[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)]
[Notices]
[Pages 22201-22202]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09082]


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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 Allergenic 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 Allergenic Products 
Advisory Committee for the Center for Biologics Evaluation and Research 
notify FDA in writing. FDA is also requesting nominations for a 
nonvoting industry representative to serve on the Allergenic 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 or upcoming 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 May 
21, 2015, (see sections I and II for further details). Concurrently, 
nomination materials for prospective candidates should be sent to FDA 
by May 21, 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 Janie 
Kim (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 
at http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Janie Kim, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-9016, FAX: 301-595-
1307, email: [email protected].

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

I. Allergenic Products Advisory Committee

    The Committee reviews and evaluates available data concerning the 
safety, effectiveness, and adequacy of labeling of marketed and 
investigational allergenic biological products or materials that are 
administered to humans for the diagnosis, prevention, or treatment of 
allergies and allergic disease, and makes appropriate recommendations 
to the Commissioner of Food and Drugs of its findings regarding the 
affirmation or revocation of biological product licenses, on the 
safety, effectiveness, and labeling of the products, on clinical and 
laboratory studies of such products, on amendments or revisions to 
regulations governing the manufacture, testing and licensing of 
allergenic biological products, and on the quality and relevance of 
FDA's research programs which provide the scientific support for 
regulating these agents.

[[Page 22202]]

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 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, 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 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.
    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: April 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09082 Filed 4-20-15; 8:45 am]
 BILLING CODE 4164-01-P