Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability, 60435-60436 [2024-16345]
Download as PDF
<![CDATA[
Federal Register / Vol. 89, No. 143 / Thursday, July 25, 2024 / Notices
receive comments on the draft guidance.
The guidance announced in this notice
finalizes the draft guidance dated July
2022.
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Impurities:
Residual Solvents in New Veterinary
Medicinal Products, Active Substances
and Excipients (Revision 2).’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in section 512(n)(1) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(n)(1)) have been
approved under OMB control number
0910–0669; the collections of
information in 21 CFR part 514 have
been approved under OMB control
number 0910–0032.
III. Electronic Access
Persons with access to the internet
may obtain an electronic version of the
draft guidance at https://www.fda.gov/
animal-veterinary/guidance-regulations/
guidance-industry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: July 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–16408 Filed 7–24–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2022–N–0150]
Revocation of Authorization of
Emergency Use of In Vitro Diagnostic
Device for Detection and/or Diagnosis
of COVID–19; Availability
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
19:41 Jul 24, 2024
Jkt 262001
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
revocation of the Emergency Use
Authorization (EUA) (the Authorization)
issued to Mesa Biotech Inc., (a legal
entity of Thermo Fisher Scientific), for
the Accula SARS–CoV–2 Test. FDA
revoked the Authorization under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) as requested by the
Authorization holder. The revocation,
which includes an explanation of the
reasons for revocation, is reprinted at
the end of this document.
DATES: The revocation of the
Authorization for the Mesa Biotech
Inc.’s Accula SARS–CoV–2 Test is
effective as of May 22, 2024.
ADDRESSES: Submit written requests for
a single copy of the revocation 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
revocation may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the revocation.
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:
SUMMARY:
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 March 23, 2020, FDA issued the
Authorization to Mesa Biotech Inc. (a
legal entity of Thermo Fisher Scientific),
for the Accula SARS–CoV–2 Test,
subject to the terms of the
Authorization. Notice of the issuance of
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
60435
this Authorization was published in the
Federal Register on June 5, 2020 (85 FR
34638), as required by section 564(h)(1)
of the FD&C Act.
Subsequent updates to the
Authorization 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. Authorization Revocation Request
In a request received by FDA on May
15, 2024, Mesa Biotech Inc. (a legal
entity of Thermo Fisher Scientific),
made by Thermo Fisher Scientific, Inc.
on behalf of Mesa Biotech Inc.,
requested the revocation of, and on May
22, 2024, FDA revoked, the
Authorization for the Mesa Biotech
Inc.’s Accula SARS–CoV–2 Test.
Because Mesa Biotech Inc., notified
FDA that they discontinued the
commercialization of the Accula SARS–
CoV–2 Test and requested FDA revoke
Mesa Biotech Inc.’s Accula SARS–CoV–
2 Test, 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 Revocation
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 Mesa
Biotech Inc.’s Accula SARS–CoV–2
Test. The revocation in its entirety
follows and provide an explanation of
the reasons for revocation, as required
by section 564(h)(1) of the FD&C Act.
E:\FR\FM\25JYN1.SGM
25JYN1
60436
Federal Register / Vol. 89, No. 143 / Thursday, July 25, 2024 / Notices
May 22, .2024
Anita 1:'argqsz:
Senior Director, Quality
Tltemto FisherSoientific
5823 Newton Drive
Carlsbad, CA. 9200~
Re: Revocation ofEUA200028
Dear Anita Targosz:
This letter is in responsdo the request from Mesa BiotechJnc. (a legal entity of Thermo Fisher
Scientific), made by Thenno FisherSoierttific, Inc. Otlbebalfof MesaBiotech Inc. in a letter
dated MayJ5, 2024, thatthe
Food and Drug Administration (FDA) revoke the EUA for the
AoculaS,'\R~CqV,2Testissued on Mm;h 23, 2020, amended on ApriJ3(), 2020:attdAugust3Q,
2020; reissued on January 7,. 2021, amended on February 3,2021 and September 23; 2021, and
reissued on Mar 16,. 2022, August 17,.2022 and March 15, 2023. Thermo Fisher Scientific Inc.
indicated thatthethave discontinued commercializaticm and support ofthe authoriZed product
lUld reqµestedthat the EUA be rev.9ked: FDA understands that as of the date of this letter there
are no viableAccul& SARS-CoV-2 Test reage11tsremilining in distribution.in the UnitedStates,
ns.
The authorization lifa devit:efotemergency use under section SIM◊fthe Federal Fodd, btug,
and C9smetic Act (the.Act) (21 U:s. C, 360bl:>b03) may~ pun;uant fo section S64(g)(2) of the Act,
be revokedwhencircum,sfmlces )llaj(e such revocation 1tpproptiatetoptote~the public, health, or
safety (section564(gX2)(C)oftheAct), BecauseMesa:Siotech fno., through Thernto Fisher
Scientific,Jnc.,..has requested that FDA.revoke the EUA for theAccula SARS•CoV-2 Test, FDA
has de:tel'!llined.that: it is ¥fitopriate tq protect the public health.or safety to revoke this
authorization. Acc-ordingly, FD.1\herebyr¢vokes EUA200Q28 furtlie A9cul• SARS°CoV~'4'l'est,
pursuanito·section564(gX2).(C) oftheAct. As of the date ofthis letter, the Acoula SARS~CoV~2
Test is no longlalrauthorizedforernergencyuse by FDA.
Nqtice ofthisrevocati9n willbe published intheJtMeral.Regt:ster,. pursuant to section 564(h)(l)
ofthe.Acl
sliicerefy,
!Isl/
Dated: July 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
Notice; establishment of a
public docket; request for information
and comments.
ACTION:
[FR Doc. 2024–16345 Filed 7–24–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2024–N–2980]
Evaluating the Immunogenicity Risk of
Host Cell Proteins in Follow-On
Recombinant Peptide Products;
Establishment of a Public Docket;
Request for Information and
Comments
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
19:41 Jul 24, 2024
Jkt 262001
The Food and Drug
Administration (FDA or Agency) is
establishing a public docket to collect
information and comments on
evaluating and mitigating the
immunogenicity risk of host cell
proteins (HCPs). For the purpose of this
request, FDA is specifically interested in
comments on suitable methods to
detect, identify, and quantify HCPs, on
achievable residual amounts of HCPs for
recombinant peptide products, and on
the use of in vitro, in silico
immunogenicity assessment (IVISIA) of
HCPs in a recombinant peptide
(rPeptide) product. For the purpose of
this request, a ‘‘follow-on’’ peptide
product refers to the applications
SUMMARY:
BILLING CODE 4161–01–P
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
currently evaluated through the
505(b)(2) pathway. Although follow-on
recombinant peptide products can rely
on FDA’s findings of safety and
effectiveness for a listed drug that is a
peptide product, differences in
recombinant expression systems used
during the peptide production could
result in quality attribute differences,
including in the HCP profile, which in
turn, could contribute to differences in
immunogenicity risks between a followon recombinant peptide product and the
listed drug. The public comments
collected will help FDA develop
recommendations on how HCP control
and characterization can support
comparative immunogenicity risk
assessment between a recombinant
follow-on peptide and the listed
product.
E:\FR\FM\25JYN1.SGM
25JYN1
EN25JY24.001</GPH>
1effi-eyE. Shuren, M.D., J.D.
Director
center for Devices andRadiofogical Health
Food and Drug Administration
]]>Agencies
[Federal Register Volume 89, Number 143 (Thursday, July 25, 2024)]
[Notices]
[Pages 60435-60436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16345]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0150]
Revocation of Authorization of Emergency Use of In Vitro
Diagnostic Device for Detection and/or Diagnosis of COVID-19;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorization (EUA) (the Authorization)
issued to Mesa Biotech Inc., (a legal entity of Thermo Fisher
Scientific), for the Accula SARS-CoV-2 Test. FDA revoked the
Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
as requested by the Authorization holder. The revocation, which
includes an explanation of the reasons for revocation, is reprinted at
the end of this document.
DATES: The revocation of the Authorization for the Mesa Biotech Inc.'s
Accula SARS-CoV-2 Test is effective as of May 22, 2024.
ADDRESSES: Submit written requests for a single copy of the revocation
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 revocation may be sent. See the SUPPLEMENTARY
INFORMATION section for electronic access to the revocation.
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 March 23, 2020, FDA issued the Authorization to Mesa Biotech
Inc. (a legal entity of Thermo Fisher Scientific), for the Accula SARS-
CoV-2 Test, subject to the terms of the Authorization. Notice of the
issuance of this Authorization was published in the Federal Register on
June 5, 2020 (85 FR 34638), as required by section 564(h)(1) of the
FD&C Act.
Subsequent updates to the Authorization 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. Authorization Revocation Request
In a request received by FDA on May 15, 2024, Mesa Biotech Inc. (a
legal entity of Thermo Fisher Scientific), made by Thermo Fisher
Scientific, Inc. on behalf of Mesa Biotech Inc., requested the
revocation of, and on May 22, 2024, FDA revoked, the Authorization for
the Mesa Biotech Inc.'s Accula SARS-CoV-2 Test. Because Mesa Biotech
Inc., notified FDA that they discontinued the commercialization of the
Accula SARS-CoV-2 Test and requested FDA revoke Mesa Biotech Inc.'s
Accula SARS-CoV-2 Test, 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 Revocation
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 Mesa Biotech Inc.'s Accula SARS-CoV-2 Test. The
revocation in its entirety follows and provide an explanation of the
reasons for revocation, as required by section 564(h)(1) of the FD&C
Act.
[[Page 60436]]
[GRAPHIC] [TIFF OMITTED] TN25JY24.001
Dated: July 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16345 Filed 7-24-24; 8:45 am]
BILLING CODE 4161-01-P
