Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Monkeypox Virus; Availability, 65071-65081 [2022-23391]
Download as PDF
<![CDATA[
Federal Register / Vol. 87, No. 207 / Thursday, October 27, 2022 / Notices
Advisory Committee was originally
announced in the Federal Register of
September 13, 2022 (87 FR 56071). The
meeting has been postponed to allow
time for FDA to review new
information. Future meeting dates will
be announced in the Federal Register.
Dated: October 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–23379 Filed 10–26–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2375]
Authorization of Emergency Use of an
In Vitro Diagnostic Device for
Detection of Monkeypox Virus;
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) in response to
an outbreak of monkeypox. FDA has
issued an Authorization for an in vitro
diagnostic device as requested by
Abbott Molecular, Inc. The
Authorization contains, among other
things, conditions on the emergency use
of the authorized product. The
Authorization follows the August 9,
2022, determination by the Secretary of
Health and Human Services (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 monkeypox virus. On the basis
of such determination, the Secretary of
HHS declared, on September 7, 2022,
that circumstances exist justifying the
authorization of emergency use of in
vitro diagnostics for detection and/or
diagnosis of infection with the
monkeypox virus, including in vitro
diagnostics that detect and/or diagnose
infection with non-variola
Orthopoxvirus, pursuant to the FD&C
Act, subject to terms of any
authorization issued under that section.
The Authorization, which includes an
explanation of the reasons for issuance,
is reprinted in this document.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:55 Oct 26, 2022
Jkt 259001
The Authorization is applicable
as of October 7, 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:
Jennifer Ross, Office of Counterterrorism
and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4332, Silver Spring,
MD 20993–0002, 301–796–8510 (this is
not a toll-free number).
SUPPLEMENTARY INFORMATION:
DATES:
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).
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
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
65071
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.
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,
or 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).
II. Criteria for EUA Authorization
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
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.
E:\FR\FM\27OCN1.SGM
27OCN1
65072
Federal Register / Vol. 87, No. 207 / Thursday, October 27, 2022 / Notices
Prevention (to the extent feasible and
appropriate given the applicable
circumstances), FDA 2 concludes: (1)
that an agent referred to in a declaration
of emergency or threat can cause a
serious or life-threatening disease or
condition; (2) that, based on the totality
of scientific evidence available to FDA,
including data from adequate and wellcontrolled 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
khammond on DSKJM1Z7X2PROD with NOTICES
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.
VerDate Sep<11>2014
16:55 Oct 26, 2022
Jkt 259001
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.
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 August
9, 2022, 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 monkeypox virus.
Notice of the Secretary’s determination
was provided in the Federal Register on
August 15, 2022 (87 FR 50090). On the
basis of such determination, the
Secretary of HHS declared, on
September 7, 2022, that circumstances
exist justifying the authorization of
emergency use of in vitro diagnostics for
detection and/or diagnosis of infection
with the monkeypox virus, including in
vitro diagnostics that detect and/or
diagnose infection with non-variola
Orthopoxvirus, pursuant to section 564
of the FD&C Act, subject to the terms of
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
any authorization issued under that
section. Notice of the Secretary’s
declaration was provided in the Federal
Register on September 13, 2022 (87 FR
56074). On October 7, 2022, having
concluded that the criteria for issuance
of the Authorization under section
564(c) of the FD&C Act are met, FDA
issued an EUA to Abbott Molecular, Inc.
for the Alinity m MPXV, subject to the
terms of the Authorization. The
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 revision to
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
E:\FR\FM\27OCN1.SGM
27OCN1
Federal Register / Vol. 87, No. 207 / Thursday, October 27, 2022 / Notices
65073
·u.s. FOOD & DRUG
·:AP:Mfli! ISJit'A'ft(i N
Qct<:iber 7, .2022
Gfoa Sairirnarto
Manager Re$UlatoryAffaits
Abbott M()letular, Inc.
1300 E touby Ave
Des :Plames,JL600ls.
Device:
EUANwnber:
Company:
Indication'.
Authorized Laboiitorles:
Aliriity mMP:XV
EUA220434
AbbottMoledilai::, Inc:
This test is authori;zed l'i'.u: the qmtlitativ:e detection of DNA. fr<>m
mmikeypox virus (dl:lde I/II)1 in humanlesfon swab specim~
(i.e., swabs ofacute pustular orvesicularrash)in viral transport
media (VTM) from individuals suspected ofmonkeyp<>x virus
infection t,y their healthcare provider;
.Emergency use oi this test is Iimi:ted fo ttuthorized laboratorit:ls.
Laboratories certified under the Clinical Laboratory ll.nptovement
Amendments of I 9~& (CLlA), 42 u. S:C. §263a, that meetthe
requirements to perfonnmQderate or high complexi.tytests.
Dear Ms. Sammarco:
This letter is in response fo your2 request that the Food and I)rug A.dmihistratlon (Fi)A) issue
an Emergency Use Authorizc\,Uon (EUA) for .emergency use ofyour product,3 pursuant to
Section 564 of the Federal Food, Drug, and CosmeticAct (the Act) (21 U.S.C. §360bbb-3);
On Aµgust 9, 2022, pµrsuantfo Section 564(1:))(l)(C)Qftbe Act; the Secretary Qftbe
Department Qf Health: and HlIDllm Services (HHS) determined that there is. a ~blic health
emergency;. or. a significant potential for a public heafth emergency, that affects or bas a
significant potential to affect national security or the health and security of United States
i On August 12, 2022; foll!lWll'J8 ·a·meeting: converted bythe Worldllealili Orgmiizatlon (WHO) morikeypox virus
variants wete renmned to align with current best practices under the International. Classification.ofDiseases !l!ld the
WHO Family .of.Intel1t!ltional Health Related Classificatioos (WHO-FfC), This Jetter will refer to the fonnet Congo
Basi1t (CentralAfrican)-cI!ide as clade one O) an4 tl"te fonner We,,;t African clade as clade two(ll). !{efer to:
·
.hfips://WWW;wh,o,intlnews/iteiii/12;0lf:2022:-111dllk¢Y@'lt::::¢li.pjl:rig.;.g.iv:e-virt1,~-yariartts-ttew~l'!lime$.
2
ease ofreference, this letter will use the term ''you" and rel!dcd tenns to refer to Abbott Molecular,Jnc ..
3 For e11s,e:of refei:en®. this: letter will use the tenn ''your product" to refer to tbllA!inity m MPXV tesh1!ied for the
indication identified above. .
VerDate Sep<11>2014
16:55 Oct 26, 2022
Jkt 259001
PO 00000
Frm 00051
Fmt 4703
Sfmt 4725
E:\FR\FM\27OCN1.SGM
27OCN1
EN27OC22.000</GPH>
khammond on DSKJM1Z7X2PROD with NOTICES
For
65074
Federal Register / Vol. 87, No. 207 / Thursday, October 27, 2022 / Notices
Page 2 - Gina Sammarco, Abbott Molecular, Inc.
citizens living abroad fhat involves monkeypox virns. 4 Pursuant to Section 564 of the Act, and
on the basis of such determination, the Secretary of HHS then declared on September 7, 2022
that circumstances exist justifying the authorization of emergency use ofin vitro diagnostics for
detection.and/or diagnosis of infection withthemonkeypoxvirus, including in vitro diagnostics
that detect and/or ~iagnose infection with non-variola Orthopoxvirus, subject to the terms of
any authorization issued under Section 564(a)ofthe Act. 5
FDA (;tonsideredthe totality of scientific infotmation available in authorizing the emergency U$e
of your product for the indication above. A su.1nmary of the performance information FDA ·
relied upon is contained in the "Alinity m MPXV AMP Kit" Package Insert. There is an FDA•
cleared test for the qualitative detection ofnon-variola Orthopoxviros, thatincludes monkeypox
virus, but this is not an adequate and available alternative to yout product: 6
Having con.eluded that the criteria for issuance of this authorization under Section 564(c) of the
Act are met; I am authorizing the emergency use of your product, described in the Scope. of
Authorization of this-letter (Section II), subject to the terms of this authorization.
L Criteria forlssuance ofAuthoriZidion
I have concluded thatthe emergency use of your product meets the criteriafor issuance ofan
authorization under Section 564(c) of the. Act, because I have concluded that:
I. Tite monkeypox virus can cause a serious or life-threatening disease or condition, to
humans infected bythis virus;
2. Based on the totality of scientific evfdence available to FDA, itis reasonable to. believe
that your product may be effective in diagnosinginfectioi1 with the monkeypox virus, and
that the known and potential benefits ofyour product when used for diagnosing
monkeypox virus, outweigh the.known and potential risks of your product; and
3. TI1ere is no adequate, approved, and available alternative to the emergency use of your
pro.duct. 7
IJ. Scope o( Authorlzatfon
I have concluded, pursuaritto Section 564(d)(1)ofthe Act, that the scope of this authorization is
limited to the indication above.
87 FR50090 (August 15, 2022)
s 87FR56074 (September I3, 2022)
6 To date, the FDA-cleared CDCNon-variola Orihopoxvirus Real-time PCR Primer and Probe Set (Product Code:
PBK; DEN070001, Kl&l205,K221658, K22l834, K222558) is the only test available in the United States with
FDA clearance for the detection of non-variola Otthopoxvims DNA, including vaccinia, cowpox,.monkeypox and
ectromelia viruses at varying concentrations. Available information indicates that timely detection of rnonkeypo.X
cases in the United States. requires wide availability of diagnostic testing to control the spread of this contagious
infection. and there is currently a need for additional diagnostic testing for rn onkeypox virus in the United States.
7 No other criteria ofissuance have been prescnbed by regulation under Section 564(cX4) of the Act
VerDate Sep<11>2014
16:55 Oct 26, 2022
Jkt 259001
PO 00000
Frm 00052
Fmt 4703
Sfmt 4725
E:\FR\FM\27OCN1.SGM
27OCN1
EN27OC22.001</GPH>
khammond on DSKJM1Z7X2PROD with NOTICES
4
Federal Register / Vol. 87, No. 207 / Thursday, October 27, 2022 / Notices
65075
!>age 3 -G:ina Sammarco, Abbott Molecular, Inc.
Authorized.Product Details
Your product hi a real-time I>CR test ii.1tended for the qualitative detection of DNAfrom
monkeypoxvirus (clad.: VII) in humanJe.sion swttb specimens (Le., swabs ofacute pustular or
vesicular rash) in viral transport media (VtM} front individuals sm;pected ofmonkeypox.
infection bytheirhealthcare provider. Testing is limited to laboratories certified under the
Clinical Laboratory lmprovement Amendments of 1988 (CLIA), 42 U ;RC. §263a, that meet the
requirement$ to perfonn moderate Qt high complexity tests.
Results are. for the identification of monkeypox virus (clade I/II) DNAwhich is generally
detectable in .human pustular or vesicular lesion specimens during the acute phase. of infection.
Positive results are indicative ofthe presence of :m:onkeypoxvirus (clade VIi) DNA; clinical.
CQrrelation with patient his(ory and other diagnostic infonnation is necessary to detennine patient
it1feqtion $fatus. Positive results do Mt rule out bacleria:l infection .or co-infection with Qther
viruses. The agent detected maynot be the definite cause of disease. Negative.results obtained
with.this device do not preclude monkeypox virus (clade I/II)infection and should not be used as
the sole basis fortreatrnent or other patient manageme11tdecisio11s. Negative results must be
combinedwith clinical observations, patienthistory, atrdepidemiological information,
The Alinity m MPXV assay is fo be used. with the Alinity m System; or other authorized
instruments (as maybe requested u11det Condition P. below) which performs sample preparatfon,
PCR assembly, amplification, detection, and result calculation and reporting. All steps ofthe
Alinity m MP:XV assay procedure are executed automatically bythe Ali11itym System, o:r other
authorized insfrurmmts, TheAlit1itym MPXV it1dudesthe materials (or other authorized
materials as· may be requested under Co11dition P. below) described in the Package. Insert.
Your product requires use of the Alit1ity m MPXV CTR.L Kit which is available from yotrwith
the "Alii:ritym MPXV C't.RL Kif' Pacl<.age Insert; or other authorized control materia{s (as may
be requested underCondition P. below) that are described in the Package Irtserts described
below. Your product also .requires the use of additional. authorized materials and authorized
ancillary reagents that are not ini::luded with your product and are described in the Package
Inserts described below:
The labeling entitled"Alinity m MPXV AMP Kit'' PackageJnserl, "Alinity m MPXV CTRL
Kit" Package Insert; "Alinity MPXVApplication Specification File" Package Insert; (available
at.https://YMYi.fda,ggV1medigal-deviQeslirnwrgency-use-autboti~atioM-med1caJ,devices/monkeypox•emergency-use"aUthorizations-medical.devices ), and the fo11owing fact
sheets pertaining to the emergency use; are. required to be made available a.,; setforth in the
Conditions of Authorization (Section IV); and are collectively referred to as "authorized
labeling":
•
•
Fact Sheet fofffealthcare Providers: AhbotCMoleculat, Inc,. -Alinity 1n MPXV
Fact Shootfor Patients: Abbott Molecular, Inc. -Alinity m MPXV
VerDate Sep<11>2014
16:55 Oct 26, 2022
Jkt 259001
PO 00000
Frm 00053
Fmt 4703
Sfmt 4725
E:\FR\FM\27OCN1.SGM
27OCN1
EN27OC22.002</GPH>
khammond on DSKJM1Z7X2PROD with NOTICES
the above .des~ribed product, when accompanied by the authorized labeling provided as setforth
h1 the Conditions of Authorization(Section IV), is authorizedfo be distributed to llt14 used by
65076
Federal Register / Vol. 87, No. 207 / Thursday, October 27, 2022 / Notices
Page 4
Gina Sammarco, Abbott Molecular, Inc.
authorized laboratories under this EUA, despite the fact that it does not meet certain
requirements otherwise required by applicable federal law.
I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that
the known and potential benefits of your product, when used consistent with the Scope of
Authorization of this letter (Section II), outweigh the known and potential risks of your product.
I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific
evidence available to FDA, that it is reasonable to believe that your product may be effective in
diagnosing infection with the monkeypox virus, when used consistent with the Scope of
Authorization of this letter (Section II), pursuant to Section 564(c)(2)(A) of the Act.
FDA has reviewed the scientific information available to FDA, including the information
supporting the conclusions described in Section I above, and concludes that your product (as
described in the Scope of Authorization of this letter (Section II)) meets the criteria set forth in
Section 564(c) of the Act concerning safety and potential effectiveness.
1he emergency use of your product under this EUA must be consistent with, and may not
exceed, the tenns of this lett.er, including the Scope of Authorization (Section II) and the
Conditions of Authorization (Section IV). Subject to the tem1s of this EUA and under the
circumstances set forth in the Secretary ofHHS's detennination under Section 564(b)(l)(C) of
the Act described above and the Secretary of HHS' s corresponding declaration under Section
564(b )( 1) of the Act, your product is authorized forthe indication above.
III. Waiver of Certain Requirements
I am waiving the following requirements for your product during the duration of this EUA:
•
Curre11t good manufacturing practice requirements, including the quality system
requirements under 21 CFR Part 820 with respect to the design, manufacture,
packaging, labeling, storage, and distribution of your product, but excluding Subpart
H (Acceptance Activities, 21 CFR 820.80 and 21 CFR 820.86), Subpart I
(Nonconforming Product, 21 CFR 820.90), Subpart O (Statistical Techniques, 21
CFR 820.250) and Subpart M (Complaint Files, 21 CFR 820.198).
IV. Conditions of Authorization
Pursuant to Section 564(e) of the Act, I am establishing the following conditions on this
authorization:
Abbott Molecular, Inc. (You) and Authorized Distributor(s) 8
A. Your product must comply with the following labeling requirements pursuant to FDA
regulations: the intended use statement (21 CFR 809.10(a)(2), (b)(2)); adequate directions
VerDate Sep<11>2014
16:55 Oct 26, 2022
Jkt 259001
PO 00000
Frm 00054
Fmt 4703
Sfmt 4725
E:\FR\FM\27OCN1.SGM
27OCN1
EN27OC22.003</GPH>
khammond on DSKJM1Z7X2PROD with NOTICES
8 "Authorized Distributor(s)" are identified by you, Abbott Molecular Inc., in your EUA submission as an entity
allowed to distribute your product.
Federal Register / Vol. 87, No. 207 / Thursday, October 27, 2022 / Notices
65077
Page 5 -GlnaSammarco,Abbott Molecular, Inc.
for use (21U:S.C. 352(f)l(21 CFR 809, 1-0(b)(5),(7), and{8)); appropriate limitations. on
the use. of the device includlng.iufoonationrequiredtmder 21 CFR809.lO(a)(4); and any
avaitableinforrnation reg11tdingptirforrnance ofth:e de'Vi:ce, includiilg requkemenw under
21 CFR809,10(b)(12),
.
B. Your product must comply .vith the following qµalify systemrequirem.ents pursuanHo
FDA regulations: 21 CFR 820 Subpart Il (Acceptance Activities, 21 CFR 820,80 and
CFil 820,86); $ubpartl(Notl®nfonn:lng Prodi.l.:t, 21 CFR 820.90), Subpart o (Statlsticlil
Techniques,.21 CFR 820.250); and Subl)art M(ComplaiutFileS; 21 CFR 820,198),
21
C. You and authorized distributor(s)must make your product available with the
authorized labeltngtQ. authorized. laboratories,
D.
Y'<>ll and allt!.nnjzed disttil>utor(s)mui make ayaifabte onJ1ourwel>siie(s)ihe
authorized labeling.
E. You and authorizedtlistrihutor(s) musdncfode a pliysfoal copy ot"the "Alinity m
MPXV AMP .Kit" Package Inserts. in each shipped producfto authorized laboratori¢s
and musttnake the "AJ,iJJity MPXV .Application $.pecifica,ion.File'' Pacl<age It1$ert
electronically·available.
F\ You and authorized clistribu.tor(s)must i.nforni atith<>rized 1ah<>tatoriesan4refovant
public health authorities ofthis EDA. lncludirtgfhe forms and conditions herein, ancl
updates made lo your product and authorized labeling,
any
G; Through iiprocess of inventory control,you and m.tthorizedilistributor(s)mustmnlntaln
records of the• authorized laboratories to which your productis distributed and the number
ofym:ir productdistribµted,
H. You and authorized distributor(s) mustcollectinformation. on the performance ofyour
product You mwtreport any si~ficantdevfatiottS:fromthe. established perfonnance
characteristics of your productof which you become awaret6 the Divisiort of
Microbiology(OMD)!OfficeofflealthTechnology 7(0HTI): Office ofin Vitro
rnagnostics.·/Office of.ProdtictEvalUationand.Quality(O~EQ)(Cent~for Devices and
Radiological Health (CDRH)(via email: CDRH"EUA"Reporting@fda.hhs.gov).
t
You ilhd auth:orizeddistributor(s) are auth<>rizedto make available additional
information re1atingto the emefgenccyuse otyourproductthatis consistent-with, and
does note1'.tceed; the tennsofthis letter of auth1,>rization.
1 You and authorized distributor(s) must make available the controlmaterial, Allnity m
MPXVCTRLKitWith the "Atinity m MPXV?TRL I<it'' Package Insert,orother
authQrized control ma,terials (as may be requested under Condition P. below), at the
same time as your product
VerDate Sep<11>2014
16:55 Oct 26, 2022
Jkt 259001
PO 00000
Frm 00055
Fmt 4703
Sfmt 4725
E:\FR\FM\27OCN1.SGM
27OCN1
EN27OC22.004</GPH>
khammond on DSKJM1Z7X2PROD with NOTICES
AhbotfMoleciilar, Inc~ (You)
65078
Federal Register / Vol. 87, No. 207 / Thursday, October 27, 2022 / Notices
Page 6
Gina Sammarco, Abbott Molecular, Inc.
K You mustregister andJistcorisistentwith 21 CFR Part 807 within.onemonthofthis
letter.
L. You must notify FDA Qf any authoriZed distributor( s) of your product, including the
name; address, and.phone number of any authorized distributot(s).
M.
You must have a signed agreement with each authorized distributor that distribution of
the authorized product must be consistent with. this Letter of Authorization.
N: If requested by FDA~ you must submit associated documents and records related to your
quality system for FDA review within 48 hours ofthe request.
Q; You.must provide authorized distributot(s) with a copy of this EUA and eommunfoate to
authorized distributor( s) any subsequent amendments tl1at might be made to this EUA
and its authorized accompanying materials (e.g., FactSheets).
P: You may request modifications to this EUA for your product, including to the Scope of
Aufuorization (Section II in this letter) or to the authorized. labeling, includittg requests to
make available. additional authorized labeling specific to an authorized distributor. Such
additional labeling may use.another name for the product but otherwise must be
consistent with the authorized labeling, and not exceed fue terms of aufuorization ofthis
letter. Any requestfor mQdification to this EUA should be submittedto
DMD/OHT7/OPEQ/CDRH and require appropriate authorization from FDA.
Q. You musthave lot release procedures and the lot release procedures, including the study
design and statistical power, must ensure that the tests releasedfor distribution have the
clinical and analytical performance claimed in the authorized labeling.
R. If requested by FDA. y-0u must submit: lot release procedures to FDA; including sampling
protocols, testing protocols, and acceptance criteri~ that you use to release lots 0.fyour
product for distribution in fue lJ.S. If such lot release procedures ate requested by FDA.
you must provide it within 48 hours of the requesL
S, You must evaluate fue analytical limit of detection and assess traceability of your
product with any FDA-rec◊mmended refetence material(s) if requested by FDA. 9 After
submission to and concurrence with the data by FDA. you must update your labeling to
reflect the additional testing. Such labeling updates will be made in consultationwith,
and requite concurrence of, D:MD/OHT7/OPEQ/CDRH.
t.
You must have a process: in place to 11:ackadverse and. report to FDA pursuant to 2 i
CFR Part 803.
Traceability refers to tracing analytical sensitivity/reactivity back to an FDA-recommended reference material.
FDA may requ~t, for example, that you p¢rfOI!(i this study in the event that we rect;ive t¢p0ns of adverse events
concerning your prodm;t
VerDate Sep<11>2014
16:55 Oct 26, 2022
Jkt 259001
PO 00000
Frm 00056
Fmt 4703
Sfmt 4725
E:\FR\FM\27OCN1.SGM
27OCN1
EN27OC22.005</GPH>
khammond on DSKJM1Z7X2PROD with NOTICES
9
Federal Register / Vol. 87, No. 207 / Thursday, October 27, 2022 / Notices
65079
Page 7 ~ Gina Sammarco, Al,bott Molecular, Inc.
U You·musf evaluate. the impact ofmonkeypox viral mutations on your product's
performance, such evaluations must occur on an. ongoing basis. and.must include any
additional data l!llalysis.tha:t is requested by FI)A iii response to @y performance
concerns you or FDA identify during routine evalua:tfon:;. Addifionally, if i:equested by
FI)A. you musf.subnritrecords ofthese tIV;aluati:ons for FDA review within 48ho:urs ()f
the request If your e:valuationidentifies viral mutations that affect the stated expected
performance of your device, you must notify FDA immediately (via email: CDRH..;EUARep<m:in$®fdµms.g9v).
v; Ifrequested by FDA. you must update your labeling within 7 calendar days to include
any additional labelit1g risk mitigations identified by FDA regarding the. impact of viral
mutations on test performance. Such updates will be made in consultation: with, and
requirecottcurrenceof, DMD/OHT7-0IR/OPEQ/CDRH.
w. You m1.1Stfurther evaluate the diriical perfonnance of your product using natural clinical
lei,ion swab specimens inVTM in an FDA agre.ed upon post authorization clinical
evaluation study withfu 6 months of'the date.of this 1etter (unless otherwise agreed to
with DMD/OHIT/OPEQ/CDRH); Aftersul,mission to and concurrence with the data by
FDA.. you must update the -authorized labeling to reflect the additionaltesting:. Such
labeling updates wi11 be made iii consultation with,. and. requite concurrence of,
DMD/OH'lWOPEQ/CDRH.
X. You must complete FDkagreedupon post authorization specimen stability studies
within 3 months.ofthe date of this letter (unless otherwise agreed to with DMD/OHT7
/OPEQ!CDRH).. Aftersubmissionofthe study data, an:d review and concurrence withthe
data by FDA. you mustupdate. your product lahelingto reflect the additional testmg.
Such labeling upd.ates mllSt be made ip consµlta.tiott with, and require conc1.1rrettce of,
DMD/OHT7/0PEQICDRH,
Y.
You must submittoDMD/OII't74)IRJO:PEQ/CDRIIwith:iti 3 months ofthe date of this
letter youtplan and artticipated timelihe to establish and maintain a quality system that i$
appropriate for your product's design amt ml!llufa.cture; and that meets the requirements
of either the 2016 edition ofISO 13485 or 21 CFR Part 820.
Autho~ed Laboratories
Z; Authorized laboratories that receive. your product must notify the relevant public health
authorities of their'fotent to run youf product priortoinitiatingtesting.
AA. AuthorizedJaboratories Using your product musthave a. ptOCt:$8. in pfac.i for reporting test
results. to healthca.re providers anff relevant public health authorities, as appropriate.
BB: Authorized taboratOries using your pi:oductmiistinclude with.test.resultieports, all
authorized Fact Sheets. Under exigent circumstances,. othera:ppropriate methods for
disseminating these Fact Sheets. may be used, which may include mass media
VerDate Sep<11>2014
16:55 Oct 26, 2022
Jkt 259001
PO 00000
Frm 00057
Fmt 4703
Sfmt 4725
E:\FR\FM\27OCN1.SGM
27OCN1
EN27OC22.006</GPH>
khammond on DSKJM1Z7X2PROD with NOTICES
CC. Authorized .laboratories using your product must use yourproduct as outlined in the
65080
Federal Register / Vol. 87, No. 207 / Thursday, October 27, 2022 / Notices
Page 8 ~ Gina Sammarco,. Abbott Molecular, Inc.
authorized labeling. Devia1ions from the authorized procedures, including the
authorized instruments, authorized extraction methods, authorized clinical specimen
types, authorized control materials, authorized other ancillary reagents and authorized
materials required to use your product are not pennitted.
DD. Authorized laboratories must have a process in place to track adverse events and report to
you (via email: email: mo1eculatsupport@abbott:com; 1-800-553-7042) and to FDA
pursuant to 21 CFR Part 803.
EE. All laboratory personnel using your productmusfbe appropriately trained.in real-time
PCR teclmiques and use appropriate laboratory and personal protective equipment when
handling youtproductand use your ptoductin accordance with the authorized labeling:.
Abbott Molectilar; Ine. (\'on), i\:uthorized Distributor(s)and Authorized Labonttories
FR You, authorized distributof(s), . and authorized laboratories mustcollectinforination on
the performance of your product and must report any significant deviations from the
established performance characteristics ofyour product of which they become aware to
DMD/OHT'T/OPEQ/CDRH (via email: CD;RH-EUA-Rew:>rting@fda.hhs.gov) In
addition. authorized distributor(s) and authorized laboratories report to you (via email:
email: moleculatsupport@abbott.com; 1-800-553-7042).
00. You, authorized distributor(s), and authorized laboratories m;ing: your product must
ensure that any records associated with this EUA; are maintained until otherwise nptified
by FDA. Such records must be made available to FDA for inspection upon request
Conditions Rela~il to. Printed Materials, Advertising and Promotion
]:Il'.L All descriptive printed matter;.advertising and promotional materials relating.to the use
of your product shall be consistent with the authorized labeling, as well.as the terms set
forth in this EUA and meet the requirements setforthin section502(a), (q)(l), and (r) of
the Act. as applicable, and FDA implementing regulations.
II. No descriptive printed matter, advertising or promotional materials relating to the use of
your product may represent or suggest that this test is safe or effective for the detection of
monkeypox virus. or other oon:.variola orthopoxviruses.
VerDate Sep<11>2014
16:55 Oct 26, 2022
•
This product has not been FDA cleared or approved; but has been authorized for
emergencyuse by FDA under an EDA for use by the authorizedlaboratories;
•
This product ha8beenauthorited only for the detectfon ofnucle:ic.acidfroni
monkeypox virus, not for any othet vi.ruses or pathogens; and
Jkt 259001
PO 00000
Frm 00058
Fmt 4703
Sfmt 4725
E:\FR\FM\27OCN1.SGM
27OCN1
EN27OC22.007</GPH>
khammond on DSKJM1Z7X2PROD with NOTICES
Jl AU descriptive printed matter, advertising and promotfonal materials r¢lating to the use
of your product shall clearly .and conspicuously state. that:
Federal Register / Vol. 87, No. 207 / Thursday, October 27, 2022 / Notices
65081
P:age 9-GinaSanunarco, A.bhott M()leclilar, Jnc.
• The e:mergencyt:1$e -o:fthi$ prodµ~ is Qllly aµtli<>rizedJ<>r the duratfon ofthe
declaraoonthatcircumstances.existjustifyingtheauthorizationofemergency use
ofin vitro diagnostics for detection and/Qr diagnosis of infection with the
n1onke-ypoxvirus, itn:ludirtg vitro dia~osues thatdetectand/i>t dia~ose
infei;;tionwith nonavarinlaOrthQpt>xvtrus, under Section 564(b)(l) Qfthe Federal
:Food,.Dru& 1U1tlC:osmetk: Acrt; 21 D'.$.C, § 3(>Qbbh~3(b){l),,untessthe
declaration is terminated orauthorizationis revoked sooner.
ht
ffo::etnetgettcy·use•ofyow•~t<>duct!i$·d¢sPtibedin•thls.1etter. ofauthorizatfonmust•®mply
withthec()nditicms. and all otherterms <>:t'this.authorizlltion:
·
V. DurationofAuthorizatfon
This EDA wm bee:ffective untffthe dedatat1on:that cfrciimstances existjusttiying the
authorization ◊ftheemergim:(;lyuseo:finvitr() llia!Wo$ticsf()rdete~i()ll M4A>t·4il11W<>$isQf
infecti()11:with the monk:eypox vints,includinginyittodiagnostics that detect and/or diagnose
ififectionwithnon~variola Orthopaxvirus, isterminated under Section 564(b)(2) oftheAct.or
the EUAisrevoked underSecti<>n 564(g) ◊fthe Act.
Sincerely,
Iii
Namandje N. Bumpus, Ph.D.
Chief'Scielrtist
Food and DrugAdtrtiliisttlltiOri•
Ericfosure
[FR Doc. 2022–23391 Filed 10–26–22; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–0085]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Substances
Generally Recognized as Safe: Best
Practices for Convening a Generally
Recognized as Safe Panel
khammond on DSKJM1Z7X2PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
VerDate Sep<11>2014
16:55 Oct 26, 2022
Jkt 259001
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by November
28, 2022.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The title
of this information collection is
‘‘Substances Generally Recognized as
Safe: Best Practices for Convening a
GRAS Panel.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
has submitted the following proposed
collection of information to OMB for
review and clearance.
I. Background
Best Practices for Convening a Generally
Recognized as Safe Panel
OMB Control Number 0910–NEW
This information collection supports
FDA’s implementation of Agency
guidance. In 2017, FDA developed and
published for comment a draft guidance
entitled ‘‘Best Practices for Convening a
Generally Recognized as Safe Panel,’’
(https://www.fda.gov/media/109006/
download) which, once finalized, would
assist persons who choose to convene a
panel of experts in support of a
conclusion that the use of a substance
in food is generally recognized as safe
(GRAS).
The Federal Food, Drug, and Cosmetic
Act (FD&C Act) requires that all food
additives (as defined by section 201(s)
(21 U.S.C. 321(s)) be approved by FDA
for their intended use in food before
they are marketed. Section 409 of the
FD&C Act (21 U.S.C. 348) establishes a
premarket approval requirement for
‘‘food additives.’’ Section 201(s) of the
E:\FR\FM\27OCN1.SGM
27OCN1
EN27OC22.008</GPH>
Dated: October 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
]]>Agencies
[Federal Register Volume 87, Number 207 (Thursday, October 27, 2022)]
[Notices]
[Pages 65071-65081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23391]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2375]
Authorization of Emergency Use of an In Vitro Diagnostic Device
for Detection of Monkeypox Virus; 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) in response
to an outbreak of monkeypox. FDA has issued an Authorization for an in
vitro diagnostic device as requested by Abbott Molecular, Inc. The
Authorization contains, among other things, conditions on the emergency
use of the authorized product. The Authorization follows the August 9,
2022, determination by the Secretary of Health and Human Services (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 monkeypox virus. On the basis
of such determination, the Secretary of HHS declared, on September 7,
2022, that circumstances exist justifying the authorization of
emergency use of in vitro diagnostics for detection and/or diagnosis of
infection with the monkeypox virus, including in vitro diagnostics that
detect and/or diagnose infection with non-variola Orthopoxvirus,
pursuant to the FD&C Act, subject to 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 applicable as of October 7, 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: Jennifer Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, 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).
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, or 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).
II. Criteria for EUA Authorization
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
[[Page 65072]]
Prevention (to the extent feasible and appropriate given the applicable
circumstances), FDA \2\ concludes: (1) that an agent referred to in a
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of
scientific evidence available to FDA, including data from adequate and
well-controlled clinical trials, if available, it is reasonable to
believe that (A) the product may be effective in diagnosing, treating,
or preventing (i) such disease or condition or (ii) a serious or life-
threatening disease or condition caused by a product authorized under
section 564, approved or cleared under the FD&C Act, or licensed under
section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product, taking into consideration the material threat
posed by the agent or agents identified in a declaration under section
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no
adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating such disease or condition; (4) in
the case of a determination described in section 564(b)(1)(B)(ii) 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.
---------------------------------------------------------------------------
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 August 9, 2022, 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
monkeypox virus. Notice of the Secretary's determination was provided
in the Federal Register on August 15, 2022 (87 FR 50090). On the basis
of such determination, the Secretary of HHS declared, on September 7,
2022, that circumstances exist justifying the authorization of
emergency use of in vitro diagnostics for detection and/or diagnosis of
infection with the monkeypox virus, including in vitro diagnostics that
detect and/or diagnose infection with non-variola Orthopoxvirus,
pursuant to section 564 of the FD&C Act, subject to the terms of any
authorization issued under that section. Notice of the Secretary's
declaration was provided in the Federal Register on September 13, 2022
(87 FR 56074). On October 7, 2022, having concluded that the criteria
for issuance of the Authorization under section 564(c) of the FD&C Act
are met, FDA issued an EUA to Abbott Molecular, Inc. for the Alinity m
MPXV, subject to the terms of the Authorization. The 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 revision to 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.
BILLING CODE 4164-01-P
[[Page 65073]]
[GRAPHIC] [TIFF OMITTED] TN27OC22.000
[[Page 65074]]
[GRAPHIC] [TIFF OMITTED] TN27OC22.001
[[Page 65075]]
[GRAPHIC] [TIFF OMITTED] TN27OC22.002
[[Page 65076]]
[GRAPHIC] [TIFF OMITTED] TN27OC22.003
[[Page 65077]]
[GRAPHIC] [TIFF OMITTED] TN27OC22.004
[[Page 65078]]
[GRAPHIC] [TIFF OMITTED] TN27OC22.005
[[Page 65079]]
[GRAPHIC] [TIFF OMITTED] TN27OC22.006
[[Page 65080]]
[GRAPHIC] [TIFF OMITTED] TN27OC22.007
[[Page 65081]]
[GRAPHIC] [TIFF OMITTED] TN27OC22.008
Dated: October 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23391 Filed 10-26-22; 8:45 am]
BILLING CODE 4164-01-C
