Revocation of Six Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability, 20211-20218 [2024-05980]

Download as PDF Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices in TAP processes and operations. All TAP Pilot participants will make up the potential group of respondents for the interviews, however, FDA intends to interview only a stratified sample of all potential participants. In addition, around 60 manufacturers will be interviewed after completing an application to participate. TAP Pilot Participant Pulse Surveys FDA seeks to obtain quantitative satisfaction ratings and free-response data from TAP Pilot participants using a 2-question survey deployed closely following TAP Pilot interactions (e.g., teleconferences, written feedback). The same pulse survey will be administered after each interaction. The purpose of these surveys is to measure level of satisfaction with the interaction and allow for an opportunity for participants to provide feedback regarding the interaction. Manufacturers will also be surveyed one additional time per year just to gauge satisfaction over time with their experience interacting with FDA. This equates to 254 burden hours per year (rounded). To supplement the data collection methods listed above, FDA would like to obtain interaction-related data by passively observing meetings among FDA staff, applicants, and external stakeholders. We plan to use an internal structured observational meeting form or checklist to standardize data collection. The purpose of these observations is to evaluate meeting attendance, level of collaboration, and the degree to which key processes and activities are being adhered. Data collected may also support identification of improvement opportunities to the TAP Pilot. We do not intend to actively collect this information from meeting participants directly (e.g., by asking questions or collecting documents). Dated: March 15, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–05970 Filed 3–20–24; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration lotter on DSK11XQN23PROD with NOTICES1 [Docket No. FDA–2024–N–1091] Revocation of Six Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID–19; Availability Food and Drug Administration, HHS. VerDate Sep<11>2014 16:53 Mar 20, 2024 Notice. The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Life Technologies Corp. (a legal entity of Thermo Fisher Scientific, Inc.), for the TaqPath COVID–19 Pooling Kit; Bio-Rad Laboratories, Inc., for the Reliance SARS–CoV–2 RT–PCR Assay Kit; Revvity, Inc., (on behalf of Revvity Omics (a Revvity, Inc. company that was a rebranding of PerkinElmer Genomics)), for the PerkinElmer SARS– CoV–2 RT–qPCR Reagent Kit; bioMe´rieux SA for the VIDAS SARS– CoV–2 IgM kit; bioMe´rieux SA for the VIDAS SARS–CoV–2 IgG kit; and Luminex Corp. for the xMAP SARS– CoV–2 Multi-Antigen IgG Assay. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document. DATES: The Authorization for the Life Technologies Corp.’s (a legal entity of Thermo Fisher Scientific, Inc.) TaqPath COVID–19 Pooling Kit is revoked as of January 16, 2024. The Authorization for the Bio-Rad Laboratories, Inc.’s Reliance SARS–CoV–2 RT–PCR Assay Kit is revoked as of January 16, 2024. The Authorization for the Revvity, Inc.’s (on behalf of Revvity Omics (a Revvity, Inc. company that was a rebranding of PerkinElmer Genomics)) PerkinElmer SARS–CoV–2 RT–qPCR Reagent Kit is revoked as of January 30, 2024. The Authorization for the bioMe´rieux SA’s VIDAS SARS–CoV–2 IgM kit is revoked as of January 31, 2024. The Authorization for the bioMe´rieux SA’s VIDAS SARS–CoV–2 IgG kit is revoked as of January 31, 2024. The Authorization for the Luminex Corp.’s xMAP SARS–CoV–2 Multi-Antigen IgG Assay is revoked as of February 22, 2024. SUMMARY: Submit written requests for a single copy of the revocations 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 revocations may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the revocations. FOR FURTHER INFORMATION CONTACT: Kim Sapsford-Medintz, Office of Product ADDRESSES: BILLING CODE 4164–01–P AGENCY: ACTION: Jkt 262001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 20211 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 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 May 25, 2021, FDA issued the Authorization to Life Technologies Corp. (a legal entity of Thermo Fisher Scientific, Inc.), for the TaqPath COVID– 19 Pooling Kit, 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 at 39043), as required by section 564(h)(1) of the FD&C Act. On January 15, 2021, FDA issued the Authorization to Bio-Rad Laboratories, Inc., for the Reliance SARS–CoV–2 RT– PCR Assay Kit, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on April 23, 2021 (86 FR 21549 at 21751), as required by section 564(h)(1) of the FD&C Act. On April 12, 2021, FDA issued the Authorization to PerkinElmer Genomics, (Revvity, Inc. (Revvity Omics, a Revvity, Inc. company that was a rebranding of PerkinElmer Genomics)) for the PerkinElmer SARS–CoV–2 RT– qPCR Reagent Kit, 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 at 39042), as required by section 564(h)(1) of the FD&C Act. On August 6, 2020, FDA issued the Authorization to bioMe´rieux SA for the VIDAS SARS–CoV–2 IgM kit, 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 at 74350), as required by section 564(h)(1) of the FD&C Act. On August 6, 2020, FDA issued the Authorization to bioMe´rieux SA for the E:\FR\FM\21MRN1.SGM 21MRN1 20212 Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices VIDAS SARS–CoV–2 IgG kit, 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 at 74350), as required by section 564(h)(1) of the FD&C Act. On July 16, 2020, FDA issued the Authorization to Luminex Corp. for the xMAP SARS–CoV–2 Multi-Antigen IgG 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 at 74350), as required by section 564(h)(1) of the FD&C Act. Subsequent updates to the Authorizations 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). lotter on DSK11XQN23PROD with NOTICES1 II. Authorizations Revocation Requests In a request received by FDA on November 13, 2023, Life Technologies Corp. (a legal entity of Thermo Fisher Scientific, Inc.), requested the revocation of, and on January 16, 2024, FDA revoked, the Authorization for the Life Technologies Corp.’s (a legal entity of Thermo Fisher Scientific, Inc.) TaqPath COVID–19 Pooling Kit. Because Life Technologies Corp. notified FDA that they are no longer commercially supporting the TaqPath COVID–19 Pooling Kit and requested FDA revoke the Authorization for Life Technologies Corp.’s TaqPath COVID–19 Pooling Kit, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. In a request received by FDA on January 7, 2024, Bio-Rad Laboratories, Inc., requested the revocation of, and on January 16, 2024, FDA revoked, the VerDate Sep<11>2014 16:53 Mar 20, 2024 Jkt 262001 Authorization for Bio-Rad Laboratories, Inc.’s Reliance SARS–CoV–2 RT–PCR Assay Kit. Because Bio-Rad Laboratories, Inc. notified FDA that they have ceased U.S. distribution of the BioRad Reliance SARS–CoV–2 RT–PCR Assay Kit and requested FDA revoke the Authorization for Bio-Rad Laboratories, Inc.’s Reliance SARS–CoV–2 RT–PCR Assay Kit, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. In a request received by FDA on January 19, 2024, Revvity, Inc. (on behalf of Revvity Omics (a Revvity, Inc. company that was a rebranding of PerkinElmer Genomics)), requested the revocation of, and on January 30, 2024, FDA revoked, the Authorization for the Revvity, Inc.’s PerkinElmer SARS–CoV– 2 RT–qPCR Reagent Kit. Because Revvity, Inc. notified FDA that they have discontinued use of the PerkinElmer SARS–CoV–2 RT–qPCR Reagent Kit at the Revvity Omics laboratory, and requested FDA revoke the Authorization for Revvity, Inc.’s PerkinElmer SARS–CoV–2 RT–qPCR Reagent Kit, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. In a request received by FDA on January 22, 2024, bioMe´rieux SA, requested the revocation of, and on January 31, 2024, FDA revoked, the Authorization for the bioMe´rieux SA’s VIDAS SARS–CoV–2 IgM kit. Because bioMe´rieux SA notified FDA that they will no longer commercially support the authorized product, and requested FDA revoke the Authorization for bioMe´rieux SA’s VIDAS SARS–CoV–2 IgM kit, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. In a request received by FDA on January 22, 2024, bioMe´rieux SA, requested the revocation of, and on January 31, 2024, FDA revoked, the Authorization for the bioMe´rieux SA’s VIDAS SARS–CoV–2 IgG kit. Because bioMe´rieux SA notified FDA that they PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 will no longer commercially support the authorized product, and requested FDA revoke the Authorization for bioMe´rieux SA’s VIDAS SARS–CoV–2 IgG kit, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. In a request received by FDA on February 19, 2024, Luminex Corp., requested the withdrawal of, and on February 22, 2024, FDA revoked, the Authorization for the Luminex Corp.’s xMAP SARS–CoV–2 Multi-Antigen IgG Assay. Because Luminex Corp. notified FDA that they have discontinued the manufacture of the authorized product, and requested FDA revoke the Authorization for Luminex Corp.’s xMAP SARS–CoV–2 Multi-Antigen IgG 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 revocations are available on the internet at https://www.regulations.gov/. IV. The Revocations Having concluded that the criteria for revocation of the Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA has revoked the EUA of Life Technologies Corp.’s (a legal entity of Thermo Fisher Scientific, Inc.) TaqPath COVID–19 Pooling Kit, Bio-Rad Laboratories, Inc.’s Reliance SARS– CoV–2 RT–PCR Assay Kit, Revvity, Inc.’s (on behalf of Revvity Omics (a Revvity, Inc. company that was a rebranding of PerkinElmer Genomics)) PerkinElmer SARS–CoV–2 RT-qPCR Reagent Kit, bioMe´rieux SA’s VIDAS SARS–CoV–2 IgM kit, bioMe´rieux SA’s VIDAS SARS–CoV–2 IgG kit, and Luminex Corp.’s xMAP SARS–CoV–2 Multi-Antigen IgG Assay. The revocations in their entirety follow and provide 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\21MRN1.SGM 21MRN1 Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices 20213 U.S. FOOD & DRUG il\PMll'IIST!tArlON January 16, 2024 Stacy Drakousis, Sr. Manager, Regulatory Affairs. Thenno Fisher Soientifio, Inc. 5781 Van Allen Way Carlsbad, CA 92008 Re: Re'il"ocation ofEUA202924 Pear Stl\cy Drakousis: This letter is in response to the request from Life Techhologies Corporation (a legal entity of Thetmo Fisher Scientific, Inc.), in a letter dated November 13, 2023; that the U.R Food ahd Drug Administrntion (FDA) revoke the EU A for the TaqPath COVID-19 Pooling Kit issued on May 25, 2021, a11d amended on September 23,.2021, and May 31, 2023. The.nno Fisher Scientific, hie. indicated that they are no longer commercially supporting the TaqPath COVID19 Pooling Kit and requested that tl1e EUA be revoked. FDA understands tllat as of the date of this letter there will 110 longer be any viable TaqPatl1 COVID- 19 Pooling Kit t·eagents remaining in distribution in the United States. • TI1e authorization of a device for emergency use under section 564 of the Federnl Food, Drug, and Cosmetic Act (the Act) (21 tr.KC. 360bbb-3) may; pursuant to section 564(g)(2) ofthe.Act, be revoked when circumstances make such revocatio11 appropriate to protect the public health or safety (sectio11 564(g)(2)(C) of the Act). Because Thermo Fisher Scientific, hie. has requested tllat FDA revoke ilie EUA for tl1e TaqPaili COVID~ 19 Pooling Kit, FDA has determi11ed that it is appropriate to protect. the public health or safety to revoke this authorization. Accordingly, FDA hereby revokes EUA202924 for the TaqPa:th COVID•19 Pooli11g Kit; pursuant to section S64(g)(2)(C) of the Act. As of the date of this letter, the TaqPath COVID-19 Pooli11g Kit is no longer autl1orized for emergency use by FDA. Notice ofthis revocatio11 will be published iiHheFederal Register; pursuant to section 564(h)(l) of the Act. Sincerely, l!s!I VerDate Sep<11>2014 16:53 Mar 20, 2024 Jkt 262001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4725 E:\FR\FM\21MRN1.SGM 21MRN1 EN21MR24.000</GPH> lotter on DSK11XQN23PROD with NOTICES1 Jeffrey E. Shuren, M.D., J.D. Director Center for Devices a11d Radiological Health Food and Drug Administration 20214 Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices ■ U.S. FOOD & DRUB APMINIS:i'IIATION January 16, 2024 Elizabeth .Platt,. FAD,. MS V.P., Regulatory & ClinicalAffairs .Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94547 Re: Revocation of EUAZ02864 Dear Dr. Platt: This letter is in response to the request from Bio-Rad Laboratories, Inc., in a letter dated January 7, 2024, that the U.S. Food and Drug Administration (FDA) revoke the EUA for the Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit issued on January 15, 2021, and amended on May 11, 2021, September 23, 2021, and October 25~ 2022. Bio-Rad.Laboratories, Inc. indicated that they have cea<ied United States (U.S.) distributio11 ofthe Bio-Rad Reliance. SARS-CoV-2 RTPCR Assay Kit and requested that the EUA be revoked. FDA understands that as of the date of this letter there will no longer be any viable Bio-Rad Reliance .SARS-CoV-2 RT-PCR Assay Kit reagents remaining in distribution in the U.S. The authorization ofa device for emergency use under section 564 pf 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 protectthe public health or safety (section 564(gX2)(C) of the Act). Because Bio-Rad Laboratories, Inc. has requested that FDA revoke the EUA for the Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit, FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization. Accordingly, FDA hereby revokes EUA202864 for the Bio-Rad Reliance SARS-Co V-2 RT-PCR Assay Ki½.pursuant to section 564(g)(2)(C)ofthe Act. As of the date ofthis letter, the Bi~Rad Reliance SARS-CoV•2 RT•PCR Assay Kit is 110 tonger authorized fotemergency use by FDA. Notice of this revo.cation will be published in the Federal Register; pursuant to section. 564(h)(l) oftheAct. Sincerely, Ifs/I VerDate Sep<11>2014 16:53 Mar 20, 2024 Jkt 262001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4725 E:\FR\FM\21MRN1.SGM 21MRN1 EN21MR24.001</GPH> lotter on DSK11XQN23PROD with NOTICES1 Jeffrey E. Shµ('en, M.D., J.D. Director Center for Devices and Radiological Health Food and Drug Admi.t'iistration Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices 20215 u~s. FOOD & DRUG AiH,ltlN!S.iiiATIPN January 30, 2024 Lisa Vershave Regulatory Affairs Manager Re,1Vity, Inc;. 940 Winter Street Waltham, MA 02451 Re: Rev~tfon otEUA:201494 Dear Lisa Vershave: This.Jetter is in response to the.request from Revvity, Inc., 011behalfofRevvity Onti~(a Revvity; Inc, companythatwas •a rebranding of Ferkin:Ehner Oenomics) in an email dated January 19; 2024, that the U.8. Food and Drug Administration (FDA) withdraw the EUA for the PerkinElmer SARS-CoV~2 RT-qPCR R.:agent Kit issued on April· 12, 2021; and amended on September 2:1, 2021. Revvity,. Jnc. indicated that as of the date of this letter they have discontinued use ol'thttPerkfuEhner SARS-Cov~2 RT"4PCR Reagent Kit at the Revvity Om:ics (formally PerkinElmer Genomics) lab-Oratory located in Pittsburgh. 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) ofthe Act; be revoked when circumstances make suchre\TQCati9ll.iippropriatet<> protect the public health or safety (section 564(g)(2)(C) of the Act). Because Revvity, Inc. has requested that FDA.revoke the EUA for the PerkinEhnerSARS-CoV-2 RT-qPCR Reagent Ki~ FDA bas detemiined that it is appropriate to protect the public health or safety to revoke this autlmrization. Accordingly, FDA. hereby te\/Qkes EUt\202494 for the J.>erkinElmer SARS-CoV~2 RT-qPCR Reagent Kit; pursuant to section 564(g)(2)(C) of the Act.As ofthti date of this ll;tter, the PerkinEhner SARSC-0V-2RT-qPCR ReagentKitisno longer authorized for emergency use by FDA. Notice of this revocation will be published in the FederalR.egister, pursuant to section 564(h)(l) QftheAct • Sincerely, Its/I VerDate Sep<11>2014 16:53 Mar 20, 2024 Jkt 262001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4725 E:\FR\FM\21MRN1.SGM 21MRN1 EN21MR24.002</GPH> lotter on DSK11XQN23PROD with NOTICES1 Jeffiey E. Sht1ren, M.D., J.D. Direct<>t: Center for Devices and Radiological Health Food and.Drug Administration 20216 Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices Jiinutll3/ 31,_ 2()24 Lalri: Zi!ni R~afory Alfairs Specialist·bioMenetixsA 3'76 Cbetniii:<fo.l'Qilne 69280:¥arcy-tittoil~1 F®t~~ Revoatttonot:Eu,dui$M·. Dear I.aura Zani: -:!tJ~.~C:o:::r~:;:i:;t;:::~~!:t:i~:dJxp~S~~~!'vJ~ 2 ~ i$$U¢on ~ugµst ~;. 2020; ndi$s_u~~n. ¥arch ll; ~Q21i:an.<J aI11e11i;ie4 on Septelllber 2$, zozi. BioMerieux SA indicated. thatthey will:no longer commerciallY support the authorized product artdtequeste4 that the EUA b¢ revoked. FDA uttderiltati-&ithat; _ll$mthe iiate tif':thisJetter th~ ;are:1to:yiable VlDAS: SARS--C_1iV~Z tgM tell,genis r¢tfiiUiiing indisttibutl()rtfrt the Jlni~d $tatel!, •- ·- Theamb@ii.tioht1faife-v.c¢Jorem.er~ey usi:JJridef$ec(ioo 564 oftlte FedetatF®d, ~g. =!i:!11!:ct:!~;$~;~:i:~f:;=;;~~t!e= i,u~u!t!;t:: 5 -_-___ - safety (section 564{g)(2)(C)oftheAct); Because bioMerieux:,SAhas--:requeste:d thafFDA revoke the EUA'fQi'the YIPAS S-ARS;.CoV,2IgM.. FDA.has detetmiMdthat it.is lip:Pfupriate'fu protect the pubfittheli.lthot sai'e-tytotev<>ke this autliorization. Ai:icot<Jihgly, Fl)Ahereby reypkes EUJ\2015~4 for the V~AS SAAS-CoV-ZigM, p ~ t o se~<m $t54{g)(2)(C:jof'th~ Ac.t, A~· g:t'th~date {jf'this l1eti;~i\tlli: VXDAS S.ARS.:Ct>V~~ lgM ~• n.o longer autltoiize4foretnerge:tt(:y usi;~yFDA. • - • • • •• • •• NQfice•· 9f'thfatev.0¢atJon•Willhe-_ptiblished-in.the.P'ed¢fatR~gfst'iif,1rursuillrl ·tq ~ecti◊ri$~)(i)•· oftheA,it • • - a VerDate Sep<11>2014 16:53 Mar 20, 2024 Jkt 262001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4725 E:\FR\FM\21MRN1.SGM 21MRN1 EN21MR24.003</GPH> lotter on DSK11XQN23PROD with NOTICES1 Je~y $hqt'.en, M.D,. J'.D. Pi:r@t<>t -· • Center for Devices .and:Radiofogfoal Health Foodand-DtugA-dministration Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices 20217 U.S. FOOD & DRUG AOMlN!STRATION January 31, 2024 Laura Zani Regulatory Affairs Specialist bioMerieux SA 376 Chemin de l'Onne 69280 Marcy-l'Etoile, France Re: Re,,ocation of EUA201553 Dear Laura Zani: This letter is in response to the request from bioMerieux SA in a letter dated January 22, 2024, that the U.S. Food and Drug Administration (FDA) revoke the EUAforthe VIDAS SARS-CoV2 IgG kit issued 011 August 6, 2020, reissued 011 March 11, 2021, and amended on September 23, 2021. Biol'v1erieux SA indicated that they will no longer commercially support the authorized product and requested that the EUA be revoked. FDA understands that as of the date of this letter there are no viable VIDAS SA.RS-Co V-2 IgG reagent'> remaining in distribution in the United States. The authorization ofa 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(gX2)(C) of the Act). Because bioMerieux SA has requested that FDA revoke the EUA for the VIDAS SARS-CoV-2 IgG, FDA has detennined that it is appropriate to protect the public health or safety to revoke this authorization. Accordingly, FDA hereby revokes EUA201553 for the VIDAS SARS-CoV-2 IgG, pursuant to section 564(g)(2)(C) of the Act As of the date of this letter, the VIDAS SARS-CoV-2 IgG is no longer authorized for emergency use by FDA. Notice of this revocation will be published in the Federal Register, pursuant to section 564(h)(l) ofthe Act. Sincerely, //s/J VerDate Sep<11>2014 16:53 Mar 20, 2024 Jkt 262001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4725 E:\FR\FM\21MRN1.SGM 21MRN1 EN21MR24.004</GPH> lotter on DSK11XQN23PROD with NOTICES1 Jeffrey E. Shuren, MJ)., J.D. Director Center for Devices and Radiological Health Food and Drug Administration 20218 Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices February 22, 2024 Tara Viviani, RAC Senior Director, Molecular Regulatory Affairs Luminex Corporation 12212 Technology Blvd. Austin, TX 78727 Re: Revocation of EUA.201881 Dear Tara Viviani: 'I11is letter is in response to the request from Luminex Corporation, in a letter dated February 19, 2024, that the U.S. Food and Drug Administration (FDA) withdraw the EUA for the xMAP SARS-CoV-2 Multi-Antigen IgG Assay issued on July 16, 2020, and amended on September 23, 2021, and March 9, 2022. Luminex Corporation indicated that they have discontinued manufacture of the authorized product and requested that the EUA be withdrawn. FDA understands that as ofthe date of this letter there are no viable xMAP SARS-CoV-2 MultiAntigen IgG Assayreagents remaining in distribution in the United States. 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) 1nay, pursuant to section 564(g)(2) of the. Act, be revoked when .circmustances make such revocation appropriate to protect the public health or safety (section 564(g)(2)(C) of the Act). Because Lmninex Corporation has requested that FDA withdraw the EUAfor the xMAP SARS-Co V 2 Multi-Antigen lgG Assay, FDA has determined that it is appropriate to ptotect the public health or safety to revoke this authorization. Accordingly, FDA hereby revokes EUA201881 for the xMAP SARS-Co V-2 Multi-Antigen IgG Assay, pursuant to section 564(g)(2)(C) of the Act As of the date of this letter, the xMAP SARS-CoV-2 Multi-Antigen IgG Assay is no longer authorized for emergency use by FDA 0 Notice of this revocation will be published in the Federal Register, pursuant to section 564(11)(1) oftheAct Sincerely, /Isl! Jeffrey E. Shuren, M.D., J.D. Director Center for Devices and Radiological Health Food and Drug Administration Cc: Jennifer Svoboda, Manager, Regulatory Affairs, Lum.inex Corporation [FR Doc. 2024–05980 Filed 3–20–24; 8:45 am] lotter on DSK11XQN23PROD with NOTICES1 BILLING CODE 4164–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–0802] Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 16:53 Mar 20, 2024 Jkt 262001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 ACTION: Notice. The Food and Drug Administration (FDA or Agency) 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 SUMMARY: E:\FR\FM\21MRN1.SGM 21MRN1 EN21MR24.005</GPH> Dated: March 15, 2024. Lauren K. Roth, Associate Commissioner for Policy.

Agencies

[Federal Register Volume 89, Number 56 (Thursday, March 21, 2024)]
[Notices]
[Pages 20211-20218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05980]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-1091]


Revocation of Six Authorizations 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.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the Emergency Use Authorizations (EUAs) (the 
Authorizations) issued to Life Technologies Corp. (a legal entity of 
Thermo Fisher Scientific, Inc.), for the TaqPath COVID-19 Pooling Kit; 
Bio-Rad Laboratories, Inc., for the Reliance SARS-CoV-2 RT-PCR Assay 
Kit; Revvity, Inc., (on behalf of Revvity Omics (a Revvity, Inc. 
company that was a rebranding of PerkinElmer Genomics)), for the 
PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit; bioM[eacute]rieux SA for 
the VIDAS SARS-CoV-2 IgM kit; bioM[eacute]rieux SA for the VIDAS SARS-
CoV-2 IgG kit; and Luminex Corp. for the xMAP SARS-CoV-2 Multi-Antigen 
IgG Assay. FDA revoked the Authorizations under the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) as requested by the Authorization holder. 
The revocations, which include an explanation of the reasons for each 
revocation, are reprinted at the end of this document.

DATES: The Authorization for the Life Technologies Corp.'s (a legal 
entity of Thermo Fisher Scientific, Inc.) TaqPath COVID-19 Pooling Kit 
is revoked as of January 16, 2024. The Authorization for the Bio-Rad 
Laboratories, Inc.'s Reliance SARS-CoV-2 RT-PCR Assay Kit is revoked as 
of January 16, 2024. The Authorization for the Revvity, Inc.'s (on 
behalf of Revvity Omics (a Revvity, Inc. company that was a rebranding 
of PerkinElmer Genomics)) PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit is 
revoked as of January 30, 2024. The Authorization for the 
bioM[eacute]rieux SA's VIDAS SARS-CoV-2 IgM kit is revoked as of 
January 31, 2024. The Authorization for the bioM[eacute]rieux SA's 
VIDAS SARS-CoV-2 IgG kit is revoked as of January 31, 2024. The 
Authorization for the Luminex Corp.'s xMAP SARS-CoV-2 Multi-Antigen IgG 
Assay is revoked as of February 22, 2024.

ADDRESSES: Submit written requests for a single copy of the revocations 
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 revocations may be sent. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the revocations.

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 May 25, 2021, FDA 
issued the Authorization to Life Technologies Corp. (a legal entity of 
Thermo Fisher Scientific, Inc.), for the TaqPath COVID-19 Pooling Kit, 
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 at 39043), as required by section 564(h)(1) of the 
FD&C Act.
    On January 15, 2021, FDA issued the Authorization to Bio-Rad 
Laboratories, Inc., for the Reliance SARS-CoV-2 RT-PCR Assay Kit, 
subject to the terms of the Authorization. Notice of the issuance of 
this Authorization was published in the Federal Register on April 23, 
2021 (86 FR 21549 at 21751), as required by section 564(h)(1) of the 
FD&C Act.
    On April 12, 2021, FDA issued the Authorization to PerkinElmer 
Genomics, (Revvity, Inc. (Revvity Omics, a Revvity, Inc. company that 
was a rebranding of PerkinElmer Genomics)) for the PerkinElmer SARS-
CoV-2 RT-qPCR Reagent Kit, 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 at 39042), as required 
by section 564(h)(1) of the FD&C Act.
    On August 6, 2020, FDA issued the Authorization to 
bioM[eacute]rieux SA for the VIDAS SARS-CoV-2 IgM kit, 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 at 74350), as required by section 564(h)(1) of the 
FD&C Act.
    On August 6, 2020, FDA issued the Authorization to 
bioM[eacute]rieux SA for the

[[Page 20212]]

VIDAS SARS-CoV-2 IgG kit, 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 at 74350), as 
required by section 564(h)(1) of the FD&C Act.
    On July 16, 2020, FDA issued the Authorization to Luminex Corp. for 
the xMAP SARS-CoV-2 Multi-Antigen IgG 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 at 
74350), as required by section 564(h)(1) of the FD&C Act.
    Subsequent updates to the Authorizations 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. Authorizations Revocation Requests

    In a request received by FDA on November 13, 2023, Life 
Technologies Corp. (a legal entity of Thermo Fisher Scientific, Inc.), 
requested the revocation of, and on January 16, 2024, FDA revoked, the 
Authorization for the Life Technologies Corp.'s (a legal entity of 
Thermo Fisher Scientific, Inc.) TaqPath COVID-19 Pooling Kit. Because 
Life Technologies Corp. notified FDA that they are no longer 
commercially supporting the TaqPath COVID-19 Pooling Kit and requested 
FDA revoke the Authorization for Life Technologies Corp.'s TaqPath 
COVID-19 Pooling Kit, FDA has determined that it is appropriate to 
protect the public health or safety to revoke this Authorization.
    In a request received by FDA on January 7, 2024, Bio-Rad 
Laboratories, Inc., requested the revocation of, and on January 16, 
2024, FDA revoked, the Authorization for Bio-Rad Laboratories, Inc.'s 
Reliance SARS-CoV-2 RT-PCR Assay Kit. Because Bio-Rad Laboratories, 
Inc. notified FDA that they have ceased U.S. distribution of the Bio-
Rad Reliance SARS-CoV-2 RT-PCR Assay Kit and requested FDA revoke the 
Authorization for Bio-Rad Laboratories, Inc.'s Reliance SARS-CoV-2 RT-
PCR Assay Kit, FDA has determined that it is appropriate to protect the 
public health or safety to revoke this Authorization.
    In a request received by FDA on January 19, 2024, Revvity, Inc. (on 
behalf of Revvity Omics (a Revvity, Inc. company that was a rebranding 
of PerkinElmer Genomics)), requested the revocation of, and on January 
30, 2024, FDA revoked, the Authorization for the Revvity, Inc.'s 
PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit. Because Revvity, Inc. 
notified FDA that they have discontinued use of the PerkinElmer SARS-
CoV-2 RT-qPCR Reagent Kit at the Revvity Omics laboratory, and 
requested FDA revoke the Authorization for Revvity, Inc.'s PerkinElmer 
SARS-CoV-2 RT-qPCR Reagent Kit, FDA has determined that it is 
appropriate to protect the public health or safety to revoke this 
Authorization.
    In a request received by FDA on January 22, 2024, bioM[eacute]rieux 
SA, requested the revocation of, and on January 31, 2024, FDA revoked, 
the Authorization for the bioM[eacute]rieux SA's VIDAS SARS-CoV-2 IgM 
kit. Because bioM[eacute]rieux SA notified FDA that they will no longer 
commercially support the authorized product, and requested FDA revoke 
the Authorization for bioM[eacute]rieux SA's VIDAS SARS-CoV-2 IgM kit, 
FDA has determined that it is appropriate to protect the public health 
or safety to revoke this Authorization.
    In a request received by FDA on January 22, 2024, bioM[eacute]rieux 
SA, requested the revocation of, and on January 31, 2024, FDA revoked, 
the Authorization for the bioM[eacute]rieux SA's VIDAS SARS-CoV-2 IgG 
kit. Because bioM[eacute]rieux SA notified FDA that they will no longer 
commercially support the authorized product, and requested FDA revoke 
the Authorization for bioM[eacute]rieux SA's VIDAS SARS-CoV-2 IgG kit, 
FDA has determined that it is appropriate to protect the public health 
or safety to revoke this Authorization.
    In a request received by FDA on February 19, 2024, Luminex Corp., 
requested the withdrawal of, and on February 22, 2024, FDA revoked, the 
Authorization for the Luminex Corp.'s xMAP SARS-CoV-2 Multi-Antigen IgG 
Assay. Because Luminex Corp. notified FDA that they have discontinued 
the manufacture of the authorized product, and requested FDA revoke the 
Authorization for Luminex Corp.'s xMAP SARS-CoV-2 Multi-Antigen IgG 
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 
revocations are available on the internet at https://www.regulations.gov/.

IV. The Revocations

    Having concluded that the criteria for revocation of the 
Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA 
has revoked the EUA of Life Technologies Corp.'s (a legal entity of 
Thermo Fisher Scientific, Inc.) TaqPath COVID-19 Pooling Kit, Bio-Rad 
Laboratories, Inc.'s Reliance SARS-CoV-2 RT-PCR Assay Kit, Revvity, 
Inc.'s (on behalf of Revvity Omics (a Revvity, Inc. company that was a 
rebranding of PerkinElmer Genomics)) PerkinElmer SARS-CoV-2 RT-qPCR 
Reagent Kit, bioM[eacute]rieux SA's VIDAS SARS-CoV-2 IgM kit, 
bioM[eacute]rieux SA's VIDAS SARS-CoV-2 IgG kit, and Luminex Corp.'s 
xMAP SARS-CoV-2 Multi-Antigen IgG Assay. The revocations in their 
entirety follow and provide an explanation of the reasons for 
revocation, as required by section 564(h)(1) of the FD&C Act.
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    Dated: March 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05980 Filed 3-20-24; 8:45 am]
BILLING CODE 4164-01-C

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