Document ID: FDA-2014-N-0899-0001
Agency: fda
Document Type: Notice
Title: Request for Notification From Industry Organizations Interested in
Participating in the Selection Process for a Nonvoting Industry
Representative and Request for Nominations for Nonvoting Industry
Representatives on the Cellular, Tissue, and Gene Therapies Advisory
Committee
Posted Date: 2014-07-09T04:00Z

[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)]
[Notices]
[Pages 38920-38921]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16038]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0899]

Request for Notification From Industry Organizations Interested 
in Participating in the Selection Process for a Nonvoting Industry 
Representative and Request for Nominations for Nonvoting Industry 
Representatives on the Cellular, Tissue, and Gene Therapies Advisory 
Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 the Cellular, Tissue, 
and Gene Therapies Advisory Committee for the Center for Biologics 
Evaluation and Research notify FDA in writing. FDA is also requesting 
nominations for a nonvoting industry representative to serve on the 
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. Nominations will be accepted for 
current or upcoming 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 8, 
2014, for the vacancy listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA by August 8, 
2014.

ADDRESSES: All letters of interest from industry organizations should 
be submitted in writing to Gail Dapolito (see FOR FURTHER INFORMATION 
CONTACT). All nominations should be submitted by logging into the FDA 
Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm

FOR FURTHER INFORMATION CONTACT: Gail Dapolito, Center for Biologics 
Evaluation and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 6124, 
Silver Spring, MD 20993-0002, 240-402-8046; gail.dapolito@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting 
industry representative to the following advisory committee:

I. Cellular, Tissue, and Gene Therapies Advisory Committee

    The Committee reviews and evaluates available data relating to the 
safety, effectiveness, and appropriate use of human cells, human 
tissues, gene transfer therapies and xenotransplantation products which 
are intended for transplantation, implantation, infusion and transfer 
in the prevention and treatment of a broad spectrum of human diseases 
and in the reconstruction, repair or replacement of tissues for various 
conditions. The Committee also considers the quality and relevance of 
FDA's research program which provides support for the regulation of 
these products, and makes appropriate recommendations to the 
Commissioner of Food and Drugs (the Commissioner).

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 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.

[[Page 38921]]

III. Application Procedure

    Individuals may self-nominate and/or an organization may nominate 
one or more individuals to serve as a nonvoting industry 
representative. Contact information, a current curriculum vitae, and 
the name of the committee of interest should be provided within 30 days 
of publication of this document (see DATES) by logging into the FDA 
Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm. 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 cell, 
tissue, and gene transfer products manufacturing industry.
    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: July 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-16038 Filed 7-8-14; 8:45 am]
BILLING CODE 4164-01-P