[Federal Register Volume 84, Number 215 (Wednesday, November 6, 2019)]
[Notices]
[Pages 59832-59833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24233]
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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 December
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 December 6, 2019.
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative nominations should be sent via email to
Prabhakara Atreya (see FOR FURTHER INFORMATION CONTACT). All
nominations for nonvoting industry representatives must 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: Prabhakara Atreya, Division of
Scientific Advisors and Consultants, Center for Biologics Evaluation
and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 6306, Silver
Spring, MD 20993-0002, 240-402-8006, Fax: 301-595-1307, email:
[email protected].
SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative(s) to the following advisory committee:
I. Allergenic Products Advisory Committee
The APAC 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 diseases, 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 via email 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 notification 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 APAC.
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
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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: October 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24233 Filed 11-5-19; 8:45 am]
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