[Federal Register Volume 79, Number 13 (Tuesday, January 21, 2014)]
[Notices]
[Pages 3389-3390]
From the Federal Register Online via the Government Publishing 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: [email protected].
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]
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