Advisory Committee; Nonprescription Drugs Advisory Committee; Renewal, 47646-47647 [2021-18396]
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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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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:
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Federal Register / Vol. 86, No. 163 / Thursday, August 26, 2021 / Notices
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety and
effectiveness of over-the-counter
(nonprescription) human drug products,
or any other FDA-regulated product, for
use in the treatment of a broad spectrum
of human symptoms and diseases and
advises the Commissioner either on the
promulgation of monographs
establishing conditions under which
these drugs are generally recognized as
safe and effective and not misbranded or
on the approval of new drug
applications for such drugs. The
Committee serves as a forum for the
exchange of views regarding the
prescription and nonprescription status,
including switches from one status to
another, of these various drug products
and combinations thereof. The
Committee may also conduct peer
review of Agency sponsored intramural
and extramural scientific biomedical
programs in support of FDA’s mission
and regulatory responsibilities.
The Committee shall consist of 10
voting members including the Chair.
Members and the Chair are selected by
the Commissioner or designee from
among authorities knowledgeable in the
fields of internal medicine, family
practice, clinical toxicology, clinical
pharmacology, pharmacy, dentistry, and
related specialties. Members will be
invited to serve for overlapping terms of
up to 4 years. Almost all non-Federal
members of this committee serve as
Special Government Employees. Federal
members will serve as Regular
Government Employees or Ex-Officios.
The core of voting members may
include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting representative
member who is identified with industry
interests. There may also be an alternate
industry representative.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
human-drug-advisory-committees/
nonprescription-drugs-advisorycommittee or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
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17:30 Aug 25, 2021
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This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
advisory-committees.
Dated: August 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–18396 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–2020–N–2319]
Evaluation of Study Data Exchange
Standards for Submission of Study
Data to the Center for Veterinary
Medicine; Request for Comments;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for comments;
extension of comment period.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
extending the comment period for the
request for comments that appeared in
the Federal Register of June 15, 2021. In
that notice, FDA requested comments
on the use of study data exchange
standards from persons involved in
study conduct, data collection, data
management, and submission of animal
study data intended to support the
approval of new animal drug
applications (NDAs), abbreviated new
animal drug applications (ANDAs), or
applications for conditional approval.
The Agency is taking this action in
response to requests for an extension to
allow interested persons additional time
to submit comments.
DATES: FDA is extending the comment
period on the request for comments
published on June 15, 2021 (86 FR
31720). Submit either electronic or
written comments by November 12,
2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before November 12,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 12, 2021.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
SUMMARY:
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47647
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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–
2020–N–2319 for ‘‘Evaluation of Study
Data Exchange Standards for
Submission of Study Data to the Center
for Veterinary Medicine.’’ 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
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]]>Agencies
[Federal Register Volume 86, Number 163 (Thursday, August 26, 2021)]
[Notices]
[Pages 47646-47647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18396]
-----------------------------------------------------------------------
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.
ACTION: Notice; renewal of federal advisory committee.
-----------------------------------------------------------------------
SUMMARY: 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, [email protected].
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
[[Page 47647]]
effective drugs for human use and, as required, any other product for
which FDA has regulatory responsibility.
The Committee reviews and evaluates available data concerning the
safety and effectiveness of over-the-counter (nonprescription) human
drug products, or any other FDA-regulated product, for use in the
treatment of a broad spectrum of human symptoms and diseases and
advises the Commissioner either on the promulgation of monographs
establishing conditions under which these drugs are generally
recognized as safe and effective and not misbranded or on the approval
of new drug applications for such drugs. The Committee serves as a
forum for the exchange of views regarding the prescription and
nonprescription status, including switches from one status to another,
of these various drug products and combinations thereof. The Committee
may also conduct peer review of Agency sponsored intramural and
extramural scientific biomedical programs in support of FDA's mission
and regulatory responsibilities.
The Committee shall consist of 10 voting members including the
Chair. Members and the Chair are selected by the Commissioner or
designee from among authorities knowledgeable in the fields of internal
medicine, family practice, clinical toxicology, clinical pharmacology,
pharmacy, dentistry, and related specialties. Members will be invited
to serve for overlapping terms of up to 4 years. Almost all non-Federal
members of this committee serve as Special Government Employees.
Federal members will serve as Regular Government Employees or Ex-
Officios. The core of voting members may include one technically
qualified member, selected by the Commissioner or designee, who is
identified with consumer interests and is recommended by either a
consortium of consumer-oriented organizations or other interested
persons. In addition to the voting members, the Committee may include
one non-voting representative member who is identified with industry
interests. There may also be an alternate industry representative.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/human-drug-advisory-committees/nonprescription-drugs-advisory-committee
or by contacting the Designated Federal Officer (see FOR FURTHER
INFORMATION CONTACT). In light of the fact that no change has been made
to the committee name or description of duties, no amendment will be
made to 21 CFR 14.100.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/advisory-committees.
Dated: August 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18396 Filed 8-25-21; 8:45 am]
BILLING CODE 4164-01-P
