Notice2024-07261
Request for Nominations on Device Good Manufacturing Practice Advisory Committee
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 5, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is requesting that any industry organization interested in participating in the selection of a nonvoting industry representative to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to fill an upcoming vacancy on DGMPAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for an upcoming vacancy effective with this notice.
Full Text
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<title>Federal Register, Volume 89 Issue 67 (Friday, April 5, 2024)</title>
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[Federal Register Volume 89, Number 67 (Friday, April 5, 2024)]
[Notices]
[Page 24012]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-07261]
[[Page 24012]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0008]
Request for Nominations on Device Good Manufacturing Practice
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 organization interested in participating in the
selection of a nonvoting industry representative to serve on the Device
Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center
for Devices and Radiological Health notify FDA in writing. FDA is also
requesting nominations for a nonvoting industry representative to fill
an upcoming vacancy on DGMPAC. A nominee may either be self-nominated
or nominated by an organization to serve as a nonvoting industry
representative. Nominations will be accepted for an upcoming vacancy
effective with this notice.
DATES: Any industry organizations 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 May 6,
2024 (see sections I and III of this document for further details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by May 6, 2024.
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative nominations should be sent to Margaret Ames
(see FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting
industry representatives should be submitted electronically by
accessing FDA's 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> 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 website
at <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a>.
FOR FURTHER INFORMATION CONTACT: Margaret Ames, Office of Management,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5213, Silver
Spring, MD 20993-0002, 301-796-5960, <a href="/cdn-cgi/l/email-protection#115c706376706374653f507c7462517775703f7979623f767e67"><span class="__cf_email__" data-cfemail="7934180b1e180b1c0d5738141c0a391f1d185711110a571e160f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Section 520 of the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 360j), as amended, provides that DGMPAC shall
be composed of two representatives of interests of the device
manufacturing industry. The Agency is requesting nominations for a
nonvoting industry representative to fill an upcoming vacancy on
DGMPAC. FDA is publishing a separate document announcing the request
for notification for voting members on DGMPAC.
I. Function of DGMPAC
DGMPAC reviews proposed regulations, prior to their issuance,
regarding good manufacturing practices governing the methods used in,
and the facilities and controls used for, the manufacture, packaging,
storage, installation, and servicing of devices, and makes
recommendations regarding the feasibility and reasonableness of those
proposed regulations. The committee also reviews and makes
recommendations on proposed guidelines developed to assist the medical
device industry in meeting the good manufacturing practice requirements
and provides advice with regard to any petition submitted by a
manufacturer for an exemption or variance from good manufacturing
practice regulations.
II. Qualifications
Persons nominated for DGMPAC should possess appropriate
qualifications to understand and contribute to the committee's work as
described in the committee's function.
III. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
views 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
views 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 the 60 days, the Commissioner will select
the nonvoting member to represent industry views.
IV. Application Procedure
Individuals may self-nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Nominations must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee, including
current business address, 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. Specifically,
nominations for nonvoting representatives of industry interests are
encouraged from the device manufacturing industry.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.) and 21 CFR part 14, relating to advisory
committees.
Dated: April 2, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-07261 Filed 4-4-24; 8:45 am]
BILLING CODE 4164-01-P
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