[Federal Register Volume 84, Number 116 (Monday, June 17, 2019)]
[Notices]
[Page 28062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12678]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2312]


Request for Nominations From Industry Organizations Interested in 
Participating in the Selection Process for Nonvoting Industry 
Representatives and Request for Nominations for Nonvoting Industry 
Representatives 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 or Agency) 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 (APAC) for the Center for 
Biologics Evaluation and Research notify FDA in writing. FDA is also 
requesting nominations for a nonvoting industry representative(s) to 
serve on the APAC. 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 FDA by July 17, 
2019, (see sections I and II of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by July 17, 2019.

ADDRESSES: All statements of interest from industry organizations 
interested in participating in the selection process of nonvoting 
industry representative nominations should be sent to Serina Hunter-
Thomas (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. 
Information about becoming a member of an FDA advisory committee can 
also be obtained by visiting FDA's website at: http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Division of 
Scientific Advisors and Consultants, Center for Biologics Evaluation 
and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 6338, Silver 
Spring, MD 20993-0002, 240-402-5771, Fax: 301-595-1307, email: 
Serina.Hunter-Thomas@fda.hhs.gov.

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

I. Allergenic Products Advisory Committee

    The committee reviews and evaluates 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 (the Commissioner) 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.

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, 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 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: June 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12678 Filed 6-14-19; 8:45 am]
BILLING CODE 4164-01-P


