Family Smoking Prevention and Tobacco Control Act Regulatory Research
The Family Smoking Prevention and Tobacco Control Act (TCA) provides the authority to regulate tobacco product manufacturing, distribution and marketing. Regulatory research will provide the scientific evidence to guide the implementation of this authority. Research areas include: 1) approaches that test the toxicity of tobacco smoke, aerosol, or specific constituents, 2) the effect of tobacco product characteristics on addiction and abuse liability, 3) the short and long term health effects of tobacco products, 4) understanding the knowledge, attitudes and behaviors related to tobacco product use, 5) understanding how to effectively communicate the health effects of tobacco products, 6) the influences of tobacco marketing, and 7) understanding the impact of potential FDA regulatory actions. The strategic priorities for these research areas can be found at http://www.fda.gov/TobaccoProducts/PublicHealthScienceResearch/Research/ucm311860.htm
General information about this opportunity
Last Known Status
National Institutes of Health, Department of Health and Human Services
Type(s) of Assistance Offered
B - Project Grants; M - Training
The Public Health Service Act and the Family Smoking Prevention and Tobacco Control Act, Public Law 111-31, 42 U.S.C. 300u-3
Who is eligible to apply/benefit from this assistance?
Applicants should review the eligibility information in the individual funding opportunity announcements issued under this CFDA.
This Tobacco Control Regulatory Research Program will support research aimed at providing guidance and evidence to develop regulation for tobacco product manufacturing, distribution and marketing. The general public will ultimately benefit.
What is the process for applying and being award this assistance?
Preapplication coordination is not applicable.
2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program. This program is excluded from coverage under 2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. Most applications must be prepared and submitted electronically. Most applicants use the SF 424 (Research & Related) for electronic submission. Information about the SF 424 form may be found on http://grants.nih.gov/grants/funding/424/index.htm, but application packages should be accessed through the appropriate funding opportunity announcement, found either on the NIH Guide to Grants and Contracts (http://grants1.nih.gov/grants/guide/index.html) or through the Grants.gov website (http://www.grants.gov/). Some institutions may submit the grant data directly (using what is called a system-to-system transfer). For further details, see grants.gov or eRA Commons. Application forms for SBIR and STTR grants may be obtained through the SBIR/STTR funding announcements posted on the NIH Guide to Grants and Contracts and the Grants.gov sites (see URLs listed above). All SBIR and STTR applications must be submitted electronically. The timeline for transition to electronic applications and the new forms may be found at: http://era.nih.gov/ElectronicReceipt/. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. Consultation on a proposed project may be obtained from the Office of Disease Prevention in the Division of Program Coordination, Planning, and Strategic Initiatives at NIH. Applications are reviewed by principally nonfederal consultants recruited nationwide. The amounts of the award and period of support are determined on the basis of merit of the project and the nature of the grant mechanism. Electronic applications are submitted through the Grants.gov website.
All applications for research grants, cooperative agreements, training, and SBIR and STTR grants are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by the National Advisory Council of the NIH Institute or Center that will manage the award. All competitive applications compete for available funds on the basis of scientific and technical merit, program relevance, and program balance. FDA Center for Tobacco Control will make final decisions on the relevance and program balance.
Contact the headquarters or regional location, as appropriate for application deadlines
Approval/Disapproval Decision Time
More than 180 days. Review the individual Funding Opportunity Announcement under this CFDA for any application-specific deadlines.
A principal investigator 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 homepage http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-064.html.
Renewal grants may only be submitted in response to a specific funding opportunity announcement under this CFDA.
How are proposals selected?
Funding decisions are based on scientific merit (42 CFR 52h) and program relevance. Scientific merit review encompasses: the peer review criteria detailed in the specific funding announcement, as well as the significance, approach, and innovation of the proposed research; the competency of the principal investigator; the adequacy of the resources and environment; the proposed budget and requested period of support; and, where applicable, the adequacy of the measures for protecting against adverse effects upon humans, animals, or the environment. Relevance to Tobacco Control Regulatory Research program priorities will also be taken into consideration.
How may assistance be used?
(1) Research project grants provide support for clearly defined projects or a small group of related research activities, and when appropriate, support of research conferences; (2) program project and center grants support large-scale, broad-based programs of research, usually interdisciplinary, consisting of several projects with a common focus; (3) exploratory/development and clinical exploratory/developmental grants encourage the development of new research activities in categorical program areas; (4) cooperative agreements support single or a group of related research activities with significant involvement of federal staff; (5) small grants support newer, less experienced investigators; investigators at institutions without a well developed research tradition and resources; the testing of new methods or techniques; small-scale exploratory and pilot studies, or exploration of an unusual research opportunity; small grants provide research support of up to $50,000 direct costs per year for a period of up to 2 years; (6) research training grants including fellowships and institutional training grants, career development grants and loan repayment contracts; and (7) SBIR Phase I grants (of approximately 6-months' duration) are to establish the technical merit and feasibility of proposed research or research and development efforts to determine the quality of performance of the small business grantees. Phase II grants are for the continuation of the research initiated in Phase I and that are likely to result in commercially viable products or processes. Only Phase I awardees are eligible to apply 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 and the quality of performance of the small business concerns. Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential of the Phase II application.
What are the requirements after being awarded this opportunity?
Expenditures and other financial records, and also administrative records, must be retained for 3 years from the day on which the grantee submits the last expenditure report for the grant period. Scientific data must be maintain to comply with Circular A-110 Shelby Amendment.
Other Assistance Considerations
Formula and Matching Requirements
Statutory formula is not applicable to this assistance listing.
Matching requirements are not applicable to this assistance listing.
MOE requirements are not applicable to this assistance listing.
Length and Time Phasing of Assistance
Award length may vary depending on the recommendation of the scientific review group, the national advisory council, successful annual performance, and availability of funds, with project periods ranging from 1 to 5 years. Funding commitments are made annually. 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
Helen I. Meissner, ScM, PhD
National Institutes of Health
6100 Executive Blvd.
Room 3B01, MSC 7530
Bethesda, MD 20892-7530 US
(Project Grants) FY 18$79,945,805.00; FY 19 est $80,000,000.00; FY 20 est $85,590,000.00; FY 17$89,111,387.00; FY 16$95,272,556.00; - Funds provided by the FDA CTP through an IDDA to NIH for the support of Family Smoking Prevention and Tobacco Control Act.
Range and Average of Financial Assistance
Regulations, Guidelines and Literature
45 CFR 74; 42 CFR 52; Guidelines are included in Funding Opportunity Announcements. Grants will be available under the authority of and administered in accordance with the NIH Grants Policy Statement and Federal regulations at 42 CFR Part 52 and 42 CFR Part 52a; Administrative requirements at 45 CFR Part 74.
Examples of Funded Projects