FEDERAL AGENCY:

NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES

AUTHORIZATION:

Public Health Service Act, Section 301, 448 and 487, as amended, Public Laws 78-410 and 99-158, as amended, 42 U.S.C. 241; 42 U.S.C. 285g; 42 U.S.C. 288; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.

OBJECTIVES:

To stimulate, coordinate, and support fundamental and clinical, biomedical, and behavioral research and research training associated with normal development from conception to maturity and those factors or special health problems that may delay or interfere with normal development. The Center for Research for Mothers and Children (CRMC) supports research for mothers, children, and families, and is designed to: (1) Advance knowledge about fetal development, pregnancy, and birth; (2) identify the prerequisites of optimal growth and development through infancy, childhood, and adolescence; and (3) contribute to the prevention and treatment of mental retardation, developmental disabilities, and other childhood and adolescent problems. 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 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: Grantee agrees to administer the grant in accordance with the regulations and policies governing the research grant programs of the Public Health Service as stated in the terms and conditions on the application for the grant. National Research Service Awards: Awarded to individuals for full-time research training in specified behavioral and biomedical shortage areas. Awardees may utilize some of their time in academic and clinical duties if such work is closely related to their research training. Awards may be made to institutions to enable them to make NRS awards to individuals selected by them. Each individual awardee is obligated upon termination of the award to comply with certain service and payback provisions. 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 which 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 and scientific and technical merit and commercial potential on Phase II application.

ELIGIBILITY REQUIREMENTS:

Applicant Eligibility:   Grants: Universities, colleges, medical, dental and nursing schools, schools of public health, laboratories, hospitals, State and local health departments, other public or private institutions, both nonprofit and for-profit, and individuals. National Research Service Award: Support is provided for academic and research training only, in health and health-related areas that are periodically specified by the National Institutes of Health. Individuals with a professional or scientific degree are eligible (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D.Eng., or equivalent domestic or foreign degree). Predoctoral research training grants to institutions are also supported. Proposed study must result in biomedical or behavioral research training in a specified shortage area and which may offer opportunity to research health scientists, research clinicians, etc., to broaden their scientific background or to extend their potential for research in health-related areas. Applicants must be citizens of the United States or be admitted to the United States for permanent residency; they also must be nominated and sponsored by a public or private institution having staff and facilities suitable to the proposed research training. Domestic nonprofit organizations may apply for the institutional NRS grant. SBIR: 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. 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 research is proposed and have no more that 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 or biobehavioral research.

Credentials/Documentation:   Grants: Applicants should submit the most recent revision of research grant application Form PHS 398 to the Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892. All required forms specified in the application kit are to be completed by the applicant and submitted with the application package. National Research Service Award: Individual Award: The applicant's academic record, research experience, citizenship, and institution sponsorship should be documented in the application. Institutional Award: the applicant organization must show 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 awards, 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 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 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.

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

Application Procedure:   Grants: The standard application forms, as furnished by PHS and required by 45 CFR, Part 92, must be used for this program. National Research Service Award: Prior to formal application, an individual must arrange for acceptance at a sponsoring institution by a sponsor who will supervise the training. Individuals must be sponsored by a domestic or foreign institution. SBIR/STTR: Same as for grants (above). NRSA applications, may be obtained at http://www.grants.nih.gov/grants/funding/416/phs416.htm; e-mail: grantsinfo@nih.gov. Completed applications should be submitted to the Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892-7710. The 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 Solicitation includes application forms, which, upon completion, should be submitted to the Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892. Small Business Technology Transfer (STTR) program uses same procedure as SBIR immediately above.

Award Procedure:   Grants: Each application receives a dual scientific review by non-NIH scientists. Awards are issued by the National Institute of Child Health and Human Development. National Research Service Awards: Applications are reviewed for scientific merit by an appropriate study section committee or by an institute review committee. If recommended for approval and a decision is made to make an award, a formal award notice will be sent to the applicant and sponsor. Institutional Awards are issued by the National Institute of Child Health and Human Development. 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 the available SBIR/STTR set-aside funds on the basis of scientific and technical merit and the commercial potential of the proposed research, program relevance, and program balance among the areas of research.

Deadlines:   New Grants: February 1, June 1, and October 1. Renewals and Supplementals: March 1, July 1, and November 1. National Research Service Awards-Individual: April 5, August 5, and December 5. Institutional: May 10. SBIR and STTR: April 1, August 1, and December 1.

Range of Approval/Disapproval Time:   Grants: From 6 to 9 months: National Research Service 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 web site at http://grants.nih.gov/grants/guide/notice-files/not97-232.html.

Renewals:   Grants: Renewal applications are accepted, except for small grants. National Research Service Awards: awards may be made for 1, 2, or 3 years. No individual may receive NIH fellowship support at the postdoctoral level for more than 3 years. Institutional Awards may be renewed.

ASSISTANCE CONSIDERATIONS:

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

Length and Time Phasing of Assistance:   Grants: Awards are usually made annually with no project period to exceed 5 years in length. National Research Service Awards: From 1 to 3 years. SBIR: Phase I awards are generally for 6 months; Phase II awards normally may not exceed 2 years. STTR Phase I awards are generally for 1 year; Phase II awards normally may not exceed 2 years.

POST ASSISTANCE REQUIREMENTS:

Reports:   Grants: Annual progress reports and financial status reports are required. National Research Service Awards: Reports are required after termination to ascertain compliance with the service and payback provisions. Institutional Awards require annual progress reports and financial status reports.

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 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:   75-0844-0-1-552.

Obligations:   (Project Grants) FY 15 $900,038,312; FY 16 est $942,921,000; and FY 17 est $933,889,000 - PROJECT GRANTS (non-SBIR/STTR and SBIR/STTR combined): FY 2015 actual $900,038,312; FY 2016 estimate $942.921,000; FY 2017 estimate $933,889,000.

Range and Average of Financial Assistance:   For research project grants, fiscal year 2016, range is $50,000 to $5,000,000; average is $462,171. Individual research fellowship awards: Basic stipend (first year beyond the doctoral degree) of approximately $45,000. The sponsoring institution will be provided, on application, with an allowance of up to approximately $8,000 per year to help defray the cost of training. No dependency allowances. SBIR: Average Phase I awards are for approximately $225,000 (grant activity R43 - for up to six months); Phase II awards may be made for amounts up to $1,500,000 (grant activity R44 - for up to two years).

Fiscal Year 2015: Fiscal year 2015 the number of competing and noncompeting research project grants actuals were 1,529. Of this number, 76 were SBIR/STTR awards. 50 research centers grants were awarded. 457 other research grants were also awarded. There were 523 institutional training awards in fiscal year 2015. The individual training award were 92 for fiscal year 2015. Fiscal Year 2016: Post third quarter reallocation: Fiscal year 2016 competing and noncompeting research project grants estimates are 1,567. Of this number, 85 are expected to be SBIR/ STTR awards. Approximately 50 research centers will be awarded. A planned 462 other research grants are anticipated to be awarded. Projected institutional training awards are 489 in fiscal year 2016. The individual training award are projected for fiscal year 2016 to be 114. Fiscal Year 2017: Budget Request: Fiscal year 2017 competing and noncompeting research project grants estimates are 1,557. Of this number, 90 are expected to be SBIR/ STTR awards. Approximately 50 research centers will be awarded. A planned 428 other research grants are anticipated to be awarded. Projected institutional training awards are 461 in fiscal year 2017. The individual training award are projected for fiscal year 2017 to be 136.

REGULATIONS, GUIDELINES, AND LITERATURE:

Grants: 42 CFR 52; 42 CFR 66; 45 CFR 74; 45 CFR 92; NIH Grants Policy Statement, (Rev.) March 1, 2001, available on the NIH website at http://grants.nih.gov/grants/policy/nihgps_2001/; NIH Guide to Grants and Contracts, available on the NIH website at http://grants.nih.gov/grants/guide/. Grants will be available under the authority of and administered in accordance with the NIH 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:   Not applicable.

Headquarters Office:   Eugene G. Hayunga, 6710-B Rockledge Drive, Room 2216, Bethesda, Maryland 20892-7510 Email: ehayunga@mail.nih.gov Phone: (301) 435-6856.

Web Site Address:  
http://www.nichd.nih.gov/Pages/index.aspx

EXAMPLES OF FUNDED PROJECTS:

Incidence of neural tube defects in hamsters reduced by folate supplementation prior to and during pregnancy; chromosome 15 linked to a subtype of dyslexia; limb development studies attempt to obtain a better understanding of how cells in the developing extremity are determined to later become muscle, cartilage, bone or connective tissue; a protein of fetal origin present in fetal urine may trigger the biochemical events leading to the onset of labor. SBIR: Motion Simulation Effectiveness of Colicky Infants; Research on an Auditory 'Mobile' for Infants; Design and Construction of Neonatal Isolette for 31P NMR; Development of Non-Sexist Toys for Children.

CRITERIA FOR SELECTING PROPOSALS:

The major elements in evaluating proposals include assessments of the significance of the proposed research; approach; innovation; investigators; and environment. 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 (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.