Allergenic Products Advisory Committee
Charter
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 Allergenic Products Advisory Committee advises the Commissioner in discharging responsibilities as they relate to helping to ensure safe and effective biological products for human use, and, as required, any other product for which the Food and Drug Administration has regulatory responsibility.
Authority
15 U.S.C. 1451 et seq.; 21 U.S.C. 321, 341, 342, 343, 343-1, 344, 345, 346, 348, 349, 350, 350a, 351, 352, 353f, 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 U.S.C. App. 2), which sets forth standards for the formation and use of advisory Committees.
Function
The Committee reviews and evaluates available data concerning the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological products or materials that are administered to humans for the diagnosis, prevention, or treatment of allergies and allergic disease, and makes appropriate recommendations to the Commissioner of Food and Drugs of its findings regarding the affirmation or revocation of biological product licenses, on the safety, effectiveness, and labeling of the products, on clinical and laboratory studies of such products, on amendments or revisions to regulations governing the manufacture, testing and licensing of allergenic biological products, and on the quality and relevance of FDA's research programs which provide the scientific support for regulating these agents.
Structure
The Committee shall consist of a core of nine voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of allergy, immunology, pediatrics, internal medicine, biochemistry, and related specialties. 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 nonvoting 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 four 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 nonvoting representative of consumer interests and a nonvoting 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 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 Center for Biologics Evaluation and Research, Food and Drug Administration.
Meetings
Meetings shall be held at least once 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 regulations (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 (5 U.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 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 $96,819. The estimated personyears of staff support required is 1.2, at an estimated annual cost of $130,107.
Reports
In the event 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 (5 U.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 the meetings, and a summary of the Committee's activities and recommendations during the proceeding 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 Allergenic Products Advisory Committee will terminate on July 9, 2010.
APPROVED:
| April 30, 2008 | /s/ Randall W. Lutter, Ph.D. Deputy Commissioner for Policy, FDA |