48736 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 

BILLING CODE 4164–01–C 

Dated: August 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18777 Filed 8–30–21; 8:45 am] 

BILLING CODE 4164–01–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 Curative Inc. for the Curative 

SARS–Cov–2 Assay. FDA revoked the 

Authorization on July 15, 2021, under 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act), as requested by 

Curative Inc. on June 16, 2021. The 

revocation, which includes an 

explanation of the reasons for the 

revocation, is reprinted in this 

document. 

DATES: The Authorization for the 

Curative SARS–Cov–2 Assay is revoked 

as of July 15, 2021. 

ADDRESSES: Submit written requests 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) 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 

16, 2020, FDA issued the Authorization 

to Curative Inc. (original issuance to 

KorvaLabs, Inc. under the name 

Curative-Korva SARS–Cov–2 Assay). 

Notice of the issuance of the 

Authorization was published in the 

Federal Register on July 14, 2020 (85 FR 

42407), as required by section 564(h)(1) 

of the FD&C Act. The authorization of 

a device for emergency use under 

section 564 of the FD&C Act may, 

pursuant to section 564(g)(2)(C) of the 

FD&C Act, be revoked when 

circumstances make such revocation 

appropriate to protect the public health 

or safety. 

II. EUA Revocation Request of an In 

Vitro Diagnostic Device 

On June 16, 2021, Curative Inc. 

requested the revocation of, and on July 

15, 2021, FDA revoked, the 

Authorization for the Curative SARS– 

Cov–2 Assay. Because Curative Inc. 

notified FDA that it will no longer be 

using the Curative SARS–Cov–2 Assay 

as of July 15, 2021, and requested FDA 

revoke the authorization effective that 

day, 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/ and 

https://www.fda.gov/media/150773/ 

download. 

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 for the 

Curative SARS–Cov–2 Assay. 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
Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48737 

Dated: August 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18789 Filed 8–30–21; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Statement of Organization, Functions, 

and Delegations of Authority 

Part R (Health Resources and Services 

Administration) of the Statement of 

Organization, Functions and 

Delegations of Authority of the 

Department of Health and Human 

Services (60 FR 56605, as amended 

November 6, 1995; as last amended at 

86 FR 6344–6349 dated January 21, 

2021) is amended to reorganize sections 

of the Office of the Administrator, the 

Healthcare Systems Bureau, and the 

Bureau of Primary Health Care. 

Key functional changes include reestablishing, retaining and renaming the 

Healthcare Systems Bureau to the 

Health Systems Bureau; changing the 

name of the Office of Provider Support 

to the Provider Relief Bureau; changing 

the name of the Office of Regional 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.042</GPH>

t /l-... . . ■ lJ.S. FOOD & DRUG ' . E .ADMINISTRAT-ION 

July 15, 2021 

Fred Turner 

Chief Executive Officer 

Curative· Inc. 

1600 Adams Drive; Suite 105 

Menlo Park, CA 94025 

Re: Revocation ofEUA2(101l2 

Deiμ- Mr .. Turner:. 

This letteris in resporute to Curative• Inc.'s (Curative) requestdated June 16, 2021, that the U.S. 

fo<>d and Drag Administta:uon (FDA) revoke the Emergency Use Ao.thmiia:til:m {EUA:200132) 

for the Curative SARS-Cbv-2Assay iss.ued on April lG; 202(}, under the original nruneCurativeKorva SARS-Covs2 Assay, and amended on June. I 1, 2020. As was also announced in its June 

16, 2021 press-release,1 Curati-ve has indicated that it ls transitioning_ to the use of different BUAauthorized SARS-Co V-2 tests: forthe testing offered at its laboratories. In itsJune 16 letter, 

Curative requested that the revocation of the Curative SARS~Co:v-2 Assiiy bil effective July 1 s_, 

2021, notins th!l.t it will no longer be in use as of July 15, 2021. 

The authorization of a device for e:metgency use under section 564 ofihe Federal Food, Drug, 

artd Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuarttto $ection. 564(g)~) of the Act, 

be revoked when circumst!l.llces make such revocati011 appropriate to protect the pμ_blic health or 

safely (section 564(g)(2)(C) of theAcQ. Because Curative has notified FDA that it will no longer 

.be using the Curative SARS..:Cov _;2 Assay as ofJuly 15, 2021. and requests FDA revoke the 

authorization effective that da:y, FDA has deterllifued that it is: appropriate to protect the public 

healih or safecy to revoke Uris authoriza:fion. Accordingly, FDAherebyrevokes: EU:A.200132 for 

the Curative SARS-Cov-2 Assay, pursuant to section 564(g)(2)(C) ofthe Act, As e>fthe date of 

this letter, the Curative SARS_;Cov-2 A:ssiiy is no lon~er authorized for emergency use by FDA. 

Notice of this rev◊cation wm be published in the Fedc.ralRMistift, pursuant. to section 564(h)(l) 

oftheAct. 

Sincerely, 

·D· en•I.S·e· I\A. brgltalfysign~cfby . (,f_\fcl••Q~μi}~M, Hint.on ·S 

Hi nto n'L§:;:;;~•t~t;X.6~.5 

RADM Denise M. Hinton 

Chief Scientist 

Foctd and Drug Administration 

1 htrps)/www,prrtewswire.com/ne\VS"teletises/cura:tivecexpantls~testirig"OPtibilSctbr-covid"l9cffoctind:.:rsv-across-, 

nationwide-healthcare-delivery-network-30.1314095:.htnil