Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 16216-16217 [2022-06053]
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Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices
The proposal informed Ms. Momin of
the proposed debarment and offered her
an opportunity to request a hearing,
providing her 30 days from the date of
receipt of the letter in which to file the
request, and advised her that failure to
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Ms.
Momin received the proposal and notice
of opportunity for a hearing at her
residence on November 26, 2021. Ms.
Momin failed to request a hearing
within the timeframe prescribed by
regulation and has, therefore, waived
her opportunity for a hearing and
waived any contentions concerning her
debarment (21 CFR part 12).
lotter on DSK11XQN23PROD with NOTICES1
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Ms. Shiba I.
Momin has been convicted of a felony
under Federal law for conduct relating
to the importation into the United States
of any drug or controlled substance.
FDA finds that the offense should be
accorded a debarment period of 5 years
as provided by section 306(c)(2)(A)(iii)
of the FD&C Act.
As a result of the foregoing finding,
Ms. Momin is debarred for a period of
5 years from importing or offering for
import any drug into the United States,
effective (see DATES). Pursuant to section
301(cc) of the FD&C Act (21 U.S.C.
331(cc)), the importing or offering for
import into the United States of any
drug or controlled substance by, with
the assistance of, or at the direction of
Ms. Momin is a prohibited act.
Any application by Ms. Momin for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2021–
N–0417 and sent to the Dockets
Management Staff (see ADDRESSES). The
public availability of information in
these submissions is governed by 21
CFR 10.20(j).
Publicly available submissions will be
placed in the docket and will be
viewable at https://www.regulations.gov
or at the Dockets Management Staff (see
ADDRESSES) between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
Dated: March 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–06036 Filed 3–21–22; 8:45 am]
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18:24 Mar 21, 2022
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0336]
Vaccines and Related Biological
Products 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 Vaccines and Related
Biological Products Advisory
Committee (VRBPAC). The general
function of the committee is to provide
advice and recommendations to FDA on
regulatory issues. This meeting will be
held to discuss considerations for use of
COVID–19 vaccine booster doses and
the process for COVID–19 vaccine strain
selection to address current and
emerging variants. 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 April 6, 2022, from 8:30
a.m. to 5 p.m. Eastern Time. Submit
either electronic or written comments
on this public meeting by April 5, 2022.
Comments received on or before March
31, 2022, will be provided to the
committee. Comments received after
March 31, 2022, and by April 5, 2022,
will be taken into consideration by FDA.
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. The
online web conference meeting will be
available at the following link on the
day of the meeting: https://youtu.be/
x8rq247E80I.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2022–N–0336.
The docket will close on April 5, 2022.
Submit either electronic or written
comments on this public meeting by
April 5, 2022. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
April 5, 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.
SUMMARY:
PO 00000
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Comments received on or before
March 31, 2022, will be provided to the
committee. Comments received March
31, 2022, and by April 5, 2022, 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–0336 for ‘‘Vaccines and Related
Biological Products Advisory
Committee (VRBPAC); Notice of
Meeting; Establishment of a Public
Docket; Request for Comments.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
E:\FR\FM\22MRN1.SGM
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lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices
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., Eastern Time 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, September18, 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:
Prabhakara Atreya or Christina Vert,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Silver Spring, MD
20993–0002, 240–506–4946,
CBERVRBPAC@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
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18:24 Mar 21, 2022
Jkt 256001
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 coming to the meeting.
SUPPLEMENTARY INFORMATION: Consistent
with FDA’s regulations, this notice is
being published with less than 15 days
prior to the date of the meeting based on
a determination that convening a
meeting of the Vaccines and Related
Biological Products Advisory
Committee as soon as possible is
warranted. This notice could not be
published 15 days prior to the date of
the meeting due to the need for prompt
discussion regarding considerations for
use of COVID–19 vaccine booster doses
and the process for COVID–19 vaccine
strain selection to address current and
emerging variants given the COVID–19
pandemic.
Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. On April 6,
2022, the committee will meet in open
session to discuss considerations for use
of additional COVID–19 vaccine booster
doses and the process for COVID–19
vaccine strain selection to address
current and emerging variants.
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 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/Advisory
Committees/Calendar/default.htm.
Scroll down to the appropriate advisory
committee meeting link. 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: On April 6, 2022, from
8:30 a.m. to 5 p.m. Eastern Time, the
meeting is open to the public. Interested
persons may present data, information,
or views, orally or in writing, on issues
pending before the committee. All
electronic and written submissions
submitted to the Docket (see ADDRESSES)
on or before March 31, 2022, will be
provided to the committee. Comments
received after March 31, 2022, and by
PO 00000
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16217
April 5, 2022, will be taken into
consideration by FDA. Oral
presentations from the public will be
scheduled between approximately 1:30
p.m. and 2:30 p.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 email addresses
of proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before March 29, 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 March 30, 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 Prabhakara
Atreya or Christina Vert (see FOR
FURTHER INFORMATION CONTACT) 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/AboutAdvisory
Committees/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: March 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–06053 Filed 3–21–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–3462]
Verification Systems Under the Drug
Supply Chain Security Act for Certain
Prescription Drugs; Draft Guidance for
Industry; Correction
Food and Drug Administration,
Department of Health and Human
Services (HHS).
AGENCY:
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[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16216-16217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06053]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0336]
Vaccines and Related Biological Products 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 Vaccines and Related
Biological Products Advisory Committee (VRBPAC). The general function
of the committee is to provide advice and recommendations to FDA on
regulatory issues. This meeting will be held to discuss considerations
for use of COVID-19 vaccine booster doses and the process for COVID-19
vaccine strain selection to address current and emerging variants. 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 April 6, 2022, from 8:30
a.m. to 5 p.m. Eastern Time. Submit either electronic or written
comments on this public meeting by April 5, 2022. Comments received on
or before March 31, 2022, will be provided to the committee. Comments
received after March 31, 2022, and by April 5, 2022, will be taken into
consideration by FDA.
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. The online
web conference meeting will be available at the following link on the
day of the meeting: https://youtu.be/x8rq247E80I.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2022-N-0336. The docket will close on April 5,
2022. Submit either electronic or written comments on this public
meeting by April 5, 2022. Please note that late, untimely filed
comments will not be considered. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of April 5, 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 March 31, 2022, will be provided to
the committee. Comments received March 31, 2022, and by April 5, 2022,
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-0336 for ``Vaccines and Related Biological Products Advisory
Committee (VRBPAC); Notice of Meeting; Establishment of a Public
Docket; Request for Comments.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be
[[Page 16217]]
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., Eastern Time
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, September18, 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: Prabhakara Atreya or Christina Vert,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD
20993-0002, 240-506-4946, [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
coming to the meeting.
SUPPLEMENTARY INFORMATION: Consistent with FDA's regulations, this
notice is being published with less than 15 days prior to the date of
the meeting based on a determination that convening a meeting of the
Vaccines and Related Biological Products Advisory Committee as soon as
possible is warranted. This notice could not be published 15 days prior
to the date of the meeting due to the need for prompt discussion
regarding considerations for use of COVID-19 vaccine booster doses and
the process for COVID-19 vaccine strain selection to address current
and emerging variants given the COVID-19 pandemic.
Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On April 6,
2022, the committee will meet in open session to discuss considerations
for use of additional COVID-19 vaccine booster doses and the process
for COVID-19 vaccine strain selection to address current and emerging
variants.
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 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 appropriate advisory committee meeting link. 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: On April 6, 2022, from 8:30 a.m. to 5 p.m. Eastern Time,
the meeting is open to the public. Interested persons may present data,
information, or views, orally or in writing, on issues pending before
the committee. All electronic and written submissions submitted to the
Docket (see ADDRESSES) on or before March 31, 2022, will be provided to
the committee. Comments received after March 31, 2022, and by April 5,
2022, will be taken into consideration by FDA. Oral presentations from
the public will be scheduled between approximately 1:30 p.m. and 2:30
p.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 email addresses of proposed participants, and
an indication of the approximate time requested to make their
presentation on or before March 29, 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 March 30, 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 Prabhakara Atreya or Christina Vert (see FOR FURTHER
INFORMATION CONTACT) 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: March 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-06053 Filed 3-21-22; 8:45 am]
BILLING CODE 4164-01-P
