81 FR 8207 - Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 32 (February 18, 2016)

Page Range		8207-8208
FR Document		2016-03283

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) 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. 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.

Federal Register, Volume 81 Issue 32 (Thursday, February 18, 2016)

[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Notices]
[Pages 8207-8208]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-03283]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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) 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. 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.

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 March 21, 
2016, (see sections I and II for further details). Concurrently, 
nomination materials for prospective candidates should be sent to FDA 
by March 21, 2016.

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 may 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 Web site at 
http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Margaret Ames, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5215, Silver Spring, MD 20993, 301-796-5960, Fax: 
301-847-8505, [email protected].

SUPPLEMENTARY INFORMATION: The Agency is requesting nominations for 
nonvoting industry representatives to certain panels identified in the 
following paragraphs:

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 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 
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 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 of Food and Drugs 
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.

A. Anesthesiology and Respiratory Therapy Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational devices for use in anesthesiology and 
respiratory therapy 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 marketed and investigational ear, nose and throat devices and makes 
appropriate recommendations to the Commissioner of Food and Drugs.

[[Page 8208]]

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 and Plastic Surgery Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational general and plastic surgery devices and 
makes appropriate recommendations to the Commissioner of Food and 
Drugs.

E. 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 of Food and Drugs.

F. Medical Devices Dispute Resolution

    Provides advice to the Center Director on complex or contested 
scientific issues between the 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.

G. 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 of 
Food and Drugs.

H. 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 of Food and Drugs.

I. 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.

J. Orthopaedic and Rehabilitation Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational orthopedic and rehabilitation devices 
and makes appropriate recommendations to the Commissioner of Food and 
Drugs.

K. Radiological Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational diagnostics or therapeutic radiological 
and nuclear medicine devices 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. Contact information, a current curriculum vitae, and 
the name of the Committee of interest may be submitted to the FDA 
Advisory Committee Membership Nomination Portal (see ADDRESSES) 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 particular device panel. 
(Persons who nominate themselves as nonvoting industry representatives 
will not participate in the selection process).
    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: February 11, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-03283 Filed 2-17-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices 8207

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total
21 CFR Section records per burden per Total hours
recordkeepers annual records
recordkeeper recordkeeping

170.36(c)(v) (CFSAN) .......................................................... 40 1 40 15 600
570.36(c)(v) (CVM) .............................................................. 20 1 20 15 300

Total .............................................................................. ........................ ........................ ........................ ........................ 900
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

For purposes of this extension DATES: Any industry organization the Medical Devices Dispute Resolution
request, we are retaining our 2012 interested in participating in the Panel, each panel, according to its
estimates. The PRA analysis for the selection of an appropriate nonvoting specialty area, advises the
GRAS final rule will take into account member to represent industry interests Commissioner of Food and Drugs
any changes to the GRAS notification must send a letter stating that interest to regarding recommended classification
procedure as set forth in the final rule FDA by March 21, 2016, (see sections I or reclassification of devices into one of
and we will revise the collection and II for further details). Concurrently, three regulatory categories; advises on
accordingly. nomination materials for prospective any possible risks to health associated
Dated: February 12, 2016. candidates should be sent to FDA by with the use of devices; advises on
March 21, 2016. formulation of product development
Leslie Kux,
ADDRESSES: All statements of interest protocols; reviews premarket approval
Associate Commissioner for Policy.
from industry organizations interested applications for medical devices;
[FR Doc. 2016–03330 Filed 2–17–16; 8:45 am]
in participating in the selection process reviews guidelines and guidance
BILLING CODE 4164–01–P of nonvoting industry representative documents; recommends exemption of
nomination should be sent to Margaret certain devices from the application of
Ames (see FOR FURTHER INFORMATION
DEPARTMENT OF HEALTH AND portions of the Act; advises on the
CONTACT). All nominations for
HUMAN SERVICES necessity to ban a device; and responds
nonvoting industry representatives may
be submitted electronically by accessing to requests from the agency to review
Food and Drug Administration and make recommendations on specific
the FDA Advisory Committee
Membership Nomination Portal: issues or problems concerning the safety
[Docket No. FDA–2016–N–0001] https://www.accessdata.fda.gov/scripts/ and effectiveness of devices. With the
FACTRSPortal/FACTRS/index.cfm or by exception of the Medical Devices
Request for Nominations on Public Dispute Resolution Panel, each panel,
mail to Advisory Committee Oversight
Advisory Panels of the Medical according to its specialty area, may also
and Management Staff, Food and Drug
Devices Advisory Committee make appropriate recommendations to
Administration, 10903 New Hampshire
AGENCY: Food and Drug Administration, Ave., Bldg. 32, Rm. 5103, Silver Spring, the Commissioner of Food and Drugs on
HHS. MD 20993–0002. Information about issues relating to the design of clinical
ACTION: Notice. becoming a member of an FDA advisory studies regarding the safety and
committee can also be obtained by effectiveness of marketed and
SUMMARY: The Food and Drug visiting FDA’s Web site at http://www. investigational devices. The Committee
Administration (FDA) is requesting that fda.gov/AdvisoryCommittees/ also provides recommendations to the
any industry organizations interested in default.htm. Commissioner or designee on
participating in the selection of FOR FURTHER INFORMATION CONTACT: complexity categorization of in vitro
nonvoting industry representatives to Margaret Ames, Center for Devices and diagnostics under the Clinical
serve on certain panels of the Medical Radiological Health, Food and Drug Laboratory Improvement Amendments
Devices Advisory Committee (MDAC) in Administration, 10903 New Hampshire of 1988.
the Center for Devices and Radiological Ave., Bldg. 66, Rm. 5215, Silver Spring,
Health (CDRH) notify FDA in writing. A. Anesthesiology and Respiratory
MD 20993, 301–796–5960, Fax: 301–
FDA is also requesting nominations for 847–8505, margaret.ames@fda.hhs.gov. Therapy Devices Panel
nonvoting industry representatives to SUPPLEMENTARY INFORMATION: The Reviews and evaluates data
serve on certain device Panels of the Agency is requesting nominations for concerning the safety and effectiveness
MDAC in the CDRH. A nominee may nonvoting industry representatives to of marketed and investigational devices
either be self-nominated or nominated certain panels identified in the for use in anesthesiology and respiratory
by an organization to serve as a following paragraphs: therapy and makes appropriate
nonvoting industry representative.
I. Medical Devices Advisory Committee recommendations to the Commissioner
Nominations will be accepted for
of Food and Drugs.
current and upcoming vacancies The Committee reviews and evaluates
mstockstill on DSK4VPTVN1PROD with NOTICES

effective with this notice. FDA seeks to data on the safety and effectiveness of B. Ear, Nose and Throat Devices Panel
include the views of women, and men, marketed and investigational devices
members of all racial and ethnic groups and makes recommendations for their Reviews and evaluates data
and individuals with and without regulation. The panels engage in a concerning the safety and effectiveness
disabilities on its advisory committees number of activities to fulfill the of marketed and investigational ear,
and, therefore encourages nominations functions the Federal Food, Drug, and nose and throat devices and makes
of appropriately qualified candidates Cosmetic Act envisions for device appropriate recommendations to the
from these groups. advisory panels. With the exception of Commissioner of Food and Drugs.

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8208 Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices

C. Gastroenterology and Urology I. Neurological Devices Panel more individuals to serve as a nonvoting
Devices Panel Reviews and evaluates data industry representative. Contact
concerning the safety and effectiveness information, a current curriculum vitae,
Reviews and evaluates data and the name of the Committee of
concerning the safety and effectiveness of marketed and investigational devices
for use in the neurological system and interest may be submitted to the FDA
of marketed and investigational Advisory Committee Membership
gastroenterology, urology and makes appropriate recommendations to
the Commissioner of Food and Drugs. Nomination Portal (see ADDRESSES)
nephrology devices and makes within 30 days of publication of this
appropriate recommendations to the J. Orthopaedic and Rehabilitation document (see DATES). FDA will forward
Commissioner of Food and Drugs. Devices Panel all nominations to the organizations
D. General and Plastic Surgery Devices Reviews and evaluates data expressing interest in participating in
Panel concerning the safety and effectiveness the selection process for the particular
of marketed and investigational device panel. (Persons who nominate
Reviews and evaluates data orthopedic and rehabilitation devices themselves as nonvoting industry
concerning the safety and effectiveness and makes appropriate representatives will not participate in
of marketed and investigational general recommendations to the Commissioner the selection process).
and plastic surgery devices and makes of Food and Drugs. This notice is issued under the
appropriate recommendations to the Federal Advisory Committee Act (5
Commissioner of Food and Drugs. K. Radiological Devices Panel U.S.C. app. 2) and 21 CFR part 14,
Reviews and evaluates data relating to advisory committees.
E. Hematology and Pathology Devices
Panel concerning the safety and effectiveness Dated: February 11, 2016.
of marketed and investigational Jill Hartzler Warner,
Reviews and evaluates data diagnostics or therapeutic radiological Associate Commissioner for Special Medical
concerning the safety and effectiveness and nuclear medicine devices and Programs.
of marketed and investigational in vitro makes appropriate recommendations to [FR Doc. 2016–03283 Filed 2–17–16; 8:45 am]
devices for use in clinical laboratory the Commissioner of Food and Drugs.
BILLING CODE 4164–01–P
medicine including pathology, II. Qualifications
hematology, histopathology,
cytotechnology and molecular biology Persons nominated for the device
DEPARTMENT OF HEALTH AND
and makes appropriate panels should be full-time employees of
HUMAN SERVICES
recommendations to the Commissioner firms that manufacture products that
of Food and Drugs. would come before the panel, or Office of the Secretary
consulting firms that represent
F. Medical Devices Dispute Resolution manufacturers, or have similar [Document Identifier OS–4040–0005 60D]

Provides advice to the Center Director appropriate ties to industry.
Agency Information Collection
on complex or contested scientific III. Selection Procedure Activities; Submission to OMB for
issues between the FDA and medical Any industry organization interested Review and Approval; Public Comment
device sponsors, applicants, or in participating in the selection of an Request
manufacturers relating to specific appropriate nonvoting member to
products, marketing applications, AGENCY: Electronic Government Office,
represent industry interests should send HHS.
regulatory decisions and actions by a letter stating that interest to the FDA
FDA, and Agency guidance and ACTION: Notice.
contact (see FOR FURTHER INFORMATION
policies. The Panel makes CONTACT) within 30 days of publication SUMMARY: In compliance with section
recommendations on issues that are of this document (see DATES). Within the 3507(a)(1)(D) of the Paperwork
lacking resolution, are highly complex subsequent 30 days, FDA will send a Reduction Act of 1995, the Electronic
in nature, or result from challenges to letter to each organization that has Government Office (EGOV), Department
Agency decisions or actions. expressed an interest, attaching a of Health and Human Services, has
G. Microbiology Devices Panel complete list of all such organizations; submitted an Information Collection
and a list of all nominees along with Request (ICR), described below, to the
Reviews and evaluates data their current resumes. The letter will Office of Management and Budget
concerning the safety and effectiveness also state that it is the responsibility of (OMB) for review and approval. The ICR
of marketed and investigational in vitro the interested organizations to confer is for a 3-year extension for OMB
devices for use in clinical laboratory with one another and to select a Control Number 4040–0005. The ICR
medicine including microbiology, candidate, within 60 days after the will expire on July 31, 2016. The ICR
virology, and infectious disease and receipt of the FDA letter, to serve as the also requests categorizing the form as a
makes appropriate recommendations to nonvoting member to represent industry common form, meaning HHS will only
the Commissioner of Food and Drugs. interests for a particular device panel. request approval for its own use of the
The interested organizations are not form rather than aggregating the burden
H. Molecular and Clinical Genetics
bound by the list of nominees in estimate across all Federal Agencies as
Devices Panel
selecting a candidate. However, if no was done for previous actions on this
OMB control number. Comments
mstockstill on DSK4VPTVN1PROD with NOTICES

Reviews and evaluates data individual is selected within 60 days,
concerning the safety and effectiveness the Commissioner will select the submitted during the first public review
of marketed and investigational in vitro nonvoting member to represent industry of this ICR will be provided to OMB.
devices for use in clinical laboratory interests. OMB will accept further comments from
medicine including clinical and the public on this ICR during the review
molecular genetics and makes IV. Application Procedure and approval period.
appropriate recommendations to the Individuals may self nominate and/or DATES: Comments on the ICR must be
Commissioner of Food and Drugs. an organization may nominate one or received on or before April 18, 2016.

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Document Created: 2016-02-18 07:46:53
Document Modified: 2016-02-18 07:46:53

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		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 March 21, 2016, (see sections I and II for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by March 21, 2016.
Contact		Margaret Ames, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5215, Silver Spring, MD 20993, 301-796-5960, Fax: 301-847-8505, [email protected]
FR Citation		81 FR 8207

81 FR 8207 - Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 32 (February 18, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration