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

Agency - Department of Health and Human Services

The Department of Health and Human Services is the Federal government's principal agency for protecting the health of all Americans and providing essential human services, especially to those who are least able to help themselves.

Selected Recipients for this Program

RecipientAmount Start DateEnd Date
Georgetown University (the) $ 158,670   2021-09-152026-08-31
University Of Kansas Medical Center Research Institute, Inc. $ 176,361   2021-09-152026-08-31
Medical University Of South Carolina The $ 18,007,395   2016-04-192026-08-31
University Of North Carolina At Chapel Hill $ 105,409,870   1997-06-012025-11-30
University Of South Florida $ 877,695   2020-09-012025-08-31
Yale University $ 377,460   2020-09-012025-08-31
University Of Georgia Research Foundation, Inc. $ 354,880   2020-09-012025-08-31
University Of Pittsburgh, The $ 84,558,804   1997-09-102025-07-31
University Of Utah, The $ 385,409   2020-07-012025-06-30
Trustees Of Boston University $ 364,183   2020-08-012025-06-30

Program Accomplishments

Not Applicable.

Uses and Use Restrictions

(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.

Research must directly support the Family Smoking Prevention and Tobacco Control Act and the Center for Tobacco Products, Food and Drug Administration Research Priorities found at

Eligibility Requirements

Applicant Eligibility

Applicants should review the eligibility information in the individual funding opportunity announcements issued under this CFDA.

Beneficiary Eligibility

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.


No Credentials or documentation are required. This program is excluded from coverage under 2 CFR 200, Subpart E - Cost Principles.

Aplication and Award Process

Preapplication Coordination

Preapplication coordination is generally not applicable, though applicants requesting direct costs of $500,000 or more for any one year must contact the appropriate NIH Institute or Center no later than 6 weeks before the anticipated submission date.

Environmental impact information is not required for this program.

This program is excluded from coverage under E.O.


Application Procedures

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, but application packages should be accessed through the appropriate funding opportunity announcement, found either on the NIH Guide to Grants and Contracts ( or through the website ( Some institutions may submit the grant data directly (using what is called a system-to-system transfer). For further details, see 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 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: For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: 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 website.

Award Procedures

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 office, as appropriate, for application deadlines.


The Public Health Service Act and the Family Smoking Prevention and Tobacco Control Act, Public Law 111-31, 42 U.S.C 300u-3.

Range of Approval/Disapproval Time

> 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


Renewal grants may only be submitted in response to a specific funding opportunity announcement under this CFDA.

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

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. See the following for information on how assistance is awarded/released: A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization.

Post Assistance Requirements


Annual progress and financial status reports for continuing projects and final reports on all projects upon conclusion are required.

Cash are applicable and will be submitted on the SF425.

Annual progress reports for continuing projects are required to assess progress.

Interim reports may also be required or requested.

Expenditure reports are applicable and will be submitted monthly on the SF425.

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.


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.

Financial Information

Account Identification



(Project Grants) FY 16 $95,272,556; FY 17 est $91,854,000; and FY 18 est $83,249,000 - 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

No Data Available.

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.

Information Contacts

Regional or Local Office


Headquarters Office

Helen I. Meissner, ScM, PhD National Institutes of Health 6100 Executive Blvd. Room 3B01, MSC 7530 , Bethesda, Maryland 20892-7530 Email: Phone: 301-451-8681 Fax: 301-480-7660

Criteria for Selecting Proposals

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.

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