[Federal Register Volume 79, Number 8 (Monday, January 13, 2014)]
[Notices]
[Pages 2179-2180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00318]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
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 12 voting members to serve on the Pharmacy Compounding
Advisory Committee, Center for Drug Evaluation and Research.
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 March 14, 2014 will be given
first consideration for membership on the Pharmacy Compounding Advisory
Committee. Nominations received after March 14, 2014 will be considered
for nomination to the committee if nominees are still needed.
[[Page 2180]]
ADDRESSES: All nominations for membership should be sent electronically
to [email protected], or by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver
Spring, MD 20993-0002. Information about becoming a member on an FDA
advisory committee can also be obtained by visiting FDA's Web site at:
http://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Jayne E. Peterson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993, 301-796-
9001; FAX: 301-847-8533, email: [email protected].
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members on the Pharmacy Compounding Advisory Committee (the Committee).
I. General Description of the Committee's Duties
The Committee provides advice on scientific, technical, and medical
issues concerning drug compounding under sections 503A and 503B of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a and 353b), and as
required, any other product for which FDA has regulatory
responsibility. The Committee also makes appropriate recommendations to
the Commissioner of Food and Drugs.
II. Criteria for Voting Members
Persons nominated for membership must have adequately diversified
research and/or experience appropriate to the work of the Committee in
such fields as pharmaceutical compounding, pharmaceutical
manufacturing, pharmacy, medicine, and related specialties. These
members will include representatives from the National Association of
Boards of Pharmacy, the United States Pharmacopoeia, pharmacists with
current experience and expertise in compounding, physicians with
background and knowledge in compounding, and patient and public health
advocacy organizations.
The specialized training and experience necessary to qualify the
nominee as an expert suitable for appointment is subject to review, but
may include experience in medical practice, pharmacy practice,
teaching, research, and/or public service relevant to the field of
activity of the Committee. Members will be invited to serve for terms
of up to 4 years.
III. Nomination Procedure
Any interested person may nominate one or more qualified persons
for membership on the Committee. Self-nominations are also accepted.
Nominations should include a cover letter and a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee, including a
current business address and/or home address, telephone number, and
email address if available. Nominations should also specify the
advisory committee for which the nominee is recommended. Nominations
should state that the nominee is aware of the nomination unless self-
nominated. Nominations should also state that the nominee is willing to
serve as a member of the advisory committee if selected and appears to
have no conflict of interest. FDA will ask potential candidates to
provide detailed information concerning such matters as financial
holdings, employment, and research grants and/or contracts in order to
permit evaluation of possible sources of conflict of interest.
Elsewhere in this issue of the Federal Register, FDA is publishing
a notice for industry organizations to participate in the nominations
for and selection of industry representatives for the Committee, a
notice for consumer organizations to participate in the nominations for
and selection of the consumer representative for the Committee, and a
final rule updating information regarding the Committee.
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: January 7, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-00318 Filed 1-10-14; 8:45 am]
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