Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee, 45253-45254 [2018-19350]
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45253
Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Total annual
responses
Average
burden per
response
Total hours
Full SE 905(j)(1)(A)(i) and 910(a) ........................................
Full SE 905(j)(1)(A)(i) and 910(a) Bundled .........................
Product Quantity Change SE Report ..................................
Product Quantity Change Bundled SE Report ....................
683
456
239
192
1
1
1
1
683
456
239
192
300
90
87
62
204,900
41,040
20,793
11,904
Total ..............................................................................
........................
........................
........................
........................
278,637
1 There
daltland on DSKBBV9HB2PROD with NOTICES
Number of
responses per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimates are based on
experience with SE Reports, initial
updated deemed registration and listing
data, interactions with the industry, and
information related to other regulated
products. The estimated number of SE
Reports is expected to increase from an
annual average of 979 to 1,570.
When groups of full or product
quantity change SE Reports have
identical content, they may be bundled;
when a group of similar reports are
bundled, the subsequent bundled
reports are expected to take less time to
prepare than the initial report.
FDA has based these estimates on
information it now has available from
interactions with the industry,
information related to other regulated
products, and FDA expectations
regarding the tobacco industry’s use of
the section 905(j) pathway to market
their products. Table 1 describes the
annual reporting burden as a result of
the implementation of the substantial
equivalence requirements of sections
905(j)(1)(A)(i) and 910(a) of the FD&C
Act (21 U.S.C. 387j(a)) for an SE
application.
FDA estimates that 683 respondents
will prepare and submit 683 section
905(j)(1)(A)(i) SE Reports each year. In
addition, anyone submitting an SE
Report is required to submit an
environmental assessment (EA) under
21 CFR 25.40. The burden for
environmental reports has been
included in the burden per response for
each type of SE report. Based on FDA’s
experience with EAs for currently
regulated tobacco products, we expect
industry to spend 80 hours to prepare
an environmental assessment for a SE
Report. Thus, FDA estimates that it will
take a manufacturer approximately 300
hours per report to prepare an SE Report
and the EA for a new tobacco product,
which is a total of 204,900 hours.
In addition, we estimate receiving 456
Full SE Bundled Reports at 90 hours per
submission for a total of 41,040 hours.
FDA estimates that it will receive 239
Product Quantity Change SE Reports
and that it will take a manufacturer
approximately 87 hours to prepare this
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16:56 Sep 05, 2018
Jkt 244001
report for a total of 20,793 hours. This
includes time to prepare the
environmental assessment, which FDA
believes will take less time due to the
typically more limited modification(s)
included in a Product Quantity Change
SE Report. We estimate receiving 192
Product Quantity Change Bundled SE
Reports at approximately 62 hours per
submission for a total of 11,904 hours,
this number excludes the time for the
initial SE Report which was previously
account for.
Therefore, FDA estimates the burden
for submission of SE information will be
278,637 hours. This is an increase of
106,759 hours from the currently
approved burden. We attribute this
increase to an increase in the number of
SE Reports we expect related to Deemed
products (e.g., based on the initial
registration and listing information).
Dated: August 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19353 Filed 9–5–18; 8:45 am]
BILLING CODE 4164–01–P
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.
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
SUMMARY:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
representatives to serve on certain
device panels of the MDAC in the
CDRH. A nominee may either be selfnominated 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.
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.
DATES:
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.
ADDRESSES:
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: margaret.ames@
fda.hhs.gov.
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45254
Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices
The
Agency is requesting nominations for
nonvoting industry representatives to
the panels listed in the table in this
document.
SUPPLEMENTARY INFORMATION:
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
Dental Products Panel (two representatives—one to represent the
medical device industry, and one to represent the dental drug industry).
Immunology Devices Panel ......................................................................
daltland on DSKBBV9HB2PROD with NOTICES
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.
VerDate Sep<11>2014
16:56 Sep 05, 2018
Jkt 244001
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
of Food and Drugs.
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.
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
re´sume´ 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
PO 00000
Frm 00049
Fmt 4703
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.
Sfmt 4703
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0609]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry: Drug Supply Chain Security
Act Implementation: Identification of
Suspect Product and Notification
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
SUMMARY:
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
------------------------------------------------------------------------
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
