Authorization of Emergency Use of a Biological Product During the COVID-19 Pandemic; Availability, 16201-16212 [2022-06009]
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Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices
We have decreased our estimated
burden associated with disclosures to
reflect a decrease in related submissions
over the past 3 years.
Dated: March 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
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.
[FR Doc. 2022–06034 Filed 3–21–22; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4164–01–P
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).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0335]
SUPPLEMENTARY INFORMATION:
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 Eli
Lilly and Company (Lilly). 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
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 February 11, 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–
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SUMMARY:
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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,
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
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16201
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
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. Under section
564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available
on the internet website of FDA. 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 in
an actual or potential emergency 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),
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.
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Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices
FDA 2 concludes: (1) That an agent
referred to in a declaration of emergency
or threat can cause a serious or lifethreatening 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 lifethreatening 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)
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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.
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in the case of a determination described
in section 564(b)(1)(B)(ii) of the FD&C
Act, 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 Authorization
The Authorization follows 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
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the criteria for issuance of the
Authorization under section 564(c) of
the FD&C Act are met, FDA has issued
the authorization for the emergency use
of a biological product during the
COVID–19 pandemic. On February 11,
2022, FDA issued an EUA to Lilly for
the biological product bebtelovimab,
subject to the terms of the
Authorization. The initial
Authorization, which is included below
in its entirety after section IV of this
document (not including the authorized
versions of the fact sheets and other
written materials), provides an
explanation of the reasons for issuance,
as required by section 564(h)(1) of the
FD&C Act. Any subsequent reissuance
of the Authorization can be found on
FDA’s web page at: https://
www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization.
IV. Electronic Access
An electronic version of this
document and the full text of the
Authorization is available on the
internet at: https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/emergency-useauthorization.
BILLING CODE 4164–01–P
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Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices
16203
February 11, 2Q::Z2
Eli tllly attd Company
Attet1-tion: Cbris:tfue Ph.illi,p.$', PhD, RAC
A4vis:or G.fobalRegulatory Affail'.S: • US
Lilly Corporate Center
D.te>p Code 2543
Illdianapulis, IN462J½5
RE;
Emergency Use A;uthori1:atiorr 111
Oear Ms. Phillips:
'th.is letter is in response t◊ Eli LIily an.d Company's etilly") requestthatthe Food and Drug
an
Administration (FDA or Agency) issue EmergencyUseAuthorization(EUA)forthe
emergency use or bebtelovimabforthe rreatrt1ent ofmild~to-moderate coronavirus disease2019
(CCiVID-19) lft certain adults ruid pediatric patients who are athigh-tisk forptogressionto
severe COVJD-19, irichrdiug.hospitali:di:<tn or death, putst1a.i:1Jt◊ Section 564 of.1he FedeQll
food, Dru& and.Coi.metic Act(the Act)(2l l1S,C. §36Obllb-3t
Orr February 4, 2020, pursuantto Section 564(b)(i )(<:;) ot'the:Act; the Secretary ot'tfre
Departmertt ofllealth attdliw:i:umServices (HFtS) determined tluttthete is a l,)ublic health
eme:rgency thathas ai;igniftc-antp◊tentlal to ~fect11;;ttiQllai security ortheheal1b.andsecurity of
United States citizens:livmgabroad, and thatinvolves the virus that-causes coronavirus disease
2DT9 (CCiVID-19). l On the basis of such detemnnation, the Secretazy ofHHS onMarch 27,
2020:, declared lhatcirc:umstances exiiajuslifyingtbe authorization o:femergency use ol'dtugs
artd bjologi_caI ptodu:cis duting:the COVU>-19 part4emic, p.urs:uartno Se:ctio:ttSM nfihe: Act (21
U.S.C. 360bbb-3),subjectto terms of any authorization issued underthatsection. 2
Bebtelovinmh fa a neutralizfogtgd-j monoclonal antibody that.hinds to an epltopewithln the•
receptor binding domain ofthespike protein of SARS.:CoW2, :8ebtelovonab is nolfDAapp:rovedfor anyµses, lncludingttSe as tnmtmentfor COVID-19,
Based on the re,,iew of the data from the BLAZE-4 clinical trial(NCT04634409); a Phase l/2
randomized, single-doae: clinic-al trial studying bebtefovonabfot !he tteatmerttofnon~
bospi~liied patiet1-ts \il-.iih nrild~to-moder$ CQVID-19; . as. well ·as .availabJephirf!11a®kinetic
data and nonclinical viral neutralization: data for Omicron and· oUla: v:ariants of concern, itis
reasonable to beHeve that bebtelovimab may be etrective f orthe treatment of mild~to-rnoderate
1 tis, t)epilJifiiimtvt"rtea:J'.1h ;ind IJum;an $&v1ci::$;l)ekrminr:Jtfo11pf(IPitMiP1ff!althEmerger,cya,ui~l.gl'(lti.qn
ihatCfrcumstancesExistJustlfyingAuthorizaiionsPU/'$Ullnt toSecti.011564(Nofihe.Fedi!n:dFood, Drug, a.nd
Cosmeiic:Act 2.1 U,S;C. §360bbb-3.Februaty4.2;020\
.·.
. ·
i LL.$;•1,kpartmcnto:fl:lcalth lllid Bummt $crv.iccs,.lk/qtlfatt0!1.th@Ctr¢.1i®1aii&tEir;ist,JiiStf/jiingAi:i#iiiniiiltdris
Pursu,rmNt>Sedirm 564(b) (Jfi_heFitderalFood,.l>n!g,andC()srneticAc1(, 21 TJ.S.:C.§360:/Jb/;.3, 85 FR 18250
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(April 1,2020),
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Page 2 - Eli Lilly and Company
COVID-19 in adults and pediatric patients ( 12 years of age and older weighing at least 40 kg)
who are at high-risk for progression to severe COVID-19, including hospitalization or death, and
for whom alternative COVID-19 treatment options approved or authorized by FDA arc not
accessible or clinically appropriate, as described in the Scope ofAuthorization(Section II), and
when used under the conditions described in this authorization, the known and potential benefits
ofbebtclovimab outweigh the known and potential risks of such product.
Having concluded that the criteria for issuance of this authorization under Section 564(c) of the
Act are met, I am authorizing the emergency use ofbebtelovimab forthc treatment of mild-tomoderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least
40 kg) who are at high-risk forprogression to severe COVID-19, including hospitalization or
death, as described in the Scope of Authorization section of this letter (Section II) and subject to
the terms of this authorization.
I.
Criteria for Issuance of Authorization
I have concluded that the emergency use ofbebtelovimab for treatment of mild-to-moderate
COVID-19, when administered as described in the Scope of Authorization (Section II), meets 1he
criteria for issuance of an authorization under Section 564(c) ofthe Act, because:
l. SARS-Co V-2 can cause a serious or life-threatening disease or condition, including
severe respiratory illness, to humans infected bythis virus;
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe
that bebtelovimab maybe effective for the treatment of mild-to-moderate COVID-19
in adults and pediatric patients ( 12 years of age and older weighing at least 40 kg) who
are at high-risk for progression to severe COVID-19, including hospitalization or
death, as described in the Scope of Authorization (section II), and that, when used
under the conditions described in this authorization, the known and potential benefits
of bebtelovimab outweigh the known and potential risks of such product; and
3. TI1ere is no adequate, approved, and available alternative 3 to the emergency use of
bebtelovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric
(12 years of age and older weighing at least 40 kg) patients as fut1her described in the
Scope of Authorization (section II). 4
II.
Scope of Autbotization
I have concluded, pursuant to Section 564(d)(l) ofthe Act, that the scope of this authorization is
limited as follows:
Although Veklury (remdesivir)is an approvedaltemativeto treat COVID-l 9in adults and pediatric patients\vithin
the scope ofthisauthorization,FDAdoesnotconsiderit to be an adequate alternative for certain patients for whom
it may not be feasible orpractical(e.g,, it requires a 3-day treatment duration}
4 No other criteria ofissuance have been prescribed by regulation under Section 564(c X4)of the Act
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3
Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices
16205
Page 3 -- Eli Lilly and Company
•
Distribution of the authorized bebtelovimab will be controlled by the United States
(U.S.) Govemment for use consistent with the tenns and conditions of this EUA.
Lilly will supply bebtelovimab to authorized distributor(s)5, who will distribute to
healthcare facilities or healthcare providers as directed by the U.S. Govemment, in
collaboration with state and local govemmentauthorities as needed;
•
Bebtelovimab may only be used for the treatment of mild-to-moderate CO VID-19 in
adults and pediatric patients (12 years ofage and older weighing at least 40 kg):
•
•
•
•
With positive results of direct SARS-CoV-2 viral testing, and
Who are at high-risk6 for progres.<iionto severe COVID, including
hospitalization or death, and
For whom altemativeCOVID-19treatmentoptions approved or authorized by
FDA are not accessible or clinically appropriate.
Bebtelovimab is not authorized for use in the following patient populations 7:
•
•
•
Adults or pediatric patients who are hospitalized due to COVID-19, or
Adults or pediatric patients who require oirygen therapy and/or respiratory
support due to COVID- 19, or
Adults or pediatric patients who require an increase in baseline oxygen flow
rate and/or respiratory support due to COVID-19 in those patients on chronic
oxygen therapy and/or oxygen support due to underlyingnon-COVID-19related comorbidity;
•
Bebtelovimab is not authorized for treatment of mild-to-moderate COVID-19 in
geographic regions where infection is likely to have been caused by a non-susceptible
SARS-Co V -2 variant, based on available information including variant susceptibility
to these drugs and regional variant frequency. 8
•
Bebtelovimab may only be administered in settings in which health care providers
have immediate access to medications to treat a severe infusion reaction, such as
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5 "AuthorizedDistributor(s)" are identified by Lilly asan entity or entities allowed to distribute authorized
bebtelovimab.
6 For information on medical conditions andfactorsassociated\vith increased risk for progression to severeCOVID
19, seethe Centers for DiseaseControland Prevention(COC)website: https://\vww.cdc.gov/coronavirus!'.2019ncov /need-extra-precautions/people-ivith-medical-conditionsh tml
7 Treatment with bebtelovimab has not been studied in pa tientshospitalizeddue to COVID-19. Monoclonal
antibodies, such as bebtelovimab, may be associated with worse clinical outcomes when administered to
hospitalized patients with COV1D-l 9requiringhigh flow oxygenormechanicalventilation.
8 FDA will monitor conditions to determine whetheruse in a geographic region is consistent with this scope of
authorization, referring to available information, including information onvariantsusceptibility (see, e.g., section
12.4 of authorized Fact Sheet for Health Care Providers), andCIX' regional variant frequency data available at:
https://covid.cdc gov/coyid-data-tracker/#variant-proportions. FDA's determination and any updates will be
available at: https://www.fda.gov/emergency-preparedness-and-remonse/mcm-)egal-regulatory-and-policyfra mework/emergency-use-authorization#coviddrugs.
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Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices
Page 4 - Eli Lilly and Company
anaphylaxis, and the ability to activate the emergency medical system (EMS), as
necessary;
•
The use ofbebtelovimab covered by this authorization must be in accordance with the
authorized Fact Sheets.
Product Description
Bebtelovimab injection (NDC 0002-7589~01) is a sterile, preservative-free clear to opalescent
and colorless to slightly yellow to slightly brown solution supplied in a single-dose vial. Each
carton contains a single vial ofbebtelovimab, which is labeled "For Use Under Emergency Use
Authorization (EUA)".
TI1e authorized storage and handling information is included in the authorized Fact Sheet for
Healthcare Providers.
Bebtelovimab is authorized for emergency use with the following product-specific information
required to be made available to healthcare providers and to patients, parents, and caregivers,
respectively, through Lilly's website www.LillyAntibody.com/bebtelovimab(referredto as the
"authorized labeling"):
•
•
Fact Sheet for Healthcare Providers: Emergency Use Authorization (EU A) for
bebtelovimab
Fact Sheet for Patients, Parents, and Caregivers: Emergency Use Authorization(EUA) of
bebtelovimab for Coronavirns Disease 2019 (COVID-19)
I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that
the known and potential benefits ofbebtelovimab, when used for the treatment ofCOVID-19
and used in accordance with this Scope of Authorization (Section II), outweigh the known and
potential risks.
I have concluded, pursuant to Section 564(d)(3) ofthe Act, based on the totality of scientific
evidence available to FDA, that it is reasonable to believe that bebtelovimab may be effective for
the treatment ofCOVID-19when used in accordance with this Scope of Authorization (Section
II), pursuantto Section 564(c)(2)(A) ofthe Act.
Having reviewed the scientific infonnation available to FDA, including the infonnation
st1pportingthe conclusions described in Section I above, I have concluded that bebteloviinab (as
described in this Scope of Authorization (Section II)) meets the criteria set forth in Section 564(c)
of the Act concerning safety and potential effectiveness.
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TI1e emergency use ofbebte!ovin1ab under this EUA must be consiste11t with, and may not exceed,
the tenns ofthe Authorization, including the Scope of Authorization (Section II) and the Cot1ditio11s
of Autlmrization (Section III). Subject to the terms of this EU A and under the circumstances set
forth in the Secretary ofHHS's determination under Section 564(b XI )(C) described above and the
Secretary ofHHS's con-espondingdeclaration under Section 564(bX1), bebtelovimab is authorized
Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices
16207
Page 5 Eli Lilly and Company
for the treatment of COVID-19 as described in this Scope of Authorizati.on (Section II) under thi~
EUA, despite the fact that it does not meet certain requirements otherwise required by.applicable
federal law.
Ill.
Conditions ofAuthorization
Pi.lrsuantto Sec1ion 564 of the Act, lam.establishing the following conditions on this authorization:
Lilly and Authorized Distributots 9
A. Lilly and authorized distributor(s) will ensure that the authorized bebtelovimab is
distributed,.as directed by the U.S. government, and the au1horized labeling (i.e., Fact
Sheets) will be made available to hea11hcare facilities and/or healthcare providers consistent
with the terms ofthis letter.
B. Lilly and authorized distributor( s) will ensure that the terms of this EU A are made available
to all relevant stakeholders (e.g., U.S. government agencies., state and local government
authorities, authorized distributors, healthcare facilities, healthcare providers) involved in
distributing or receiving bebtelovimab. Lilly will provide to all relevant stakeholders a copy
of this Letter of Au1horization and communicate any subsequent amendm.ents that might be
made to this Letter of Authorization and its authorized accompanying materials (i.e., Fact
Sheets).
C. Lilly may request changes to this authorization, irtcludingto the authorized Fact Sheets for
bebtelovimab. Any request for changes to this EU A must be submitted to the Office of
Infectious Diseases/Office ofN ew Drugs/Center for Drug Evaluation and Research. Such
changes require appropriate authorization priorto implementation. 10
D. Lilly may develop and disseminate instructional a1,d educational materials (e.g., materials
providing infonnation on product administration amVor patient monitoring) that are
co11siste11t with the authorized emergency use ofbebtelovimab as described in this Letter of
Authorization and authorized labeling, without FD A's review a11d co11currertce, when
11ecessaiy to meet public health needs. Any instrw.,i:ional and educational materials that are
i11consistent with the autho,ized labeli11g for bebtelovitnab are prohibited. If the Agency
notifies Lilly that. any instructional and educational materials are inconsistent with the
autholized labeling, Lilly mrn'lt cease distribution of such instructional and educational
Supra a.tNote5.
The following types ofrevisions maybeauthorizedwithoutreissuingthis letter: (1) changes to the authorized
labeling; (2)non-substantive editorialcorrections to this letter; (3)newtypes of authorized labeling, including new
fact sheets; (4)new carton/container labels; (5 )expira tiondating extensions; (6)changes to manufacturing
processes, including tests or other authorized components ofmanufacturing; (7) new conditions of authorization to
require data collection or study; (8)new strength5 of the authorized product, new product sourc.es (e.g., of active
phannaceuticalingredient)or of product. components. For changes to the authorization, includingthe authorized
labeling, of the type listed in (3), (6), (7), or(S), review and concurrence is required from the Counter-Terrorism and
Emergency Coordination Staff/Office ofthe CenterDirector/CDER. and the Office ofCounterterrorism and
Emerging Threats/Office of the ChiefScientist.
9
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10
16208
Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices
Page t3-Eli Lilly and Company
materials. FurthfflllOre, asp art ofits notification,theAgency may also.requite Lilly to
.issue corrective communication(s).
E. Ltlly wiilreporttoFDAallsetious adverse events andmedication errorspotenuallytelated
tobebtelovimab usethatarerepQttedio LillyU$ingeithert>fthefollowingoptions;
Optfon'l:Submitreportsllitoughthe SafetyRepoftingPortal(SRP) as described on theIDA
SRP web page.
Option 2: $ut>m:lt repurts di/.lclly through th.e Eleciroriic $ubUll$si-OnS Qil.tewaY (~) l!S•
describedontheFAERS eleclroriicsubmissionswebpage.
Submi:ttedrep0rts under both optionsmuststate:"Bebtelqviniab useforCOVID,191.111det
Emergency Use Autlroriz.ation (EtJAr Forreports submitted under Option include. this
1l!llguage at 'the beginningofthe quemion "Describe Event''forfuttheramtlysis. For~orls
.subµii,ttett under Option 2,. include this lil,llgtu.ige atthe beginningo:fthe •~cruie Nanati:ve"
field.
1,
R
AA manufactuting; packaging, and.testlngsites torboth diugsubstmce and drug product
usedfot EtJAsupplywill comply with currentgood manufaj:Uringpractice re~.nts
ofSection 501(~)(2X]3Jofthe Act.
·
G: Ulfywill subrn:itinfotntlltionto~Agencywithinthtee·wod{mgdaysof'receipt..of~
infonmition cuncerniftgsjgt1ifiCil.nt (}Ulllifyptub1ems with distributed drug productof
bebtelovimab that includes the foUowing:
•
•
Information concerning any incident that causes the drug product or its labeling
to be mistaken for,, or applied to,anotherarticle; or
Information concerning anymicrobiologkal contamination, or any significant
chemiCil.l,physical, or.other.change or·detem>ration in the distnbuteddrug
product, or anyfailure.oforte ormore·.distributed batchesofthedrugprotluctto
meet.the·estab1ished.specifteatioos.
If a significantquality problem .affects tm.ieleasedprocfucl and may almi111pactprodrict(s)
previooslyreleased.and<listributed,then.informationmustbesubinittedforallpotentially
impacted lots.
Lilly will include in its notification to the Agency whether the batch, or batches, in question
will be recalled.IfFDArequeststhatthese,oranyotherbatches, atanytime, berecalled,
Lilly must recall them.
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Ifnot included in its initialnotification, Lil1y:mustsubmitinformatfon confttnringthat
Liily has identifi~d the root cause ofthe significaniquality problems, taken corrective
action, and provide ajustificafion confirming that the corrective action is appropriate
and effective. Lilly mustsubmit this informationas soon as possible but no later than
45 calendan:i~ysfromthe initiil.l ttotificatfrm,
Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices
16209
Page 7 - Eli Lilly and Company
H. Lil]y will manufacture bebtelovimab to meet all quality s1andards and per the
manufacturing process and control strategy as detailed in Lilly's EU A request. Lilly will
not implement any changes to the description of the product,manufacturing process,
facilities and equipment, and elements ofthe associated control strategythatassure process
perfonnanceand quality of the authorized product, without notification to and concurrence
by the Agency as described under coodition D.
I. Lilly wiii listbebtelovimab with a unique produi.,--t:NDCunderthemarketing category of
Emergency Use Authorization. Further, the listing will include each establishment where
manufacturing is perfonnedforthe drug and the type of operation performed at each such
establishment
J.
Through a process of inventory control, Lilly and authorized dishibutor(s) will maintain
records regarding distribution ofbebtelovimab (i.e., lot numbers, quantity, receiving sire,
receipt dare).
K. Lilly will establish a processforniorutoring genomic database(s) for the eniergence of
global viral variants of SARS-CoV-2. A summary of Lilly's process should be submitted1o
the Agency as soon as practicable, butnolaterthan30calendardaysoftheissuanceofthis
letter, and within 30 calendar days of any.material changes to such process. Lilly will
provide reports to the Agency on a monthly basis summarizing any fmdings as a result of
its monitoring activities and, as needed, any folow-up assessments planned or conducted
L. FDA may require Lilly to assess the activity oftheauthoriz:edbebrelovimabagainstany
global SARS-CoV-2 variant(s)ofinterest(e:g,, variants that are prevalent or becoming
prevalent that hatborsubstitutions in the targetprotein or in protein(s) thatinteractwith the
target protein). Lilly will petfonn the required assessment in. a manner and timefranie
agreed upon by Lilly and the Agency. Lilly will submit to FD A a preliminary summary
report immediately upon comp Ietion of its assessment followed by a detailed study report
within. 30 calendar days of study .completion. Lilly will submit any relevant proposal(s)to
revise the authorized labeling based on theresults of its assessment,asmay be necessary or
appropriate based on the foregoing assessment
M. Lilly shall provide samples as requested of the. authorized bebtelovimab to the HHS for
evaluation of activity against emergmgglobal viral variants of SARS-CoV-2, mcludmg
specific amino acid substitution(s)of mterest ( e.g., variants that are higluyprevalent or that
harborsubstitutions in the target protein) within. 5 business days of any request made by
HHS. Analyses performed with the supplied quantity of authorized bebtelovimab may
mdude,but are not limited to, cell culture potency assays, protein bmdingassays, cell
culture variantassays(pseudotyped virus-like particles and/or authentic virus), and in viw
efficacy assays.
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N. Lilly must provide the following information to the Agency:
16210
Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices
Page 8 - Eli Lilly antJ Company
1 Lilly will:sul:mih.study i:ep<>tt.to 11DAcharacterizingthe developmentQf~ARSCo Y::2 resis1ancetobebtelovimab in cellculture passage experiments noJaterthan
30dil:ys of'the com:pteri:on oftheseexperunems..
2. ti11y wi1lsubmitttiFDAall:sequencmgdata assessirtg;hebtefo\ilma:h; ilicluduig
sequencingofanyparticjpantsarnplesfmmthefullanalyi,~•.·populationfrom
PYAH arms 9;.14that havenotyetbeencompfoted no laterth'llll.March3 l, 20-22.
3, Lilly wmsubmita proposed clinical trial protocolto further evaluate bebtelovimab
fotthette atm.ent of 111ild4:o,;1110detate COVID-l9m rton~hospitali.zed palierits rtti
laterthan.MatchJ, 2()22.
0, Lilly and authorized.distributor(s) will make available to FDA uponrequesfany records
.maintained inconnectionwiththis EU:A.
He'afthcare Facilitiest0Whoo1Bebfulovimah·1:s Disiribut:edandltealthcare Providers.Adinii:listering
bebtelovimab
P. Healthcare.facilities and healthcare. providers will ensurethatthey are.aware ofthe. letter of
authoiization, an<lthe·te~•.heiem.and;thatthe .• aUlhorized:Faqt·$eetsaremide available
tq healthcareproyiders'andto patien!sa.11.d,-ca:regivers;respectiyely, through appropriate
meansi priorto administrationofbebteloyimab as <les<:ribedm.the :Scope ofAuthoru:ation
(Sectionll)_underthis BUA
·
Q: ltea:1th¢i!Je facjlities andl1:ealthcate1,r1.>vklerst¢¢¢1"uigbebtelo'1ntuihWilHtllCkall Sef'j:()IJ$
.ad\!eI':se ey@ts arid ~ili.cation. ettOI'Sthat are c~msidtlt¢dwbe poten1ialty: related to
bebtelovitnabuseand musfrepotttheseioFI)A.inaccordancewiththe Fac(Sheetfor
·ttealthcare.Providers..Complete.andsubmitaMedWatchform.
(W:WW:fdago:v/medwatch!report:htm); or com:pleteandsuhmitFOA. Fot'm 3$06(h:eaith
professional}byfax(1-8()()..FDA·Ol'78)(these fonm:canbe.foundv.ialirikabove) Calil&IJl}•:FDA~rosgrorqueSti.()11:s,. Submitted.reports musts~ ''Bebtelovimabuse for
.
COVIIJ..19under Emergency Use Authorizatiori"'atthe beginning ofthe.question
''.DescribeEvent"fodurtheranalysis.
R, Hea.lthbltrefiicilities andhelllthwe providerswill ertstttethatappr<>ptiate stora.geis
tllllinui:ihe<lm,µlthe produ~isS!ill'littjstere<lc~stetdwitl:l.the~o:(tl:l.isletterl\11dthe
authori:zedlabeling.
s.
Thrtiughaprocessofiriventotycofili~•heait:hcarefacilltiesWill111ahtliirirecOi'dsl'e~
the dispensihgand admini:strafion.ofbebtefov:irnabfortheu:se authorizeclin·thisletter(i,e;,
lotnUlll~; quaI1tify; receiving:si~ receipt ¢tte), pn>dl!Cts\Qrage; and:maintain patie1.1t
·i:¢'011n1.WQ11(e.g;,pati~1tname,age;diiiease matUfesiatiQn..nmnberqfl:lose~adulttlist«ed
perpatien½ otherdrugs administered)
t ·Healthcarefacilities will ensureth;danyr¢4ords:associatedwith:this:Et)Aaremafutamed
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lotter on DSK11XQN23PROD with NOTICES1
u1.1tllrtotified byLill'yand/01:Fl>A. Such records will l:letlllirle 11:vailable tqLilly, HHS, and
FDAforimipechonuponrequest
Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices
16211
P;age 9 - Eli Lilly and Gompany
TJ: Healthcare.facilities andprc>viders wiUnmort therapeutics infonnation an4 utilization data
as directedbyHHS~
dondilions ReiatedtoPrirtted Mattet A.d.vertismg,ili:id Promotion
V. All descriptive printedmatter, advertising, and promotioruilmafurnilsrelatingfotheuse of
·bebtelovimabundetthisauthorizationshallbeconsistentwi1hthe.authoriz.edla:bel~·as
wellas.the terms set.forth in thisEUA. and me et the requirements setforthirtSeclfon
502(a)and(ri) ofthe Act,as a:pp1foabte, artd EDA implementingtegulatfon& .Rifetences to
l~tfug'\''pmtiiff~ll!cb!:lin:g" or·siruilar t1a:rm1rin·these.r:1a:qµiri;ti;1ents1:1hi:ul bl:
' 1ttpproyed
un:derstood torefertotheauthorizedlabelingforthe·use:ofbebtelovitnabunderthis
authorization; In addition, suchmaterilil.s shlil.l:
• 13e Wlored to the.intended audience,
• Nottakethe fonnofremmderadverlisemerils, as:thattermis describedin21
CFR202. i(e)(2X'.i), 21 CFR200:200 and21 dFR201. lOO(f).
• Presefitthe sattteriskinfottnationtelatingto thema:jotside 'effects an.ii
cQnil:aindic;m:ons cQncim:ent.1:yinth.:.1n1,diO'andviS!llilpa:rw.ofthepres@fu.1i.on
f9tady~ifig art!! ptottioti®al t'lflrteri:al$'in.'a.ti/li(Fvisual for:rnat .
• Be acconipaniedbythe authorized libeling; ifthe pronio:ti9natn:rntetfa1s are not
slJbjectto Section 5Q2(n)oftheAct
·
·
• BesubmiitedtoFOA accompaniedhy FonrtFfi:A~225aattheiimeofihltfai
di~sei:nifitttimorfmit.µi:ie;
·
fi'thei\gen~n:otWKJs ti.i1ythatartydescriptiveprintedmatter,adV¢rtiliingOt prorn◊tfouaI
material$ do not meetthetei11JS s¢tfc>tth.incot:tditi<>mtY·throughX◊fthisEUA.,LlllymU$t
cease distribution o:fsuch descriptiye ptfuted matter; advertising, orprc>Ill()tional materials
·in accordance.wilhthe•Agency'snotification.Furlheimore;.aspart·ofitsnotification,ithe
Agencymay.a:Isorequite·Lillyto issue•correciivecommumcation(s}
w. N~ cleseriptive priqt~bnlliter, a:dvertisfug; otpi:om.o1iotialmai¢rlal$te1a.1ingto the use of
bebtelovimabunder:this. authorizationmayrepresentor~ggestthatbebfulovimabi$Sllfeor
.effectivewhenusedforthetreatmentofCOVIl),19..
x:
Ail descriptive printedmatter; advertismi.andpr-0motio11airnaterla1~re1a:~tothe use of
bebtelovimab•umlerthisautlmri.Z!ltionclea:dy·and conspic.uoll$ly·shall stltteth'l!I;:
•· tJetiteloV:iinab ha:s :tRJfbe~ approye4. btitba:sheert-a:uihqrized for ernetgettcy
use·by FDA:underanEUAiforthetreabnentofmild.to•modemteCOVID-19
inaduitsartd pediatticpatients(l2yearsofage and older:weigbirtgat1east 40
kg)wMarea:t liig1t,;;risk fut progression tll.seveteCOV:rt)-19,includittg
hospitalization ordeath,-atidforwhonialtetna:1iv:eCdVID-19treatmentoptions
l!cPprovedor autl:1Qtized.by1IT:>A,ai;e11otaccessil:il~orclm.fcl!clfy·!ippiut>Jiate; and
•
The·emergencyuseofbebtelovimabis onlyauihorizedforthedurationofthe
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declarationthlitcircumsfance.sexistjustifyingthe authoriz.ationofthe
16212
Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices
Page l O - Eli Lilly and Company
emergency use of drug; and biological products during the COVID-19
pandemic under Section 564(b)(l )ofthe Act, 21 U.S.C. § 360bbb-3(bXI),
unless the declaration is temiinated or au1horizatiort revoked sooner.
IV.
Duration of Authonzation
This EUA will be effective until the declaration that circuinstances exist justifymgthe
authorization ofthe emergency use of drugs and biological ptoductsdurmgthe COVID-19
pandemic is tennmated under Section 564(b)(2) of the Actor the EDA is revoked under Section
564(g)ofthe Act.
Smcerely,
Isl
Jacquelme A. O'Shaughnessy, Ph,D.
Acting Chief Scientist
Food and DrugAdmmistration
You may submit comments
as follows. 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
June 21, 2022. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are postmarked or the
delivery service acceptance receipt is on
or before that date.
ADDRESSES:
[FR Doc. 2022–06009 Filed 3–21–22; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0236]
Prioritizing the Addition of Maximum
Daily Exposure Information and
Removing Dosage Form Information
From the Inactive Ingredient Database;
Establishment of a Public Docket;
Request for Comments
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice; establishment of a
public docket; request for comments.
AGENCY:
The Food and Drug
Administration (FDA, we, or Agency) is
announcing the establishment of a
docket to solicit comments that will
assist the Agency in determining how
best to prioritize the addition of
maximum daily exposure (MDE)
information for inactive ingredients that
do not currently include MDE
information in the Center for Drug
Evaluation and Research’s Inactive
Ingredient Database (IID) and whether to
restructure the IID by removing dosage
form information.
DATES: Submit either electronic or
written comments on the notice by June
21, 2022.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
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18:24 Mar 21, 2022
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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
PO 00000
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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–0236 for ‘‘Prioritizing the
Addition of Maximum Daily Exposure
Information and Removing Dosage Form
Information From the Inactive
Ingredient Database; Establishment of a
Public Docket; Request for Comments.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
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., 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
E:\FR\FM\22MRN1.SGM
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Dated: March 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
]]>Agencies
[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16201-16212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06009]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0335]
Authorization of Emergency Use of a Biological Product 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 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 Eli Lilly and Company (Lilly). 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 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 February 11, 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, 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
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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. Under section 564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available on the internet website of
FDA. 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 in an actual or potential emergency 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),
[[Page 16202]]
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) of the FD&C Act,
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.
---------------------------------------------------------------------------
\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.
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No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act.
III. The Authorization
The Authorization follows 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 Authorization under
section 564(c) of the FD&C Act are met, FDA has issued the
authorization for the emergency use of a biological product during the
COVID-19 pandemic. On February 11, 2022, FDA issued an EUA to Lilly for
the biological product bebtelovimab, subject to the terms of the
Authorization. The initial Authorization, which is included below in
its entirety after section IV of this document (not including the
authorized versions of the fact sheets and other written materials),
provides an explanation of the reasons for issuance, as required by
section 564(h)(1) of the FD&C Act. Any subsequent reissuance of the
Authorization can be found on FDA's web page at: 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
Authorization is 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: March 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-06009 Filed 3-21-22; 8:45 am]
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