Authorization of Emergency Use of Monkeypox Polymerase Chain Reaction Test Home Collection Kit in Response to an Outbreak of Mpox; Availability, 55601-55611 [2024-14714]
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Federal Register / Vol. 89, No. 129 / Friday, July 5, 2024 / Notices
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6200, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
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I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug or biologic product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: a testing phase and
an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological product becomes effective
and runs until the approval phase
begins. The approval phase starts with
the initial submission of an application
to market the human biological product
and continues until FDA grants
permission to market the biological
product. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of USPTO may award
(for example, half the testing phase must
be subtracted as well as any time that
may have occurred before the patent
was issued), FDA’s determination of the
length of a regulatory review period for
a human biological product will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA has approved for marketing the
human biologic product VABYSMO
(faricimab-svoa). VABYSMO is
indicated for treatment of patients with
neovascular (Wet) age-related macular
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degeneration and diabetic macular
edema. Subsequent to this approval, the
USPTO received patent term restoration
applications for VABYSMO (U.S. Patent
Nos. 8,268,314 and 9,695,233) from
Genentech, Inc.(Agent of Hoffmann-La
Roche Inc.), and the USPTO requested
FDA’s assistance in determining this
patents’ eligibility for patent term
restoration. In a letter dated September
28, 2023, FDA advised the USPTO that
this human biological product had
undergone a regulatory review period
and that the approval of VABYSMO
represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
VABYSMO is 3,046 days. Of this time,
2,800 days occurred during the testing
phase of the regulatory review period,
while 246 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: September 28, 2013.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on September 28, 2013.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): May 28, 2021. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
VABYSMO (BLA 761235) was initially
submitted on May 28, 2021.
3. The date the application was
approved: January 28, 2022. FDA has
verified the applicant’s claim that BLA
761235 was approved on January 28,
2022.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 931 and 1,646 days
of patent term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
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55601
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
Nos. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: July 1, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–14720 Filed 7–3–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–2823]
Authorization of Emergency Use of
Monkeypox Polymerase Chain
Reaction Test Home Collection Kit 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 an Emergency Use
Authorization (EUA) (the Authorization)
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) in response to
an outbreak of Mpox. FDA has issued
the Authorization for Labcorp
Monkeypox PCR (Polymerase Chain
Reaction) Test Home Collection Kit as
requested by Laboratory Corporation of
America. 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
SUMMARY:
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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,
and can be accessed on FDA’s website
from the link indicated.
DATES: The Authorization is effective as
of March 22, 2024.
ADDRESSES: Submit written requests for
single copies of an EUA to the Office of
Policy, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed 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: Kim
Sapsford-Medintz, Office of Product
Evaluation and Quality, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3216,
Silver Spring, MD 20993–0002, 301–
796–0311 (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,
radiological, or nuclear agent or 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 lifethreatening diseases or conditions
caused by biological, chemical,
radiological, or nuclear agent or 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
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
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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on FDA’s website. 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 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.
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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Federal Register / Vol. 89, No. 129 / Friday, July 5, 2024 / Notices
No other criteria for issuance have
been prescribed by regulation under
section 564(c)(4) of the FD&C Act.
III. The Authorization
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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
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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 March 22, 2024, 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 Laboratory
Corporation of America, for the Labcorp
Monkeypox PCR Test Home Collection
Kit, 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
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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 from FDA’s
web page at: https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/emergency-useauthorization.
IV. Electronic Access
An electronic version of this
document and the full text of the
Authorization is available at: https://
www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization.
BILLING CODE 4164–01–P
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U.S. FOOD &: DRUG
}ll)MJNISTlfATION
March 22, 2024
C. Donald Kafader II
Senior Director, Regulafol')': Affairs
Laborat-0ry Corporation of America
8790 Devon Ridge Court
Sunbury,Ohio 43074
Device:
l,abc<1rp Monkeypox PCR Test Home Collection Kit
EUA Number:
EUA230044
Company:
Laboratory Corporation of America ("Labcorp")
Indication:·
For the collection oflesion swab specimens at home by individuals
18 years ofage or older (self-collected), presenting with acute,
generalized pustular or vesicular rash suspected -of mpox 1•when
deterniinedto be appropriate by a healthcare provider.
Authorized Laboratories:
Testingis limited toJhe Center for Esoteric Testing, Bu:dington,
North Carolina, and laboratories designated by Labcorp and
certified under the Clinical Laboratory Iniprovement A:rnendme11ts
ofl988 (CLIA\ 42 US.C. §263a, to perform high complexity
tests and that test the lesion swab specimens collected using the
Labcorp MonkeypQx PCRTest HQme Collection Kitw,ith CDC's
Non-Variola Otthopoxvirus Real-timePCR Primer and Probe SetEUA when used consistent with its authorization.
bear Donald Kafader:
This fotteris in response to your2requesf that the Food and Drug Admiriistration (FDA) issue
an Emergency Use Authoriz.ation (EUA) for emergency use ofyow: product? porswmt to
Secfam .564 oflhe Federal Food, Drug, and Cosmeti.cAct (the Act).(21 IJ.S.C. §3601).bb~J);
On August 9, 2022; pursuant to Section 564(b)(l)(C)ofthe Act, the Secretary of the
DepartmentofHealth and Human Services (HHS) determined thatthere.is a public health
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1 Ori November .28, 2022,followihg a series ofoonsultations with global experts, the Wotid. Health Organization
(WHO) begrui using a new prefetred t1>1111 ''lnpox" as a synonym fot monkeypox, the disease ct111Se.1:)y the
monkey•p(ix virus. Refer to: hl\ps;ffW\Yl&\WhQ:int!neys/itemi28-l l -2Q22-whQ-twnunertds-oew.-name-formonkeypo1,'-disease.
2 J•'or ease of reference, this: lettetwill use the. term "you'' and.related tmns to refer to Laboraio:ey .CoipOratiori of
America.("Labcorp.'').
s For ease of reference; this letttJr will use the term "your product" to refer to theLabcorp Monkeypox PCRTest
Home Collection Kit t~..ed for the. indication identified above.
Federal Register / Vol. 89, No. 129 / Friday, July 5, 2024 / Notices
55605
Page 2 - Donald Kafader, Laboratory Corporation of America
emergency, or a significant potenfoil for a public health emergency, that affects or has. a
significant potential to affect national security otthe health and security ofUnited States
citizens livingabtoad that involves. monkeypox virus. 4 Pursuantto Section 564 of the Act, and
on the basis of such detetminatioli; 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 with the. monkeypox virus, including. in vitro diagnostics
thatdetect arid/or diagnose infectionwith non~variola Orthopoxvitus, subjectto the terms of
any authorization issued. under Section 564(a) of the Act.5
FDA considered the.totality of scientific information available in authorizing the emergency use
of your product for the indication above. Asummary of the performance information FDA
relied. upon is.contained in the EUA Summary (identifiedbelow).
Having concluded that the criteria for issuance ofthis authorization under Section564(c) of the
Act are met, I am authorizing the emergency use ofyour product, described in the Scope of
Authorization of this letter (Section II), subject to the tetms ofthis authorization.
I. Criteria for Issuance ofAuthorization
lhave concluded that the emergency use of your productmeets the criteria for issuance of an
authorization under Section 564(c) ofthe Act, because I have Conduded.that:
1. The virus that causes mpox can: cause a seripu:s odife-threatening disease or condition,
to humans infected by this virus;
2. Based on the totality ofscientific evidence avallableto FDA, itfa reasonable .to believe
that your product may be effective in diligllosing infection with the virus that causes
mpox by serving as an appropriate means to coUect and transport human specimens so
that an authorized laboratory can detect.this virus DNA from the collected human
specimen, and that the known and potential benefits of your product when usedfor such
use, outweigh the known and potential risks of your product; and
3. there is no adequate, approved, and available alternative to the emergencyuse ofyout
•
product. 6
it: Scope of Authorization
I have concluded; pursuant to Section 564(d)( 1) of the Act, thatthe scope ofthis authorization is
limited to the indication above.
87 ER:50090 (August 15,.2022)
87ER 56074 (September 13, 2022)
• No other criteria ofissuance have been prescribed by regulation under Section 564(c)(4) oftheAct
4
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Page 3 - Donald Kafader, Laboratory CClrporation of America
Authorized Product Details
Your product is a collection.kit 1nte11ded forthe collectfon of lesion swab specimens by any
individual age 18 years or older (self-col1ected) presenting with acute, generalized pustular or
vesicular rash suspected ofmpoxwhen determined to be appropriate by a healthcare provider.
Collection kit supptiesfor your product are sent to the desighated entity by the authorized
distributor; The Dot Corporation, where they are assembled and distributed to patients, when
determined to be appropriate by a healthcaricl provider, Individuals using your product; then
collect the specimen according to the provided authorized sample collection instructions
(summarized in the authorized labeling below) and ship the specimen to Labcorp via FedEx
according to the specimen return instructions.
Lesion swab specimens. collected using your product are transported at ambient temperature for
testing at an authorized laboratory. The. non-variola Orthopoxvirus nucleic acid from the lesion
swabs is maintained in the specimen packaging. Testing is limited to the Center for Esoteric
Testing, Burlington, North Carolina, and laboratories designated by Labcorp and certified under
the Clinical Laboratory ImprovementAmendments of l988(CLIA), 42 tJ.S;C. §26~a, to
perform high complexity tests and that testthe lesion swab specimens collected using the
Labcorp Monkeypox PCR TestHomeCollection Kit with CDC's Non-Variola Orthopoxvirus
Real-time PCR Primer and Probe Set ~ EUAwhen used consistent with. its authorization.
The. Labcorp Monkeypox PCR test Flome CollectiCln Kit includes specimen collection and
storage materials (or other authorized materials. as may be requested under Condition Q; below)
as well as instructions for shipping the specimen to Labcorp via. FedEx described in the "Labcorp
Monkeypox PCR Test Home Collection Kit InstrUctions for Use."
The labeling entitled "Labcorp Monkeypox: PCR Test ftonwCollection Kit fu,truc#ons for
Use/' the EUA Summary (available at https:1/www.fda.gov tmedical•devices/emergency-useauthorizations-medical-devices/monkeypox-emergency-use-authorizations-medical-devices);the.
following standard operating procedures (SOPs ): "SQNM-MPX• l0l. Accessioning Acceptance
Questionnaire", and "Handling and Processing ofSatnples.SubmittedforSQNM-MPX-101
SOP", and the documents providedto authorized entities as part ofthe contract provisions is
required to be made available as set forth in the Conditions of Authorization (Section IV), and
are collectively referred to as "authorized labeling".
The above described product, when accompanied by the authorized labeling provided. as set forth
in the Conditions. ofAuthorizatiotl(SeciionJV); is authorized to be distributed and used 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(dy(2) of the Act, thaHt is reasonable to believe that
the known and potential benefits of your product, whenused consistent with the Scope of
Authorization of this letter (Section II),. outweigh the known and.potential risks of your product.
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Lhave concluded, pursuantto Section 564(d)(3)ofthe Act, based Ott the totality ofscientific
Federal Register / Vol. 89, No. 129 / Friday, July 5, 2024 / Notices
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Donald Kafader, Laboratory Corporation of America
evidence available to FDA, that itis reasonable to believe that your product may be effective in
diagnosing.infection with the mortkeypox vims by serving as an appropriate means to collect and
transport human specimens so that an authorized laboratory can detect mortkeypox vims DNA
from the collected human.specimen,when used consistent with the Scope of Authorization of
this letter(Section II), pursuantto Section 564(c)(2)(A) of the Act.
fDA has reviewed the scientific inforination available to FDA, including the infortriation
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.
The emergency use of your product under this EUA must be consistent with, and may not
exceed, the terms ofthis letter, including the Scope of Authorization (Section II) and the
Conditions of Authorization (Section IV)c Subjecttothe terms of this BUA 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 of HHS 's corresponding declaration under Section
564(b)(1) ofthe Act, your product is authorized for the indication above.
III. Waiver of Certain Requirements
I am waiving the following requirernents for your product during the duration of this EUA:
•
Current good manufacturing practice requirements, including the quality system.
requirements.under 21 CFR Part 820 withrespectto the design, manufacture;
packaging, labeling, storage, and distribution of your product, but excluding Subpart
H(AcceptanceActivities, 21 CFR820.80and21 CFR 820.86),.SubpartI
(Nonconforming Product, 21 CFR 820.90), Subpart O (Statistical Techniques, 21
CFR 820.250) and Subpart M (Complaint Files, 21 C:FR 820.198).
IV, Conditions of Authorization
Pursuantto Section 564(e) ofthe Act, lain establishing thefollowing conditions orithis
authorization:
Labcorp (You) and Authorized Oistributor(s) 7
A. Your product must comply with the following labeling requirements pursuaritto FDA
regulations: the intended use stateinent(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 infonnation required under .21 CFR
809 .10(a)(4); and any available information regarding.performance ofthe device,
including requirements under.21. CFR 809.1 O(b)(l2).
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7 "Authorized Distributor(s)" are identified by you, Laboratory Corporation of America. (''Labcorp"), in.your EUA
submission as an entity allowed to distribute your product.
55608
Federal Register / Vol. 89, No. 129 / Friday, July 5, 2024 / Notices
Page 5 - Donald Kafader, Laborato1yCorporation of America
B. Your product must comply with the following quality system requirements pursuant to
FDAregulations:. 21 CFR 820 Subpart H (Acceptance Activities, 21 CFR820,80 and 21
CFR 820,86), Subpart I .(Nonconforming J>roduct,. 21 CPR 820.90), Subpart O (Statistical
Techniques, 2l CFR 820.250), and Subpart M (ComplainfFiles; 21 CFR 820.198).
C. You and authorized.distribtitor(s)must make yourproductavailable with.the
authorized labeling to authorized laboratories.
I), You and authorized distribufor{s)must make available on yourwebsite(s) the
authorized labeling,
E. You and authorized distributor(s) must make aVaffable all instructions related to the
self-collection of lesion swab specimens using the :Labcorp Monkeypox PCR Test
Home Collection Kit both in the shipped.kit: and on your website,
F. You arid authorized distribufor(s)must inform authorized laboratories arid relevarit
public health authorities of this EUA, including the tertns arid conditions herein, arid
any updates made to your product and authorized labeling.
G. Through a process ofinvenfory confrol;you and authorized distributor(s)must maintain
records of the numbers and locations to which your product is distributed.
H. You and authorized distributor(s) are authorized to m.ake available additional
information relating to the emergency use of yourproduct that is consistent with, and
does not exceed, the tertns of this letter ofa:uthorization.
l
You and authorized distributor(s) must maintain customercomplaint files on record.
You will report to FDA any significant complaints about usability or deviations from
tbe established performance chata:cteristies of the product ofwhich you become aware.
J. You and. authorized distnoutors.must have lot release procedures and the lot release
procedures, including the study design a:nd statistical power, must ensure thatthe tests
released for distribution have the performance claimed in the authorized labeling,
K If requested byFDA, you a:rtd authorized distributors must submit lotrelease
procedures to FDA, including sampling protocols, testing protocols, and acceptance
criteria, that you use to release lots. ofthe Labcorp Monkeypox PCitTestHom:e
Collection Kit for distributionfo the US. If such lot release procedures are reqµested
by FDA, you must provide itwithiu.48 hours of the request.
Labcorp (You)
L You must register and list consisterttwith21 CFR J>art 807 within one. month of this
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ddrumheller on DSK120RN23PROD with NOTICES1
letter.
Federal Register / Vol. 89, No. 129 / Friday, July 5, 2024 / Notices
55609
Page 6 - O<>najd Kafader, Laboratory Corporation of.America
M. Youmusfnotify FDA of any authorized distributor(s) of your product, including the
name, address, and pho:netrumber of any authorized disttibutor(s).
N.
you must have a signed agreement with each authorized. dist:ribuforthatdistribution of
the authorized product must be consistent with this Letter of Authorization.
o. If requested by FDA, you mustsubm:1.t associated docilinents and recordsrefated t<em your
quality system for FDA review within 48 hours ofthe request
P'. Youmustprov'ideauthorized distributor(s) with a copyofthis EUAand communicate to
authorized distributor(s) any subsequent amendments that might be made to this EUA
and its authorized accompanying materials.
Q.
You mayrequest modifications to this EUAfoty◊ur product, including to the Scope of
Authorization(Sectionllinthisletter}or to the. authorized labeling,: including requests to
make, available additional. authorized labeling specific to an authorized distn'butor. Such
additional labeHng may useMother name for the product butothenvise must be
consistent with theauthorizedJabeling, and notexceed the terms of authorization ofthis
letter, Any request for modification to this EUAshould be submitted. to
DMD/OHT7/0PEQ/CDRH and require appropriate authorization from.FDA
K
You must have a ptocessdri place to track adverse e:vents associated with the tabcotp
Monkeyp<>X PCR: Test ijome Collection Kit, including any occurrences offalse results
with your product, and report any such events to FDA pursuant to 21 Cf'RPart 803,
Serious adverse events~ especially unexpected biosafety concerns,. should immediately
be reported to DMD/OHT7/0PEQ/CDRH (via email: CDRRs
E0AR:eportin:g@fda.hhs.gov:
S. You must further evaluate the clinical performance ofyourproductin an FDA agreed
uRon post authorization clinical evaluationstudy;.After submission t() ·and ~oncurrence
with the data by FDA,you must update the authorized labeling to reflect the additional
testing, Such labeling updates will be made in corniultatitinwith, and require concurrence
of, DMD/OHt7/0PEQ/CDRlt
T, You must submiUo FDA asummaryreportsummarizing the results ofanytesting
performed inclusive of the r1tst ten positive lesion swab specimens <mllected with the
Labcorp Monkeypox PCR TestHome Collection Kit, including the. p◊Sitivityrate for
lesion swab specimens,.
AuthorizedLaboratotles
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U Authorized lab()taforfos testing lesil)n swa1tspecimens cmlledtld usi:ngytiut Pf(jducf must
followthe•"SQNM~MPX~101·•Accessioning AcceptanceQuestionnaire'\and ''.Handling
and Processin~ of Samples SubmittedforSQNM•MPX-101 SOP" Standard Operating
Procedure (SOP)whett accepting specitnensfortesting.
55610
Federal Register / Vol. 89, No. 129 / Friday, July 5, 2024 / Notices
Page 7 - Donald Kafader, Laboratory Corporation of America
V: Authorized laboratories using yourproductmustuse it only in conjunction with CDC's
NM-Variola Orth-Opoxvirus Real4iine. PCRPrimer and Probe Set EUAtestconsistent
with its EtJA
W, Authorized laboratories musthave .a process in place to track adverse events. associated.
with your product and report to you (l-800,833~3935 or
OrtDemandSupportia!Labcotp.Com)) imdto FDA pursuimt to .2 i CFR Patt &03.
Labcorp (You), Authorized Distributor(s) and Authorized Laboratories
X. You, authorized distributor(s), .and authorized laboratories must collect information on
the performance of your productand mustreport any significant deviations from the
established performance characteristics ofyour pmduct of which they become aware to
DMD/OHTI/OPEQ/CDRH (via email: CDRH·EUA"Reporting@fda.hhs.gov) In
addition, authorized distributor(s) and authorized laboratories report to you (1-,800~
833-:3935 or OrtDemandSupport@Labcotp.com).
Y. Yon, authorized distributor{s), and authorized laboratories using your product must
ensure that any records associated with this EUA, are maintained until otherwise notified
by. FDA Such records must be made available to FDA for inspection upon request.
Conditions Related to Printed Materials, Advertising and Promotion:
Z.
All descriptive printed matter,.advertising and promotional materials relating to.the use
of your product shall be consistent with the authorized labeling,as we.II as the terms set
forth in this EUA and meet the requirements set forth in section 502(a), (qXl), and (r) of
the.Act,. as applicable, and FDA implementing regulations ..
AA 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 non°Variola orthopoxviruses.
VerDate Sep<11>2014
17:16 Jul 03, 2024
•
This product has not been FDAcleared ot approved, but has been authorized for
emergency use by FDAunder an EUA;
•
This product has been authorized only for the collection and maintenirnce of
lesion swab specimens as an aid in detection of nucleic.acid from non-variola
Orthopoxvirus, including monkeypox virus, not for any other viruses or
pathogens; and
•
The emergency use of this product is.only authorized for the duration ofthe
declaration that circumstances existjustifying the authorization of emergency use
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BB. All descriptive printed matter, advertising and promotional materials relating to the use
ofyour product shall clearly and conspicuously state that:
Federal Register / Vol. 89, No. 129 / Friday, July 5, 2024 / Notices
55611
Page 8 - Donald Kafader, Laboratory Corporation of America
of in vitro diagnostics for detection and/or diagnosis of infection with the
monkeypox vims, including in vitro diagnostics that detect and/ot diagnose
infection with non-variola: 0rthopoxvini:s, underSection 564(b)(i) of the Federal
Food,. Drug, and Cosmetic Act, 21 U.S.C, § 3(i0bbb-3(b)(l)~ unle$s the
declaration is terminated or authorizationis revoked sooner.
The emergencytise of your product as described. in this letter ofauthorizatioririmstcomply
with the conditions and all otherterms ofthisMthorization;
V. fit:rration of Authorization
This EDA wiU be effective until the decfaiat1on thatcirctimstances exist justicyingthe
authorization ofthe emergency use of in.vitro diagnostics fot detection and/or diagnosis of
infection with the monkeypox virus, including in vitro diagnostics .that detect and/or diagnose
infection with non-variolaOrthopoxvirus, ts tenninat.edundet Section 564(b)(2) of the Act or
the EUAis revoked under Section 564(g) of the Act
. .
[Digitallysigned by
EII en J.
.lEllen l Flariilefy-S
Flannery··. ·. ~ :i1at~2024;03,22
/i'
10:12:42-04'00'
Ellen l Flannery;lD.
Deputy .Center Director for Policy
Director, Office of Policy
Centetfor Devices and Radiological Health
Food and Orug Administration
Dated: July 1, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–14714 Filed 7–3–24; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket Nos. FDA–2023–E–2035 and FDA–
2023–E–2247]
ddrumheller on DSK120RN23PROD with NOTICES1
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ENJAYMO
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for ENJAYMO and is publishing this
notice of that determination as required
SUMMARY:
VerDate Sep<11>2014
17:16 Jul 03, 2024
Jkt 262001
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
September 3, 2024. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by September 3, 2024.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
January 2, 2025. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
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
DATES:
Food and Drug Administration
AGENCY:
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human
biological product.
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
ADDRESSES:
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]]>Agencies
[Federal Register Volume 89, Number 129 (Friday, July 5, 2024)]
[Notices]
[Pages 55601-55611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14714]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2823]
Authorization of Emergency Use of Monkeypox Polymerase Chain
Reaction Test Home Collection Kit 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 an Emergency Use Authorization (EUA) (the Authorization)
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in response
to an outbreak of Mpox. FDA has issued the Authorization for Labcorp
Monkeypox PCR (Polymerase Chain Reaction) Test Home Collection Kit as
requested by Laboratory Corporation of America. 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
[[Page 55602]]
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, and can be accessed on FDA's website from the
link indicated.
DATES: The Authorization is effective as of March 22, 2024.
ADDRESSES: Submit written requests for single copies of an EUA to the
Office of Policy, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
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: Kim Sapsford-Medintz, Office of
Product Evaluation and Quality, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 3216, Silver Spring, MD 20993-0002, 301-796-0311 (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,
radiological, or nuclear agent or 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, radiological, or nuclear agent or 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 FDA's website. 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.
---------------------------------------------------------------------------
[[Page 55603]]
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 March 22, 2024, 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 Laboratory Corporation of America, for
the Labcorp Monkeypox PCR Test Home Collection Kit, 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 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
Authorization is available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
BILLING CODE 4164-01-P
[[Page 55604]]
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[GRAPHIC] [TIFF OMITTED] TN05JY24.040
[[Page 55606]]
[GRAPHIC] [TIFF OMITTED] TN05JY24.041
[[Page 55607]]
[GRAPHIC] [TIFF OMITTED] TN05JY24.042
[[Page 55608]]
[GRAPHIC] [TIFF OMITTED] TN05JY24.043
[[Page 55609]]
[GRAPHIC] [TIFF OMITTED] TN05JY24.044
[[Page 55610]]
[GRAPHIC] [TIFF OMITTED] TN05JY24.045
[[Page 55611]]
[GRAPHIC] [TIFF OMITTED] TN05JY24.046
Dated: July 1, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-14714 Filed 7-3-24; 8:45 am]
BILLING CODE 4164-01-C
