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

CourtFood And Drug Administration
Citation86 FR 48712
Publication Date31 Aug 2021
Record Number2021-18777
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
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48713
Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices
1
Non-NIOSH approved FFRs were previously
recommended by CDC as a crisis capacity strategy
when there was a severe shortage of NIOSH-
approved FFRs available for healthcare personnel
(HCP). Available information now shows an
increase in the current and projected U.S. supply
of NIOSH-approved respirators, including N95s
(https://www.cdc.gov/niosh/npptl/topics/
respirators/disp_part/N95list1.html). As such, on
April 9 and May 27, 2021, CDC updated their
recommendations to reflect that healthcare facilities
should return to conventional capacity strategies
and thus CDC no longer recommends the use of
non-NIOSH-approved FFRs. On May 27, 2021, FDA
also recommended that healthcare facilities and
HCP ‘‘transition away from crisis capacity
conservation strategies, such as using non-NIOSH-
approved disposable respirators, including
imported respirators such as KN95s’’ (https://
www.fda.gov/medical-devices/letters-health-care-
providers/update-fda-recommends-transition-use-
non-niosh-approved-and-decontaminated-
disposable-respirators). In addition, on June 21,
2021 (86 FR 32376), OSHA issued an Emergency
Temporary Standard (ETS) to adequately address
the hazard of COVID–19 for HCP. The ETS requires,
among other things, healthcare employers to
provide NIOSH-approved or FDA-authorized
respirators for healthcare workers potentially
exposed to COVID–19.
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/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;
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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
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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 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
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:,•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
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
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
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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.
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,
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@DiagnosticEllA-
1'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
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,
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
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,
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:s-
nqtifie<l
FQAthatithasce-a,sc;dopera1ipnsand-associated_activities
an<l,