Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Draft Guidance for Industry; Correction, 16217-16218 [2022-06006]
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Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices
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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,
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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 This notice could not be
published 15 days prior to the date of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
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on or before March 31, 2022, will be
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received after March 31, 2022, and by
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April 5, 2022, will be taken into
consideration by FDA. Oral
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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.
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FURTHER INFORMATION CONTACT) at least 7
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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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16218
ACTION:
Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice entitled ‘‘Verification Systems
Under the Drug Supply Chain Security
Act for Certain Prescription Drugs; Draft
Guidance for Industry’’ that appeared in
the Federal Register of March 10, 2022.
The document omitted the date by
which comments on the draft guidance
should be submitted to FDA. This error
is corrected in this document for clarity.
FOR FURTHER INFORMATION CONTACT:
Sarah Venti, Office of Compliance,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–3130, drugtrackandtrace@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of March 10, 2022 (87
FR 13738), appearing on page 13738, in
FR Doc. 2022–05018, in the second
column, the DATES section is corrected
to read as follows:
DATES: The announcement of the
guidance is published in the Federal
Register on March 10, 2022. Although
you can comment on any guidance at
any time (see 21 CFR 10.115(g)(5)), to
ensure that the Agency considers your
comment on this draft guidance before
it begins work on the final version of the
guidance, submit either electronic or
written comments on the draft guidance
by May 9, 2022.
SUMMARY:
Dated: March 17, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation,
and International Affairs, U.S. Food and Drug
Administration.
[FR Doc. 2022–06006 Filed 3–21–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
lotter on DSK11XQN23PROD with NOTICES1
National Institute of Diabetes and
Digestive and Kidney Diseases;
Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Diabetes and Digestive and Kidney
Diseases Special Emphasis Panel, March
23, 2022, 09:00 a.m. to March 24, 2022,
04:00 p.m., National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD, 20892 which was
published in the Federal Register on
February 25, 2022, 308582.
Dr. Kozel wants to change the date for
his meeting. The meeting is closed to
the public.
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Dated: March 16, 2022.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2022–05966 Filed 3–21–22; 8:45 am]
Center for Scientific Review; Amended
Notice of Meeting
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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: Microbiology,
Infectious Diseases and AIDS Initial Review
Group; Acquired Immunodeficiency
Syndrome Research Study Section; Acquired
Immunodeficiency Syndrome Research
Study Section (AIDS).
Date: April 20, 2022.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F40A,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Dimitrios Nikolaos
Vatakis, Ph.D., Scientific Review Officer,
Scientific Review Program, Division of
Extramural Activities, National Institute of
Allergy and Infectious Diseases, National
Institutes of Health, 5601 Fishers Lane, MSC–
9823, Bethesda, MD 20892, (301) 761–7176,
dimitrios.vatakis@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: March 16, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–05968 Filed 3–21–22; 8:45 am]
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National Institutes of Health
Notice is hereby given of a change in
the meeting of the Sleep Disorders
Research Advisory Board, April 7, 2022,
12:00 p.m. to 5:00 p.m., Virtual Meeting,
which was published in the Federal
Register on March 09, 2022, V 87 Vol.
46, Page 13302, FR Doc No. 2022–
04982.
Meeting is being amended to change
the telephone call in number to 1–669–
254–5252 (Meeting ID: 161 532 8417
Passcode: 330488). The meeting is open
to the public.
Dated: March 16, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–05969 Filed 3–21–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Clinical Trials and
Comparative Effectiveness Studies in
Neurology.
Date: March 28–29, 2022.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Shanta Rajaram, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Activities,
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Agencies
[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16217-16218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06006]
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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
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
[[Page 16218]]
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
entitled ``Verification Systems Under the Drug Supply Chain Security
Act for Certain Prescription Drugs; Draft Guidance for Industry'' that
appeared in the Federal Register of March 10, 2022. The document
omitted the date by which comments on the draft guidance should be
submitted to FDA. This error is corrected in this document for clarity.
FOR FURTHER INFORMATION CONTACT: Sarah Venti, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130,
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of March 10, 2022
(87 FR 13738), appearing on page 13738, in FR Doc. 2022-05018, in the
second column, the DATES section is corrected to read as follows:
DATES: The announcement of the guidance is published in the Federal
Register on March 10, 2022. Although you can comment on any guidance at
any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers
your comment on this draft guidance before it begins work on the final
version of the guidance, submit either electronic or written comments
on the draft guidance by May 9, 2022.
Dated: March 17, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation, and International Affairs,
U.S. Food and Drug Administration.
[FR Doc. 2022-06006 Filed 3-21-22; 8:45 am]
BILLING CODE 4164-01-P