Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability, 61334-61335 [2022-21998]

Download as PDF 61334 Federal Register / Vol. 87, No. 195 / Tuesday, October 11, 2022 / Notices 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: SUPPLEMENTARY INFORMATION: I. Background Notice. The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Laboratorio Clinico Toledo for the Laboratorio Clinico Toledo SARS– CoV–2 Assay. 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. SUMMARY: The Authorization for the Laboratorio Clinico Toledo SARS–CoV– 2 Assay is revoked as of September 21, 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 DATES: khammond on DSKJM1Z7X2PROD with NOTICES 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, 301–796–8510 (this is not a toll-free number). VerDate Sep<11>2014 17:37 Oct 07, 2022 Jkt 259001 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 July 6, 2020, FDA issued an EUA to Laboratorio Clinico Toledo for the Laboratorio Clinico Toledo SARS–CoV–2 Assay, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on November 20, 2020 (85 FR 74346), 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 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 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 September 8, 2022, Laboratorio Clinico Toledo requested withdrawal of, and on September 21, 2022, FDA revoked, the Authorization for the Laboratorio Clinico Toledo SARS–CoV–2 Assay. Because Laboratorio Clinico Toledo notified FDA that Laboratorio Clinico Toledo has decided to no longer test using the Laboratorio Clinico Toledo SARS–CoV–2 Assay and requested FDA withdraw the EUA for the Laboratorio Clinico Toledo SARS–CoV–2 Assay, 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 Laboratorio Clinico Toledo for the Laboratorio Clinico Toledo 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\11OCN1.SGM 11OCN1 61335 Federal Register / Vol. 87, No. 195 / Tuesday, October 11, 2022 / Notices September 21, 2022 JJia M. T<iledQ. Garcia President& Director Laboratorio Clinico Toledo 51P.ahnast Atecibo .PR O(X,12 R~~ Revot:ation of EIJ:Al00207 Dear lliaM. Toledo Garcia: 'JJtlS: lmteris in resp.Qnse tQ the request fto111 Lab-Or:1¢0:tio CJinico 'l'oledp, received via email .pn September &, 2022, thatthe US .. Food. and Drug Administration{FDA) \'.\cithdraw the EUA for the Laboratorio Clinico Toledo SARS-CoVc2 Assay issued on July 6; :2020, and amended on Pecembet 28, 202J):, and Septembet 23, 202:L Laboratorio Clinico Toledb indicated in their email ®d cover letter that they are 11.p longer testing with fb,eLaborato.i:io CHnic.P Toled0: SARS 0 Cov:.2 As:i,ay ~d have none of the reagents .in stock in their faborat<>ty, The authorization of a device tor emergency use undet section 564 oftheFede:tal Food, Drug, and C0$11\etlc Act (the Act) {21 us.c. 360bbb·3) may, p:t)tsuantto sectiQn 564@(:2) 6ftheAct, be revo:ked W11en circµm:stiuwes !Uake· sttcll revocation appr0:pi:iatl'l to prQtect th,e p11blic h.ealth or safety (section 564(g)(2)(C) oftheAct). Because Laboratorio Clinico Toledo has notified FDA that it has dedded to no longer test-using tbeLaboratorio Clinico Toledo SARScCoV4 Assay and requested FDA withdraw the EUA f:otthe Laboratorio Cllnico Toledo SARS~CoV~2 Assay, IDA has determined that itis appropriate iQ protect the pi,iblic health or safety to revoke this authorization, Acc'->rdingly, FDA heret,y revokes EUA200207 forthe Labrnat.prio t:Iinico Toledo SARS-CoV -2 Assay, pursuant to section 564(gJ(2)(C) of the Act As ofthe date ofthis letter, the Labotatorio Clinfo.o Toledo SARS~CoV-2 Assay i:s no lortger authori1ed for emergency use by FPA Notice ofthis revocation will 1le pµbH$hed ln the FederatRegister, pµrs:q~t<> s~ti<>n 564(h.).(I) oftheAct. Isl NamandjeN, Bimip11S.Ph.D, ChiefScientist Food and Drug Administration [FR Doc. 2022–21998 Filed 10–7–22; 8:45 am] khammond on DSKJM1Z7X2PROD with NOTICES BILLING CODE 4164–01–C ACTION: Food and Drug Administration SUMMARY: [Docket No. FDA–2022–D–1253] Laser-Assisted In Situ Keratomileusis Lasers—Patient Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 17:37 Oct 07, 2022 Jkt 259001 Notice of availability; extension of comment period. DEPARTMENT OF HEALTH AND HUMAN SERVICES PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of July 28, 2022. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled ‘‘LaserAssisted In Situ Keratomileusis (LASIK) Lasers—Patient Labeling Recommendations.’’ The Agency is taking this action in response to requests for an extension to allow E:\FR\FM\11OCN1.SGM 11OCN1 EN11OC22.000</GPH> Dated: October 4, 2022. Lauren K. Roth, Associate Commissioner for Policy.

Agencies

[Federal Register Volume 87, Number 195 (Tuesday, October 11, 2022)]
[Notices]
[Pages 61334-61335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21998]



[[Page 61334]]

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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 Laboratorio Clinico Toledo for the Laboratorio Clinico Toledo 
SARS-CoV-2 Assay. 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 Laboratorio Clinico Toledo SARS-CoV-2 
Assay is revoked as of September 21, 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, 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. 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 July 6, 2020, FDA issued an 
EUA to Laboratorio Clinico Toledo for the Laboratorio Clinico Toledo 
SARS-CoV-2 Assay, subject to the terms of the Authorization. Notice of 
the issuance of this Authorization was published in the Federal 
Register on November 20, 2020 (85 FR 74346), 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 September 8, 2022, Laboratorio 
Clinico Toledo requested withdrawal of, and on September 21, 2022, FDA 
revoked, the Authorization for the Laboratorio Clinico Toledo SARS-CoV-
2 Assay. Because Laboratorio Clinico Toledo notified FDA that 
Laboratorio Clinico Toledo has decided to no longer test using the 
Laboratorio Clinico Toledo SARS-CoV-2 Assay and requested FDA withdraw 
the EUA for the Laboratorio Clinico Toledo SARS-CoV-2 Assay, 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 Laboratorio Clinico Toledo for the Laboratorio 
Clinico Toledo 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 61335]]

[GRAPHIC] [TIFF OMITTED] TN11OC22.000


    Dated: October 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21998 Filed 10-7-22; 8:45 am]
BILLING CODE 4164-01-C

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