Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher, 52790 [2022-18523]
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Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.regulations.gov, https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances.
Dated: August 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–18517 Filed 8–26–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
countermeasure priority review
vouchers and the approval of products
for which a voucher was redeemed.
FDA has determined that the
application for MOUNJARO
(tirzepatide) injection, approved May
13, 2022, meets the redemption criteria.
For further information about the
Material Threat Medical
Countermeasure Priority Review
Voucher Program and for a link to the
full text of section 565A of the FD&C
Act, go to https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/21st-century-cures-act-mcmrelated-cures-provisions. For further
information about MOUNJARO
(tirzepatide) injection, go to the ‘‘Drugs@
FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: August 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Food and Drug Administration
[Docket No. FDA–2019–N–0895]
[FR Doc. 2022–18523 Filed 8–26–22; 8:45 am]
Notice of Approval of Product Under
Voucher: Material Threat Medical
Countermeasure Priority Review
Voucher
AGENCY:
BILLING CODE 4164–01–P
Food and Drug Administration,
HHS.
ACTION:
Food and Drug Administration
Notice.
[Docket No. FDA–2021–N–0335]
The Food and Drug
Administration (FDA) is announcing the
approval of a product redeeming a
priority review voucher. The Federal
Food, Drug, and Cosmetic Act (FD&C
Act), as amended by the 21st Century
Cures Act, authorizes FDA to award
priority review vouchers to sponsors of
a material threat medical
countermeasure application that meets
certain criteria upon approval of such
application. FDA is required to publish
notice of the issuance of priority review
vouchers as well as the approval of
products redeeming a priority review
voucher. FDA has determined that the
application for MOUNJARO
(tirzepatide) injection, approved May
13, 2022, meets the redemption criteria.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Sadove, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–8515 (this is not
a toll-free number), email: EUA.OCET@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under
section 565A of the FD&C Act (21 U.S.C.
360bbb–4a), which was added by
section 3086 of the 21st Century Cures
Act (Pub. L. 114–255), FDA will report
the issuance of material threat medical
SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
17:01 Aug 26, 2022
Jkt 256001
Authorization of Emergency Use of a
Biological Product During the COVID–
19 Pandemic; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of an Emergency Use
Authorization (EUA) (the Authorization)
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) for use during
the COVID–19 pandemic. FDA has
issued one Authorization for a
biological product as requested by
Novavax, Inc. The Authorization
contains, among other things,
conditions on the emergency use of the
authorized product. The Authorization
follows the February 4, 2020,
determination by the Secretary of Health
and Human Services (HHS) that there is
a public health emergency that has a
significant potential to affect national
security or the health and security of
U.S. citizens living abroad and that
involves a novel (new) coronavirus. The
virus, now named SARS–CoV–2, causes
the illness COVID–19. On the basis of
such determination, the Secretary of
HHS declared on March 27, 2020, that
SUMMARY:
PO 00000
Frm 00054
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circumstances exist justifying the
authorization of emergency use of drugs
and biological products during the
COVID–19 pandemic, pursuant to the
FD&C Act, subject to the terms of any
authorization issued under that section.
The Authorization, which includes an
explanation of the reasons for issuance,
is reprinted in this document.
DATES: The Authorization is effective as
of July 13, 2022.
ADDRESSES: Submit written requests for
a single copy of the EUA to the Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1,
Rm. 4338, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request or include a Fax number to
which the Authorization may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorization.
FOR FURTHER INFORMATION CONTACT:
Michael Mair, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4340, Silver Spring, MD 20993–0002,
301–796–8510 (this is not a toll-free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) allows FDA to
strengthen public health protections
against biological, chemical, nuclear,
and radiological agents. Among other
things, section 564 of the FD&C Act
allows FDA to authorize the use of an
unapproved medical product or an
unapproved use of an approved medical
product in certain situations. With this
EUA authority, FDA can help ensure
that medical countermeasures may be
used in emergencies to diagnose, treat,
or prevent serious or life-threatening
diseases or conditions caused by
biological, chemical, nuclear, or
radiological agents when there are no
adequate, approved, and available
alternatives (among other criteria).
II. Criteria for EUA Authorization
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (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 biological, chemical, radiological,
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29AUN1
]]>Agencies
[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Notices]
[Page 52790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18523]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0895]
Notice of Approval of Product Under Voucher: Material Threat
Medical Countermeasure Priority Review Voucher
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
approval of a product redeeming a priority review voucher. The Federal
Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century
Cures Act, authorizes FDA to award priority review vouchers to sponsors
of a material threat medical countermeasure application that meets
certain criteria upon approval of such application. FDA is required to
publish notice of the issuance of priority review vouchers as well as
the approval of products redeeming a priority review voucher. FDA has
determined that the application for MOUNJARO (tirzepatide) injection,
approved May 13, 2022, meets the redemption criteria.
FOR FURTHER INFORMATION CONTACT: Elizabeth Sadove, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8515
(this is not a toll-free number), email: [email protected].
SUPPLEMENTARY INFORMATION: Under section 565A of the FD&C Act (21
U.S.C. 360bbb-4a), which was added by section 3086 of the 21st Century
Cures Act (Pub. L. 114-255), FDA will report the issuance of material
threat medical countermeasure priority review vouchers and the approval
of products for which a voucher was redeemed. FDA has determined that
the application for MOUNJARO (tirzepatide) injection, approved May 13,
2022, meets the redemption criteria.
For further information about the Material Threat Medical
Countermeasure Priority Review Voucher Program and for a link to the
full text of section 565A of the FD&C Act, go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions. For
further information about MOUNJARO (tirzepatide) injection, go to the
``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: August 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18523 Filed 8-26-22; 8:45 am]
BILLING CODE 4164-01-P
