[Federal Register Volume 77, Number 236 (Friday, December 7, 2012)]
[Notices]
[Pages 73035-73036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-29574]
[[Page 73035]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Request for Notification From Industry Organizations Interested
in Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nominations for Nonvoting Industry
Representatives on Public Advisory 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 Medical Devices
Advisory Committee (MDAC) in the Center for Devices and Radiological
Health (CDRH) notify FDA in writing. FDA is also requesting nominations
for nonvoting industry representatives to serve on certain device
panels of the MDAC in the CDRH. 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 organization 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
January 7, 2013, for the vacancies listed in this notice. Concurrently,
nomination materials for prospective candidates should be sent to FDA
by January 7, 2013.
ADDRESSES: All letters of interest and nominations should be submitted
in writing to Margaret Ames (see FOR FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Margaret Ames, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5234, Silver Spring, MD 20993. 301-796-5960, FAX:
301-847-8505, email: [email protected].
SUPPLEMENTARY INFORMATION: Section 520(f)(3)of the Federal Food, Drug
and Cosmetic Act (the 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. The Agency is requesting
nominations for nonvoting industry representatives to certain panels
identified in the following paragraphs.
I. Functions of MDAC
(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.
A. Circulatory System Devices Panel
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational devices for use in the circulatory and
vascular systems and makes appropriate recommendations to the
Commissioner of Food and Drugs.
B. Ear, Nose and Throat Devices Panel
Reviews and evaluates data concerning the safety and effectiveness
of market and investigational ear, nose and throat devices and make
appropriate recommendations to the Commissioner of Food and Drugs.
C. Gastroenterology and Urology Devices Panel
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational gastroenterology, urology and
nephrology devices and makes appropriate recommendations to the
Commissioner of Food and Drugs.
D. General Hospital and Personal Use Devices Panel
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational general hospital, infection control and
personal use devices and makes appropriate recommendations to the
Commissioner of Food and Drugs.
E. Neurological Devices Panel
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational devices for use in the neurological
system and makes appropriate recommendations to the Commissioner of
Food and Drugs.
F. Obstetrics and Gynecology Devices Panel
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational obstetrics and gynecology devices and
makes appropriate recommendations to the Commissioner of Food and
Drugs.
G. Ophthalmic Devices Panel
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational devices for use in the eye and makes
appropriate recommendations to the Commissioner of Food and Drugs.
II. Qualifications
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.
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 FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). 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 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.
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IV. Application Procedure
Individuals may self nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Contact information, 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 30 days of
publication of this document (see DATES). FDA will forward all
nominations to the organizations expressing interest in participating
in the selection process for the panel. (Persons who nominate
themselves as nonvoting industry representatives will not participate
in the selection process).
FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees, and therefore encourages nominations of
appropriately qualified candidates from these groups. Specifically, in
this document, nominations for nonvoting representatives of industry
interests are encouraged from the device 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: December 3, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-29574 Filed 12-6-12; 8:45 am]
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