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Purpose: 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 Risk Communication Advisory Committee advises the Commissioner in discharging responsibilities as they relate to communicating effectively with the public to help facilitate effective and safe use of all products for which the Food and Drug Administration has regulatory responsibility.
Authority:
15 USC 1451 et seq.; 21 U.S.C. 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 U.S.C. 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 and designees on 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.
Structure:
The committee shall consist of a core of 15 voting members including the Chair.
Members will be appointed as Special Government Employees except for members
representing industry interests. Members and the chair are selected by the Commissioner
or designee from among authorities knowledgeable in the fields of risk communication,
social marketing, health literacy, cultural competency, journalism, bioethics,
and other relevant behavioral and social sciences. 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. Depending on the meeting topic(s), at least one nonvoting
member identified with relevant industry interests may be invited from existing
members of other FDA Advisory Committees.
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.
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 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.
Management and support services shall be provided by the Office of Planning in the Office of the Commissioner, Food and Drug Administration.
Meetings:
Meetings shall be held approximately four times a year at the call of the Designated
Federal officer, who shall also approve the agenda. A Designated Federal officer
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 regulation (21 CFR ยง14.22 (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 in accordance with the Government in the Sunshine Act (5U.S.C. 552b (c)) and the Federal Advisory Committee Act. 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 meeting 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 $186,212. The
estimated personyears of staff support required is 1.25, at an estimated annual
cost of $120,589.
Reports:
In the event that the Commissioner or designee determines that a portion of
a meeting is closed to the public in accordance with the Government in the Sunshine
Act (5U.S.C. 552b (c)) and the Federal Advisory Committee Act, 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 place 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 Risk Communication
Advisory Committee will terminate two years from the date this charter is filed.
Approved:
Date: May 11, 2007
Randall Lutter, Ph.D. Associate Commissioner for Policy and Planning, FDA