[Federal Register: September 11, 2008 (Volume 73, Number 177)]
[Notices]
[Page 52862-52863]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11se08-73]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0475]
Request for Notification From Industry Organizations Interested
in Participating in Selection Process for Nonvoting Industry
Representatives on Public Advisory Panels or Committees and Request for
Nonvoting Industry Representatives on Public Advisory Panels or
Committees
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 Devices Good
Manufacturing Practice Advisory Committee (DGMPAC) and certain device
panels of the Medical Devices Advisory Committee 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 member to represent industry
interests must send a letter stating that interest to FDA by October
14, 2008, for the vacancies listed in this notice. Concurrently,
nomination materials for prospective candidates should be sent to FDA
by October 14, 2008.
ADDRESSES: All letters of interest and nominations should be sent to
Kathleen L. Walker (see FOR FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Kathleen L. Walker, Center for Devices
and Radiological Health (HFZ-17), Food and Drug Administration, 7520
Standish Pl. (MPN1), Rockville, MD 20855, 240-276-8938, e-mail:
kathleen.walker@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The agency intends to add nonvoting industry
representatives to the following advisory committees:
I. CDRH--Various Committees and Panels
A. Devices Good Manufacturing Practice Advisory Committee (DGMPAC)
Section 520 of the Federal Food, Drug, and Cosmetic Act (the 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.
B. Medical Devices Advisory Committee
Section 520(f)(3) of the act, as amended by the Medical Device
Amendments of 1976, provides that each medical device panel include one
nonvoting member to represent the interests of the medical device
manufacturing industry.
[[Page 52863]]
II. CDRH--Committee and Panels Functions
FDA is requesting nominations for nonvoting members representing
industry interests for the following vacancies listed in table 1 of
this document.
TABLE 1.
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Committee Name or Panel Approximate Date Needed
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DGMPAC--The functions of the committee Immediately
are to 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.
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Certain Panels of the Medical Devices ..............................
Advisory Committee--The medical device
panels perform the following functions:
(1) Review and evaluate data on the
safety and effectiveness of marketed
and investigational devices and make
recommendations for their regulation,
(2) advise the Commissioner of Food and
Drugs (the Commissioner) regarding
recommended classification or
reclassification of these devices into
one of three regulatory categories, (3)
advise on any possible risks to health
associated with the use of devices, (4)
advise on formulation of product
development protocols, (5) review
premarket approval applications for
medical devices, (6) review guidelines
and guidance documents, (7) recommend
exemption to certain devices from the
application of portions of the act, (8)
advise on the necessity to ban a
device, (9) respond to requests from
the agency to review and make
recommendations on specific issues or
problems concerning the safety and
effectiveness of devices, and (10) make
recommendations on the quality in the
design of clinical studies regarding
the safety and effectiveness of
marketed and investigational devices.
Circulatory System Devices Panel July 1, 2009
Ear, Nose and Throat Devices Panel November 1, 2008
Neurological Devices Panel December 1, 2008
Obstetrics and Gynecology Devices February 1, 2009
Panel
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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 contact
person (see FOR FURTHER INFORMATION CONTACT) within 30 days of
publication of this notice. 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 or device
panel. 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 will select the nonvoting
member to represent industry interests.
IV. Qualifications
A. DGMPAC
Persons nominated for membership as an industry representative on
the DGMPAC should possess appropriate qualifications to understand and
contribute to the committee's work. The particular needs for this
committee are listed in section II of this document.
B. Medical Devices Advisory Committee
Persons nominated for the device panels should be full-time
employees of firms that manufacture products that would come before the
panel, or consulting firms that represent manufacturers, or have
similar appropriate ties to industry.
V. Application Procedure
Individuals may self nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. A current curriculum vitae and the name of the
committee or panel of interest should be sent to the FDA contact person
(see FOR FURTHER INFORMATION CONTACT) within 30 days. FDA will forward
all nominations to the organizations expressing interest in
participating in the selection process for the committee or panel.
(Persons who nominate themselves as nonvoting industry representatives
will not participate in the selection process).
FDA has a special interest in ensuring that women, minority groups,
individuals with physical disabilities, and small businesses are
adequately represented on its advisory committees, and therefore,
encourages nominations for appropriately qualified candidates from
these groups.
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: September 3, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-21016 Filed 9-10-08; 8:45 am]
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