Document ID: FDA-2016-N-0001-0057
Agency: fda
Document Type: Notice
Title: Advisory Committee; Allergenic Products Advisory Committee, Renewal
Posted Date: 2016-05-31T04:00Z

[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34343-34344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12636]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

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

[[Page 34344]]

expiration date. The new charter will be in effect until July 9, 2018.

DATES: Authority for the Allergenic Products Advisory Committee will 
expire on July 9, 2016, unless the Commissioner formally determines 
that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Janie Kim, Division of Scientific 
Advisors and Consultants, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
6129, Silver Spring, MD 20993-0002; 301-796-9016, 
Janie.kim@fda.hhs.gov.

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). 
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 which 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 http://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 visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: May 24, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-12636 Filed 5-27-16; 8:45 am]
BILLING CODE 4164-01-P