Revocation of Authorization of Emergency Use of a Medical Device During COVID-19; Availability

• Citation: 86 FR 17162
• Record Number: 2021-06711
• Published date: 01 April 2021
• Section: Notices
• Court: Food And Drug Administration

17162

Federal Register / Vol. 86, No. 61 / Thursday, April 1, 2021 / Notices

2. The date the application was

initially submitted with respect to the

human drug product under section

505(b) of the FD&C Act or section 351

of the Public Health Service Act:

December 8, 2017. FDA has verified the

applicant’s claim that the new drug

application (NDA) for TPOXX (NDA

208627) was initially submitted on

December 8, 2017.

3. The date the application was

approved: July 13, 2018. FDA has

verified the applicant’s claim that NDA

208627 was approved on July 13, 2018.

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.

However, the USPTO applies several

statutory limitations in its calculations

of the actual period for patent extension.

In its applications for patent extension,

this applicant seeks 1,273 days or 1,585

days of patent term extension.

III. Petitions

Anyone with knowledge that any of

the dates as published are incorrect may

submit either electronic or written

comments and, under 21 CFR 60.24, ask

for a redetermination (see

DATES

).

Furthermore, as specified in § 60.30 (21

CFR 60.30), any interested person may

petition FDA for a determination

regarding whether the applicant for

extension acted with due diligence

during the regulatory review period. To

meet its burden, the petition must

comply with all the requirements of

§ 60.30, including but not limited to:

Must be timely (see

DATES

), must be

filed in accordance with § 10.20, must

contain sufficient facts to merit an FDA

investigation, and must certify that a

true and complete copy of the petition

has been served upon the patent

applicant. (See H. Rept. 857, part 1, 98th

Cong., 2d sess., pp. 41–42, 1984.)

Petitions should be in the format

specified in 21 CFR 10.30.

Submit petitions electronically to

https://www.regulations.gov at Docket

No. FDA–2013–S–0610. Submit written

petitions (two copies are required) to the

Dockets Management Staff (HFA–305),

Food and Drug Administration, 5630

Fishers Lane, Rm. 1061, Rockville, MD

20852.

Dated: March 26, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for

Policy.

[FR Doc. 2021–06696 Filed 3–31–21; 8:45 am]

BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA–2020–N–1584]

Revocation of Authorization of

Emergency Use of a Medical Device

During 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 NovaSterilis, Inc. for the

Nova2200 using the NovaClean

decontamination process. FDA revoked

the Authorization on February 12, 2021,

under the Federal Food, Drug, and

Cosmetic Act (FD&C Act). The

revocation, which includes an

explanation of the reasons for the

revocation, is reprinted in this

document.

DATES

: The Authorization for the

Nova2200 using the NovaClean

decontamination process is revoked as

of February 12, 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 August

20, 2020, FDA issued the Authorization.

Notice of the issuance of the

Authorization was published in the

Federal Register on November 20, 2020

(85 FR 74346), as required by section

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

authorized the Nova2200 using the

NovaClean decontamination process for

use in decontaminating compatible N95

respirators identified in the EUA

consistent with the Authorization.

Subsequent to the issuance of the

Authorization, as described in the

revocation letter reprinted in this notice,

FDA considered new data and evidence,

including from testing performed by the

Centers for Disease Control and

Prevention (CDC) and in published

literature, indicating that the compatible

N95 respirators identified in the EUA

may not maintain adequate fit and

filtration efficiency following one

decontamination cycle using the

authorized product.

II. EUA Criteria for Issuance No Longer

Met and Other Circumstances Make

Revocation Appropriate To Protect the

Public Health or Safety

Under section 564(g)(2)(B) and (C) of

the FD&C Act, the Secretary of HHS may

revoke an EUA if, among other things,

the criteria for issuance are no longer

met or other circumstances make such

revocation appropriate to protect the

public health or safety. On February 12,

2021, FDA revoked the Authorization

because the criteria for issuance were no

longer met and other circumstances

made such revocation appropriate to

protect the public health or safety.

Under section 564(c)(2) of the FD&C

Act, an EUA may be issued only if FDA

concludes that, based on the totality of

scientific evidence available, including

data from adequate and well-controlled

clinical trials, if available, it is

reasonable to believe that the product

may be effective in diagnosing, treating,

or preventing such disease or condition

and that the known and potential

benefits of the product, when used to

diagnose, prevent, or treat such disease

or condition, outweigh the known and

potential risks of the product.

Given the new data and evidence

from CDC and recently reported in the

literature, FDA has concluded it is not

reasonable to believe the product may

be effective in preventing healthcare

provider exposure to pathogenic

biological airborne particulates.

Additionally, based on this new

information, FDA can no longer

conclude that the known and potential

benefits of the product outweigh the

known and potential risks of its

emergency use. Further, based on the

same information and the risks to public

health and to healthcare providers from

using decontaminated respirators with

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17163

Federal Register / Vol. 86, No. 61 / Thursday, April 1, 2021 / Notices

reduced fit and filtration performance,

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. Accordingly, FDA has revoked

the Authorization, pursuant to section

564(g)(2)(B) and (C) of the FD&C Act.

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/145913/

download.

IV. The Revocation

Having concluded that the criteria for

revocation of the Authorization under

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

FDA has revoked the EUA for the

Nova2200 using the NovaClean

decontamination process. 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

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JJ.S.

FOOD

&

DRUG

At1MllliisrltArlON

Mt:

TQlly

Eisenhut

NovaSterilis,Ine;.

3109

N.

Triphamrrier

Rel.

Lansing, NY'14882

Re:

R.evm:atfon:of.EUA201.745

:Dt;ar

Mc

Ei~nhut

February

12, 2021

this

Mtet

isfo

response

fu

NovaSteriUs,

Inc.

's

letter

dated

November 24, 2020, informing FDA

that

it

is

withdrawing

the

Emergency

use Attthorization(EUA201745)•for

the

Nova:2200

using

the NovaClean

de"-ontaminati!m

process (hereafter referred to as "Nova2200")tssued

on

August

20,

2020.

We

interpret

this:

letter to

mean

that

NovaSterili$,

Inc. will

n◊

longer

rnake the

Nova220Oavailablefortheauthorized emergency

use,

The

authorizationofa.devicefor

emergeooy

use

under

section

564oftheFederal

Food,

Drug~

and

Cosmetic

Act{theAct)

{21

US.

C.

36Qbbb~3)

niay,.

pµrsua.ntto ~ction 564(g)(2) ofthe Act,

be

revoked,

when

the

c:dteria

imder section 564(c)

of

the Act

for

issuance

of

such authorization areno longer

met

(section

564(gX2)(B)

ofthe

Abt),

or

other

ciroumsances

make

suchtevocation

appropriate

to

protectfhe

public

health

orsafety

{sectielrt

5o4(g)(:2)(C)

of

the Act).

FDA

hereby notifiesNovaSterilis,

1rtc.

of

the

rev9Catio11

ofthe,EUAZ0

1745f

or the Noviazoo pllniµant to

section

564(g;(2XB)

oftl:1.e

Actan<l

section

,564(g)(2)(C::)

oftheAct

On August

20,

2020;

FbA

authorized

the

einetgehcy

use

oftheN&va2200

for

ttse

in

deCX>ntannnating

compali~1e

N95respirators1 that

are

contaminated

or

potentjaUy

contaminated

with

SARS-CoV-2orofher

pathogenic

microorganisms,

forammdmumofone

(1)

decontaminafion

cycle

pet

respirator,

forsingle-user

reuse

2

by

healthcare

personnel

(B:CP;3to

prevent

exposure

to

pathogenic

biologica:Utlrborrte

particulates

dtiritig

the

Corona

virus

Disease

2019

(C::QVD.)..19}pandennc,

Based,

Qll the,totality pfscientifi~evidence avai)able at

the

ti111e,

FI)Aconcluded that

it

was

reasonable

to

believe

that

the

Nova2200111ay

be

e.ffec;tive

at

1

Fqr

purpQSes

of

this

EUA,

"compatible

N'9$

resprrators"

are

lnn.ited.

to

lhe

3M

Mmlel

is66

or

Halyard,

FLUIDSHIELDN93 respirators.

2 Single-userreqse

means

frult!h'!l

sll1!1.eresph-atm:

is

returnedforreµsew

thesameli.ealthcare

persotu1elfoll~wlng

its decontamirtatiott.

t

HCP

refers

to.

all paid

and·

unpaid persons serving,in

healthcare

settings

who

have

ilie potential for

direct

or.

indirectexposure to

patients•orinfectious

materials,

including body substances

(e.g,;

blood; tissue,

and

specific body

fluids);.ooritarrtinated

medical supplies, devices, andequipm:ent;coritarttirtated

envirortmerttal

sil.rfaces;or

contaminated air.

These

HCP

include,

but are not limited to, emergency medical seivice personnel, nurses, nursing

Msistartts,

phyiiicians,

technicians, therapists,

piilebo~ists,

phanrtacists, dentists and dental hnienillts, students

and

trainees, contractual

staff

not employed.by

the

healthcare facility,

and

persons not directly involved

in

patient

care, but

who

could

be1:Xpo~edto

infectious

agents

thatcanbetransmitted

irt

th~

healthcar.i setting(e.g'.'

cleric;il,

dii;t;11-y,

envirortlnental

services,Jallildcy,

security,

engineering

andfaciliti~

mlinag1;1nent,

adinin'istrative,

1:iillil)g,

and volunteer personnel), · · · · · ·

17164

Federal Register / Vol. 86, No. 61 / Thursday, April 1, 2021 / Notices

Dated: March 24, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for

Policy.

[FR Doc. 2021–06711 Filed 3–31–21; 8:45 am]

BILLING CODE 4164–01–C

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA–2021–N–0262]

Food and Drug Administration Science

Forum 2021; Public Workshop

AGENCY

: Food and Drug Administration,

HHS.

ACTION

: Notice of public workshop.

SUMMARY

: The Food and Drug

Administration (FDA, Agency, or we) is

announcing the following virtual public

workshop entitled ‘‘FDA Science Forum

2021.’’ The purpose of the public

workshop is to inform the public about

the groundbreaking science conducted

at the Agency and to show how

scientific research is used in FDA’s

regulatory decisions to protect and

promote public health.

DATES

: The public workshop will be

held virtually on May 26, 2021 (Day 1),

from 9 a.m. to 3:30 p.m. Eastern Time,

and May 27, 2021 (Day 2), from 9 a.m.

to 2 p.m. Eastern Time. See the

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Page 2 - Revocation

of

ElJA201745

decontaminating compatible

N95

respirators for single-user reuse

by

HCP

to

prevent

exposure

to

pathogenic biological aitbofue partic.ulates

when

there are insufficient supplies

offiltering

fac¢piece respfrators

(FFRs)

resuiting from

the

COVID-19 pandemic, and

that

the

known and

potentfal benefits

ofNova2200

outweigh

the

~ow11

and R9tenihll.1isks

Qf

its

use;

Since then,

FDA

has

become aware

of

new

data

and

evidence suggesting that

3M

Model 1860

and H:al.yardFLUIDSHIELD N95respirato:rs,

the

only

compatible

N95respiratorsidentifieditt

thi.$

EUA,

in:ay

not mamtaiti adtlqllllte fitlilldfiltration efficiencyfollowing on¢ (

1)

decontamination cycle

using

the

Nova2200, Specifically,

I?Dt\

has reviewed

new

dataindicating

thatJM

Model 1&60N95 respirators

maynotmaintainadequate

fit and filtration efficiency after

undergoing one (1) decontamination cycle using

the

Nova2200. 4 Additionally,

FDA

has

become

aware

of

preliminary evidence suggesting that duckbi11N95 resprnrtors,

such

as Halyard

FLUIDSHIELD

N9.5

respirators, maynotmai11tain adequate fit to support reuse. 5

A&such,

FDAcanno.

longerconcludethat

itis

reasonable

to

believe

thatNova2200

may

be

effective in preventing

HCP

exposure

to

pathogenicbiologjcalaitbome

particulates.

Additionally, based

on

this

new

information,

FDA

caitno

longer

conclude

that

the

known

and

potential benefits o:f'the N ova2200 outweigh

the

known and potentialrisks

of

its use; thrn,, the

criteriaundersecfion

564(c) oftl1e Act for issuance

ofan

EUA

are no longer

met

Moreover,

based

on

the

same information,

and

the

potential risks

to

HCPfromusing

decontaminated

respirators

with

reduced.fit

and

filtration petfonnance,

FDA

has. concluded under

section

564(g)(2)(G)

of

the

Act

that

other circumstances .make revoca1ion>ofthjs EUAappropriate

t9

protect

the

public

healtkot

safety.

Accordingly,

FDA

hereby

revokes EUA201745

for

the

Nova2200, pursuarit:to section

564(g)(:2)(B)andsection 564(gX2.)(C)

oftheAct.

As

ofthe

date

ofthisletter,

theNova2200js

no

h;>:nger

authorizedf<>r eniergenc)' use

t>y

FDA.

FDA

encourages NovaSterilis Irie.

to

inform its customers

ofthis

xevocation.

Notfoe ofthi!rrevocation

will

be

published

in

the.Federal

Register,

pursuant to section

564(h)(l)

ofthe.Act.

Sincerely;

DeniseM.

Hinton-S

,~,{;:~\signed

b>fooil;.M.

\;:~~,2021JJ2.12: l5i47SH

-OSni

...

.

RADM DeniseM. Hinton

ChiefScienti$t

Food and Drug Adminisfration

4

Diliailed

test

r~lts,

can

b~

found

in

the

publi.cly-availa~ie

test

reportcat . . . . . .

..

.

..

..·

:fMww.cdc:

iniosh/rt

tifte

fuitotslttis

· , ·

039

Reda6red<so8:

df

5

I)eg;esysNE,

Wang

RC,~wan.E;.Ji'ilhil:iiir,

Nqble.J;<\,

............ ,

<;orretil:tion

U~tw¢iin:t<l9$}!xtepdetlt1seartd

Reuse and

i<"it

Fail~

nan

Emergency Department

J;,\ll,1A,

2020;324(1):94~96.

clcti:IQ,

lQOlf.iama.2020.9843.

·