Document ID: FDA-2016-N-0001-0049
Agency: fda
Document Type: Notice
Title: Advisory Committee; Pulmonary-Allergy Drugs Advisory Committee, Renewal
Posted Date: 2016-05-13T04:00Z

[Federal Register Volume 81, Number 93 (Friday, May 13, 2016)]
[Notices]
[Pages 29868-29869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11323]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Advisory Committee; Pulmonary-Allergy Drugs 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 Pulmonary-Allergy Drugs 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 Pulmonary-
Allergy Drugs Advisory Committee for an additional 2 years beyond the 
charter expiration date. The new charter will be in effect until May 
30, 2018.

DATES: Authority for the Pulmonary-Allergy Drugs Advisory Committee 
will expire on May 30, 2016, unless the Commissioner formally 
determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Cindy Hong, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, 
PADAC@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Issued in 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services issued in 45 CFR part 11 
and by the General Services Administration, FDA is announcing the 
renewal of the Pulmonary-Allergy Drugs Advisory Committee. The 
committee is a discretionary Federal advisory committee established to 
provide advice to the Commissioner. The Pulmonary-Allergy Drugs 
Advisory 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 the 
Food and Drug Administration has regulatory responsibility. The 
Committee reviews and evaluates available data concerning the safety 
and effectiveness of marketed and investigational human drug products 
for use in the treatment of pulmonary disease and diseases with 
allergic and/or immunologic mechanisms and makes appropriate 
recommendations to the Commissioner of Food and Drugs.
    The Committee shall consist of a core of 11 voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of pulmonary medicine, allergy, clinical immunology, and 
epidemiology or statistics. Members will be invited to serve for 
overlapping terms of up to four 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/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/ucm107567.htm or by contacting the 
Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). Since 
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.

[[Page 29869]]

    Dated: May 10, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-11323 Filed 5-12-16; 8:45 am]
 BILLING CODE 4164-01-P