[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]
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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.
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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
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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.
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Dated: October 4, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22390 Filed 10-6-23; 8:45 am]
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