Authority:

The Advisory Committee on Risk Communication, referred to herein as the Risk Communication Advisory Committee, was established by 21 U.S.C. 360bbb-6, as added by section 917 of the Food and Drug Administration Amendments Act of 2007. 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 Risk Communication Advisory Committee advises the Commissioner of Food and Drugs or designee on methods to effectively communicate risks associated with products regulated by the Food and Drug Administration and in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and any other product for which the Food and Drug Administration has regulatory responsibility.

Description of Duties:

The Committee reviews and evaluates strategies and programs designed to communicate with the public about the risks and benefits of FDA-regulated products so as to facilitate optimal use of these products. The Committee also reviews and evaluates research relevant to such communication to the public by both FDA and other entities. It also facilitates interactively sharing risk and benefit information with the public to enable people to make informed independent judgments about use of FDA-regulated products.

Agency or Official to Whom the Committee Reports:

The Committee provides advice to the Commissioner of Food and Drugs.

Support:

Management and support services shall be provided by the Risk Communication Staff, Office of Policy and Planning, Office of the Commissioner of Food and Drugs.

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 $262,200. The estimated person years of staff support required is 1.25, at an estimated annual cost of $145,485.

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.

Duration:

Continuing this committee is mandated by statute with no specific end date.

Termination:

Sec. 14 of the Federal Advisory Committee Act does not apply to the duration of this committee, as stated in 21 USC 360bbb-6(a)(4). This charter will remain in effect until amended or terminated by the Commissioner.

Membership and Designation:

The Committee shall consist of a core of fifteen voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in fields such as social marketing, health literacy, and other relevant areas. Members will include experts on risk communication, experts on emerging postmarket drug risks and individuals knowledgeable about and experienced in the work of patient, consumer, and health professional organizations. Almost all non-Federal members of this committee serve as Special Government Employees. Some members will be selected to provide experiential insight on the communication needs of the various groups who use FDA-regulated products. The latter may include patients and patients’ family members, health professionals, communicators in health, medicine and science, and persons affiliated with consumer, specific disease, or patient safety advocacy groups. The Commissioner or designee shall also have the authority to select from a group of individuals nominated by industry to serve temporarily as nonvoting members who are identified with industry interests. The number of temporary members selected for a particular meeting will depend on the meeting topic(s).

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 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.

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.

Subcommittee:

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.

Recordkeeping:

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 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.

Approved:

Date: July 10, 2009

Randall Lutter, Ph.D.

Deputy Commissioner for Policy