Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability, 48736-48737 [2021-18789]

Download as PDF 48736 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices BILLING CODE 4164–01–C 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. ADDRESSES: 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 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 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. SUMMARY: The Authorization for the Curative SARS–Cov–2 Assay is revoked as of July 15, 2021. khammond on DSKJM1Z7X2PROD with NOTICES DATES: VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 II. EUA Revocation Request of an In Vitro Diagnostic Device SUPPLEMENTARY INFORMATION: 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. I. Background III. Electronic Access 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) 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. FOR FURTHER INFORMATION CONTACT: [Docket No. FDA–2021–N–0412] 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. 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). PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 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 E:\FR\FM\31AUN1.SGM 31AUN1 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48737 /l-.. . .■ lJ.S. FOOD & DRUG t ' .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-CoV-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 1s_, 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 ChiefScientist Foctd and Drug Administration htrps)/www,prrtewswire.com/ne\VS"teletises/cura:tivecexpantls~testirig"OPtibilSctbr-covid"l9cffoctind:.:rsv-across-, nationwide-healthcare-delivery-network-30.1314095:.htnil Dated: August 26, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. khammond on DSKJM1Z7X2PROD with NOTICES [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 VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 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 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.042</GPH> 1

Agencies

[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Notices]
[Pages 48736-48737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18789]


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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 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 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) 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

[[Page 48737]]

[GRAPHIC] [TIFF OMITTED] TN31AU21.042


    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