Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices 28849 

Dated: May 24, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–11385 Filed 5–27–21; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0455] 

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 Battelle Memorial Institute for 

the Battelle Critical Care 

Decontamination System. FDA revoked 

the Authorization on April 30, 2021, 

under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) as requested 

by Battelle Memorial Institute on April 

2, 2021. The revocation, which includes 

an explanation of the reasons for the 

revocation, is reprinted in this 

document. 

DATES: The Authorization for the 

Battelle Critical Care Decontamination 

System is revoked as of April 30, 2021. 

ADDRESSES: Submit written requests for 

a single copy of the revocation to the 

Office of Counterterrorism and 

Emerging Threats, Food and Drug 

Administration, 10903 New Hampshire 

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

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

office in processing your request or 

include a Fax number to which the 

revocation may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the revocation. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer J. Ross, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4332, Silver Spring, MD 20993–0002, 

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

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb–3) allows FDA to 

strengthen the public health protections 

against biological, chemical, nuclear, 

and radiological agents. Among other 

things, section 564 of the FD&C Act 

allows FDA to authorize the use of an 

unapproved medical product or an 

unapproved use of an approved medical 

product in certain situations. On March 

28, 2020, FDA issued the Authorization 

to Battelle Memorial Institute for the 

Battelle Critical Care Decontamination 

System. Notice of the issuance of the 

Authorization was published in the 

Federal Register on June 5, 2020 (85 FR 

34638), 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) 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 


EN28MY21.010</GPH>

DEN20003J - Kristen Kanack Page .8 

bttps://w-wwJaa,gov/combittation-productsfguidance-regulatory-infonnation/postmarketinll:-safety-rep-Ortmgcombination-productskgood manufacfuring praetk.e requirements as set forth in the qualify systems (QS) 

.regulation (21 CPR.Part 820) funlevices oi-currenf good manufacturing practices (21 CFR4, SubpartA)foi: 

combination products; and if applicable, the electronic product radiation control provisions (Sections 531-

542 of1he FD&C Act); 21 CFR louiF 1050. . . 

A notice announcing ihis classil'ication order will be published m1:he Federal Register. A copy of this order 

and supporting docinnentation are on file in the Dockets Management Branch (HFA-305), Food and Drug 

Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 and are available for inspection 

between 9 a.:m, and4 p.m., Monday through Friday. 

As a result of1his order, you may innllediately market your device as. described in the De.Novo request 

subject to the geneml: control provisions of 1he FD&C Act and the special controls identified in ihis order: 

For comprehensive regu}afoiy infmmation about medical devices and radiation-emitting products, please see 

·Device.Advice {hqps:/fwww.fda.govfmedical.a.devic.es/device-advic.e-comprehensive-regularory-assiirtance) 

and CDRH Learn (https:/lw-ww.fda.govlttajmng-and-continuing-education/cdrh-leam). Additionally, you 

may contact.the Division of Industry and Consumer Education (DICE)toask a question about a specific 

regulatory topic. See 1he DICE website (hltps://www..fda.gov1medical~deviceyde\.'lrecadvice-commehensiveregulatory-assistanee/contact-ns-division-,industry-and-consumer-education-dice)·for more information or 

contactDICEbyemail (DIC£'lilfda.hhs.gov)orpbone(HW1Hi38-:2041 ot 30M96-7100). 

Jf you have anyqnestionsconceming the contents of the. letter; please contact Ricky Soong at 301-348-i894. 

Sincerely,. 

Uwe Scherf, M;Sc,, PhD. 

Director 

Division ofMiciobiology Devices 

OHTT: Officeofin Vitro Diagnostics 

and Radiological Hea11h 

Office of Product.Evaluation and Quality 

Centet for Devices and Radiological IIealth 
28850 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices 

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 Request for a 

Medical Device During COVID–19 

On April 2, 2021, Battelle Memorial 

Institute requested the revocation of, 

and on April 30, 2021, FDA revoked, the 

Authorization for the Battelle Critical 

Care Decontamination System. Because 

Battelle Memorial Institute notified FDA 

that it has ceased operations and 

associated activities and requests 

withdrawal of the Authorization, 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/148132/ 

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 

Battelle Critical Care Decontamination 

System. 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 


EN28MY21.011</GPH>

'Mf; J~ff:l{ose 

BaftelleMetrtotfaI lnstltute 

505lCingAvenue 

Columlms,9H 4~201 

Re! Revocatfon ot:EUA2002:to 

April-30, 2021 

!hisfotfot Isiht-esponse to B~ftelle 'Memotitd1nstitute~~ (Battelle's) requestdated April 2,2021, 

that1he U.S. Food and Drug Administration (FDA)withdtawtheEmergency Use Authorization 

(EUA20Q210) for the Bi:rrtelleC:ritical Qar.e I)eco11tamination System(her:eatlerr:ef<me4 tQ as 

"Battelle Dec:ontamintitionSystem") issuedun MiW:lh28, 2020,:a:nd ri::vised and reissued on ¥arc~ 29, 2020, Jlltte 6, 2020, and Jlttlttaty 2l~ 2021. fo its request, Battelle·cottl1rn1ed thatit 

has ceased opetationofall Battelle Decontamination System sites as well as associated 

m1,1tl<:eting activities, 

the authorization of a device for eroergenc;yuse ooder s~tfon 554. offhe:Federa,t Food, Drug, 

and CosmeticAct(theAct) (21 U.S,C.360bbb·3) may, putsuantto section $64(g)(2) of1heAct, 

be revokedwhe11 thectjteria un4ersectio115(i4(c)qf'the Act fQrissμance ofsuchauthqrj~t'.ion 

~~ no fonger met (sect'.ion5()4(g)(2)(13) oftheAct),OtQther circmn~cesmiil<e suchrevQCation 

appropriateto protect the public health or safety (sec~onS()4(sX+XC) oftheAct). Jkqause 

'.Battelle has notifted FDA that it has ceased operations and associated activities and requests 

withdrawal oftlie aμtliqrizatfon, FPAhas detei:mhied. d1at itis appr<>priate t9 protectthe public 

l\e:alth pr safetytore:voke this aiithorizatj'on. 

Accotdingly,FDA herebytttvokes mJA2002iO tot the Batteifo DecontammatiOn Systeli(,, 

pursuantto lllld sectiQtJ. 564(g)(2)(C) ofthel\;ct; Asofthedate ofthi~ letter~theBattelle 

Decontamination System is no longer authoriz\'.l4 for emergency use by FDA. 

FDA.ericourages'.Battelle toiiifortnitscustomets of this revocation. 

Notice ofthisrevocatiQU will be publishe.d inthe FederalRegisJer, pursuant fo section5()4(hXI) 

oftheAct. 

Sincerely; 

RADM Denise M. Hinton 

Chief Scientist 

Food and DrugAdtninistration 
Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices 28851 

1 50 U.S.C. 4558(c)(1). 

2 85 FR 18403 (Apr. 1, 2020). 

3 DHS Delegation 09052, Rev. 00.1 (Apr. 1, 2020); 

DHS Delegation Number 09052 Rev. 00 (Jan. 3, 

2017). 

Dated: May 24, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–11384 Filed 5–27–21; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Eye Institute 

Special Emphasis Panel; NEI Clinical Trials 

and Clinical Applications I. 

Date: June 24, 2021. 

Time: 11:00 a.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Eye Institute, National 

Institutes of Health, 6700B Rockledge Drive, 

Suite 3400, Bethesda, MD 20892 (Virtual 

Meeting). 

Contact Person: Jennifer C Schiltz, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Activities, 

National Eye Institute, National Institutes of 

Health, 6700B Rockledge Drive, Suite 3400, 

Bethesda, MD 20817, 240–276–5864, 

jennifer.schiltz@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.867, Vision Research, 

National Institutes of Health, HHS) 

Dated: May 24, 2021. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–11294 Filed 5–27–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Eye Institute 

Special Emphasis Panel; NEI Clinical Trials 

and Clinical Applications II. 

Date: June 28, 2021. 

Time: 10:00 a.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Eye Institute, National 

Institutes of Health, 6700B Rockledge Drive, 

Suite 3400, Bethesda, MD 20892 (Virtual 

Meeting). 

Contact Person: Jennifer C. Schiltz, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Activities, 

National Eye Institute, National Institutes of 

Health, 6700B Rockledge Drive, Suite 3400, 

Bethesda, MD 20817, 240–276–5864, 

jennifer.schiltz@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.867, Vision Research, 

National Institutes of Health, HHS) 

Dated: May 24, 2021. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–11293 Filed 5–27–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID FEMA–2020–0016] 

Pandemic Response Voluntary 

Agreement Under Section 708 of the 

Defense Production Act; Plans of 

Action To Respond to COVID–19 

AGENCY: Federal Emergency 

Management Agency, Department of 

Homeland Security. 

ACTION: Notice. 

SUMMARY: The Federal Emergency 

Management Agency (FEMA) 

announces the formation of four Plans 

of Action under the Voluntary 

Agreement for the Manufacture and 

Distribution of Critical Healthcare 

Resources Necessary to Respond to a 

Pandemic: Plan of Action to Establish a 

National Strategy for the Manufacture, 

Allocation, and Distribution of 

Diagnostic Test Kits and other Testing 

Components to Respond to COVID–19; 

Plan of Action to Establish a National 

Strategy for the Manufacture, 

Allocation, and Distribution of Drug 

Products, Drug Substances, and 

Associated Medical Devices to Respond 

to COVID–19; Plan of Action to 

Establish a National Strategy for the 

Manufacture, Allocation, and 

Distribution of Medical Devices to 

Respond to COVID–19; and Plan of 

Action to Establish a National Strategy 

for the Manufacture, Allocation, and 

Distribution of Medical Gases to 

Respond to COVID–19. This notice 

contains the text of all four Plans of 

Action. 

FOR FURTHER INFORMATION CONTACT: 

Robert Glenn, Office of Business, 

Industry, Infrastructure Integration, via 

email at OB3I@fema.dhs.gov or via 

phone at (202) 212–1666. 

SUPPLEMENTARY INFORMATION: 

Background and Legal Authority 

The Defense Production Act (DPA), 50 

U.S.C. 4501 et seq., authorizes the 

making of ‘‘voluntary agreements and 

plans of action’’ with, among others, 

representatives of industry and business 

to help provide for the national 

defense.1 The President’s authority to 

facilitate voluntary agreements was 

delegated to the Secretary of Homeland 

Security with respect to responding to 

the spread of COVID–19 within the 

United States in Executive Order 

13911.2 The Secretary of Homeland 

Security has further delegated this 

authority to the FEMA Administrator.3

On August 17, 2020, after the 

appropriate consultations with the 

Attorney General and the Chairman of 

the Federal Trade Commission and after 

requesting and considering public 

comments, FEMA completed and 

published in the Federal Register a 

‘‘Voluntary Agreement, Manufacture 

and Distribution of Critical Healthcare 

Resources Necessary to Respond to a