[Federal Register Volume 79, Number 8 (Monday, January 13, 2014)]
[Notices]
[Pages 2178-2179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00319]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Request for Nominations for a Voting Consumer Representative on
the Pharmacy Compounding Advisory Committee and Request for
Notification From Consumer Organizations Interested in Participating in
the Selection Process for Nominations for a Voting Consumer
Representative on the 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 that any
consumer organizations interested in participating in the selection of
a voting consumer representative to serve on the Pharmacy Compounding
Advisory Committee notify FDA in writing. FDA is also requesting
nominations for a voting consumer representative to serve on the
Pharmacy Compounding Advisory Committee for which a vacancy currently
exists. Nominees recommended to serve as the voting consumer
representative may be self-nominated or nominated by a consumer
organization. Nominations will be accepted for the current vacancy
through February 12, 2014.
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: Any consumer organization interested in participating in the
selection of an appropriate voting member to represent consumer
interests on an FDA advisory committee should send a letter or email
stating that interest to FDA (see ADDRESSES) by February 12, 2014, for
the vacancy in this notice. Concurrently, nomination materials for
prospective candidates should be sent to FDA (see ADDRESSES) by
February 12, 2014.
ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process and consumer
representative nominations should be sent electronically to
[email protected], or by mail to Advisory Committee Oversight and
Management Staff, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, FAX: 301-847-
8640. Information about becoming a member of an FDA advisory committee
can be obtained by visiting FDA's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Dornette Spell-LeSane, Advisory
Committee Oversight and Management Staff, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-
0002, 301-796-8224, email: [email protected].
For questions relating to the Pharmacy Compounding Advisory
Committee, 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 a voting
consumer representative listed in table 1:
[[Page 2179]]
Table 1--Committee Description, Type of Consumer Representative
Vacancy, and Approximate Date Needed
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Committee areas of expertise Approximate date
needed Current vacancies needed
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Pharmacy Compounding-- 1--Voting........ Immediately.
Knowledgeable in the fields
of pharmaceutical
compounding; pharmaceutical
manufacturing; pharmacy,
medicine, and related
specialties.
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I. Pharmacy Compounding Drugs Advisory Committee
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, and makes appropriate recommendations to the
Commissioner of Food and Drugs.
II. Criteria for Members
Persons nominated for membership as consumer representatives on
committees should meet the following criteria: (1) Demonstrate ties to
consumer- and community-based organizations; (2) be able to analyze
technical data; (3) understand research design; (4) be able to discuss
benefits and risks; and (5) be able to evaluate the safety and efficacy
of products under review. The consumer representative should be able to
represent the consumer perspective on issues and actions before the
advisory committee; serve as a liaison between the committee and
interested consumers, associations, coalitions, and consumer
organizations; and facilitate dialogue with the advisory committees on
scientific issues that affect consumers.
III. Selection Procedures
Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and consumer advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments may
also participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
member to represent consumer interests should send a letter stating
that interest to FDA (see ADDRESSES) within 30 days of publication of
this document.
Within the subsequent 30 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing at least two
qualified nominees selected by the Agency based on the nominations
received, along with each nominee's current curriculum vitae or
r[eacute]sum[eacute]. Ballots are to be filled out and returned to FDA
within 30 days. The nominee receiving the highest number of votes
ordinarily will be selected to serve as the member representing
consumer interests for that particular advisory committee.
IV. Nomination Procedures
Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Agency's
advisory committees. 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, email
address if available, and a list of consumer- or community-based
organizations for which the candidate can demonstrate active
participation.
Nominations also should specify the advisory committee for which
the nominee is recommended. In addition, nominations should include
confirmation that the nominee is aware of the nomination, 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 conflicts of interest. Members
will be invited to serve for terms of up to 4 years.
FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of qualified
nominees. Names not selected will remain on a list of eligible nominees
and will be reviewed periodically by FDA to determine continued
interest. Upon selecting qualified nominees for the ballot, FDA will
provide those consumer organizations that are participating in the
selection process with the opportunity to vote on the listed nominees.
Only organizations vote in the selection process. Persons who nominate
themselves to serve as voting consumer representatives will not
participate in the selection process.
Elsewhere in this issue of the Federal Register, FDA is publishing
a notice requesting nominations for voting members of the Committee, a
notice for industry organizations to participate in the nominations for
and selection of the industry representatives 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. 2014-00319 Filed 1-10-14; 8:45 am]
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