[Federal Register Volume 84, Number 152 (Wednesday, August 7, 2019)]
[Notices]
[Page 38634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16877]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2832]


Request for Nominations From Industry Organizations Interested in 
Participating in the Selection Process for Nonvoting Industry 
Representatives and Request for Nomination for Nonvoting Industry 
Representatives 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 or Agency) 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 (VRBPAC) 
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 VRBPAC. 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 September 
6, 2019, (see sections I and II of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by September 6, 2019.

ADDRESSES: All statements of interest from industry organizations 
interested in participating in the selection process of nonvoting 
industry representative nomination 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: https://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, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 71, Rm. 6338, Silver Spring, MD 20993-0002, 240-402-5771, Fax: 
301-595-1307, [email protected].

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

I. CBER Advisory Committee

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 products 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 
(Commissioner).

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, as well as 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, 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: July 31, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16877 Filed 8-6-19; 8:45 am]
 BILLING CODE 4164-01-P