Federal Register / Vol. 87, No. 54 / Monday, March 21, 2022 / Notices 16005 

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). 

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. 

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. 

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 

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 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: 

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 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 


khammond on DSKJM1Z7X2PROD with NOTICES
16006 Federal Register / Vol. 87, No. 54 / Monday, March 21, 2022 / Notices 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0093] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; New Molecular 

Entity New Drug Applications and 

Original Biologics License 

Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: 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 


khammond on DSKJM1Z7X2PROD with NOTICESEN21MR22.036</GPH>

Angela Dfysdale 

VP, Regulatory Aff aits 

AbbottDiagnqstics Scarborough, Inc; 

10 Southgate Road 

Scarborough, ME04014 

Re: Revocation ofEUA2l0272 

Dear Ms. Drysdale: 

Febr:uary 24, 2022 

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) of the 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 

Jacqueline A. O'Shaugh:nessy, Ph.D. 

Actitig Chief Seientist 

Food and Drug Administration