[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:
[email protected]; 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,
[email protected].
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]
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