[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Pages 36594-36595]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13042]
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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 or the Agency) is
requesting nominations for members to serve on the Pharmacy Compounding
Advisory Committee (the Committee), Division of Advisory Committee and
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.
DATES: Nominations received on or before August 17, 2020, will be given
first consideration for membership on the Pharmacy Compounding Advisory
Committee. Nominations received after August 17, 2020, 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 Committee 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,
[[Page 36595]]
MD 20993-0002. Information about becoming a member on an FDA advisory
committee can also be obtained by visiting FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for
membership, the primary contact is: Yvette Waples, 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].
SUPPLEMENTARY INFORMATION: 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.
FDA is requesting nominations for voting members on the Pharmacy
Compounding Advisory Committee.
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 one to two 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 (Pub. L. 92-463). 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, including
current business address and/or home address, telephone number, and
email address if available, and a signed copy of the Acknowledgement
and Consent form available at the FDA Advisory Committee 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: June 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13042 Filed 6-16-20; 8:45 am]
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