Document ID: FDA-2019-N-2272-0001
Agency: fda
Document Type: Notice
Title: Request for Nominations From Industry Organizations Interested in
Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nominations for Nonvoting Industry
Representatives on the Cellular, Tissue, and Gene Therapies Advisory
Committee
Posted Date: 2019-06-14T04:00Z

[Federal Register Volume 84, Number 115 (Friday, June 14, 2019)]
[Notices]
[Pages 27782-27783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12565]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2272]

Request for Nominations From Industry Organizations Interested in 
Participating in the Selection Process for Nonvoting Industry 
Representatives 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.

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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 the Cellular, Tissue, 
and Gene Therapies Advisory Committee for the Center for Biologics 
Evaluation and Research (CBER) notify FDA in writing. FDA is also 
requesting nominations for a non-voting industry representative(s) to 
serve on the Cellular, Tissue, and Gene Therapies Advisory Committee 
Blood Products 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 
vacancies effective with this notice.

DATES: Any industry organization interested in participating in the 
selection of an appropriate non-voting member to represent industry 
interests must send a letter stating that interest to FDA by July 15, 
2019 (see sections I and II of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by July 15, 2019.

ADDRESSES: All statements of interest from industry organizations 
interested in participating in the selection process of nonvoting 
industry representative(s) should be sent to Prabhakara Atreya and 
Jeannette Devine (see FOR FURTHER INFORMATION CONTACT). All nominations 
for nonvoting industry representatives may be submitted electronically 
by accessing the FDA Advisory Committee Membership Nomination Portal 
at: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm.
    Information about becoming a member of an FDA advisory committee 
can also be obtained by visiting FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm.

[[Page 27783]]

FOR FURTHER INFORMATION CONTACT: Prabhakara Atreya, Division of 
Scientific Advisors and Consultants, Center for Biologics Evaluation 
and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 6306, Silver 
Spring, MD 20993-0002, 240-402-8006, Fax: 301-595-1307, email: 
Prabhakara.Atreya@fda.hhs.gov; and Jeannette Devine, Division of 
Scientific Advisors and Consultants, Center for Biologics Evaluation 
and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 6334, Silver 
Spring, MD 20993-0002, 240-402-0403, Fax: 301-595-1307, 
Jeannette.Devine@fda.hhs.gov.

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

I. CBER Cellular, Tissue, and Gene Therapies Advisory Committee

    The 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 scientific support for the 
regulation of these products and makes appropriate recommendations to 
the Commissioner of Food and Drugs.

II. Selection Procedure

    Any industry organization interested in participating in the 
selection of an appropriate non-voting 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.

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 sent to the FDA 
Advisory Committee Membership Nomination Portal (see ADDRESSES) 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 non-voting industry representatives will not 
participate in the selection process).
    FDA seeks to include the views of women, 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.
    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: June 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12565 Filed 6-13-19; 8:45 am]
BILLING CODE 4164-01-P