Content provided by the Catalog of Federal Domestic Assistance
93.113 Biological Response to Environmental Health Hazards
NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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:
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.
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.
Pre-application Coordination: Not applicable. This program is excluded from coverage under E.O. 12372.
Formula and Matching Requirements: This program has no statutory formula or matching requirements.
POST ASSISTANCE REQUIREMENTS:
Reports: Research Grants and Awards: Annual and final progress reports and reports of expenditures are required.
Account Identification: 75-0862-0-1-552.
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.
Regional or Local Office:
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.