Authorization and Revocations of Emergency Use of Certain In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability, 52580-52584 [2022-18529]

Download as PDF 52580 Federal Register / Vol. 87, No. 165 / Friday, August 26, 2022 / Notices 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. 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 RealTime 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 lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:46 Aug 25, 2022 Jkt 256001 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 MultiTarget 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 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. With this EUA authority, FDA can help ensure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or lifethreatening 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 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 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. 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 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. E:\FR\FM\26AUN1.SGM 26AUN1 Federal Register / Vol. 87, No. 165 / Friday, August 26, 2022 / Notices 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 wellcontrolled 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 lifethreatening 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 lotter on DSK11XQN23PROD with NOTICES1 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. VerDate Sep<11>2014 17:46 Aug 25, 2022 Jkt 256001 52581 III. Authorizations IV. EUA Revocation Requests 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 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). 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 RealTime 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. 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 lifethreatening 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. PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 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-policyframework/emergency-useauthorization-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 E:\FR\FM\26AUN1.SGM 26AUN1 52582 Federal Register / Vol. 87, No. 165 / Friday, August 26, 2022 / Notices July 19, 2022 Jon Nakam1:>to Amazon.com ServicesLLC do Amazofi Legal Dept 410 Tetcy Ave. N.. Sel,\ttle; WA 98109 Re: Revocation. ofEUA21DJ08 This letter is in r~ponse to a reguesifrom STS Lab Holdco (a su!)sidiary or Amazon.com Services LLC),. received July 11, 2022, that the U.S. Food and Drug Administration (FDA) revoke the :EUA for the AtnazonReal-'!iroe RT-PCR DTC Test fotDeteeting SARS•CoV-2 iss.ued oi1 May 28, 2021, t1a0 fssued.on Janua~• 26, 2022, and amended ott December 17, 2021 . .FDA understands there is no viable (non-ex:pire'(l) Amazon Real-Trme RT-PCR DTC J:est for Detecting SARS-CoV~2 remaining in distribution in the United States, The authorization of a de:vtce for emergency'1Se JJnder section 564 nfthe Federal 'FCifid, Drug, and Cosmetic Act (theAct) (2111,s.c: 360bhb-3) may; pursuant to section 564{g)(2) of the Act, be revoked when circumstances make such revocation appropriate to protect the public health or safety. Because STS U:bHoldco .(a subsidiary of Amazon.com Services LLCJhas notified FDA tbatthere is n() viable {n◊n~xpired) Amaz.on ReaFTitne Rt'-P.CR. DTC Testfor Detecting SARS-CoV-2 remllining in distribtttionin·the Uniteli Sla,tes 1'1lld requested FDA revoke the authorization of the Amazon Real-Time RT-PGR DJ:C Test for Detecting SARS.Co\t-2, .FDA has determined that it.is appr:npriate to protect the public health or safety tb tevolce this autbori:r.ation" Accotdingly, FDA hetel>y revokes E1JA2103'08 for the Amazon Real-Time RT-PCR DTC Test for Detecting SARs:.cov~2, pursuant to l!ection564(g)(2)(C) ofthe Acl As. of the date of this letter, the Amazon Real-Time RT-PCRDTC Testfor Detecting SARS-CoV-2 is hOfo:nget authorizedf&t emergency use by FDA. Notice ◊f this" revocation will be published in: the Federt:1l Re:g,lsl'ff, porsuanlto secl.ion 564(h)(1) oftheAcL · JacqueUrteA Q'Shaugl:messy. Ph.D. Acting Clrief Scienti$t VerDate Sep<11>2014 16:59 Aug 25, 2022 Jkt 256001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4725 E:\FR\FM\26AUN1.SGM 26AUN1 EN26AU22.007</GPH> lotter on DSK11XQN23PROD with NOTICES1 Food and Drug Administration Federal Register / Vol. 87, No. 165 / Friday, August 26, 2022 / Notices 52583 July 19, 2022 Jon Nakatn◊to Amaz.on..com Servi'ces LLC Cleo Amazon Legal Dept 4l0'tetryAve. N. Se!:\ttlf;l, WA 98109 Re:: Revocation ofEUA210480 This fetter is in response to a reqqest from STS Lab Holdco (a subsidiary of .Amazon.Qom SerVices tLC), receiYed July 11, 2022, that the U.S. Food andJ)rug Administration (FDA) tetokethe :EDA for the AmazonMultf.:rarget S.ARS•CoV-2 n.ea1..:ume Rt-PCitDtc. Test issued ol'.I Augqst l h 2021, re,-Jssued on January 26; 2Q22, and qpdated on December 1'J, 2021. FDA µnderstands thf;lre .is no viable (non•expired} Amazon M11lti-'J"'.arget SARs-..:coV-2 RealTime RT~ PCR. btC test remaining in distrlbuti:on in the United States. The autho:t:ization of a device for emergency qse µnder section 5(i4 qfthe Federal Food, Drug, tUIQ Co~eiic A-0t (theAct) (21 U.$..C. 360bbb--3) may, pnrsUtUitto section 564(~)(2)oftheAct, be .revoked when circumstances make such revocation appropriate to proteclt the pub1ic health or safety; Because sts Lab ll:oldco (a subsidiary of Amazon,com Services LLC)has notified FDA lh.atlh.ere is no viable (nons~pired) Amazon. Multi-Target SAAS~COV-2: Real.'fittte.RT-PCR DTC Test rermrlning in distribution in the United States and, requested FDA revoke lh.e authorization ofthe Amazon Multi-Target SARS--CoV-2Real~time RT-PCR DIC Test, FDA has determined that it is appropriate to protecttbe public health or.safety t() revoke this autn◊nzati◊n, Acc()tdingJy; FDA hereby revo~es EUA:210480 for the Arna1on Mtiltt•Target SARS-CoV-2 Real'"Time RT-PCR DTC Test pt1rsuantto secti-011564{g)(2)(C) oftheAct As of the date of:this letter:, ihe Amazon Multi-Target SARS.aCoV-2. Real-Time RT-PCR DTC Testis no longer authorized for emergency use by FDA Notice ◊£ 1h.i$ revocation will be published in the Pederql R:egWer, pursuantt◊ section 564(h)O) oftheAct. ls/ Jacqueline A. Q'Shaughnessy, Ph.D. Acting Chief Scienlist VerDate Sep<11>2014 16:59 Aug 25, 2022 Jkt 256001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4725 E:\FR\FM\26AUN1.SGM 26AUN1 EN26AU22.008</GPH> lotter on DSK11XQN23PROD with NOTICES1 Food and Drug Administratlon 52584 Federal Register / Vol. 87, No. 165 / Friday, August 26, 2022 / Notices July 19, 2022 Jon NakatnOlO Amazon.com :Services LLC c/o Amazon Legal I>ept 410 T¢t:ry Ave. N. Sel\ttle, WA 98lQ9 Re: Revocation ofEUA2l0481 This letter is in response to areguesl from STS Lab H6ldco (a: subsidiary ofAmazon,com :Services LLC),. received July 11, 2022, that the U.S. Food and.Drug Administration (FDA) revoke the :BUA forthe Amaz()nMuitM"trrget SMS-Cov:.2 Realmrne RT-PCRTest issued on August 1.1, 2()21; lifid amendedcmPe:cember 17; -2021, lifidJanuary 26, 2022, FDA @derstands thereis no viable (non-expired) Amazon.Multi~Targ~ SAR:Sa(;.oV-2 Real-Time RT-PCR Test remaining in distribution in the United States. Thea11thorizat:fon of: a de-vice for emergency U$e under section $64 of the Federal Food, Drugi and Cosmetic Act (theA:ct) (21 U.S:C, 360bbb-3) may, purswm:t to secti:Qn 564(g)(2) of theAGt, be revoked when circumstances make such revocation appropriate to protect the public health or safety:. aecaU$e STS Lab.Holdco {a subsidiary of Amazoo..com Services LLC)has notified FDA that I.here is M viable (JW.tkei\pired) Amaz;on Mulii"Target SAR.S.,CoW2 Real•T:imeRT-PCR Test remaining in distribu1.ic>n in .lhe United States and requested FDA revok!) tlu, aulhQrizaliQn of the Amazon Multi-Target SAR.S.,CoV-2 Real-TuneRT;_J>CR Test, FDA has determined that it i.s appropriate to protect the publi:c health ot safety to revoke th.is amhorization. Accordingly, FDA hereby revokes EtJA2.104:81. fottbe ArnazonMulti•Target SARS~CoW2 Real-Time RT• PCR Test; purs~antto sectipn 564(g)(2)(C}ofthe Act As of the di.ife of this letter, the Amazon Multi-Target SARS-CoV-2 Re~Tme RT.,PCR Test is no longer authorized for emergency use byf'OA. Notice of I.his revocation wUl be published in lhe b.e:rJen:.il 8.egtsler, pursuantto section S64.(b)(J) oftheAcL Isl JaGqu:eline A. Q'Shaugbttessy, Ph.D. Acting Chief Sc.ienti;st Food and Drug Administration [FR Doc. 2022–18529 Filed 8–25–22; 8:45 am] lotter on DSK11XQN23PROD with NOTICES1 BILLING CODE 4164–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS–0990–0407–30D] Agency Information Collection Request. 30-Day Public Comment Request Office of the Secretary, HHS. Notice. AGENCY: ACTION: In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the SUMMARY: VerDate Sep<11>2014 16:59 Aug 25, 2022 Jkt 256001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Comments on the ICR must be received on or before September 26, 2022. DATES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular ADDRESSES: E:\FR\FM\26AUN1.SGM 26AUN1 EN26AU22.009</GPH> Dated: August 22, 2022. Lauren K. Roth, Associate Commissioner for Policy.

Agencies

[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]]

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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.
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    \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.
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    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

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    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

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