[Federal Register Volume 76, Number 66 (Wednesday, April 6, 2011)]
[Notices]
[Page 19101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8125]
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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 Allergenic Products
Advisory Committee notify FDA in writing. 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 the interest to FDA by May 6, 2011
for vacancies listed in the notice. Concurrently, nomination material
for prospective candidates should be sent to FDA by May 6, 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, Food and Drug Administration, 1401 Rockville
Pike, Rockville, MD 20852-1448, 301-827-1289, FAX: 301-827-0294, e-
mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Agency requests nominations for a nonvoting industry
representative on the Allergenic Products Advisory Committee. The
Allergenic Products Advisory Committee advises the Commissioner or
designee in discharging responsibilities as they relate to the
regulation of allergenic products. This Committee has nine 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 allergenic biological
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. 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 Allergenic Products 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 of Food and Drugs 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 within
the 30 days following nomination. 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
allergenic product 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: March 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8125 Filed 4-5-11; 8:45 am]
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