Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability, 2163-2167 [2022-00521]
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2163
Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Notices
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Manufactured Food Regulatory
Program Standards
OMB Control Number 0910–0601—
Extension
This information collection supports
FDA’s ‘‘Manufactured Food Regulatory
Program Standards’’ (2019) (https://
www.fda.gov/media/131392/download).
We recommend that States use these
program standards as the framework to
design and manage their manufactured
food programs. There are 44 State
programs currently enrolled in the
Manufactured Food Regulatory Program
Standards (MFRPS) under cooperative
agreements.
The goal of the MFRPS is to
implement a nationally integrated, riskbased, food safety system focused on
protecting public health. The MFRPS
establish a uniform basis for measuring
and improving the performance of
prevention, intervention, and response
activities of manufactured food
regulatory programs in the United
States. The development and
implementation of the standards will
help Federal and State programs better
direct their regulatory activities toward
reducing foodborne illness. For more
information we invite you to visit our
website at: https://www.fda.gov/federalstate-local-tribal-and-territorialofficials/regulatory-program-standards/
manufactured-food-regulatory-programstandards-mfrps.
FDA recommends that a State
program enrolled in the MFRPS use the
worksheets and forms contained in the
standards; however, alternate forms that
are equivalent may be used. The State
program maintains documentation
(guidance, procedures, documents, and
forms) required by the 10 standards,
which must be current and fit for use.
In the first year of implementing the
program standards, the State program
conducts a baseline self-assessment of
the documentation to determine if it
meets the elements of each standard.
The State program must participate in
additional verification audits in
subsequent years. After 5 years, FDA
will conduct a comprehensive program
audit of the documentation. As part of
the program audit, the auditor reviews
the records and supporting documents
required by the criteria in each standard
to determine if the self-assessment and
improvement plan accurately reflect the
State program’s level of conformance
with each of the standards. If the State
program fails to meet all program
elements and documentation
requirements of a standard, it develops
a strategic plan which includes the
following: (1) The individual element of
documentation requirement of the
standard that was not met, (2)
improvements needed to meet the
program element or documentation
requirement of the standard, and (3)
projected completion dates for each
task.
Description of Respondents:
Respondents are State Departments of
Agriculture or Health enrolled in the
MFRPS (State Governments).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Type of respondent; activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
State Governments; Development and reporting of data
consistent with MFRPS ....................................................
44
1
44
569
25,036
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Type of respondent; activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
State Governments; Maintenance of data records consistent with MFRPS ..........................................................
44
10
440
40
17,600
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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We have adjusted the number of
respondents to the information
collection to reflect the enrollment of an
additional State since our last
evaluation.
Dated: January 6, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–00559 Filed 1–12–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0973]
Revocation of Three Authorizations of
Emergency Use of In Vitro Diagnostic
Devices for Detection and/or Diagnosis
of COVID–19; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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The Food and Drug
Administration (FDA) is announcing the
revocation of the Emergency Use
Authorizations (EUAs) (the
Authorizations) issued to Becton,
Dickinson & Company (BD) for the
BioGX SARS–CoV–2 Reagents for BD
MAX System, Boston Medical Center for
the BMC–CReM COVID–19 Test, and
Akron Children’s Hospital for the Akron
Children’s Hospital SARS–CoV–2
Assay. FDA revoked these
Authorizations on December 8, 2021,
under the Federal Food, Drug, and
SUMMARY:
E:\FR\FM\13JAN1.SGM
13JAN1
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Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Notices
Cosmetic Act (FD&C Act). The
revocations, which include an
explanation of the reasons for each
revocation, are reprinted in this
document.
DATES: The Authorizations for the
BioGX SARS–CoV–2 Reagents for BD
MAX System, BMC–CReM COVID–19
Test, and Akron Children’s Hospital
SARS–CoV–2 Assay are revoked as of
December 8, 2021.
ADDRESSES: Submit written requests for
a single copy of the revocations to the
Office of Counterterrorism and
Emerging Threats, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4338, 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:
Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4332, Silver Spring, MD 20993–0002,
240–402–8155 (this is not a toll-free
number).
SUPPLEMENTARY INFORMATION:
jspears on DSK121TN23PROD 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,
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. On April
2, 2020, FDA issued an EUA to BD for
the BioGX SARS–CoV–2 Reagents for
VerDate Sep<11>2014
18:18 Jan 12, 2022
Jkt 256001
BD MAX System, 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.
On July 10, 2020, FDA issued an EUA
to Boston Medical Center for the BMC–
CReM COVID–19 Test, subject to the
terms of the Authorization. Notice of the
issuance of this Authorization was
published in the Federal Register on
November 20, 2020 (85 FR 74346), as
required by section 564(h)(1) of the
FD&C Act. On September 29, 2020, FDA
issued an EUA to Akron Children’s
Hospital for the Akron Children’s
Hospital SARS–CoV–2 Assay, subject to
the terms of the Authorization. Notice of
the issuance of this Authorization was
published in the Federal Register on
April 23, 2021 (86 FR 21749), 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. EUA Revocation Requests
On December 3, 2021, FDA received
a request from BD for the revocation of,
and on December 8, 2021, FDA revoked,
the Authorization for the BioGX SARS–
CoV–2 Reagents for BD MAX System.
Because BD notified FDA that BD
discontinued the sale of the authorized
product and requested FDA revoke the
Authorization, FDA has determined that
it is appropriate to protect the public
health or safety to revoke this
Authorization. On October 4, 2021 (and
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reconfirmed December 6, 2021), FDA
received a request from Boston Medical
Center for the revocation of, and on
December 8, 2021, FDA revoked, the
Authorization for the BMC–CReM
COVID–19 Test. Because Boston
Medical Center notified FDA that the
BMC–CReM COVID–19 Test is no longer
performed pursuant to the EUA and
requested FDA withdraw the
Authorization, FDA has determined that
it is appropriate to protect the public
health or safety to revoke this
Authorization. On December 3, 2021,
FDA received a request from Akron
Children’s Hospital for the revocation
of, and on December 8, 2021, FDA
revoked, the Authorization for the
Akron Children’s Hospital SARS–CoV–
2 Assay. Because Akron Children’s
Hospital notified FDA that it stopped
performing the Akron Children’s
Hospital SARS–CoV–2 Assay and
requested that FDA revoke the
Authorization, 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 Authorizations under
section 564(g)(2)(C) of the FD&C Act are
met, FDA has revoked the EUAs for
BD’s BioGX SARS–CoV–2 Reagents for
BD MAX System, Boston Medical
Center’s BMC–CReM COVID–19 Test,
and Akron Children’s Hospital’s Akron
Children’s Hospital SARS–CoV–2
Assay. The revocations in their entirety
follow and provide an explanation of
the reasons for each revocation, as
required by section 564(h)(1) of the
FD&C Act.
BILLING CODE 4164–01–P
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[FR Doc. 2022–00521 Filed 1–12–22; 8:45 am]
jspears on DSK121TN23PROD with NOTICES1
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
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552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
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: Surgical Sciences,
Biomedical Imaging and Bioengineering
Integrated Review Group; Clinical
Translational Imaging Science Study Section.
Date: February 17–18, 2022.
E:\FR\FM\13JAN1.SGM
13JAN1
EN13JA22.002</GPH>
Dated: January 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
2167
]]>Agencies
[Federal Register Volume 87, Number 9 (Thursday, January 13, 2022)]
[Notices]
[Pages 2163-2167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00521]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0973]
Revocation of Three Authorizations of Emergency Use of In Vitro
Diagnostic Devices 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 Authorizations (EUAs) (the
Authorizations) issued to Becton, Dickinson & Company (BD) for the
BioGX SARS-CoV-2 Reagents for BD MAX System, Boston Medical Center for
the BMC-CReM COVID-19 Test, and Akron Children's Hospital for the Akron
Children's Hospital SARS-CoV-2 Assay. FDA revoked these Authorizations
on December 8, 2021, under the Federal Food, Drug, and
[[Page 2164]]
Cosmetic Act (FD&C Act). The revocations, which include an explanation
of the reasons for each revocation, are reprinted in this document.
DATES: The Authorizations for the BioGX SARS-CoV-2 Reagents for BD MAX
System, BMC-CReM COVID-19 Test, and Akron Children's Hospital SARS-CoV-
2 Assay are revoked as of December 8, 2021.
ADDRESSES: Submit written requests for a single copy of the revocations
to the Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, 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: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002, 240-402-8155 (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, 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. On April 2, 2020, FDA issued an
EUA to BD for the BioGX SARS-CoV-2 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 June 5, 2020 (85
FR 34638), as required by section 564(h)(1) of the FD&C Act. On July
10, 2020, FDA issued an EUA to Boston Medical Center for the BMC-CReM
COVID-19 Test, subject to the terms of the Authorization. Notice of the
issuance of this Authorization was published in the Federal Register on
November 20, 2020 (85 FR 74346), as required by section 564(h)(1) of
the FD&C Act. On September 29, 2020, FDA issued an EUA to Akron
Children's Hospital for the Akron Children's Hospital SARS-CoV-2 Assay,
subject to the terms of the Authorization. Notice of the issuance of
this Authorization was published in the Federal Register on April 23,
2021 (86 FR 21749), 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. EUA Revocation Requests
On December 3, 2021, FDA received a request from BD for the
revocation of, and on December 8, 2021, FDA revoked, the Authorization
for the BioGX SARS-CoV-2 Reagents for BD MAX System. Because BD
notified FDA that BD discontinued the sale of the authorized product
and requested FDA revoke the Authorization, FDA has determined that it
is appropriate to protect the public health or safety to revoke this
Authorization. On October 4, 2021 (and reconfirmed December 6, 2021),
FDA received a request from Boston Medical Center for the revocation
of, and on December 8, 2021, FDA revoked, the Authorization for the
BMC-CReM COVID-19 Test. Because Boston Medical Center notified FDA that
the BMC-CReM COVID-19 Test is no longer performed pursuant to the EUA
and requested FDA withdraw the Authorization, FDA has determined that
it is appropriate to protect the public health or safety to revoke this
Authorization. On December 3, 2021, FDA received a request from Akron
Children's Hospital for the revocation of, and on December 8, 2021, FDA
revoked, the Authorization for the Akron Children's Hospital SARS-CoV-2
Assay. Because Akron Children's Hospital notified FDA that it stopped
performing the Akron Children's Hospital SARS-CoV-2 Assay and requested
that FDA revoke the Authorization, 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
Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA
has revoked the EUAs for BD's BioGX SARS-CoV-2 Reagents for BD MAX
System, Boston Medical Center's BMC-CReM COVID-19 Test, and Akron
Children's Hospital's Akron Children's Hospital SARS-CoV-2 Assay. The
revocations in their entirety follow and provide an explanation of the
reasons for each revocation, as required by section 564(h)(1) of the
FD&C Act.
BILLING CODE 4164-01-P
[[Page 2165]]
[GRAPHIC] [TIFF OMITTED] TN13JA22.000
[[Page 2166]]
[GRAPHIC] [TIFF OMITTED] TN13JA22.001
[[Page 2167]]
[GRAPHIC] [TIFF OMITTED] TN13JA22.002
Dated: January 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-00521 Filed 1-12-22; 8:45 am]
BILLING CODE 4164-01-C
