
[Federal Register Volume 76, Number 129 (Wednesday, July 6, 2011)]
[Notices]
[Pages 39403-39404]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16828]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


Request for Notification From Industry Organizations Interested 
in Participating in the Selection Process for a Nonvoting Industry 
Representative and Request for Nominations for a Nonvoting Industry 
Representative on an FDA 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 
industry organizations interested in participating in the selection of 
a nonvoting industry representative to serve on its Cellular, Tissue, 
and Gene Therapies Advisory Committee notify FDA in writing. FDA is 
also requesting nominations for nonvoting industry representatives to 
serve its Cellular, Tissue, and Gene Therapies Advisory Committee. A 
nominee may either be self-nominated or nominated by an organization to 
serve as a nonvoting industry representative. Nomination will be 
accepted for current vacancies effective with this notice.

DATES: Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests must send a letter stating that interest to FDA by August 5, 
2011, for vacancies listed in the notice. Concurrently, nomination 
material for prospective candidates should be sent to FDA by August 5, 
2011.

ADDRESSES: All letters of interest and nominations should be submitted 
in writing to Gail Dapolito (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Gail Dapolito, Center for Biologics 
Evaluation and Research (HFM-71), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-

[[Page 39404]]

1448, 301-827-1289; Fax: 301-827-0294; E-mail: 
gail.dapolito@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Cellular, Tissue, and Gene Therapies Advisory Committee

    The Agency requests nominations for a nonvoting industry 
representative on the Cellular, Tissue, and Gene Therapies Advisory 
Committee. The Cellular, Tissue, and Gene Therapies Advisory Committee 
advises the Commissioner of Food and Drugs (the Commissioner) or 
designee in discharging responsibilities as they relate to the 
regulation of cellular and gene therapy products.
    This committee has 13 voting members. Members are asked to provide 
their expert scientific and technical advice to FDA to help make sound 
decisions on the safety, effectiveness, appropriate use, and labeling 
of cellular and gene therapy products.

II. Selection Procedure

    Any industry 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 organization that has expressed an interest, attaching 
a complete list of all such organizations; and a list of all nominees 
along with their current resumes. The letter will also state that it is 
the responsibility of the interested organizations to confer with one 
another and to select a candidate, within 60 days after the receipt of 
the FDA letter, to serve as the nonvoting member to represent industry 
interests for the Cellular, Tissue, and Gene Therapies Advisory 
Committee. The interested organizations are not bound by the list of 
nominees in selecting a candidate. However, if no individual is 
selected within 60 days, the Commissioner will select the nonvoting 
member to represent industry interests.

III. Application Procedure

    Individuals may self nominate and/or an organization may nominate 
one or more individuals to serve as a nonvoting industry 
representative. A current curriculum vitae and the name of the 
committee of interest should be sent to the FDA contact person (see FOR 
FURTHER INFORMATION CONTACT) within the 30 days (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).
    FDA has a special interest in ensuring that women, minority groups, 
individuals with physical disabilities, and small businesses are 
adequately represented on its advisory committees, and therefore, 
encourages nominations for appropriately qualified candidates from 
these groups. Specifically, in this document, nominations for nonvoting 
representatives of industry interests are encouraged from the cellular 
and gene therapy products biotech industry.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: June 29, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-16828 Filed 7-5-11; 8:45 am]
BILLING CODE 4160-01-P


