[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)]
[Notices]
[Pages 45253-45254]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19350]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3179]


Request for Nominations on Public Advisory Panels of the Medical 
Devices Advisory Committee

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 panels of the 
Medical Devices Advisory Committee (MDAC or Committee) 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 and upcoming 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 FDA by October 9, 
2018 (see sections I and II of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by October 9, 2018.

ADDRESSES: All statements of interest from industry organizations 
interested in participating in the selection process of nonvoting 
industry representative nomination should be sent to Margaret Ames (see 
FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting 
industry representatives should be submitted electronically by 
accessing the FDA Advisory Committee Membership Nomination Portal: 
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or 
by mail to Advisory Committee Oversight and Management Staff, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, 
Silver Spring, MD 20993-0002. Information about becoming a member of an 
FDA advisory committee can also be obtained by visiting FDA's website 
at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Margaret Ames, Division of Workforce 
Management, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5264, Silver 
Spring, MD 20993, 301-796-5960, Fax: 301-847-8505, email: 
[email protected].

[[Page 45254]]


SUPPLEMENTARY INFORMATION: The Agency is requesting nominations for 
nonvoting industry representatives to the panels listed in the table in 
this document.

I. Medical Devices Advisory Committee

    The Committee reviews and evaluates data on the safety and 
effectiveness of marketed and investigational devices and makes 
recommendations for their regulation. The panels engage in a number of 
activities to fulfill the functions the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) envisions for device advisory panels. With the 
exception of the Medical Devices Dispute Resolution Panel, each panel, 
according to its specialty area, advises the Commissioner of Food and 
Drugs (the Commissioner) regarding recommended classification or 
reclassification of devices into one of three regulatory categories; 
advises on any possible risks to health associated with the use of 
devices; advises on formulation of product development protocols; 
reviews premarket approval applications for medical devices; reviews 
guidelines and guidance documents; recommends exemption of certain 
devices from the application of portions of the FD&C Act; advises on 
the necessity to ban a device; and responds to requests from the Agency 
to review and make recommendations on specific issues or problems 
concerning the safety and effectiveness of devices. With the exception 
of the Medical Devices Dispute Resolution Panel, each panel, according 
to its specialty area, may also make appropriate recommendations to the 
Commissioner on issues relating to the design of clinical studies 
regarding the safety and effectiveness of marketed and investigational 
devices. The Committee also provides recommendations to the 
Commissioner or designee on complexity categorization of in vitro 
diagnostics under the Clinical Laboratory Improvement Amendments of 
1988.

------------------------------------------------------------------------
                 Panels                              Function
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Dental Products Panel (two               Reviews and evaluates data
 representatives--one to represent the    concerning the safety and
 medical device industry, and one to      effectiveness of marketed and
 represent the dental drug industry).     investigational products for
                                          use in dentistry, endodontics,
                                          or bone physiology relative to
                                          the oral and maxillofacial
                                          area and makes appropriate
                                          recommendations to the
                                          Commissioner of Food and
                                          Drugs.
Immunology 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
                                          oncology, immunology, and
                                          allergy 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 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. Nomination must include a current, complete 
r[eacute]sum[eacute] or curriculum vitae for each nominee including 
current business address and telephone number, email address if 
available, and a signed copy of the Acknowledgement and Consent form 
available at the FDA Advisory Committee Membership Nomination Portal 
(see ADDRESSES) within 30 days of publication of this document (see 
DATES). Nominations must also specify the advisory panel for which the 
nominee is recommended. Nominations must also acknowledge that the 
nominee is aware of the nomination unless self-nominated. FDA will 
forward all nominations to the organizations expressing interest in 
participating in the selection process for the particular device panels 
listed in the table. (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.
    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: August 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19350 Filed 9-5-18; 8:45 am]
BILLING CODE 4164-01-P