The Secretary and, by delegation, the Assistant Secretary for the Office of Public Health and Science, and the Commissioner of Food and Drugs are charged with the administration of the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, and various provisions of the Public Health Service Act.  The Drug Safety and Risk Management Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility.

Authority

15 USC 1451 et seq.; 21 USC 321, 341, 342, 343, 343-1, 344, 345, 346, 348, 349, 350, 350a, 351, 352, 353(f), 355, 360b, 360c-j, 371, 375, 376, 378, 379e, 381, 393, 394, 881(b); 42 USC 217a, 241, 242, 242a, 262, 264; 21 CFR Part 14, 330.10(a); the Committee is governed by the provisions of Public Law 92-463, as amended (5 USC App. 2), which sets forth standards for the formation and use of advisory committees.

Function

The Committee advises the Commissioner of Food and Drugs on risk management, risk communication, and quantitative evaluation of spontaneous reports for drugs for human use and for any other product for which the Food and Drug Administration has regulatory responsibility. The Committee also advises the Commissioner of Food and Drugs regarding the scientific and medical evaluation of all information gathered by the Department of Health and Human Services and the Department of Justice with regard to safety, efficacy, and abuse potential of drugs or other substances, and recommends actions to be taken by the Department of Health and Human Services with regard to the marketing, investigation, and control of such drugs or other substances. 

Structure

The Committee shall consist of a core of 13 voting members including the Chair.  Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in risk communication, risk management, drug safety, medical, behavioral, and biological sciences as they apply to risk management, and drug abuse.  The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons.  In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests. 

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.

If functioning as a medical device panel, a non-voting representative of consumer interests and a non-voting representative of industry interests will be included in addition to the voting members.

Members shall be invited to serve for overlapping four-year terms.  Terms of more than two years are contingent upon the renewal of the Committee by appropriate action prior to its expiration. 

Temporary subcommittees consisting of two or more committee members may be established 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.

Management and support services shall be provided by the Center for Drug Evaluation and Research, Food and Drug Administration.

Meetings

Meetings shall be held approximately four times a year at the call of the Chair with the advance approval of a Government official, who shall also approve the agenda.  A Government official shall be present at all meetings.

Because of the size of the Committee and the variety in the types of issues that 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.

Meetings shall be open to the public except as determined otherwise by the Commissioner or designee.  Notice of all meetings shall be given to the public.

Meetings shall be conducted and records of the proceedings kept as required by applicable laws and Departmental regulations.

Compensation

Members who are not full-time Federal employees shall be paid at the rate of the General Schedule 15, step 10, per day for time spent at meetings plus per diem and travel expenses in accordance with Standard Government Travel Regulations.

Annual Cost Estimate

The estimated annual cost for operating the Committee, including compensation and travel expenses for members but excluding staff support, is $192,101.10.  The estimated personyears of staff support required is 1.27, at an estimated annual cost of $147,069.49.

Reports

In the event that a portion of a meeting is closed to the public, a report shall be prepared not later than November 1 of each year which contains as a minimum the function of the Committee, a list of members and their business addresses, the dates and places of meetings, and a summary of the Committee's activities and recommendations during the preceding year.  A copy of the report shall be provided to the Department Committee Management Officer.

Termination Date

Unless renewed by appropriate action prior to its expiration, the Drug Safety and Risk Management Advisory Committee will terminate on May 31, 2010.

Approved: