Authorization of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability, 46127-46139 [2024-11640]
Download as PDF
<![CDATA[
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 103 / Tuesday, May 28, 2024 / Notices
narrowly. Rather, an activity that is
‘‘appropriate to include in a submission
to the FDA . . . is ‘reasonably related’
to the ‘development and submission of
information under . . . Federal law’’
(Merck KGaA v. Integra Lifesciences I,
Ltd., 545 U.S. 193, 207 (2005)).
In a previous action requiring
mandatory debarment under section
306(a)(2)(A) of the FD&C Act for
conduct relating to the development or
approval, including the process for
development or approval, of any drug
product, FDA stated that ‘‘the statutory
language ‘relating to the development or
approval’ . . . by definition,
encompasses all things that are logically
connected with the development or
approval of a drug product.’’ (Atul Shah;
Denial of Hearing; Final Debarment
Order, (59 FR 62399, December 5, 1994),
(citing Webster’s Collegiate Dictionary,
Merriam-Webster Inc., Springfield, MA,
1990, ‘‘relate’’); see also Ray Nathan;
Denial of Hearing; Final Debarment
Order, (76 FR 48869 at 48870, August 9,
2011), (affirming the Shah definition of
‘‘relates to,’’ and going further to define
‘‘develop’’ . . . ‘‘to explore the
possibilities of’’ and ‘‘to make suitable
for commercial * * * purposes.’’ (see
‘‘Merriam-Webster’s Collegiate
Dictionary,’’ 10th Edition (2002))).2
Palacio’s felony conviction is related
to the development and approval,
including the process for development
and approval, of a drug. The trial
established that Palacio held the role of
clinical trial coordinator at the clinical
trial site, Unlimited, which contracted
to conduct a clinical trial to study
certain asthma drugs in pediatric
subjects between the ages of 4 and 11
years. As ORA explained in the Notice,
drug sponsors, like GSK, submit clinical
trial data in support of drug product
applications for review and approval by
FDA, and the Agency relies upon the
integrity of the data and information in
the applications to determine whether a
drug meets required safety and
effectiveness standards. The basis for
Palacio’s Federal felony conviction for
false statements in a signed affidavit is
regarding conduct in her role as clinical
trial coordinator. Specifically, in her
signed affidavit Palacio ‘‘represented
. . . that she had performed a screening
visit for D.H. in the Study, when in
truth and in fact, and as [Palacio] then
and there well knew, she had not
performed a screening for D.H. . .’’
Palacio’s false statements about her role
in the conduct of a clinical trial related
to the development or approval,
2 See also, The Drug Development Process | FDA.
(https://www.fda.gov/patients/learn-about-drugand-device-approvals/drug-development-process).
VerDate Sep<11>2014
18:43 May 24, 2024
Jkt 262001
including the process for development
or approval, of any drug product.
Palacio’s role and statements regarding
her role pertaining to the Vestri Study,
a clinical study meant to inform GSK’s
submission to FDA, are logically
connected to the development or
approval of a drug product. Palacio’s
Memorandum does not provide any
material facts capable of overcoming the
clear language in section 306(a)(2)(A) of
the FD&C Act and the logical
connection of her conduct to the
development or approval, including the
process for development or approval, of
any drug product. Therefore, Palacio has
failed to raise a genuine and substantial
issue of fact warranting a hearing to
determine whether she is subject to
permanent debarment. Accordingly, the
OSI Director need not address Palacio’s
other arguments, including her efforts to
distinguish her own conduct from that
of other debarred individuals.
III. Findings and Order
Therefore, the OSI Director, under
section 306(a)(2)(A) of the FD&C Act
and authority delegated to him by the
Commissioner of Food and Drugs, finds
that Palacio has been convicted of a
felony under Federal law for conduct
relating to the development or approval,
including the process for development
or approval, of any drug product.
As a result of the foregoing findings,
Palacio is permanently debarred from
providing services in any capacity to a
person with an approved or pending
drug product application under sections
505, 512, or 802 of the FD&C Act (21
U.S.C. 355, 360b, or 382), or under
section 351 of the Public Health Service
Act (42 U.S.C. 262), effective May 28,
2024 (see 21 U.S.C. 335a(c)(1)(B) and
(c)(2)(A)(ii) and 21 U.S.C. 321(dd)). Any
person with an approved or pending
drug product application, who
knowingly uses the services of Palacio,
in any capacity during her period of
debarment, will be subject to civil
money penalties (section 307(a)(6) of the
FD&C Act (21 U.S.C. 335b(a)(6))). If
Palacio, during her period of debarment,
provides services in any capacity to a
person with an approved or pending
drug product application, she will be
subject to civil money penalties (section
307(a)(7) of the FD&C Act). In addition,
FDA will not accept or review any
abbreviated new drug applications
submitted by or with the assistance of
Palacio during her period of debarment
(section 306(c)(1)(B) of the FD&C Act).
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
46127
Dated: May 21, 2024.
George M. Warren,
Director, Office of Scientific Integrity.
[FR Doc. 2024–11546 Filed 5–24–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–2222]
Authorization of Emergency Use of a
Drug Product During the COVID–19
Pandemic; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of an Emergency Use
Authorization (EUA) (the Authorization)
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) for use during
the COVID–19 pandemic. FDA has
issued an Authorization for the drug
product PEMGARDA (pemivibart) as
requested by Invivyd, Inc. (Invivyd).
The Authorization contains, among
other things, conditions on the
emergency use of the authorized
product. The Authorization follows the
February 4, 2020, determination by the
Secretary of Health and Human Services
(HHS), as amended on March 15, 2023,
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 novel (new) coronavirus. The
virus, named SARS–CoV–2, causes the
illness COVID–19. On the basis of such
determination, the Secretary of HHS
declared on March 27, 2020, that
circumstances exist justifying the
authorization of emergency use of drugs
and biological products during the
COVID–19 pandemic, pursuant to the
FD&C Act, subject to the terms of any
authorization issued under that section.
The Authorization, which includes an
explanation of the reasons for issuance,
is reprinted in this document.
DATES: The Authorization is effective as
of March 22, 2024.
ADDRESSES: Submit written requests for
a single copy of the EUA to the Office
of Executive Programs, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, 6th Floor,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
SUMMARY:
E:\FR\FM\28MYN1.SGM
28MYN1
46128
Federal Register / Vol. 89, No. 103 / Tuesday, May 28, 2024 / Notices
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:
Johanna McLatchy, Office of Executive
Programs, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, 6th Floor, Silver Spring,
MD 20993–0002, 301–796–3200 (this is
not a toll-free number).
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with NOTICES
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
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,
VerDate Sep<11>2014
18:43 May 24, 2024
Jkt 262001
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 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, and 360e) or section
351 of the PHS Act (42 U.S.C. 262), or
conditionally approved under section
571 of the FD&C Act (21 U.S.C. 360ccc).
FDA may issue an EUA only if, after
consultation with the HHS Assistant
Secretary for Preparedness and
Response, the Director of the National
Institutes of Health, and the Director of
the Centers for Disease Control and
Prevention (to the extent feasible and
appropriate given the applicable
circumstances), FDA 2 concludes: (1)
that an agent referred to in a declaration
of emergency or threat can cause a
serious or life-threatening disease or
whether to make a declaration under section
564(b)(1) of the FD&C Act, and, if appropriate, shall
promptly make such a declaration.
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.
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
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.
No other criteria for issuance have
been prescribed by regulation under
section 564(c)(4) of the FD&C Act.
III. The Authorization
The Authorization follows the
February 4, 2020, determination by the
Secretary of HHS, as amended on March
15, 2023, 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 novel (new)
coronavirus. The virus, named SARS–
CoV–2, causes the illness COVID–19.
Notice of the Secretary’s determination
was provided in the Federal Register on
February 7, 2020 (85 FR 7316) and
notice of the Secretary’s amended
determination was provided in the
Federal Register on March 20, 2023 (88
FR 16644). On the basis of such
determination, the Secretary of HHS
declared on March 27, 2020, that
circumstances exist justifying the
authorization of emergency use of drugs
and biological products during the
COVID–19 pandemic, pursuant to
section 564 of the FD&C Act, subject to
the terms of any authorization issued
under that section. Notice of the
Secretary’s declaration was provided in
the Federal Register on April 1, 2020
E:\FR\FM\28MYN1.SGM
28MYN1
Federal Register / Vol. 89, No. 103 / Tuesday, May 28, 2024 / Notices
(85 FR 18250). Having concluded that
the criteria for issuance of the
Authorization under section 564(c) of
the FD&C Act are met, on March 22,
2024, FDA issued an EUA to Invivyd for
the drug product PEMGARDA
(pemivibart), subject to the terms of the
Authorization. The initial
Authorization, which is included below
in its entirety after section IV of this
document (not including the authorized
versions of the fact sheets and other
written materials), provides an
explanation of the reasons for issuance,
as required by section 564(h)(1) of the
FD&C Act. Any subsequent reissuance
of the Authorization can be found on
FDA’s web page at: https://
www.fda.gov/drugs/emergencypreparedness-drugs/emergency-useauthorizations-drugs-and-non-vaccinebiological-products.
46129
IV. Electronic Access
An electronic version of this
document and the full text of the
Authorization is available on the
internet at: https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/emergency-useauthorization.
BILLING CODE 4164–01–P
U.S. FOOD & DRUG
AOM!NlSTIV\TIPN
April 3, 2024
Tnvh,yd, Inc,
Barry Sickels, PhD
Senior Vice President
Regulatory Affairs and Quality Assurance
1601 Trapelo Road, Suite 178
Waltham, MA02451
RE:
Emergency Use Authorization 122
Dear Dr. Sickels:
This letter is in response to Tnvivyd, The. 's (Tnvivyd) request that the Food and Drug
Administration (FDA or Agency) issue an Emergency Use Authorization (EUA) for the
emergency use of PEMGARDA (pemivibart) for the pre-exposure prophylaxis of coronavims
disease 2019 (COVID-19) in certain adults and adolescents, pursuant to Section 5M of the
Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).
1 U.S. Department of Health and Hnman Services,Dctemrination'qf a Public llealthEmettency and Declaration
that Circumstances Rxisl .lustifjingAuthorizalion.• Pursuant lo Section 564(bj cifthe Federal Food, Drug, and
CosmeticAct, 2 l U.S.C. § 360bbb-3. February 4, 2020; U.S. Department ofIIealth and Human Setvices,Amended
Detuminarion ofa Public Health Emergency or Sign(/ictmtPotentialfor·a Public HealthEmergettcy Pursuant to
Section 564(b) of th.! Federal Food, Drug, and CosmeticA:t, 21 [[.SC. § 360bbb-3(b). March 15, 2023. 88 FR
16644 (March20, 202'.l) ("Amended Determination''},
2 U.S. Deparlmte'Iil. of Health and Human Ste'I'Vices, Declaration thatCfrcumstances.ExistJustifying.Authorizatii'Jns
Pursuantto Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 2.1 U.S:C. § 360bbb-3, 85 I<'R 18250
(Aprill, 2026). See Arn ended Dctcrillination ("The dcclaratiortsc issued pursuant ti1 section 564(b)(l) of the Fh&C
Act that circumstances exist justifying the. authorization of emergency use of certain in vitro diagnostics, personal
respiratory protective devices, other medical devices and drugs and biological products, as set forth in those
declardtions, and fhal are bastXI on the February 4, 2020 detertilinalitm, wma:in in effec:L until those declarations arli
terminated in accordance with section 564 of the FD&C Act.").
VerDate Sep<11>2014
18:43 May 24, 2024
Jkt 262001
PO 00000
Frm 00075
Fmt 4703
Sfmt 4725
E:\FR\FM\28MYN1.SGM
28MYN1
EN28MY24.039</GPH>
khammond on DSKJM1Z7X2PROD with NOTICES
On February 4,2020, as amended on March 15, 2023, pursuant to Section 564(b)(l)(C) of the
Act, the Secretary ofthe 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 has a
significant potential to aITect national security or the health and security of United States citiLens
living abroad, and that involves the virus that causes coronavirus disease 2019 (COVID-19). 1 On
the basis of such determination, the Secretary of HHS on March 27, 2020, declared that
circumstances exist justifying the authorization of emergency use of drugs and biological
products during the COVID-19 pandemic, pursuant to Section 564 of the Act (21 U.S. C. 360bbb3), subject to terms of any authorization issued under that sectlon. 2
46130
Federal Register / Vol. 89, No. 103 / Tuesday, May 28, 2024 / Notices
Page 2 - Invivyd,Inc.
On March 22, 2024, FDA issued an EUAa,uthorizing the emergency use of PEMGA.RDA for the
pre-exposure prophylaxis of COVID-19.in certain adults and adolescents.
:PEMGARDAis a recotnbinant hun11m monocfonat lgGh antibody thatta:rgets:the SARS-QoV-2
spike ptotein receptor l)fuding domain, thereby inhibitin:gvirus attacmnent tp. the human ACE2
receptor on host cells, PEMGARDA is not FDA-approvedfor an:y indication; including for use
as pre-exposure prophylaxis ofCOVID-19;
On April 3, 2024, having Mncluded thatrevisirtg th1s EDA. is appropriate to protect the public
health orsa:tefy under Section 564(g')(2} oflhe A.ct, FDA is reissuingthe March 22, 2024 fotter in
its entirety,to revise a deadline in post~authorization requiremetit 7 ofC.:>ndition P regarding the
submission to FDA allgenotypic an phenotypic resistance analysis data for subjects failing
pemivibart prophylaxis .in the CANOPY clinical trial.
Ba:sed.011 the totalityofscien:ti:ttc evidence available to FDA, iticludingdatafromC,ffiQPY
(NCT06039449); a Phase.3 clinical trial evalµating PEMGARPAfor protection ~nst COVlD19 based on an immunobridging approach; it is reasonable to believe. that PEMGARDA may be
eflective for use as pre-exposure prophylaxis ofCOVID-19 h1 certain adults and adolescents, as
described in the Scope ofAutho:rization (Section II),and.whenusedunderthe conditions
described in this authorization, the knoWti and potential benefits of:PEMGARDA outweigh the
known andpotential risks of 11uch product.
Having conduded that the cn'tetia. for isstfance ot'thisauthoriza.t1on w'lder Sectlon564(c}ofthe
Act are met, ant authorizing the emergencytl!le of PEMGARDA for pre-exposure prophylaxis
of COVID-19, 11~ described in the Scope of Authorization section of this letter (Section II) and
subjectto the terms ofthis authorization,
I
I.
Criteria for Issuance ot Atitlforization
fhaye co.ncluded th.at the !ltn!lrgency use ofPEMdAAbAfor pte-e;qiosure prophylaxis of
COVID-19;, when administered as described in the Scope of Authorization(Section II), meets the
criteria for issuance ofan.authorizationunder Section564(c) ofthe Act, because:
l. SARS:.CoV-2·can cause a serious orlifo threateningdisease or condition, iticluding
severe respiratory illness; to humans infected. bythis virus;
0
VerDate Sep<11>2014
18:43 May 24, 2024
Jkt 262001
PO 00000
Frm 00076
Fmt 4703
Sfmt 4725
E:\FR\FM\28MYN1.SGM
28MYN1
EN28MY24.040</GPH>
khammond on DSKJM1Z7X2PROD with NOTICES
2. Based on the tota1ity ofscientifk evidence available to. FDA, ids reasonabfo to. believe
that PEMGARDAmay be effective for use as pre-exposure prophylaxis of COVID-19
in certairt adulis. and adolescenis, as described in the Scope of Authorization (Section
II), and that, when usedunder the conditions: described in this authorization, the known
and potential benefits of PEMGARDA outweigh the known and potential risks of such
product; and
Federal Register / Vol. 89, No. 103 / Tuesday, May 28, 2024 / Notices
46131
P~e :3 - In:viv:y4, Inc.
l, there ism,1 adequate, appro:vecl, a11d a:v¢l:able .iltemattve to: the emergency use. of
PEMGARDAforpre~exposure prophylaxis ofCOVID-19 as further described in the
Scope·.ofAtithorizatfon (sectionII)}
Ihave co:ncluded,pursuantto Section 564(<:l)(I) oftheAct, thatthe scope ofthis authorization is
limited as follows:
• PEMGARDA mayon1y·he usei.lby healthcare providers for pre-exposure prophyfaids
QfCQVII);.19 in /.ldµlts and l:tdQlespent$ (12 years ofage and older weigh:intrat leai.t
40kg):
• Who:at¢•no{cµrrenily·inf~tedwithSARS~CoV~z and.who haye1;tothad:a
knQwn recent exposureto an individual infected withSARS-Coy;;.z and
•• Wh0:have moderate to severe immune\Xltnpromis:e quetoamedic.al condition
or receipt ofimmunosuppressivemedications orireatments and. are unlikely to
mourttan adequate immune response to COVID-19vaccinatiort
1..lmitatiQtlS ort Atithorlzed Use
•
PEM:GARDAis notauthorizedlorthefollowinguses:
o Fortreatnierit of COVID-19, or
o: Fot post-exposure prophyfuxis ofCOVID-19 mini.livi1.foals who haw
been exposildt9 som1;1one infei::tedwith SARS-CoV-2.
• Pre~expQsure prophy1~isw1th PEMGARPA is m~ta $UhstituteJ6rvaccin!ttiQn in
individuals forwhomCOVID- 19 vaccination is recommended. Individuals forwho:m
COVID-,19 vaccination is recommended, including individuals with moderate to
severeim:mune C'Qrt'!ptomise who nmy derive hertefit from CQVIb-19 vaccirtitti◊n,
should receive CQVID-19 vaccirtation.
•
PEMQA.RJ)A. shouI<i.Qll1Jbeaibtrinistere4 irt $ettln:gsfo which healthcare provi4ero
haveitntnediate access to tlledications to treat a severe hypersensitivity reaction, such
as anaphylaxis; and the ability to activate the. emergencymedical system (EMS), as
rtooesSafy,
• PEMdARDA may only be presctlbedfot a11 individual patientby physicians,
adya11ced practice registered nurses, and physician assistants that are Hcensed or
authorized under State law to prescribe drugs. 4
No other criteria of issuance have been prescribed.bytegulatiortUrtclet1Sectioo564(c)(4)ofthe Act
Under section 20l(a)(I) of the Act; the term "State" is defmed to mean "any Sfate,oriTerritoty of the United States,
the District ofColum bia, and the Commonwealth of Puerto Rico,"
3
VerDate Sep<11>2014
18:43 May 24, 2024
Jkt 262001
PO 00000
Frm 00077
Fmt 4703
Sfmt 4725
E:\FR\FM\28MYN1.SGM
28MYN1
EN28MY24.041</GPH>
khammond on DSKJM1Z7X2PROD with NOTICES
4
46132
Federal Register / Vol. 89, No. 103 / Tuesday, May 28, 2024 / Notices
P11ge 4-Invivyd, Inq.
•
Inindividuals who have. recently receiyed a COVID-l9yaccine, PEMG:ARDA
should b.e· administer,ed at least two weeks after yaccination,
•
The use ofJ>EMGA;'.RPAcovered 'by tbis autl'Iodz~iori nwstbe in accorel,l.llce with
the authorized Fact Sheets.
Piodtict Description
:PE.MGAAPAinj¢ction i:s asterj.1e, pte$~a:tlve•:free, cleartQ11Hghtly opa:l~cent; c<>lOrle$S:fo
yellow solution supplied itl, a single dose 61:l vialintended forintravenous i~~on only.
PEMGARDA1s suppliedin a single-dose vial at a concentration. of125 mg/mL.. Each
PEMGARDAcarton contains nine vials of:PEMG:ARDA. Each vial.qontains an overfiilto allow
the withdrawal ofsoon1g (4:0;tiiL) of PEMOAROA
0
The authorized storage and fol.lldling infonnalionfor PmvIGARDA is included in the authorized
FactSheetfor Healthcare Providers.
PEMOAADAis authotizeclfor e1tietgeney µse Wttlt tht'; followingprodµcf,speciftc il)fo:rnlation
requitedto t,e made availabletohea1il1careproviders an:dtopatients~ parents, and care.givers;
respectively; throughlnvivyd's website at www.PEMGARDA.c,"Om(referred.foas the
"'authorizedlabeling''):
Fact Sh¢:etforHea:t:th date Providers: Emergency Use Authorization (EDA)for
PEMGARDA
• Fact SheetfotPatients,Parents, and Caregivers; Emergency UseAuthm'i.zatiori
(E.UA) of PEM:0Al{IJA f◊t Coronaviros Disease2Ql9 (COVID-19)
•
Ihave conchide~ pursuanttoSection 564(d)(2) ofthe Act,· based on thetotality ofscientific
evidence available to FDA, that itis reasonable to believe that the known and.pot¢ntialbenefrts
of PEMG.ARDA,. wherr used for pre,exp◊sure pn:>phylruds ofCOVII)-19 in adults and
adolescents and
in aqcordance with thisSco_pe Qt\1\.ttthQriza:tion (Section . II);Qut-weigh: the
known and poteiltihl ri$l..~, pursuantto Sectiort564(c)(2J(B) ofthe Act,
used
l have corteiuded, ptirstiantto section 564(d)(3J?fthe Act. based orithetotaiityofscieritific
evidence available to FDA,. thatitis reasonable to beHevethat PEMGAIU)Amaybeeffectiye
when use4 forpre•exposute prophylaxis of:COVI0.19 in adults and adolescents an/.i useqin
accQrdance.with this SCope ofAtd,h.()]'.i:z'lltiQn (Section: ll), p~rsuantfo SecUon $64(¢)(2)(A)oftbe
Act
HaVihgteviewed the scientific mfomfatiqttavailable to FDA, including the infonfiaifoti
supportingthe conclusions described i11 Section I above, !have concluded that PEMGARDA.(a..~
described in this Scope ofAuthorization. (Section II))meets the criteria setforth in Section564(c)
of the Act concerning safety and potentiaLeffectiveness.
VerDate Sep<11>2014
18:43 May 24, 2024
Jkt 262001
PO 00000
Frm 00078
Fmt 4703
Sfmt 4725
E:\FR\FM\28MYN1.SGM
28MYN1
EN28MY24.042</GPH>
khammond on DSKJM1Z7X2PROD with NOTICES
The emergency use ofPEMGAA])A under this EU.A musfbe co11Sistentwith, iind may ilOt
exceed,theterms oftheAuthorization, including the Scope ofAuthorization(SectionII) and the
Federal Register / Vol. 89, No. 103 / Tuesday, May 28, 2024 / Notices
46133
Conditions of Authorization (Section III). Subject to the tenns of this. EUA and under the
circumstances set forth in the Secretary ofHHS's detennination under Section 564(b)(l)(C)
described above and the Secretary of HHS 's corresponding declaration. under Section 564(b)(1 ),
PEM GARDA is authorized. for use as pre-exposure prophylaxis of COVID-19 as described in
this Scope of Authotization (Section II) under this EDA, despite the fact that it does not meet
certain i-equirements otherwise required by applicable foderal law.
Ill,
Conditions of Authorization
Pursuant to Section 564 of the Act, I am establishing the l'ollowillg conditions on this authorization:
Inviyyd and Authorized Distributors5
A. Invivyd a:nd authorized distri.butor(s)will e1isure that PEMGARI)A is distributed and the
authorized labeling (ie., Fru.-'1: Sheets) will be made available t() healthcare facilities and/or
healthcare providers as described in Section Ilofthis Letter of Authorization.
B. Invivyd and auth.orized distributor(s) will ensure that appropriate storageil! maintained until
the product is delivered to healthcare facilities and/or healthcare providers.
C. Invivyd and authorized distributor(s) will ensure that the tenns of this EU A are made
avail;ble to all relevant stakeholders (e.g., U.S. government agencies, state and local
government authorities, autho.rized distributors, healthcare facilities, healthcare providers)
involved in distributing O!' receiving PEMGARDA. Invivyd will provide to all relevant
stakeholders a copy of this Letter of Authorization and communicate any subsequent
amendments ihat might be made to this Letter of Authorization and its. authorized
accompanying materials (i.e., Fact Sheets).
D. Invivyd may request changes to this authorization, including to the authorized Fact Sheets
for PEMGARDA. Any request fO!' changes to this EUA must be submitted to the Office of
Infee,1ious Disease/Office of New Dmgs/Center for Drug Evaluation and Research. Such
changes require appropriate authorization prior to implementation. 6
E. Invivyd may develop and disseminate instructional and educational materials (e.g.,
materials providing information on ptoduct adminisiration and/or patient monitoring) that
are consistent with the authorized emergency use of PEMGARDA as described in this
5
"Authorized Distributor(s)" are. identified by Invivyd as an entity or entities allowed to distribute the authorized
PEMGARDA
The following types ofrevisions may be authorized without reissuing this letter:(!) changes to the authorized
labeling; (2)non-substatrtive editorial corrections to this letter; (J) new types of authorized labeling, including new
fact sheets; (4) 11ew carton/container labels; (5) expiration dating extensions; (6) changes to manufacturing
processes, including tests or ,ither authoriz,~d components of manufacturing; (7) new conditions of authorization to
require data collection 01· study; (8) new strengths of the authorized ptoduct, new product sources (e.g., of active
pharmacei1tical ingredient) or of prodLJct components. For changes to the authorization, including the authorized
labeling, of the type listed in (3),. (6), (7), or (8), review and c,mcwence is .required from the Counter• Terrorism and
Emergency Coordination Staff/Office of the Center Director/Cl)ER and the Office of Counterterrorism and.
Emergi11g Threats/Office of the Chief Scientist.
VerDate Sep<11>2014
18:43 May 24, 2024
Jkt 262001
PO 00000
Frm 00079
Fmt 4703
Sfmt 4725
E:\FR\FM\28MYN1.SGM
28MYN1
EN28MY24.043</GPH>
khammond on DSKJM1Z7X2PROD with NOTICES
6
46134
Federal Register / Vol. 89, No. 103 / Tuesday, May 28, 2024 / Notices
Page <> - Invivyd,. Inc.
Letter ofAuthorizatioµ and authorized labeling, .\VithoutFDA's review (llld concurrence,
when.necessaryto meet publichealthneeds,.Anyinstructional and educationalmaterials
that ate inconsistent withthe authorized Iabelingfot PENiGARDAareprohibited. If the
Ag~cy notifies Invivyd that any instructional an4 educational matl!rials llfeniconsistent
with the authorize4 Iabeling. InVivyd mliStcease distril:>mion ofsucn instiucilonaI and
educational materials. Furthermore, as part:ofits notification; the Agency may also require
Invivyd to issue corrective communication(s);
F: lrt'\>ivydwill teportto FDAallserious adverseeverits::andmeillcation errors potentially
relafetlto PEMGARDA: use thllt are n:portedto Invivyd usin.g either ofth.e foUo\Vi.ng
option&
Optionl: SubmitrepQrtsthtotighthe SafetyReportit1g Portai (SRPJ as described oti the FDA
SRPwebpage.
Option 2: Submit reports directly through the Electronic Submissions Gateway (ESG) as
described on the.FAERS electronic submissions wehpage.
Subm;itted reports under l:>oth options. roust sta~: ''PEMGARJ:>A use for pre.:ex:ppsure
prophylaxis of COVID-19 under Emergency Use Authorization (EDA)." For reports
submitted under Option 1, include this language at the beginning ofthe question "Describe
Event" for further analysis. For reports stibmitted underOption2; include this. language at
the beginni:iigofthe "Case Narrative" field.
G: .All manufacturing, packaging, andtesl;ing sites for both dtug substance and drQgproducl
usedforEUAsupplywillcomply with current good manufacturing practice requirements
of Section 50l(aX2)(B) oflhe Act.
H. Invivydwill $nbrnitinformlitiortto1he Agency within three working days of receipt of any
infonn:aiton concetning significant quality problerm; with drug product distributedunder
this. EUAfor PEMGARDA that includes the.following:
•
•
Information concerninganyincidentthat caitses the dfugproduct: or its labelil'1g
to bernistakenfot. orappliedto, another..uticle; or
fuformation concetningany microbiological cont:amination, otany sigfilficant
chemical, physical, or other change or deterioration inlhe distributed drug
product or any failure ofone ormore distributed l;>atclu::s of the product to m:-eet
the established specifications,
If a significant qualify problem affects urireleased product ai1d may also impact product(s)
previously released and distributed, 1hen information mnst be sublliitted for a11 potentially
itnpacted lots.
VerDate Sep<11>2014
18:43 May 24, 2024
Jkt 262001
PO 00000
Frm 00080
Fmt 4703
Sfmt 4725
E:\FR\FM\28MYN1.SGM
28MYN1
EN28MY24.044</GPH>
khammond on DSKJM1Z7X2PROD with NOTICES
Itivtvyd. \.\1ll inl:lfude iii its notification fo the Agency whether the batch, ot batches, in
question will be.recalled. lfFDArequests. that these, or any other b~tches, at anytime, be
recalled, Invivyd must recall them.
Federal Register / Vol. 89, No. 103 / Tuesday, May 28, 2024 / Notices
46135
Pl!ge 7 ~ Invivyd,Jnc.
Ifoot in9Iuded in its initial notificati<>n, Invivyd must submit infonnation confirming
that Invivydhasideritifiedthe·r-oot:cause ofthe significant quality problems; taken
corrective action:,. and provide ajustification conf'mning that the corrective action is
appropriate and effectiv¢. :tnvhtyd must i,ubmit this infonnation as soon: as possible but
no latertharr 45 calendar, days from the initiiltnotiffoalion,
L Invivydwill manufaclurePEMGARDAtomeetall quality standards and per the
manufact:ut:irtg process and cortWlsttategy as detailed in InviVyd's EUArequest. IrtviVyd
willnot intptem:ertt any changes to the description ofthe product, manufacturing process;
µtei@~ amt eqqipn:ient, andeletnents9f the ~soi::iated controli,tra~gytlaj assure prq<:¢Sll:
perfonnance arrd quali:iyofthe authorized product, with◊utnotificatio11 to and concurrence
by the Agency as described under Condition D,
t
htvivydw:iH listl?EMdARl)Awith a uni.que pr0ductNDC undetthe marketing
category ofEmergencYUse Authorization, Further, thelis~gw:ill ihclude each
establishmentwhere manufacturihg is performed for the drug and the type ofoperatfon
perfonned at each such.establishment
R. Through a process ofinventory i::onlrol:,. )nviyyi:farrd authorized distribtrtot(~)willmaihtain
records regardingdisfnbutiun of PEMGARDA (ie;, fotnunibers; quantity, receiving site,
.receipt date):
t.
Invivyd Will estabitsh a process tor monttoririg genomic daiabase(i) rorthe emergence of
global vimlvariants Qf SA.RS-CoV~2; A sumntary ◊f Invivyd''$ l)l:'Oc¢ss should 'be
·su!:,mittedto the Agency as soon as pl'.llciicable~ but no later than 30 calendar.days of the
issuance of this lettert and within 30calendar days of any material changes to such. process.
Invivyd will provide reports to the Agency onunonthly basis summarizihg any fihdihgi, as
aresultofitsmonitorihgactivitiesand,.asneeded,.anyfollow,upassessmentsplarrnedor
conducted.
M. •FDAmay,reqriireinvivydto assess the activity ofthe authorized PEMGARDAagainstany
globaLSARS-CoV•2 varimrt(s) of irtterest(e.g., variarrts that are:pre:valent or becoming
prevalent thathliiborsubstitutiOnsinthe tatgetproteinJ. .IrtviVydWill perform: therequited
assessmentin a manner andtimeframe agreed uponbyfuviVyd-and the Agency, lnvivyd
willsubmitto··J:lDAapreliminarys:ummaryreport immediatelyupon.·completionofits
.assessmentfollowed.by a detailed- studyreportwithin30-calendardays of study
completioo. lnviVydwillsubmitanytelevant propOSal(s)to revise the authoriz¢dla.beilrig
based on the results otits assessment, as may be necessary otappropriate rn;tSecl on the
f~g◊ing assessment.
• • •
N'. Invivyd shallprmride samples as requested ofthe authorized PEMGARDAto the HHS
VerDate Sep<11>2014
18:43 May 24, 2024
Jkt 262001
PO 00000
Frm 00081
Fmt 4703
Sfmt 4725
E:\FR\FM\28MYN1.SGM
28MYN1
EN28MY24.045</GPH>
khammond on DSKJM1Z7X2PROD with NOTICES
fot·evaluatfon of activity against emergihg global virttl-variants of SARS-Co V-2;
including spei::ific amin-0 acid stibstitution(s)ofinterest(e.g.• variants thabrre highly
prevaleI1:t ◊t that harbQr substifutiQm; in the targeipr9ieirt) within 5 busihess days QfllnY
request made by HHS. Analyses performed with the supplied quantity ofauthorized
pemi:vibart may ihclude, but are not limited to, cell culture J;IQtertcy assays, protein
46136
Federal Register / Vol. 89, No. 103 / Tuesday, May 28, 2024 / Notices
]?:age 8- -lnvivyd,Jnc.,
1,ind;ing {lllSllys, celJ qultul'.e yari,at1t.{lllgays (pseudt>typed; vinis-like pruthzllli; and;/of
mitlientic virus}~ and-in vivo:activify assays',
n
·mvivydmustconduct additionalstudies selecting SA:RSaCo:V~2witli:reduced
·:;=~~~fn:!:i=f:dc!! :!::Y~::i~::::::;f[/:;!:l~~~:0:f
W:ithitt 3Q calend'll!'. days <f the i!lsu!ltlc.e
Jliis: tetf1;m
•
••
•I>; lnyiyydttlllll{pmvide·thll-followi:ng infi)nna'ti:ont()the)\:~cy::
L Antl-drilg antil,()dy{ADA) i1$s¢ssments fot:attparticipants fronfthe CANOPY
-dirlii::al.trilll ooJ)ays l and2$'hyMity 31, :Z024;Mtlnth3 byJunf3iJ.'20l4;·llhd
MQllth !Shy July-at, 2024.
-- 2, Atopline safety summaryfonillparliciparits (CohorlsAand:B}througl1c'Morith 6
(lastpatient.1ast visit)fromthe.CANOPY clinical trial by June 30, 2024.
3. -Art mteriiliI;liiiical stodyteportfortlie CANOPYcliitical ttilitwith:PK, safety and
:~tt=~~~;tit~
(Qohortl! AllhdB)~ou!!11Mmtth6-{last p&tient
4,. All phannacokinclicilida :and the·bfoanalytical repmffor all participants through
M<>nth l2JromtheCANOPY clmicaltrfal l!yMarch 31,:2025.
:: if::£i;1:::r~~~!:~;!t~<i~°!;!Js!!:;:!~::-
h~llnsiti;vjty·rti~~ms;,_ittcluding:!ltl11pltyl!l,Xis, ~iunpg9n,'s-:cfit~ri1tmi01µdbe
usedto-appropriately classifyreportedhypersenSiti'vityreacfions as anaphylaxis, fu
the·bimomhly aggregate reports;.includeihe followinginfol'tfiatioo. atminlinwn.
==~~)
•
Total dosage ofpemivibartiiifused,
.: ==!!en (medicati~ hospttaiJzatl~ eW,J
if •()µtc()meweven.t
7, All genotypic and phenotypicresistance analysisdat1t-:f01'.subje~failihg
pemivibart prophylaxis intlie CANOPYclinicaltriill by August 30, 2024{ftrst
a:1=:-~~;~~~~-:.i-
K fuvivycl mustsubmii-spike-sequencedatafor·each.treafment failure identified in
the CANOPYtrial as soon as practicable, butno laterthan6 weeks after failure
detenninatfon. Phenotypic data for spike variants with substitutions: in the
P.EMGARDAepitope at contact llhd adjai!entresidues,sh()tildbedbtained and
sttbmitted within2 calendar da_ys from receipffrom-the contractOI'..
VerDate Sep<11>2014
18:43 May 24, 2024
Jkt 262001
PO 00000
Frm 00082
Fmt 4703
Sfmt 4725
E:\FR\FM\28MYN1.SGM
28MYN1
EN28MY24.046</GPH>
khammond on DSKJM1Z7X2PROD with NOTICES
Q: Iiivivyd an:dat.ithorizeddistributot(s)wili1nakeavaitableto·FDAtiporirequestiifiytecords
•- -maintained.in connectfon witli tlti$ EUA
Federal Register / Vol. 89, No. 103 / Tuesday, May 28, 2024 / Notices
46137
Jl.ige 9 -Inyivyd,Jnc.
Healthcare Facilities to Whom PEMG-ARDAis Distributed and Healthcare Providers Administering
PEMGARDA
lt ltealth¢are:faclfiti¢s !Uid heaithcaN Pm'Vtdets will etisure that'theyateaw~ otthe L¢tter
of Au:titQtizati®; fill.ii :the iertns llerein, Md that the 1Ui:th:Q11Zed FactSheets me made
available tQ healthcare providers andtopatiimts and caregivers,TilSpe:ciiyely~ through
appropriate means, prior to administration ofPEMG-ARDA asdescribedinthe Scope of
Authorizatloti(Sectibft]I)tm:derthis EUA. .
Si JJ:elllthci!tef@ilities Md lleatlliei!te pwvii.ters rllqe.ivm:gl>tMO~Awilltmckall$eri◊us
adversrreve~ aritltnedicatiQll e~that ilte co11Sidl)l'l;ldto be potentially relatedto·
PEMGARDAuseand.mustreportthesetoFDAinaccordancewiththe Fact She:etfor
Heal:thcare:Providel'ii. Coropfote!Uid submit aJ\,:ledWatchform
(www:;f4goy/ril:edwatcl'.l!re@rt.ht:rti), or c0i:np1ete and submit FDA Form 350() (heaith
pt:Qfessional)·byfax{l-80().J:i'DA-OJ78)(ihese fQtms.canbefound vi!llirik{il,9ye),~U l800•FDA4088forquestions, Submitted reports must state, ·~EMG-ARDAuse.for pre•
exposure. prophylaxisofCOVID-19·under Emergency Use Authorization?' at the beginning
ofthe-question "Describe Event''Sorfurther analysisiAcopy Qfthe completed FbA Form
3:500'tnusl~9b¢I)I{)videdt9mvivyd1>et:the•insttucil-Ons in·theautfrorized.labelin~.
T, Helllthcarefacilities andhealthcare providers will ensurethahppropriatesforageis
maintained.untiitheptodtictis administered consistent with thetertns: ofthisietter and the
authorizedlabelitig.
t;; Througha.process ofinyentorycontrol, healthcarefacilitie!! will ma:intainrecordsregarding
the dispensing and administration of PEMG-ARDAfor the use. authoriZed in this letter (i.e.,
lotnumbers,. quantity, receiving site, receipt date), product stor.ige, and maintain patient
mfontration (e.g:, patient name, age, disease :tmi:riifesta:tion, number ofdoses administered
pet patient; other drugs administered}
V: Healthcare facilities will ensurethahmyrecords associated with this EUA are.maintained
until notified by Invivyd and/or FDA. Such records will be made availabletolnvivyd,
Bl:1$,.and FDA for in$pection upon request
ConditionsRelat'edfoPrinted Malter; Advertising, and Promotion
W. .All descriptive printed matter; advertising, andpromotiori!tlmaterlais relating to the use of
PEMGARt>Allfidetthis authorization shall be consistentwiththe authorized labeling, as
wellas :theterins setforth in this :ElJA, andmeetthe requirements setforth in Seclion •
502(a) and (n)oftheAcl; as applicablt\ and FDA implementing regulations, References to
"approved labeling'', •'permitted labeling'', or similarterms.inthese.requirem:ents ghall be
understood torefert:otheauthoriZedlabelitigforthe use of PEMGARDA under this
aufh9rizatfon:'. Inaddition,suchmaterialsshm}:
VerDate Sep<11>2014
18:43 May 24, 2024
Jkt 262001
Be tailored to the intended audience.
PO 00000
Frm 00083
Fmt 4703
Sfmt 4725
E:\FR\FM\28MYN1.SGM
28MYN1
EN28MY24.047</GPH>
khammond on DSKJM1Z7X2PROD with NOTICES
•
46138
Federal Register / Vol. 89, No. 103 / Tuesday, May 28, 2024 / Notices
Page 10 - faviyy<J, Inc.
•
Not take 1heform of reminder advertisements or reminder labeling,. as those
terms aredescribedin:21 CFR2Q2, l(eX2Xi) and2lCFR20l.lOO(f),
~specti:yely; excq,t tha,tremfucler ~dyertiiein,errts aml,rc:mfuder labeling
intendedonlyloprovideprice:informationtoconsumers, asdescribedin21
CFR200;200, arepemtlssibleso long as suchmaterialsmeetalLconditions
described in. 21 cFR2Q0.200(aX1}(a)(4).
.•· :i>resentfue same risk inf'otmation teiatingtothe major sideeEects and.
contraindicatiofill concurrently ·m the audi'ctandvisual. parts of the presentation
for:advertising anq promoti()nalmat.irjalsin iuulio•yisuitl format.
•• tki•accompaniedb.y:the aµihprlze41al);)lmg;_ if the promc)tional rtia,terialsare m~t
subject-to Section 502(n)ofthe.Act
•
•
·• Be @brtiitied,t9 ImAacc()mpaniedl>y Eb-rm':FDA~2~~ for:~idetati® i1J
leastl4•calendar,days·•priortoinitialdisseniinatfon.or•first·use.
x. !:!:!::.Ji~~!!;!!!:!~~,!';!;~Ei::g~;e:!~:f;et~::::na1.•
descriptions of safety results and.efl:icacyresultson aclinical.endpoint(s) or surrogate
endpoint(sJ:from the clinical trial(s).summarized in 1he authorized labeling, Such
.ni:aterialsrtiust inch.ide any-liniitatiom -0f the clinical trial data, as:-described:in the
tt.!;tJ:!!:!1!ti!W:J::::::
·::::::.~,{!t~::!::ts:t!
preaexposure pmphylaxis ofCOVID-19;!'
Y.
.Alt•de$criptiye printed W-!iUef; ajyertisjn:g;.iut4p~mgifotialni:~i.ttrelatit'itt<ftheµlle.(lf
•PEMGARDAtinderthis authorizationdeaify and conspicuously-shall sfuiethat,
•
PEM:GARDA basnotbeen approved, but has been authorized for
•ct1~::~~!:~:=~~t:~xr=~r;~ t~~
1
·andol<.lerwefWiingat least4QkgJ;.and
•
••
~ etn¢rgelley'µlie of PEN!G:~Ais•Qrily authorized:forthe duration
·ofthedeclaration 1haf circumstances.existjustilyingtheauthorization··of
the ert1ergency use ofdtugs artdb1ofogical prt)ducts during the COVID19 pandemictiiidet Sectioo: 564(bXi) of the Act, :itU.S,C, l360bbb-
3(b)(i),.urilessthedec1;3ration.istenninated.i'.>t'•authotization•r¢vokecl
S<><mer:
Iftiie,.Ageiicyriotif'ies•Irivivydthatanydesctlptive.•priiited,matter, advertisllig;.orpfomotfon:a1
materWs do notmeettheterms setfottlrin Conditions Wthrough Y of1his EDA, lnvivyd must
cease distribution of such descriptive printed matter, advertising; orpromotioruil materials in
acoorclan~ with 1he Agency's notification. Furthermore; as Jmri. ofitsn()tifiCatiOQ; ibe Agenc:ymay
VerDate Sep<11>2014
18:43 May 24, 2024
Jkt 262001
PO 00000
Frm 00084
Fmt 4703
Sfmt 4725
E:\FR\FM\28MYN1.SGM
28MYN1
EN28MY24.048</GPH>
khammond on DSKJM1Z7X2PROD with NOTICES
alsorequrre·Invivyd·to issue.correclive·communication(s);
Federal Register / Vol. 89, No. 103 / Tuesday, May 28, 2024 / Notices
46139
~agta:
l1 -Jnvivyd,Jnc.
.
.
IY,:
l)u~n ofAuth~uizat,io11
ThiSEUA wll[beeffective until the declaration that circmnstances.existjustifyingthe
autho_riZ~tfo;i. (ifthe emergency useofdru~ a;i.d bio!Qgi!)al products during the CQVID-19
~:t;~:ete;;;~a~dund¢r'Se¢tiQtt 564(b)(1}of1he Act Prthe lR!A i$ teypkeduntler Secti9n
sllicereiy.
~=~~i~~-~
P:attizfa>Cava:zz:c;rti, 'M.:rt •
Dire,c't;-0r
•
Centerfor Drug Evalmrlfun and Research
U.S ..Food and Drug-Administration
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–2245]
Issuance of Priority Review Voucher;
Material Threat Medical
Countermeasure Product; PAXLOVID
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a material threat medical
countermeasure (MCM) product
application. The Federal Food, Drug,
and Cosmetic Act (FD&C Act) authorizes
FDA to award priority review vouchers
to sponsors of approved material threat
MCM product applications that meet
certain criteria. FDA is required to
publish notice of the award of the
priority review voucher. FDA has
determined that PAXLOVID
(nirmatrelvir co-packaged with
ritonavir) tablets, approved on May 25,
2023, manufactured by Pfizer, Inc.,
meets the criteria for a material threat
MCM priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:43 May 24, 2024
Jkt 262001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FDA is
announcing the issuance of a material
threat MCM priority review voucher to
the sponsor of an approved material
threat MCM product application. Under
section 565A of the FD&C Act (21 U.S.C.
360bbb–4a) FDA will award priority
review vouchers to sponsors of
approved material threat MCM product
applications that meet certain criteria
upon approval of those applications.
FDA has determined that PAXLOVID
(nirmatrelvir co-packaged with
ritonavir) tablets, manufactured by
Pfizer, Inc., meets the criteria for a
material threat MCM priority review
voucher. PAXLOVID was approved on
May 25, 2023, for the treatment of mildto-moderate coronavirus disease 2019
(COVID–19) in adults who are at high
risk for progression to severe COVID–19,
including hospitalization or death.
For further information about the
material threat MCM Priority Review
Voucher Program and for a link to the
full text of section 565A of the FD&C
Act, go to https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/21st-century-cures-act-mcmrelated-cures-provisions#prv. For
further information about PAXLOVID
(nirmatrelvir co-packaged with
ritonavir) tablets go to the ‘‘Drugs@
FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Food and Drug Administration
SUPPLEMENTARY INFORMATION:
[FR Doc. 2024–11640 Filed 5–24–24; 8:45 am]
AGENCY:
301–796–1394, email: Cathryn.Lee@
fda.hhs.gov.
Dated: May 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–11643 Filed 5–24–24; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
[Docket No. FDA–2024–N–2219]
Progynon Associates, et al.; Proposal
to Withdraw Approval of Four New
Drug Applications; Opportunity for a
Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Drug Evaluation and Research
(CDER) is proposing to withdraw
approval of four new drug applications
(NDAs) and is announcing an
opportunity for the NDA holders to
request a hearing on this proposal. The
basis for the proposal is that the NDA
holders have repeatedly failed to file
required annual reports for those NDAs.
DATES: The NDA holders may submit a
request for a hearing by June 27, 2024.
Submit all data, information, and
analyses upon which the request for a
hearing relies July 29, 2024. Submit
electronic or written comments by July
29, 2024.
ADDRESSES: The request for a hearing
may be submitted by the NDA holders
by either of the following methods:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments to
submit your request for a hearing.
Comments submitted electronically to
https://www.regulations.gov, including
E:\FR\FM\28MYN1.SGM
28MYN1
EN28MY24.049</GPH>
Dated: May 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
]]>Agencies
[Federal Register Volume 89, Number 103 (Tuesday, May 28, 2024)]
[Notices]
[Pages 46127-46139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11640]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2222]
Authorization of Emergency Use of a Drug Product During the
COVID-19 Pandemic; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of an Emergency Use Authorization (EUA) (the Authorization)
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for use
during the COVID-19 pandemic. FDA has issued an Authorization for the
drug product PEMGARDA (pemivibart) as requested by Invivyd, Inc.
(Invivyd). The Authorization contains, among other things, conditions
on the emergency use of the authorized product. The Authorization
follows the February 4, 2020, determination by the Secretary of Health
and Human Services (HHS), as amended on March 15, 2023, 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 novel (new) coronavirus. The virus, named
SARS-CoV-2, causes the illness COVID-19. On the basis of such
determination, the Secretary of HHS declared on March 27, 2020, that
circumstances exist justifying the authorization of emergency use of
drugs and biological products during the COVID-19 pandemic, pursuant to
the FD&C Act, subject to the terms of any authorization issued under
that section. The Authorization, which includes an explanation of the
reasons for issuance, is reprinted in this document.
DATES: The Authorization is effective as of March 22, 2024.
ADDRESSES: Submit written requests for a single copy of the EUA to the
Office of Executive Programs, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, 6th
Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive
label to
[[Page 46128]]
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: Johanna McLatchy, Office of Executive
Programs, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, 6th Floor, Silver
Spring, MD 20993-0002, 301-796-3200 (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 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, and 360e) or section 351 of the PHS Act (42 U.S.C. 262),
or conditionally approved under section 571 of the FD&C Act (21 U.S.C.
360ccc). FDA may issue an EUA only if, after consultation with the HHS
Assistant Secretary for Preparedness and Response, the Director of the
National Institutes of Health, and the Director of the Centers for
Disease Control and Prevention (to the extent feasible and appropriate
given the applicable circumstances), FDA \2\ concludes: (1) that an
agent referred to in a declaration of emergency or threat can cause a
serious or life-threatening disease or condition; (2) that, based on
the totality of scientific evidence available to FDA, including data
from adequate and well-controlled clinical trials, if available, it is
reasonable to believe that: (A) the product may be effective in
diagnosing, treating, or preventing (i) such disease or condition; or
(ii) a serious or life-threatening disease or condition caused by a
product authorized under section 564, approved or cleared under the
FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing,
treating, or preventing such a disease or condition caused by such an
agent; and (B) the known and potential benefits of the product, when
used to diagnose, prevent, or treat such disease or condition, outweigh
the known and potential risks of the product, taking into consideration
the material threat posed by the agent or agents identified in a
declaration under section 564(b)(1)(D) of the FD&C Act, if applicable;
(3) that there is no adequate, approved, and available alternative to
the product for diagnosing, preventing, or treating such disease or
condition; (4) in the case of a determination described in section
564(b)(1)(B)(ii) of the FD&C Act, that the request for emergency use is
made by the Secretary of Defense; and (5) that such other criteria as
may be prescribed by regulation are satisfied.
---------------------------------------------------------------------------
\2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------
No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act.
III. The Authorization
The Authorization follows the February 4, 2020, determination by
the Secretary of HHS, as amended on March 15, 2023, 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 novel (new) coronavirus. The virus, named
SARS-CoV-2, causes the illness COVID-19. Notice of the Secretary's
determination was provided in the Federal Register on February 7, 2020
(85 FR 7316) and notice of the Secretary's amended determination was
provided in the Federal Register on March 20, 2023 (88 FR 16644). On
the basis of such determination, the Secretary of HHS declared on March
27, 2020, that circumstances exist justifying the authorization of
emergency use of drugs and biological products during the COVID-19
pandemic, pursuant to section 564 of the FD&C Act, subject to the terms
of any authorization issued under that section. Notice of the
Secretary's declaration was provided in the Federal Register on April
1, 2020
[[Page 46129]]
(85 FR 18250). Having concluded that the criteria for issuance of the
Authorization under section 564(c) of the FD&C Act are met, on March
22, 2024, FDA issued an EUA to Invivyd for the drug product PEMGARDA
(pemivibart), subject to the terms of the Authorization. The initial
Authorization, which is included below in its entirety after section IV
of this document (not including the authorized versions of the fact
sheets and other written materials), provides an explanation of the
reasons for issuance, as required by section 564(h)(1) of the FD&C Act.
Any subsequent reissuance of the Authorization can be found on FDA's
web page at: https://www.fda.gov/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products.
IV. Electronic Access
An electronic version of this document and the full text of the
Authorization is available on the internet at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TN28MY24.039
[[Page 46130]]
[GRAPHIC] [TIFF OMITTED] TN28MY24.040
[[Page 46131]]
[GRAPHIC] [TIFF OMITTED] TN28MY24.041
[[Page 46132]]
[GRAPHIC] [TIFF OMITTED] TN28MY24.042
[[Page 46133]]
[GRAPHIC] [TIFF OMITTED] TN28MY24.043
[[Page 46134]]
[GRAPHIC] [TIFF OMITTED] TN28MY24.044
[[Page 46135]]
[GRAPHIC] [TIFF OMITTED] TN28MY24.045
[[Page 46136]]
[GRAPHIC] [TIFF OMITTED] TN28MY24.046
[[Page 46137]]
[GRAPHIC] [TIFF OMITTED] TN28MY24.047
[[Page 46138]]
[GRAPHIC] [TIFF OMITTED] TN28MY24.048
[[Page 46139]]
[GRAPHIC] [TIFF OMITTED] TN28MY24.049
Dated: May 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11640 Filed 5-24-24; 8:45 am]
BILLING CODE 4164-01-C
