Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of Mpox; Availability, 69932-69935 [2023-22390]
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69932
Federal Register / Vol. 88, No. 194 / Tuesday, October 10, 2023 / Notices
the terms of the generic. Burden
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New Program Monitoring Forms ....................................................................
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2023–22382 Filed 10–6–23; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
Casi
Alexander, Office of Digital
Transformation, Food and Drug
Administration, FDA Library, 5630
Fishers Lane, Rm. 1087, Rockville, MD
20857, 240–402–5171, email:
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Food and Drug Administration
In the
Federal Register of September 19, 2023
(88 FR 64435), in FR Doc. 2023–20136,
the following correction is made:
On page 64436, in the third column,
in the second paragraph, ‘‘Fiscal Years
2024–2026’’ is corrected to read ‘‘Fiscal
Years 2024–2027.’’
AGENCY:
BILLING CODE 4184–79–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2023–N–3636]
Food and Drug Administration
Information Technology Strategy;
Request for Comments; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA or Agency) is
correcting a notice entitled ‘‘Food and
Drug Administration Information
Technology Strategy; Request for
Comments’’ that appeared in the
Federal Register of September 19, 2023.
The document announced the
availability of an information
technology (IT) strategic plan entitled
the ‘‘FDA Information Technology
Strategy’’ and a request for comment on
this IT Strategy. The document was
published with an incorrect set of fiscal
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
OPREinfocollection@acf.hhs.gov.
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VerDate Sep<11>2014
18:39 Oct 06, 2023
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Dated: October 4, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–22388 Filed 10–6–23; 8:45 am]
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[Docket No. FDA–2023–N–4202]
Revocation of Two Authorizations of
Emergency Use of In Vitro Diagnostic
Devices for Detection and/or Diagnosis
of Mpox; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
revocations of the Emergency Use
Authorizations (EUAs) (the
Authorizations) issued to Life
Technologies Corp. (a part of Thermo
Fisher Scientific Inc.), for the TaqPath
Monkeypox/Orthopox Virus DNA Kit,
and Becton, Dickinson and Co., for the
VIASURE Monkeypox virus Real Time
PCR Reagents for BD MAX System. FDA
revoked these Authorizations under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) as requested by these
Authorization holders. The revocations,
which include an explanation of the
reasons for each revocation, are
reprinted in this document.
DATES: The Authorization for the Life
Technologies Corp. (a part of Thermo
SUMMARY:
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Federal Register / Vol. 88, No. 194 / Tuesday, October 10, 2023 / Notices
Fisher Scientific Inc.)’s, TaqPath
Monkeypox/Orthopox Virus DNA Kit is
revoked as of April 18, 2023. The
Authorization for the Becton, Dickinson
and Co.’s, VIASURE Monkeypox virus
Real Time PCR Reagents for BD MAX
System is revoked as of May 24, 2023.
ADDRESSES: Submit written requests for
a single copy of the revocations 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
revocations may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the revocations.
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:
ddrumheller on DSK120RN23PROD with NOTICES1
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) as amended by the
Project BioShield Act of 2004 (Pub. L.
108–276) and the Pandemic and AllHazards Preparedness Reauthorization
Act of 2013 (Pub. L. 113–5) allows FDA
to strengthen the 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.
On December 13, 2022, FDA issued the
Authorization to Life Technologies
Corp. (a part of Thermo Fisher Scientific
VerDate Sep<11>2014
18:39 Oct 06, 2023
Jkt 262001
Inc.) for the TaqPath Monkeypox/
Orthopox Virus DNA Kit, subject to the
terms of the Authorization. Notice of the
issuance of this Authorization was
published in the Federal Register on
January 11, 2023 (88 FR 1587), as
required by section 564(h)(1) of the
FD&C Act. On December 23, 2022, FDA
issued the Authorization to Becton,
Dickinson and Co. for the VIASURE
Monkeypox virus Real Time PCR
Reagents for BD MAX System subject to
the terms of the Authorization. Notice of
the issuance of this Authorization was
published in the Federal Register on
January 31, 2023 (88 FR 6262), as
required by section 564(h)(1) of the
FD&C Act. Subsequent updates to the
Authorizations were made available on
FDA’s website. The authorization of a
device for emergency use under section
564 of the FD&C Act may, pursuant to
section 564(g)(2) of the FD&C Act, be
revoked when the criteria under section
564(c) of the FD&C Act for issuance of
such authorization are no longer met
(section 564(g)(2)(B) of the FD&C Act),
or other circumstances make such
revocation appropriate to protect the
public health or safety (section
564(g)(2)(C) of the FD&C Act).
II. Authorizations Revocation Request
In a request received by FDA on April
13, 2023, Life Technologies Corp. (a part
of Thermo Fisher Scientific Inc.),
requested the revocation of, and on
April 18, 2023, FDA revoked, the
Authorization for the Life Technologies
Corp. (a part of Thermo Fisher Scientific
Inc.)’s TaqPath Monkeypox/Orthopox
Virus DNA Kit. Because Life
Technologies Corp. (a part of Thermo
Fisher Scientific Inc.), notified FDA that
it is not commercially supporting the
TaqPath Monkeypox/Orthopox Virus
DNA Kit and no kit reagents were
distributed in the United States and
requested FDA revoke the Life
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69933
Technologies Corp. (a part of Thermo
Fisher Scientific Inc.)’s TaqPath
Monkeypox/Orthopox Virus DNA Kit,
FDA has determined that it is
appropriate to protect the public health
or safety to revoke this Authorization.
In a request received by FDA on May
22, 2023, Becton, Dickinson and Co.,
requested the withdrawal of, and on
May 24, 2023, FDA revoked, the
Authorization for the Becton, Dickinson
and Co.’s VIASURE Monkeypox virus
Real Time PCR Reagents for BD MAX
System. Because Becton, Dickinson and
Co., notified FDA that it is not
commercially manufacturing the
VIASURE Monkeypox virus Real Time
PCR Reagents for BD MAX System and
no reagents were distributed in the
United States and requested FDA revoke
the Becton, Dickinson and Co.’s
VIASURE Monkeypox virus Real Time
PCR Reagents for BD MAX System, FDA
has determined that it is appropriate to
protect the public health or safety to
revoke this Authorization.
III. Electronic Access
An electronic version of this
document and the full text of the
revocations are available on the internet
at https://www.regulations.gov/.
IV. The Revocations
Having concluded that the criteria for
revocation of the Authorization under
section 564(g)(2)(C) of the FD&C Act are
met, FDA has revoked the EUA of Life
Technologies Corp. (a part of Thermo
Fisher Scientific Inc.)’s TaqPath
Monkeypox/Orthopox Virus DNA Kit,
and Becton, Dickinson and Co.’s
VIASURE Monkeypox virus Real Time
PCR Reagents for BD MAX System. The
revocations in their entirety follow and
provide an explanation of the reasons
for revocations, as required by section
564(h)(1) of the FD&C Act.
BILLING CODE 4164–01–P
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69934
Federal Register / Vol. 88, No. 194 / Tuesday, October 10, 2023 / Notices
April 18, 2023.
$tacey M()ltch®.ott
Reguiatory•.AfIIUl'S Manager
file Techno1ogies.•.Corporation(apiiitBf'.Themi◊ F1shet:Scientific,Jnc.}
5781 V:anA.llen\Vay
C!ltlsbad; GA92Q0$
Re: Revocation ofEUA:220461
ThisJeUer is lll resp<>nsefo therequeslfromLffeTechnologies Corporation (a part of Thermo
FishetScientific Inc), in .aJetter receiy<:dApril B, 2023, that theU.S. Food and Dntg
Administration.(FDA)re:voke the EUAfofTaqPath M()nkeyi,ox/Ortho~ox V'irus DNA I<.it
issued on De~mber 13, 2Q22. Thermo Fisher Scientific Inc; hl:t& decided not.Jo comtneI"cially
support the EUA product and requested that the ~UA be re~oked, FDA understands that, as of
the date of:thisJetter,noTaqPathMonke:ypox/Orthopox Vin.I$ DNAKttreagents wete
distributed mthe United States.
The authorizationofa deviceforemergency use undersectfon 564 ofthe Federal Food, Drug,
and Cosmetic Act (the,Act) (21 U.S.C. 360bbb•3) may,pursuanFto section 564(g)(2) oftheAct,
be revoked-when circumstiirices tnake sttchrevocation appropriate to. ptotectthe.public health. or
safety (section $64(g)(2)(C} ofthe0Act), Because Toenno Fisher Scientificlnc. has,requested
thiltFl)Are:vokt}the El.J.Aforthe TaqPilthMonkeypox/Orlhopox Vir:tlS DNAKit, FDAhas.
determined that ifis appt:~priate, to protect the pubHo health or safe~; i~ t'e~ke this
authqrization: Accordingly. FI)J\ here~y revokes EUA220Mit for the TaqPath
MonkeyPoXl'.OrthopoxVirus DNA Kit, pursuanU<>: section S64(gX2)(C) qfthe A¢{ As ofilie
4* ofthisJetter; the TaqPilth Monkeypox/Orth()pux Vi~ DNA Kitis no lon~r attthgrized,for
emergency use by FDA
Notice ofthisrevocatiortwill·t;e··published mtlieftedeti'ttRegister,putsuant tosectfort564(h)(l)
oftheAct
JeffreyE. Shuren, M.D., J~D.
Director
Centerfor Devi~ an.41flldi<>fogical aeatttx
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ddrumheller on DSK120RN23PROD with NOTICES1
Food an<l't>rugA,d,:nt.iµistr~timt •
Federal Register / Vol. 88, No. 194 / Tuesday, October 10, 2023 / Notices
69935
May24,2023
Melissa Barhoover, Ph.D., RAC
Sen:ior Regulatory Affairs Manager
BectQn, Dickinson and Company
7 Loveton Circle,
Sparks, MD 21152-0999
Re: Revocation ofEUA220453
Dear Dr. Barhoover:
This letter is ill response to the request from Becton, Dickinson and Company ("BD')~ ill a ktter
received May 22, 2023, that the U.S. Food and Drug Admillistration (FDA) withdraw the EUA
for the VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System issued on
December 23, 2022. BD has decided not to manufacture or sell these kits moving forward and
requested that the EUA be withdrawn. FDA understands that, as of the date of this letter, no
VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System reagents were
distributed ill the United States.
The authorization of a device for. emergency use under section 564 of the Federal Food, Drug,
and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuantto section 564(gX2) oftlie Act,
be revoked. when circumstam:es make such revocation appropriate to pr-0tect ihe public health Qr
safety (section 564(g)(2)(C) of the Act). Because BD has requested that FDA withdraw the EUA
for the VIASURE Monkeypox vnus Real Time PCR Reagents for BD MA,X System, FDA has
determined that itis appropriate, to protect the public health or safety, to revoke this
authorization. Accordingly, FDA hereby revokes EUA220453 for the VIASURE MonkeYPox
virus Real Time PCR Reagents for BD MA,XSystem, pursuant to.section 564(g)(2XC) of the
Act. As of the date ofthis letter, the VIASURE Monkeypox virus Real Time PCR Reagents for
BD MA,X System is no longer authorized for emergency use by FDA.
Notice ofthis tevoc.ation wiil be published in the Federal Regzs.tet, p0rsu:ant to section 564(hXl)
oftheAct.
•
Sincerely~
Jeffrey E. Shuren, M.D., J.D.
Director
Center for Devices and Radiological Health
Food and Drug Admillistration •
[FR Doc. 2023–22390 Filed 10–6–23; 8:45 am]
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meeting
BILLING CODE 4164–01–C
ddrumheller on DSK120RN23PROD with NOTICES1
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
VerDate Sep<11>2014
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as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel;
Implementing Comprehensive HIV Services
in Syringe Service Program Settings.
Date: November 17, 2023.
Time: 12:00 to 2:00 p.m.
E:\FR\FM\10OCN1.SGM
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EN10OC23.021</GPH>
Dated: October 4, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
]]>Agencies
[Federal Register Volume 88, Number 194 (Tuesday, October 10, 2023)]
[Notices]
[Pages 69932-69935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22390]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4202]
Revocation of Two Authorizations of Emergency Use of In Vitro
Diagnostic Devices for Detection and/or Diagnosis of Mpox; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocations of the Emergency Use Authorizations (EUAs) (the
Authorizations) issued to Life Technologies Corp. (a part of Thermo
Fisher Scientific Inc.), for the TaqPath Monkeypox/Orthopox Virus DNA
Kit, and Becton, Dickinson and Co., for the VIASURE Monkeypox virus
Real Time PCR Reagents for BD MAX System. FDA revoked these
Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) as requested by these Authorization holders. The revocations,
which include an explanation of the reasons for each revocation, are
reprinted in this document.
DATES: The Authorization for the Life Technologies Corp. (a part of
Thermo
[[Page 69933]]
Fisher Scientific Inc.)'s, TaqPath Monkeypox/Orthopox Virus DNA Kit is
revoked as of April 18, 2023. The Authorization for the Becton,
Dickinson and Co.'s, VIASURE Monkeypox virus Real Time PCR Reagents for
BD MAX System is revoked as of May 24, 2023.
ADDRESSES: Submit written requests for a single copy of the revocations
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 revocations may be sent. See the SUPPLEMENTARY
INFORMATION section for electronic access to the revocations.
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) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the 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. On December 13, 2022,
FDA issued the Authorization to Life Technologies Corp. (a part of
Thermo Fisher Scientific Inc.) for the TaqPath Monkeypox/Orthopox Virus
DNA Kit, subject to the terms of the Authorization. Notice of the
issuance of this Authorization was published in the Federal Register on
January 11, 2023 (88 FR 1587), as required by section 564(h)(1) of the
FD&C Act. On December 23, 2022, FDA issued the Authorization to Becton,
Dickinson and Co. for the VIASURE Monkeypox virus Real Time PCR
Reagents for BD MAX System subject to the terms of the Authorization.
Notice of the issuance of this Authorization was published in the
Federal Register on January 31, 2023 (88 FR 6262), as required by
section 564(h)(1) of the FD&C Act. Subsequent updates to the
Authorizations were made available on FDA's website. The authorization
of a device for emergency use under section 564 of the FD&C Act may,
pursuant to section 564(g)(2) of the FD&C Act, be revoked when the
criteria under section 564(c) of the FD&C Act for issuance of such
authorization are no longer met (section 564(g)(2)(B) of the FD&C Act),
or other circumstances make such revocation appropriate to protect the
public health or safety (section 564(g)(2)(C) of the FD&C Act).
II. Authorizations Revocation Request
In a request received by FDA on April 13, 2023, Life Technologies
Corp. (a part of Thermo Fisher Scientific Inc.), requested the
revocation of, and on April 18, 2023, FDA revoked, the Authorization
for the Life Technologies Corp. (a part of Thermo Fisher Scientific
Inc.)'s TaqPath Monkeypox/Orthopox Virus DNA Kit. Because Life
Technologies Corp. (a part of Thermo Fisher Scientific Inc.), notified
FDA that it is not commercially supporting the TaqPath Monkeypox/
Orthopox Virus DNA Kit and no kit reagents were distributed in the
United States and requested FDA revoke the Life Technologies Corp. (a
part of Thermo Fisher Scientific Inc.)'s TaqPath Monkeypox/Orthopox
Virus DNA Kit, FDA has determined that it is appropriate to protect the
public health or safety to revoke this Authorization.
In a request received by FDA on May 22, 2023, Becton, Dickinson and
Co., requested the withdrawal of, and on May 24, 2023, FDA revoked, the
Authorization for the Becton, Dickinson and Co.'s VIASURE Monkeypox
virus Real Time PCR Reagents for BD MAX System. Because Becton,
Dickinson and Co., notified FDA that it is not commercially
manufacturing the VIASURE Monkeypox virus Real Time PCR Reagents for BD
MAX System and no reagents were distributed in the United States and
requested FDA revoke the Becton, Dickinson and Co.'s VIASURE Monkeypox
virus Real Time PCR Reagents for BD MAX System, FDA has determined that
it is appropriate to protect the public health or safety to revoke this
Authorization.
III. Electronic Access
An electronic version of this document and the full text of the
revocations are available on the internet at https://www.regulations.gov/.
IV. The Revocations
Having concluded that the criteria for revocation of the
Authorization under section 564(g)(2)(C) of the FD&C Act are met, FDA
has revoked the EUA of Life Technologies Corp. (a part of Thermo Fisher
Scientific Inc.)'s TaqPath Monkeypox/Orthopox Virus DNA Kit, and
Becton, Dickinson and Co.'s VIASURE Monkeypox virus Real Time PCR
Reagents for BD MAX System. The revocations in their entirety follow
and provide an explanation of the reasons for revocations, as required
by section 564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P
[[Page 69934]]
[GRAPHIC] [TIFF OMITTED] TN10OC23.020
[[Page 69935]]
[GRAPHIC] [TIFF OMITTED] TN10OC23.021
Dated: October 4, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22390 Filed 10-6-23; 8:45 am]
BILLING CODE 4164-01-C
