
[Federal Register Volume 79, Number 8 (Monday, January 13, 2014)]
[Notices]
[Pages 2177-2178]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00320]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Request for Notification From Industry Organizations Interested 
in Participating in the Selection Process for Nonvoting Industry 
Representatives and Request for Nominations for Nonvoting Industry 
Representatives 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 
industry organizations interested in participating in the selection of 
nonvoting industry representatives to represent the interests of the 
pharmacy compounding industry and the pharmaceutical manufacturing 
industry on the Pharmacy Compounding Advisory Committee for the Center 
for Drug Evaluation and Research notify FDA in writing. A nominee may 
either be self-nominated or nominated by an organization to serve as a 
nonvoting industry representative. Nominations will be accepted for two 
vacancies effective with this notice.
    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. Specifically, in 
this document, nominations for nonvoting representatives of industry 
interests are encouraged from the pharmacy compounding industry and the 
pharmaceutical manufacturing industry.

DATES: Any industry organization interested in participating in the 
selection of appropriate nonvoting members to represent the interests 
of the pharmacy compounding industry and the pharmaceutical 
manufacturing industry should send a letter stating the interest to FDA 
by February 12, 2014, for the vacancies listed in this notice. 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by February 12, 2014.

ADDRESSES: All letters of interest and nominations should be submitted 
electronically to PCAC@fda.hhs.gov, or in writing by mail to 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.

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: PCAC@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The Agency requests nominations for 
nonvoting industry representatives on the Pharmacy Compounding Advisory 
Committee (the Committee) to represent the interests of the pharmacy 
compounding industry and the pharmaceutical manufacturing industry.

I. Pharmacy Compounding Advisory Committee

    The Committee advises the Commissioner of Food and Drugs (the 
Commissioner) or designee in discharging responsibilities as they 
relate to the regulation of compounded drug products. 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.
    The Committee will include one or more nonvoting members who 
represent industry interests. These members will include one 
representative of the pharmacy compounding industry and

[[Page 2178]]

one representative of the pharmaceutical manufacturing industry. With 
this notice, nominations are being sought for one representative from 
the pharmacy compounding industry and one representative from the 
pharmaceutical manufacturing industry.

II. Criteria for Nonvoting Members

    Any pharmacy compounding organization and any pharmaceutical 
manufacturing organization interested in participating in the selection 
of an appropriate nonvoting member to represent industry interests 
should send a letter stating that interest to the FDA contact (see FOR 
FURTHER INFORMATION CONTACT) within 30 days of publication of this 
document (see DATES).
    Within the subsequent 30 days, FDA will send a letter to each 
pharmacy compounding organization that has expressed an interest and 
attach a complete list of all such organizations. A list of all 
nominees from the pharmacy compounding industry along with their 
current r[eacute]sum[eacute]s will also be attached. The letter will 
also state that it is the responsibility of the interested 
organizations to confer with one another and select a candidate to 
serve as the nonvoting member to represent the pharmacy compounding 
industry on the committee within 60 days of receiving the FDA letter. 
FDA will send similar letters to the pharmaceutical manufacturing 
organizations that have expressed interest, and they will be expected 
to follow a similar process to select their nominee.
    Interested organizations are not bound by the list of nominees when 
selecting a candidate. However, if no individual is selected within 60 
days, the Commissioner will select the nonvoting member in each 
category to represent industry interests.

III. Nomination Procedure

    Individuals may self-nominate, and/or an organization may nominate 
one or more individuals to serve as a nonvoting industry 
representative. Nominations should include contact information and a 
current, complete r[eacute]sum[eacute] or curriculum vitae for each 
nominee. Nominations should also include the name of the Committee and 
should be sent to the FDA contact person (see FOR FURTHER INFORMATION 
CONTACT) within 30 days of publication of this document (see DATES). 
FDA will forward all nominations to the organizations expressing 
interest in participating in the selection process for the Committee. 
(Persons who nominate themselves as nonvoting industry 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 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. 2014-00320 Filed 1-10-14; 8:45 am]
BILLING CODE 4160-01-P


