Authorizations of Emergency Use of Certain Biological Products During the COVID-19 Pandemic; Availability, 42850-42868 [2021-16705]
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Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
section for electronic access to the
Authorizations.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
[Docket No. FDA–2021–N–0335]
Authorizations of Emergency Use of
Certain Biological Products 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 two Emergency Use
Authorizations (EUAs) (the
Authorizations) under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) for
biological products for use during the
COVID–19 pandemic. FDA has issued
one Authorization for a biological
product as requested by
GlaxoSmithKline LLC and one
Authorization for a biological product as
requested by Genentech, 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
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 Authorizations, which include an
explanation of the reasons for issuance,
are reprinted in this document.
DATES: The Authorization for
GlaxoSmithKline LLC is effective as of
May 26, 2021, and the Authorization for
Genentech, Inc. is effective as of June
24, 2021.
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
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SUMMARY:
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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
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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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),
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
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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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)
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.
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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 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 has issued
two authorizations for the emergency
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42851
use of biological products during the
COVID–19 pandemic. On May 26, 2021,
FDA issued an EUA to GlaxoSmithKline
LLC for sotrovimab, subject to the terms
of the Authorization. On June 24, 2021,
FDA issued an EUA to Genentech, Inc.
for ACTEMRA (tocilizumab), subject to
the terms of the Authorization. The
initial Authorizations, which are
included below in their entirety after
section IV of this document (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-policyframework/emergency-useauthorization.
IV. Electronic Access
An electronic version of this
document and the full text of the
Authorizations and are 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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42852
Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
Mey 26,2021
GlaxoSmithKline LLC
Attention: .Debra H. Lake; M~S.
SenJor Dir®tor, Olol>al Regulatory All'iilits
Five Moore Drive
·
POl3oxB398
i)urham. North Carolina 21109RE:
Emergency TJseAut;hQnzath:m IO.ff
nits letterJs in resppnse fo Qla.xoStnithKline LLC's (GS!<,,) reque-st that the Food and Dmg
Adrnini~tfon (FDA) issue an Emergency IJse Authorization (BUA) 19r the emergency use 9f
sotrovimab for the treatment of mild-to-moderate coronavirus dlsease 2019 (COVID-19), as
described in :t:he Scope of Authorization: (Section II) or this letter,. pursuanno Section 564 of the
Fecleral Food1 I)mg; and Cos:i;neuc Act (the Act) (21 IJ.S~C. §$60bb:l>~$),
On February 4, 1.020, pursuant to Section 564(b)(l)(C) oiihe Act;_ the Secretary of the
Department ofHealth andB:uman Services. (AAS) determined that there is a public health
emergency that.has a signifi:can:t potential to affect national security <lt the health and :security of
United Sta:t¢.s citi1,e1i:s Jiving• ~Wad; and 1ha,t itrvo:lves the· vints that Gas1.JS!:lS cornnavi~ diseMe
2019 .(COVID-19).. 1 On the basis ofsuch determination, the Secretary ofHHS on March 27,
2020, declared thatcircumstances exist justifying the authorization of emergency use old.rugs
and bfologfoal ptoducts during tbe COVlI>•19 pandemic, putsuant to: Section 564 of the Federal
Food; Pru,g, :and CQstnetic Act (the Act) (21 U.S,C, J6Qbbb·3); :subject to terms ofany
authorization i(;sµed. µnder that $ectkm/
Sottovimab is a recombinant huii1ai1 IgG'itc monoclonal .antibody that binds to a COllSetved
epiippe on: the spike· protein r®ept<ltbindin:g domain or SAllS·CoV-2, Sottovi:tnab does not
cornpete with lluinan ACE2 l'.eceptor bin.ding, Sotro,i:ma,b Js an inve$tig21tio.n.al drug :and Js nQt
currently 4ppnxved for any indication,
Based on review· ofthe interim analysis ofphase 1/2/3 data from the COMET~ICE,clinical trial
(NCT #0454$060), a rand<li;nizecl; doubte--blind, placeba-contr<illed clirrical trial evaluating the
saf~ an4 e:fficacy o:fsotrovi:tnaP 500 mgIV in outpatient (l1Qn-h.osp~talizedJ ad'lllts with SAASCoV'-'2 infection, it is reasonable .to beliew that sotmvimah may be effective for the treatment of
1 U.S. I)eparlment.ofR~ !j!liJ Ruman
Service.$;D¢terminatfpn.·of'a l':t-1.hltc Hea#k EmergNIC:Y at!iJDecJ:aration
that CirclJU!stanr;e:s Exist J~stJJJ,iris Afffelorizati0f!$Pur:rnarit to}ieqtiot'l-564(b) ofi!heFede,:1;1lFoptJ, Dr11g, arid
CO$itll!ticA.¢t; 21 U.S.C.§ 360bblF5..Febrtlaly,4,2020,
1
:OcpanmcntofHClllth !l!1!1. Rmnm:i: Sciyiccs,D«efi.!r(itir.m tkq.lC./'rC1im~iaru;Ysl3xi$i.JriS/'ijJing,~tfmri1.(J(i<1~
Pur.rtlant ta Se:ctian 564(h} ofthe .PederatFood,.Drug; tmdCcsmetic.Act, 2I tf:S.'C. J 360bbh 5; 85 FR 18250
(April 1, 2020),
US,
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42853
Page 2 --- GlaxoSmithKline
mild~to-moderate COVID-19 in adults and pediatric patients ( 12 years of age and older weighing
at least 40 kg)with positive results of direct SARS•CoV-2 viral testing, and who are at high risk
for progression to severe COVID-19, including hospitalization or death, and when used under
the conditions describedjn this authorization, the known and potential benefits of sotrovimab
outweigh theknow11 and potential risks ofsuchproduct.
Having concluded that the criteria for issuance of this authorization under Section 564(c) ofihe
Act are met, I am: authorizing the emergency use of sotrovimab for trea1ment of COV~19, as
described in the Scope of Authorization section_ of this letter (Se;;tion II)and subject to the terms
of this authorization.
·
t
Criteria for Issuance of Authorization
I have concluded that the emerget1cy use ofs-0trovin1ab for the treatment of COVID-19 when
administered as described in the Scope of Authorization (Section II)meets the criteria for
issuance ofan authorization under Section 564(c) of the Act, because:
L SARS-CoV-2 can cause a .serious or life-threatening disease or condition, including
severe respiratory illness, to humans infected by this virus;
2. Based on the totality ofscientific-evidence available to FDA, it is reasonable to believe
that sotrovirnab may be effective in treating mild-to-:moderate COVID-19 in adults and
pediatric patients (12 years of age and older weighing at least 40 kg) with positive
results of direct SARS-CoV•2 viraltesting, and who are at high risk for progression to
severe COVID-19,.including.hospitalization or death; and that, when used under the
conditions described in this authorization, the known and potential benefits of
sotrovintab outweigh the known and potential risks of such products; and
3. There is no adequate, approved, and available alternative to the emergency use of
sotrovimabfor the trea1ment of mild-to•moderate COVID-19 in adults and pediatric
patients (12 years of age and older weighing at least 40 kg) with positive results of
direct SARS-CoV-2 viraLtesting, and who are at high risk for progression to severe
COVID- 19, including hospitalization or death, l
II.
Scope of Authorization
I have concluded, pursuant to Section 564(dXi) of the Act; that tbe scope ofthis authodzation is
limited as follows:
•
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No other criteria of issuance have been prescribed by regulatlohunder Secti_ori 564(cX 4) of the Act.
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3
Sotrovimab will be used onl)'by healthcare providers to treat mildato•moderate
COVID-19 in adults and pediatric patients (12 years ofage and older weighing at
least 40 kg) with positive t'esnlts ofditect SARS-CoV-2 viral testing, and who are at
high.riskfor progression to severe COVID-19, including hospitalization ordeath;
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Page 3 -- GlaxoSmithKline
•
Sotrovimab is not authorized for use in the following patient populations 4:
• Adults or pediatric patients who are hospitalized due to COVID-19, or
• Adults or pediatric patients who require oxygen therapy due to Cov1D19, or
• Adults or pediatric patients who recquire an in.crease i:n baseline oxygen
flow rate dueto COVID-l9inthose patients on chronic mqrgenilierapy
due to underlying no1r-COVID• 19-related comorbidity.
•
Sotrovimab may only be administered in settings in which health care pi:oviders have
immediate access to medications to freat a. severe infusion reaction, such as
anaphylaxis, and the ability to activate the emei:gency medical system (EMS), as
necessary.
•
The use ofsotrovimab covered by this authorization must bein accordance with the
authorized fact Sheets.
Product Description
Sotrovnnab is supplied 111 individual single dose vials. Individual vials and carton container labeling for
sotr<>vimabare clearly marked "For use um:fer Emergency Use Authorization." Sotrovimab is a
recombinant humanigG h: monoclonal antibody that binds to a consei:ved epitope on the spike
protein receptor binding domain of SARS-Co V-2, Sotrovimab does not compete with. human
ACE2 receptor bindirtg.
Sotrovimabis available as a 500 mg/8mL (625 mg/mL) sterile, preservative-free, clear;
colorless or yellow to brown solution tobe diluted prior to infusion. Unopened vials ofsotrovimab
should be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F). The vials should be
kept in theirtdividual original cartons to protect from light. The diluted infusiort. solution of
sottovimab should be adm.inisteted int1I1ediately. If immediate administration is not possible,
store the diluted infusion solution for up to 24 hours at refrigerated temperature (2°C to &°C
[36"F to 46°F]) or up fo 4 hours at room temperature (20°C to 250C [68°F to 77°F]) including
transportation and infusion time.
Each carton containing a single treatment courSe of the authorized sotrovimab will include a
single copy each of the following product~specific doctnnents detailing information pertaining to
its emergency use (referred to as "authorized labeling)5:
•
Fact Sheet for Healthcare Provide!'.$: Emergency Use Authorization (EUA) ofsotroviinab
•
Fact Sheet for Patients, Patents and Caregivers: Emei:gency Use Autb()rization (EUA) of
sotrovimab for the treatmertt Coronavitu.'! Disease 2019 (COVID-19)
Benefit of treatmentwith.sotrnvimab has not.been observed 1h patients hospitalized due to COVID-19. SARS~
CoV-2 monoclonal antibodies may be associated with worse clinical outcomes.when. administered to hospifuliz:ed
patients with COVID 19 requiring high flow oxygen ormechm:iicalventilation.
5 The authorized labcling for EUA 100 will also be available on GSK' s website at www.sotrovimlih.com
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Page 4 -GlaxoSmithKline
I have concluded, pursuanttoSection 564(d)(2) ofthe Act, that it is reasonable to believe that
theknovvn and potential benefits ofsotrovimab, when. used.for the treatrnentofCOVID-19 and
~din accordance with this Scope of Authorization (Section 11), outweigh: the known and.
pQtentialris~,
l have concluded; pursuantto Section 564(d)(3) ofthe Act, based on the totality. ofscientific
evidence available to FDA, that it is reasonable to believe that sotrovimab may be effective forthe
treatment ofCOV:ID-19whenused in 11.ccorclance with lhjs Scope of Authorization (Section U),
pursuant to Section564(c)(2XA) oftheAct
Having reviewed the scientific informationavailabletoFDA,. including the information
supp0rtingthe conclusions described in Section! above, lhaveconcludedthat sotrovimab.(as
described in this Scope of Author:ization (Section Il))meet& the criteria set forth in Section 564(c)
ofthe Act concemingsafety and potential effecliyeness.
The erri~ency use ofy~lll' product underan EUAmust be consistenfwith, and Ulay notexceed, the
terms ofthe Allthorization, including the Scope ofAuthorization(Section 11) and.the Conditions of
Authorization (S~ion. UI). Sl;lbject to the tenns. of.this EUAand tind.rr the circumstances. setforth in
tlte Secretary of lffiS's detennination unde.r Section $64(b)(lXG) described <lbo.ve anc,l ihe Secretary
ofHHS's corresponding declaration.tmder Section 564(bXl), sotrovimab is authorized to trealmildto-moderate COVID-19 illness in adults and pediatric patients (l2 years ofage .and oldetweighing
at least 4o kg) with.positive results ofdirect. SARS-CoV-2 vintlte$ting, who:are at high: risk for
progression to severe COVI0-19;. including hospitalization or death, described in the Scbpe of
Authorization (Section ll) under this EUA; deSpite thefactthatitdoes not meetcertain requirements
otherwise required by applicable federal law,
as
nt
Conditions of.Authorization
Pursuant to Section 564. ofihe Act, lam establishing the following conditions: on this authorization:
GSK and Authorized Distcibutors:!i
A GSK and autliorized !liiitribufor(s) will ensure th;ii tile authorizedlabeling (i.e.; f actSbeets)
will accompany the authorized sotrovimab as.de&.-ribed in Section II of this Letter of
Authorization,
R GS:t(and authorized distributor(s)will ensure that appropriate storage and cold chain is
maintained until the product is delivered to healtlttare facihties and/or healthcare providers.
C. GSKand authorized distributot(s) wtll ensure that the terins oftlns EUA are made
available to all relevant stakeholders (e.g., tJ.S. iovemment agencies, state andJocal
go-vernmentauthorities, authorized di.stcibutorS, healthcare facilities, heal1hcare providers)
involved in distributing or receiving authorized sottQyimab, GSK will provide to all
relevant stakeholders a copy ofthis letter of authorization and. connnunicate any
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6 «Authorized Distribut-0r(s)" are identified by <1SK as. an entity or entities allowed to di;;tribute authorized.
sottovim.ab.
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Page S - GlaxoSmithKline
subsequent amendments that might be.made to this letter. of authorization.and its authorized
accompanyit1g materials (Le,, Fact Sheets).
D. GSKmayreques.t changes to this atrlhorization, ittQludittgtothe authorizedF!lcl Sheets for
sotrovimab, Any requestforchanges.totluf:l EUA 111ustbe submitted to the OffiCl:l of
Infectious Diseases/Office ofNew Drugs/Center for Drug Evaluation and Research, Such
changes t'llqtlire appropriate authorization prior to implementation. 7
E. GSKm.aydevelop &id diss.em.inate itt~clional and ~ucalional materials(e:g,, materials
providing infonnation on product administratibmmd/orpatientmonitoring} that are
consistent with the authorized emergency use.ofsotrovimab.as described in thisletter of
authorization and authoozed labeling, without FDA's review and concmtence, when
necessary to me¢t pu'!,Jichtlalth needs. Any ~clional 1111d educational mllteriahitl:ud: are
inconsistent. \Vi.th the atrlhorlzed labelittgfor sotrovimab are prohibited. If the Agency
notifiesGSKthat any instructional andeducationalmaterials are inconsistent with.the
atrthorized labelittg, GSKmust cease distribution.ofsuch.inst:ructional and educational
materials in accordattce with the Agency•s.notification. Forih:ermore, as part of its
notification, the Agency may also ri:,quire OSK. to issue corrective communication(s).
R GSKwillreporl to FDA serious adverse events.and all medication errors associated with
the use. of the authorized sotrovimab that are reported to GSK using.either of the following
options.
Option l: Submit reports through the Safety Reporting :Portaj(SRP)asdes.cribed on the~
SRPwebpage.
Option 2: Submit reports directly thiwgli the Ele¢tronk: $qbnussions Gateway (ESGj as
descnoeil on the FAER.S electronic submissions web page.
·
Submitted reports under both options should state: "Sotrovimab useforCOVI1).19under
Emergency Use Authorization. (EUA);'' For reports submitted under Option 11 include this
language at tht:1 be~g ofthe question "Describe Event''T<>rfurther analysis. For: reports
submitted :under Option Z include th.is langµage at the beg]jttiing of the ''()lllle "Nattittjve"
field.
The foHowingt~s of~visions may be authorized\viiliouUeissuirig thls letter: (l) changes to the mitlforized
lab<iling; (2) tton-substantiye edi~oriatct1n:e¢ti0Mto this leµer; (3}new ty:pes ()fa,'Utlilirized labelirtf induding new
factsheets; (4) new CB.l'tort/container label$; (5) t:itpiratibn,ting e~tensio~; (6) ·ch:anges to·manufacturing
prbcesses, inc!udil% tests ot oilier authorized Cort1pommts o( manufacturing; (7) ne~ c,oriditions of auth()ritatiort to
requite d(lta bollection <>(study; ($) new sttertgth,s of tl'.te authorized prodi;ict, neyrprqduct squrce~(e.g., ofacti.ve
pMt:maceutibal. ingte.die11t)or ofwoouc[9())rtponimts.ftit chart~WS' to the ll.utllorization;. insluclmg the ~~orited
labeling, ofthe type listed in(3), (6); (7); or(8), review and c;<m¢urrenceif\reqt1ired from the Counter-Ten:oru;rrt and
Emergency CootdinatiQll $tllff}()ffice of the Center pirector/@ER !liid the Office of C-Ountertettorism and
En1 erging Thl:ea~/Off1® tiftlie Qhief Scientist.
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1
Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
42857
!>age 6 -GlaxoSmithKline
Gs AUmamifacturing, packaging, and testing sites for both drug substance.and drug product
willcomplywithcutrent gomfn1anuf'actutingpl"licticerequitements ofthe FD&C Act
section 50l(a)(2)(B).
ff: G.S.K wilts11bnutinfQQ11ation fo the Ageu.cywil:hii:t threewQn011g days 'Qf~ipfofatiy
information concerning significant quality problems with distributed drug productof
so1rovimabthat•includ¢s.the. folloWing:
·• llifonnatioo c9ncetitrng any mcidentthat causes the drug product otits Iahelfu:g
·fu be mistilken t«, ()tapplied to, another artide; or
•· lnfonnatioo ciJfi'Cettiinganymicrobfofogfoal contammation, otany$igtillicaril:
chet'niqaJ; pbysi~ m: other cluQ1ge or 4eterl.oni,ti◊11in:the dis.tribul.l4 drug
product, orltt'lif failure of one ormoredistributedbatches ofilte producttomeet
·the.establishedspecifi41atiom.
Ifa si~crurt.qualityproolem;affects tmteleased produclandn1ayalso itnpacfJ?fOducl(~)
preyi~lyreleasedan4 dis.tribul.ld; th~ infonni.tti,011 should besubm~d fQI'all potentially
itnpactedlots.
oSRWill: iru.;fod~iti its fiOttlic:ation.to the Ag¢rtcywhethetthehatcfi; otbatehe$; tit
qµe$tion \\'iU beii:icalled. If FPA:req11~tbatthelie~ or attYother batches; atmiyfune,~
iecallecl, G$K must-recall them,
IfnoHncluded in its initial notification, GSKmusf submit information confinliingfhat
GSKhasidentifiedthe root cause ofthe· Significant quality problems, taken :corrective
aetio;
provide aJustificati9n coliflnning thatthe con:ectlve actiQil is llpptopriate
and effecti:ve. GSKmust submit this infonnation as soon as possible hut rtCi later.than
4Scal~ndar days ffom the initiitl notifi<:atiQ11,
and
L GSKWtlf mmufaciin'e shtroVihihli to meetan quality stantla.fds mdperthe.mmufacti.J.riiig
processandconttolsttat¢zy,is detail~foGSl<:sEUAreq11¢$t. OSK will not implert1ent
any changes to ibe de$Cription of the proituct..manuf~~process, ~ilities and
equipment.and elemerits ·ofthe associatedcontrolstrategy that assure ~perfonnance
and quality ofthe authorized product, wi1hout notificafionto and concurrence by the
Agency a$ describedurtdetconditionD,
1 0$:r<\\'ill lis1;sotf9yimabw:ith a iJ.Ui.<1.tte :Nt>t;: w4ertbe rnark:etmgllateg'<>ty oftJuapprttved
Drug-Other. Ftll'.ther;•thelistingwillinclude each establishment ~heremanlifacluringis·
perfonnedforfhe drug andfhe type ofoperation perfonnedatsuchestliblislnnent;
R. lln'.ougha p~.ess ofinventory control, GSKand attth<>tized distributot(s)will.maintatn
n,,cQI'ds niga,rdin:g~blltion oftl.le~orized s<>irqvimab Q..:., lc)t:µumbers, qllatltj1;y.,
receivingsite,receipt date}
.
.
t. ·GSK and amhorized diS1ributot(s}witlmake available to EDAuponre@est anyreconls
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maintained in com1ectionwitb:this EDA
42858
Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
Page 7 - GlaxoSmithKline
M. GSK will establish-a process for monitoring genomic database(s) for the emergence of
global 'Viralvmants of SARS-CoV,2,.Astimnlacy of GSK'sprocess should be.submitted
to the Agency as soon as practicable, but no latetthan 30.calendat days ofthe issuance of
this letter, and within 30 calet1dat days ofany mat.malchanges to suchprocess. G$Kwill
provide reports to the Agency on amontlily biisissUiillllllrizing any findings as a result of
its monitoring acti\rities and,. as needed,. any follow-up assessments planned or conducted..
N. FDAmayrequireGSl{t{)assessthe activity of the authorized sottovinrab againstany
global SARS-CoV~:2 variant(s) ofinterest (e;g,, variants thatare prevalent or becoming
prevalent that harbor substitutions inthe target protein or in protein(!t) thatinteractwith the
target protein), GSK will perform the required assessment in a manner andtimeframe
•~.upon by GSK and the Agency. GSK will submit to FDA a preliminary summary
report inimediatelyupon completi'on.-0f its li$sessment followed by a detailed study report
within30calendardays ofstudycompletiolli GSKwill submitanyrelevant proposal(s)to
revise the authorized labeling based on the results of its assessment,. as may be necessary.or
appropriate based on the foregoingasse$sment
n
GSK..shall provide $1llllples as requested of the authorized sottovimab tQ the U.S.
Deparlmeut ofHealth and Human Services (HHS)fonvaluation of activity .against
emerging.global·viral. variant, of SARS.:CoW2, including specific amino acid
substitution(s) ofinterest (e.g., variants that are highly prevalentorthat harbor substitutfons
in the target protein) within 5 business days. ofany request made by HHS. Analyses
performed with the supplied quantity of authorizedsottovimab may include, but are not
limited to, cell culture potency assays, protein binding assays, cellcuffure variant assays
(pseudotyped virus-like particles and!or:authentic virus1 and in vivo efficacy assays.
P. GSKwill submitto'FDA all sequencing 4ata assessing sotrovunab, including sequencing
ofany participruitsamples from the :full analysis population from<JOMET-JCE that.have
not yet been completed no later than September 30,·2021, GSK will provide the Agency
with aftequency table reporting all substitutions detected for.all participants at all available
timepoints at af'tequency.>1 %.
Q; OSK.: will suhmjtto FDA allSA'R:S;;CoV~2 viraj.shedding and viral. load data; including
quantitation.ofviral shedding and viral load for any participant samples fromthe full
analysis population from COMET-ICE that have not yet been completed, noJaterthan
June 30,2021.
Healthcare Facilities to Whom the Authorized Sotrovimab Is Distrib:uted and Healthcare J>roviders
Administering the Authorized Sotrovimab
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R Healthcare facilities and healthcare pr9videts will ensure that they are aware ofthe lett~ Qf
authorization, Md thetenns herein; and that the authorized FacfSheets are made available
to healthcare providers and to patients and. caregivers, respecti.vely;.through appropnirte
means~ prior to administration of sotrovimab,
42859
Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
Page 8 --Glaxo$mithKlin:e
S;
Healthcare.facilities andhealthoare providers receivingsotrovimabwill1rackserious
-adverse events that are consi'detedtobe pot¢ntililltattrlbutab1e 10 sotrovima(;use and must
repott1hesi:!10 FDAinaccordan.~ wi1hthe FactSheetfot llealtbcare ~\iidets. C6mplet¢
~ct,s_µJ!tµit-aMedWllfch::t'<mtt{W:WW;filaJtov/ittedwatchlt@m:t;htm,lor Cc»:t1plete~i;t
:$Ul>lJ!lt,:F:Pi\-F<>mi~sQO tlwmttrprof~,icm{ll}l>yfl,llfi(l,,~OP-Jtr>4"0f'.!$,) (~f~.:im
'.befoundvia]ink:above).
Call 1-..800,:FDA.-'108&.for-questions. Submtltedreporls·should
state, •'Sotrovimab ®fot00VJ:]).l9ooder Etnetg!fflcy Use Authorization" at the
.he~#fili'¢ tprestimt "Pe$crlbe E:v!int"forfurihet apaiy$i:$;
T, Heal1hcare·facilities and healthcare providers will ensure1hatapproprfate storage andoold
chain.ismaintained.untiL1he.produotis administeredconsistentwifu thetennsof1his.tetter.
u:
').lm)µgha pmc_esi; ofinventory cQltl:tot healthcarefaciliti~ \¥ill mlliil:taitf ®ords regmfuig
1hedispensed aµthorize4sob;ovirnab(i.e.,fotnumbets; quantity; receiv:i/1gsite, receipt
date),produclstorage;and.maintainpatientinfonnation{e.g.,.patientname; age;.disease
·
mariffestation, tlill'l1her- of doses ildministered per patient, oilier drugs adlninisteied).
v:
1:tea11hclitefaciiities will ensurirffiatlliiy rec'OttJil asi;ocia:ted with this; EQA.c are. m~ed_
ut1tilµqfifi.ed by 0$:K lllldlqrf:'DA, Siwh recordi;willbemade availlµ>Je-toGSl\. lUIS, imd
FDA;forinspeclion.uponrequest-
Comlitions. Relatedto,Prirtted Matter, Adveft®t)g and Promotion
w. Alldescriptiy~ prurted rn~er, adv~ing; anci promoti()tlalmateriaTu relatirtgfo the~ of
1he,sotrovimab under1his authorization shall be consistent witlt.1he authorized labeling; as
wellasthe terms setfortli.inthisEt:rA, andmeettherequiiements setforthin section
S02(;1) and (n)ofthe Act atid FPA:implementin:gregulations. lh addition, such.material~
shall:.
•
Be tailored to the inten4ed llUdil,U,l"Ce,
• Nqftaketliefonn oft¢mfudet'adv:ettisements. asiliatJenni~ describe4in.J1
CFR202,l(eX2Xi). 21 CFR20MOOand21 CFR201.100(f);
•• ~etlfril<kfufoftl11lfiottCOI1currenfurinthe iµi(.lioa:iid•.\iisnat·parls-ofthe
presentationforadvertisementsdisseminated.through•mediasuch•asradio,
television, ottelephone communications.
.. Beaccotrtpariiedbyffie authorizedl:abeling,
•; Besubmittedto FDAaccompaniedby FonnFDA-2253 atthe.timeofinitial
dissemittation or-tii"Stuse.
lfffie Ag.;ncyrt()tifi~ G$K that a:ny'd~scr:ipti,ve printe4 t®tter; adv:ert;isi~otptQUl()tionat
•materials do nofmeef1he-terms setforth inoonditions W,-,Yof1hisEUA, GSKmust cease
distribution of such descriptive printed matter. advertising; or promotionalmaterials in.
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.~cordance•withtheAgency;snoti.fication.·Furthermore,_aspart-of·itsnotification.the
_Agency may also require OSK to issue -cotte~~ comtt1.urticatitm(s).
42860
Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
Page 9 ... GlaxoSmithKline
X. No desc-'t'iptive printed matter, advertising, or promotional materials relating to the use of
sotrov:imabunder thi.s aulhorization may represent or suggest that sottovimab is safe or
effective when used forthe treatment ofmild-t.o-moderate C0Vll).19in. adults and
pediatric patients ( 12 years of age a11d older weighing at least 40 kg) with positive resu.hs of
direct SARS-Cov~2 viral testing, and who are at high risk. for progression to severe
COVID-19,includinghospitalization or death.
Y. All descriptive printed matter, advertising, .and promotion.al materiai, relating to the use of
the sottovimab clearly and conspicuously shalls:tate that:
•
Sotrovin1ab has not been approved, but has been aulhorized for emergency use
by FDA under an EUA, to treat mild-to-moderate COVID-19 in adults and
pediatric patients ( 12 years of age a11d older weighing at least 40 kg) with
positive results of direct SAAS-CoV•2 viral testing, .and who are at high risk for
progressi<>n to severe COVID-19; including h<>spitalizatio11 or death; and
• 111e em.ergency use ofsotrovimab is oruy authorized for the duration of the
declaration that circumstances exist justifying the authorization of the
einergencyu.<ie of dl'tlgs and biological prodi1cts doring the COVID-19
pandemic under Sectioi1 S64(b)(l) ofthe Act, 21 U.S.C. § 360bbb•3(b)(l),
unless the declaration its terminated or authorization revoked sooner. ·
IV.
.Duration of Authorization
This EUA will be effective until the declaration that circumstances exist justifying the
authorization of the emef8e11cy use of dmi'!! and biological products during tbe COVID-19
pandemic is tem1inated under Section 564(bX2) of the Act or the EUA is revoked under S.ection
.564(g) of the Act.
Sincerely,
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RADM Denise M. Hinton
Chief Scientist
Food and Drug Adininistratioo.
Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
42861
June:M, 2021
r2i~:~t~•Ltt1..
.Attention: :q~y J;'hanibipillai
Regtilatbfy: Project•Matiiigeftient
I DN.A:Way,.Bldg45-l
S§'!ltl:t S~JJ~i~(@ 9494~Q
lUtt
Bmergem:;rt.Jse.Authoiizat:ion.Q~9
bear•·Ms;. l'harribtpillah
Tfilslettedsinrespoiiseto'·C'kn:entec};fuc,+s.(Gimente6h).requestthattheFoodand·0rug
Admini:stration(EDA)issueanEmerg-encyUse Authorization(EUA)fortheeme1¥ency·use of
.Ac:teµit:a 1(tqc~b).•f¢i'fb¥··tteattrieyij:~f¢:otQiliivirosdi:~~¢2Ql9(CO\ffD~19) ·uJ§~
hospitalized patients;. aS describedfothe Scope of.Authorization (Sectirn .ti) of this letter~
pu:rsuantto.Section·5~4ofthe:Federal.•Food,Qrug, •.andQosmeticAc:t•(the·Act)(2l.U;S,Q.•
.§36Ubbl);;3)2
.
.
iqti. Il~btwify4,202Q,•ptiisplltjtto ~e¢tioii~6~(1:>)(I)(Q)<>ftheJ\cit,. .tlte $eqr¢tatypfthe
DepartmentofHealthand.Jlitrnan.Setvices(HH$)detetmined:tbatthereis•li:publichealth
E:itl.erget:icY thaj:.11l'lsJt $ig~i.fi¢lt:irt.pot¢ii,tiaJ:tQ a+fectlli!.1i◊miJ. ~cµtify ◊,ttlie. h.~tl:tJri14 $¢cuiifyof
United•Stlitescit:izenslivingabroacl,•and•thatinvohresthe.V1Ii.:is·ihat•causes corbtlav.imstlisease
1619•·(dOVIb. rn)?Orr·the•basis·ofsuch.·deterrnination,.the SecrefuryofHHS onMarch21;
·2020,.4ec1a.redtlfut:~cmrista.ndes ~stj~lifyirtgthe ailthori,zati611. 6fertt~gency~~◊fdftig~·
0
•andbiologicalproduds duringthecoVID~l9.pandemit;pursuantto Seclion564◊ftheAct:01
·u. ~;C\ 3:Ql>ol1~1),. sul:>jec:t totermsofariyauthorizati@issuedlm4erthatsecti@?·•
Actemraisarecombinanthuma:nizecl.monodooal 0antlbmlythat:se1ec1iveiybinds·•.fo·ooth·•sohible.
·•aridfuerriptarte~Qoil.¢hurtiiinIL-~fecept~•(~L-6R,andiflIL•6R):and.siibs:e4uentlymhipi~.IL6'-Jtiedi~t~p$j"g't1aljitgtht®gh·tl:t~se t.eceptot$. Ac~isgpA-wov-@f'otseVe@,µtdi¢~ti®s4';
itowever; Acterm:a is notapprovedfor theJreatment ofCOV1D-i9.
··
·
·
i1•Fortheptitposesofthis:Letttt.·ofAtith&izlitio:n,·lheuseofthetraderiameiActernra;iiiiiiteridedfo:refei'fo1:he
·cotninerdally11vailable:Actemrathat is. in- United·Stiites•dii!tribiitiort under the apPtoved Biologjcs•·License
Appliclitiori 125276; otil.y:.Asdistus!ied•filrth«·in.SectioliIIofthiS·letter,Acteirirathafis·ci:itnmetcially available
•imderthis·licensure:ii.•authorizedforeritergfflcy:·•USeCoosistentwiththetc:nns·andconditions. ofthis.letter,.
·2U;lJ;.DtjiattmenfofHeiilth•andHi.itrninSeivices,.Deteritiini:itiiinqfahiblii:.Hei,JthEiiiei'gencycitid1Jecliiriiti<in
tJtarctriimlsti:iik:es.ExistJurtfhmgAJliJtoi:fziiliri!J.J>ursuanfto.Seiioon·sM(bJ<Jftbe.FeciiriilFood.•Dtug; and·
lm11~~~~%t,7Je•~es~~~lfi~~~~~-~~£&k>,~
CatmtticAct, .21 U£C. §36Qbb/j;J;:FebrullryA,:.t020.
.
.
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.•;Ig:1;:~:::::r~~==~~:s1t~;J;~ff~~ns~lbLpcft
42862
Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
Page 2 - Genentech, Inc.
Based on review ofthe d.ata from the RECOVERY clinical trial (NCT #04381936), a
randomized, open-label, controlled, platform trial; the COV ACTA
trial (NCT
#04320615), a randomized, double-blind, placebo-controlled clinical trial; the EMPACTA
clinical trial (NCT #04372186), a randomized, double-blind, placebo-controlled clinical trial;
clinical trial (NCT #04409262), .. a randomized, double-blind, pla.ceboand the 1"1..:,Jcv1u•nv
coutrolled clinical trial, it is reasonable to believe that. Acternra may he effective for the
and older)
treatment of COVID-19 in. hospitalized adults and pediatric patients (2 years
who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or
invasive mechanical ventilation, or ex1racorporeal.membrane oxygenation (ECMO), and when
used under the conditions described in this authorization, the known and potential benefits of
Actetnta outweigh the know11 a11d potential risks ofsuch product.
Having concluded that the criteria for issuance ofthls. authorization under Section 564(c) ofthe
Act are met, I am authorizing the emergency use of Actemra for the treatment of COVID-19, as
described in the Scope of Authorization section of this letter (Section 1I) a11d subject to theterms
ofthis authorization.
I.
Criteria for Issuance of Authorization
l have concluded that the emergency use of Actemra for the treatment ofCOVID-19 when
administered as described in the Scope of Authorizati0l1 (Section lI) meets .the criteria for
issuance ofan authorization under Section 564(c) of the Act, because:
l. SARS-CoV-2 can cause a serious or life~threatening disease or condition, including
severe te.spiratory iltness, to humans inf'ected by this. virus;
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe
that Actemra may be effective for the treatment ofCOVID-19. in hospitalized adults
and pediatric patients (2 years of age and older)who are receiving systemic
corticosteroids and require supplemental oxygen, non°lnvasive or invasive mechanical
ventilation, or ECMO, an.cl that, when used under the conditions described in this
authorization, the known and potential benefits of Actemra outweigh the known and
potential risks of such product; and
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3. There is no adequate, approved, and available alternative to the emergency use of
Actemra for the treatment ofCOVID-19 in hospitalized adults a11d pediatric patients (2
Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
42863
Page 3 - Genentech, Inc.
yeiirs of age and older) who are receiving systemic corticosteroids and require.
supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECM0. 5•6
II.
Scope ofAnthorization
Ihave concluded, pursUartt to Section 564(dX1) of the Act, that the scope Qfthis authorization is
limited as fQllQWs:
•
Actemra will be used only by heatthca:te providers to treat COVID-19 in hospitalized
adults and pediatric patients(2 years of age and older) who are receiving systemic
.corticosteroids and require supplemental oxygen, non-invasive or invasive
mechanical ventilation, or- ECMO.
•
Actemramay ®ly be administered ViafottaVetrous infusion;
•
The use of Actemra covered by this authorization must be in accordance withihe
authorized Fact Sheets;
Product Description
Actemra is supplied in individual single dose vials. Actemra is a recotnbinilnt htltl'l.anized monoclonal
antibody that selectively binds to both soluble and membrane-bound human IL-6 receptors (slL6R and mIL-6R)and subsequently inhibits IL-6-mediated signaling through these receptors.
Actemra injection is a preservative-free, !lierile clear; colorless to pale yellow solution, The
authorized product includes commercially available 7Actemra, which is supplied as SO mg/4 mL
(NDC 50242-135-01 ), 200 mg/10 mL (NDC 50242• 136-01). and.400 mg/20 mL (NDC 50242137-01) individually packaged 20 mg/mLsingle-dose vials for further dilution prior to
intravenous infusion. Do not use beyond the expiration date on the container or package.
Actemra must be refrigerated at 36"F to 466 F {2°C to 8°C). Do not freeze. Prote~t the vials from
light by storage in the original package until tiine ofuse.
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5 On October 22, 2020, Veklury (remdesivir) was approved to treat COVID-Hfin adults and pediatric patients (12
yean, of age and older and weighing at least 40 kg)requiri:ng hospitalization, Vek;lury is a nucleoside nbonucleic
acid polymerase inhibitor lhathas dem.onstrated antiviral activity against SARS-COV-2. Actemraisarecombinant
humanized monoclonal ®tlbody that selectively binds to both soluble andmembrane 0 boundhuman IL·6 receptors
(sIL"6R and mlL•6R) and subsequently inhibits IL-6-mediated signaling through these receptors. Severe COVID-19
infection has been associated with hyperinflammation. In this context, high.levels of IL~6, as well as other proinflammatary cytokines and inflammatory.markers, have been. observed in some patients.with severe COVID0 19
infection, ThllS, a product inhibiting IL-6, such as Acremra, may potentially act on tlw COVID-19-associated
inflammatory response. This.is distinct from Veklury,. which acts as an.antiviral agent We also note thatVekiury''s
FDA-approved indication is for a narrower population than the use authorized forActemra under this EUA
6 Noother criteria .of i$:.~ance have ~n prescribed by regulation under Section 564(c)(4}of the Act
7 Supm at Note 1.
·
42864
Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
Rage 4-Qenentech, Inc.
Act¢mrai~ authijriz'edfo,r,emergency use with the followitlgproduct~st>e¢itlc information
requireijt!:l be m~de ayailabletohealthoil,l'epr!:!'\'iqetshrtd Jiatietlts, parents, Attd oaregivei:s,
resp~tivefy', througll.G®.ente9'h's wel!site irtwww.;aotemrahcp.99m/covid~19(referi-edto as~the
••authorizedlabeling"}:
·
·
•
Fact Sheet fur Healthcare Providers: Emergency UseAuthorizatfon (EUA) forAcfemra
•
FMt Sheet fur Patients, Parents and.care~!e~LEm~gertqy Use Authorization(EUA) of
,A.ctemrafor>ebron'a\'ifus.l)iseasti:2019(CPVJD;.19)
lhave conclud¢; pur~uantto Sec:tionS64(4)(2)ofthe,A.ct;.that it is rell$o,nabletobelieve th~t
the known and potentfalhenefits ofActemra,when usedforthetreatmentofCOVID~19 and
used in accordance with this Scope of Authorizatioo (S~tion.lI),.outweighthe kn◊wtt and
pi)tentfalrisks.
lhave concluded;. pursuanft.o Section 564(d)(3)ofthe A:ct, based ollthefotality ofscientific
evidence available to FDA, thatitisreasonableto believe that Actemramay be.effective.for the
treatmertto£CQVID-i9whenused macoordancewith this. Soope.ofAttth<>rization(Seotfontl),
pursuantto:Seotion S,64(c)(2)(A)ofthe.Act.
Havingreviewed the sdentificinfonnatfun available to FDA,;·.includingtheinfonnation
sup~ortmgthe .eonclusions descdbe?in Section I. ab<>v~,Ihave concluded th4:1.Actentra(~
de!iertbedirt.this S.:ope of AUth<>rization(Sectlon Il)) meets the criteriasetfotfuin.$ectioo 564{d)
ofthe Act oonoeming sawty and potential effectiveness.
Conditions ofAuthorization
ill.
~tt<> Section SM ofthe Act.I am estabiishlngth.eJo1lowntgcontfitions onthisatitb.QriZatfon:
Genentech and AuthorizedDistribtitorss:
A. Genentech and atitht>rized distti'butor(srwiilensure that Actemra is distributed. with the
FDA·llJ>PfOVe4 paokagemsertandtheattthorizedlabeling (i.e., FactSheets)willbemade
aVllil@le ~ healthcare :faoilitiesa:n:<V◊rhealthca.t"¢ pt◊viders as des:,:rt"bed iRSectionJl <>f
this Letter.ofAuthorization..
R denentecliand.authortzeddistributor(s)\¥illensurethat~riatesto~atidcotd.chairt
is maintau:ied until the product is delivered to healthC8.1"¢facilities and/or healthc11te
providers,
c.
-Oenentecli andautboriZed dtstributor(s)wiif ensure thatthetetiris oftfilsEUA are made
availableto.allrelevantstakeholders{e;g., U.S. go.vet:nmentag¢ncies,state andlocal
govemm.entauthorities, authorized distribut<>rs,. healthcarefacilities; healthoareipr:ovidets)
irtvtilvednt:distri~titµlg•OJ.'.TCCeiyiµgAct.imra.•Ge11.en:techwiU·provideto•allrelev~t
"Atithorized0istributor(s)" are.identifiedbyGenentechas. an.entity or·entities.allowedfo.·disb:ibuteActemrn for
the useauthorized.inthisJetter.
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8
Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
42865
Page 5 - Genentech, fuc.
:stakeholder$ a copy of this LetterofAuthoriza1ionand coi:mnunicate any subsequent
ameniJments·that•rhightbe1nadetothistetfer•ofAuthorizaiion: md·its:autborized
acc;ompan¥iug.materials (i;e,, FllCt Sheets),
a Genentechmaytequest dumgesto this authorization. mdudihgto the authorized Fact
Sheets for Act¢111ta. Any requestfor changes to this E:UA must be submitted t◊ :the
Diyision ofPulmonology; Allergy and Critical Care/Office of Immunology and
fuflammation/Office ofNew Drugs/Centerfor DrugEvafuationand Research (CDER).
Such ch~··requireappropriateauthorization·priortoiinplementation,9
E. dertentecfrmaydevelop and di$seminate.msttuctfortalan:d eilucational material.if(e.g.,
material$ provirungf1rl'otmitti()il Oil. pmdiJ'1t•~isfrati?ilM4/orpati~t.monitotitigjthl¢
areco11$istentwi1Jithe authorizedemergencyuseofAc;t¢mraas describedin this Letterof
Authorization•and authorized labeling; ·withoutFDA's·•review•.and concurrence,when
rtecessacyto meet public health11eeds. Any inslructiortal iiiid educatio11almaterial.sth~tate
in.con:sistentwiththe autho1:1Zed labeling·forActenitalltepte>hibited.. IftheAgertcynotifo~!i
G:enentechtha.tany i.rtstructi()QaI Md edµcatiortaI mat¢riaisare inc;(}tl$istentwiththe
authorized labeling, Genent¢chmust ceasedistributionofsuch inslructionaland
educatiortal materials. Furthermore, as pmt ofi.tsrtotiffoatiort,the Agertcymity alsorequire
Oenentechtoissue·c~ve.COtnill:Ui1ication(s).
Fi Genentechwillteporlto FDAserious adv~e events and.all medication errors associat,ed
with the use ofActemra:for·furauthorized. use that are reporledto Genentech. using either of
the follo'wirtg options.
Optic>nl: Subtriitreporlathroughthe SafetyReporlm:glforfuJ. ($RP)ll$ de$Crl.bed onthefJjA
·
··
,mwebpage,
Option 2, stlbihlt.teports dt:ectiythrou@tthe Electrotiic subtriissions:0atewaJ(ESG)as
desenbed on theFAERS el@@i¢subrtiissrons.webpage,
$'llbmitte4 repo).1ll 11t1d~ both. options shoi.ild state: "A:cjenira 11se for COVll).;19 under
Emergency Use Authorization. (EUA)/' For reports sUbrhitted under Option], include this
langwtge at the ~~ of the ~estlon ''Des'Cribe Event"forfu.rthei:anal.)'Sis. Forreportis
submitted . nndet Option 2, inclµde .this 1 ~ a,t the begin.tiiugofthe ''Case Natrativ:e"
fie1&
.
~ The
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followipg:types. ofrevisions.ma:y birauthorizedwithout.reissuing this lefter, (1) changes to the 11Uthorized
labeling; (2) non.substantive editorial couectionsto this letter; (3Jnew types of authorized labeling; includipg: new
factsheets;(4)new carton/container labels;(5)expiration·dating.extensions; {('i)changes•tomanufacturing
processes; inclu~ tests or other authoriz.ed components of manufacturing; (7Jnew conditions ofauthoriz.litionfo
require data collection orstudy; (8) new strengths of the authorizedproduct,newproduct sources(e,g.; of active
pharmaceutical ingredient)or ofproduc.t.components. For changes to the11Uthoriz.ation; includipg: the authorized
labeling; ofthe type.listed in(3), (6), (7), or.(8}, review andconcurrenceisrequired.ftom the Couriter..Te1Torism and
Emergency Coordination S!afli'Officeofthe Genter Pirector/cPERand the OfficeofCounterterrorism and
Emergipg: ThreaWOffice ofthe•Chief Scientist.
42866
Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
Page 6 - Genentech, fuc.
G; A1fmahilfacturing, pack;igin~.and:testing $hes.for both drug substance and drug product
\\'ill comply With c-atrent good manufacturing practice requitem:enti; ofSection
5Ql(a)(2)(B) ofthe.Act
H.
.Genentecliwi.Ilsuhmitmfonnation tothe:Agency withlri.threeworkirig days <>ftece1.pto:t'
anyinfonnationconcerningsigriifi¢ahtqualitypfoblems with dtugproductdistributed.
un.derthis em:ergency•us.e ®thotitatio11·.forAcletnfathatinclud¢$thefollo~:
•
lmormati.011. ~ncemfu:ganyin!:idetttthatcauses·thedrug product or ib:•·tabeling
to be mistaken for; orapph'ed to, another article; or
•
Information concerningmiymicrobiologicalcontamin.atio~ or any sigriificant
chenucal, physica1, or. other. change or deterioration in the dismbuted dt:ug
produ~ oranyfail~ ofone ormoredi$1tt"buted batches ofthe ptoduiJtto m~t
the esta:blishedspeci:fications,
affects
Ifa sigriificantqualityproblem
unreleasedproductandmay atsoinipactproduct(s)
pr¢viomlyreleaseda:11d distributed, then .infortnati6n should be submittedfor a1lp()te11tially
iillpacted Jots.
·
Genentech will include inits notification to the Agency whether the batch. or batches, in
question will berecalled.
lfnotit1cluded in its ihitial n◊ti:fication, Qenentech must submit i11formation cottfirming
that Genen~;;:h hi.tS ide1:itifie<fth.erQOt Clluseofthe ~ignificantqualityprobiems,taken
corrective action, and provide ajustification confttming thatthe corrective action is
appropriate and effective. Gene11tech mustsubmitthis information as soon as possible
·
butn() httetthan 45 calen.dat daysfrorn the Initial notific4tion.
L GenentecllwillmanufactureA-1'temra to meet all qualify sta:ndards and per the
processandconlrolstrategy as detailedfo Genentech~s EUArequest.
lllllllilf~
Genet1techwillnotim:pleni.entany changes to the description. ofthe product, manufncturifig
process, facilities.ani.lequipment; and ele111en.~ ofthe llS!lOCili.ted control. str:ategythatass~
prgcessproonnance,aJ:1.d.qu@ty Qftheautb~d prgduct, \Vithout11otificatiot),.to and,
concurrence T)ytheAgency as described qndercondition D.
J. Thfough aproceS$ ()tinventory con~ol. denentectandauthorlzed.dtstributOI(s)wi.U
maintain records regarding•dismbutionofActetnta(i.e,, iotnumbers, quantity;receiving
site,r:eclilip~~}
·
K. Genentechmid authorizeddistributor(s)willmake available to FDA upon request any
records maimained in connectil:>tt.With this BUA.
Healthcare Facilities to Whom ActemralsOistriouted.andHealthcare Pt()viders.Adminisforing
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Actemra
Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
42867
Page 7 -Genentech, fuc.
L Heal1hcarefacilities and.hea11hcare providers will ensure 1hatthey are aware ofthe Letter
o.fAuthorization, and 1he tenns herein, and that 1he authorized Fact Sheets are made
available to. heal1hcare providers and to patients, parents, and.caregiv~ respectively,
through appropriate means, prior to administrati-OU of Actemra.
M. Healthcare facilities and healthcare providers receiving Actemra will track seriousadvetse
eventl> that are considered to be poten(ially attributable.to Actemra use and must report
1hese to FDA in accordance wi1h 1he Fact Sheet for Heal1hcare Provid.ers. Complete and
submit a MedWatch form (www;fda:.gov1medwatch/mporth1m). or complete and submit
FDA Form 3500 (heal1h professional) byfax (l-800-FDA-0178) (1hese forms can befouiid
via link above). Call l-800.:FDA-1088 for questions. Submitted reports should state,
"Actemra usefor COVID-19 undetEmergenc:yOseAu1horization'' atthe beginnfugo.fthe
question "Describe Event" for further analysis. A copy of1he completed FDA Form 3500
.should also be providedto Genentech per 1he instructions in the au1horized labeling.
N. Heal1hcare facilities and healthcate providers will ensure that appropriate storage and cold
chain is maintained until1he product is administered consistent with 1he terms of1his letter
and the authorizedlabeling.
o. Through a process of inventory control, healthcare facilities will maintain records regarding
the. dispensing and administration of Actemra for the use authorized in 1his letter (i.e., lot
numbers, quantity, receiving site, receipt date), producfstorage, and maintain patient
information (e:g.., patient name,, age; disease manifestation, number of doses administered
per patient, other drugs administered).
P: Heal1hcare facilities will ensure 1hat any records associated with this EUA are maintained
until notified by Genentech and/or FDA Such records will be made available to
Genentech, HHS~ and FDA for inspection uponrequest.
Conditions Related to Printed Matter, Advertising, and Promotion
Q. All descriptive printed matter, advertising, and promotional materials relating to the use of
Actemra under1his authorization shall be consistent with 1he authorized labeling, as well as
the terms set forth in 1his EUA, and meet 1he requirements set forth in Section 502(a) and
(n) ofthe Act, as applicable, and FDA implementing regulations. References to "approved
labeling'', "permitted labeling'' or similar terms in these requirements shall be understood
to refer to 1he authorized labeling for 1he use of Actemra under 1his authorization. In
addition,.such materials shall:
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•
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Be tailored to 1he intendedaudience.
Not take 1he form of reminder advertisements, as 1hat ferm is descnbed in 21
CFR202.l(eX2Xi), 21 CFR200.200 and21 CFR201.100(t).
Present 1he sanie risk mfurmatioilrelatiilg to the major side effects and
contraindications concurrently in 1he audio and visual parts ofthe presentation
for advertising and promotional materials inaudio-visual format
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•
•
42868
Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
Page 8 - Genentech, Inc.
•
•
Be accompanied by the authorized labeling, ifthe promotional materials are not
subject to Section 502(n) of the Act.
Be.submitted to FDA accompanied by Fortn FDA:2253 at the time of initial
dissemination or fast use.
lfthe Agency notifies Genentech that any descriptive printed matter, advertising or
promotional materials do not meet the terms set forth in conditions Q-S of this EUA;
Genentech must cease distribution of such descriptive printed matter, advertising,-0r
promotional materials in accordance with the Agency's notificati-On. Furthermore, as part
of ifs notification, the Agency may also require Genentecht-0 issue rorrective
communication(s ).
No descriptive printed matter, advertising, or promotional materials relating to the use of
Actemra underthis authorization may represent or suggest that Actemra is safe or effective
when used for :the treatment of COVID-19 in hospitalized adults and pediatric patients (2
years of age and older) who are receiving systemic c-0rticosteroids and require
supplemental oxygen,non-invasiveorinvasivemechamcal ventilation, or ECMO.
R
S. Ail descriptive printed matter, advertising, and promotional material, relating to the use of
Actemra under this authorization clearly and ronspicuously shall state that:
IV.
•
Actemra.has not been approved, but has been authorized for emergency use by
FDA under an EUA, to treat COVID-19 in hospitalized adults and pediatric
patients (2 years of age and older) who are receiving systemic corticosteroids
and require supplemental oxygen,non-invasive or invasive mechanical
ventilation, or ECMO; and
••
Theemergencyuse of Actemrais only anthorizedforthe durationofthe
declaration that circumstances existjustifying the authorization of the
emergency use of drugs and biological products during the COVID-19
pandemic under Section 564(bX1) of the Act, 2 lU.S.C. § 36dbbb-3(bXl ),
unless the declaration is terminated or authorization revoked sooner;
Duration ofAuthorb.ation
This EUA will be effective until the declaration that circumstances exist justifying the
authorization of the emergency use of drugs and biological products during the COVID-19
pandemic is terminated under Section 564(b)(2) ofthe Act or the EUA is revoked under Section
564(g) ofthe Act.
Sincerely,
--JS!--
Dated: July 30, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
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[FR Doc. 2021–16705 Filed 8–4–21; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; 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.
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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 cooperative agreement
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the cooperative agreement applications,
the disclosure of which would
E:\FR\FM\05AUN1.SGM
05AUN1
EN05AU21.036</GPH>
RADM Denise M. Hinton
Chief Scientist
Food_ ancl Drug Administration
]]>Agencies
[Federal Register Volume 86, Number 148 (Thursday, August 5, 2021)]
[Notices]
[Pages 42850-42868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16705]
[[Page 42850]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0335]
Authorizations of Emergency Use of Certain 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 two Emergency Use Authorizations (EUAs) (the
Authorizations) under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) for biological products for use during the COVID-19 pandemic. FDA
has issued one Authorization for a biological product as requested by
GlaxoSmithKline LLC and one Authorization for a biological product as
requested by Genentech, 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 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 Authorizations, which include an explanation of the reasons for
issuance, are reprinted in this document.
DATES: The Authorization for GlaxoSmithKline LLC is effective as of May
26, 2021, and the Authorization for Genentech, Inc. is effective as of
June 24, 2021.
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 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),
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
[[Page 42851]]
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 has issued two
authorizations for the emergency use of biological products during the
COVID-19 pandemic. On May 26, 2021, FDA issued an EUA to
GlaxoSmithKline LLC for sotrovimab, subject to the terms of the
Authorization. On June 24, 2021, FDA issued an EUA to Genentech, Inc.
for ACTEMRA (tocilizumab), subject to the terms of the Authorization.
The initial Authorizations, which are included below in their entirety
after section IV of this document (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 and are available on the internet at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
BILLING CODE 4164-01-P
[[Page 42852]]
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[GRAPHIC] [TIFF OMITTED] TN05AU21.021
[[Page 42854]]
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[[Page 42855]]
[GRAPHIC] [TIFF OMITTED] TN05AU21.023
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Dated: July 30, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-16705 Filed 8-4-21; 8:45 am]
BILLING CODE 4164-01-C
