Notice2023-05358
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 Blood Products Advisory Committee
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Published
March 16, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 Blood Products Advisory Committee (BPAC) 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 BPAC. 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.
Full Text
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<title>Federal Register, Volume 88 Issue 51 (Thursday, March 16, 2023)</title>
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[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Pages 16266-16267]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-05358]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0008]
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 Blood 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 Blood
Products Advisory Committee (BPAC) 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
BPAC. 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 April 17,
2023 (see sections I and II of this document for further details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by April 17, 2023.
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
Christina Vert (see FOR FURTHER INFORMATION CONTACT). All nominations
for nonvoting industry representatives must be submitted electronically
by accessing the FDA Advisory Committee Membership Nomination Portal
at: <a href="https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm">https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm</a>. Information about becoming a member of an FDA advisory
committee can also be obtained by visiting FDA's website at: <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a>.
FOR FURTHER INFORMATION CONTACT: Christina Vert or Marie DeGregorio,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1244, Silver
Spring, MD 20993-0002, 240-402-8054, email: <a href="/cdn-cgi/l/email-protection#66252423342436272526000207480e0e1548010910"><span class="__cf_email__" data-cfemail="094a4b4c5b4b59484a496f6d682761617a276e667f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative(s) to the following advisory committee:
I. Blood Products Advisory Committee
BPAC reviews and evaluates available data concerning the safety,
effectiveness, and appropriate use of blood products derived from blood
and serum or biotechnology that are
[[Page 16267]]
intended for use in the diagnosis, prevention, or treatment of human
diseases, and, as required, any other product for which FDA has
regulatory responsibility. BPAC also advises the Commissioner of Food
and Drugs (the Commissioner) of its findings regarding screening and
testing (to determine eligibility) of donors and labeling of the
products, on clinical and laboratory studies involving such products,
on the affirmation or revocation of biological products licenses, and
on the quality and relevance of FDA's research program that provides
the scientific support for regulating these agents.
BPAC will function at times as a medical device panel under the
Federal Food, Drug, and Cosmetic Act (FD&C Act) Medical Device
Amendments of 1976. As such, BPAC recommends classification of devices
subject to its review into regulatory categories, recommends the
assignment of a priority for the application of regulatory requirements
for devices classified in the standards or premarket approval category,
advises on formulation of product development protocols and reviews
premarket approval applications for those devices to recommend changes
in classification as appropriate, recommends exemption of certain
devices from the application of portions of the FD&C Act, advises on
the necessity to ban a device, and responds to requests from the Agency
to review and make recommendations on specific issues or problems
concerning the safety and effectiveness of devices.
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
r[eacute]sum[eacute]s. 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. Nomination must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee, including
current business address and telephone number, email address if
available, and a signed copy of the Acknowledgement and Consent form
available at the FDA Advisory Committee Membership Nomination Portal
(see ADDRESSES) within 30 days of publication of this document (see
DATES). Nominations must also specify the advisory committee for which
the nominee is recommended. Nominations must also acknowledge that the
nominee is aware of the nomination unless self-nominated. 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: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05358 Filed 3-15-23; 8:45 am]
BILLING CODE 4164-01-P
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