Amended September, 2012
The Tobacco Products Scientific Advisory Committee was established under section 917 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)(21 U.S.C. 387q), as added by section 101 of the Family Smoking Prevention and Tobacco Control Act, Pub. L. 111-31. The Committee is also governed by 21 CFR Part 14 and Pub. L. 92-463 (5 U.S.C. App.), the Federal Advisory Committee Act, which sets forth standards for the formation and use of advisory committees.
Objectives and Scope of Activities
The Tobacco Products Scientific Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to the regulation of tobacco products.
Description of Duties
The Committee reviews and evaluates safety, dependence, and health issues relating to tobacco products and provides appropriate advice, information and recommendations to the Commissioner of Food and Drugs.
Specifically, the Committee will submit reports or recommendations on tobacco-related topics, including:
- The impact of the use of menthol in cigarettes on the public health, including such use among children, African Americans, Hispanics and other racial and ethnic minorities
- The nature and impact of the use of dissolvable tobacco products on the public health, including such use on children
- The effects of the alteration of nicotine yields from tobacco products and whether there is a threshold level below which nicotine yields do not produce dependence on the tobacco product involved
- Any application submitted by a manufacturer for a modified risk tobacco product
The Committee may provide recommendations to the Commissioner regarding any regulations to be promulgated under the act and may review any applications for new tobacco products or petitions for exemption under Section 906(e) of the FD&C Act. The Committee may consider and provide recommendations on any other matter as provided in the Family Smoking Prevention and Tobacco Control Act.
Agency or Official to Whom the Committee Reports
The Committee provides advice to the Commissioner of Food and Drugs.
Management and support services shall be provided by the Center for Tobacco Products, Food and Drug Administration.
Estimated Annual Operating Costs and Staff Years
The estimated annual cost for operating the Committee, including compensation and travel expenses for members, but excluding staff support is $357,832. The estimated person years of staff support required is 4.35, at an estimated cost of $557,227.
Designated Federal Officer
FDA will select a fulltime or permanent part-time Federal employee to serve as the Designated Federal Officer (DFO) to attend each Committee meeting and ensure that all procedures are within applicable statutory, regulatory, and HHS General Administration Manual directives. The DFO will approve and prepare all meeting agendas, call all of the Committee and subcommittee meetings, adjourn any meeting when the DFO determines adjournment to be in the public interest and chair meetings when directed to do so by the official to whom the Committee reports. The DFO shall be present at all meetings of the full committee and subcommittees.
Estimated Number and Frequency of Meetings
Meetings shall be held approximately four times a year. Meetings shall be open to the public except as determined otherwise by the Commissioner or designee in accordance with the Government in the Sunshine Act (5 U.S.C. 552b(c)) and the Federal Advisory Committee Act. Notice of all meetings shall be given to the public. A report will be prepared which will contain, as a minimum, a list of members and their business addresses, the Committee’s functions, the dates and places of meetings, and a summary of the Committee’s activities and recommendations made during the fiscal year. A copy of this report will be provided to the Department Committee Management Officer.
Continuing; this committee is mandated by statute with no specific end date.
Section 14 of the Federal Advisory Committee Act does not apply to the duration of this committee, as stated in section 917(D)(3) of the FD&C Act (21 U.S.C. 387q(d)(3)). This charter will remain in effect until amended or terminated by the Commissioner.
Membership and Designation
The Committee shall consist of 12 members including the Chair. Members and the Chair are selected by the Commissioner or designee from among individuals knowledgeable in the fields of medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products. Members will be invited to serve for overlapping terms of up to four years. Almost all non-Federal members of this committee serve as Special Government Employees. The Committee shall include nine technically qualified voting members, selected by the Commissioner or designee. The nine voting members shall be physicians, dentists, scientists, or health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, or any other relevant specialty. One member shall be an officer or employee of a state or local government or of the Federal Government. The final voting member shall be a representative of the general public. In addition to the voting members, the Committee shall include 3 non-voting members who are identified with industry interests. These members shall include one representative of the tobacco manufacturing industry, one representative of the interests of tobacco growers, and one representative of the interests of the small business tobacco manufacturing industry. This final position can be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Committee. The Commissioner or designee shall have the authority to select, from a group of individuals nominated by industry, the group of representatives eligible to serve as nonvoting representatives of the interests of small business tobacco manufacturers. The Commissioner or designee shall also have the authority to designate which of the eligible representatives will serve as the representative of the interests of the small business tobacco manufacturing industry for a particular Committee meeting based on the area of expertise relevant to the topics being considered by the Committee at that meeting
The Commissioner or designee shall designate one of the voting members of the committee to serve as chairperson.
The Commissioner or designee shall have the authority to select members of other scientific and technical FDA advisory committees (normally not to exceed 10 members) to serve temporarily as voting members and to designate consultants to serve temporarily as voting members when: (1) expertise is required that is not available among current voting standing members of the Committee (when additional voting members are added to the Committee to provide needed expertise, a quorum will be based on the combined total of regular and added members), or (2) to comprise a quorum when, because of unforeseen circumstances, a quorum is or will be lacking. Because of the size of the Committee and the variety in the types of issues it will consider, FDA may, in connection with a particular committee meeting, specify a quorum that is less than a majority of the current voting members. The Agency's regulations (21 CFR §14.22(d)) authorize a committee charter to specify quorum requirements.
Temporary subcommittees consisting of two or more Committee members may be established by the Commissioner or designee as needed to address specific issues within their respective areas of expertise.
Subcommittees make preliminary recommendations regarding specific issues for subsequent action by the full Committee. The Department Committee Management Officer shall be notified upon establishment of each subcommittee, and shall be provided information on its name, membership, function, and estimated frequency of meetings.
The records of the Committee, established subcommittees, or other subgroups of the committee, shall be handled in accordance with General Records Schedule 26, Item 2 or other approved agency records disposition schedule. The records shall be available for public inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552.
A report will be prepared containing, as a minimum, a list of members and their business addresses, the Committee’s functions, the dates and places of meetings, and a summary of the Committee’s activities and recommendations made during the fiscal year. A copy of this report will be provided to the Department Committee Management Officer.
Dated: September 10, 2012
Jill Hartzler Warner, J.D.
Acting Associate Commissioner for Special Medical Programs, FDA