General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 60691-60693 [2022-21746]
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60691
Federal Register / Vol. 87, No. 193 / Thursday, October 6, 2022 / Notices
into interstate commerce (including
importation) of infant formula that is
safe and nutritionally adequate but that
may not comply with all FDA statutory
and regulatory requirements. Consistent
with the policies described in the May
2022 Enforcement Discretion Guidance,
certain manufacturers have submitted
information to FDA to substantiate the
safety and nutritional adequacy of
specific infant formula products and,
following FDA’s thorough review of the
information provided, are marketing
such products under FDA’s exercise of
enforcement discretion.
This guidance sets forth our current
thinking on circumstances under which
we intend to exercise temporary
enforcement discretion for certain infant
formula products beyond November 14,
2022, and to advise infant formula
manufacturers marketing products in
accordance with letters of enforcement
discretion issued under the May 2022
Enforcement Discretion Guidance about:
(1) the type of information to provide to
FDA; and (2) our timing expectations
related to such information, if they
would like us to consider the continued
exercise of enforcement discretion with
respect to their products. This guidance
document will remain in effect until
October 18, 2025, and FDA expects that
all infant formula products will comply
with applicable U.S. requirements by
the end of the enforcement discretion
period.
We issued this guidance without prior
public comment under section
701(h)(1)(C) of the FD&C Act (21 U.S.C.
371(h)(1)(C)) and 21 CFR 10.115(g)(2)
because we determined that prior public
participation is not feasible or
appropriate, as this guidance provides
time-sensitive clarifications regarding
FDA’s intent to exercise enforcement
discretion with respect to specific
formula products that are currently
fulfilling the needs of infants in the
United States.
As with all FDA guidance documents,
the public may comment on the
guidance at any time.
II. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/FoodGuidances or https://
www.regulations.gov. Use the FDA
website listed in the previous sentence
to find the most current version of the
guidance.
III. Paperwork Reduction Act of 1995
FDA requested, and OMB has
approved, emergency processing of this
proposed collection of information
under section 3507(j) of the PRA (44
U.S.C. 3507(j) and 5 CFR 1320.13).
Immediate implementation of the
information collection is critical to
providing predictability, stability, and
continuity in the infant formula market,
specifically with respect to those
products currently available to infants
in the Unites States under FDA’s
exercise of enforcement discretion.
Because we believe that routine
procedures, which allow for a 60-day
comment period, would prevent our
ability to immediately implement the
information collection, we requested a
waiver from the requirement to publish
a 60-day notice for the information
collection (see 5 CFR 1320.13(a)(2)(iii)).
With respect to the following
collection of information, FDA invites
comments on these topics: (1) whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ONE-TIME ANNUAL REPORTING BURDEN 1
Number of
respondents
Information collection activity
Total
annual
responses
Average
burden
per response
Total hours
Submit information in accordance with timing and content
schedule discussed in guidance document for both exempt and non-exempt infant formulas .............................
Letter of Intent ......................................................................
Plan to Meet Applicable Infant Formula Requirements .......
115
15
15
1
1
1
115
15
15
24
5
90
2,760
75
1,350
Total ..............................................................................
........................
........................
........................
........................
4,185
1 There
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Number of
responses per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate is based on submissions
received in response to the May 2022
Enforcement Discretion Guidance, for
which we account for 115 respondents,
each of whom submitted one request.
We assume it requires an average of 24
hours to prepare each submission, and
therefore calculate a total of 2,760
burden hours (115 requests × 24 hours).
Of those 115 respondents, we have
currently issued 12 letters of
enforcement discretion but may issue
additional letters through November 14,
2022. We therefore assume that a total
of 15 respondents will initiate
requesting enforcement discretion and
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17:46 Oct 05, 2022
Jkt 259001
final a letter of intent. We assume this
requires an average of 5 hours to
prepare, for a total of 75 burden hours
(15 letters × 5 hours). We estimate these
same 15 respondents will then submit a
compliance plan and assume each plan
will require an average of 90 hours to
prepare, for a total of 1,350 burden
hours (15 plans × 90 hours).
Dated: September 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0589]
General and Plastic Surgery Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
[FR Doc. 2022–21794 Filed 10–5–22; 8:45 am]
HHS.
BILLING CODE 4164–01–P
ACTION:
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Food and Drug Administration,
Notice; establishment of a
public docket; request for comments.
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60692
Federal Register / Vol. 87, No. 193 / Thursday, October 6, 2022 / Notices
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
FDA on 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
virtually on October 26, 2022, from 9
a.m. Eastern Time to 6:15 p.m. Eastern
Time and October 27, 2022, from 9 a.m.
Eastern Time to 3 p.m. Eastern Time.
ADDRESSES: Please note that due to the
impact of the COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions,
including information regarding special
accommodations due to a disability,
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2022–N–0589.
Please note that late, untimely filed
comments will not be considered. The
docket will close on November 28, 2022.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 28, 2022.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are received on or before that
date.
Comments received on or before
October 11, 2022, will be provided to
the committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments as
follows:
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
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
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17:46 Oct 05, 2022
Jkt 259001
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2022–N–0589 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, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• 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.’’ FDA
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
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viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
If you do not wish your name and
contact information be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify the 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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Candace Nalls, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5216, Silver Spring,
MD 20993–0002, 301–636–0510,
Candace.Nalls@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
FDA’s website 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 the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. On day 1,
October 26, 2022, in the morning, the
committee will discuss and make
recommendations on the classification
proposal for tissue expanders and
accessories, which are currently
unclassified preamendments devices, to
be class III (general controls and
premarket approval) and class II
(general and special controls), and
mammary sizers, which are currently
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lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 193 / Thursday, October 6, 2022 / Notices
unclassified preamendments devices, to
be class II (general and special controls).
In the afternoon on the first day, the
committee will discuss and make
recommendations on the classification
proposals for wound dressings with
animal-derived materials, absorbable
synthetic wound dressings, and
hemostatic wound dressings with or
without thrombin, which are all
currently unclassified preamendments
devices, to be class II (general and
special controls).
On day 2, October 27, 2022, the
committee will discuss and make
recommendations on the classification
proposals for nail prostheses, which are
currently unclassified preamendments
devices, to be class I (general controls);
and ultrasonic surgical instruments,
single-use reprocessed ultrasonic
surgical instruments, and neurosurgical
ultrasonic instruments, which are all
currently unclassified preamendments
devices, to be class II (general and
special controls).
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting, and the background
material will be posted on FDA’s
website after the meeting. Background
material is available at https://
www.fda.gov/AdvisoryCommittees/
Calendar/default.htm. Scroll down to
the advisory committee meeting link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions to the Docket (see
ADDRESSES) on or before October 11,
2022, will be provided to the committee.
Oral presentations from the public will
be scheduled on October 26, 2022,
between approximately 9:30 a.m. and 10
a.m. Eastern Time, and 2 p.m. and 2:30
p.m. Eastern Time, and on October 27,
2022, between approximately 9:30 a.m.
and 10 a.m. Eastern Time. 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 September 30, 2022. 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
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17:46 Oct 05, 2022
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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 October 3, 2022.
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 Ann Marie
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 website 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: September 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–21746 Filed 10–5–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Innate
Immunity and Inflammatory Responses.
Date: November 2, 2022.
Time: 10:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
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60693
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Bakary Drammeh, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 805–P,
Bethesda, MD 20892, (301) 435–0000,
drammehbs@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Neurodevelopment, Synaptic
Plasticity and Neurodegeneration.
Date: November 2, 2022.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Kathryn Partlow, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1016D,
Bethesda, MD 20892, (301) 594–2138,
partlowkc@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Epidemiology and Population
Sciences.
Date: November 3–4, 2022.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Randolph Christopher
Capps, Ph.D., Scientific Review Officer,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Room 1009J, Bethesda, MD 20892 (301) 435–
1042 cappsrac@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel The Cellular
and Molecular Biology of Complex Brain
Disorders.
Date: November 3, 2022.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Adem Can, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4190,
MSC 7850, Bethesda, MD 20892, (301) 435–
1042, cana2@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; The BloodBrain Barrier, Neurovascular System and
CNS Therapeutics.
Date: November 3, 2022.
Time: 10:00 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Mariam Zaka, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1009J,
E:\FR\FM\06OCN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 193 (Thursday, October 6, 2022)]
[Notices]
[Pages 60691-60693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21746]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0589]
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.
-----------------------------------------------------------------------
[[Page 60692]]
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
FDA on 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 virtually on October 26, 2022, from 9
a.m. Eastern Time to 6:15 p.m. Eastern Time and October 27, 2022, from
9 a.m. Eastern Time to 3 p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of the COVID-19 pandemic,
all meeting participants will be joining this advisory committee
meeting via an online teleconferencing platform. Answers to commonly
asked questions, including information regarding special accommodations
due to a disability, may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2022-N-0589. Please note that late, untimely
filed comments will not be considered. The docket will close on
November 28, 2022. The https://www.regulations.gov electronic filing
system will accept comments until 11:59 p.m. Eastern Time at the end of
November 28, 2022. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
received on or before that date.
Comments received on or before October 11, 2022, will be provided
to the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2022-N-0589 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, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
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.'' FDA 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 Dockets Management Staff. If you do not wish your name
and contact information be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify the 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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Candace Nalls, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993-0002, 301-636-0510,
[email protected], 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 FDA's website 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 the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On day 1,
October 26, 2022, in the morning, the committee will discuss and make
recommendations on the classification proposal for tissue expanders and
accessories, which are currently unclassified preamendments devices, to
be class III (general controls and premarket approval) and class II
(general and special controls), and mammary sizers, which are currently
[[Page 60693]]
unclassified preamendments devices, to be class II (general and special
controls). In the afternoon on the first day, the committee will
discuss and make recommendations on the classification proposals for
wound dressings with animal-derived materials, absorbable synthetic
wound dressings, and hemostatic wound dressings with or without
thrombin, which are all currently unclassified preamendments devices,
to be class II (general and special controls).
On day 2, October 27, 2022, the committee will discuss and make
recommendations on the classification proposals for nail prostheses,
which are currently unclassified preamendments devices, to be class I
(general controls); and ultrasonic surgical instruments, single-use
reprocessed ultrasonic surgical instruments, and neurosurgical
ultrasonic instruments, which are all currently unclassified
preamendments devices, to be class II (general and special controls).
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting, and the background material
will be posted on FDA's website after the meeting. Background material
is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the advisory committee meeting link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions to the Docket (see ADDRESSES) on
or before October 11, 2022, will be provided to the committee. Oral
presentations from the public will be scheduled on October 26, 2022,
between approximately 9:30 a.m. and 10 a.m. Eastern Time, and 2 p.m.
and 2:30 p.m. Eastern Time, and on October 27, 2022, between
approximately 9:30 a.m. and 10 a.m. Eastern Time. 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 September 30, 2022. 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 October 3, 2022.
For press inquiries, please contact the Office of Media Affairs at
[email protected] 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 Ann Marie Williams, at [email protected] 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 website 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: September 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21746 Filed 10-5-22; 8:45 am]
BILLING CODE 4164-01-P
