[Federal Register Volume 83, Number 134 (Thursday, July 12, 2018)]
[Notices]
[Pages 32310-32311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14942]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2475]


Advisory Committee; Allergenic Products Advisory Committee; 
Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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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, 
[email protected].

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

[[Page 32311]]

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.
[FR Doc. 2018-14942 Filed 7-11-18; 8:45 am]
 BILLING CODE 4164-01-P


