To foster understanding of human health effects of exposure to environmental agents in the hope that these studies will lead to: the identification of agents that pose a hazard and threat of disease, disorders and defects in humans; the development of effective public health or disease prevention strategies;

credit:

the overall improvement of human health effects due to environmental agents; the development of products and technologies designed to better study or ameliorate the effects of environmental agents; and the successful training of research scientists in all areas of environmental health research.

Supported grant programs focus on the following areas: (1) Understanding biological responses to environmental agents by determining 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; (2) Determining the mechanisms of toxicity of ubiquitous agents like metals, natural and synthetic chemicals, pesticides, and materials such as nanoparticles, and natural toxic substances, and their effects of on various human organ systems, on metabolism, on the endocrine and immune systems, and on other biological functions; (3) Developing and integrating scientific knowledge about potentially toxic and hazardous chemicals by concentrating on toxicological research, testing, test development, validation and risk estimation; (4) Identifying interactions between environmental stressors and genetic susceptibility and understanding biologic mechanisms underlying these interactions, including the study of environmental influences on epigenomics and transcriptional regulation; (5) Conducting environmental public health research, including in areas of environmental justice and health disparities, that requires communities as active participants in all stages of research, dissemination, and evaluation to advance both the science and the development of practical materials for use in communities, with a focus on translating research findings into tools, materials, and resources that can be used to prevent, reduce, or eliminate adverse health outcomes caused by environmental exposures; (6) Expanding and improving 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; (7) Expanding and improving the 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; (8) Providing support for broadly based multi-disciplinary research and training programs in environmental health .These programs include the Environmental Health Sciences Core Centers , which serve as national focal points and resources for research and manpower development.

The Centers for Neurodegenerative Science addresses the need for integrated research efforts involving basic and clinical scientists in a quest to discover the causes of and possible treatments for neurodegenerative diseases.

The Breast Cancer and the Environment Research Program (co-funded with NCI) studies the impact of prenatal?to-adult environmental exposures that may predispose a woman to breast cancer.

A special emphasis is on the impact of environmental factors on a girl?s pubertal development, a known risk fact for breast cancer.

Through these programs, NIEHS expects to achieve the long range goal of developing new clinical and public health applications to improve disease prevention, diagnosis, and therapy.

Additional Centers programs developed in recent years, include the Centers for Oceans and Human Health (co-funded with NSF), Children's Environmental Health Centers (co-funded with US EPA) and the Autism Centers of Excellence (co-funded with other NIH Institutes) and the ; (9) Supporting research training programs which serve to increase the pool of trained research manpower with needed expertise in the Environmental Health Sciences through support of Individual and Institutional National Research Service Awards (NRSAs); (10) The Outstanding New Environmental Scientist Program which provides first time research grant funding to outstanding junior scientists in the formative stages of their career who are proposing to make a long term commitment to environmental health sciences research and to address the adverse effects on environmental exposures on human biology, human pathophysiology and human disease.

Selected Recipients for this Program

Fiscal Year 2016: In FY 2016 NIEHS issued 641 Research Project Grant awards (including SBIR and STTR Awards), 29 Research Center awards, 35 Individual and 43 Institutional training awards. Information about NIEHS present and past Funding Opportunity Announcements (FOA) can be found at https://www.niehs.nih.gov/funding/grants/index.cfm. Fiscal Year 2017: Fiscal Year 2017: In FY 2017 NIEHS anticipates issuing 578 RPG awards (including SBIR and STTR Awards), 28 Research Center awards, 35 Individual and 44 Institutional training awards. Information about NIEHS present and past FOAs can be found at https://www.niehs.nih.gov/funding/grants/index.cfm. Fiscal Year 2018: In FY 2018 NIEHS anticipates issuing 480 RPG awards (including SBIR and STTR Awards), 25 Research Center awards, 29 Individual and 34 Institutional training awards. Information about NIEHS present and past FOAs can be found at https://www.niehs.nih.gov/funding/grants/index.cfm.

Uses and Use Restrictions

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 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, scientific and technical merit, and commercial potential of the Phase II application.

A number of Career Development awards are supported.

The Independent Scientist Award provides up to five years of salary support for newly independent scientists who have recently obtained independent research funding, generally an R01 research grant from NIEHS.

The award is intended to allow the candidate protected time to focus on the further development of the independent research career and does not include additional research support.

The Mentored Clinical Research Career Development Award provides three to five years of salary support for investigators with clinical degrees (e.g., M.D., D.V.M.).

The Transition to Independent Environmental Health Research (TIEHR) Career Development Award provides three years of support for candidates who are within three years of their first independent faculty appointment and who have not yet obtained significant research grant funding (an R01 or equivalent).

The award includes salary support and pilot funding.

The Mentored Patient-Oriented Research Career Development Award provides up to five years of support for clinically trained investigators who make a commitment to focus on patient-oriented research.

The Mid Career Investigator Award in Patient-Oriented Research provides up to five years of support to outstanding clinical scientists who are actively engaged in patient-oriented research and who are within 15 years of their specialty training.

The Mentored Quantitative Research Development Award provides up to five years of support for junior faculty with quantitative scientific and engineering backgrounds outside of biology or medicine that are transitioning to behavioral or biomedical research.

The NIH Pathway to Independence Award is divided into two phases.

The initial award (K99) provides up to two years of mentored, postdoctoral support.

The second phase (R00) provides up to three years of independent research support, when the awardee accepts a full-time tenure track, or equivalent, faculty position.

All these Career Development awards provide salary consistent with the level of effort devoted to the research career development activities, plus fringe benefits, an allowance for career development activities and 8 percent fiscal and administrative costs.

All Career Development Awards, except for the NIH Pathway to Independence Award, have a US citizenship requirement.

Details of specific restrictions for the Career Development Awards can be found at http://www.niehs.nih.gov/careers/research/trainingfrom/career/index.cfmt.

NIEHS Core Center grants (P30) are primarily intended to provide infrastructure support and the support of core research facilities.

In addition, an appropriate facilities and administrative cost is provided as determined by negotiated agreement with the grantee's cognizant government organization.

National Research Service Awards (NRSAs): Individual predoctoral and postdoctoral training awards are made for the support of fellows who engage in research training in environmental toxicology, environmental pathology, environmental mutagenesis, or environmental epidemiology/biostatistics.

In addition to individual training awards, institutional training grants (T32) are made to institutions to enable institutions to make awards to individuals selected by them, for both predoctoral and postdoctoral research training in the aforementioned areas.

Each individual who receives a postdoctoral NRSA, either through an institutional or individual training award mechanism, is obligated upon termination of the award to comply with certain service and payback provisions.

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Eligibility Requirements

Applicant Eligibility

Research Grants, Cooperative Agreements, Science Education Grants, SBIR Grants, Independent Scientist Awards, Mentored Research Scientist Development Award, Mentored Clinical Scientist Development Award, and the Academic Career Awards: A university, college, hospital, State, local or tribal governments, 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 Awards and Midcareer Investigator Awards in Patient Oriented Research 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 and Mentored Patient Oriented Research Career 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 or research doctorate degree.

Those eligible for the Development Award must be able to devote at least 75 percent effort.

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.

Centers: A university-based, nonprofit research institution, or for-profit organization proposing an integrated research program established to accomplish a stated mission, covering activities ranging from very basic research to the actual application of research results in the prevention and control of environmental health problems, may submit an application under the direction of a named Center Director.

National Research Service Awards: (1) Nonprofit domestic organizations may apply for the Institutional NRSA; (2) Individual NRSA awardees must be nominated and sponsored by a public for-profit or nonprofit private institution having staff and facilities appropriate to the proposed research training program; (3) all awardees must be citizens or have been admitted to the United States for permanent residence; (4) to be eligible, predoctoral awardees must have completed the baccalaureate degree and postdoctoral awardees must have a professional or scientific degree (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D.Eng., or equivalent domestic or foreign degree).

Beneficiary Eligibility

For Research Grants: Any nonprofit or for-profit organization, company, or institution engaged in biomedical research. For Centers and Training Grants: University-based nonprofit institutions; for-profit organizations conducting research; and individuals nominated by a private institution conducting research.

Credentials/Documentation

Applications must be signed by appropriate officials of the submitting institution. The cost principles for awards under this program are set forth in HHS regulations at 45 CFR 75, Subpart E and Appendix IX (hospitals) to Part 75. Commercial organizations are subject to the cost principles located at 48 CFR 31.2 Federal Acquisition Regulation. See the NIH Grants Policy Statement (NIH GPS) for further guidance on the applicability of cost principals (http://grants.nih.gov/grants/policy/nihgps/index.htm). 2 CFR 200, Subpart E - Cost Principles applies to this program.

Aplication and Award Process

Preapplication Coordination

Preapplication coordination is not applicable.

Environmental impact information is not required for this program.

This program is excluded from coverage under E.O.

12372.

Application Procedures

2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program. Awards made under this program are subject to 2 CFR 200, as implemented by 45 CFR 75 ?Public Welfare, Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards?. The policies and procedures generally applicable to NIH grants are set forth in the NIH GPS (http://grants.nih.gov/grants/policy/nihgps/index.htm). Application forms and instructions for their submission are available at http://grants.nih.gov/grants/forms.htm. Applicants are encouraged and in some cases required to consult with NIEHS Program Officials prior to submission of an application. Detailed information about NIEHS grant programs and staff contacts can be found at http://www.niehs.nih.gov/research/supported/index.cfm.

Award Procedures

Made on the basis of dual review by peer groups of all applications. The first level of reviews is by a study section for scientific merit. In addition, a national advisory council provides a secondary level of review for all applications. As required by P.L. 109-482, the NIH Health Reform Act of 2006, all research grant and cooperative agreements must undergo Advisory Council/Board review and approval prior to funding. Review of Individual NRSA applications by an Advisory Council/Board is not required. Final approval of these recommendations and decisions concerning funding are made by the Director, NIEHS.

Deadlines

Contact the headquarters or regional office, as appropriate, for application deadlines.

Authorization

Public Health Service Act, Sections 301, 401, 437, 463 and 487, Public Laws 78-410 and 99-158, as amended, 42 U.S.C. 241, and 42 U.S.C. 288, as amended, SBIR and STTR Reauthorization Act of 2011, Public Law 113-6.

Range of Approval/Disapproval Time

> 180 Days. Receipt, review and approval processes range in length from six to nine 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-064.html.

Renewals

Research Grants, Cooperative Agreements, Center Grants, and Institutional Training Grants: Renewal applications are subject to same criteria as new applications. Independent Scientist Awards, Mentored Research Scientist Development Awards, Mentored Clinical Scientist Development Award, Academic Career Awards, and Individual Training grants are non-renewable.

Assistance Considerations

Formula and Matching Requirements

This program has no statutory formula. This program has no matching requirements. This program does not have MOE requirements.

Length and Time Phasing of Assistance

Research Grants, Cooperative Agreements, Center Grants, and NRSA Institutional grants may be awarded for up to 5 years, generally in 12-month budget periods and may be extended through a competitive renewal. Science Education Grants may be awarded for up to 5 years, in 12-month budget periods, and are not renewable. Independent Scientist Awards are awarded for 5 years in 12-month budget periods, and are non-renewable. Mentored Research Scientist 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 years and are 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. National Research Service Awards: Individual awards are non-renewable and may be for 1, 2, or 3 years, but no individual may receive NRSA support at the predoctoral level for more than 5 years and at the postdoctoral level for more than 3 years. See the following for information on how assistance is awarded/released: Funds are released via an Electronic Transfer System.

Post Assistance Requirements

Reports

Annual and final progress reports are required for all Grant Awards.

Annual financial reports are due for a subset of grant awards.

Final financial reports are due for all grant awards.

Additional reports are required after termination of National Research Service Awards to ascertain compliance with the service and payback provisions.

Cash reports are not applicable.

Annual and final progress reports are required for all Grant Awards.

Annual financial reports are due for a subset of grant awards.

Final financial reports are due for all grant awards.

Additional reports are required after termination of National Research Service Awards to ascertain compliance with the service and payback provisions.

Expenditure reports are not applicable.

Review of annual performance reports is conducted by appropriate agency staff prior to issuance of additional funding.

Audits

In accordance with the provisions of 2 CFR 200, Subpart F - Audit Requirements, non-Federal entities that expend financial assistance of $750,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Non-Federal entities that expend less than $750,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in 2 CFR 200.503. Awards made under this program are subject to the audit requirements of OMB 2 CFR 200, as implemented by 45 CFR 75, Subpart F, and in the NIH GPS (http://grants.nih.gov/grants/policy/nihgps/index.htm).

Records

In accordance with the provisions of 45 CFR 75, Subpart D ? Post Federal Award Requirements, Record Retention and Access, §75.361, 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.

Obigations

(Project Grants) FY 16 $324,460,107; FY 17 est $316,349,000; and FY 18 est $242,315,000

Range and Average of Financial Assistance

Range: $2,000 to $1,749,000 Average: $339,863.

Regulations, Guidelines, and Literature

42 CFR 52; 45 CFR 75; 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 NIH GPS 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.

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.