Document ID: FDA-2013-N-0001-0124
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2014-01-13T05:00Z

[Federal Register Volume 79, Number 8 (Monday, January 13, 2014)]
[Notices]
[Pages 2178-2179]
From the Federal Register Online via the Government Printing 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 
cv@oc.fda.gov, 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: dornette.spelllesane@fda.hhs.gov.
    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: PCAC@fda.hhs.gov.

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]
BILLING CODE 4160-01-P