Document ID: FDA-2021-N-0412-0005
Agency: fda
Document Type: Notice
Title: Authorization and Revocations of Emergency Use of Certain In Vitro Diagnostic Devices for Detection and/ or Diagnosis of COVID–19; Availability
Posted Date: 2022-08-26T04:00Z

[Federal Register Volume 87, Number 165 (Friday, August 26, 2022)]
[Notices]
[Pages 52580-52584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18529]

[[Page 52580]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0412]

Authorization and Revocations of Emergency Use of Certain 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 
issuance of one, and revocation of three, Emergency Use Authorizations 
(EUAs) (the Authorizations) issued to STS Lab Holdco (a subsidiary of 
Amazon.com Services LLC) (``STS''). FDA issued one Authorization under 
the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by 
STS, for the Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2. 
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) that there is a public health emergency that has a 
significant potential to affect national security or the health and 
security of U.S. citizens living abroad, and that involves the virus 
that causes COVID-19, and the subsequent declaration on February 4, 
2020, that circumstances exist justifying the authorization of 
emergency use of in vitro diagnostics for detection and/or diagnosis of 
the virus that causes COVID-19, subject to the terms of any 
authorization issued under the FD&C Act. The Authorization, which 
includes an explanation of the reasons for issuance, is listed in this 
document, and further information can be accessed on FDA's website from 
the links indicated. FDA is also announcing the subsequent revocation 
of the Authorization issued to STS for the Amazon Real-Time RT-PCR DTC 
Test for Detecting SARS-CoV-2. In addition, FDA is announcing the 
revocation of the Authorizations issued to STS for the Amazon Multi-
Target SARS-CoV-2 Real-Time RT-PCR DTC Test and Amazon Multi-Target 
SARS-CoV-2 Real-Time RT-PCR Test. FDA issued and revoked the 
Authorizations under the FD&C Act. The revocations, which include an 
explanation of the reasons for each revocation, are reprinted in this 
document.

DATES: The Authorization for the Amazon Real-Time RT-PCR DTC Test for 
Detecting SARS-CoV-2 was effective May 28, 2021. The revocations for 
the Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2, Amazon 
Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test, and Amazon Multi-
Target SARS-CoV-2 Real-Time RT-PCR Test are effective as of July 19, 
2022.

ADDRESSES: Submit written requests for a single copy of the 
Authorization or 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 documents may be sent. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
documents.

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, 301-796-8510 (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. 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.

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 of the 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 the FDA 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 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 section 505, 510(k), 512, or 515 of the FD&C 
Act (21 U.S.C. 355, 360(k), 360b, or 360e) or section 351 of the PHS 
Act (42 U.S.C. 262), or

[[Page 52581]]

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), 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
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

III. Authorizations

    Having concluded that the criteria for the issuance of the 
Authorization under section 564(c) of the FD&C Act are met, on May 28, 
2021, FDA issued an EUA to STS for the Amazon Real-Time RT-PCR DTC Test 
for Detecting SARS-CoV-2, subject to the terms of the Authorization. 
Notice of the issuance of this Authorization is provided, as required 
by section 564(h)(1) of the FD&C Act.\3\
---------------------------------------------------------------------------

    \3\ An explanation of the reasons for issuance of the 
Authorization is provided, as required by section 564(h)(1) of the 
FD&C Act. As set forth in the EUA for the Amazon Real-Time RT-PCR 
DTC Test for Detecting SARS-CoV-2, FDA has concluded that (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition, 
including severe respiratory illness, to humans infected by this 
virus; (2) based on the totality of scientific evidence available to 
FDA, it is reasonable to believe that the Amazon Real-Time RT-PCR 
DTC Test for Detecting SARS-CoV-2 may be effective in diagnosing 
COVID-19, and that the known and potential benefits of the Amazon 
Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 when used for 
diagnosing COVID-19, outweigh the known and potential risks of the 
Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2; and (3) 
there is no adequate, approved, and available alternative to the 
emergency use of Amazon Real-Time RT-PCR DTC Test for Detecting 
SARS-CoV-2.
---------------------------------------------------------------------------

    On August 11, 2021, FDA issued EUAs to STS Lab Holdco for the 
Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test and Amazon 
Multi-Target SARS-CoV-2 Real-Time RT-PCR Test, subject to the terms of 
the respective Authorizations. Notice of the issuance of these 
Authorizations was published in the Federal Register on October 28, 
2021 (86 FR 59738), 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).

IV. EUA Revocation Requests

    On July 11, 2022, STS Lab Holdco requested revocation of, and on 
July 19, 2022, FDA revoked, the Authorizations for the Amazon Real-Time 
RT-PCR DTC Test for Detecting SARS-CoV-2, Amazon Multi-Target SARS-CoV-
2 Real-Time RT-PCR DTC Test, and Amazon Multi-Target SARS-CoV-2 Real-
Time RT-PCR Test. Because STS Lab Holdco has notified FDA that there is 
no viable (non-expired) Amazon Real-Time RT-PCR DTC Test for Detecting 
SARS-CoV-2, Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test, 
or Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test remaining in 
distribution in the United States and requested FDA revoke the 
Authorizations for these devices, FDA has determined that it is 
appropriate to protect the public health or safety to revoke these 
Authorizations.

V. 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/. The full text of the Authorization, including any 
revisions, and of the revocations and can be accessed from the FDA web 
page available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information.

VI. 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 STS Lab Holdco's Amazon Real-Time RT-PCR DTC 
Test for Detecting SARS-CoV-2, Amazon Multi-Target SARS-CoV-2 Real-Time 
RT-PCR DTC Test, and Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR 
Test. 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 52582]]

[GRAPHIC] [TIFF OMITTED] TN26AU22.007

[[Page 52583]]

[GRAPHIC] [TIFF OMITTED] TN26AU22.008

[[Page 52584]]

[GRAPHIC] [TIFF OMITTED] TN26AU22.009

    Dated: August 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18529 Filed 8-25-22; 8:45 am]
BILLING CODE 4164-01-C