Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability, 16005-16006 [2022-05892]

Download as PDF Federal Register / Vol. 87, No. 54 / Monday, March 21, 2022 / Notices the size and composition of the RHC survey team and AAAASF’s comparable criteria on determining the parameters for each survey to be comparable to those of the State Survey Agency as outlined per § 488.5(a)(4). Dated: March 16, 2022. Lynette Wilson, Federal Register Liaison, Centers for Medicare & Medicaid Services. [FR Doc. 2022–05910 Filed 3–18–22; 8:45 am] BILLING CODE 4120–01–P B. Term of Approval Based on our review and observations described in section III. of this final notice, we approve AAAASF as a national accreditation organization for RHCs that request participation in the Medicare program. The decision announced in this final notice is effective March 23, 2022 through March 23, 2026. Due to travel restrictions and the reprioritization of survey activities brought on by the 2019 Novel Coronavirus Disease (COVID–19) Public Health Emergency (PHE), CMS was unable to observe an RHC survey completed by AAAASF surveyors as part of the application review process, which is typically one component of the comparability evaluation. Therefore, we are providing AAAASF with a shorter period of approval. Based on our discussions with AAAASF and the information provided in its application, we are confident that AAAASF will continue to ensure that its accredited RHCs will continue to meet or exceed the required standards. While AAAASF has taken actions based on the findings noted in section IV. of this final notice (Differences Between AAAASF’s Standards and Requirements for Accreditation and Medicare Conditions and Survey Requirements), as authorized under § 488.8, we will continue ongoing review of AAAASF’s RHC survey processes and will conduct a survey observation once the COVID– 19 PHE has expired. khammond on DSKJM1Z7X2PROD with NOTICES V. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). The Administrator of the Centers for Medicare & Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. VerDate Sep<11>2014 21:01 Mar 18, 2022 Jkt 256001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0412] Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device 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 revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Abbott Diagnostics Scarborough, Inc. (Abbott) for the BinaxNOW COVID–19 Ag Card 2 Home Test. FDA revoked this Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document. DATES: The Authorization for the BinaxNOW COVID–19 Ag Card 2 Home Test is revoked as of February 24, 2022. ADDRESSES: Submit a written request for a single copy of the revocation 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 revocation may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the revocation. 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: 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 All- PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 16005 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 March 31, 2021, FDA issued an EUA to Abbott for the BinaxNOW COVID–19 Ag Card 2 Home Test, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on July 23, 2021 (86 FR 39040), 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. EUA Revocation Request In a request received by FDA on February 21, 2022, Abbott requested revocation of, and on February 24, 2022, FDA revoked, the Authorization for the BinaxNOW COVID–19 Ag Card 2 Home Test. Because Abbott notified FDA that the EUA for BinaxNOW COVID–19 Ag Card 2 Home Test is no longer required and requested FDA revoke the EUA for the BinaxNOW COVID–19 Ag Card 2 Home 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 revocation is 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 Abbott for the BinaxNOW COVID–19 Ag Card 2 Home Test. The revocation in its entirety follows and provides an explanation of the reasons for revocation, as required by section 564(h)(1) of the FD&C Act. BILLING CODE 4164–01–P E:\FR\FM\21MRN1.SGM 21MRN1 16006 Federal Register / Vol. 87, No. 54 / Monday, March 21, 2022 / Notices Febr:uary 24, 2022 Angela Dfysdale VP, Regulatory Affaits AbbottDiagnqstics Scarborough, Inc; 10 Southgate Road Scarborough, ME04014 Re: Revocation ofEUA2l0272 Dear Ms. Drysdale: Tb:is letter is in response to the request from Ab tmtt Diagnostics Scarborough, Inc. ("Abbott"), received via email on February 21, 2022; that the U.S. Food and Drug Administration (FDA) revoke the EDA for the HinaxNOWCOVTD-l9AgCard2HorneTestisstted on March 31, 2021 and amended. on September23, 2021 a:ndJa:nmuy 7, 20:22. FDA understands no product-was distributed under the EDA Abbott indicated thatauthoi:ization of the Bina.ffeOW COVID-19 Ag Card2 Home Testis no longer required, in consideration of Abbott's product available under another BUA issued to Abbott Th.e authorization of a devi.ce for emergency ~se under section 564 ofthe FederaLFood, Drug, and Cosmetic Act (the Act)(21 U. S.C. 360hbb-3)may, J;>ursuantto section 564(g)(2) of the Act, be revokecl when circumstances make such revocation 11,tiJ;>rOJ:>riateto protect the public health or safety (sectiun. 564(g)(2)(C) of :Qie Act); BecauseAbhottlias notified FDAthatthe EUAfor Binax.NOW COVID-19 Ag Card 2 Home Test is no longer required and requested FDA revoke the BUA fat theBinaxNOW COVID-19 Ag Card 2Home Test, FDA has determined that it is approptiate to protect the public health or safety torevoke this authorization. Accordingly, FDA hereby revokes EUA2l02nfor theBinaxNOW COVID-19 Ag Catd 2 I:Iome'fest pttrsuantto section 564(g)(2)(C) ofthe Act. As of the date ofthis letter~ the Binax:N OW COVID~l 9 Ag Card 2 HomeTest is no longer authorized for emergency use by FDA Notice of this revocation wtll be published in the Federaf.kegisrter, pursuantto section 564(h)(l) of the Act. Sincerely, Isl Dated: March 15, 2022. Andi Lipstein Fristedt, Deputy Commissioner for Policy, Legislation, and International Affairs, U.S. Food and Drug Administration. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2022–05892 Filed 3–18–22; 8:45 am] [Docket No. FDA–2013–N–0093] BILLING CODE 4164–01–C Agency Information Collection Activities; Proposed Collection; Comment Request; New Molecular Entity New Drug Applications and Original Biologics License Applications Food and Drug Administration AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 21:01 Mar 18, 2022 Jkt 256001 PO 00000 Frm 00099 Fmt 4703 Sfmt 4703 ACTION: Notice. The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in SUMMARY: E:\FR\FM\21MRN1.SGM 21MRN1 EN21MR22.036</GPH> khammond on DSKJM1Z7X2PROD with NOTICES Jacqueline A. O'Shaugh:nessy, Ph.D. Actitig Chief Seientist Food and Drug Administration

Agencies

[Federal Register Volume 87, Number 54 (Monday, March 21, 2022)]
[Notices]
[Pages 16005-16006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05892]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Revocation of Authorization of Emergency Use of an 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 Abbott Diagnostics Scarborough, Inc. (Abbott) for the 
BinaxNOW COVID-19 Ag Card 2 Home Test. FDA revoked this Authorization 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The 
revocation, which includes an explanation of the reasons for 
revocation, is reprinted in this document.

DATES: The Authorization for the BinaxNOW COVID-19 Ag Card 2 Home Test 
is revoked as of February 24, 2022.

ADDRESSES: Submit a written request for a single copy of the revocation 
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 revocation may be sent. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the revocation.

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 March 31, 2021, FDA issued an 
EUA to Abbott for the BinaxNOW COVID-19 Ag Card 2 Home Test, subject to 
the terms of the Authorization. Notice of the issuance of this 
Authorization was published in the Federal Register on July 23, 2021 
(86 FR 39040), 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. EUA Revocation Request

    In a request received by FDA on February 21, 2022, Abbott requested 
revocation of, and on February 24, 2022, FDA revoked, the Authorization 
for the BinaxNOW COVID-19 Ag Card 2 Home Test. Because Abbott notified 
FDA that the EUA for BinaxNOW COVID-19 Ag Card 2 Home Test is no longer 
required and requested FDA revoke the EUA for the BinaxNOW COVID-19 Ag 
Card 2 Home 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 
revocation is 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 Abbott for the BinaxNOW COVID-19 Ag Card 2 Home 
Test. The revocation in its entirety follows and provides an 
explanation of the reasons for revocation, as required by section 
564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P

[[Page 16006]]

[GRAPHIC] [TIFF OMITTED] TN21MR22.036


    Dated: March 15, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation, and International Affairs, 
U.S. Food and Drug Administration.
[FR Doc. 2022-05892 Filed 3-18-22; 8:45 am]
BILLING CODE 4164-01-C

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