[Federal Register Volume 72, Number 141 (Tuesday, July 24, 2007)]
[Notices]
[Pages 40311-40313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14206]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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 organizations interested in participating in the selection of 
nonvoting industry representatives to serve on the National Mammography 
Quality Assurance Advisory Committee (NMQAAC) and certain device panels 
of the Medical Devices Advisory Committee in the Center for Devices and 
Radiological Health notify FDA in

[[Page 40312]]

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 the FDA by August 
23, 2007, for the vacancies listed in this notice. Concurrently, 
nomination materials for prospective candidates should be sent to FDA 
by August 23, 2007.

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: 
[email protected].

SUPPLEMENTARY INFORMATION: The agency intends to add nonvoting industry 
representatives to its advisory committee identified below:

I. CDRH--Various Committees and Panels

A. National Mammography Quality Assurance Advisory Committee (NMQAAC)

    The Mammography Quality Standards Reauthorization Act of 2004 
(Public Law 108-365) requires the addition of at least two industry 
representatives with expertise in mammography equipment to the NMQAAC.

B. Medical Devices Advisory Committee

    Section 520(f)(3) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360j(f)(3)), 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.

II. CDRH--Committee and Panel 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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NMQAAC-The functions of the NMQAAC are    February 1, 2008
 to advise FDA on the following topics:
 (1) Developing appropriate quality
 standards and regulations for
 mammography facilities, (2) developing
 appropriate standards and regulations
 for bodies accrediting mammography
 facilities under this program, (3)
 developing regulations with respect to
 sanctions, (4) developing procedures
 for monitoring compliance with
 standards, (5) establishing a mechanism
 to investigate consumer complaints, (6)
 reporting new developments concerning
 breast imaging that should be
 considered in the oversight of
 mammography facilities, (7) determining
 whether there exists a shortage of
 mammography facilities in rural and
 health professional shortage areas and
 determining the effects of personnel on
 access to the services of such
 facilities in such areas, (8)
 determining whether there will exist a
 sufficient number of medical physicists
 after October 1, 1999, and (9)
 determining the costs and benefits of
 compliance with these requirements
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Certain Panel 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.
    Clinical Chemistry and Clinical       March 1, 2008
     Toxicology Devices Panel
    Gastroenterology and Urology Devices  January 1, 2008
     Panel
    Medical Devices Dispute Resolution    October 1, 2008
     Panel
    Microbiology Devices Panel            March 1, 2008
    Molecular and Clinical Genetics       June 1, 2008
     Devices Panel
    Orthopaedic and Rehabilitation        September 1, 2008
     Devices Panel
    Radiological Devices Panel            February 1, 2008
------------------------------------------------------------------------

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

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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 of Food and Drugs will select the nonvoting member to 
represent industry interests.

IV. Qualifications

A. NMQAAC

    Persons nominated for membership as an industry representative on 
the NMQAAC must meet the following criteria: (1) Demonstrate expertise 
in mammography equipment, and (2) be able to discuss equipment 
specifications and quality control procedures affecting mammography 
equipment. The industry representative must be able to represent the 
industry perspective on issues and actions before the advisory 
committee, serve as liaison between the committee and interested 
industry parties, and facilitate dialogue with the advisory committee 
on mammography equipment issues.

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 of interest should be sent to the FDA contact person (see FOR 
FURTHER INFORMATION CONTACT) within the 30 days. 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 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. Specifically, in this document, nominations for nonvoting 
representatives of industry interests are encouraged from the food 
production and manufacturing industry; the dietary supplement 
manufacturing industry; and the agricultural biotechnology 
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: July 16, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-14206 Filed 7-23-07; 8:45 am]
BILLING CODE 4160-01-S