Declaration That Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (Monkeypox), 56074-56075 [2022-19752]
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Federal Register / Vol. 87, No. 176 / Tuesday, September 13, 2022 / Notices
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
On page 41322, in the table, the
entries for ANDAs 204180 and 205790
are removed.
Dated: September 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–19715 Filed 9–12–22; 8:45 am]
BILLING CODE 4164–01–P
Dated: September 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2022–19714 Filed 9–12–22; 8:45 am]
BILLING CODE 4164–01–P
Office of the Secretary
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice of Interest Rate on Overdue
Debts
Food and Drug Administration
Section 30.18 of the Department of
Health and Human Services’ claims
collection regulations (45 CFR part 30)
provides that the Secretary shall charge
an annual rate of interest, which is
determined and fixed by the Secretary
of the Treasury after considering private
consumer rates of interest on the date
that the Department of Health and
Human Services becomes entitled to
recovery. The rate cannot be lower than
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value of funds rate or the applicable rate
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Certified Interest Rates with Range of
Maturities’’ unless the Secretary waives
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quarterly. The Department of Health and
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The current rate of 83⁄4%, as fixed by
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This rate is based on the Interest Rates
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[Docket No. FDA–2022–N–1349]
Mikart, LLC, et al.; Withdrawal of
Approval of 31 Abbreviated New Drug
Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on July 12, 2022. The
document announced the withdrawal of
approval (as of August 11, 2022) of 31
abbreviated new drug applications
(ANDAs) from multiple applicants. The
document indicated that FDA was
withdrawing approval of the following
ANDAs after receiving withdrawal
requests from USpharma Windlas, LLC,
115 Blue Jay Dr., Suite 101, Liberty, MO
64068: ANDA 204180, Amiloride
Hydrochloride Tablets, 5 milligrams
(mg); and ANDA 205790, Prasugrel
Tablets, Equivalent to (EQ) 5 mg base
and EQ 10 mg base. Before FDA
withdrew the approval of these ANDAs,
USpharma Windlas, LLC, informed FDA
that it did not want the approval of the
ANDAs withdrawn. Because USpharma
Windlas, LLC, timely requested that
approval of ANDAs 204180 and 205790
not be withdrawn, the approvals are still
in effect.
SUMMARY:
jspears on DSK121TN23PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
David C. Horn,
Director, Office of Financial Policy and
Reporting, (202) 260–9658.
[FR Doc. 2022–19780 Filed 9–12–22; 8:45 am]
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In the
Federal Register of Tuesday, July 12,
2022 (87 FR 41322), in FR Doc. 2022–
14798, the following correction is made:
SUPPLEMENTARY INFORMATION:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Declaration That Circumstances Exist
Justifying Authorizations Pursuant to
Section 564 of the Federal Food, Drug,
and Cosmetic Act (Monkeypox)
Department of Health and
Human Services (HHS).
ACTION: Notice.
AGENCY:
The Secretary of Health and
Human Services (HHS) is issuing this
notice pursuant to the Federal Food,
Drug, and Cosmetic (FD&C) Act. On
August 9, 2022, the Secretary
determined pursuant to his authority
under the FD&C Act that there is a
public health emergency, or a
significant potential for a public health
emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
United States citizens living abroad that
involves monkeypox virus.
On the basis of this determination, he
declared on September 7, 2022 that
circumstances exist justifying
authorizations of emergency use of in
vitro diagnostics for detection and/or
diagnosis of infection with the
monkeypox virus, including in vitro
diagnostics that detect and/or diagnose
infection with non-variola
Orthopoxvirus, pursuant to the FD&C
Act.
DATES: The determination was effective
August 9, 2022 and the declaration is
effective September 7, 2022.
FOR FURTHER INFORMATION CONTACT:
Dawn O’Connell, Assistant Secretary for
Preparedness and Response,
Administration for Strategic
Preparedness and Response, Department
of Health and Human Services, 200
Independence Avenue SW, Washington,
DC 20201, Telephone (202) 205–2882
(this is not a toll-free number).
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Under section 564 of the FD&C Act,
21 U.S.C. 360bbb–3, the Commissioner
of Food and Drugs of the U.S. Food and
Drug Administration (FDA), acting
under delegated authority from the
Secretary of HHS, may issue an
Emergency Use Authorization (EUA)
authorizing: (1) the emergency use of an
unapproved drug, an unapproved or
uncleared device, or an unlicensed
biological product; or (2) an unapproved
use of an approved drug, approved or
cleared device, or licensed biological
product. Before an EUA may be issued,
the Secretary of HHS must declare that
circumstances exist justifying the
authorization based on one of four
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Federal Register / Vol. 87, No. 176 / Tuesday, September 13, 2022 / Notices
determinations: (1) A determination by
the Secretary of Homeland Security that
there is a domestic emergency, or a
significant potential for a domestic
emergency, involving a heightened risk
of attack with a, chemical, biological,
radiological, or nuclear (‘‘CBRN’’) agent
or agents; (2) the identification of a
material threat by the Secretary of
Homeland Security pursuant to section
319F–2 of the Public Health Service
(PHS) Act [1] sufficient to affect national
security or the health and security of
United States citizens living abroad; (3)
a determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to United States military
forces, including personnel operating
under the authority of title 10 or title 50,
of attack with (i) a biological, chemical,
radiological, or nuclear agent or agents;
or (ii) an agent or agents that may cause,
or are otherwise associated with, an
imminently life-threatening and specific
risk to United States military forces; or
(4) a determination by the Secretary that
there is a public health emergency, or a
significant potential for a public health
emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
United States citizens living abroad, and
that involves a CBRN agent or agents, or
a disease or condition that may be
attributable to such agent or agents.[2]
Based on any of these four
determinations, the Secretary of HHS
may then declare that circumstances
exist that justify the EUA, at which
point the Commissioner of Food and
Drugs may issue an EUA if the criteria
for issuance of an authorization under
section 564 of the FD&C Act are met.
The ASPR requested that the
Secretary issue the declaration to allow
the Department to take measures based
on information currently available about
monkeypox virus. The determination of
a public health emergency or a
significant potential for a public health
emergency, and the declaration that
circumstances exist justifying
emergency use of in vitro diagnostics for
detection and/or diagnosis of infection
with the monkeypox virus, including in
vitro diagnostics that detect and/or
diagnose infection with non-variola
Orthopoxvirus by the Secretary of HHS,
as described below, enable the
Commissioner of Food and Drugs to
issue EUAs for in vitro diagnostics for
detection and/or diagnosis of infection
with the monkeypox virus, including in
vitro diagnostics that detect and/or
diagnose infection with non-variola
Orthopoxvirus for emergency use under
section 564 of the FD&C Act.
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II. Determination by the Secretary of
Health and Human Services
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
On August 9, 2022, pursuant to
section 564 of the FD&C Act, I
determined that there is a public health
emergency, or a significant potential for
a public health emergency, that affects,
or has a significant potential to affect,
national security or the health and
security of United States citizens living
abroad that involves monkeypox virus.
[Document Identifier: OS–0990–New]
III. Declaration of the Secretary of
Health and Human Services
On September 7, 2022, on the basis of
my August 9, 2022 determination that
there is a public health emergency, or a
significant potential for a public health
emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
United States citizens living abroad and
that involves monkeypox virus, I
declared that circumstances exist
justifying authorizations of emergency
use of in vitro diagnostics for detection
and/or diagnosis of infection with the
monkeypox virus, including in vitro
diagnostics that detect and/or diagnose
infection with non-variola
Orthopoxvirus, pursuant to section 564
of the FD&C Act, subject to the terms of
any authorization issued under that
section.
Notice of the EUAs issued by the
Commissioner of Food and Drugs
pursuant to this determination and
declaration will be provided promptly
in the Federal Register as required
under section 564 of the FD&C Act.
Xavier Becerra,
Secretary, U.S. Department of Health and
Human Services.
Footnotes
1. 42 U.S.C. 247d–6b.
2. As amended by the Pandemic and AllHazards Preparedness Reauthorization
Act, Public Law 113–5, the Secretary
may make a determination of a public
health emergency, or a significant
potential for a public health emergency,
under section 564 of the FD&C Act. The
Secretary is no longer required to make
a determination of a public health
emergency in accordance with section
319 of the PHS Act, 42 U.S.C. 247d to
support a determination or declaration
made under section 564 of the FD&C Act.
[FR Doc. 2022–19752 Filed 9–12–22; 8:45 am]
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Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before October 13, 2022.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 264–0041. When submitting
comments or requesting information,
please include the document identifier
0990-New-30D and project title for
reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Evaluation of
the Extension of the Certified
Community Behavioral Health Clinic
(CCBHC) Demonstration Program.
Type of Collection: New.
OMB No.: 0990–NEW—Office of the
Assistant Secretary for Planning and
Evaluation.
Abstract: The Office of the Assistant
Secretary for Planning and Evaluation
(ASPE) at the U.S. Department of Health
and Human Services (HHS) is
requesting Office of Management and
Budget (OMB) approval for new data
collection activities to support its
SUMMARY:
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]]>Agencies
[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Pages 56074-56075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19752]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Declaration That Circumstances Exist Justifying Authorizations
Pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act
(Monkeypox)
AGENCY: Department of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Secretary of Health and Human Services (HHS) is issuing
this notice pursuant to the Federal Food, Drug, and Cosmetic (FD&C)
Act. On August 9, 2022, the Secretary determined pursuant to his
authority under the FD&C Act that there is a public health emergency,
or a significant potential for a public health emergency, that affects,
or has a significant potential to affect, national security or the
health and security of United States citizens living abroad that
involves monkeypox virus.
On the basis of this determination, he declared on September 7,
2022 that circumstances exist justifying authorizations of emergency
use of in vitro diagnostics for detection and/or diagnosis of infection
with the monkeypox virus, including in vitro diagnostics that detect
and/or diagnose infection with non-variola Orthopoxvirus, pursuant to
the FD&C Act.
DATES: The determination was effective August 9, 2022 and the
declaration is effective September 7, 2022.
FOR FURTHER INFORMATION CONTACT: Dawn O'Connell, Assistant Secretary
for Preparedness and Response, Administration for Strategic
Preparedness and Response, Department of Health and Human Services, 200
Independence Avenue SW, Washington, DC 20201, Telephone (202) 205-2882
(this is not a toll-free number).
SUPPLEMENTARY INFORMATION:
I. Background
Under section 564 of the FD&C Act, 21 U.S.C. 360bbb-3, the
Commissioner of Food and Drugs of the U.S. Food and Drug Administration
(FDA), acting under delegated authority from the Secretary of HHS, may
issue an Emergency Use Authorization (EUA) authorizing: (1) the
emergency use of an unapproved drug, an unapproved or uncleared device,
or an unlicensed biological product; or (2) an unapproved use of an
approved drug, approved or cleared device, or licensed biological
product. Before an EUA may be issued, the Secretary of HHS must declare
that circumstances exist justifying the authorization based on one of
four
[[Page 56075]]
determinations: (1) A determination by the Secretary of Homeland
Security that there is a domestic emergency, or a significant potential
for a domestic emergency, involving a heightened risk of attack with a,
chemical, biological, radiological, or nuclear (``CBRN'') agent or
agents; (2) the identification of a material threat by the Secretary of
Homeland Security pursuant to section 319F-2 of the Public Health
Service (PHS) Act \[1]\ sufficient to affect national security or the
health and security of United States citizens living abroad; (3) a
determination by the Secretary of Defense that there is a military
emergency, or a significant potential for a military emergency,
involving a heightened risk to United States military forces, including
personnel operating under the authority of title 10 or title 50, of
attack with (i) a biological, chemical, radiological, or nuclear agent
or agents; or (ii) an agent or agents that may cause, or are otherwise
associated with, an imminently life-threatening and specific risk to
United States military forces; or (4) a determination by the Secretary
that there is a public health emergency, or a significant potential for
a public health emergency, that affects, or has a significant potential
to affect, national security or the health and security of United
States citizens living abroad, and that involves a CBRN agent or
agents, or a disease or condition that may be attributable to such
agent or agents.\[2]\
Based on any of these four determinations, the Secretary of HHS may
then declare that circumstances exist that justify the EUA, at which
point the Commissioner of Food and Drugs may issue an EUA if the
criteria for issuance of an authorization under section 564 of the FD&C
Act are met.
The ASPR requested that the Secretary issue the declaration to
allow the Department to take measures based on information currently
available about monkeypox virus. The determination of a public health
emergency or a significant potential for a public health emergency, and
the declaration that circumstances exist justifying emergency use of in
vitro diagnostics for detection and/or diagnosis of infection with the
monkeypox virus, including in vitro diagnostics that detect and/or
diagnose infection with non-variola Orthopoxvirus by the Secretary of
HHS, as described below, enable the Commissioner of Food and Drugs to
issue EUAs for in vitro diagnostics for detection and/or diagnosis of
infection with the monkeypox virus, including in vitro diagnostics that
detect and/or diagnose infection with non-variola Orthopoxvirus for
emergency use under section 564 of the FD&C Act.
II. Determination by the Secretary of Health and Human Services
On August 9, 2022, pursuant to section 564 of the FD&C Act, I
determined that there is a public health emergency, or a significant
potential for a public health emergency, that affects, or has a
significant potential to affect, national security or the health and
security of United States citizens living abroad that involves
monkeypox virus.
III. Declaration of the Secretary of Health and Human Services
On September 7, 2022, on the basis of my August 9, 2022
determination that there is a public health emergency, or a significant
potential for a public health emergency, that affects, or has a
significant potential to affect, national security or the health and
security of United States citizens living abroad and that involves
monkeypox virus, I declared that circumstances exist justifying
authorizations of emergency use of in vitro diagnostics for detection
and/or diagnosis of infection with the monkeypox virus, including in
vitro diagnostics that detect and/or diagnose infection with non-
variola Orthopoxvirus, pursuant to section 564 of the FD&C Act, subject
to the terms of any authorization issued under that section.
Notice of the EUAs issued by the Commissioner of Food and Drugs
pursuant to this determination and declaration will be provided
promptly in the Federal Register as required under section 564 of the
FD&C Act.
Xavier Becerra,
Secretary, U.S. Department of Health and Human Services.
Footnotes
1. 42 U.S.C. 247d-6b.
2. As amended by the Pandemic and All-Hazards Preparedness
Reauthorization Act, Public Law 113-5, the Secretary may make a
determination of a public health emergency, or a significant
potential for a public health emergency, under section 564 of the
FD&C Act. The Secretary is no longer required to make a
determination of a public health emergency in accordance with
section 319 of the PHS Act, 42 U.S.C. 247d to support a
determination or declaration made under section 564 of the FD&C Act.
[FR Doc. 2022-19752 Filed 9-12-22; 8:45 am]
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