[Federal Register Volume 79, Number 13 (Tuesday, January 21, 2014)]
[Notices]
[Pages 3390-3391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01003]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1633]
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 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 (see
ADDRESSES) by February 20, 2014, for the vacancies listed in this
notice. Concurrently, nomination materials for prospective candidates
should be sent to FDA (see ADDRESSES) by February 20, 2014.
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. Telephone: 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 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. Dental Products Panel
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational products for use in dentistry,
endodontics, or bone physiology relative to the oral and maxillofacial
area and makes appropriate recommendations to the Commissioner.
B. Hematology and Pathology 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 pathology, hematology, histopathology,
cytotechnology, and molecular biology and makes appropriate
recommendations to the Commissioner.
C. 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.
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 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 device panel. The
interested organizations are not
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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 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: January 13, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-01003 Filed 1-17-14; 8:45 am]
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