The FDA's looking for a few good medtech members
The FDA solicits candidates for medical device industry representatives to join the Center for Devices & Radiological Health's Device Good Manufacturing Practice Advisory Committee.
The federal watchdog agency asked for written recommendations of medical device industry representatives who will hold a non-voting seat on the DGMPAC, a committee tasked with reviewing proposed regulations and making recommendations on medical device manufacturing practices.
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[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Notices]
[Pages 71804-71805]
From the Federal Register Online via the Government Printing 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, margaret.ames@fda.hhs.gov.
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]
BILLING CODE 4160-01-P
Daniel G. Schultz, MD 
David W. Feigal, JR, MD, MPH
Donna-Bea Tillman, PhD 
Timothy Alan Ulatowski, MS