2018-14942. Advisory Committee; Allergenic Products Advisory Committee; Renewal

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; renewal of advisory committee.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the renewal of the Allergenic Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Allergenic Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until July 9, 2020.

DATES:

Authority for the Allergenic Products Advisory Committee expired on July 9, 2018; however, the Commissioner formally determined that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT:

Serina Hunter-Thomas, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6338, Silver Spring, MD 20993-0002; 240-402-5771, [e-mail].

SUPPLEMENTARY INFORMATION:

Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Allergenic Products Advisory Committee. The committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The 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 FDA has regulatory responsibility.

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 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 that provide the scientific support for regulating these agents.

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. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. 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.

Further information regarding the most recent charter and other information can be found at https://www.fda.gov/​AdvisoryCommittees/​CommitteesMeetingMaterials/​BloodVaccinesandOtherBiologics/​AllergenicProductsAdvisoryCommittee/​ucm129360.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100.

This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please check https://www.fda.gov/​AdvisoryCommittees/​default.htm.

Dated: July 9, 2018.

Leslie Kux,

Associate Commissioner for Policy.