in research and have the potential to develop into independent investigators. Supplementation from nonfederal funds is allowed. Academic Career Awards (Supersede the former Academic Award in Environmental/Occupational Medicine): Up to $50,000 (salary), $10,000 to $20,000 for research support, plus 8 percent indirect costs and fringe benefits, to develop environmental/occupational medicine curriculum/faculty at schools of medicine and osteopathy. Supplementation from nonfederal funds is allowed.

ELIGIBILITY REQUIREMENTS:

Applicant Eligibility:   Research Grants, Cooperative Agreements, SBIR Grants, Independent Scientist Awards, Mentored Research Scientist Development Award, Mentored Clinical Scientist Development Awards, and the Academic Career Awards: A university, college, hospital, State or local government, nonprofit research institution, or for-profit organization may submit an application and receive a grant for support of research by a named principal investigator. Candidates for Academic Career Awards must have a doctoral degree and peer-reviewed, independent, research support at the time the award is made. Candidates for Mentored Clinical Scientist Development Awards must have a clinical degree or its equivalent and must have initiated post-graduate clinical training. Candidates holding a Ph.D. degree are ineligible. Candidates who have served as principal investigators on PHS-supported research projects are ineligible. A candidate for Academic Career Awards must have a clinical research or doctorate degree. Those who are eligible for the Development Awards must be able to devote at least 75 percent effort. Those eligible for the Leadership Award must have an academic appointment at a level sufficient to enable him/her to exert an influence on the coordination of research, teaching, and clinical practice in an emerging field and must be able to devote at least 25 percent effort to the program. 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. and its possessions. 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.

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

Credentials/Documentation:   Research Grants, Cooperative Agreements, Independent Scientist Awards, Mentored Research Scientist Development Awards, Mentored Clinical Scientist Development Awards, and Academic Career Awards: Applications must be signed by appropriate officials of the submitting institution. 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 by HHS Regulations 45 CFR, Part 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 SBIR Phase I and Phase II awards, respectively, Grant forms PHS 6246-3 and 6246-4 are used to apply for STTR Phase I and Phase II, respectively.

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

Application Procedure:   Research Grants, Cooperative Agreements, SBIR Grants and Awards: Application forms and instructions for their submission are available 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. The standard application forms, as furnished by PHS and required by 45 CFR, Part 92, must be used for this program by those applicants that are State and local units of government. 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: telephone: (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:   Grants and Awards are made on the basis of a dual review of an investigator-prepared application. The reviews are made by peer groups: the first by a study section for scientific merit; the second by an advisory council for program relevance. Final approval of these recommendations and decisions concerning funding are made by the Director, NIEHS. 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. Formal award notices are sent to successful applicants.

Deadlines:   Independent Scientist Awards, Mentored Research Scientist Development Awards, Mentored Clinical Scientist Development Awards, and Academic Career Awards: All new applications: February 1, June 1, and October 1; Supplemental applications and all renewal applications: March 1, July 1, and November 1. SBIR applications: April 15, August 15, and December 15. STTR Applications: December 1, only.

Range of Approval/Disapproval Time:   Research Grants and Awards: From 6 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. A description of the NIH Peer Review Appeals procedures is available on the NIH home page www.nih.gov/grants/guide/1997/97.11.21/n2.html.

Renewals:   Research Grants and Cooperative Agreements: Subject to same criteria as new applications. Independent Scientist Awards, Mentored Research Scientist Development Awards, Mentored Clinical Scientist Development Awards, and Academic Career Awards are non- renewable.

ASSISTANCE CONSIDERATIONS:

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

Length and Time Phasing of Assistance:   Research Grants and Cooperative Agreements may be awarded for up to 5 years, generally in 12-month budget periods, and may be extended through a competitive renewal. Funds are released primarily on basis of an Electronic Transfer System. Independent Scientist Awards are awarded for 5 years in 12-month budget periods, and are non-renewable. Mentored Research Development Awards are for up to 5 years, 12-month budget periods, and are non- renewable. Mentored Clinical Scientist Development Awards and Academic Career Awards are for up to 5-year periods and are non-renewable. 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:   Research Grants and Awards: Annual and final progress reports and reports of expenditures are required.

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 financial status report for the report period.

FINANCIAL INFORMATION:

Account Identification:   75-0862-0-1-552.

Obligations:   (Grants) FY 01 $25,048,000; FY 02 est $29,000,000; and FY 03 est $32,000,000.

Range and Average of Financial Assistance:  
Research Grants: $71,326 to $1,278,963; Average: $294,680. SBIR Grants: Phase I, $100,000; Phase II, up to $750,000; STTR Grants: Phase I, $100,000; Phase II, up to $500,000.

In fiscal year 2001, 85 research grant awards were made, of which 50 were competing RPG applications. In addition, three STTR and 38 SBIR awards were made, of which 34 were competing. In fiscal year 2002, it is anticipated that 92 research grant awards (including SBIR and STTR awards) will be made. In fiscal year 2003, it is anticipated that 95 research grants and awards (including SBIR and STTR awards) will be made. Knowledge of the toxicity and carcinogenicity of chemicals has come primarily from studies conducted on individual chemicals at relatively high concentrations. The mechanistic information gained from years of studying single agents has contributed to developing a rational basis for extrapolation of experimental results to assessing risk to humans, but has not been as successful when applied to a mixture of chemicals. Rarely are people exposed to single chemicals, but rather they are exposed throughout their lifetimes to a myriad of chemicals at low concentrations. From a public health perspective, a major concern is whether an unusual toxicity could result from the interaction of two or more chemicals when individually, they are without measurable effect. NIEHS and the Environmental Protection Agency recognized the need to stimulate research in this very challenging area. And thus, in fiscal year 1998, they issued a joint Request for Applications entitled Chemical Mixtures in Environmental Health. $4.5 million were allocated for this program and 10 grants were awarded.

REGULATIONS, GUIDELINES, AND LITERATURE:

42 CFR 52; 45 CFR 74; 45 CFR 92; NIH Guide for Grants and Contracts, various other publications and application kits, Division of Extramural Outreach and Information Resources, Office of Extramural Research, NIH, Room 6207, 6701 Rockledge Drive, Bethesda, MD 20892. 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 U.S.C. 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 Contracts: Research Grants, Dr. William Suk, Director, Office of Program Development, DERT, NIEHS, E- mail, suk@niehs.nih.gov. Telephone: (919) 541-0797; or Dr. Michael McClure, Chief, Organ and Systems Toxicology Branch, E-mail: mcclure@niehs.nih.gov. Telephone: (919)541-5327. Science Education Grants, Dr. Allen Dearry, Program Administrator, Chemical Exposures and Molecular Biology Branch, Telephone: (919)541-4943; Cooperative Agreements, SBIR Grants, Independent Scientist Awards, Mentored Research Scientist Development Award, Mentored Clinical Research Scientist Development Award, Academic Career Award and SBIR and STTR Grant Programs: Dr. Jerrold Heindel, Program Administrator, Organ and Systems Toxicology Branch, E-mail: heindelj@niehs.nih.gov. Telephone: (919)541-0781. For each program contact, the rest of the mailing address is: Division of Extramural Research and Training, National Institute of Environmental Health Sciences, National Institutes of Health, P.O. Box 12233, Research Triangle Park , NC 27709. Grants Management Contact: Ms. Dorothy Duke, Chief, Grants Management Officer, Grants Management Branch, Division of Extramural Research and Training, National Institute of Environmental Health Sciences, National Institutes of Health, P.O. Box 12233, Research Triangle Park, NC 27709. Telephone: (919)541-2749. E-mail: duke3@niehs.nih.gov.

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

EXAMPLES OF FUNDED PROJECTS:

The following projects have been supported: (1) Development of an earthworm model for analyzing xenobiotic immunotoxicity; (2) an in vivo assay of environmental toxins using magnetic resonance imaging; (3) chick embryos for detecting environmental mutagens; (4) short-term mutagen testing with human and murine cells; (5) a study of rainbow trout: a model for environmental carcinogenesis; and (6) a study of cadmium nephrotoxicity: a cell culture approach.

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 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 the stated 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 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 requested 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.