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) understanding
the diversity of tobacco products, (2) reducing addiction to tobacco products, (3) reducing toxicity and carcinogenicity of tobacco products and smoke, (4) understanding the adverse health consequences of tobacco use, (5) understanding communications about tobacco products, (6) understanding tobacco product marketing, and (7) understanding how economics and policies affect tobacco product use.

This regulatory research will help understand tobacco and its ingredients and constituents, tobacco addiction, tobacco marketing and labeling, and childhood tobacco use.

The strategic priorities for these research areas can be found at
http://www.fda.gov/downloads/TobaccoProducts/NewsEvents/UCM293998.pdf.

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.



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 http://www.fda.gov/downloads/TobaccoProducts/NewsEvents/UCM293998.pdf.

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 guidence and evidence to develop regulation for tobacco product manufacturing, distribution and marketing. The general public will ultimately benefit.

Credentials/Documentation

No Credentials or documentation are required. This program is excluded from coverage under OMB Circular No. A-87.

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.

12372.

Application Procedures

This program is excluded from coverage under OMB Circular No. A-102. OMB Circular No. A-110 applies to this program. 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.

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.

Deadlines

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

Authorization

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.

Appeals

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.

Renewals

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

Reports

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 access 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.

Audits

In accordance with the provisions of OMB Circular No. A-133 (Revised, June 27, 2003), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133.

Records

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

75-0846-0-1-552 - NIH OD APPROPRIATION.

Obigations

(Project Grants) FY 12 $27,865,594; FY 13 est $101,755,000; and FY 14 est $116,000,000 - 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

None.

Headquarters Office

Helen I. Meissner, ScM, PhD National Institutes of Health
6100 Executive Blvd.
Room 3B01, MSC 7530
, Bethesda, Maryland 20892-7530 Email: TRSP@mail.nih.gov 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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