General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 47645-47646 [2021-18394]
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Federal Register / Vol. 86, No. 163 / Thursday, August 26, 2021 / Notices
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Centers for Disease Control
and Prevention, 1600 Clifton Road NE,
MS H24–8, Atlanta, Georgia 30329–
4027, Attn: August 30–31, 2021 ACIP
Meeting.
Instructions: All submissions received
must include the Agency name and
Docket Number. All relevant comments
received in conformance with the
https://www.regulations.gov suitability
policy will be posted without change to
https://www.regulations.gov, including
any personal information provided. For
access to the docket to read background
documents or comments received, go to
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Stephanie Thomas, ACIP Committee
Management Specialist, Centers for
Disease Control and Prevention,
National Center for Immunization and
Respiratory Diseases, 1600 Clifton Road
NE, MS–H24–8, Atlanta, GA 30329–
4027; Telephone: 404–639–8367; Email:
ACIP@cdc.gov.
SUPPLEMENTARY INFORMATION: Notice is
hereby given of a change in the meeting
of the Advisory Committee on
Immunization Practices (ACIP); August
24, 2021, 10:00 a.m.–5:00 p.m., EDT
(times subject to change), in the original
FRN.
The virtual meeting was published in
the Federal Register on Wednesday,
August 18, 2021, Volume 86, Number
157, pages 46256–46257.
The virtual meeting is being amended
to change the dates to August 30, 2021
and August 31, 2021, update meeting
times and supplemental information.
In accordance with 41 CFR 102–
3.150(b), less than 15 calendar days’
notice is being given for this meeting
due to the exceptional circumstances of
the COVID–19 pandemic and rapidly
evolving COVID–19 vaccine
development and regulatory processes.
A notice of this ACIP meeting has also
been posted on CDC’s ACIP website at:
https://www.cdc.gov/vaccines/acip/
index.html. In addition, CDC has sent
notice of this ACIP meeting by email to
those who subscribe to receive email
updates about ACIP.
Purpose: The committee is charged
with advising the Director, CDC, on the
use of immunizing agents. In addition,
under 42 U.S.C. 1396s, the committee is
mandated to establish and periodically
review and, as appropriate, revise the
list of vaccines for administration to
vaccine-eligible children through the
Vaccines for Children (VFC) program,
along with schedules regarding dosing
interval, dosage, and contraindications
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to administration of vaccines. Further,
under provisions of the Affordable Care
Act, section 2713 of the Public Health
Service Act, immunization
recommendations of the ACIP that have
been approved by the Director of the
Centers for Disease Control and
Prevention and appear on CDC
immunization schedules must be
covered by applicable health plans.
Matters To Be Considered: The agenda
will include discussions on Pfizer’s
COVID–19 vaccine, and additional
discussions on mRNA booster doses. A
recommendation vote on Pfizer’s
COVID–19 vaccine is planned. No
Vaccines for Children (VFC) votes are
scheduled. Agenda items are subject to
change as priorities dictate. For more
information on the meeting agenda visit
https://www.cdc.gov/vaccines/acip/
meetings/meetings-info.html.
Meeting Information: The meeting
will be webcast live via the World Wide
Web; for more information on ACIP
please visit the ACIP website: https://
www.cdc.gov/vaccines/acip/.
Public Participation
Interested persons or organizations
are invited to participate by submitting
written views, recommendations, and
data. Please note that comments
received, including attachments and
other supporting materials, are part of
the public record and are subject to
public disclosure. Comments will be
posted on https://www.regulations.gov.
Therefore, do not include any
information in your comment or
supporting materials that you consider
confidential or inappropriate for public
disclosure. If you include your name,
contact information, or other
information that identifies you in the
body of your comments, that
information will be on public display.
CDC will review all submissions and
may choose to redact, or withhold,
submissions containing private or
proprietary information such as Social
Security numbers, medical information,
inappropriate language, or duplicate/
near duplicate examples of a mass-mail
campaign. CDC will carefully consider
all comments submitted into the docket.
Oral Public Comment: This meeting
will include time for members of the
public to make an oral comment. Oral
public comment will occur before any
scheduled votes including all votes
relevant to the ACIP’s Affordable Care
Act and Vaccines for Children Program
roles. Priority will be given to
individuals who submit a request to
make an oral public comment before the
meeting according to the procedures
below.
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47645
Procedure for Oral Public Comment:
All persons interested in making an oral
public comment at the August 30, 2021,
ACIP meeting must submit a request at
https://www.cdc.gov/vaccines/acip/
meetings/ no later than 11:59 p.m., EDT,
August 28, 2021, according to the
instructions provided.
If the number of persons requesting to
speak is greater than can be reasonably
accommodated during the scheduled
time, CDC will conduct a lottery to
determine the speakers for the
scheduled public comment session.
CDC staff will notify individuals
regarding their request to speak by email
by August 29, 2021. To accommodate
the significant interest in participation
in the oral public comment session of
ACIP meetings, each speaker will be
limited to 3 minutes, and each speaker
may only speak once per meeting.
Written Public Comment: The docket
is currently open to receive written
comments. Written comments must be
received on or before August 31, 2021.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2021–18453 Filed 8–24–21; 11:15 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0008]
General and Plastic Surgery Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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.
SUMMARY:
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47646
Federal Register / Vol. 86, No. 163 / Thursday, August 26, 2021 / Notices
The meeting will take place
virtually on October 20, 2021, from 9
a.m. Eastern Time to 6 p.m. Eastern
Time.
ADDRESSES: Please note that due to the
impact of this 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.
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, candace.nalls@
fda.hhs.gov, 301–636–0510, 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 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 October
20, 2021, the committee will discuss,
make recommendations, and vote on
information regarding the premarket
approval application (PMA) for the
SurgiMend PRS Acellular Bovine
Dermal Matrix (SurgiMend PRS ABDM)
by Integra LifeSciences Corporation.
The proposed Indication for Use, as
stated in the PMA, is as follows:
SurgiMend PRS Acellular Bovine
Dermal Matrix is intended for use as soft
tissue support in post-mastectomy
breast reconstruction. SurgiMend PRS
Acellular Bovine Dermal Matrix is
specifically indicated for immediate,
two-stage, submuscular, alloplastic
breast reconstruction.
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
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DATES:
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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 and the link to the online
teleconference meeting room will be
available at https://www.fda.gov/
advisory-committees/medical-devicesadvisory-committee/general-and-plasticsurgery-devices-panel. Select the link
for the 2021 Meeting Materials. The
meeting will include slide presentations
with audio components to allow the
presentation of materials in a manner
that most closely resembles an in-person
advisory committee meeting.
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 October 6, 2021.
Oral presentations from the public will
be scheduled on October 20, 2021,
between approximately 2 p.m. Eastern
Time and 3 p.m. Eastern Time. Those
individuals interested in making formal
oral presentations should notify the
contact person (see FOR FURTHER
INFORMATION CONTACT). The notification
should include 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
September 28, 2021. 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 sessions. The contact person
will notify interested persons regarding
their request to speak by September 29,
2021.
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
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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 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–18394 Filed 8–25–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0806]
Advisory Committee; Nonprescription
Drugs Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing the renewal of the
Nonprescription Drugs Advisory
Committee by the Commissioner of
Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
Nonprescription Drugs Advisory
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until the
August 27, 2023, expiration date.
DATES: Authority for the
Nonprescription Drugs Advisory
Committee will expire on August 27,
2021, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Moon Hee V. Choi, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301
837–7126, NDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Nonprescription Drugs Advisory
Committee (the Committee). The
Committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
SUMMARY:
E:\FR\FM\26AUN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 163 (Thursday, August 26, 2021)]
[Notices]
[Pages 47645-47646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18394]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0008]
General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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.
[[Page 47646]]
DATES: The meeting will take place virtually on October 20, 2021, from
9 a.m. Eastern Time to 6 p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of this 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.
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,
[email protected], 301-636-0510, 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 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 October
20, 2021, the committee will discuss, make recommendations, and vote on
information regarding the premarket approval application (PMA) for the
SurgiMend PRS Acellular Bovine Dermal Matrix (SurgiMend PRS ABDM) by
Integra LifeSciences Corporation. The proposed Indication for Use, as
stated in the PMA, is as follows: SurgiMend PRS Acellular Bovine Dermal
Matrix is intended for use as soft tissue support in post-mastectomy
breast reconstruction. SurgiMend PRS Acellular Bovine Dermal Matrix is
specifically indicated for immediate, two-stage, submuscular,
alloplastic breast reconstruction.
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
and the link to the online teleconference meeting room will be
available at https://www.fda.gov/advisory-committees/medical-devices-advisory-committee/general-and-plastic-surgery-devices-panel. Select
the link for the 2021 Meeting Materials. The meeting will include slide
presentations with audio components to allow the presentation of
materials in a manner that most closely resembles an in-person advisory
committee meeting.
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
October 6, 2021. Oral presentations from the public will be scheduled
on October 20, 2021, between approximately 2 p.m. Eastern Time and 3
p.m. Eastern Time. Those individuals interested in making formal oral
presentations should notify the contact person (see FOR FURTHER
INFORMATION CONTACT). The notification should include 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 September 28, 2021. 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 sessions. The contact
person will notify interested persons regarding their request to speak
by September 29, 2021.
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: August 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18394 Filed 8-25-21; 8:45 am]
BILLING CODE 4164-01-P
