Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability, 71372-71374 [2024-19724]

Download as PDF 71372 Federal Register / Vol. 89, No. 170 / Tuesday, September 3, 2024 / Notices Instrument Interviews with program directors ........................................ Interviews with caseworkers ................................................ Focus groups with residents ................................................ Self-sufficiency matrix .......................................................... Service receipt questionnaire .............................................. 2023 Version—Semi-Annual Quantitative Report Mandatory Form .......................................................................... 2024 Version—Semi-Annual Quantitative Report Mandatory Form .......................................................................... 2023 Version—Semi-Annual Quantitative Report Optional Form ................................................................................. 2024 Version—Semi-Annual Report Optional Form ........... Quarterly Narrative PPR ...................................................... Estimated Total Annual Burden Hours: 1,411.5. Authority: Section 1110, Social Security Act, 42 U.S.C. 1310. Mary C. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2024–19695 Filed 8–30–24; 8:45 am] BILLING CODE 4184–24–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–N–0150] Revocation of Authorization of Emergency Use of 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 Roche Molecular Systems, Inc, for the cobas SARS-CoV–2 & Influenza A/B nucleic acid test for use on the cobas Liat System, that includes the cobas SARS-CoV–2 & Influenza A/B Quality Control Kit. FDA revoked the Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocation, which includes an explanation of the reasons for revocation, is reprinted at the end of this document. DATES: The revocation of the Authorization for the Roche Molecular Systems, Inc.’s for the cobas SARS-CoV– 2 & Influenza A/B nucleic acid test for use on the cobas Liat System, that includes the cobas SARS-CoV–2 & tkelley on LAP7H3WLY3PROD with NOTICES2 SUMMARY: VerDate Sep<11>2014 22:46 Aug 30, 2024 Jkt 262001 Total number of responses per respondent Total number of respondents Average burden hours per response 1 1 1 3 3 1.5 1 1.5 1.5 .25 27 36 157.5 3,060 510 9 12 52.5 1,020 170 3 4 3 36 12 15 3 3 135 45 1 5 18 4 3 6 3 3 2 12 45 216 4 15 72 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, radiological, or nuclear agent or 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 September 14, 2020, FDA issued the Authorization to Roche Molecular Systems, Inc, for the cobas SARS-CoV– 2 & Influenza A/B nucleic acid test for use on the cobas Liat System, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on Frm 00123 Fmt 4703 Annual burden hours 18 36 105 680 680 Influenza A/B Quality Control Kit is effective as of July 3, 2024. ADDRESSES: Submit written requests for a single copy of the revocation to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, 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: Kim Sapsford-Medintz, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3216, Silver Spring, MD 20993–0002, 301– 796–0311 (this is not a toll-free number). SUPPLEMENTARY INFORMATION: PO 00000 Total burden hours Sfmt 4703 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. Authorization Revocation Request In a request received by FDA on June 21, 2024, Roche Molecular Systems, Inc., requested the revocation of, and on July 3, 2024, FDA revoked, the Authorization for the Roche Molecular Systems, Inc.’s cobas SARS-CoV–2 & Influenza A/B nucleic acid test for use on the cobas Liat System, that includes the cobas SARS-CoV–2 & Influenza A/ B Quality Control Kit. Because Roche Molecular Systems, Inc., notified FDA that they have ceased the manufacture and distribution of the cobas SARSCoV–2 & Influenza A/B nucleic acid test for use on the cobas Liat System, that includes the cobas SARS-CoV–2 & Influenza A/B Quality Control Kit and requested FDA revoke Roche Molecular Systems, Inc.’s, cobas SARS-CoV–2 & Influenza A/B nucleic acid test for use on the cobas Liat System, that includes the cobas SARS-CoV–2 & Influenza A/ B Quality Control Kit, 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 U:\REGISTER\03SEN1.SGM 03SEN1 Federal Register / Vol. 89, No. 170 / Tuesday, September 3, 2024 / Notices revocations are 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 Roche Molecular Systems, Inc.’s cobas SARSCoV–2 & Influenza A/B nucleic acid test for use on the cobas Liat System, that includes the cobas SARS-CoV–2 & 71373 Influenza A/B Quality Control Kit. 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 July 3, 2024 Aradhana Karthikeyan Senior Manager Regulatory Affairs RA Functional Partner, molecular PoC Roche Molecular Systems. Inc. 4300 Hacienda Drive Pleasanton. CA 94588 Re: Revocation ofEUA201779 Dear Aradhana Karthikeyan: This letter is in response lo the request from Roche Molecular Systems. Inc.. in a letter dated June 21, 2024, that the U.S. Food and Drug Administration (FDA) revoke the EUA for the cobas SARS-Co V-2 & Influenza A/B nucleic acid test for use on the co bas Liat System, that includes the cobas SARS-CoV-2 & InfluenzaA/B Quality Control Kit, issued on September 14, 2020, and revised on September I 8, 2020, November 19, 2020, December I 0, 2020, May 7, 2021, May 14, 2021, June 24, 2021, September 23, 2021, January 6, 2022, March 25, 2022, August 11, 2022, October 26, 2022, February 16, 2023 and June 16, 2023. Roche Molecular Systems, Inc. indicated that they have ceased the manufacture and distribution of the cobas SARS-CoV-2 & Inlluenza A/B nucleic acid test for use on the cobas Liat System reagents for the EUA labeled product. that includes the cobas SARS-CoV-2 & Influenza A/B Quality Control Kit, and requested that the EUA be revoked. As of the date of this letter Roche Molecular Systems. Inc., has fully transitioned to the co bas SARS-Co V-2 & Influenza A/B Nucleic acid test for use on the cobas Liat System product that was cleared under K223591. FDA understands that as of the date of this letter Roche Molecular Systems, Inc. has ceased the manufacture and distribution of the cobas SARS-CoV-2 & Influenza A/B nucleic acid test for use on the cobas Liat System reagents, that also includes the cobas SARS-CoV-2 & Influenza A/B Quality Control Kit, for the EUA labeled product, but that there remains some viable EUA labeled product in distribution in the United States. VerDate Sep<11>2014 22:46 Aug 30, 2024 Jkt 262001 PO 00000 Frm 00124 Fmt 4703 Sfmt 4725 U:\REGISTER\03SEN1.SGM 03SEN1 EN03SE24.085</GPH> tkelley on LAP7H3WLY3PROD with NOTICES2 The authorization of a device for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may. pursuant to section 564(g)(2) of the Act. be revoked when circumstances make such revocation appropriate to protect the public health or safety (section 564(g)(2)(C) of the Act). Because Roche Molecular Systems, Inc. has requested that FDA revoke the EUA for the cobas SARS-CoV-2 & Influenza A/B nucleic acid test for use on the co bas Liat System, that includes the co bas SARS-Co V-2 & Influenza A/B Quality Control Kit, FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization. Accordingly, FDA hereby revokes EUA201779 for the cobas SARS-CoV-2 & Influenza A/B nucleic acid test for use on the cobas Liat System, pursuant to section 564(g)(2)(C) of the Act. As of the date of this letter, the cobas SARS-CoV-2 & Influenza A/B 71374 Federal Register / Vol. 89, No. 170 / Tuesday, September 3, 2024 / Notices P:age2nucleic acid test for use on the cobas Liat System, that includes the cobas SARS-Co V-2 & Influenza AIB Quality Control Kit, is no longer authorized for emergency rise hy FDA. A!>discµssed,FDA does nothave concerns with the use of any remaining viable inventory of the cobas SARS-Co V~2 & Influenza AIB nucleic acid test for use on the cobas Liat System, that includes the cobas SARS~Co y;;2 & Influenza A/B QualityControl Kit; that is the. EUA labeled product and that was distributed prior to revocation of the EUA, when such product.is used in conjunction with the cleared package insert/manufacturer instructions for use cleared as part of the J11ly 27, 2023 5l0(k.) cleared cobas. SARS-CoV~2& InfluenzaA/BNucleic acicltestforuse on the cobas Liatsystem, Importantly, the cobas SARS-Cov~2 & Influenza.A/BNucleic acid test for. use on the cobas Liat System pro.duct for which FDA had issued an EUA and the product fotwhich FDA has cleared under 510(k) are 1nanufacturedw1derthe same quality system with the same lot release criteria;. Roche Molecular Systems, Inc. should instruct customers who have remaining cobas SARS-Co W2 & Influenza AJBNucleic.acid testfor use on the cobas Liat System EUA labeled product inventory that they may use theirEUA product in combination with the package insert/manufacturer instructions for Use labeling associated with the 510(k.) clearance issued on July 27, 2023. Roche Moleculai' Systems, Inc. should also instruct customers who have remaining cdbas SARS-CoV-2& InfluenzaA/B QualityControl KitEllA product inventory that they may use their EUA product in combination.with the package insert/manufacturer instructions for use labeling associated. with the 5l0(k.) clearance on Jilly 27, 2023 and. that the cobas SARS-Co V-2 & Influenza A/B Quality Co11trol Kit EUA labeled product inventory may also be used in combination with the C◊bas SARSsCoV~2 & Influenza A/B nucleic acid test for use on. the cobas Liat System product, which FDA has cleared under 510(k), FDA encourages Roche Molecular Systems; Inc., to use all appropriate means,(e.g,, mail, email, or website link.)fo.notify affected customers ofthis EUArevocation and provide accessto the packageinsert/manufa:cturer instructions for use labeling associated with the 510(k) cleara.nce on July 27, 2023, Notice ofthis revocation will be published in the Federal Register., pursuant to section 564(h)(l) of the Act. Sincerely, !Js/l Dated: August 28, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–19724 Filed 8–30–24; 8:45 am] BILLING CODE 4164–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–3904] tkelley on LAP7H3WLY3PROD with NOTICES2 Identifying Priority Focus Areas for Future Guidance Development and Engagement With Interested Parties in Model-Informed Drug Development; Request for Information AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for Information. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) within the Food and SUMMARY: VerDate Sep<11>2014 22:46 Aug 30, 2024 Jkt 262001 PO 00000 Frm 00125 Fmt 4703 Sfmt 4703 Drug Administration (FDA or Agency) are announcing a request for information (RFI) for advancing modelinformed drug development (MIDD). The purpose of this request is to obtain feedback on how to increase application of established MIDD approaches in regulatory decision making, to identify how emerging MIDD approaches are being incorporated within drug product development, and to identify opportunities to enhance interactions with FDA when discussing MIDD approaches. We intend to use the information submitted in response to this request to identify and prioritize potential focus areas for future policy or guidance development and enhance engagement with interested parties, including interactions as part of the U:\REGISTER\03SEN1.SGM 03SEN1 EN03SE24.086</GPH> Jeffrey E. Shuren, M.D,, J;D, Director Centerfot DevicesandRadiologfoaI Health Food and t>rugAdrninistration

Agencies

[Federal Register Volume 89, Number 170 (Tuesday, September 3, 2024)]
[Notices]
[Pages 71372-71374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19724]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0150]


Revocation of Authorization of Emergency Use of 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 Roche Molecular Systems, Inc, for the cobas SARS-CoV-2 & 
Influenza A/B nucleic acid test for use on the cobas Liat System, that 
includes the cobas SARS-CoV-2 & Influenza A/B Quality Control Kit. FDA 
revoked the Authorization under the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) as requested by the Authorization holder. The 
revocation, which includes an explanation of the reasons for 
revocation, is reprinted at the end of this document.

DATES: The revocation of the Authorization for the Roche Molecular 
Systems, Inc.'s for the cobas SARS-CoV-2 & Influenza A/B nucleic acid 
test for use on the cobas Liat System, that includes the cobas SARS-
CoV-2 & Influenza A/B Quality Control Kit is effective as of July 3, 
2024.

ADDRESSES: Submit written requests for a single copy of the revocation 
to the Office of Policy, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
5431, 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: Kim Sapsford-Medintz, Office of 
Product Evaluation and Quality, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 3216, Silver Spring, MD 20993-0002, 301-796-0311 (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, radiological, or nuclear agent or 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 September 14, 2020, FDA issued the Authorization to Roche 
Molecular Systems, Inc, for the cobas SARS-CoV-2 & Influenza A/B 
nucleic acid test for use on the cobas Liat System, 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. Authorization Revocation Request

    In a request received by FDA on June 21, 2024, Roche Molecular 
Systems, Inc., requested the revocation of, and on July 3, 2024, FDA 
revoked, the Authorization for the Roche Molecular Systems, Inc.'s 
cobas SARS-CoV-2 & Influenza A/B nucleic acid test for use on the cobas 
Liat System, that includes the cobas SARS-CoV-2 & Influenza A/B Quality 
Control Kit. Because Roche Molecular Systems, Inc., notified FDA that 
they have ceased the manufacture and distribution of the cobas SARS-
CoV-2 & Influenza A/B nucleic acid test for use on the cobas Liat 
System, that includes the cobas SARS-CoV-2 & Influenza A/B Quality 
Control Kit and requested FDA revoke Roche Molecular Systems, Inc.'s, 
cobas SARS-CoV-2 & Influenza A/B nucleic acid test for use on the cobas 
Liat System, that includes the cobas SARS-CoV-2 & Influenza A/B Quality 
Control Kit, 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

[[Page 71373]]

revocations are 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 Roche Molecular Systems, Inc.'s cobas SARS-CoV-2 
& Influenza A/B nucleic acid test for use on the cobas Liat System, 
that includes the cobas SARS-CoV-2 & Influenza A/B Quality Control Kit. 
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
[GRAPHIC] [TIFF OMITTED] TN03SE24.085


[[Page 71374]]


[GRAPHIC] [TIFF OMITTED] TN03SE24.086


    Dated: August 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19724 Filed 8-30-24; 8:45 am]
BILLING CODE 4164-01-C
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