
[Federal Register Volume 80, Number 90 (Monday, May 11, 2015)]
[Notices]
[Pages 26928-26929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11258]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Request for Nominations on the Vaccines and Related 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(s) 
to serve on 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. 
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 the FDA by June 
10, 2015, (see sections I and II of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by June 10, 2015.

ADDRESSES: All statements of interest from interested industry 
organizations interested in participating in the selection process of 
nonvoting industry representative nomination should be sent to Sujata 
Vijh (see FOR FURTHER INFORMATION CONTACT). All nominations for 
nonvoting industry representatives may be submitted electronically by 
accessing the FDA Advisory Committee Membership Nomination Portal: 
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or 
by mail to Advisory Committee Oversight and Management Staff, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, 
Silver Spring, MD 20993-0002. Information about becoming a member of an 
FDA advisory committee can also be obtained by visiting FDA's Web site: 
http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Sujata Vijh, Division of Scientific 
Advisors and Consultants, Center for Biologics Evaluation and Research, 
10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993-
0002, 240-402-7107, FAX: 301-595-1307, email: Sujata.vijh@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting 
industry representative(s) to the following advisory committee:

[[Page 26929]]

I. CBER Vaccines and Related Biological Products Advisory Committee

    The CBER Vaccines and Related Biological Products Advisory 
Committee (the Committee) reviews and evaluates data concerning the 
safety, effectiveness, and appropriate use of vaccines and related 
biological products which are intended for use in the prevention, 
treatment, or diagnosis of human diseases, and, as required, any other 
product for which FDA has regulatory responsibility. 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 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 
(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 (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.
    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: May 5, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-11258 Filed 5-8-15; 8:45 am]
 BILLING CODE 4164-01-P


