Authorizations of Emergency Use of Certain Drug and Biological Products During the COVID-19 Pandemic; Availability
| Published date | 19 February 2021 |
| Citation | 86 FR 10290 |
| Record Number | 2021-03429 |
| Section | Notices |
| Court | Food And Drug Administration |
10290
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1
In the case of a determination by the Secretary
of Defense, the Secretary of HHS shall determine
within 45 calendar days of such determination,
whether to make a declaration under section
564(b)(1) of the FD&C Act, and, if appropriate, shall
promptly make such a declaration.
scientific and academic experts, notify
FDA of their intent to participate in the
periodic stakeholder consultation
meetings on MDUFA reauthorization.
FDA believes that consistent
stakeholder representation at these
meetings will be important to ensure
progress in these discussions. If you
wish to participate in the stakeholder
consultation meetings, please designate
one or more representatives from your
organization who will commit to
attending these meetings and preparing
for the discussions. Stakeholders who
identify themselves through this notice,
and are otherwise eligible to attend, may
participate in all stakeholder
consultation discussions while FDA
negotiates with the regulated industry.
These stakeholder discussions will
satisfy the consultation requirement in
section 738A(b)(3) of the FD&C Act.
II. Notification of Intent To Participate
in Periodic Stakeholder Consultation
Meetings
If you intend to participate in
continued periodic stakeholder
consultation meetings regarding
MDUFA reauthorization, please provide
notification by email to
MDUFAVReauthorization@fda.hhs.gov
by February 26, 2021. Your email
should contain complete contact
information, including name, title,
affiliation, address, email address,
phone number, and notice of any
special accommodations required
because of disability. Stakeholders will
receive confirmation and additional
information about the first meeting from
FDA after the Agency receives this
notification.
Dated: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03428 Filed 2–18–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2305]
Authorizations of Emergency Use of
Certain Drug and Biological Products
During the COVID–19 Pandemic;
Availability
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice.
SUMMARY
: The Food and Drug
Administration (FDA) is announcing the
issuance of five Emergency Use
Authorizations (EUAs) (the
Authorizations) under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) for
drug and biological products for use
during the COVID–19 pandemic. FDA
issued one Authorization for a drug as
requested by Baxter Healthcare
Corporation (Baxter); one Authorization
for a biological product as requested by
the Office of the Assistant Secretary for
Preparedness and Response at the U.S.
Department of Health and Human
Services (ASPR/HHS); an Authorization
for a drug and an Authorization for a
biological product as requested by Eli
Lilly and Company; and one
Authorization for biological products as
requested by Regeneron
Pharmaceuticals, Inc. The
Authorizations contain, among other
things, conditions on the emergency use
of the authorized products. The
Authorizations follow the February 4,
2020, determination by the Secretary of
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
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 Authorizations, which include an
explanation of the reasons for issuance,
are reprinted in this document.
DATES
: The Authorization for Baxter is
effective as of August 13, 2020; the
Authorization for ASPR/HHS is
effective as of August 23, 2020; the
Authorizations for Eli Lilly and
Company are effective as of November
9, 2020, and November 19, 2020,
respectively; and the Authorization for
Regeneron Pharmaceuticals, Inc. is
effective as of November 21, 2020.
ADDRESSES
: Submit written requests for
single copies of the EUAs 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 Authorizations may be sent.
See the
SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorizations.
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 the 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.
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,
or nuclear agent or agents; (2) 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 U.S. military forces,
including personnel operating under the
authority of title 10 or title 50, U.S.
Code, of attack with (A) a biological,
chemical, radiological, or nuclear agent
or agents; or (B) an agent or agents that
may cause, or are otherwise associated
with, an imminently life-threatening
and specific risk to U.S. military
forces;
1
(3) a determination by the
Secretary of HHS 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 U.S. citizens living
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2
The Secretary of HHS has delegated the
authority to issue an EUA under section 564 of the
FD&C Act to the Commissioner of Food and Drugs.
abroad, and that involves a biological,
chemical, radiological, or nuclear agent
or agents, or a disease or condition that
may be attributable to such agent or
agents; or (4) the identification of a
material threat by the Secretary of
Homeland Security pursuant to section
319F–2 of the Public Health Service
(PHS) Act (42 U.S.C. 247d–6b) sufficient
to affect national security or the health
and security of U.S. citizens living
abroad.
Once the Secretary of HHS has
declared that circumstances exist
justifying an authorization under
section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
Agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is
required to publish in the Federal
Register a notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
reasons for the action. Section 564 of the
FD&C Act permits FDA to authorize the
introduction into interstate commerce of
a drug, device, or biological product
intended for use when the Secretary of
HHS has declared that circumstances
exist justifying the authorization of
emergency use. Products appropriate for
emergency use may include products
and uses that are not approved, cleared,
or licensed under sections 505, 510(k),
512, or 515 of the FD&C Act (21 U.S.C.
355, 360(k), 360b, and 360e) or section
351 of the PHS Act (42 U.S.C. 262), or
conditionally approved under section
571 of the FD&C Act (21 U.S.C. 360ccc).
FDA may issue an EUA only if, after
consultation with the HHS Assistant
Secretary for Preparedness and
Response, the Director of the National
Institutes of Health, and the Director of
the Centers for Disease Control and
Prevention (to the extent feasible and
appropriate given the applicable
circumstances), FDA
2
concludes: (1)
That an agent referred to in a
declaration of emergency or threat can
cause a serious or life-threatening
disease or condition; (2) that, based on
the totality of scientific evidence
available to FDA, including data from
adequate and well-controlled clinical
trials, if available, it is reasonable to
believe that: (A) The product may be
effective in diagnosing, treating, or
preventing (i) such disease or condition;
or (ii) a serious or life-threatening
disease or condition caused by a
product authorized under section 564,
approved or cleared under the FD&C
Act, or licensed under section 351 of the
PHS Act, for diagnosing, treating, or
preventing such a disease or condition
caused by such an agent; and (B) the
known and potential benefits of the
product, when used to diagnose,
prevent, or treat such disease or
condition, outweigh the known and
potential risks of the product, taking
into consideration the material threat
posed by the agent or agents identified
in a declaration under section
564(b)(1)(D) of the FD&C Act, if
applicable; (3) that there is no adequate,
approved, and available alternative to
the product for diagnosing, preventing,
or treating such disease or condition; (4)
in the case of a determination described
in section 564(b)(1)(B)(ii), that the
request for emergency use is made by
the Secretary of Defense; and (5) that
such other criteria as may be prescribed
by regulation are satisfied.
No other criteria for issuance have
been prescribed by regulation under
section 564(c)(4) of the FD&C Act.
III. The Authorizations
The Authorizations follow the
February 4, 2020, determination by the
Secretary of 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. Notice of the Secretary’s
determination was provided in the
Federal Register on February 7, 2020
(85 FR 7316). On the basis of such
determination, the Secretary of HHS
declared on March 27, 2020, that
circumstances exist justifying the
authorization of emergency use of drugs
and biological products during the
COVID–19 pandemic, pursuant to
section 564 of the FD&C Act, subject to
the terms of any authorization issued
under that section. Notice of the
Secretary’s declaration was provided in
the Federal Register on April 1, 2020
(85 FR 18250). Having concluded that
the criteria for issuance of the
Authorizations under section 564(c) of
the FD&C Act are met, FDA issued five
authorizations for the emergency use of
drug and biological products during the
COVID–19 pandemic. On August 13,
2020, FDA issued an EUA to Baxter for
REGIOCIT, subject to the terms of the
Authorization. On August 23, 2020,
FDA issued an EUA to ASPR/HHS for
COVID–19 convalescent plasma, subject
to the terms of the Authorization. On
November 9, 2020, FDA issued an EUA
to Eli Lilly and Company for
bamlanivimab, subject to the terms of
the Authorization (technical correction
on November 10, 2020). On November
19, 2020, FDA issued an EUA to Eli
Lilly and Company for OLUMIANT
(baricitinib), for use in combination
with VEKLURY (remdesivir), subject to
the terms of the Authorization. On
November 21, 2020, FDA issued an EUA
to Regeneron Pharmaceuticals, Inc. for
casirivimab and imdevimab,
administered together, subject to the
terms of the Authorization. The
Authorizations, which are included
after section IV of this document in their
entirety (not including the authorized
versions of the fact sheets and other
written materials), provide an
explanation of the reasons for issuance,
as required by section 564(h)(1) of the
FD&C Act. Any subsequent reissuances
of these Authorizations can be found on
FDA’s web page: https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policy-
framework/emergency-use-
authorization.
IV. Electronic Access
An electronic version of this
document and the full text of the
Authorizations are available on the
internet at https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policy-
framework/emergency-use-
authorization.
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Dated: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03429 Filed 2–18–21; 8:45 am]
BILLING CODE 4164–01–C
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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; RFP–NIH–NIAID–DAIT–
75N93020R00018: Transplantation Statistical
and Clinical Coordinating Center (T–SCCC).
Date: March 18, 2021.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G53,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Konrad Krzewski, 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, Room 3G53, Rockville, MD
20852, 240–747–7526, konrad.krzewski@
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: February 12, 2021.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–03387 Filed 2–18–21; 8:45 am]
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; Microbiology and Infectious Diseases
B Subcommittee MID–B Review Committee
03/2021.
Date: March 15–17, 2021.
Time: 11:00 a.m. to 6:00 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 3F30,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Ellen S. Buczko, 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, Room 3F30, Rockville, MD
20852, 301–451–2676, ebuczko1@
niaid.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)
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