
[Federal Register: October 28, 2010 (Volume 75, Number 208)]
[Notices]               
[Page 66382-66384]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc10-48]                         

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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: margaret.ames@fda.hhs.gov.

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
------------------------------------------------------------------------
NMQAAC...............................  February 1, 2011.
Anesthesiology and Respiratory         December 1, 2011.
 Therapy Devices Panel.
General and Plastic Surgery Devices    September 1, 2011.
 Panel.
------------------------------------------------------------------------

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]
BILLING CODE 4160-01-P

