[Federal Register Volume 86, Number 41 (Thursday, March 4, 2021)]
[Notices]
[Pages 12696-12697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04450]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2430]


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 April 5, 
2021 (see sections I and III of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by April 5, 2021.

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 
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm 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 https://www.fda.gov/AdvisoryCommittees/default.htm.

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#2944485b4e485b4c5d0748444c5a694f4d480741415a074e465f"><span class="__cf_email__" data-cfemail="cca1adbeabadbea9b8e2ada1a9bf8caaa8ade2a4a4bfe2aba3ba">[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 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 
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 the 60 days, the Commissioner will select 
the nonvoting member to represent industry interests.

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

[[Page 12697]]

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. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04450 Filed 3-3-21; 8:45 am]
BILLING CODE 4164-01-P


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