Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability, 48712-48736 [2021-18777]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES 48712 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices The additional funding will not be used to begin new projects, but to expand existing activities under the existing grant. Specifically, supplemental funds will be used to: 1. Increase the number of states that will participate in the upcoming pilot project to field test a competency-based, entry-level respite provider-training curriculum and recruitment campaign. This also includes the option to request additional funding for increased administrative and management oversight; the provision of stipends, if necessary; and increased technical assistance to the pilot states. 2. Enhance documentation and reporting on the pilot project, which could include reports, journal articles, or blogs on pre- and post-pilot work. For example, topics may include, but are not limited to: a. Detailing the methodology for developing the core competencies being piloted from conception to pilot implementation; and b. Documenting state successes as a part of the pilot program and/or detailing findings, positive or negative, learned from the one-year pilot. 3. Expand/enhance the respite care tracking (mapping) system that will be available to state program policy personnel to allow them ready access to the findings of the state scans of respite programs and services and build on case studies being developed under this grant program. 4. Expand and enhance the planned communication and information dissemination strategy to reach larger audiences of potential users of the materials developed under this project. Program Name: Lifespan Respite Care Program: Promoting Best Practices, Building State Capacity. Recipient: Center for Health Policy Development. Period of Performance: The supplement award will be issued in the second year of this three-year, fully funded, project scheduled to be completed on September 29, 2023. Total Award Amount: $562,737 in FY 2020. Award Type: Cooperative Agreement Supplement. Statutory Authority: The statutory authority for grants under this program announcement is contained in Title XXIX of the Public Health Service Act (42 U.S.C. 300ii–1: Lifespan Respite Care Grants and Cooperative Agreements), as amended by the Public Health Service Act Public Law 109–442. (Catalog of Federal Domestic Assistance 93.072). Basis for Award: The Lifespan Respite Care Program: Special Projects to VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 Strengthen Program Development, Implementation and Sustainability is currently funded to carry out the objectives of this project for the period of September 30, 2020 through September 29, 2023. Since project implementation began in late 2020, the grantee has accomplished a great deal. The supplement will enable the grantee to carry their work even further, reaching more states with workforce development assistance, information dissemination, direct technical assistance and tracking of state innovations and advancements in respite service design and delivery. The additional funding will not be used to begin new projects or activities. Dated: August 25, 2021. Alison Barkoff, Acting Administrator and Assistant Secretary for Aging. [FR Doc. 2021–18748 Filed 8–30–21; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0762] Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID–19; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the revocation of 15 Emergency Use Authorizations (EUAs) (the Authorizations), including 12 Authorizations for decontamination systems for personal protective equipment, 1 Authorization for a bioburden reduction system for personal protective equipment, and 2 umbrella Authorizations for certain imported, non-NIOSH (National Institute of Occupational Safety and Health)approved disposable respirators. FDA revoked the Authorizations for the decontamination and bioburden reduction systems for personal protective equipment on June 30, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by each Authorization holder. FDA revoked the umbrella Authorizations issued to manufacturers and other stakeholders of imported non-NIOSH approved filtering facepiece respirators manufactured in China (China FFR Authorization), and to manufacturers and other stakeholders of imported nonNIOSH approved filtering facepiece SUMMARY: PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 respirators (Imports FFR Authorization) on June 30, 2021, under the FD&C Act. The revocations, which each include an explanation of the reasons for the revocation, are reprinted in this document. DATES: The Authorizations for the decontamination and bioburden reduction systems are revoked as of June 30, 2021. The Authorizations for the China FFR Authorization and Imports FFR Authorization are revoked as of July 6, 2021. ADDRESSES: Submit written requests for a single copy of the revocations 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 revocations. FOR FURTHER INFORMATION CONTACT: Michael Mair, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4340, 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) 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. Notice of the issuance of the Authorizations was published in the Federal Register as follows, as required by section 564(h)(1) of the FD&C Act: (1) Published June 5, 2020 (85 FR 34638) for Imports FFR Authorization (Certain Imported, NonNIOSH-Approved Disposable Filtering Facepiece Respirators) issued March 24, 2020; China FFR Authorization (Certain Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China) issued April 3, 2020; and STERIS Corporation for the STERIS Sterilization Systems (STERIS V–PRO 1 Plus, maX, and maX2 Low Temperature Sterilization Systems) issued April 9, 2020; (2) published July 14, 2020 (85 FR 42407) for Advanced Sterilization Products, Inc. for the ASP STERRAD Decontamination Systems issued April 11, 2020; Stryker E:\FR\FM\31AUN1.SGM 31AUN1 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices Instruments for the STERIZONE VP4 Sterilizer issued April 14, 2020; Sterilucent, Inc. for the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer issued April 20, 2020; Duke University Health System for the Duke Decontamination System issued May 7, 2020; (3) published November 20, 2020, (85 FR 74346) for STERIS Corporation for the AMSCO Medium Steam Sterilizers + the STERIS STEAM Decon Cycle issued May 21, 2020; Stryker Sustainability Solutions (SSS) for the SSS VHP N95 Respirator Decontamination System issued May 27, 2020; Technical Safety Services LLC for the 20–CS Decontamination System issued June 13, 2020; MSU for the MSU Decontamination System issued July 24, 2020; (4) published April 23, 2021, (86 FR 21749) for Roxby Development, LLC for the Zoe-Ann Decontamination System issued October 20, 2020; 3B Medical, Inc. for the Lumin LM3000 Bioburden Reduction UV System issued December 3, 2020; Ecolab Inc. for the Bioquell Technology System issued December 4, 2020; and Yale New Haven Health System for the Yale New Haven Health FILTERING FACEPIECE RESPIRATOR Decontamination System issued January 15, 2021. Any subsequent reissuances of the Authorizations are listed in the revocation letters reprinted at the end of this document. 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). khammond on DSKJM1Z7X2PROD with NOTICES II. EUA Revocation Criteria Met On June 30, 2021, FDA revoked the China FFR Authorization and Imports FFR Authorization. FDA reviewed the totality of scientific evidence available, including data provided by device manufacturers, distributors, Group Purchasing Organizations, FDA Imports database, healthcare organizations, and Federal/State stockpiles. Based on the change in the Centers for Disease Control and Prevention (CDC) recommendations, the increase in availability of NIOSH-approved respirators, the Occupational Safety and Health Administration (OSHA) Emergency Temporary Standard (ETS) requirements, and information provided VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 by healthcare organizations and others,1 FDA has concluded that the known and potential benefits of these respirators, when used for such use, no longer outweigh the known and potential risks of continued use, and pursuant to section 564(g)(2)(B), the criteria under section 564(c) of the FD&C Act for issuance of the Authorizations are no longer met. In addition, based on the same information, revocation of the Authorizations is appropriate to protect the public health and safety pursuant to section 564(g)(2)(C) of the FD&C Act. On June 30, 2021, FDA revoked the Authorizations for decontamination and bioburden reductions systems pursuant to requests from the following entities on the following dates: • April 9, 2021, from Duke for the Duke Decontamination System; • April 15, 2021, from Sterilucent, Inc. for the Sterilucent HC 80TT Hydrogen PeroxideSterilizer; • April 16, 2021, from Yale for the Yale New Haven Health FFR Decontamination System; • May 13, 2021, from STERIS Corporation for the STERIS Sterilization Systems, as well as the AMSCO Medium Steam Sterilizers + the STERIS STEAM Decon Cycle; • May 25, 2021, from Stryker Sustainability Solutions (SSS) for the SSS VHP N95 Respirator Decontamination System; • May 27, 2021 from MSU for the MSU Decontamination System; • June 4, 2021, from Advanced Sterilization Products, Inc. for the ASP STERRAD Decontamination Systems; • June 7, 2021, from Technical Safety Services LLC for the 20–CS Decontamination System; 1 Non-NIOSH approved FFRs were previously recommended by CDC as a crisis capacity strategy when there was a severe shortage of NIOSHapproved FFRs available for healthcare personnel (HCP). Available information now shows an increase in the current and projected U.S. supply of NIOSH-approved respirators, including N95s (https://www.cdc.gov/niosh/npptl/topics/ respirators/disp_part/N95list1.html). As such, on April 9 and May 27, 2021, CDC updated their recommendations to reflect that healthcare facilities should return to conventional capacity strategies and thus CDC no longer recommends the use of non-NIOSH-approved FFRs. On May 27, 2021, FDA also recommended that healthcare facilities and HCP ‘‘transition away from crisis capacity conservation strategies, such as using non-NIOSHapproved disposable respirators, including imported respirators such as KN95s’’ (https:// www.fda.gov/medical-devices/letters-health-careproviders/update-fda-recommends-transition-usenon-niosh-approved-and-decontaminateddisposable-respirators). In addition, on June 21, 2021 (86 FR 32376), OSHA issued an Emergency Temporary Standard (ETS) to adequately address the hazard of COVID–19 for HCP. The ETS requires, among other things, healthcare employers to provide NIOSH-approved or FDA-authorized respirators for healthcare workers potentially exposed to COVID–19. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 48713 • June 7, 2021, from Roxby Development, LLC for the Zoe-Ann Decontamination System; • June 7, 2021, from 3B Medical, Inc. for the Lumin LM3000 Bioburden Reduction UV System; • June 7, 2021, from Ecolab Inc. for the Bioquell Technology System; and • June 8, 2021, from Stryker Instruments for the STERIZONE VP4 Sterilizer. Because these entities notified FDA that they have ceased operations and associated activities and request withdrawal of their respective Authorizations, and consistent with FDA’s belief that the known and potential benefits of these systems, when used for their emergency use, no longer outweigh the known and potential risks of such use, FDA has determined that it is appropriate to revoke the Authorizations because the criteria for issuance of an EUA under section 564(c)(2)(B) of the Act are no longer met. Moreover, based on the same information, FDA has concluded under section 564(g)(2)(C) of the FD&C Act that other circumstances make revocation appropriate to protect the public health or safety. 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/emergencypreparedness-and-response/mcm-legalregulatory-and-policy-framework/ emergency-use-authorization-archivedinformation#covid19. IV. The Revocations Having concluded that the criteria for revocation of the Authorizations under section 564(g)(2)(B) and 564(g)(2)(C) of the FD&C Act are met, FDA has revoked the following Authorizations: • China FFR Authorization; • Imports FFR Authorization; • Duke’s Duke Decontamination System; • Sterilucent, Inc.’s Sterilucent HC 80TT Hydrogen Peroxide Sterilizer; • Yale’s Yale New Haven Health FFR Decontamination System; • STERIS Corporation’s STERIS Sterilization Systems, as well as the AMSCO Medium Steam Sterilizers + the STERIS STEAM Decon Cycle; • Stryker Sustainability Solutions’s SSS VHP N95 Respirator Decontamination System; • MSU’s MSU Decontamination System; • Advanced Sterilization Products, Inc.’s ASP STERRAD Decontamination Systems; E:\FR\FM\31AUN1.SGM 31AUN1 48714 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices • Technical Safety Services LLC’s 20– CS Decontamination System; • Roxby Development, LLC’s ZoeAnn Decontamination System; • 3B Medical, Inc.’s Lumin LM3000 Bioburden Reduction UV System; • Ecolab Inc.’s Bioquell Technology System; and • Stryker Instruments’s STERIZONE VP4 Sterilizer. 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 Jtme30:,.2021 T-0.: Manufacturers ofNbmNIOSHApproved Filtering Eacepiece Respirators Manufactured in chma;. treatih: c)w PeraQi'met; ·a:0J1pita1· Purclr~ing.~pliftmtll.'ltil• andiOistriln:d◊tsI Importers and Commercial Wholesalers; and Any Other Stakeholders This letter is to revoke the Emergency Use Authorization(EUA)issuedApril 3, 2020 and revised and reissued on Ma,y 7, 2020~ June 61 2020,.and October .15~ 202(},for e1nergency use of nonaN'ational Institutef◊rOccupational ~llfetyand Health (NIOSH)approve~ respirators manµf'actured in China1 in healtln,are s~gs l:iy healthcare pets(Jnnel (HC.P)1, whetn1sedin accordance with Centers for Disease Contr~land Pre;ention (CI)C) recommendations to prevent HCP exposure to pathogenic biologicaLairbome particulates during filtering facepiecerespiratot (f'FR) sltottag~ res11ltingfrom tlre COVID-i9 ◊utl:miak Toe rev:ocationis.effecti~ July 6, 2021., . The authoriiatfod ofa dcv1cct'or etri'crgcncy uscutldcfscctfort 564oftlicFedcraf Food, Pfug,. and Qosmetic A.ct (the Act) (21 l.LS.C ~601:ibl:,-3) n1ay be re:V<;ked whenthe circumstances described undersection.!i64(b)(l)ofthe Act no longer exist (section :S64(g)(2)(.I\,) oftheA.ci), the criteria undersection564(c)ofthe Act for issuance ofsuch authorization are no longermet (sectiort$64(g)(21(B)ofthe Act), ~r Other ~ircumstances tnitke suchrev:ocatiofi appropriate to protect the public health or safety (section 564(g)(2)(C)oftheAct). FDA has reviewed the totality ofscientific evidence available, including data provided by device tnanufacttirers, disttibutorS, GroupPurchasingOrganizations(GPOs),FDAimportsdatabase, healthcare grganization&, and federal/state stockpiles. BIU!ed on the change in CDC recommendations.the in:creasein availahilityofNIOSH-approved~spirators,theOcc;11pational Safety and Health Admirlistration (OSHA)Emergency Temporary Standard (ETS) requirements, and information provided. by healthcare organizations>and others/ FDA has concluded thatthe 1 vwmnaEtJA,.•Non~:mosu AmJtbv;est~iiblg ltllieriiiiiti@ipies~:fili;;p@ts#Mimwwwm~ .g(lll1tlicare~el. refots··tollilpaid!ll'lO;~aidp~$e,:Virlg.m~care ~e~wlto·ha.ve·th(l potep.~al.foi:•dirett.ilr 2 indirect ilXp(l~eto patients or infectious mllteriiils, in¢ludmg body substances {e:g:, ~lciod, tissue, and specific btl!ly fluids); eontamirtated.med~fsuppli~;devites:,•and 7quipm~t; contaminatedenyii:onmentalsurfaces;or·tonti!mihll.Wd.air;.Tlres!i: healtheate petsQnnlll illclude;.bµt ate not limitlld to, em~rg~ncy medical ~tvice perii011rtel, nutSes:, nursirig assistants, $:l?!l:E::!o/~!~=$;!firf~:li$:l;:1!rc~t faundiy;c security; engineeringand.faci1itiesmenagement;adminis'ttlltive, bil!mg,,andvolUrtteerpersonnel); .Non~NIOSHa.pprovedFFRswerepreviously.recommended•by·CDCasa.crisiscapru:ity.strategywhenthere>was·a.severe shortage dfNIOSH-approvedFFRs available:fotHCP.. Availableinfonnationnow•shows anincrease:in the current and projected U.S ..·supply cif NIOSH,aRPIQ~d·respirators;•inc!J.!gingN95s,As such. on April 9 mdMay27, 2021,CDCupd!i.W theitrecommendaiions.foreflect that healthcare, fati1itres should returnfo conventiOilll! capacity strategies and thus CDC no l~errecommends the use of non.:NIOSI!:.SpprovedFFRs. On.May 27;.2021, FDA lilso•recOrt!mended that helilthcare facilities.andHCP"transition·away fromctisis·capacity conserviltion·strategies;such·asusirignon~NIOSH-approved disposablerespirafors,includingimportedrespiraforssuchasKN95s'."Jn·addifum.·on1une21,202l;OSHAissuedan VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.012</GPH> khammond on DSKJM1Z7X2PROD with NOTICES •3 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48715 known and potential benefits of these respirators, when usedfor such use, no longer outweigh the known and potential risks ofcofitifiued use, andpursuantto section 564(g)(2)(B), the chteria under section 564(c)of the Act [Qr issuance of the EUAare hQ fonger met. In addition, based on the same information,.revocation ofthe EUA is appropriate to protect the public health and safety pursuant to section 564(g)(2)(C) of.the Act. Accoi:dingly, pursuant to.section 564(g)(:2XB) and 564(gj(2)(C) ofthe Act, FDA revokes the EUA. . . Effective ofrJui:y6; 2021, which is 15 days afterthe effective date of the OSHAETS, arid the date by which compliance by healthcll.fe facilities. is required, the devices listed in APPendix A as C'Q"Veted by the Octoher 15, 2020 EtrA are not authorized by.FDA for use as respirators in healthcare settuigs by .EICPto pi:ey~t)t HCP exposure to pathogenic l',iological airborne particulates during FFRshorta:ges resulting from the COVID-19 outbreak, and therefore cannot be legally mfroducedifito interstate colilinetce with that intended use. · FOA encourages mmufacturers and other stakeholders to infow theitcusfomers a11d HCP, as applicable; ofthis revocation, Manufacturers, HC;P, hospital purchasing deparnnents, distrillutQrs, importers, commercial wholesalers, states; mid any otha- stakeholders who have questions about options to redistribute or reconditiontheir supply ofnon-~msEr~approved respirators that will notbe autllorfaed effective July 6: 202 l, may reference the publicly posted frequently asked. questiOt)s (FAQ)regatd.ingthi,s re.v()cation letter or c()11tact a>A~ CDRH~NonDiagnosticEUA~ Teruplates@[da,hhs.gov, Notice <>fthis revocation will be published ii:itheFederaiRegtsier, putstianffosection 564(h)(l) oftheACt, Sincerely, ~ - -Isl' - ' - - - - ' ~ - ~ ~ ' - - - - ' RADM Denise M. Hint-0n Chief Scientist Food md })rug Administration •Em~encyTemporar_y standard.(ET§Jto.~guat¢ly ilddtes~the.~pfpQ:yJI)-J9forHCI>; Jhll··.ET$te:quir¢s,IU'llong c@ettlljrig$, he:itlttr¢~e: etni,loytimto provilie: N):OSH-llpprOVe4 lit @t,i-!l~orjzedresp~tors for health¢11re Wlltkers VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 . Frm 00057 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.013</GPH> khammond on DSKJM1Z7X2PROD with NOTICES potentiallyexposedwCOVlD~W- 48716 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices U,;S; FOOD & DRUG APM-INllrii>.t1<>n June.30,2021 To: Manufacturers ofbnported, Non-NIOSH Approved Filtering Facepiece Respirators; ijealth Cartl Personnel; Hospital Purchasing.Departments and Pistribut()ts; bnporters and.Commercial Whole~alers; and Any other Stakeholders This lette:r is. to revoke the En1ergenc)1Use Authorization (EUA) issued Ma:rch .24, 202(): and revised and :reissued on Marcil 28, 2020,Jhne 6; 2020, and March 24, 2021,Jor emergency use ofimported non-Nationalinstitute for Occupational. Safety and Health (NIOSH) approved respirators 1 in healthcare.settings by healthcare personnel (HCP)2, when used in accordance with Centers for Dise~e C<>ntrol and Prevention (CDC) recommendations. to prevent HCP exposure to pathogenic biological. airborne particulates during filtering facepiece respirator (FFR) shortages resulting. from the COVID-19 outbreak. The :revocation is effective July 6, 202 L 111e authorization of a device for emergency use urtdersecti0n $64 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U,S.C. .360bbb-J) may be revoked when the circumstances described under section :S64(b)(l)ofthe Act no longer exist (section 564(g)(2)(A) ofthe Act), the criteria under section 564(c) of the Act for issuance of such authorization are fio longer met (section $64(g)(:2)(]3:}ofthe Act), or other circumstances make su<::h revocation appropriate to protect the public health-or safety (section 564(g)(2)(C)oftheAct), FDA has reviewed the totality of'scientific evidence available, including data provided by device manufacturers, distributors, Group Purchasing Organizatiorts(GPOs), FDAbnports database, healthcare organizations, and federal/state stockpiles. Based on the changefa CDC recommendations; the increase in availability ofNIOSH-approved respirators;the Occupational Safety and Health Admifiistratiofi (QSHA)Eme:rgertcy Temporary Standard (ETS) requirements, and ifil:ormation provided by healthcare organizations and others,3 FDA. has concluded that the Umbrella EUA: Imported,.Non-NIOSH Approved DWQSable Filtering Facepiece Respirators Healthcare personnelrefers to aUpaid anlunpaid petsdns: servii:ig irt healthc:m-e settiJ:J¥S who have the potential for direct or indirect. exposore to patients or jnfectibilS materials, incltidirtg body substartces (e;g,, blood, tis$Ue; lll14 specific bodyJ1uids); contaminated medical supplies, devices,an4 equipment; contiitrtinatedenvitohrriental surfaces; or contaminated air. These healthcare persollrtel irtclude,. but ate not liniite4 to, emergency medical. service personnel, nurses, nursirtg assistants, physicians, technicians,. therapists, phlebotQm ists, pharmacists; d~ntists and dental hygienists, students and traine.es, contractual staff not employed by the. healthcare fac:ility,. and persons net direcUy involved.in. patient care, but who c()uld be exposed W infectious agents that can be transmitted in the healthcare setting (e,g,, clerical, dietary, eriv:ironmerital services, laundry; security, engineering and facilities management,. admini$trative; billing;,.and volunteer personnel). 3 Non-NIOSHapptovedFFRs were previouslyrecominended by CDC Ma crisis capacity strategy when there wa:sa severe shof(ageofNIOSH-approvedFFRs available HCP: Available information now shows an increase .in the current ai14 projected U.S, supply ofNIOSH-~rovedre§Pirators, including.;N95s_ Aiisuch, on April 9 arid May 27; 2021, CDCupdsttl<l theinecommen4ations to reflect that healthca!'eJadlities should return tt:i conventional caplKlity strategies md thus CDC no longer.recommends the. use of nort-NIOSH-4lPpr()ve4FFRs, Qn. Mi!y 27, 2021, FDA l!lso recommencled that health.care facilitiesandHCP ''transition away from crisis capacity conservation strategies, such as using rton-NIOSH-appfoved disposable respirators, including imported respirators such as KN95s:" Iii addition, on June 21, 2021, OSHA issued art I 2 for VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.014</GPH> khammond on DSKJM1Z7X2PROD with NOTICES EmeraenCyTemporary Standar4 (ETS) to adequately address the hazard of CQVID-19 for HCP, The ETS requires, among other things, healthcare employers to provide NIOSH-approved or FDA-authorized respirators for healthcare workers potentially exposed to COVID-19. Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48717 known.and potential benefits ofthese.respirators, whenusedforsuch use, no longer outweigh the known and potential risks ofcontinued use, and pursuant t~ section 564(gX2)(B), the criteria undersection .564(c) of the Act for issuance of the EUA are noJongermet Irt additio11, based on the same information, revocation ofthe .EUA.is appropriate to protect the public health and safety pursuant to section 564(g)(2)(C) ofthe. Act. Accordingly, pursuant to section 564(g)(2)(B) and 564(g)(2)(C)()ffhe Act, FDA reyok;es the EUA Effective 011 July<6, 2021, \vhich is 15 days afforthe effective date ofthe OSHA ETS, artcl the date by which compliance by healthcate facilities is required, the,devices listed in Exhibit 1 as coveredl'ly·tne March'.24, 2021 EtJAare not authorized b)1 FDAfot use as respiratom in helllthcare settings 1:iy HCP to prevent :t{CP expQSl.lfe to path9ge11ic biologi<,:alah'bQme particulates during FFRshortages resulting from the COVID~l9 outbr~ and therefore cannot be legallyurtroducecl into interstate commerce with that intended use. FDA encouragesmanufactuters and other sta.keholde:rsto intotm.theitcustomers andHC:J.i, as applicable; of this revocafo:m, Manufacturers, HCP; hospiud purchasing. depattmen~. distribu.tors, importers, commercial wholesalers_, states, and any other stakeholders who have questions about options fo redistribute or rec?ndition their supply of~on-NIOSH~approv~d ~spirators that will not be authorized effective July 6, 2021'. may reference the publicly posted frequently asked questions(FAO) regarding this re:V<.>cati<.>n letter or cont~t FI)A.at{}DRH~N@DiagnosticEllA1'emplates@faa.hhs,gov, Notice ofthis revocation will be published iritheFed~ral.Register, pursuant to. section 564(h)OJ oftheAct. · Sincerely, rs!- ~ - - ~ - ~ RADM DeniseM. Hinton Chief Scientist Food and t>rugAdmirtistration VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.015</GPH> khammond on DSKJM1Z7X2PROD with NOTICES -~~ 48718 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices June 30,2021 Monte Brown, MD Vice President of Administration and Secretaty Duke University Health System 107B DavisonBuilding Durham, NC 27710 Re: Revocation ofEOA Dear Dr. Brown: This letter is in responseto Duke University Health System's (Duke's) requestdatedApril9, 2021, that the U.S. Food and Drug Administration (FDA) ·withdraw the Emergency Use Authorization (EUA) forthe Duke Decontamination System for Decontamination and Reuse of N95Respirators 'with Hydrogen Peroxide Vapor (hereafter referred to as "Duke Decontamination System") issued on May 7, 2020-,. and revised and reissued on June 6, 2020, and January 21, 2021. Duke will no longer make the Duke Decontamination System available for the. authorized emergency use. In its request, Duke confirmed that it has ceased operation of all Duke Decontamination System sites as well as associated activities. The authorization of a device for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act(the Act)(2 l U.S.C. 360bbb-3) may be revoked when the circumstances described under section 564(b)(l) ofthe Act no longer exist (section 564(g)(2)(A) ofthe Act), the criteria under section 564(c) of the Act for issuance ofsuch authorization are no longer met (section 564(g)(2)(B) of the Act), or other circumstances make such revocation appropriate to protect the public health or safety (section 564(g)(2)(C)of the Act). Because Duke has notified FDA that it has ceased operations and associated activities and requeSts withdrawal ofthe authorization, and consistent with.FDA 's belief that the known and potential benefits ofthis. system, when used for its emergency use, no longeroutweigh the known and potential risks of such use, FDA has determined thatit is appropriate to revoke this authorization becausethe criteria for issuance of an EUA under section 564(c)(2 )(B) of the Act are no longer met. Moreover, based on the same information, FDA has concluded under section 564(g)(2)(C)ofthe Act that other circumstances make revocation of this EUA appropriate to protectthe public health or safety. Accordingly, FDA hereby revokes Duke's EUA for the Duke Decontamination Sysrern, pursuant to sections 564(g)(2)(B) and 564(g)(2)(C) ofthe Act. Asof the date ofthis letter, the Duke Decontamination System is no longer authorized for emergency use by FDA. FDA encourages Duke to.inform its customers of this revocation. Notice of this revocation w-ill be published in the Federal Register, pursuant to section 564(hXI) ottheAct. ls/ RADM Denise M.. HintQn Chief Scientist FQ<id an1.fDtugAdminiiltratiQ11 VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.017</GPH> Sinc.erely, EN31AU21.016</GPH> khammond on DSKJM1Z7X2PROD with NOTICES Page 2 - Dr. BrQwn, I)µke: Uniye£$ity HealthSyst.:m Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48719 June:30,2021 Peter Ka]kbren:r1er. Stenlucent,1nc, 1400 MarshaUS~ef)lilE MihMa:polis, MN 55413 Re: Re:vocationo(EQ;,\ Dear Mr. Kalkbrenner: This letter is in resp{)t:iseto $terilucent~c','s (Sterilµceµf's)i:equest: date(! April l 5,.2021_, t!iait the; lJ;S. F{)od: apd PmgAd::o:iil.'ifstrati9n{FDA)withdt1:twthei:EmergencyP~A:uth:qrizatiori: (EUAJ fodheSterilucentlIC 80Tt Jiydmgen:J)~r()xideStetilizet (hereatlerreferredto ii;s "SterihicentIJecortta:nfrnation Systetn")iS$ued.onAptilM~:2020, and revisedartd teiss~d on June 6,·2020~ andJanuary 21,2021. Sterilucent wiltnolongermake:the sterilucent Dec:ontaminatior1Systemavailable for the authqdzed-emergc;ncyµ~., In itsrvqul:lst, ;Steril1.1ceri:t c:qnfirtned thaiit has ceased operation:of all SterilucentPll'contaminaiion System sitesil:$'\11/ellas ass(>'ciated.activi:ties, · ·rhe a11lliorizatiorrofadeyfoeforemerge:ncyuseunder sectio11564 9f1heFffl.ieralFood; Drugi ·ari:d:- CosmeticAct(theAc,:t)(21 lJ::S,Q,360bbb~3)ma,y•be revoked·whenthe:circumstapces describedundersectiqn5'64(Q)(l) 9fth¢'Actno lorrgc,,rexist:(se.ctipn 5Q4(g)(2)(A)oftheAct), the ttiteria under section564(c)ofthe Actfoiissuanoo-ofsuch authorization a.re rto:Jortgetmet (sec.tionS64(g)(2)(B)oftheAct),.orother circumstances make suchrevocationappropriatelo pr<>tc;ct:the pul;lii;:. h:ealth9rsa;f~cy-(~ti9n ~64(gX2XC) oftlic;Act)c~caµse.~wrilucellt ha:snqtifie<l FQAthatithasce-a,sc;dopera1ipnsand-associated_activities an<l, reque$Withdrawal9f the authorization, artd consisten:twith FDNs belii:i'fthatthe kno-vvrt andpoteirtiiilhenetits of this system~when u-sedforitsemergertcy use; no fongeroutweigh•the,known.and potential risks.of sµch use} FDA has determined thatitis appropriate 1P revoke this authorization because the criteria.for issuance o.f anEUA under sectionS64(c,X2)(B)ofthe Aetare no longe:r met Moreover, based on the sam(linfon:nntion,·FoA has cortch1ded urtdersection 564(g)(2)(())'ofthe Act that other circumstances makerevocationofthisEUA appropriate to protect:the public heiilth or safety, · FDA encc:mrages Stenlucenttoinfonn itS:customem:ifthis rev()catiott. Noticeofthisrevocafronwill be ptibltshed irrtheFederalRegister; pursuantfo section564(hXl) oftheAct. Page 2 - Peter Kalkbrenner, Stvrilucent,Jnc. RAJ)MDenise M. Hinwn ()hie:£' Scientist _- ______ _ Food_andDru-gAdmirtfsttation VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.019</GPH> !sf EN31AU21.018</GPH> khammond on DSKJM1Z7X2PROD with NOTICES Sincerely, 48720 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices June-30.,2021 Mt Nancy Havil~ Managet,-IrifectidnPteverttlonAmhtifatory Services ·y-a:le NewJiiwenJiealth$ystet11 20 York Street NewHaven,-CT06504 Re: Re.vQca&n-ofE:t1A, Dear:Ms. Havi1l: ~~st~e::~.:!ru;_P::::::;~~11:~~:!~~~A)~;JiS~~:~~:~~:;t~:ril 1.6_, Au'ihorization (BUA) for the:Ya:le New Havenl:lea:ith.EFRDecontamitia:1ion System(hereal:ter referred to as "YafoDecotimminatlon System'')issuedon January 15.2021. YaleWillnofonger ma:ketheYa:le Decontamination$Ystem available for thecauthorized emergency1.1se,]nits tequest~ Ya:le cortfitmed thatithas cea-sedo_peration- bfall Yale Decontamimtticm System sites as -well.asii:ssociated.activities,. J;;~:~;~:::~;!~i:1r~I0{r~;c~;~rbu;~⇒)==-~~c::;::i:e!tJ;!:~:ug, ~~~!:o;u:::::::::ti~s 1J~!!!~o~~;=!~:t-:~~::~~~:1:~~~!~~it~:~~:t (section-S64(g)(~)(BJofthe Ac!).9rothei: circumstan~s make suchre.voai,tiwrapprop~~-to prot¢ctthe public Iiealth orsafety (section S64(g)(2)(C) oftheAct).13¢ca:qseY:ate hairnotified FDA thatit has ceased o.peta:tions:and assocfateid a:ctlvitii::s a:ndxequestswithdrawal ofihe a:uthotizatiort,iartdconststentwithFDA's betieftltatthe knoWrt a:nd pbtefitia:l bertefitsofthis: system, when ~sedfor its emergency use, no longer ou{Weightheknownand potential risks of such use~ FDA has determined that:itiSappropiiate to·revokethis authorization because the criteria for issuance of anEUAundeniection 564(:c)(2)(BJoftheActa:re no longer met. Moreover, based on the same information~ FDA has--c()ncluded undersection 564(g)(2)(C):ofthe Act that oth~ circurristances-makerevoai,tio11of this EUA appropriate tnprotectthe public health or l!afety, · · · Accotdfngly, IDA hereby revcikesYa:fo•s Etf:A ftitthe Ya:le :Oecontamina:tlon System\ pursuant tosections-S64(gX2)(B)and 564(g)(2XC)oftheA:ct As ofthe date ofthfa letter, the Yale Decontamination System:isno longer authorized.for emergemzy use by FDA--FDAencourages Yaie toinf'orrntts customers of'thlsre:vocation, Page 2 - Ms. H1tYill, Yale New Haven Health System VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.021</GPH> RADM Denise M. Hinton ChiefScientist 'Fo()d.a:nd I>rucg·Admifiistration EN31AU21.020</GPH> khammond on DSKJM1Z7X2PROD with NOTICES Sincerely, Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48721 June30,2021 Ph Bro4f!cck Sen:fotDirecwt, Regulat6tyAffru.ra STERIS Corporation 5960 Heisley Road Mentor,OH44060 DearDriBfodbeck: Thislettet is in respotisi.ft6 S IER1$ Coij)6fatfon'§(SIBRIS's) request dated .May 13,2021, that the U.S. Food and DrugAdministration (FDA)withdra~theEmergency Use Authorization (EUA) for the V•PROl Plus;V-PROmaX, V-PROmaX2, V-PR060~and V-PR0s2models:of the vaporized hydrogen peroxide (VHP)Jowtemperature sterilization systems (hereafter referred to as ''STERIS.Pecontam!nati~nsystems"}issued onApriL9,2020;and revised and reissued onJune6tib2(l,andJanuary 21, 2021. S'I'filUS will no.longermaketheSJERI~ Pecontaminatfon~ystetns availablefottheauthotized emetgertcyu~e. lnits.reqtu~~, STE:IUS confirmed thatithasceasedoperationofall STERISDec.ontami11ation.Systemssitesaswell.·as associated.activities; ·theauthorizationofadevfoefotemtrgeooy·useundetsectfon5~oftheFedetafFood,Drug, andCosmeticAct(theAct)(21 tLS.C. 360bbb-3)maybe revoked when the.circumstances described under sectiqn564(b')(l) of the Act no lqngerexist(section564(g)(2)(A) oftheJ\ct), the criteria 1;U1der section564(Q) 6ftheAct fodssuance ofsuchauthoriiationare no longetmet (sei>tiort564(g)(~)03) oftheAct), or ctther circumstances 111ake suchrevqca~onappropriateto protectthe public healthorsafety(section 564(sX2)(C)oftheAct); Because STERIS has nqtified f'PA thalitbasceased qpera,tit11:1s an4 associated activities and reqµe~swith!lrawa;f<)f the aµfum:izatio.n, and consistent withf'OA's behef thatthe knqwn attd pqtentialhenetits qfthese SJ$tems~ whe~ used for its eme~nc;yµse, n? longer outweighthe known andpotentialri$ksof such use, FDA has determined thatitisappropriate to. te'V'oke this authorization b.ecause the criteria forissuance of anEUAµndersection 5<i4(c)(2)(B) oftheActare no longer met. Moreover, based on the $ameinfqrmation,FDA has concluded under section 564(g)(2)(0) ofihe Actthat Qther citcumsta.ncesmakereyQcationof this EDA appropriate to proteclthe public health or safety. · A(;coltlingly, IDA hereby tl;lyok:esS'l'.ERIS'sEtTA fo(the $1'.ERIS De~m1tamination Systeins, pµrsuant to sections $64(g)(2)(B) and564(g){2)(C}oftheAct.As ofthe date of this letter, the STER.IS DecontarriinittionSystemsareno longerauthorizedfor e·mergency usebyFDA. F.DJ\. encourages STERIStqinformi'fscustqmers 9fthisrevocatiqn, VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.022</GPH> khammond on DSKJM1Z7X2PROD with NOTICES Notice of thisrevocatfonwilibe published ifi the Pedera!Regtster,pursuantto section 564(h-):'1) oftheAct 48722 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices Page 2 - Dr. Br9db-eck, STERI.S C9rporati9n Sin~rely, VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.023</GPH> khammond on DSKJM1Z7X2PROD with NOTICES RADM Denise M. Hinton Ch,ief S'1ienti!!f ·Food,:llild I:)r:ugi\dmfui$1:i:'ilnon Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48723 June30,2021 DtBrndbeck SenfotDirector, Regulatory Af:f11.1i'$ S:TmUS Corpo:raJion 5960 Heisley Road Mentor,.OH44060 Re: Revocafion:.otEUA DearDr,.Brodbeck: IhisJetter is Jnrespofisifto S'IEi{lS Cotpotilti<in's.(SIBlUS's) requesUiatedMay n,~021, thatthe US: Fo?d and Dtug.P.dministtation(FI)AJ'-VithdrawtheEmetgencyUseAuthorization (EUA) fotthe AMSCOMediumSteam Sterilizers and the SIBlUS STEAM Decontamination CycleinAMSCO Medium Steam Sterilizers as the cycletbr decontamination ofcompatible N95respirators(hereafterreferred to as ''STERISSteam DecontaminatiotlSystem") issued on May21.,2020, and revised and.reissued.onJanuary21:2-021. STER1Swill nti longermake·the STERIS SteamDecontaminationSystem available for the authorized emergencyuse. In its request, STERIS confirmed thatithasceased operation.of an STERIS Sterun Decontamination System sites as well as associated activities. theauthonzatirinofa. devfoe•fotemergencyi:1se•un:det.se1ction564 ◊fthe:Federall?ood,Drug, and CosmeticAct{theAct)(:2:1 U.S.C. 360bbb 03)may be revoked when the:ciroumstances descfibi#undei:sec;tion564(b)(l) q:ftheActno longere~isl{sectjo11 ?64(g)(2)(-!\) ofth:c:iAqt); the criteria u11dersecfa:'.)it 564(c)ofthe Actfor issuance ofsuch a.uthortZAtionare ® longerttiet (secti~rt $64(gXi)(B) of the Act), or other circnrt1Stances rnake suchte)!Ocationapptopriateto protectthe public healthorsafety(sectioh 564(g)(2)(C)oftheAct), Because STERIShas. notified FDAthalithas <;eased operations and. associated acti:vities an4 reqoests withllrawal of the authorization, and consistentwith FI>A's belief that the known and potential benefitsofthis systern,when usedfor itsemergencyuse1 ® longeroutwei$htheknownand potential iisksof such use,FDAhas determined thatit.isappropriate to re1"okethis authorization because the criteriafod!>suat1,ce of ~EUA:under.sectio115t>4(<;)(2)(B}ofth:eActare t1,o longe:r met, Moreq:v~. j)11;se4 on th:e s11:meinf9rmatjon, FI>A has.cpncluded µndersection 564(g)(::Z)(C)ofthe Actth:at other circumstances malce~vo<:lliio11.qfth:isEUA appi:opriate toJ>rotectthe publtc health or safety. Accordingly~ FDA hereby revokesSTERIS's EUA f():rthe STERIS Steam Deco11tamination.System,.pursuantto•sec1ions 564(g)(2)(B)amt564(g)(2)(CJ·•ofthe·.Act As of the-date of this letter.the STERIS Ste11;m Decon:JaminaticmSystem is no longer authorizedforemergencyuseby FDA, VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.024</GPH> khammond on DSKJM1Z7X2PROD with NOTICES Noticeofth1srevocation\vt1!.he pubffshcii in the Federal Register; pursuantto .section 564(hjl) oftheAct. 48724 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices Pag<} 2 - Dr, Brodbec,k, !-;TERIS Corporation Sinc..:rely, AAD'MDenise M:Hilifoii CJ:i,ief$-Cie,.i.tist VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.025</GPH> khammond on DSKJM1Z7X2PROD with NOTICES .·Food.arrd:J?nrgAdministra1ion Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48725 ■•U.S. FOOD & DRUG APMlt,!lSTRATlON June 30, 2021 Moira Barton-Varty, RAC Senior Principal Regulatory Affairs Stryker Sustainability Solutions 1810 WestDrake Drive Tempe,AZ8528 Re: RevocationofEUA DearMs, Barton-Varty: This letter is in response to Stryker Sustainability Solution's (SSS' s) request dated May 25, 2021, that the tJ.S. Food and Drug Administration (FDA) withdraw the Emergency Use Authorization (EUA) for the Stryker Sustainability Solutions VHPN95 RespiTator Decontamination System (hereafter referred to as "SSS Decontamination System') issued on May 27, 2020, and revised and reissued on Jime6, 2020, and January 21,2021. SSS will no longer make the SSS becontamination System available for the authorized emergency use. In its request, SSS confirmed that it has ceased operation of all SSS Decontamination System sites as well as associated activities. 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 be revoked when the circo:mstances described under section564(b)(l)oftheActno longerexist(section 564(g)(2)(A) of the Act), the criteria under section 564(c) of the Act for issuance. ofsuch authorization are no longer met (section S64(g)(2)(B)ofthe Act), or other circumstances make such revocation appropriate to protectthe public health orsafety(section 564(g)(2)(C) ofthe Act). Because SSS has notified FDA that it has ceased operations and associated activities and requests withdrav.al of the authorization, and consistent with FDA' s belief that the known and potential benefits of this system, when used for its emergency use, no longer outweigh the known and potential risks of such use, FDA has determined that it is appropriate to revoke this authorization because the criteria for issuance of anEtJA under section564(c )(2)(B) of the Act are no longer met. Moreover, based on the same information, FDA has concluded under section 564(g)(2)(C) of the Actthat other circumstances makerevocationofthis EUA appropriate toprotect the public · health or safety. Accordingly, FDA hereby revokes SSS EUA for the SSS Decontamination System, pursuantto sections 564(g)(2)(B) and 564(g)(2)(C)ofthe Act. As of the date of this letter, the SSS Decontamination System is no longer authorized for emergency use by FDA. FDA encourages SSS to inform its customers of this revocation. Notice ofthis revocation will be published in the Federal Register, pursuant to section 564(hXl) VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.026</GPH> khammond on DSKJM1Z7X2PROD with NOTICES oftheAct. 48726 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices Page 2 -Ms. Bai:tqn-Vruiy, StrykerSu!ltainability $QhltiQlls Sincerely, RADM Denise NL Hin.tori. C:l:ti.~fScien:tiiit VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.027</GPH> khammond on DSKJM1Z7X2PROD with NOTICES FQ<,:d lttl:d Dt-µg .Adminiiii(i\ti~11 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48727 June3Q,.2021 JbsephR,Haywood As:sistan.t v'ice PresiderttofR.egulatocyAffairs Q/l>/o F, Cl11ire :ffanl<iell:son, P~ MS,Diri;:cl:or CampusAnimalResourvesandtJniversity Vtterinarlan Michigan State UniversityAnima1 Care.Program 4000 Collins,Suite 120 Lansi'.ng;MI 48910 Re: Revocatii:m:of~UA. beai'Mr. Haywood: Thisletter is in re.sPQnseto Michigan state University AnimaLCare Prc>gram 's (MSU' s) request dated May 27, 2021, th:atthetJ.S. .Food and DrugAdministratioo(FOA)withdrawthe Eme~ncy Us:eAuthorization(EU.A) forthe MSUSystemforDecontlitninating Compatible N95Respirators(hereafter referred to as "MSUDecon1amination System") issued onJuly 24, 2020, and revised llll:dreissued on January 21, 2021. MSU will no longi;:rmake the MSU Dec0ntamitllltiPnSystent~vailable fottheautho~zedetllergencyuse, In itsreqµest,~V confirmed 'that it has ceased operation ofall MSU Decontan1i11atitm Systemsites:aswetl as associated activities, Theauthorizati◊il<>f::adevicef◊remerg¢hCY use under: sectiprt 564 of th't'FederatFcmd, Drug, and CosmetfoAct(theAct)(2l U.S.C, '.36:0bhb.:S)mayhe revokedwhettthe cfrcumstancei; described under secticm564(b)(l) oftheAttno longer e:xist(section 564(g)(2)(A)oftheAct), the criteria under s.ection 564(c)ofthe Actfor issuru1oe-0fsuch authorization are nolongermet (section564{g)(2)(BJofthe Act),orother circumstanci;:s make sqchrevocationappropriateto protectthe public health orsafety(section 564($)(2)(C) of'tbeAct). Because MSUhasnotified FDAthatit hasceased OJ>erationsandassociated activities andrequestswithdrawruorthe authorization; andconsistentwithFDA 's beliefthatthe known and potential benefitsofthts syste111. whe~ usedJorits eme~ency i,se. nq longerqufyVeig}l the l<irrown and. potential risks qf st1ch use, FDA has detennined thatitisappropri.ate to revoke this !lµth◊riZ!ltion ~Cltllsethe crit¢ditf6J" issmtnce ◊fartEUAunder sectionJ64(c)(2)(B) oftheActare no lon~rmet Moreover, based on'tbe sameinformation.,FDA hits concluded under section 564(g)(2)(C)of:the Act that other circumstances make revocation of this EtTA apprqpriate to protect the public health or safety. Accordingty1 FDA hereby revokesMStl'sEUA £ortheMSUDecon:tamination:$ystemt pursuantto sectiqns564(g)(2)(B)and :S64(g)(2)(C}ofthi::Act. As ofthe date ofthis letter, the.MSU Decontamination systemisno lon~erauthorized for emergency use by FDA.. . FDAencourages MSUto inform its c:ustomersofthis revocation, VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.028</GPH> khammond on DSKJM1Z7X2PROD with NOTICES Notice of this revocationwill be published in the F.ederalRegisier, pursuanttQ section $64(hXI) of the Act. · 48728 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices Page 2 -)oS:ephR. Hayw:9Qd,Michi~S~te University Animal Care PrQgram RADM .Denise M. Hinton Chief Scientist VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.029</GPH> khammond on DSKJM1Z7X2PROD with NOTICES Fooct and. Dm1rAdminis1ration Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48729 ■ ADM!NtSTUfflOlt U.S. FOOD & DRUG June30,2021 Ms. Carolyn Shelton VP, Global Regulatory & Medical Affairs, ProductStewardship Advanced Sterilization Products, Inc. 6920 Seaway Blvd. Everett, WA 98-203 Re: RevocationofEUA Dear Ms. Shelton: This-letter is in response to Advanced Sterilization Products, Inc. (ASP) STERRAD's request dated June 4, 202 I, that the tJ.S. Food and Drug Administration (FDA) withdraw the Emergency Use Authorization (EUA) forthe ASP STERRAD 100S, ~ and I 00NX Sterilization Systems (hereafterreferredto as"ASPSTERRAD Decontamination Systems") issued on April 11,2020,andrevised and reissued on June 6, 2020, and January 21, 2021. ASP STERRAD .viii no longer make the ASP STERRAD Decontamination Systems available fot 1he authorized emergency use. In its request,ASPSTERRADconfirmed thatithas ceased operation ofall ASP STERRAD Decontamination Systems sites as well as associated activities. The authorization ofa.device for emergency use undet section 564 of the Federal Food, Drug, and Cosmetic Act (theAct)(21 U.S.C. 360bbb-3) may be revoked '\\hen the.circumstances described under section 564(b)(1) of the Act no longer exist ( section 564(g)(2)(A) ofthe Act), the criteria under section 564(c) ofthe Act for issuance ofsuch authorization are no longer met ( section 564(g)(2)(B) of the Act), orother circumstances make such revocation appropriate to protectthe public health or safety (section 564(g)(2)(C) of the Act). Because ASPSTERRAD has notified FDA that it has ceased operations and associated activities and requests ~vithdrawal of the authorization, and consistent with FDA 's belief that the known and potentialbenefits of these systems, when used for their emergency use, no longer outweigh the known and potential risks of such use, FDA has determined thatitis appropriate to revoke this authorization because the criteria for issuance of anEUA under section 564(c)(2)(B) ofthe Act are no longer met. Moreover, based onthesameinformation, FDA has concluded under section 564(g)(2)(C) of the Act that other circumstances make revocation of this EUA appropriate to protect the public health or safety. · Accordingly, FDA hereby revokes ASP STERRAD's EUA for the ASP STERRAD Decontamination Systems, pursuant to sections 564(g)(2)(B) and 564(g)(2)(C) ofthe Act. As ofthe date of this letter, the ASP STER.RAD Decontamination Systems are no longer authorized for emergency us-e by FDA. FDA encourages ASP STERRADto inform its customers of this revocation. VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.030</GPH> khammond on DSKJM1Z7X2PROD with NOTICES Notice of thisrevocation will be published in theFedera/Registerf pursuant to section 564(hXI) ofthe.Act. 48730 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices Page 2 - Ms. QaroJyn &helton, .'\S~ STERRAP Sinc.erely, Isl RADM Denise M .. Hinton VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.031</GPH> khammond on DSKJM1Z7X2PROD with NOTICES ChiefScientist ·Fo.odand])rugAdmfuistr.ation Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48731 June30,2021 Mb BrtmfHart Te¢hrticm Safety ServicesttC (iWH:earst,Ave11ue Betkeley~ CA 94710 Re: RtvocationofEUA be:a:l'Mt. Harl: This.letter is in response tp 'I'echni<;al Safety Se:i:vices I,LC:1s (TS S's) request <lat!')d June 7. 702!,thatibe: u:s, FQoda11dDrugAdmii1istmtiot1 ('.FQA)withdrawthe:EmergtmQY Use· AuthorizatiQtt;(EUA) fQtthe:2()sCS Pe<;J:)lltan:umttiot1Sy$k:m.(here:after referredtQ a:s 'f'I'SS Dec;ontamin11tlm'fSystem")issuedbti June 1:S.2000, iirt<l revised artd·teissuedon Januaty2l, 2021. TSS will no longermake the TSS DecontaminationSystem available forthe authorized emergency use.•. Inits req11e!!t; '.l'SS confirmed that it has ce:ased operation of all 1:SS Decontamination System sites as well a:s associti:fed activities. the authori.za:tionofa dev'foe fotemefgency.use.urider sectiori564 o:ftheF.e.deial Food.Drug, andCosmeticAct(theAct)(21 lJ;S.C:,360bbl:>.•3)maybere:v9ked·whenthecircumstances de~fibed unde:rsec:ti.on564(1:>)(1) qfthe:Actno longer exist(section ~(g)(2)(A) ofthe,A<;t). the criteria um!er section 564(c)-ofthe Acfforissµan'-" qfsuch authorii4tion are rt◊ tongennet {section $64(g)(2)(B)oftheAct), orothet c1rcumstances make such revocation-appropriate to prote.ctthe public health or safety (section 564(gX2XC)ofthe:Act). Because TSS has notified 1:"DA tllatit h!l~ceased ope~atj.ons and a~s9ciat'\l4 a<;tiv:ities andreqtJ.ests withqraw.d (}fthe ll,llthorization,. and.cot:tsistenf:with :FDA' s be:lie:fthat the k110:wn:and potenti;,d b~efitsofthis: S)tstem,whert usedfor its emergency use, tid longer outweigh the known and potential risks of such use, FDAhas determined thatitisappropriate to revoke this authorization because the. criteria.for issuance of anEUA under section 564(cX2)(B) oftheA.ctare no longer met. Moreover, based on the same information, FDA has concluded under secti9n S(i4(g)(2)(C) of the Acttha:t ◊thet circurnstanc:esmakete:v-0cati:onof this EUA appropriate toprotecttlte public hearth or satety. A.ccorrJingly, FJJA hereby revokes TSS'sEUAJorthe T$$~cQt1tatriinatjon, System. pursuantto sections$64(gX2')(B)artd So4(g)(2XC) br'theAct. As bf the date ofthis letter, the tSS: Decm1tamination Systetrt:is rto lortger authoriied foremergertey use by FDA. Noticeofth.is.revocationwiil he pubHshed inthe:PederalRegtster~ purSuantto section 564(hjl) oftheAct. Page. 2 - ~- BrentHart, Technical Safety Serviceg LLG RADM Denise M. Hinton Chi~f.$cienfo,t food.•artl.\Dt1,rgAdmt1.1f$1f;ttiQt1 VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.033</GPH> Isl EN31AU21.032</GPH> khammond on DSKJM1Z7X2PROD with NOTICES Since~ely, 48732 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices M,r. J~ffre:yIMotrls President Roxl?y Development, LLC 102 Ciutnel Road Wheeling, WV26003 Re: Re:VQCatiQnolEVA Deat Mr. :fvfoms: Thislefter is in respbnsefo Roxby I)evelopment:,LLC's (Roxby's) request dated June 7, 2021, thatthe US. Food and DrugAdministration{.FDA) withdfawthe EmergencyUse Authorization (EUA) for the Zoe-Ann Decontamination System (hereafter referred to as"Roxby DecontaminationSy1;tem'')issued on October 20;2020. Roxby will no longer make th~ Roxby Decontamin11tion System available for the authorized emergency use. In its request, Ro}{by cortfirm.ed thatit has ceased operation ofall Rox by Oecontamination System s1tes as wellaS a,SSbciated·activities, The autllorization of: a d~vice for emergency use under section 564 of tl:le Fede:n11Food, Drug, and Cqsmetic J\ct(the Act) (21 U.S.C.• 360bl>b-3)m11y be revoked when the circumsumces describedundersection564(b)(l) oftheActnD longerexist(section 564(g)(2)(A)ofthe Act), the criteria wider section 564(c) of the Act fotissuartce ofsuch autho:ritationare rio Iongetmet ( section564(gX2)(B)of the Act), or other circumstances make such revocation appropriate to protect the public health or safety (section 564(gX2)(C) ofthe. Act). Because Roxby has notified FDA that it has ceased operations and associated activities andrequests withdrawal of the authorization, and consistent with FDA':s belief thatthe: kno\\.n.and potential benefits ofth:is system, when used for its emergency use, no longer outweigh the known and potential risks of such use, .FDA has determined tl:lat itis appropriate toi:evoke this authorization becausethe criteria forissuance ofanEUJ\ under section 564(cX2)(B) oftlleActare no longer met, Moreover, based on thesamefnformation,FDA has concluded under section 564(g)(2)(C)ofthe Act that other circumstances make:tevocationof this EUA appropriate to protectthe public health or safety. Accordingly, FDA hereby revokes Roxby's EUAfor the Roxby Decontamination system, putsuanttosections 564(g)(2)(B) and 564(g)(2)(C)ofthe:Act. As ofthe: date of this letter, the Roxby DecontaminationSystem isnolonger authorized for emergency use by FDA FDA encourages Roxl?yto infotmits customers ofthi:s revocation. Notice ofthisrevocation will.be published in theFederalRegiste,:;pursuantto section 564(hXI) ofthe:Act. Page 2 - Mr. Jeffrey J. Morris, Roxby Development, LLC RADM Denise M. Hinton Chief Scientist Food and Drug Administration VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.035</GPH> /si EN31AU21.034</GPH> khammond on DSKJM1Z7X2PROD with NOTICES Sincerely, Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48733 June30.,2021 Mr, Yi!:sser Es:tafan.ol.l!I Ditec:tot torReguhttory At'ta:irstmd Q11afay.Assurance '.3BMe4foa:h Inc, 21J3.Avet1tt¢ANW, Suittf:300 Winter Haven,.FL3388l Dear:Mr, Estafanous, l~i~~~P~!!na:Jt'!:~!t=::~~;f;!:f:::::~:~~!:;i~Au16=J~:at (EOA) for theLumin:LM:3000 BioburdenReduction W Systetrt (hereaftet referred to as "'.lB MedicalBioburdenReduction System")issued on December 3,2020. 3BMedl.cal will no longer makethe3BMedical Biciburden:Reducticm System.available forthe authorizedeme:rgencyuse. Irtits reqttest,3B Medical ctmfirmat thatithas ceased operation ofalllBMedical Biobutdert Reduc1ion Syswm sites aswell.as associated activities. The:aqthoriza:tionpfa deV'iceforemergency·use un4~ sectionS:(14 ofthe Federal Fomi, Dn.lg~ at1d Cosmeti¢Act(theAct)(2J lJ:S.<tj6()bbb-'3) may .·be revoked when the,circumstances described under sectionS64(b)(1) oftheActnci fongei exist(section sM('g)(:Z)(A.) ofthc-Act), the criteria under section564(c)ofthe Acrfodssulllire ofimch authoriiaticinare no fongermet (sc::ction564(g)(2)(B) 9ftbe,A:cO, qr ptber circ11111Stances m/l-ke su¢hrevocati:onapprqpriate to profectthe pitblic liealth.onafety(secti:on 564(g)(2)(C)oftheA:ct); :B¢ca:u:se 3:8Medi¢al has n()tified FDAthatithasceased operationsandass®ia:ted•activities and requests withdrawal()f the authorization, and consistentwith]IDA ;s ®liefthattheknown andpotentialbenefiisofthis system; when usedfor its emergency use, no longeroutweighthekno~ and, potential risks of such use,-FDAhas defunnined thatitis appropriate to revoke this authorization because the criteriafotissuance ofanEUA: under section $64(cX:Z)(B) oftheActare rt◊ longer met. Moreover, hased on the same information, FDA has concfuded undetsectfon 564(g)(2)(C)◊fthe J\cHlutt other circµmstances makerevocatiq110fthisEUA appropriate tcrprotectthe pt1b!Jc health w safety, · ·· Accordingly~ FDA hereby te:vokesJ1fMedical'sEUA£6.r·the 3B.MedicaLBfobutdert Reduction System, pursuantto sections S64(g)(2XB) and 564(g)(2)(C)ofthe.ActAs cif the date ofthisletwr, the 3BMedicaJBio burdenRed uctionSystem is no longer · · authorized fm emersencyusc:: by EDA. FDA.encourages 3BMetHcafto 1nform1ts customers ofthh1revocation. is! .RADM Denise M.Hifrfori . ··QhiefS~iim:#st •FQod-/tlld.Pt"tlgA:dmiilistt'atfQi.l VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.037</GPH> Sine:erdy. EN31AU21.036</GPH> khammond on DSKJM1Z7X2PROD with NOTICES Page 2 - Mr. Yasser Estafanous, :}B MedicaJ, Inc 48734 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices June30~2021 Mt. RaghuJil:inapur Vfoe: Preside:nt,:Regufatofy Affaits~ Global He:althcru-e E<:o:labinc., l EcolabI>ia:ce St Paul,MN55l02 DearMt. Jainapur: fo Thislette:r is response to Ecolab lnc"s·(Ecolab's)request<lated Ji.me 7,2021, tha,tthe U$. Food and DtugA<lministration (FDA}\lilithdrawthe Btnergen~y Use Authorization (ElJA)for the Bioque:11 Technology System (hereafter referred to as "Ecolab Decootamination System") issued on December4, 2020. Ecolab wilt no longer make theEcolabDecontamination System available{or the authoriz.ed emergency use. In its request Ecolab confirmed thafit has. ceased operation of all Ecolab DecontaminatiQnSystem J!ite:sas we:11 asassociated activities. The authorization ofadevicefor emergency use under section564 of the Federal Food, Drug, an<lCpsme.tic.Act(theAct}(21 U.$.C. 3{)0bbb.:3)maybe revokedwhenthecircumstances describeduudersection. •564(h)(l). ofihe:Act·l1{).l01igere1rist(se~ou.564(~(2)(A).ofthe.1\ct), the criteria under section564(c)ofthe Actforissuarice ofsucha11thoriz.ationare nolongermet (section 564(g)(2)(B}oftheAct), orothet circumstances make such revocation appt.opriateto pt"pte:ctfl1e puhli9 he111thqrs11fet)r(J!ection 564(g)(2XC}pftheAc1XBecalJSe Ecolahha$m>-tified FDAthatit hascea$ed op¢rationsan<l assQciated activities and requests withdrawal of the autl10rization, and c()nsistentwithFDA 's belielthattheckn:o.vn and PC!tential b¢nefits orthis system.when used for its emet.gency use, no longer.outweigh the: known and poterttfal risks of such use, FDA. has determined thatitjs a;ppropriate to revoke this authorization be.cause the c1iteriaforissuance ofanEUAunder section S64(c)(2)(B) ofthe Actat.e nQ longer met Moreover~ based on the same informl'ltion, FDA has conciuded under.section 564(g)(2)(C) ofthe Actthat other. circ.umstances makenwocaticmofthis EUA appropriate to protectfhe public health or safety. Accordingly, FDA hereby rev()kes~lab'sEUA forthe)Scob11tDe:contMXin~◊n System, Pi)t.Stiarttto sections 564(gX2)(B) and 564(g)(2)(C}ofthe Act.As of the date of this letter,the Ecolab Decontamination System is no longer authorized for emergency use byIDA FDA encpµrages Ecolal> to.informitscustomersofthis revocation. N'otice of thisrevocutipn will be published in the f'ederalRegisler:; pursuantto section564(h:X1) ofthe.Act. Page 2 - Mr. RaghuJainapur, Ecolab Inc. VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.039</GPH> RADM Denise M.. Hinton Chief Scientist F<>od.aildI)rugAdministration EN31AU21.038</GPH> khammond on DSKJM1Z7X2PROD with NOTICES Sincerely, Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48735 June30,2021 Ms, Susanne tialin Stryker Instruments 2505Ave11\lel>alto11 Quebec, QCGTP3S5 Canad's: DearMs. Galin: 1,'hisJe*r is ii:l respollseto Strykedtiiitrtnnen~'(Strylcer'iO request dated Jµne.8,202-l,thattlie U,Sc.Food and Pi:'µgA,d,111ini*ati:on@AJ'WithdrawtheEmerge11cy U:seAuthorization;(EIJA) forthe Strykerins:tru111ent's SteriZoneVP4SttiriHzerN95 RespfraklI'DecontaminatibnCycle (hetellfter referredto a$ ''Strykerl1e¢ontamfrtaifon $ystem')issu¢d.onAprll 14, 2020,.and revised and reissuedonJtme 6, 2020~and January 21,202 l. Strykerwtllno longer make the StrykerDeconta,mination~stem available.for the-authorized emergen9y use, In its request~ ·stiykerconfirmed that it has ceasedopetation ofall Stryker Uecontamination System sites as wen. asassociatedactivi't:ies. The.authorizationofa devicefo:remergency useunder section564 9ft1ie·FederalFood, Drugi and. CosmeficAct(the:J\ct){2l lfS.C_,360bbbs3)may•l?e revokedwhenthe circumstances descr!bedundersection.$(i4(b)(1) qfthe0Actno Iong¢r exist(section.564(g)(~)(.A)oftheAct)~ the criteria ili1der section 564(<:) ofthe Actfo:rissUili1(»-ofsuch.authoritation ooiortgetmet (s:ection:564(g)(2)(B)ofiheAc1),. or Other circumstances make such revocationappropriate<to prote9t:the pub\ic he11lth qrs:afety (se9tiQn ~64(g)(2)(C) oftlle Act)/Bec11use Stryker has notified :FDAth11titl1as ceased operatign;s and assp<:~ted activities andrt::qui,sts withdra~I pflhe authotization,andconsistentw:ithFDA's beliefthat theknown·and potential benefitsofthis system/when used for its:.emetgertcy use, no longer outweigh the krtownand potential risks•of such use:,FDAhas determined thatitisappropriate toreyokethis authorization becausethe: criteriafor issuance qfanEUA undersection564(c)(2XB)ofthe.Actare no longer m¢t. Motei:)ve:t, based onthe:sameinformiltiort, FDA has concluded under section 564(g)(2)(C) ofthe Actthat other circumstances makerevocationofthis EUA appropriate to protect the public health or safety. are Ac¢ottfirtgly, IDA hereby tevokes$ttyker'sEUA forthe-StryketDecontaminatioit System. pursuantto sections 564(g)(2~) and 564(g)(2)(C)ofthe Act. As of the date of this letter, •fue:Stryke:rDecontaminatiotrSystem is noJongetauthorized foremetgency usebyFDA. FDAencouta:ges Strybrto inform its customers ofthis rtivocation. Nottceofthisrevocationw:ill.be pubitshed in theFederalRegister.,pursuantto sect:ion564(hXl) oftheAct. Pa:ge 2 -Ms. Ga.fin, Stryker Ins:truments VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4725 E:\FR\FM\31AUN1.SGM 31AUN1 EN31AU21.041</GPH> RADM Denise M.Hinton Chief Scientist Food•·illld•Pn:tg•Administration EN31AU21.040</GPH> khammond on DSKJM1Z7X2PROD with NOTICES Sincerely,. 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

Agencies

[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Notices]
[Pages 48712-48736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18777]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0762]


Revocation of Authorization of Emergency Use of Certain Medical 
Devices During COVID-19; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of 15 Emergency Use Authorizations (EUAs) (the 
Authorizations), including 12 Authorizations for decontamination 
systems for personal protective equipment, 1 Authorization for a 
bioburden reduction system for personal protective equipment, and 2 
umbrella Authorizations for certain imported, non-NIOSH (National 
Institute of Occupational Safety and Health)-approved disposable 
respirators. FDA revoked the Authorizations for the decontamination and 
bioburden reduction systems for personal protective equipment on June 
30, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as 
requested by each Authorization holder. FDA revoked the umbrella 
Authorizations issued to manufacturers and other stakeholders of 
imported non-NIOSH approved filtering facepiece respirators 
manufactured in China (China FFR Authorization), and to manufacturers 
and other stakeholders of imported non-NIOSH approved filtering 
facepiece respirators (Imports FFR Authorization) on June 30, 2021, 
under the FD&C Act. The revocations, which each include an explanation 
of the reasons for the revocation, are reprinted in this document.

DATES: The Authorizations for the decontamination and bioburden 
reduction systems are revoked as of June 30, 2021. The Authorizations 
for the China FFR Authorization and Imports FFR Authorization are 
revoked as of July 6, 2021.

ADDRESSES: Submit written requests for a single copy of the revocations 
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 revocations.

FOR FURTHER INFORMATION CONTACT: Michael Mair, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4340, 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) 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. Notice of the issuance of the Authorizations was published 
in the Federal Register as follows, as required by section 564(h)(1) of 
the FD&C Act: (1) Published June 5, 2020 (85 FR 34638) for Imports FFR 
Authorization (Certain Imported, Non-NIOSH-Approved Disposable 
Filtering Facepiece Respirators) issued March 24, 2020; China FFR 
Authorization (Certain Non-NIOSH-Approved Disposable Filtering 
Facepiece Respirators Manufactured in China) issued April 3, 2020; and 
STERIS Corporation for the STERIS Sterilization Systems (STERIS V-PRO 1 
Plus, maX, and maX2 Low Temperature Sterilization Systems) issued April 
9, 2020; (2) published July 14, 2020 (85 FR 42407) for Advanced 
Sterilization Products, Inc. for the ASP STERRAD Decontamination 
Systems issued April 11, 2020; Stryker

[[Page 48713]]

Instruments for the STERIZONE VP4 Sterilizer issued April 14, 2020; 
Sterilucent, Inc. for the Sterilucent HC 80TT Hydrogen Peroxide 
Sterilizer issued April 20, 2020; Duke University Health System for the 
Duke Decontamination System issued May 7, 2020; (3) published November 
20, 2020, (85 FR 74346) for STERIS Corporation for the AMSCO Medium 
Steam Sterilizers + the STERIS STEAM Decon Cycle issued May 21, 2020; 
Stryker Sustainability Solutions (SSS) for the SSS VHP N95 Respirator 
Decontamination System issued May 27, 2020; Technical Safety Services 
LLC for the 20-CS Decontamination System issued June 13, 2020; MSU for 
the MSU Decontamination System issued July 24, 2020; (4) published 
April 23, 2021, (86 FR 21749) for Roxby Development, LLC for the Zoe-
Ann Decontamination System issued October 20, 2020; 3B Medical, Inc. 
for the Lumin LM3000 Bioburden Reduction UV System issued December 3, 
2020; Ecolab Inc. for the Bioquell Technology System issued December 4, 
2020; and Yale New Haven Health System for the Yale New Haven Health 
FILTERING FACEPIECE RESPIRATOR Decontamination System issued January 
15, 2021.
    Any subsequent reissuances of the Authorizations are listed in the 
revocation letters reprinted at the end of this document.
    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 Criteria Met

    On June 30, 2021, FDA revoked the China FFR Authorization and 
Imports FFR Authorization. FDA reviewed the totality of scientific 
evidence available, including data provided by device manufacturers, 
distributors, Group Purchasing Organizations, FDA Imports database, 
healthcare organizations, and Federal/State stockpiles. Based on the 
change in the Centers for Disease Control and Prevention (CDC) 
recommendations, the increase in availability of NIOSH-approved 
respirators, the Occupational Safety and Health Administration (OSHA) 
Emergency Temporary Standard (ETS) requirements, and information 
provided by healthcare organizations and others,\1\ FDA has concluded 
that the known and potential benefits of these respirators, when used 
for such use, no longer outweigh the known and potential risks of 
continued use, and pursuant to section 564(g)(2)(B), the criteria under 
section 564(c) of the FD&C Act for issuance of the Authorizations are 
no longer met. In addition, based on the same information, revocation 
of the Authorizations is appropriate to protect the public health and 
safety pursuant to section 564(g)(2)(C) of the FD&C Act.
---------------------------------------------------------------------------

    \1\ Non-NIOSH approved FFRs were previously recommended by CDC 
as a crisis capacity strategy when there was a severe shortage of 
NIOSH-approved FFRs available for healthcare personnel (HCP). 
Available information now shows an increase in the current and 
projected U.S. supply of NIOSH-approved respirators, including N95s 
(https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/N95list1.html). As such, on April 9 and May 27, 2021, CDC updated 
their recommendations to reflect that healthcare facilities should 
return to conventional capacity strategies and thus CDC no longer 
recommends the use of non-NIOSH-approved FFRs. On May 27, 2021, FDA 
also recommended that healthcare facilities and HCP ``transition 
away from crisis capacity conservation strategies, such as using 
non-NIOSH-approved disposable respirators, including imported 
respirators such as KN95s'' (https://www.fda.gov/medical-devices/letters-health-care-providers/update-fda-recommends-transition-use-non-niosh-approved-and-decontaminated-disposable-respirators). In 
addition, on June 21, 2021 (86 FR 32376), OSHA issued an Emergency 
Temporary Standard (ETS) to adequately address the hazard of COVID-
19 for HCP. The ETS requires, among other things, healthcare 
employers to provide NIOSH-approved or FDA-authorized respirators 
for healthcare workers potentially exposed to COVID-19.
---------------------------------------------------------------------------

    On June 30, 2021, FDA revoked the Authorizations for 
decontamination and bioburden reductions systems pursuant to requests 
from the following entities on the following dates:
     April 9, 2021, from Duke for the Duke Decontamination 
System;
     April 15, 2021, from Sterilucent, Inc. for the Sterilucent 
HC 80TT Hydrogen PeroxideSterilizer;
     April 16, 2021, from Yale for the Yale New Haven Health 
FFR Decontamination System;
     May 13, 2021, from STERIS Corporation for the STERIS 
Sterilization Systems, as well as the AMSCO Medium Steam Sterilizers + 
the STERIS STEAM Decon Cycle;
     May 25, 2021, from Stryker Sustainability Solutions (SSS) 
for the SSS VHP N95 Respirator Decontamination System;
     May 27, 2021 from MSU for the MSU Decontamination System;
     June 4, 2021, from Advanced Sterilization Products, Inc. 
for the ASP STERRAD Decontamination Systems;
     June 7, 2021, from Technical Safety Services LLC for the 
20-CS Decontamination System;
     June 7, 2021, from Roxby Development, LLC for the Zoe-Ann 
Decontamination System;
     June 7, 2021, from 3B Medical, Inc. for the Lumin LM3000 
Bioburden Reduction UV System;
     June 7, 2021, from Ecolab Inc. for the Bioquell Technology 
System; and
     June 8, 2021, from Stryker Instruments for the STERIZONE 
VP4 Sterilizer.
    Because these entities notified FDA that they have ceased 
operations and associated activities and request withdrawal of their 
respective Authorizations, and consistent with FDA's belief that the 
known and potential benefits of these systems, when used for their 
emergency use, no longer outweigh the known and potential risks of such 
use, FDA has determined that it is appropriate to revoke the 
Authorizations because the criteria for issuance of an EUA under 
section 564(c)(2)(B) of the Act are no longer met. Moreover, based on 
the same information, FDA has concluded under section 564(g)(2)(C) of 
the FD&C Act that other circumstances make revocation appropriate to 
protect the public health or safety.

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/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information#covid19.

IV. The Revocations

    Having concluded that the criteria for revocation of the 
Authorizations under section 564(g)(2)(B) and 564(g)(2)(C) of the FD&C 
Act are met, FDA has revoked the following Authorizations:
     China FFR Authorization;
     Imports FFR Authorization;
     Duke's Duke Decontamination System;
     Sterilucent, Inc.'s Sterilucent HC 80TT Hydrogen Peroxide 
Sterilizer;
     Yale's Yale New Haven Health FFR Decontamination System;
     STERIS Corporation's STERIS Sterilization Systems, as well 
as the AMSCO Medium Steam Sterilizers + the STERIS STEAM Decon Cycle;
     Stryker Sustainability Solutions's SSS VHP N95 Respirator 
Decontamination System;
     MSU's MSU Decontamination System;
     Advanced Sterilization Products, Inc.'s ASP STERRAD 
Decontamination Systems;

[[Page 48714]]

     Technical Safety Services LLC's 20-CS Decontamination 
System;
     Roxby Development, LLC's Zoe-Ann Decontamination System;
     3B Medical, Inc.'s Lumin LM3000 Bioburden Reduction UV 
System;
     Ecolab Inc.'s Bioquell Technology System; and
     Stryker Instruments's STERIZONE VP4 Sterilizer.
    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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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