82 FR 27265 - Request for Nominations on Device Good Manufacturing Practice Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 113 (June 14, 2017)

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.

[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)]
[Notices]
[Pages 27265-27266]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-12326]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
 BILLING CODE 4164-01-P