83 FR 13133 - Request for Nominations for Voting Members on a Public Advisory Committee; Pharmacy Compounding Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 59 (March 27, 2018)

The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Pharmacy Compounding Advisory Committee (Committee), Division of Advisory Committee Consultant Management, Center for Drug Evaluation and Research. The Committee provides advice on scientific, technical, and medical issues concerning human drug compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and makes appropriate recommendations to the Commissioner of Food and Drugs. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)]
[Notices]
[Pages 13133-13134]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06062]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0965]


Request for Nominations for Voting Members on a Public Advisory 
Committee; Pharmacy Compounding Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for members to serve on the Pharmacy Compounding Advisory 
Committee (Committee), Division of Advisory Committee Consultant 
Management, Center for Drug Evaluation and Research. The Committee 
provides advice on scientific, technical, and medical issues concerning 
human drug compounding under the Federal Food, Drug, and Cosmetic Act 
(FD&C Act), and, as required, any other product for which FDA has 
regulatory responsibility, and makes appropriate recommendations to the 
Commissioner of Food and Drugs.
    FDA seeks to include the views of women and men, members of all 
racial and ethnic groups, and individuals with and without disabilities 
on its advisory committees and, therefore, encourages nominations of 
appropriately qualified candidates from these groups.

DATES: Nominations received on or before May 29, 2018, will be given 
first consideration for membership on the Pharmacy Compounding Advisory 
Committee. Nominations received after May 29, 2018, will be considered 
for nominations to the Committee as later vacancies occur.

ADDRESSES: All nominations for membership should be sent electronically 
by logging into the FDA Advisory Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail 
to Advisory Committee Oversight and Management Staff, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver 
Spring, MD 20993-0002.

FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for 
membership, the primary contact is: Cindy Chee, 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, Fax: 301-847-8533, email: [email protected].
    Information about becoming a member on an FDA advisory committee 
can also be obtained by visiting FDA's website by using the following 
link: https://www.fda.gov/AdvisoryCommittees/default.htm.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
members on the Pharmacy Compounding Advisory Committee.

[[Page 13134]]

I. General Description of the Committee's Duties

    The Committee provides advice on scientific, technical, and medical 
issues concerning human drug compounding under sections 503A and 503B 
of the FD&C Act (21 U.S.C. 353a and 353b), and, as required, any other 
product for which FDA has regulatory responsibility, and makes 
appropriate recommendations to the Commissioner of Food and Drugs.
    In implementing sections 503A and section 503B of the FD&C Act, the 
Agency may consult the Committee on: (1) Drug products for inclusion on 
a list of drug products that have been withdrawn or removed from the 
market because such drug products or components of such drug products 
have been found to be unsafe or not effective, and therefore cannot be 
compounded; (2) bulk drug substances for inclusion on lists of bulk 
drug substances that may be used in compounding; and (3) drug products 
for inclusion on a list of drug products that present demonstrable 
difficulties for compounding.
    Meetings are held approximately two to three times a year, 
announced in the Federal Register, and are 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.

II. Criteria for Voting Members

    The Committee consists of a core of 12 voting members including the 
Chair. Members and the Chair are selected by the Commissioner or 
designee from among authorities knowledgeable in the fields of 
pharmaceutical compounding, pharmaceutical manufacturing, pharmacy, 
medicine, and related specialties. These members will include 
representatives from the National Association of Boards of Pharmacy, 
the U.S. Pharmacopeia, pharmacists with current experience and 
expertise in compounding, physicians with background and knowledge in 
compounding, and patient and public health advocacy organizations. 
Almost all non-Federal members of this committee serve as Special 
Government Employees. Members will be invited to serve for terms of up 
to 4 years.

III. Nomination Procedures

    Any interested person may nominate one or more qualified 
individuals for membership on the advisory committee. Self-nominations 
are also accepted. Nominations must include a current, complete 
r[eacute]sum[eacute] or curriculum vitae for each nominee and a signed 
copy of the Acknowledgement and Consent form available at the FDA 
Advisory Nomination Portal (see ADDRESSES). Nominations must also 
specify the advisory committee for which the nominee is recommended. 
Nominations must also acknowledge that the nominee is aware of the 
nomination unless self-nominated. FDA will ask potential candidates to 
provide detailed information concerning such matters related to 
financial holdings, employment, and research grants and/or contracts to 
permit evaluation of possible sources of conflicts of interest.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06062 Filed 3-26-18; 8:45 am]
 BILLING CODE 4164-01-P