
[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
------------------------------------------------------------------------

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]

BILLING CODE 4160-01-S
