[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)]
[Notices]
[Pages 27265-27266]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12326]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-2463]
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) 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 serve
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 the 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 July 14,
2017 (see sections I and III of this document for further details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by July 14, 2017.
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 Web site
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. 5264, Silver
Spring, MD 20993, 301-796-5960, FAX: 301-847-8505, email:
[email protected].
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 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 of Food and
Drugs 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. 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 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, in
this document, 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.
[[Page 27266]]
Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12326 Filed 6-13-17; 8:45 am]
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