Authorization of Emergency Use of Two In Vitro Diagnostic Devices in Response to an Outbreak of Mpox; Availability, 6262-6281 [2023-01987]
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6262
Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
tobacco use by minors, FDA requests
OMB approval to collect data for the
Monthly Monitoring Study.
In the Federal Register of July 26,
2022 (87 FR 44405), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. One PRA related comment
was received.
(Comment) The commenter stated that
they believed the study should include
children as young as age 10 years.
(Response) The age range for
inclusion of this study (15 to 24 years)
is based on the target audience for CTP/
Office of Health Communication and
Education’s campaigns, which are
adolescents and young adults.
Additionally, we are limited by the
social media mode of data collection
(platforms generally do not allow
children younger than 13 years old to
have accounts) and by the Children’s
Online Privacy Protection Rule, which
does not allow us to contact youth 13
years old and under without parental
permission. Furthermore, lowering the
age range would greatly increase the
time needed to field the survey, as well
as the costs. Given that parental
permission is not feasible for the social
media-based recruitment, we must be
granted a waiver of parental permission
from our institutional review board. Our
institutional review board has not
historically granted a waiver of parental
permission for respondents younger
than 15 years old.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED REPORTING BURDEN 1
Number of
respondents
Type of respondent/activity
Total annual
responses
Youth Screener ......................................................
Youth Assent ..........................................................
Youth Online Survey ..............................................
Young Adult Screener ............................................
Young Adult Consent .............................................
Young Adult Online Survey ....................................
135,000
27,000
27,000
135,000
27,000
27,000
1
1
1
1
1
1
135,000
27,000
27,000
135,000
27,000
27,000
Total ................................................................
........................
........................
........................
1 There
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Number of
responses per
respondent
Average burden
per response
0.04167
0.04167
0.33333
0.04167
0.04167
0.33333
Total hours
(2.5 minutes)
(2.5 minutes)
(20 minutes) ..
(2.5 minutes)
(2.5 minutes)
(20 minutes) ..
5,625
1,125
9,000
5,625
1,125
9,000
.....................................
31,500
are no capital costs or operating and maintenance costs associated with this collection of information.
We expect the screening process (2.5
minutes per response) to yield a 5 to 1
ratio of eligible participants. We will
need to screen approximately 270,000
potential participants (135,000 youth
and 135,000 young adults) over the
study period. Participants determined to
be eligible through the screener will
complete a youth assent or young adult
consent (2.5 minutes per response) and
the online survey (20 minutes per
response).
Over the course of the study period,
we intend to survey approximately
1,500 youth ages 15 to 17 years old, and
young adults ages 18 to 24 years old,
every 1 to 2 months. The survey will be
repeated with a new cross-sectional
sample approximately every month or
every other month over a period of 18
months. We will obtain a final sample
size of 54,000 youth and young adults
(27,000 youth and 27,000 young adults)
over the course of the study period.
Respondents will be allowed to
complete an additional, cross-sectional
survey after 6 months.
We made the following changes
between the 30-day and 60-day
publications: In reviewing recruitment
metrics for two similar CTP studies, we
found an average of 5:1 screening to
survey completion ratio. Therefore, we
adjusted the number of required
screeners and burden hours accordingly.
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Dated: January 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–01978 Filed 1–30–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0249]
Authorization of Emergency Use of
Two In Vitro Diagnostic Devices in
Response to an Outbreak of Mpox;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of Emergency Use
Authorizations (EUAs) (the
Authorizations) under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) in
response to an outbreak of mpox. FDA
has issued an Authorization for an in
vitro diagnostic device as requested by
Becton, Dickinson & Company (BD) and
DiaCarta, Inc. The Authorizations
contain, among other things, conditions
on the emergency use of the authorized
products. The Authorizations follow the
August 9, 2022, determination by the
Secretary of Health and Human Services
SUMMARY:
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(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 Authorizations, which include an
explanation of the reasons for issuance,
are reprinted in this document.
DATES: The Authorization issued to BD
for the VIASURE Monkeypox virus Real
Time PCR Reagents for BD MAX System
is effective as of December 23, 2022. The
Authorization issued to DiaCarta, Inc.
for the QuantiVirus MPXV Test Kit is
effective as of January 10, 2023.
ADDRESSES: Submit written requests for
a single copy 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
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Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
which the Authorizations may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorizations.
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).
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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
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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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).
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
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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6263
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
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 Authorizations
The Authorizations follow 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 December 23, 2022, having
concluded that the criteria for issuance
of the Authorization under section
564(c) of the FD&C Act are met, FDA
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Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
issued an EUA to BD for the VIASURE
Monkeypox virus Real Time PCR
Reagents for BD MAX System, subject to
the terms of the Authorization. On
January 10, 2023, 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 DiaCarta, Inc. for the
QuantiVirus MPXV Test Kit, subject to
the terms of the Authorization. The
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 revision to
the Authorizations can be found from
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
Authorizations 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
U.S. FOOD & DRUG
i!.l>MlNfST:lh\tlO ~
December23,2022
Melissa: Barhoover
Senior RegulatoryAffairs Manage1\
Becton, Dickinson and Company
7Lov:eton Circle,
Sparks, MD 21152~0999
VlASlJREMonkeypox virus Real Time PCR Reagents for BD
Device:
EUA "NUttl.bei:
Cco:npany:
Indication:
Authorized Laboratories:
MAXSystem
EUA220453
Becton, nicldrisoo &Company (SI>)
This test is authonzed for the qualitative detection of DNA from
monkey pox: virus (MPXV, clade I/It) 1 in human .lesion swab
specimens (i.e., sw'abs of acute pustular or vesicular tash) from
individuals suspected ofmpox2 by theil' heillthcare provider;
·Emergency use of this test i.s Hmitedto authorized laboratories,
Laboratories certified under the Clinical Laboratory Improvement
Amendments of 1.988 (CLIA), 42 U. s.c. §263a, that meetthe
requirem~ts to perform: moderate or high complexify tests .
Dear Dr. Barhoover:
This letter is in response toyour3l'eqµestthat the Food and Drug Admstration (FDA) issue
an Emergency Use ·Authorization (EUA) for emergency use ofyour product,4 pursuant to
Section 564 oftheFederal Food, Drug, and CosmeticAct(theAct) (21 U.S,C §360bbb-3).
1
On August 12, 20.22,, following a 1rteeting convened by the. Wmld Health ()rgartfaation (WHO) moilkeypoxvirus
https.:/{Wroy:\>,1!0.i@'newstruwtl2-08.2Q22•l'l'IOnkeypo~x;perts;,giv(M'®!l:Variants-new-mnne,1.
2 On November 2S, 20:ii,followiliga s,~tie1rofoonsultations withgfo.bal.experts, the World Health Orgaruzatioo:
(WHO) begm using a new preferred term "'lnpox" as a ~ynonym for monkeypox, the disease cause by the
mo:ukeypox virus.. Refer to: httpsif»'.\YW,~hu int/wrw!!l~l 1~2nz2-wb,o;reoom~w·Xll!me:fm:•
monkeypgx-disease. . . . .
• For ease ofreference, thfa. iet~:t wm use the term "you'' .and.related terms to tefer tti Becton,. Diekirtson iirld .
Company (BD).
4 Fqr ease of reference, thi..<i: letter will use the term ''your product''to refer to the VlASURE Monkc,ypµi;; vitus Rt;lll1
Time .PCR Reagents.forBD MAX System used for the. indication identified above.
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variant/1 wercIWl!lllled to alignwith current best practices:lll.lder tilt) In~tiomtlCla$sitlcation ofDisemes and.the
WHO Fa111ily of Inietnittional Heiilth Relitted Classification$ (WHO-Fl:C).. This letter wiU ref-e;: to the form.er Congo
Basin (Central African). clade as clade one:(I)and the forn,er West.African elai.le a,; elade two (IT). Refer to:
Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
Page 2
6265
Melissa Barhoover, Becton, Dickinson and Company (BD)
On August 9, 2022, pursuant to Section 564(b)( l)(C) of the Act; the Secretary of the
Department of Health and Human Services (HHS) determined 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 ofUnited States
citizens living abroad that involves monkeypox virus. 5 Pursuant to Section. 564 of the Act, and
on the basis of such detem1inafion, the Secretary of HHS then declared onSeptember7, 2022
that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for
detectiou.and/or diagnosis of illfection with the monkeypox virus, including in vitro diagnostics
that detect and/or diagnose infectiou with non-variola Orthopoxvirus, snbjectto the terms of
any authorization issued under Section 564(a) of the Act. 6
FDA considered thetotality ofscientific infom1ation available iri authorizing the emergency use
ofyour product for the indication above. A summary of the performance information FDA
relied upon is contained in the "v'1ASURE M onkeypox vim$ Real Time PCR Reagents for BD
MAX System" Instructions for Use. There is an FDA-cleared test for the qualitative detection
of non-variola Orthopoxvirus, that includes monkeypox virus, but this is not an adequate and
available alternative to your product. 7
Having conctuded that the criteria.for issuance of this authorization under Section 564(c) ofthe
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 for Issuance ofAnthmization
I have concluded that the emergency use of your product meets the criteria for issuance of an
authorization under Section 564(c) of the Act, because I have concluded that:
1. 1'he mollk:eypox virus can cause a serious or life-threatening disease or condition; to
humans infected bythis virus;
2. Based onthetotaiity of scientific evidence available to FDA,, it is reasonable to believe
that your product may be effective in diagnosing infection with the monkeypox virus; and
that the known and potential benefits of your product when used for diagnosing infection
with the monkeypox virus, outweigh the known and. potential risks of your product;· and
3. There is no adequate, approved, ru1d available altemativetothe emergency use ofyour
product. 8
87 FR50090 (August 15, 2022)
87FR56074 (September 13, 2022)
7 To date, the FDA-cleared CDC Non-variola Orthopoxwrus Real-time PCR Primer and Probe Set (Product Code:
PBK; DEN070001, K181205, K221658, K221834, K222558) is the only test available in the United States with
FDA clearance for the detection ofnon-variola Orthopox:virus DNA, including \'accinia, coWpax, monkeypoxand
ectromelia viruses at varying concentrations. Available information indicates that timely detection of mpox cases in
the United States requires wide availability of diagnostic.testing to control the spread of this contagious infection
and there js currently a need for additional diagnostic testing for monkeypox virus in the United. States.
8 No other criteria of issuance have been prescribed by regulation under Section564(c X4) of the Act
5
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6
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Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
Page 3 - Melissa Barhoover, Becton, Dickinson and Company (BD)
II. Scope of Authorization
I have concluded, pursuant to Section 564(d)( 1) of the Act, thatthe scope of this authorization is
limited to the indication above..
·
Authorized Product Details
Your product is a real-time PCR assay intended for the qualitative detection of DNA from
monkeypox vims (MPXV, clade I/II) in human lesion swab specimens (i.e., swabs of acute
pustular or vesicular rash) from individuals suspected of mpox. by their healthcare provider.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to pe1form moderate
or high complexity tests.
Results are for the identification of monkeypox virus (MPXV, clade I/II) DNA, which is
generally detectable in human lesion swab specimens during the acute phase of infection.
Positive tesults are indicative ofthe presence ofmonkeypox vims (MPXV, clade I/II) DNA;
clinical correlation with patient history and other diagnostic infonnatiot1 is necessary to
detennine patient infection status. Positive results do not mle out bacterial infection or coinfection with other viruses. The agent detected may not be the definite cause of disease.
Negative results obtained with this device do not preclude monkeypox virus (MPXV, clade I/II)
infection and should not be used as the sole basis for treatment or other patient management
decisions. Negative results must be combined with clinical observations, patient history, and
epidemiological infotmation.
'.The VIAS URE Monkeypox virus Real Time PCR Reagents are to be used with the BD MAX
System, or other authorized instruments (as may be requested under Condition 0. below) which
is based on fully automated. sample preparation (nucleic acid extraction and purification)
followed by PCR amplification and detection. Automated data management is performed by the
BD MA,"'\ System software release V5.14A or later. 111e VIASURE Monkeypox virus Real Time
PCR Reagents for BD MAX System includes the materials (or other authorized materials as may
be requested un.der Condition 0. below) described in the ''VIASURE Monkeypox vims Real
Time PCR Reagents for BD MAX System'' Instructions for Use.
Your product requires control materials (or other authorized control materials as may be
requested under Condition 0. below)that are not included with your product and are described in
the Instructions for Use. Your product also requires the use of additional aut11orized materials
and authorized ancillary reagents that are not included with your product and are described in th.e
Instructions for Use described below,
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The labeling entitled "VIAS URE Monkeypox virus Real Time PCR Reagents for BD MAX
System" Instructions for Use (also available at https://www.fda.gov/medical-devices/emergencyuse-authorizations-medical-devices/monkeypox-emergency-use-authorizations-medical•devices),
and the following fact sheets pertaining to the emergency use, are required to be made available
as set forth in the Conditions of Authorization (Section IV), and are collectively referred to as
"authorized labeling":
Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
6267
Page 4 - Melissa Barhoover, Becton, Dickinson and Company (BD)
•
•
Fact Sheet for Healthcare Providers: Becton, Dickinson and Company - VIASURE
Monkeypoxvirus Real Time PCRReagents for BD MAX System
Fact Sheet for Patients: Becton, Dickinson and Company - VIAS URE
Monkeypox vitus Real Time PCR Reagents for BD MAX System
The above described product, when accompanied by the authorized labeling provided as set forth
in the Conditions of Authorization (Section IV), is authorized to be distributed to and used by
authorized laboratories under this EUA, despite the fact that it does not meet certain
requiren1ents otherwise required by applicable federal law.
I have concluded, pursuantto Section 564(dX2)ofthe 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(dX3) of the Act, base!l 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 infom1atfon
supporting the conclusions described in Section.I above, and concludes that yourproduct (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.
The emergency useofyourproductunderthis EUAmust be consistent with; and may not
exceed, the terms of this letter; including the Scope of Authorization (Section II) and the
Conditions of Authorization (Section IV). Subject to the terms ofthis EUA and under the
circumstances set forth in the Secretary ofHHS's detennination under Section 564(b)(lXC)of
the Act described above and the Secretary ofHHS's corresponding declaration u11der Section
564(bX1J ofthe Act, yourproduct is authorized for the indication above.
III. Waiver of Certain Requirements
I am waiving the followingtequirements for your product during the duration ofthis EUA:
•
Current good manufacturing practice requirements, including the quality system
requirements tmder 21 CFR Part 820 with respectto the design, manufactnre;
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
(Nonconfom1ing Product, 21 CFR 820.90), Subpart Q (Statistic.al Techniques, 21
CFR 820.250) and Subpart M (Complaint Files, 21 CFR, &20, 198).
IV. Conditions of Authorization
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Pursuant to Section 564(e) of the Act, I am establishing the folfowirtg conditions on:this.
6268
Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
Page 5 - Ivlelissa Barhoover, Becton, Dickinson and Company (BD)
authorization:
Becton, Dickinson and Company (You) and Authorized Distributor(s) 9
A. Your product must comply ,vith the following labeling requirements pursuant to FDA
regulations: the intended use statement (21 CFR 809.10(a)(2), (b)(2)); adequate
directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5), (7), and (8)); appropriate
limitations on the use of the device including infommtion required under 21 CFR
809.1 0(a)( 4); and any available infonnation regarding pertonnance of the device,
including requirements under 21 CFR 809.10(b)(l2).
B. Your product must comply with the following quality system requirements pursuant to
FDA regulations: 21 CFR 820 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 Subpa:ti M (Complaint Files, 21 CFR 820.198).
C. You and authorized distributor(s) must make your product available with the
authorized labeling to authorized laboratories.
D. You and authorized distributor( s) must make available on your website(s) the
authorized labeling.
E. You and authorized distributor(s) must include a physical copy of the "VIASURE
Monkeypox virus Real Time PCR Reagents for BD Mfu'\: System" Instructions for
Use with each shipped product to authorized laboratories.
F. You and authorized distributor(s) must infonn authorized laboratories a:t1d relevant
public health authorities of this EUA, including the terms and conditions herein, and
ru1y updates made to your product and authorized labeling.
G. 'Ihrough a process of inventory control, you and authorized distributor(s) must maintain
records of the authorized laboratories to which your product is distributed and the number
of your product distributed.
H. You a:t1d authorized distributor(s) must collect infonnation on the perfom1a:t1ce of your
product. You must report any significant deviations from the established performance
characteristics of your product of which you become aware to the Division of
Microbiology (DMD)/Office ofHealth Technology 7 (OHT7): Office ofin Vitro
Diagnostics /Office of Product Evaluation and Quality (OPEQ)/Center for Devices and
Radiological Health (CDRH) (via email: ~~t:!:.!~~~:1.QI!ll]g(g!!Q!!:.!1]!!§:J~~J.
I.
You and authorized distributor(s) are authorized to make available additional
information relating to the emergency use of your product that is consistent with, and
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9 "Authorized Distributor(s)" are identified by you, Becton, Dickinson and Company, in your EUA submission as an
entity allowed to distribute your product.
Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
6269
Page 6 - Melissa Barhoover, Becton, Dickinson and Company (BD)
does not exceed, the terms of this letter of authorization.
Becton, Dickinson and Company (You)
J. You mustregister and list consistent with 21 CFR Part 807 within one month of this
letter.
:K.
You must notify FDA of any authorized distttbutor(s) of your product, indUding the
name, address, and phone number of any authorized distributor(s).
L. You must have a signed agreement with each authorized distributor that distribution of
the authorized product must be consistent with this Letter ofAuthorization.
M. If requested by FDA, you must submit assqciated documents and records related to your
qualify system for FDA review within 48 hours of the request
N. You must provide authorized distributor(s) with a copy of this EUA and communicate to
authorized distributor(s) any subsequent amendments that might be made to this EUA
and its authorized accompanying materials (e.g., Fact Sheets).
O, You mayrequest tnudi:fications to this EUA for your product, including to the Scope of
Authorization (SectionII in this letter) orto the authorized labeling, including 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 the terms of authorization of this
letter. Any request for modification to this EUA should be submitted to.
DMD/OHT7/OPEQ/CDRH and require appropriate authorization fromFDA
P. Youmusfhave lotreleaseprocedures and the Iotreleaseprocedures,includingthe study
design and statistical power, must ensure that the tests released for distribution have the
clinical and analytical performance claimed in the authorized labeling.
Q; If requested.by FDA, you mustsubmit lot release procedures to FDA, including sampling
protocols, testing protocols, and acceptance criteria, that you use to release lots of your
product for distribution in the U.S. If such lot release procedures are requested by FDA,
you must provide it within 48 hours of the request.
R. You must evaluate the analytical limit of detection and assess traceability of your
productwith any FDA-recommendedreferencematerial(s) if requested by FDA. 10
After submissionto and concurrence with the data by FDA, you must update your
labeling to reflect the additional testing. Such labeling updates will be made in
consultation with, and require concurrence of, DMD/OHTI/OPEQ/CDRH.
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10 Traceability refers to tracing analyticai sensrtivitylreactivity back to an :FDA-recommended reference material.
F'.DA may request, for example, that you perform this study in the event that we receive reports of adverse eventll
concerning your product
6270
Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
Page 7 ~MelissaBarhoµver, Becton, Dickinson and Company (BD)
S. You must have a process in place to track adverse and report to FDA pursuant to 21
CFRPart:803.
T, You must evaluate the impactofmonkeypox viral mutations on your product's
performanc<(,Such evaluations must oc..,"'Ut Qn an ongoing bllsis and must im;lude any
additional data analysis.that is,requested by FDA in response toanyperformance
concerns you or FDA identify during routine evaluation. Additionally, if requested by
FDA, you m1.1St submit records of these eval1.iati:0ns for FDA i:eviewwithin 4S hours of
the request Jf:yourevaluation identifies viral mutations that affect the stated expected
performance of yourdevice;you mustnotify FDA immediately {Via email: CDRH-EUAReporting@fda.hhs ..gov).
U. If requested by FDA, yJ:>umust update your lil.belingwithin 7 calendar days to include
any a:ddiµona1 ·labeling ri~k tn.itigations identifietl by FDA regarding the impact ofviral
mutations on test performance.. Such updates will be made in consultation with, and
require concurrence of, DMDIOHT7/OPEQ/CDRH.
V'. Ybu must further evaluate the clinicalperformance of yow- product using natural clinical
lesioncSwab specimensin VTM in an FDA agi:eed u.pon postanthorizafam clinic;il
evaluation study within 6months of the date.of this letter (unless otherwise agreed to
with DMDiOHTI/OPEQ/CDRH} After submission to and concurrence with the data hy
FDA,, you must update the authorized labeling to re~ect the additional testing. Such
fabeiing updates will be made in consultation with, and require concuri:ence of;
DMD/OHT7/OPEQ7CDRH,
..
W. You must complete FbAagreed upon post authorization. frozen specimen stability
studies within 3 months ofthe date of this letter (unless otherwise agreed to with
DMD/OHt7/OPEQ/CDRH). After submission of the study data, and review and
concurrence with the data by FDA, youmustupdateyourproduct labelingtoreflecUhe
additional testing, Such labeling. updates must be made in consultation with, and require
concurrence of, DMD/OHT7/OPEQ/CDRH.
X You must submit to DMD/OHT7/OPEQ/CDJU:lwithin 3 months ofthe date ofthis letter
your plan and anticipated timeline to establish and maintain. a quality system that is
a:ppropriate for your product's design. and manufacture, and that meets the requirements
ofeitherthe 2016 editionofISO 13485 or 21 CFR Part 820 ..
Authorized.Laboratories
Y. Authorized laboratories that receive your product must notify the relevant public health
authorities oftheir intent to mn your J>roduct J>rior tQ initiating testing.
Z.
Authorized laboratories using your product must havea<process in place for r'(J)orting test
results to healthcare providers and relevant public health authorities, as appropriate.
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AA.. Authorized laboratories using your ptoduct must include with test tesultreports, a:il
authorized Fact Sheets. Under exigent circumstances, other appropriate methods for
Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
6271
Page 8 - Melissa Barhoover, Becton, Dickinson and Company (BD)
disseminatingthese FaclSheets.maybe•used, whichmayinclude mass media.
ijI:3. Authorizedlaboratorie$ using your product mustuse your product R$ outlined in the
authorize4 labeling, Deyfations fromthe authorized proce4ures, includihgthe
authorized instnun:ents,: ltQthorized extractio11 tllethods; authorized clinical specimen
types, authorized controlmaterials, &.11horized oilier ancillary reagents and authorized
·
materials required to use your product ate riot petmitted.
CC. .Authorized biboratorieirmusf have aprocessjn: placefotrack adyerseevents and. report to
you(viaBeclon, Dickinson and CompanyCusfomerTechnical S'upport 1-800•638~&663)
and to. FDA pursuantto 2LCFRPart 803..
PILAll laboratory pet$onnel usingyour product must be appropriately trainedin real-time
:PQRtechniques and ulle llJ)propriate laboratory and pers◊Ilal. protectiw eqllip~11t when
handling your product and
your product in accordance with the authorized labeling,
use
Becton, I>ickiitson anil Company{Y011). Authorized I>istrlbntor(s) and .Authorized
Laboratories
··
··
·
EE. You; authorized•dis&ibtifor(s), and authorizedlaboratories mustcolfoctirtformation on
the petfotmance ofyout product and must report any signfficantde:viaiions from the
established petformance characteristics of your procluct of which they become aware to
I)MD/QlI1'1/OPEQIC1:>RlI(viaernml: ct>rrn:EtrA~llepottlng@fda;hhs;gov) lii
addition; authorized distributor(s}and authorized laborafories report to you (via
Becton; Dickinsonand Company Customer Technical .Support 1-800.638...8663);
Fit V6u~ atithoriz.ed distributm(s); and authocltedfaboratories usirtgyourproduct:must
e11Sun, thafany rec~rds R$sociate4 with this EDA. ~ majntainedun:tjlQtherwisie: nptified
by FDA Suchrecordsmust be made availableto FDAforinspectionupon request.
Condi6.1>ns'Rehtted to Printed Materlais; AdvertiShi1ranil Pt'omotion
00'.,.Afl llescripti:ve printed tllafter; atlvertising and-promotional mllterialll relating·fothe ~e
of yourproductshall be.·consistent wifu·the authorized labelin& as well as-the terms set
forth. in this EUAand meet the requirements setforth in section 502(a), (q)(l), artd.(r).of
·
·
the,Act, R$ applicable. and FDA iili.plementing regulations;
HH;
No ~criptive printed matter; adverli~ingor pronmtionalmaterials relating to 1he
.use of your product mayrepresenLor suggest.that this-tesf is:.safo.or effective for the
detection oftnOnkeypox virus ID" othernort-variolaorthopoxvirttses,
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•• This product has not been FDA deared or approve'4 bufhas been authorized for
emergencyuse by FDAunder an EUA foruse bythe authorized laboratories;
6272
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Page 9 - Melissa Barhoover, Becton, Dickinson and Company (BD)
•
This product has been authorized only for the detection of nucleic acid from
monkeYJ>OX virus, not for any other viruses ot pathogens; and
•
The emergency use oftbis product is only authorized. for the duration of the
declaration that circumstances exist justif}ing 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, under Section 564(b)( 1) of the Federal
Food, Drug, and Cosmetic Ac1, 21 U.S.C. § 360bbb-3(b)(l); unless the
declaration is terminated or authorization is revoked sooner.
The emergency use ofyour product as described in this letter of authorization must comply
withtheconditions and all othertenns of this authorization.
V. Duration ofAuthorization
This EUA wtllbe effective until the declaration that circumstances exist justi:fytng the
authorization ofihe emergency use of in vitro diagnostics for detection and/or diagnosis of
infection with the monk.eypox virtu,, inclu<ling iirvitro diagnostics that detect and/or diagnose
infection with non-variolaOrthopax:virus, is tenninated under Section 564(b)(2) ofthe Act or
the EUAis revoked under Section 564(g) of the Act.
Sincereiy~
!sl
Namandje N. Bumpus, Ph.D,
Chief Scientist
Food. and Drug Administration
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Enclosure
Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
6273
u~s. FOOD &. DRUG
·. . APMINl!!Y!tAitON.
January 1O, 2023
Kirig C. Lee, PhD; RAC
King Lee PhD; LLC
R~presentii:lg DiaCarta, Irie.
Dia.Carta, Inc. ·
4385 Hopyard ltd; Suite too
Pleasanton, CA 94588
Device:
QuantiVirus M:PXVTesf Kit
E:UANumber:
C<)mpany:
EUA220458
Indfoation:
This t'es( i~ authorized f6t the· qualtt.ative detection of DNA from
monk:eypox virus (dade l/lI)1in human lesion swab specimens
DiaCarta, Inc.
Authorized Lahoraiories:
(i.e., swabs ofacute pustular or vesiculat' rash) from individuals
suspected ofmpox.2 by their healthcare provider,
Emergency useoithis test is limited to authorized laboratories.
Laboratories certified under the Clinical Laboratory Improvement
Amendments of 19&8(CLIA), 42 U.S.C. §263a, that meet the
requirements to perform higll complexity tests,
Dear Dr. Lee:
This letter is in rest,onse fo yom3 request that the Food and Drug Admhristration (FDA) issue
an Emergency Use Authorization (EDA) for emergency use otyour product;.4 pursuant to
Section564 of the Federal Food,. Drug, and Cosmetic Act (ihe Act) (2J O.S.C, §360bbb-3).
1 On August 12, 2Q22, following a meeting Cl,jnVened by the WorldFieaJ:th Organizaiion (WHO) morikeypox virus
variants were renamed to align with ctlmli).t best practices under th!: International Cl.assifi¢atio11 of Diseases and the
WHO Family of.lntemationatHealth Related Clas.~ifications (WHO.F!C). This Jetter ~ill refer to the Rltn\et Congo
Basin (CentralAfrican) clade as c1ade one (I)and the formet West African clade as clade two (fl), Refer tQ:
·
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ht!lt(:/fMJ/:13(;)rtio.mt/news/itemJ12~0S,2022-Plgnk§;)ill6X~rtS-givg•Vitll!hVaqtllrtg.;tte'\¥•Mffi~.
2 On November 28., ·2022,.following a series of corn11.1Hatiorut with global experts, the World Health (kganizatfon
(WHO) beganusing a. new prefen:ed lenn "mpox'' as a synonym for monkeypox, the disease cause by the
monkeypoxvirus .. Refer to: •h.t:m,~J.l'?{V1:w,whQ.intfne:w£jtew,12lhl 1-2022•Wh9::001.mmerui'hlll:W"n.am:e•(m:·
!l!i'>llklM/QX•diseliSq;
.
a For case of reference, th.fa letter will u.'10 the term "you" and related terms to refer to DiaCii:tia,.Inc,
4 For eas1:1ofreference; this letter will~ the tenn "yourproduct''torefer totheQulllltiVirusMPXV test Kit u.sed
for the indication identified above.
6274
Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
Page 2
King C. Lee, PhD, RAC, Representing DiaCarta, Inc.
On August 9, 2022, pursuant to Section 564(bXI)(C)ofthe Act, the Secretary of the
Department of Health and Human Services (HHS) determined 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 United States
citizens living abroad that involves monkeypox virus: 5 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. of in vitro diagnostics for
detection and/or diagnosis ofinfection with the monkeypox Vims, including in vitro diagnostics
that detect and/or diagnose infection with non-variola Orthopoxvirus, surtlect to the terms of
any authorization issue<l under Section 564(a) of the Act. 6 ·
FDA considered the totality of scientific information available in authorizing the emergency use
of your product for the indication above. A summary ofthe performance information FDA
relied upon is contained in the "Instroctions for Use QuantiVims MPXV Test Kit." There is an
FDA-cleared test for tl1e qualitative detection of non-variola Orthopoxvirus, that includes
monkeypox virus, but this is not an adequate and available alternative to your product/
Having concluded that tlie criteria for issuance of this authorization under Section 564(c) of the
Act are met, I am iiuthorizing the emergency use of your product, described in the Scope of
Authorization of this letter (Section U), subject to the terms of this authorization,
I. Criteria for issuance of Authorization
I have concluded that the emergency use of your product meets the criteria for issuance of an
authorization under Section 564(c) of the Act, because lhave concluded that:
1. The monkeypox virus can cause a serious or life-threatening disease or condition; to
humans infectedbythis virus;
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe
that your product may be effective in diagnosing infection with the monkeypox virus~ and
that the known and potential benefits of your product when used for diagnosing infection
with the monkeypoxvirus, outweigh the known and potential risks of:your product; and
3. There is no adequate, approved, and available alternative to the emergency use ofyour
product. 8
87 FR50090 (August 15,2022)
87 FR 56074 (September 13, 2022)
7 To date, the FDA-cleared CDC Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (ProductCode:
PBK; DEN0700bl, KlSI205, K221658, K221834, K222558) is the. only test available in the United: States with
FDA clearance for the detection of noncvariola Orthopoxvirus DNA, including vaccinia, cowpox, monkeypox and
ectromeliaviruses at varying concentrations. Available information indicates that timely detection of mpox 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 monkeypox virus in the United States.
8 No other criteria of issuance have been prescribed byregulation under Section 564{cX4) of the Act
5
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6
Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
6275
Page :3 - King C. Lee, PhD, RAC, Representing DiaCarta, h1c.
IL Scope ofAutlmrizationIhave concluded, pursuantto S~ction 564(d)(1) ofthe Act, thatthe scope of this authorization is
limited to the indication above.
Authorized. Product Details
Your product is a real-time multipiex PCR test intetitled for the qUalitative detection of DNA
from monkeypox virus (clade 1/II) in human lesion swab specimens (i.e., swabs. of acute pustular
or vesicular rash) from individuals.suspected ofmpox by their healthcare provider. Testing is
limited to laboratories certified under the Clinical Laboratory Improvement Amendments of
1988 (CLIA), 42 U.S:C. §263a, that meet the requirements to perfonn high complexitytests:
Resµlts are for the identification of monkeypo~ virus (clade I/II) PNA, which is generally
detectable in human pustular or vesicular lesion specimens during the acute phase of infection.
Positive results are indicative ofthe presence ofmonkeypox virus (clade 1/Il) DNA; clinical
correlation with patienthistory and other diagnostic information is necessary to determine patient
infection status. Positive results do notrule out bacterial infection or co-infection with other
viruses. The agent detected may not be the definite cause of disease. Negative results olitained
with this device do not preclude monkeypox virus ( clade I/II) infection and should not be used. as
the sole basis for treatment or other patient management decisions. Negative results mu<it be
combinedwith clinical observations, patient history, and epidemiological information.
To use your product;. monkeypoxvirus (clade IIII}nucleic acid is firstell.iracted, isolated 1md
purified from lesion swab specimens followed by PCR amplification and detection using an
authorized RT-PCR instrument described in the. authorized labeling (described below). The
Quan1iVirus MPXV Test Kit includes the materials (or other authorizedmaterials as may be
requested under Condition Q. below) described in the ''fustructions for Use QuantiVirus MPXV
Test Kit."
Your product requites control materials (or other authorized control materials as may be
requested under Condition Q: below) that are described in both of the Instructions for Use. Your
product also requires the U!le of additional authorized materials and authorized ancillary reagents
that are not included with your product and are described in the authorized labeling deseribed
below.
The labeling entitled ''Instructions for Use QuantiVirtls MPXV Test Kit" (available at
https://wwwJaa.gov/medical~devices/emergency-use~authorizations-medical•
devices/monkewox•emerEency-µse-authorgati9ns-medicaj"devices), andthe followingfact
sheets pertaining to the emergency use,,are required to be made available as set forth in the
Conditions of Authorization (Section IV), and are collectively referredto as "authorized
labeling":
VerDate Sep<11>2014
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Fact Sheet fot· Healthcare Providers: l)faCarla, Inc; - QuantiVfrns MP:XV test Kit
Fact Sheet for Pa,tients: DiaCarta, Inc. - QuantiVirus MPXV Test Kit
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•
•
6276
Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
Page 4
King C .. Lee, PhD, RAC, Representing DiaCarta, Inc.
The above described product; when accompanied by the authorized labeling provided as set forth
in the Conditions of Authorization (Section IV), is authorized to be distributed to and used by
authorized laboratories under this EDA, despite the fact that it does not meetcertain
requirements otherwise required by applicable federal law.
I have concluded, pursuant to Section 564(d)(2)ofthe 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 risk<: of your product.
I have concluded, pursuantto Section 564(dX3) 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)(2XA) 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 ofthis letter (Section II)) meets the criteria set forth in
Section 564(c) of the Ad concerning safety and potential effectiveness.
The emergency use of your product under this EUA must be consistent with; and may not
exceed, the terms of this Jetter, including the Scope of Authorization (Section II) and the.
Conditions of Authorization (Section IV). Subject to the terms of this EUA and under the
circumstances set forth in the Secretary ofHHS's determination under Section 564(b)(l)(C) of
the Act described above and the Secretary ofHHS's corresponding declaration under Section
564(b)(l) of the.Act, your product is authorized for the indication above.
III. Waiver of Certain Requirements
lam waiving the following requirements for your product during the duration of this EUA:
•
Current good .manufacturing practice requirements, including the quality system
requirements under 21 CFR Part 820 with respectto the design,. manufacture,
packaging, labeling, storage, and distribution ofyour 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 CFR820.198).
IV. Conditions of Authorization
Pursuant to Section 564(e) ofthe Act; I am establishing the following conditions on this
authorization:
DiaCarta, Inc~ (\iou)a:ndAuthorized Distributot(s)9
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• "'Authorized Distributor(s)" are identified by you,, Diaearta, !rte,, in your BUA submissioil as: an entity· allowed to
distribute your prod:uct
Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
6277
Page $-KingC.. Lee, PhD,RAC, Representing DiaGarta, Inc.
A. Your producfmust comply with the following labeling requirements pursuant to FDA
regulations: the intended use statement (21 CFR 809.10(a)(2), (b)(2)); adequate
.directions foruse(21 U.S,C, 352(£)), (21 CFR 8()9.10(1,)($), (7), and (8)); appropriate
limitations on the use of the deviqe including infonnation required under.21 CFR
8Q9.1 0(a,)(4); and any available infonnation n~gardingperformance of the devjce;
including requirements under 21 CFR 809, lO(b)(l2).
B.
Your product must comply With the folfowing quality systeti1 requiremehtsputsimrtt to
FDA regulations: 21 CFR 820 Subp.art H (Acceptance Activities, 21 CF'R82Q:80 and 21
CFR 820.86), Subpartl{Nonconforming Product; 21 CFR 820.90), Subpart O (Statistical
Techniques,21 CFR 820.250), and Subpart M(ComplaintFiles, 21 CFR 820.198).
C, You. ancl authorized distribttfor(s) must make your product available with. the
authorize4 labelingtoauthorize4.laboratorle$,
n. You arid arithorizeddistributot(s) r1111st make available ori yollf website(s) the
authorized labelin,g.
K You and authorized distributor(s) mustinclude a physical copy of the authorized
''Instructions for Use QuantiVirus MPXV Test Kit" with each shipped product
F. You and auth<>rized distributot(s)nmst inform auth()tized laboratories and relevant
public health authorities of this Et1A, includingthetenns and conditions hetein, and
any updates made to your product and authorized labeling,
G. Thro11gh aprocess ofiiiventofy conttotyou arid arithorized distribt1tor(s)m11stmillritain
records of the authorized laboratories to which your productis,distributed and the number
of your product distributed.
H. You and authorized distributor(s) must colleclinformation on the.performance of your
product You.must report any significant·deviations frotnthe ·established t)erfonnance
characteristic:s ofy()ur productofwhich you become aware to the Division of
fyficrobiology (DMD)/Office of Health T.:chnology7(OHT7): Office ofln Vfuo
Diagnostics /Office of.Product Evaluation and Quality (OPEQ)/Center for Devices and
Radiological Health (CDRH)(via email: CDRH-EU:A-Re:porting@fda.hhs.g<}v).
I.
You and authorized distributor(s) are authotizedto make a.vailable additional
information relating to the emergency use ofyour productthat is consistent with, and
does not, exceed, the terms ofthis letter ofauthorization,
DiaCarta,/Inc. {You)
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J. You must register and listcottsistefitWith 21 CFR Part 8()7within one month of this
letter.
6278
Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
Page 6 - King C. Le.e, PhD, RAC, Representing DiaCarta, Inc.
K. Youmuslnotify FDA of any authorized distributor(s) of your product, including the
name, address, and phone number of any authorized distributor(s ).
L. You musthave asignedagreement with each aufh()rized distributotthatdistribution of
the authorized product illust ~ consistent with this Letter ofAuthorization.
M. If requested by FDA, y()u must submit associated documents and recotdsrelated to your
ciuality systeill for FDA review Within 48 hours ()f the request.
N. You must provide authorized distnlmtor(s) with a copy of this EUA and communicate to
authorized disttibutor(s) any subsequent amendments that might be. made to this EUA
and its. authorized accoillpanying materials (e.g., Fact Sheets).
0: You may request modifications to this EUA for your product, including tn the Scope of
Authorization (Section II in this letter) orto the authorized labeling, including requests to
make available additional authorized labeling specific to an authorized distnbutor. Such
additional labeling may use another naille for the pMduct but otherwise must be
consistent with the authorized labeling, and not exceed the tenns ofauthorizati()n of this
letter. Any request for modification to this EUA should be submitted to
DMD/OlIT7/OPEQ/CDRH andrequire appropriate authorization from FDA.
P, You must have lotretease pr()cedures and the lot release procedures, includmg the study
design and statistical power, must ensure that the tests released for•distributiortha:vethe
clinical and analytical perfonnance claimed in the authorized labeling.
Q:
If requested by FDA, you .must submit lot release procedures to FDA, induding sampling
prot()cols, testing protocols, and acceptance criteria, that you use t() release lots of your
product for distribution in the U.S. If such lot release procedures are requested by FDA,
you must provide it within.48 hours ofthe request.
R. Y()u must evaluate the analytical limit of.detection arid assess traceability of your
product with any FDA-recommended reference material(s) if requested by FDA.10
After submission to and concurrence with the data by FDA., you must update your
labeling to.reflectthe additional testing. Such labeling updates will be madein
consultation with, and require concurrence of, DMD/OHTI/OPEQ/CDRH.
Sc You must have a pmcess in place to track adverse and report to FDA pursuant to 21
CFR Part 803.
T, Y()U must evaluate the impact ofmonkeypox viral mutatioos on your product's
performance, Such evaluations must occur on an ongoing basis and must include any
additional data analysis that is requested by FDA in response to anyperfonnance
concems you or FDAidentify during routine evaluation. Additionally, if requested by
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10 Traceability refers to tracing analytical sensitivity/reactivity back to an FDA-recommendedreference materiaL
FJ)A may request, for exam;ple, that you perform this study in the event that we receive reports of adverse events
concerning your product,
Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
6279
Page 7 ~ King C. Lee, PhD, RAC, Representing DiaCarta, Inc.
FDA, you must submi.trecords ofthese evaluations for FDA review within 48 hours of
the request. If your evaluation identifies viral mutations that affect the stated <.lxpected
performance of your device, you must notify FDA inmiediately (via email: CDRH-ElJAReporting@fda.hhs.gov).
U. If requested by FDA, you must update your labeling within 7 calendar days to include
any additional labelingrisk mitigationsidentifiedby FDA regarding the impact of vital
mutations on test performance. Such updates will be made in consultation with, and
require concurrence of; DMD/OHT7/OPEQ/CDRH.
V. You must further evaluate the clinical performance of your product using natural clinical
lesion swab specimens in VTM in an FDA agreed upon post authorization clinical
evaluation study within6 months of the date oftlris letter (unless otherwise agreed to
with DMD/OHT7/OPEQ/CDRH).. After submission to and concurrence with the. data by
FDA, you must update the authorized labeling to reflect the additional testing. Such
labeling updates will be made in consultation with, and require concurrence of;
I)MD/OHT7/OPEQ/CDRH
W. You must submit to DMD/OHT7/OPEQ/CDRH within 3 months ofthe date ofthis Jetter
your plan and anticipated timeline to establish and maintain a quality system that is
appropriate for your product's design and manufacture, and that meets the requirements
of eitherthe 2016 edition ofISO 13485 or 21 CFR Part 820.
Authorized Laboratories
X Authorized laboratories that receive your product must notify the relevant public health
authorities of their intent to run your product prior to initiating testing.
Y. Authorized laboratories using your product must have a process in place for reporting test
results to healtl1care providers and .relevant public health authorities, as appropriate.
z;
Autl1orized laboratories using your product mustinclude with test result reports, all
authorized Fact Sheets. Under exigent circumstances, other appropriate methods for
disseminating these Fact Sheets may be used, which may include mass media.
AA. Authorized laboratories using your product must use your product as outlined in the
authorized labeling. Deviations 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 requited to use your product are not permitted.
BB. Authorized laboratories musthave a process in place to track adverse· events and.report to
you (via email: information1mdiacarta.com; J-800-246~&878) and to FDA pursuant to 21
CFR Part 803.
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CC. All laboratory personnel using your product must be appropriately trained in real-time
PCR techniques. and use appropriate laboratory and personal protective equipment when
6280
Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
Page 8 - KingC.Lee, PhD.RAC, Representing DiaCarta, Inc.
handling your product.and.use yourproductin accordance with the authorized labeling.
DiaCartai In¢: ·(Yon), .Authorized OOtrlb:uto:t(s)and. Authorized Laboratories
I>tt Yol½ authqrizeddistr:ibutor(s)tand authwized laboratories mustcollectinfoflllation on
the performanceofyourproductand must report any significant deviations from the
established pert'ormance characteristics ofy()ut]>toduct ofwhichthey become aware to
DMD/OflT7J6PEQ/CD1Ul(vi'a email: CDRH-EUA~R_eportins@fda,hb$.goy) In
addition, authorized. dis:tributor($)and authorized laboratories reportto.you(via email:
information,(a!diacarta.:com; 1~800~246-8878),
EE. You, authorized distributot($),Jmd atiflmrizedJaboratodes using yoill'-prodtict 111ttst
e11sure that 1tny records as$9ciated with thi$ EtJA, ·are maintain;ed until <>tlierwise notified
by FI>A Sucli recordsmust be made avajllll'>le t<> l'PAfor iµspeclion upo11 request,
Conditions'ReJaud to.Printed Matenals,.Advertismgand Promotion
PF. All descriptive printed matter, advertising andpromotionalmaterialstelatingtotheuse
ofy<>urpro<luctshall.beconsisten.t witli tlie·auth9rized labeling; as we1Las·thetel1ll!l s~
forth .in this EUAand meet the requirements setforth. in section502(a), (q)(l); and (r) of
the Act, as applicable, and FDA implementing regulations'.
®· N◊ descriptive printed matter. i;id'vertising or promotional material$ relatirtg tt:> the use ◊f
your product may represent or suggestthatthistesf is safe or effective forthe detection of
monkeypox virus or other non-variola orthopoxvirnses.
lilI. Ali descriptive printed matter, advertising·and promo:ffonal materials relatingto the use
ofyout productshall :clearlyand conspicmiuslysfate that;
•
This product has not been FDAcleared or approved, buf has been authorized for
emergency use by FDA under an EUA for use by the authorized laboratories;
•
This product has been authorized only for the detection of nucleic acid from
morikeYl)oxvirtlS, i10tfor any other vimses or pathogens; and
•
Th() emergency use of tliis product i$ only authorized for the duration ofthe
declaration that circumstances existjustifyingthe .anthorizationof emergency use
of in vitro diagnosti:cs for detection and/or diagnosis of infection with the
monkeypoxvirus, including in vitro diagnostics that detect and/or diagnose
infection with non°vatiola0rthopoxviros. under·Section 564(b)(l) ofthe Federal
Food, Drµg, and Cosmetic Act, 21 U:KC. § 36Qbbb-3(b)(1),unlessthe
declaration is tenriinated or authorization is revoked sooner.
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The emer.gency use of your product as described inthis letter of authorization. must comply
with the conditions and all otherterms ofthisauthorization.
Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
6281
Page 9 ~ King C. Lee, PhD, R,~C, Representing DiaCarta, Inc.
V. Duration of Authorization
This EUA will be effective until the declaration that circumstances exist justifying the
authorization of the 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 Orthopo:XVirus, is terminated under Section 564{b)(2) of the Act or
the EUA is revoked under Section 564(g) of the Act.
Sincerely,
Namandje N. Bumpus, Ph.D.
Chief Scientist
Food and Drug Administration
Enclosure
[FR Doc. 2023–01987 Filed 1–30–23; 8:45 am]
Either electronic or written
comments on the collection of
information must be submitted by April
3, 2023.
BILLING CODE 4164–01–C
ADDRESSES:
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0598]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Current Good
Manufacturing Practice Regulations for
Type A Medicated Articles
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the recordkeeping
requirements for the collection of
information regarding Type A
Medicated Articles.
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SUMMARY:
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You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
April 3, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
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• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2010–N–0598 for ‘‘Current Good
Manufacturing Practice Regulations for
Type A Medicated Articles.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
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Dated: January 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
]]>Agencies
[Federal Register Volume 88, Number 20 (Tuesday, January 31, 2023)]
[Notices]
[Pages 6262-6281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01987]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0249]
Authorization of Emergency Use of Two In Vitro Diagnostic Devices
in Response to an Outbreak of Mpox; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of Emergency Use Authorizations (EUAs) (the Authorizations)
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in response
to an outbreak of mpox. FDA has issued an Authorization for an in vitro
diagnostic device as requested by Becton, Dickinson & Company (BD) and
DiaCarta, Inc. The Authorizations contain, among other things,
conditions on the emergency use of the authorized products. The
Authorizations follow 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 Authorizations, which include an explanation of the
reasons for issuance, are reprinted in this document.
DATES: The Authorization issued to BD for the VIASURE Monkeypox virus
Real Time PCR Reagents for BD MAX System is effective as of December
23, 2022. The Authorization issued to DiaCarta, Inc. for the
QuantiVirus MPXV Test Kit is effective as of January 10, 2023.
ADDRESSES: Submit written requests for a single copy 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
[[Page 6263]]
which the Authorizations may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorizations.
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).
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, 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).
FDA may issue an EUA only if, after consultation with the HHS
Assistant Secretary for Preparedness and Response, the Director of the
National Institutes of Health, and the Director of the Centers for
Disease Control and Prevention (to the extent feasible and appropriate
given the applicable circumstances), FDA \2\ concludes: (1) that an
agent referred to in a declaration of emergency or threat can cause a
serious or life-threatening disease or condition; (2) that, based on
the totality of scientific evidence available to FDA, including data
from adequate and well-controlled clinical trials, if available, it is
reasonable to believe that (A) the product may be effective in
diagnosing, treating, or preventing (i) such disease or condition or
(ii) a serious or life-threatening disease or condition caused by a
product authorized under section 564, approved or cleared under the
FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing,
treating, or preventing such a disease or condition caused by such an
agent and (B) the known and potential benefits of the product, when
used to diagnose, prevent, or treat such disease or condition, outweigh
the known and potential risks of the product, taking into consideration
the material threat posed by the agent or agents identified in a
declaration under section 564(b)(1)(D) of the FD&C Act, if applicable;
(3) that there is no adequate, approved, and available alternative to
the product for diagnosing, preventing, or treating such disease or
condition; (4) in the case of a determination described in section
564(b)(1)(B)(ii) 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 Authorizations
The Authorizations follow 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 December 23, 2022, having concluded that the criteria
for issuance of the Authorization under section 564(c) of the FD&C Act
are met, FDA
[[Page 6264]]
issued an EUA to BD for the VIASURE Monkeypox virus Real Time PCR
Reagents for BD MAX System, subject to the terms of the Authorization.
On January 10, 2023, 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 DiaCarta, Inc. for the QuantiVirus MPXV Test Kit,
subject to the terms of the Authorization. The 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
revision to the Authorizations can be found from 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
Authorizations 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
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[GRAPHIC] [TIFF OMITTED] TN31JA23.081
Dated: January 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01987 Filed 1-30-23; 8:45 am]
BILLING CODE 4164-01-C
