[Federal Register: October 5, 2006 (Volume 71, Number 193)]
[Notices]
[Page 58866-58868]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05oc06-64]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Nonvoting Members Representing
Industry Interests 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
nominations for 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.
DATES: Industry organizations interested in participating in the
selection of a nonvoting member to represent industry for the vacancies
listed in this document must send a letter to FDA by November 6, 2006,
stating their interest in the NMQAAC or one or more panels.
Concurrently, nomination materials for prospective candidates should be
sent to FDA by November 6, 2006. A nominee
[[Page 58867]]
may either be self-nominated or nominated by an organization to serve
as a nonvoting industry representative.
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, 301-827-7293, e-mail:
kathleen.walker@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. 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.
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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Approximate Date
Committee/Panel Representative is Needed
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NMQAAC February 1, 2007
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Certain Panels of the Medical Devices Advisory Committee
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General and Plastic Surgery Devices Panel Immediate
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Hematology and Pathology Devices Panel Immediate
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II. Functions
A. NMQAAC
The functions of the NMQAAC are 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 which 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.
B. 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.
II. Selection Procedure
Any organization representing the mammography device industry or
the medical device manufacturing industry wishing to participate in the
selection of a nonvoting member to represent industry should send a
letter stating that interest to the contact person (see FOR FURTHER
INFORMATION CONTACT) within 30 days of publication of this notice.
Persons who nominate themselves as industry representatives will not
participate in the selection process. It is, therefore, recommended
that nominations be made by someone within an organization, trade
association, or firm who is willing to participate in the selection
process. Within the subsequent 30 days, FDA will send a letter to each
organization and a list of all nominees along with their resumes. The
letter will state that the interested organizations are responsible for
conferring with one another to select a candidate, within 60 days after
receiving the letter, to serve as the nonvoting industry representative
on a particular committee or device panel. If no individual is selected
within that 60 days, the Commissioner may 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
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consulting firms that represent manufacturers, or have similar
appropriate ties to industry.
V. Application Procedure
Individuals may nominate themselves, or an organization
representing the mammography device industry or medical device industry
may nominate one or more individuals to serve as a nonvoting industry
representative. A current curriculum vitae (which includes the
nominee's business address, telephone number, and e-mail address) and
the name of the committee or panel of interest should be sent to the
contact person (see FOR FURTHER INFORMATION CONTACT). FDA will forward
all nominations to the organizations that have expressed interest in
participating in the selection process for that committee or panel.
FDA has a special interest in ensuring that women, minority groups,
individuals with disabilities, and small businesses are adequately
represented on its advisory committees. Therefore, the agency
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 28, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-16438 Filed 10-4-06; 8:45 am]
BILLING CODE 4160-01-S