[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Notices]
[Pages 60506-60507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25120]


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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 and Request for Nominations 
for a Nonvoting Industry Representative on the Vaccines and Biological 
Products 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 Vaccines and 
Related Biological Products 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 the Vaccines and Related Biological Products Advisory Committee. 
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 that interest to the FDA by 
October 31, 2011, for the vacancy listed in this document. 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by October 31, 2011.

ADDRESSES: All letters of interest and nominations should be submitted 
in writing to Donald Jehn (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Donald Jehn, Center for Biologics 
Evaluation and Research (HFM-71), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-0314, FAX: 301-827-
0294, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting 
industry representative on the CBER Advisory Committee.

I. Vaccines and Related Biological Products Advisory Committee

    The Vaccines and Related Biological Products Advisory Committee 
(the Committee) advises the Commissioner

[[Page 60507]]

of Food and Drugs (the Commissioner) or designee in discharging 
responsibilities as they relate to the regulation of vaccines and 
related biological products. Members are asked to provide their expert 
scientific and technical advice to FDA to help make sound decisions on 
the safety, effectiveness, and appropriate use, of vaccines and related 
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 and 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 
(for the roles specified in this document). Nominations must include a 
current resume or curriculum vitae of the nominee including current 
business address and/or home address, telephone number, email address 
if available, and the role for which the individual is being nominated. 
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.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: September 23, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-25120 Filed 9-28-11; 8:45 am]
BILLING CODE 4160-01-P