[Federal Register Volume 75, Number 208 (Thursday, October 28, 2010)]
[Notices]
[Pages 66382-66384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27230]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Request for Notification From Industry Organizations Interested
in Participating in the Selection Process for Nonvoting Industry
Representatives on Public Advisory Committees and Panels and Request
for Nonvoting Industry Representatives on Public Advisory Committees
and Panels
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 National Mammography
Quality Assurance Advisory Committee (NMQAAC) and certain device panels
of the Medical Devices Advisory Committee (MDAC) in the Center for
Devices and Radiological Health (CDRH) 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 the FDA by
November 29, 2010, for the vacancies listed in this document.
Concurrently, nomination materials for prospective candidates should be
sent to FDA by November 29, 2010.
ADDRESSES: Send all letters of interest and nominations 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,
[[Page 66383]]
MD 20993, 301-796-5960, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: The agency intends to add nonvoting industry
representatives to the following advisory committees:
I. CDRH--Various Committees and Panels
A. National Mammography Quality Assurance Advisory Committee (NMQAAC)
The Mammography Quality Standards Reauthorization Act of 2004 (Pub.
L. 108-365) requires the addition of at least two industry
representatives with expertise in mammography equipment to the NMQAAC.
B. Medical Devices Advisory Committee (MDAC)
Section 520(f)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C
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 Panels Functions
FDA is requesting nominations for nonvoting members representing
industry interests for vacancies listed in table 1 of this document as
follows:
TABLE 1--Nominations Requested for Nonvoting Members Representing
Industry Interests on Public Advisory Committees and Panels
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Committee name or panel Approximate date needed
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NMQAAC............................... February 1, 2011.
Anesthesiology and Respiratory December 1, 2011.
Therapy Devices Panel.
General and Plastic Surgery Devices September 1, 2011.
Panel.
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A. NMQAAC
The functions of the NMQAAC are to advise FDA on: (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. 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 FD&C 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.
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 r[eacute]sum[eacute]s. 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 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. MDAC
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. Within 30 days, the following information should be
sent to the FDA contact person (see FOR FURTHER INFORMATION CONTACT): A
current curriculum vitae of each nominee, current business and/or home
address, telephone number, e-mail address, and the name of the
committee or device panel of interest. 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
[[Page 66384]]
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: October 22, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-27230 Filed 10-27-10; 8:45 am]
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