General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, Establishment of a Public Docket, Request for Comments, 52695-52696 [2016-18814]
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52695
Federal Register / Vol. 81, No. 153 / Tuesday, August 9, 2016 / Notices
The purpose of this information
collection is to document and track
clinical inquiries made to the CDC EOC
call center and to systematically collect
standardized clinical/demographic/
epidemiological information about
suspected cases. The emergency
clearance for this information collection
dealt specifically with Zika-related
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operates this call center to answer and
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responding to emergency situations.
These information collections will
align with their legislative authority,
Section 301 of the Public Health Service
Act (42 U.S.C. 241). There are no total
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time. The total annualized burden
requested is 305 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
State and Local Health Departments .............
Clinicians and Other Providers .......................
Clinical Inquiries Database ............................
Clinical Inquiries Database ............................
Jeffrey M. Zirger,
Health Scientist, Acting Chief, Information
Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for
Science, Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2016–18837 Filed 8–8–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2147]
General and Plastic Surgery Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting,
Establishment of a Public Docket,
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice, establishment of a
public docket, request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the General and Plastic
Surgery Devices Panel of the Medical
Devices Advisory Committee. The
general function of the committee is to
provide advice and recommendations to
the Agency on FDA’s regulatory issues.
The meeting will be open to the public.
FDA is establishing a docket for public
comment on this document.
DATES: The meeting will be held on
September 20 and 21, 2016, from 8 a.m.
to 6 p.m.
ADDRESSES: Hilton Washington, DC
North/Gaithersburg, Grand Ballroom,
620 Perry Pkwy., Gaithersburg, MD
20877. The hotel’s telephone number is
301–977–8900. Answers to commonly
asked questions including information
regarding special accommodations due
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:00 Aug 08, 2016
Jkt 238001
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
You may submit comments as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
420
800
Number of
responses per
respondent
1
1
Average
burden per
response
(in hrs.)
15/60
15/60
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–N–2147 for ‘‘General and Plastic
Surgery Devices Panel of the Medical
Devices Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
E:\FR\FM\09AUN1.SGM
09AUN1
asabaliauskas on DSK3SPTVN1PROD with NOTICES
52696
Federal Register / Vol. 81, No. 153 / Tuesday, August 9, 2016 / Notices
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Evella Washington, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1535, Silver Spring,
MD 20993–0002, 301–796–6683,
Evella.Washington@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area).
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site at
https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On September 20 and 21,
2016, the Committee will discuss and
make recommendations regarding the
classification of certain wound care
products containing antimicrobials and
other drugs as part of the routine
process for device classification. These
products are regulated under product
code FRO, ‘‘Dressing, Wound, Drug,’’
and are considered ‘‘pre-amendments’’
because they were in commercial
distribution prior to May 28, 1976,
when the Medical Devices Amendments
were enacted, and have not yet been
classified under section 513 of the
Federal Food, Drug, and Cosmetic Act.
As a part of the classification process,
FDA is seeking committee input on the
indications for use, risks to health, and
safety and effectiveness of these wound
VerDate Sep<11>2014
20:00 Aug 08, 2016
Jkt 238001
care products, and how they should be
classified. They may be classified in
class I (general controls), class II (special
and general controls), or class III
(premarket approval (PMA), requiring
demonstration of safety and
effectiveness for each product).
FDA believes some of these products
may meet the definition of class II
whereas others may meet the definition
of class III in light of their intended use,
composition, the extent of evidence of
clinical benefit, and the risks they pose.
For the subset of the these products that
contain antibiotics, FDA appreciates the
importance of appropriately addressing
the risk of antimicrobial resistance
(AMR) in light of the increasingly
significant national public health
concern posed by AMR. FDA is also
aware of differences in the claims made
for some products even though they
may be regulated in the same manner.
FDA intends to make background
material available to the public on its
Web site at least 2 business days before
the meeting. If FDA is unable to post the
background material on its Web site
prior to the meeting, the background
material will be made publicly available
at the location of the meeting, and the
background material will be posted on
FDA’s Web site after the meeting.
Background material will be available at
https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before September 6, 2016.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. on September 20 and
between approximately 9 a.m. and 10:30
a.m. on September 21, 2016. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before August 26, 2016. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
notify interested persons regarding their
request to speak by August 29, 2016.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA is establishing a docket for
public comment on this document. The
docket number is FDA–2016–N–2147.
The docket will close on October 20,
2016. Comments received on or before
September 1, 2016, will be provided to
the committee. Comments received after
that date will be taken into
consideration by the Agency.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact AnnMarie
Williams at AnnMarie.Williams@
fda.hhs.gov, or 301–796–5966 at least 7
days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 3, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special
Medical Programs.
[FR Doc. 2016–18814 Filed 8–8–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Deafness and
Other Communication Disorders;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
E:\FR\FM\09AUN1.SGM
09AUN1
Agencies
[Federal Register Volume 81, Number 153 (Tuesday, August 9, 2016)]
[Notices]
[Pages 52695-52696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18814]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2147]
General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting, Establishment of a Public
Docket, Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice, establishment of a public docket, request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the General and Plastic Surgery
Devices Panel of the Medical Devices Advisory Committee. The general
function of the committee is to provide advice and recommendations to
the Agency on FDA's regulatory issues. The meeting will be open to the
public. FDA is establishing a docket for public comment on this
document.
DATES: The meeting will be held on September 20 and 21, 2016, from 8
a.m. to 6 p.m.
ADDRESSES: Hilton Washington, DC North/Gaithersburg, Grand Ballroom,
620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone number
is 301-977-8900. Answers to commonly asked questions including
information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-N-2147 for ``General and Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee; Notice of Meeting; Establishment of
a Public Docket; Request for Comments.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your
[[Page 52696]]
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Evella Washington, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993-0002, 301-
796-6683, Evella.Washington@fda.hhs.gov, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area).
A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On September 20 and 21, 2016, the Committee will discuss
and make recommendations regarding the classification of certain wound
care products containing antimicrobials and other drugs as part of the
routine process for device classification. These products are regulated
under product code FRO, ``Dressing, Wound, Drug,'' and are considered
``pre-amendments'' because they were in commercial distribution prior
to May 28, 1976, when the Medical Devices Amendments were enacted, and
have not yet been classified under section 513 of the Federal Food,
Drug, and Cosmetic Act.
As a part of the classification process, FDA is seeking committee
input on the indications for use, risks to health, and safety and
effectiveness of these wound care products, and how they should be
classified. They may be classified in class I (general controls), class
II (special and general controls), or class III (premarket approval
(PMA), requiring demonstration of safety and effectiveness for each
product).
FDA believes some of these products may meet the definition of
class II whereas others may meet the definition of class III in light
of their intended use, composition, the extent of evidence of clinical
benefit, and the risks they pose. For the subset of the these products
that contain antibiotics, FDA appreciates the importance of
appropriately addressing the risk of antimicrobial resistance (AMR) in
light of the increasingly significant national public health concern
posed by AMR. FDA is also aware of differences in the claims made for
some products even though they may be regulated in the same manner.
FDA intends to make background material available to the public on
its Web site at least 2 business days before the meeting. If FDA is
unable to post the background material on its Web site prior to the
meeting, the background material will be made publicly available at the
location of the meeting, and the background material will be posted on
FDA's Web site after the meeting. Background material will be available
at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
September 6, 2016. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on September 20 and between
approximately 9 a.m. and 10:30 a.m. on September 21, 2016. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
August 26, 2016. Time allotted for each presentation may be limited. If
the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by August 29, 2016.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA is establishing a docket for public comment on this document.
The docket number is FDA-2016-N-2147. The docket will close on October
20, 2016. Comments received on or before September 1, 2016, will be
provided to the committee. Comments received after that date will be
taken into consideration by the Agency.
For press inquiries, please contact the Office of Media Affairs at
fdaoma@fda.hhs.gov or 301-796-4540.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact AnnMarie Williams at AnnMarie.Williams@fda.hhs.gov, or 301-796-
5966 at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 3, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-18814 Filed 8-8-16; 8:45 am]
BILLING CODE 4164-01-P