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 

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. 

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 nonNIOSH 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 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 


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Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48713 

1Non-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. 

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. 

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/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; 


khammond on DSKJM1Z7X2PROD with NOTICES
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 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.012</GPH>

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~ 2.g(lll1tlicare~el. refots··tollilpaid!ll'lO;~aidp~$e,:Virlg.m~care ~e~wlto·ha.ve·th(l potep.~al.foi:•dirett.ilr 

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); 

•3 .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 
Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48715 


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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 of the 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 inf ow 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 

potentiallyexposedwCOVlD~W- . 
48716 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 


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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 

respirators1 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 

I Umbrella EUA: Imported,.Non-NIOSH Approved DWQSable Filtering Facepiece Respirators 2 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 for 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 

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 


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known.and potential benefits ofthese.respirators, whenusedforsuch use, no longer outweigh 

the known and potential risks of continued use, and pursuant t~ section 564(gX2)(B), the criteria 

undersection .564( c) of the Act for issuance of the EU A 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 
48718 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.016</GPH> EN31AU21.017</GPH>

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) of the Act), 

the criteria under section 564( c) of the Act for issuance of such 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 of the 

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) of the Act. Asof the date of this 

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. 

Page 2 - Dr. BrQwn, I)μke: Uniye£$ity HealthSyst.:m 

Sinc.erely, 

ls/ 

RADM Denise M .. HintQn 

Chief Scientist 

FQ<id an1.fDtugAdminiiltratiQ11 
Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48719 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.018</GPH> EN31AU21.019</GPH>

Peter Ka]kbren:r1er. 

Stenlucent,1nc, 

1400 MarshaUS~ef)lilE 

MihMa:polis, MN 55413 

Re: Re:vocationo(EQ;,\ 

Dear Mr. Kalkbrenner: 

June:30,2021 

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)of the 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. 

Sincerely, 

!sf 

RAJ)MDenise M. Hinwn 

()hie:£' Scientist _- ______ _ Food_andDru-gAdmirtfsttation 
48720 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.020</GPH> EN31AU21.021</GPH>

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~I {r~;c~;~rbu;~)==-~~c::;::i:e!tJ;!:~:ug, ~~~!:o;u:::::::::ti~s1

J~!!!~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 

Sincerely, 

RADM Denise M. Hinton 

Chief Scientist 

'Fo()d.a:nd I>rucg·Admifiistration 
Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48721 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.022</GPH>

Ph Bro4f!cck 

Sen:fotDirecwt, Regulat6tyAffru.ra 

STERIS Corporation 

5960 Heisley Road 

Mentor,OH44060 

DearDriBfodbeck: 

June30,2021 

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, 

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 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.023</GPH>

Page 2 - Dr. Br9db-eck, STERI.S C9rporati9n 

Sin~rely, 

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 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.024</GPH>

DtBrndbeck 

SenfotDirector, Regulatory Af:f11.1i'$ 

S:TmUS Corpo:raJion 

5960 Heisley Road 

Mentor,.OH44060 

Re: Revocafion:.otEUA 

DearDr,.Brodbeck: 

June30,2021 

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 of compatible 

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. 360bbb03)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 Actf or 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, 

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 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.025</GPH>

Pag<} 2 - Dr, Brodbec,k, !-;TERIS Corporation 

Sinc . .:rely, 

AAD'MDenise M:Hilifoii 

CJ:i,ief$-Cie,.i.tist 

.·Food.arrd:J?nrgAdministra1ion 
Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48725 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.026</GPH>

■ U.S. FOOD & DRUG • APMlt,!lSTRATlON 

Moira Barton-Varty, RAC 

Senior Principal Regulatory Affairs 

Stryker Sustainability Solutions 

1810 WestDrake Drive 

Tempe,AZ8528 

Re: RevocationofEUA 

DearMs, Barton-Varty: 

June 30, 2021 

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. of such 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) of the 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) 

oftheAct. 
48726 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.027</GPH>

Page 2 -Ms. Bai:tqn-Vruiy, StrykerSu!ltainability $QhltiQlls 

Sincerely, 

RADM Denise NL Hin.tori. 

C:l:ti.~fScien:tiiit 

FQ<,:d lttl:d Dt-μg .Adminiiii(i\ti~11 
Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48727 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.028</GPH>

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 of all 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, 

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 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.029</GPH>

Page 2 -)oS:ephR. Hayw:9Qd,Michi~S~te University Animal Care PrQgram 

RADM .Denise M. Hinton 

Chief Scientist 

Fooct and .. Dm1rAdminis1ration 
Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48729 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.030</GPH>

■ U.S. FOOD & DRUG ADM!NtSTUfflOlt 

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 1 00S, ~ 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) of the Act), 

the criteria under section 564( c) of the Act for issuance of such 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) of the 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. 

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 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.031</GPH>

Page 2 - Ms. QaroJyn &helton, .'\S~ STERRAP 

Sinc.erely, 

Isl 

RADM Denise M .. Hinton 

ChiefScientist 

·Fo.odand])rugAdmfuistr.ation 
Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48731 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.032</GPH> EN31AU21.033</GPH>

Mb BrtmfHart 

Te¢hrticm Safety ServicesttC 

(iWH:earst,Ave11ue 

Betkeley~ CA 94710 

Re: RtvocationofEUA 

be:a:l'Mt. Harl: 

June30,2021 

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~efitsof this: 

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(c X2)(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 

Since~ely, 

Isl 

RADM Denise M. Hinton 

Chi~f.$cienfo,t 

food.•artl.\Dt1,rgAdmt1.1f$1f;ttiQt1 
48732 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.034</GPH> EN31AU21.035</GPH>

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:n11F ood, 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) of the. Act). Because Rox by 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 

Sincerely, 

/si 

RADM Denise M. Hinton 

Chief Scientist 

Food and Drug Administration 
Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48733 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.036</GPH> EN31AU21.037</GPH>

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 of the 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)◊f the 

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. 

Page 2 - Mr. Yasser Estafanous, :}B MedicaJ, Inc 

Sine:erdy. 

is! 

.RADM Denise M.Hifrfori . 

··QhiefS~iim:#st 

•FQod-/tlld.Pt"tlgA:dmiilistt'atfQi.l 
48734 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.038</GPH> EN31AU21.039</GPH>

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: 

Thislette:r is fo 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) of the 

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. 

Sincerely, 

RADM Denise M .. Hinton 

Chief Scientist 

F<>od.aildI)rugAdministration 
Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48735 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.040</GPH> EN31AU21.041</GPH>

Ms, Susanne tialin 

Stryker Instruments 

2505Ave11\lel>alto11 

Quebec, QCGTP3S5 Canad's: 

DearMs. Galin: 

June30,2021 

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 of all 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(<:) of the Actfo:rissUili1(»-ofsuch.authoritation are 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 belief that 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. 

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 

Sincerely,. 

RADM Denise M.Hinton 

Chief Scientist 

Food•·illld•Pn:tg•Administration 
48736 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0412] 

Revocation of Authorization of 

Emergency Use of an In Vitro 

Diagnostic Device for Detection and/or 

Diagnosis of COVID–19; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

revocation of the Emergency Use 

Authorization (EUA) (the Authorization) 

issued to Curative Inc. for the Curative 

SARS–Cov–2 Assay. FDA revoked the 

Authorization on July 15, 2021, under 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act), as requested by 

Curative Inc. on June 16, 2021. The 

revocation, which includes an 

explanation of the reasons for the 

revocation, is reprinted in this 

document. 

DATES: The Authorization for the 

Curative SARS–Cov–2 Assay is revoked 

as of July 15, 2021. 

ADDRESSES: Submit written requests for 

a single copy of the revocation to the 

Office of Counterterrorism and 

Emerging Threats, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4338, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request or 

include a fax number to which the 

revocation may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the revocation. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer J. Ross, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4332, Silver Spring, MD 20993–0002, 

240–402–8155 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb-3) allows FDA to 

strengthen the public health protections 

against biological, chemical, nuclear, 

and radiological agents. Among other 

things, section 564 of the FD&C Act 

allows FDA to authorize the use of an 

unapproved medical product or an 

unapproved use of an approved medical 

product in certain situations. On April 

16, 2020, FDA issued the Authorization 

to Curative Inc. (original issuance to 

KorvaLabs, Inc. under the name 

Curative-Korva SARS–Cov–2 Assay). 

Notice of the issuance of the 

Authorization was published in the 

Federal Register on July 14, 2020 (85 FR 

42407), as required by section 564(h)(1) 

of the FD&C Act. The authorization of 

a device for emergency use under 

section 564 of the FD&C Act may, 

pursuant to section 564(g)(2)(C) of the 

FD&C Act, be revoked when 

circumstances make such revocation 

appropriate to protect the public health 

or safety. 

II. EUA Revocation Request of an In 

Vitro Diagnostic Device 

On June 16, 2021, Curative Inc. 

requested the revocation of, and on July 

15, 2021, FDA revoked, the 

Authorization for the Curative SARS– 

Cov–2 Assay. Because Curative Inc. 

notified FDA that it will no longer be 

using the Curative SARS–Cov–2 Assay 

as of July 15, 2021, and requested FDA 

revoke the authorization effective that 

day, FDA has determined that it is 

appropriate to protect the public health 

or safety to revoke this Authorization. 

III. Electronic Access 

An electronic version of this 

document and the full text of the 

revocations are available on the internet 

at https://www.regulations.gov/ and 

https://www.fda.gov/media/150773/ 

download. 

IV. The Revocation 

Having concluded that the criteria for 

revocation of the Authorization under 

section 564(g)(2)(C) of the FD&C Act are 

met, FDA has revoked the EUA for the 

Curative SARS–Cov–2 Assay. The 

revocation in its entirety follows and 

provides an explanation of the reasons 

for revocation, as required by section 

564(h)(1) of the FD&C Act. 

BILLING CODE 4164–01–P 


khammond on DSKJM1Z7X2PROD with NOTICES