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, 19101 [2011-8125]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 66 (Wednesday, April 6, 2011)]
[Notices]
[Page 19101]
From the Federal Register Online via the Government Printing 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: gail.dapolito@fda.hhs.gov.

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]
BILLING CODE 4160-01-P