Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
To foster late –stage translational phase 4 research and facilitate the understanding of multi-level processes and factors associated with successful integration of evidence-based interventions within specific clinical and public health settings related to heart, lung, and blood diseases and sleep disorders. Programs support the career development including training of early-stage scientists and established investigators to conduct late-stage translation and implementation research in heart, lung, and blood diseases and sleep disorders. Small Business Innovation Research (SBIR) program: To stimulate technological innovation; use small business to meet Federal research and development needs; foster and encourage participation in innovation and entrepreneurship by socially and economically disadvantaged persons; and increase private-sector commercialization of innovations derived from Federal research and development funding. Small Business Technology Transfer (STTR) program: To stimulate technological innovation; foster technology transfer through cooperative R&D between small businesses and research institutions, and increase private sector commercialization of innovations derived from federal R&D.
General information about this opportunity
Last Known Status
Agency: Department of Health and Human Services
Office: National Institutes of Health
Type(s) of Assistance Offered
Public Health Service Act, Section 301, 422 and 487, as amended, Public Laws 78-410 and 99-158, 42 U.S.C. 241, 42 U.S.C. 285, and 42 U.S.C. 288, as amended; Small Business Reauthorization Act of 2000, Public Law 106-554.
Who is eligible to apply/benefit from this assistance?
Any nonprofit organization engaged in biomedical research and institutions or companies organized for profit may apply for almost any kind of grant. Only domestic, non-profit, private or public institutions may apply for NRSA Institutional Research Training Grants. An individual may apply for an NRSA or, in some cases, for a research grant if adequate facilities to perform the research are available. SBIR grants can be awarded only to United States small business concerns (entities that are independently owned and operated for profit, or owned by another small business that itself is independently owned and operated for profit, are not dominant in the field in which research is proposed, and have no more than 500 employees including affiliates). 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. SBIR projects must be performed at least 67% by the applicant small business in Phase I and at least 50% of the Project in Phase II. STTR grants can be awarded only to United States small business concerns (entities that are independently owned and operated for profit and have no more than 500 employees) that formally collaborate with a university or other non-profit research institution in cooperative research and development. The principal investigator of an STTR award may be employed with either the small business concern or collaborating non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant small business concern. At least 40% of the project is to be performed by the small business concern and at least 30% by the non-profit research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions.
Any nonprofit or for-profit organization, company or institution engaged in biomedical research. Only domestic for-profit small business firms may apply for SBIR and STTR programs.
Individual NRSA awardees and Institutional NRSA trainees must be citizens or noncitizen nationals of the United States, or have been admitted for permanent residency. Two levels of training are available: graduate level predoctoral training and postdoctoral training. All potential trainees must possess a desire for training in one of the health or health-related areas specified by the National Institutes of Health. Each applicant must be sponsored by an accredited public or private nonprofit institution engaged in such training. For-profit organization costs are determined in accordance with Subpart 31.2 of the Federal Acquisition Regulations. For SBIR and STTR grants, the applicant organization (small business concern) must present a research plan 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. SBIR and STTR applicants must use the SF424 Research and Related (R&R) application for electronic submission through grants.gov. Electronic submission of NIH Research Performance Progress Reports (RPPR) apply for non-competing continuations (e.g., second year of Phase II). 2 CFR 200, Subpart E - Cost Principles applies to this program.
What is the process for applying and being award this assistance?
Preapplication coordination is not applicable. Environmental impact information is not required for this program. This program is excluded from coverage under E.O. 12372.
2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program.
All accepted applications are evaluated by an appropriate initial review group (study section). All grant applications receive a final secondary review by the National Heart, Lung, and Blood Advisory Council. Staff inform applicants of the results of the review. If support is contemplated, staff will initiate preparation of awards for grants. 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.
Contact the headquarters or regional office, as appropriate, for application deadlines.
Approval/Disapproval Decision Time
> 180 Days. > 180 Days.
Regular Grants: From 7 to 9 months.
SBIR/STTR Grants: About 7-1/2 to 9 months.
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 in the NIH Guide at the following URL http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-064.html.
> 180 Days. > 180 Days. Renewal applications are reviewed in the same manner as new applications.
How are proposals selected?
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 announced 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 importance of the problem the proposed research will address; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation of the proposed research; (5) the potential of the proposed research for commercial application; (6) the appropriateness of the budget requested; (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. 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.
How may assistance be used?
Grants may support stipends, research expenses, supplies, travel, and research training tuition as required to perform the research effort. Restrictions or limitations are imposed against the use of funds for entertainment, foreign travel, general-purpose equipment, alterations and renovations, and other items not regularly required for the performance of research. Individual Predoctoral and Postdoctoral National Research Service Awards (NRSAs) are made directly to individuals for research training in specified biomedical shortage areas. Institutional NRSA awards may be made to eligible institutions to enable them to appoint individuals selected by the institution for research training. Certain service and payback provisions may apply to postdoctoral individuals upon termination of the award or termination of the appointment. SBIR Phase I awards (of approximately 6-months' duration) are to establish the scientific and technical merit of the proposed research effort, and feasibility of ideas that appear to have commercial potential. Phase II awards are for the continuation of research initiated in Phase I that meets particular program needs and exhibits potential for commercial application. STTR Phase I awards (normally of 1-year duration) are to establish the scientific and technical merit of the proposed cooperative research effort between a small business and non-profit research institution, and feasibility of ideas that appear to have commercial potential. Phase II awards are for the continuation of research initiated in Phase I that meets particular program needs and exhibits potential for commercial application. Fast-Track is an option whereby Phase I and Phase II SBIR or STTR projects are submitted and reviewed concurrently with the aim of reducing or eliminating the funding gap between Phase I and Phase II. Direct-to-Phase II SBIR awards are intended to enable a small business that has already performed proof-of-concept or feasibility studies to initiate the Phase II SBIR stage of development, without needing to perform more early stage, Phase-I-SBIR-type research. While the intent of the SBIR/STTR programs is commercialization (Phase III), no SBIR/STTR funds are allowed for commercialization activities such as patents; market and sales; market research; business development/product development/market plans; legal fees, travel and other costs including labor relating to license agreements and partnerships.
What are the requirements after being awarded this opportunity?
No program reports are required. No cash reports are required. Annual reports on progress and expenditures are required. Final reports are required within 120 days of termination. Reports are required after termination of NRSAs to ascertain compliance with the service and payback provisions. Annual reports on progress and expenditures are required. Final reports are required within 120 days of termination. Reports are required after termination of NRSAs to ascertain compliance with the service and payback provisions. No performance monitoring is required.
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.
Grantees generally must retain financial and programmatic records, supporting documents, statistical records, and all other records that are required by the terms of a grant, or may reasonably be considered pertinent to a grant, for a period of 3 years from the date the annual FSR is submitted. For awards under SNAP (other than those to foreign organizations and Federal institutions), the 3-year retention period will be calculated from the date the FSR for the entire competitive segment is submitted. Those grantees must retain the records pertinent to the entire competitive segment for 3 years from the date the FSR is submitted to NIH. Foreign organizations and Federal institutions must retain records for 3 years from the date of submission of the annual FSR to NIH. See 45 CFR 75.361 and 45 CFR 75.364 for exceptions and qualifications to the 3-year retention requirement (e.g., if any litigation, claim, financial management review, or audit is started before the expiration of the 3-year period, the records must be retained until all litigation, claims, or audit findings involving the records have been resolved and final action taken). Those sections also specify the retention period for other types of grant-related records, including F&A cost proposals and property records. In accordance with 45 CFR 75.364, the HHS Inspector General, the U.S. Comptroller General, or any of their duly authorized representatives have the right of timely and unrestricted access to any books, documents, papers, or other records of recipients that are pertinent to awards in order to make audits, examinations, excerpts, transcripts, and copies of such documents. This right also includes timely and reasonable access to a recipients personnel for the purpose of interview and discussion related to such documents. The rights of access are not limited to the required retention period, but shall last as long as records are retained.
Other 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
The National Heart, Lung, and Blood Advisory Council may recommend funding for periods ranging from 1 to 5 years. Funding commitments are made annually. 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. Award length may vary depending on the recommendation of the scientific review group, the national advisory council, successful annual performance, and availability of funds. A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. See the following for information on how assistance is awarded/released: Award length may vary depending on the recommendation of the scientific review group, the national advisory council, successful annual performance, and availability of funds. A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization.
Who do I contact about this opportunity?
Regional or Local Office
Dana A. Phares 6701 Rockledge Drive, Room 7176, Bethesda, Maryland 20892 Email: firstname.lastname@example.org
(Project Grants) FY 14 Not Available(Exp: Program not started); FY 15 Estimate Not Available(Exp: Program not started); and FY 16 Estimate Not Available(Exp: Obligations not set as of 9/2015) - The obligations will begin in FY 2016; and has no current expiration date.
Range and Average of Financial Assistance
Range of Dollar Amount: $0 - $5,000,000. Average Dollar Amount: $0 - $500,000.
Regulations, Guidelines and Literature
42 CFR 52; 42 CFR 66; 45 CFR 75; "NIH Guide for Grants and Contracts, and Supplements"; 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.
Examples of Funded Projects