[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Notices]
[Pages 71804-71805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-29165]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Request for Notification From Industry Organizations Interested 
in Participating in the Selection Process for Nonvoting Industry 
Representatives and Request for Nominations for Nonvoting Industry 
Representatives on the 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 
nonvoting industry representatives to serve on the Device Good 
Manufacturing Practice Advisory Committee (DGMPAC) in the Center for 
Devices and Radiological Health notify FDA in writing. 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 organizations interested in participating in the 
selection of an appropriate nonvoting members to represent industry 
interests must send a letter stating that interest to FDA by January 3, 
2013, for the vacancies listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA by January 
3, 2013.

ADDRESSES: All letters of interest and nominations should be submitted 
in writing to Margaret J. Ames (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Margaret J. Ames, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5234, Silver Spring, MD 20993, 301-796-
5960, [email protected].

SUPPLEMENTARY INFORMATION: Section 520 of the Federal Food, Drug and 
Cosmetic Act (21 U.S.C. 360j), as amended, provides that the DGMPAC 
shall be composed of two representatives of interests of the device 
manufacturing industry. The Agency is requesting nominations for 
nonvoting industry representatives on the DGMPAC.

I. Function of DGMPAC

    Review proposed regulations issuance regarding good manufacturing 
practices governing the methods used in, and the facilities and 
controls used for manufacture, packaging, storage, installation, and 
servicing of devices, and make 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 the DGMPAC should possess appropriate 
qualifications to understand and contribute to the committee's work as 
described in the committee's function.

[[Page 71805]]

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 a particular 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 contact 
person (see FOR FURTHER INFORMATION CONTACT) 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 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: November 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29165 Filed 12-3-12; 8:45 am]
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