[Federal Register Volume 79, Number 13 (Tuesday, January 21, 2014)]
[Notices]
[Pages 3389-3390]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00964]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-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 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. 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.
    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.

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 the FDA by 
February 20, 2014, for the vacancy listed in this notice. Concurrently, 
nomination materials for prospective candidates should be sent to FDA 
by February 20, 2014.

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: margaret.ames@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Section 520 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(j)), 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 a 
nonvoting industry representative on the DGMPAC.

I. Function of DGMPAC

    The DGMPAC reviews 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 DGMPAC 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 DGMPAC'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. Attached 
to the letter will be 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 select a candidate to 
serve as the nonvoting member to represent industry interests for a 
particular committee within 60 days of receiving the FDA's

[[Page 3390]]

letter. 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. The nominee's 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).
    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: January 14, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-00964 Filed 1-17-14; 8:45 am]
BILLING CODE 4160-01-P