[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]



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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]
BILLING CODE 4160-01-P