[Federal Register Volume 77, Number 181 (Tuesday, September 18, 2012)]
[Notices]
[Page 57570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22866]
[[Page 57570]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Request for Notification From Industry Organizations Interested
in Participating in the Selection Process for Nonvoting Industry
Representative on the Transmissible Spongiform Encephalopathies
Advisory Committee, and Request for Nominations for Nonvoting Industry
Representatives on the Transmissible Spongiform Encephalopathies
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 Transmissible
Spongiform Encephalopathies Advisory Committee for the Center for
Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is
also requesting nominations for a nonvoting industry representative to
serve on the Transmissible Spongiform Encephalopathies 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 nonvoting member to represent industry
interests must send a letter stating that interest to FDA by October
18, 2012, for the vacancy listed in this notice. Concurrently,
nomination materials for prospective candidates should be sent to FDA
by October 18, 2012.
ADDRESSES: All letters of interest and nominations should be submitted
in writing to Bryan Emery (see: FOR FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Bryan Emery, Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike (HFM-71), Rockville, MD 20852-1448, 301-827-1277, FAX: 301-827-
0294, [email protected].
SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative to the following advisory committee:
I. CBER Advisory Committee
Transmissible Spongiform Encephalopathies Advisory Committee
Members are selected by the Commissioner of Food and Drugs (the
Commissioner) or designee from among authorities knowledgeable in the
fields of clinical and administrative medicine, hematology, virology,
neurovirology, neurology, infectious diseases, immunology, transfusion
medicine, surgery, internal medicine, biochemistry, biostatistics,
epidemiology, biological and physical sciences, sociology/ethics, and
other related professions.
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 r[eacute]sum[eacute]s. 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 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).
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 blood, epidemiology, and
neurovirology 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: September 12, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-22866 Filed 9-17-12; 8:45 am]
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