[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)]
[Notices]
[Pages 13133-13134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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]
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