FEDERAL AGENCY:

NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES

AUTHORIZATION:

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

OBJECTIVES:

To focus on understanding how chemical and physical agents cause pathological changes in molecules, cells, tissues, and organs and become manifested as respiratory disease, neurological, behavioral and developmental abnormalities, cancer, and other disorders. Understanding biological responses to environmental agents is one key to understanding the human health effects of exposure to environmental agents, and is the cornerstone to identifying those exposures that pose a hazard and threat of disease, disorders and defects in humans. A first step in understanding biological responses is identifying and characterizing those biological, chemical and physical environmental agents that are hazardous to health. By understanding the relationship between environmental exposures and the subsequent development of disease or biological injury, human health may be better protected. These studies are conducted in the hope that they will lead to the development of effective disease prevention strategies. The National Institute of Environmental Health Sciences (NIEHS) grants also support studies of the mechanisms of toxicity of such ubiquitous agents as metals, natural and synthetic chemicals, pesticides, and materials such as asbestos and silica, and natural toxic substances. Specific attention is paid to the effects of these agents on various human organ systems, on metabolism, on the endocrine and immune systems, and on other biological functions. 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 h 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. Environmental Health Sciences Education Program: To improve the understanding of environmental health sciences research and services occupations by developing educational materials and training instructors to implement the newly developed materials for Grades K-12.

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. Environmental health sciences education grants are limited to $100,000 direct costs plus indirect costs calculated at 8 percent of appropriate direct cost base, and they should promote the development of instructional material. 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 (supersedes the former Research Career Development Award): 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 supplies 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 Award (encompasses the previous Physician Scientist Awards and Clinical Investigator Awards). Awards up to $50,000 (salary) $10,000 to $20,000 for research support 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 (supersedes the 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 Grant and Cooperative Agreements, Science Education Grants, Independent Scientist Awards, Mentored Research Scientist Development Award, the mentored Clinical Scientist Development Award, 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 Award 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 or research doctorate degree. Those eligible for the development award 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). For SBIR grants 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, Science Education Grants, Cooperative Agreements, Independent Scientist Awards, Mentored Research Scientist Development Awards, Mentored Clinical Scientist Development Award, 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 Phase I and Phase II awards, respectively, of SBIR and STTR programs. For SBIR grants, each applicant 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. Use Forms PHS 6246-1 and 6246-2 for Phase I and Phase II applications, respectively. Use forms PHS 6246-3 and PHS 6246-4 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, Science Education Grants, and Cooperative Agreements: Application forms and instructions for their submission are available from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910. The standard application forms, as furnished by PHS and required by 45 CFR 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: 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 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:   New research, Independent Scientist Awards, Mentored Research Scientist Development Award, Mentored Clinical Scientist Development Award and Academic Career Awards: 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 Grants: December 1, only. Education Awards are announced in the NIH Guide.

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 Appeal 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 Awards. Mentored Clinical Scientist Development Award, 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 the basis of an Electronic Transfer System. Science Education Grants may be awarded for 1 to 4 years, in 12-month budget periods, and are non-renewable. Independent Scientist Awards are awarded for 5 years in 12-month budget periods and are non-renewable. Mentored Research Scientist Development Awards are for up to 5 years, in 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 Grants: Normally, Phase I awards are for 6 months; normally, Phase II awards are for 2 years. STTR: Normally, Phase I awards are generally 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 submit the last expenditure report for the report period.

FINANCIAL INFORMATION:

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

Obligations:   (Grants) FY 01 $150,135,000; FY 02 est $171,174,000; and FY 03 est $178,961,000.

Range and Average of Financial Assistance:  
Range: $2,000 to $1,798,242 Average: $328,621.

In fiscal year 2001, 500 research grant awards were made, of which 125 were competing RPG applications. In fiscal year 2002, it is anticipated that 495 research grant awards will be made. In fiscal year 2003, approximately 462 research grant awards will be made. A Federal Executive Order signed by President Clinton April 21, 1997, "Protection of Children from Environmental Health Risks and Safety Risks," charges agencies to consider special environmental risks to children. The centers, each funded for 5 years, provide an atmosphere for scientists to interact in establishing outstanding, state-of-the-art research programs addressing environmental contributions to children's health and disease. The centers will facilitate the transition of basic knowledge from the laboratory into strategies that reduce the incidence of environmentally related childhood disease, and establish a national network that fosters communication, innovation, and research.

REGULATIONS, GUIDELINES, AND LITERATURE:

42 CFR 52; 45 CFR 74; 45 CFR 92; NIH Guide to Grants and Contracts; various other publications and application kits, the 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 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. Program Contacts: Research Grants: Dr. William A Suk, Chief, Hazardous Substances Research Branch, DERT, NIEHS, E-mail: suk@niehs.nih.gov. Telephone: (919) 541-0797; or Dr. Cindy Lawler, Chief, Genes, Environment, and Health Branch, E-mail lawler@niehs.nih.gov. Telephone: (919)316-4671; or Dr. Claudia Thompson, Chief, Population Health Branch, E-mail: thomps14@niehs.nih.gov; Telephone: (919) 541-4638; or Dr. David Balshaw, Chief, Exposure, Response, and Technology Branch, Email: balshaw@niehs.nih.gov. Telephone: (919) 541-2448. NRSA Institutional Training Grants, Independent Scientist Awards, Mentored Research Scientist Development Awards, Mentored Clinical Research Scientist Development Awards, Academic Career Awards: Dr. Carol Shreffler, Program Administrator, Exposure, Response, and Technology Branch, E-mail: shreffl1@niehs.nih.gov. Telephone:(919)541-1445. SBIR and STTR Grant Programs: Dr. Daniel Shaughnessy, Program Administrator, Exposure, Response, and Technology Branch, E-mail: shaughn1@niehs.nih.gov. Telephone: (919)541-2506. P30 Core Centers Program Contact: Dr. Claudia Thompson, Chief, Population Health Branch, E-mail: thomps14@niehs.nih.gov; Telephone: (919) 541-4638; AREA grants: Dr. Lisa Chadwick, Email: lisa.chadwick@nih.gov, Telephone: (919) 491-4702; and NRSA Individual Fellowships: Dr. Michael Humble, Program Administrator, Genes, Environment, and Health Branch, E-mail: humble@niehs.nih.gov. Telephone: (919) 316-4621. Grants Management Contact: Mr. George Tucker, Chief, Grants Management Officer, Grants Management Branch, E-mail: george.tucker@nih.gov. Telephone: (919) 541-2749. 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.

Headquarters Office:  
Benny Encarnacion 111 TW Alexander Drive, Research Triangle Park, North Carolina 27709 Email: encarna1@niehs.nih.gov Phone: (919) 541-5147.

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

EXAMPLES OF FUNDED PROJECTS:

(1) Molecular mechanisms of organ phosphate immunotoxicity; (2) a cellculture approach to understanding cadmium nephrotoxicity; (3) the efforts of hexanedione on Testicular Sertoli cell function; (4) a probable mechanism for the carcinogenicity of 2-nitropropane; and (5) the mechanisms of hepatobiliary transport of mercury.

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 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 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 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.