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

As Enacted ( Federal Register)

Cited in

Citation	86 FR 48712
Record Number	2021-18777
Published date	31 August 2021
Section	Notices
Court	Food And Drug Administration

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 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

VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\31AUN1.SGM 31AUN1

khammond on DSKJM1Z7X2PROD with NOTICES

48713

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

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.

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,

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/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;

VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\31AUN1.SGM 31AUN1

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 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.

BILLING CODE 4164–01–P

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

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

revoke the Emergency

Use

Authorization(EUA)issuedApril 3, 2020 and

revised

and

reissued

Ma,y

2020~

June

61 2020,.and October

.15~

202(},for

e1nergency

use

nonaN'ational

Institutef◊rOccupational

~llfetyand Health (NIOSH)approve~ respirators

manµf'actured

in China1in 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

prevent

HCP

exposure to pathogenic biologicaLairbome particulates during filtering facepiecerespiratot

(f'FR) sltottag~

res11ltingfrom

tlre

COVID-i9

◊utl:miak

Toe

rev:ocationis.effecti~

July

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

re:V<;ked

whenthe circumstances

described undersection.!i64(b)(l)ofthe Act

longer exist (section

:S64(g)(2)(.I\,)

oftheA.ci),

the criteria undersection564(c)ofthe Act for issuance ofsuch authorization

are

longermet

(sectiort$64(g)(21(B)ofthe

Act),

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

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

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

infectious

mllteriiils,

in¢ludmg

body substances

{e:g:,

~lciod,

tissue,

and

specific

btl!ly

fluids);

eontamirtated.med~fsuppli~;devites:,•and7

quipm~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

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

48715

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

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

known and potential benefits

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

the EUAare hQ fonger

met.

addition, based on

the same information,.revocation

the EUA

appropriate

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

days afterthe effective date of the OSHAETS,

arid

the

date

which compliance

healthcll.fe

facilities.

required, the devices listed in APPendix A

C'Q"Veted

by the Octoher

15,

2020

EtrA are

not

authorized by.FDA for

use

respirators

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

theitcusfomers

a11d

HCP,

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

202

l, may reference the publicly posted frequently

asked.

questiOt)s

(FAQ)regatd.ingthi,s

re.v()cation

letter

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

Hint-0n

Chief Scientist

Food

})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

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

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.

revoke the

En1ergenc)1Use

Authorization (EUA) issued

Ma:rch

.24,

202():

and

revised

and

:reissued

Marcil

28,

2020,Jhne

2020,

and

March

24,

2021,Jor emergency

use

ofimported non-Nationalinstitute for

Occupational.

Safety and

Health

(NIOSH)

approved

respirators1 in healthcare.settings

healthcare personnel

(HCP)2,

when used

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

effective

July

202

111e

authorization

a device for emergency

use

urtdersecti0n

$64

the Federal

Food,

Drug,

and

Cosmetic

Act

(the

Act)

(21

U,S.C . .360bbb-J)

may

revoked

when

the circumstances

described under section :S64(b)(l)ofthe

Act

longer exist (section 564(g)(2)(A) ofthe

Act),

the criteria under section 564(c)

the

Act

for

issuance

such authorization

are

fio

longer

met

(section

$64(g)(:2)(]3:}ofthe

Act),

or other circumstances

make

su<::h

revocation appropriate

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

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

healthcare organizations

and

others,

FDA.

has

concluded that the

Umbrella

EUA:

Imported,.Non-NIOSH

Approved

DWQSable

Filtering

Facepiece

Respirators

Healthcare

personnelrefers

aUpaid

anlunpaid

petsdns:

servii:ig

irt

healthc:m-e

settiJ:J¥S

who

have

the

potential

for

direct

indirect.

exposore

patients

jnfectibilS

materials,

incltidirtg

body

substartces

(e;g,,

blood,

tis$Ue;

lll14

specific

bodyJ1uids);

contaminated

medical

supplies,

devices,an4

equipment;

contiitrtinatedenvitohrriental

surfaces;

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

the.

healthcare

fac:ility,.

and

persons

net

direcUy

involved.in.

patient

care,

but

who

c()uld

exposed

infectious

agents

that

can

transmitted

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

CDC

crisis

capacity

strategy

when

there

wa:sa

severe

shof(ageofNIOSH-approvedFFRs

available

for

HCP:

Available

information

now

shows

increase

.in

the

current

ai14

projected

U.S,

supply

ofNIOSH-~rovedre§Pirators,

including.;N95s_

Aiisuch,

April 9

arid

May

27;

2021,

CDCupdsttl<l

theinecommen4ations to

reflect

that healthca!'eJadlities

should

return

tt:i

conventional

caplKlity

strategies

thus

CDC

longer.recommends

the.

use

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

using

rton-NIOSH-appfoved

disposable

respirators,

including

imported

respirators

such

KN95s:" Iii

addition,

June

21,

2021,

OSHA

issued

art

EmeraenCyTemporary Standar4 (ETS)

adequately address the hazard

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.

48717

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

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

known.and potential benefits ofthese.respirators, whenusedforsuch

use,

longer outweigh

the

known

and potential risks

continued use,

and

pursuant t~ section 564(gX2)(B), the criteria

undersection

.564(

the Act for issuance

the

are

noJongermet Irt

additio11,

based

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

days

afforthe effective

date

ofthe

OSHA

ETS,

artcl

the

date

which compliance

healthcate facilities is required, the,devices listed in Exhibit 1

coveredl'ly·tne

March'.24,

2021

EtJAare

not

authorized

b)1

FDAfot

use

respiratom

helllthcare

settings

1:iy

HCP to prevent

:t{CP

expQSl.lfe

path9ge11ic

biologi<,:alah'bQme

particulates during FFRshortages resulting

from

the

COVID~l9

outbr~

and therefore cannot

legallyurtroducecl into interstate

commerce

with that intended

use.

FDA

encouragesmanufactuters

and

other

sta.keholde:rsto

intotm.theitcustomers

andHC:J.i,

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

redistribute or rec?ndition their supply of~on-NIOSH~approv~d ~spirators that will

not be authorized effective

July

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@DiagnosticEllA-

1'emplates@faa.hhs,gov,

Notice

ofthis

revocation

will

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

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

EN31AU21.016</GPH> EN31AU21.017</GPH>

khammond on DSKJM1Z7X2PROD with NOTICES

June

30,2021

Monte

Brown,

Vice President

Administration

and

Secretaty

Duke

University

Health

System

107B

DavisonBuilding

Durham,

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

N95Respirators

'with

Hydrogen

Peroxide Vapor (hereafter referred

"Duke

Decontamination

System")

issued

May

2020-,.

and

revised

and

reissued

June

2020,

and

January

21,

2021.

Duke

will

longer

make

the

Duke

Decontamination System available

for

the. authorized emergency use.

its request,

Duke

confirmed

that

has

ceased

operation

all

Duke

Decontamination

System

sites

well

associated activities.

The

authorization

a device

for

emergency use under section

564

the

Federal

Food,

Drug,

and

Cosmetic

Act(the

Act)(2

l U.S.C.

360bbb-3)

may

revoked

when

the

circumstances

described under

section

564(b)(l)

ofthe

Act

longer

exist

(section 564(g)(2)(A)

the

Act),

the

criteria

under

section

564(

the

Act

for

issuance

such

authorization are

longer

met

(section

564(g)(2)(B)

the

Act),

other

circumstances make

such

revocation appropriate

protect

the

public health

safety (section

564(g)(2)(C)of

the Act). Because Duke

has

notified

FDA

that

has

ceased

operations

and

associated activities

and

requeSts withdrawal

the

authorization,

and

consistent with.FDA

belief

that the known

and

potential benefits

ofthis.

system,

when

used

for

its emergency use,

longeroutweigh the

known

and

potential risks

such

use,

FDA

has

determined

thatit

is appropriate to revoke this authorization

becausethe

criteria

for

issuance

EUA

under

section 564( c

)(2

)(B)

the

Act

are

longer met.

Moreover,

based

the

same

information,

FDA

has

concluded under section

564(g)(2)(C)ofthe

Act

that

other

circumstances

make

revocation

this

EUA

appropriate

protectthe

public

health

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)

the Act.

Asof

the date

this

letter,

the

Duke

Decontamination System

longer authorized

for

emergency

use

FDA.

FDA

encourages

Duke

to.inform its customers

this revocation.

Notice

this revocation

w-ill

published

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

48719

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

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

EN31AU21.018</GPH> EN31AU21.019</GPH>

khammond on DSKJM1Z7X2PROD with NOTICES

Peter

Ka]kbren:r1er.

Stenlucent,1nc,

1400 MarshaUS~ef)lilE

MihMa:polis,

55413

Re: Re:vocationo(EQ;,\

Dear

Mr.

Kalkbrenner:

June:30,2021

This letter is

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:s-

nqtifie<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;

fongeroutweigh•the,known.and

potential

risks.of

sµch

use}

FDA

has determined thatitis appropriate

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

ptibltshed irrtheFederalRegister; pursuantfo section564(hXl)

oftheAct.

Page 2 - Peter Kalkbrenner, Stvrilucent,Jnc.

Sincerely,

!sf

RAJ)MDenise

Hinwn

()hie:£'

Scientist

______

Food_andDru-gAdmirtfsttation

48720

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

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

EN31AU21.020</GPH> EN31AU21.021</GPH>

khammond on DSKJM1Z7X2PROD with NOTICES

June-30.,2021

Nancy

Havil~

Managet,-IrifectidnPteverttlonAmhtifatory

Services

·y-a:le

NewJiiwenJiealth$ystet11

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

"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

-well.asii:ssociated.activities,.

J;;~:~;~:::~;!~i:1r~I

{r~;c~;~rbu;~

⇒

)==-~~c::;::i:e!tJ;!:~:ug,

~~~!:o;u:::::::::ti~s

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,

longer ou{Weightheknownand

potential

risks

such

use~

FDA

has determined that:itiSappropiiate to·revokethis authorization because the

criteria

for

issuance

anEUAundeniection 564(:c)(2)(BJoftheActa:re

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

l!afety,

· · ·

Accotdfngly,

IDA

hereby

revcikesYa:fo•s

Etf

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

Hinton

Chief Scientist

'Fo()d.a:nd

I>rucg·Admifiistration

48721

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

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

Bro4f!cck

Sen:fotDirecwt, Regulat6tyAffru.ra

STERIS

Corporation

5960

Heisley

Road

Mentor,OH44060

DearDriBfodbeck:

June30,2021

Thislettet

respotisi.ft6

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)

the Act

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

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

proteclthe public

health or safety. ·

A(;coltlingly,

IDA

hereby

tl;lyok:esS'l'.ERIS'sEtTA

fo(the

$1'.ERIS

De~m1tamination

Systeins, pµrsuant

sections $64(g)(2)(B) and564(g){2)(C}oftheAct.As ofthe date

this letter, the

STER.IS

DecontarriinittionSystemsareno longerauthorizedfor

e·mergency

usebyFDA.

F.DJ\.

encourages STERIStqinformi'fscustqmers 9fthisrevocatiqn,

Notice

thisrevocatfonwilibe

published

ifi

the

Pedera!Regtster,pursuantto

section

564(h-):'1)

oftheAct

48722

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

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

Page

2 -

Dr.

Br9db-eck,

STERI.S

C9rporati9n

Sin~rely,

RADM

Denise

Hinton

Ch,ief

S'1ienti!!f

·Food,:llild

I:)r:ugi\dmfui$1:i:'ilnon

48723

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

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

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

the

cycletbr

decontamination

compatible

N95respirators(hereafterreferred to

''STERISSteam DecontaminatiotlSystem")

issued

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

well

associated

activities.

theauthonzatirinofa

devfoe•fotemergencyi:1se•un:det.se1ction564

◊fthe:Federall?ood,Drug,

and

CosmeticAct{theAct)(:2:1 U.S.C. 360bbb03)may

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

issuance

ofsuch

a.uthortZAtionare

® longerttiet

(secti~rt

$64(gXi)(B)

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

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

~EUA:under.sectio115t>4(<;

)(2)(B}ofth:eActare

t1,o

longe:r

met,

Moreq:v~.

j)11;se4

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

the-date

this

letter.the

STERIS

Ste11;m

Decon:JaminaticmSystem

longer

authorizedforemergencyuseby

FDA,

Noticeofth1srevocation\vt1!.he

pubffshcii

the

Federal

pursuantto

.section

564(hjl)

oftheAct.

48724

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

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

Pag<}

2 -

Dr,

Brodbec,k,

!-;TERIS

Corporation

Sinc . .:rely,

AAD'MDenise

M:Hilifoii

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

.·Food.arrd:J?nrgAdministra1ion

48725

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

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

■

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

response

Stryker Sustainability Solution's (SSS'

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

May

27,

2020,

and

revised and reissued

Jime6,

2020, and January

21,2021.

SSS will no

longer

make

the

SSS

becontamination

System available

for

the authorized emergency use.

its

request, SSS confirmed

that

has

ceased operation

all SSS Decontamination System sites as

well

associated activities.

The authorization

a device for emergency

use

under section 564

the

Federal Food, Drug,

and

Cosmetic

Act(the

Act)

(21 U.S.C. 360bbb-3}may

revoked when

the

circo:mstances

described under

section564(b)(l)oftheActno

longerexist(section 564(g)(2)(A)

the Act),

the criteria under section 564(

the

Act

for

issuance.

such authorization are

longer met

(section S64(g)(2)(B)ofthe Act),

other circumstances make such revocation appropriate to

protectthe public health

orsafety(section

564(g)(2)(C)

the

Act). Because SSS has notified

FDA that

has

ceased operations and associated activities

and

requests withdrav.al

the

authorization,

and

consistent with

FDA'

belief

that

the known and potential benefits

this

system,

when

used

for

its emergency use,

longer outweigh the

known

and potential risks

such use, FDA has determined that

is appropriate to revoke this authorization because the

criteria

for

issuance

anEtJA

under

section564( c )(2)(B)

the

Act

are

longer met.

Moreover, based

the same information, FDA has concluded under section 564(g)(2)(C)

the

Actthat

other circumstances

makerevocationofthis

EUA appropriate

toprotect

the public

health

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.

the date

this

letter, the SSS Decontamination System is

longer authorized for emergency use by

FDA.

FDA

encourages SSS to inform its customers

this revocation.

Notice

ofthis

revocation will

published in the Federal Register, pursuant to section 564(hXl)

oftheAct.

48726

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

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

Page 2

-Ms.

Bai:tqn-Vruiy, StrykerSu!ltainability $QhltiQlls

Sincerely,

RADM

Denise

Hin.tori.

C:l:ti.~fScien:tiiit

FQ<,:d

lttl:d

Dt-µg

.Adminiiii(i\ti~11

48727

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

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

June3Q,.2021

JbsephR,Haywood

As:sistan.t

v'ice

PresiderttofR.egulatocyAffairs

Q/l>/o

Cl11ire

:ffanl<iell:son,

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

(MSU'

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

has

ceased operation

all

MSU

Decontan1i11atitm

Systemsites:aswetl as

associated activities,

Theauthorizati◊il<>f::adevicef◊remerg¢hCY

use

under:

sectiprt

564

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

st1ch

use,

FDA

has detennined thatitisappropri.ate

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

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

this revocationwill be published in the F.ederalRegisier, pursuanttQ section $64(hXI)

the Act. ·

48728

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

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

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

Animal

Care

PrQgram

RADM

.Denise M. Hinton

Chief Scientist

Fooct

and

Dm1rAdminis1ration

48729

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

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

■

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,

98-203

Re: RevocationofEUA

Dear

Ms. Shelton:

This-letter is in

response

Advanced

Sterilization Products, Inc. (ASP)

STERRAD's

request

dated

June

202

that

the

tJ.S.

Food

and

Drug

Administration (FDA)

withdraw

the

Emergency

Use

Authorization

(EUA)

forthe

ASP

STERRAD

00S,

and

00NX

Sterilization Systems

(hereafterreferredto

as"ASPSTERRAD

Decontamination

Systems")

issued

April

11,2020,andrevised

and

reissued

June

2020,

and

January

21,

2021.

ASP

STERRAD

.viii

longer

make

the

ASP

STERRAD

Decontamination

Systems available

fot

1he

authorized

emergency use.

its

request,ASPSTERRADconfirmed

thatithas

ceased

operation

ofall

ASP

STERRAD

Decontamination

Systems sites

well

associated activities.

The

authorization

ofa.device

for

emergency

use

undet

section

564

the

Federal

Food,

Drug,

and

Cosmetic

Act

(theAct)(21

U.S.C.

360bbb-3)

may

revoked '\\hen the.circumstances

described

under

section 564(b )(1)

the

Act

longer

exist

( section 564(g)(2)(A)

the

Act),

the

criteria

under

section

564(

the

Act

for

issuance

such

authorization

are

longer

met

( section 564(g)(2)(B)

the

Act),

orother

circumstances

make

such

revocation appropriate

protectthe

public health

safety

(section 564(g)(2)(C)

the Act). Because

ASPSTERRAD

has

notified

FDA

that

has

ceased

operations

and

associated activities

and

requests ~vithdrawal

the

authorization,

and

consistent

with

FDA

belief

that

the

known

and

potentialbenefits

these

systems,

when

used

for

their

emergency use,

longer outweigh the

known

and

potential

risks

such

use,

FDA

has

determined

thatitis

appropriate

revoke

this

authorization because

the

criteria

for

issuance

anEUA

under

section 564(c )(2)(B)

ofthe

Act

are

longer

met.

Moreover,

based

onthesameinformation,

FDA

has

concluded

under

section 564(g)(2)(C)

the

Act

that

other

circumstances

make

revocation

this

EUA

appropriate to protect

the

public

health

safety. ·

Accordingly,

FDA

hereby

revokes

ASP

STERRAD's

EUA

for

the

ASP

STERRAD

Decontamination

Systems, pursuant

sections

564(g)(2)(B)

and

564(g)(2)(C)

the

Act.

ofthe

date

this letter,

the

ASP

STER.RAD

Decontamination

Systems

are

longer

authorized

for

emergency

us-e

FDA.

FDA

encourages

ASP

STERRADto

inform

its

customers

this revocation.

Notice

thisrevocation

will

published

theFedera/Registerf pursuant

section 564(hXI)

ofthe.Act.

48730

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

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

Page 2 -

Ms.

QaroJyn &helton,

.'\S~

STERRAP

Sinc.erely,

Isl

RADM

Denise M

Hinton

ChiefScientist

·Fo.odand])rugAdmfuistr.ation

48731

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

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

EN31AU21.032</GPH> EN31AU21.033</GPH>

khammond on DSKJM1Z7X2PROD with NOTICES

Mb BrtmfHart

Te¢hrticm

Safety

ServicesttC

(iWH:earst,Ave11ue

Betkeley~

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:

(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

: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

all

1:SS

Decontamination System sites

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

prote.ctthe public health

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'

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

such use, FDAhas determined thatitisappropriate to revoke

this

authorization because

the.

criteria.for issuance

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)

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

the

date ofthis

letter,

the

tSS:

Decm1tamination

Systetrt:is

rto

lortger authoriied foremergertey use

FDA.

Noticeofth.is.revocationwiil

pubHshed

inthe:PederalRegtster~

purSuantto

section

564(hjl)

oftheAct.

Page.

2 -

BrentHart, Technical Safety

Serviceg

LLG

Since~ely,

Isl

RADM Denise

Hinton

Chi~f.$cienfo,t

food.•artl.\Dt1,rgAdmt1.1f$1f;ttiQt1

48732

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

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

EN31AU21.034</GPH> EN31AU21.035</GPH>

khammond on DSKJM1Z7X2PROD with NOTICES

M,r.

J~ffre:yIMotrls

President

Roxl?y Development, LLC

102

Ciutnel Road

Wheeling,

WV26003

Re:

Re:VQCatiQnolEVA

Deat

Mr.

:fvfoms:

Thislefter is

respbnsefo

Roxby

I)evelopment:,LLC's

(Roxby's)

request dated June

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

October 20;2020. Roxby will

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

wellaS

a,SSbciated·activities,

The autllorization of: a d~vice for emergency use under section

564

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)

the

Act

fotissuartce

ofsuch

autho:ritationare rio

Iongetmet

( section564(gX2)(B)of the Act),

other circumstances make such revocation appropriate

protect the public health

safety (section 564(gX2)(C)

the. Act). Because Rox by

has

notified

FDA

that

has ceased operations

and

associated activities andrequests withdrawal

the

authorization,

and

consistent with

FDA'

belief

thatthe: kno\\.n.and potential benefits ofth:is

system, when used

for

its emergency use, no longer outweigh the known and potential risks

such use,

.FDA

has determined

tl:lat

itis

appropriate toi:evoke this authorization becausethe

criteria forissuance

ofanEUJ\

under

section 564( cX2)(B)

oftlleActare

longer met,

Moreover, based

thesamefnformation,FDA has concluded under section 564(g)(2)(C)ofthe

Act

that other circumstances make:tevocationof this EUA appropriate

protectthe public

health

safety.

Accordingly, FDA hereby revokes Roxby's

EUAfor the Roxby Decontamination system,

putsuanttosections

564(g)(2)(B) and 564(g)(2)(C)ofthe:Act.

ofthe: date

this

letter, the Roxby DecontaminationSystem

isnolonger

authorized for emergency use

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

Hinton

Chief

Scientist

Food and Drug Administration

48733

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

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

EN31AU21.036</GPH> EN31AU21.037</GPH>

khammond on DSKJM1Z7X2PROD with NOTICES

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

"'.lB

MedicalBioburdenReduction System")issued on December 3,2020. 3BMedl.cal

will

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

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,

ptber

circ11111Stances

m/l-ke

su¢hrevocati:onapprqpriate

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

such use,-FDAhas defunnined thatitis appropriate

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

no longer

authorized

emersencyusc::

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

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

EN31AU21.038</GPH> EN31AU21.039</GPH>

khammond on DSKJM1Z7X2PROD with NOTICES

June30~2021

Mt.

RaghuJil:inapur

Vfoe:

Preside:nt,:Regufatofy

Affaits~

Global

He:althcru-e

E<:o:labinc.,

EcolabI>ia:ce

Paul,MN55l02

DearMt. Jainapur:

Thislette:r

response

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

"Ecolab Decootamination System")

issued on December4,

2020.

Ecolab

wilt

no longer

make

theEcolabDecontamination

System

available{or the

authoriz.ed

emergency

use.

its

request Ecolab

confirmed

thafit

has.

ceased

operation

all

Ecolab

DecontaminatiQnSystem

J!ite:sas

we:11

asassociated activities.

The

authorization ofadevicefor emergency use under section564

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

the

autl10rization,

and c()nsistentwithFDA

belielthattheckn:o.vn

and

PC!tential

b¢nefits orthis

system.when used for its

emet.gency

use,

longer.outweigh

the:

known

and

poterttfal

risks

such use,

FDA.

has determined thatitjs

a;ppropriate

revoke

this authorization

be.cause

the

c1iteriaforissuance ofanEUAunder section

S64(c

)(2)(B) ofthe Actat.e

longer

met

Moreover~

based on the

same

informl'ltion,

FDA

has

conciuded under.section

564(g)(2)(C)

the

Actthat

other.

circ.umstances

makenwocaticmofthis

EUA

appropriate

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

the date

this letter,the Ecolab Decontamination System

longer authorized for emergency

use

byIDA

FDA

encpµrages

Ecolal>

to.informitscustomersofthis revocation.

N'otice

thisrevocutipn

will

be published

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

48735

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

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

EN31AU21.040</GPH> EN31AU21.041</GPH>

khammond on DSKJM1Z7X2PROD with NOTICES

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

''Strykerl1e¢ontamfrtaifon $ystem')issu¢d.onAprll 14, 2020,.and

revised and reissuedonJtme

2020~and January 21,202

Strykerwtllno longer make the

StrykerDeconta,mination~stem available.for

the-authorized

emergen9y

use,

its

request~

·stiykerconfirmed that

has ceasedopetation

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)

qfthe

0Actno

Iong¢r

exist(section.564(g)(~)(.A)oftheAct)~

the

criteria

ili1der

section

564(<:)

the

Actfo:rissUili1(»-ofsuch.authoritation

are

ooiortgetmet

(s:ection:564(g)(2)(B)ofiheAc1),.

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,

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

protect

the

public

health

safety.

Ac¢ottfirtgly,

IDA

hereby

tevokes$ttyker'sEUA

forthe-StryketDecontaminatioit

System.

pursuantto

sections

564(g)(2~)

and

564(g)(2)(C)ofthe Act. As

the date

this

letter,

•fue:Stryke:rDecontaminatiotrSystem

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 self-

addressed adhesive label to assist that

office in processing your request or

include a fax number to which the

revocation may be sent. See the

SUPPLEMENTARY INFORMATION

section for

electronic access to the revocation.

FOR FURTHER INFORMATION CONTACT

Jennifer J. Ross, Office of

Counterterrorism and Emerging Threats,

Food and Drug Administration, 10903

New Hampshire Ave., Bldg. 1, Rm.

4332, Silver Spring, MD 20993–0002,

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

VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\31AUN1.SGM 31AUN1

khammond on DSKJM1Z7X2PROD with NOTICES

Subscribers can access the reported version of this case.

You can sign up for a trial and make the most of our service including these benefits.

Request your trial

Why Sign-up to vLex?

Over 100 Countries

Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
Thousands of Data Sources

Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
Find What You Need, Quickly

Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
Over 2 million registered users

Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.

Subscribers are able to see a list of all the cited cases and legislation of a document.

You can sign up for a trial and make the most of our service including these benefits.

Request your trial

Why Sign-up to vLex?

Over 100 Countries

Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
Thousands of Data Sources

Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
Find What You Need, Quickly

Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
Over 2 million registered users

Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.

Subscribers are able to see a list of all the documents that have cited the case.

You can sign up for a trial and make the most of our service including these benefits.

Request your trial

Why Sign-up to vLex?

Over 100 Countries

Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
Thousands of Data Sources

Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
Find What You Need, Quickly

Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
Over 2 million registered users

Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.

Subscribers are able to see the revised versions of legislation with amendments.

You can sign up for a trial and make the most of our service including these benefits.

Request your trial

Why Sign-up to vLex?

Over 100 Countries

Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
Thousands of Data Sources

Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
Find What You Need, Quickly

Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
Over 2 million registered users

Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.

Subscribers are able to see any amendments made to the case.

You can sign up for a trial and make the most of our service including these benefits.

Request your trial

Why Sign-up to vLex?

Over 100 Countries

Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
Thousands of Data Sources

Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
Find What You Need, Quickly

Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
Over 2 million registered users

Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.

Subscribers are able to see a visualisation of a case and its relationships to other cases. An alternative to lists of cases, the Precedent Map makes it easier to establish which ones may be of most relevance to your research and prioritise further reading. You also get a useful overview of how the case was received.

Request your trial

Why Sign-up to vLex?

Over 100 Countries

Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
Thousands of Data Sources

Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
Find What You Need, Quickly

Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
Over 2 million registered users

Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.

Subscribers are able to see the list of results connected to your document through the topics and citations Vincent found.

You can sign up for a trial and make the most of our service including these benefits.

Request your trial

Why Sign-up to vLex?

Over 100 Countries

Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
Thousands of Data Sources

Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
Find What You Need, Quickly

Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
Over 2 million registered users

Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.

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

You can sign up for a trial and make the most of our service including these benefits.

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

You can sign up for a trial and make the most of our service including these benefits.

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

You can sign up for a trial and make the most of our service including these benefits.

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

You can sign up for a trial and make the most of our service including these benefits.

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

You can sign up for a trial and make the most of our service including these benefits.

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

You can sign up for a trial and make the most of our service including these benefits.

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users