
[Federal Register Volume 76, Number 211 (Tuesday, November 1, 2011)]
[Notices]
[Pages 67465-67466]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28224]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


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 organizations interested in participating in the selection of 
nonvoting industry representatives to serve on certain device panels of 
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 a nonvoting industry representative(s) 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 organizations interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests must send a letter stating that interest to FDA by December 
1, 2011, for vacancies listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA by December 
1, 2011.

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: margaret.ames@fda.hhs.gov.

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

[[Page 67466]]

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 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.

A. Clinical Chemistry and Clinical Toxicology Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational in vitro devices for use in clinical 
laboratory medicine, including clinical toxicology, clinical chemistry, 
endocrinology, and oncology, and makes appropriate recommendations to 
the Commissioner.

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 makes 
appropriate recommendations to the Commissioner.

C. Medical Devices Dispute Resolution Panel

    Provides advice to the Center Director on complex or contested 
scientific issues between FDA and medical device sponsors, applicants, 
or manufacturers relating to specific products, marketing applications, 
regulatory decisions and actions by FDA, and Agency guidance and 
policies. The panel makes recommendations on issues that are lacking 
resolution, are highly complex in nature, or result from challenges to 
Agency decisions or actions.

D. Microbiology Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational in vitro devices for use in clinical 
laboratory medicine, including microbiology, virology, and infectious 
disease, and makes appropriate recommendations to the Commissioner.

E. Molecular and Clinical Genetics Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational in vitro devices for use in clinical 
laboratory medicine, including clinical and molecular genetics, and 
makes appropriate recommendations to the Commissioner.

F. Orthopaedic and Rehabilitation Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational orthopaedic and rehabilitation devices, 
and makes appropriate recommendations to the Commissioner.

G. Radiological Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational diagnostic or therapeutic radiological 
and nuclear medicine devices and makes appropriate recommendations to 
the Commissioner.

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.

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 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 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: October 26, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-28224 Filed 10-31-11; 8:45 am]
BILLING CODE 4160-01-P


