69932 Federal Register / Vol. 88, No. 194 / Tuesday, October 10, 2023 / Notices 

the terms of the generic. Burden 

estimates have been updated. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review-Open 

for Public Comments’’ or by using the 

search function. You can also obtain 

copies of the proposed collection of 

information by emailing 

OPREinfocollection@acf.hhs.gov. 

Identify all requests by the title of the 

information collection. 

SUPPLEMENTARY INFORMATION: 

Description: Program monitoring is a 

post-award process through which ACF 

assesses a recipient’s programmatic 

performance and business management 

performance. Monitoring activities are 

necessary to ensure timely action by 

ACF to support grantees and protect 

federal interests. 

Program offices use information 

collected under this generic clearance to 

monitor funding recipient activities and 

to provide support or take appropriate 

action, as needed. The information 

gathered is or will be used primarily for 

internal purposes, but aggregate data 

may be included in public materials 

such as Reports to Congress or program 

office documents. Following standard 

OMB requirements, ACF will submit a 

request for each individual data 

collection activity under this generic 

clearance. Each request will include the 

individual form(s) or instrument(s), a 

justification specific to the individual 

information collection, and any 

supplementary documents. OMB is 

requested to review requests within 10 

days of submission. 

Respondents: ACF funding recipients. 

Annual Burden Estimates 

This request will extend approval of 

currently approved monitoring forms. 

Currently approved forms and related 

burden can be found here: https://

www.reginfo.gov/public/do/ 

PRAICList?ref_nbr=202307-0970-014. 

Burden estimates for the next three 

years have been updated to reflect 

trends in use over the past three years. 

These are based on averages and actual 

individual requests will vary based on 

program office need. 

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Avg. burden 

per response 

(in hours) 

Total burden 

(in hours) 

New Program Monitoring Forms .................................................................... 1600 2.5 12 48,000 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–22382 Filed 10–6–23; 8:45 am] 

BILLING CODE 4184–79–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3636] 

Food and Drug Administration 

Information Technology Strategy; 

Request for Comments; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

correcting a notice entitled ‘‘Food and 

Drug Administration Information 

Technology Strategy; Request for 

Comments’’ that appeared in the 

Federal Register of September 19, 2023. 

The document announced the 

availability of an information 

technology (IT) strategic plan entitled 

the ‘‘FDA Information Technology 

Strategy’’ and a request for comment on 

this IT Strategy. The document was 

published with an incorrect set of fiscal 

year information. This document 

corrects that error. 

FOR FURTHER INFORMATION CONTACT: Casi 

Alexander, Office of Digital 

Transformation, Food and Drug 

Administration, FDA Library, 5630 

Fishers Lane, Rm. 1087, Rockville, MD 

20857, 240–402–5171, email: 

Casi.Alexander@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of September 19, 2023 

(88 FR 64435), in FR Doc. 2023–20136, 

the following correction is made: 

On page 64436, in the third column, 

in the second paragraph, ‘‘Fiscal Years 

2024–2026’’ is corrected to read ‘‘Fiscal 

Years 2024–2027.’’ 

Dated: October 4, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22388 Filed 10–6–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4202] 

Revocation of Two Authorizations of 

Emergency Use of In Vitro Diagnostic 

Devices for Detection and/or Diagnosis 

of Mpox; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

revocations of the Emergency Use 

Authorizations (EUAs) (the 

Authorizations) issued to Life 

Technologies Corp. (a part of Thermo 

Fisher Scientific Inc.), for the TaqPath 

Monkeypox/Orthopox Virus DNA Kit, 

and Becton, Dickinson and Co., for the 

VIASURE Monkeypox virus Real Time 

PCR Reagents for BD MAX System. FDA 

revoked these Authorizations under the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) as requested by these 

Authorization holders. The revocations, 

which include an explanation of the 

reasons for each revocation, are 

reprinted in this document. 

DATES: The Authorization for the Life 

Technologies Corp. (a part of Thermo 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 194 / Tuesday, October 10, 2023 / Notices 69933 

Fisher Scientific Inc.)’s, TaqPath 

Monkeypox/Orthopox Virus DNA Kit is 

revoked as of April 18, 2023. The 

Authorization for the Becton, Dickinson 

and Co.’s, VIASURE Monkeypox virus 

Real Time PCR Reagents for BD MAX 

System is revoked as of May 24, 2023. 

ADDRESSES: Submit written requests for 

a single copy of the revocations to the 

Office of Policy, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, 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 

revocations may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the revocations. 

FOR FURTHER INFORMATION CONTACT: Kim 

Sapsford-Medintz, Office of Product 

Evaluation and Quality, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 3216, 

Silver Spring, MD 20993–0002, 301– 

796–0311 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb–3) as amended by the 

Project BioShield Act of 2004 (Pub. L. 

108–276) and the Pandemic and AllHazards Preparedness Reauthorization 

Act of 2013 (Pub. L. 113–5) allows FDA 

to strengthen the public health 

protections against biological, chemical, 

radiological, or nuclear agent or 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 December 13, 2022, FDA issued the 

Authorization to Life Technologies 

Corp. (a part of Thermo Fisher Scientific 

Inc.) for the TaqPath Monkeypox/ 

Orthopox Virus DNA Kit, subject to the 

terms of the Authorization. Notice of the 

issuance of this Authorization was 

published in the Federal Register on 

January 11, 2023 (88 FR 1587), as 

required by section 564(h)(1) of the 

FD&C Act. On December 23, 2022, FDA 

issued the Authorization to Becton, 

Dickinson and Co. for the VIASURE 

Monkeypox virus Real Time PCR 

Reagents for BD MAX System subject to 

the terms of the Authorization. Notice of 

the issuance of this Authorization was 

published in the Federal Register on 

January 31, 2023 (88 FR 6262), as 

required by section 564(h)(1) of the 

FD&C Act. Subsequent updates to the 

Authorizations were made available on 

FDA’s website. 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. Authorizations Revocation Request 

In a request received by FDA on April 

13, 2023, Life Technologies Corp. (a part 

of Thermo Fisher Scientific Inc.), 

requested the revocation of, and on 

April 18, 2023, FDA revoked, the 

Authorization for the Life Technologies 

Corp. (a part of Thermo Fisher Scientific 

Inc.)’s TaqPath Monkeypox/Orthopox 

Virus DNA Kit. Because Life 

Technologies Corp. (a part of Thermo 

Fisher Scientific Inc.), notified FDA that 

it is not commercially supporting the 

TaqPath Monkeypox/Orthopox Virus 

DNA Kit and no kit reagents were 

distributed in the United States and 

requested FDA revoke the Life 

Technologies Corp. (a part of Thermo 

Fisher Scientific Inc.)’s TaqPath 

Monkeypox/Orthopox Virus DNA Kit, 

FDA has determined that it is 

appropriate to protect the public health 

or safety to revoke this Authorization. 

In a request received by FDA on May 

22, 2023, Becton, Dickinson and Co., 

requested the withdrawal of, and on 

May 24, 2023, FDA revoked, the 

Authorization for the Becton, Dickinson 

and Co.’s VIASURE Monkeypox virus 

Real Time PCR Reagents for BD MAX 

System. Because Becton, Dickinson and 

Co., notified FDA that it is not 

commercially manufacturing the 

VIASURE Monkeypox virus Real Time 

PCR Reagents for BD MAX System and 

no reagents were distributed in the 

United States and requested FDA revoke 

the Becton, Dickinson and Co.’s 

VIASURE Monkeypox virus Real Time 

PCR Reagents for BD MAX System, 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/. 

IV. The Revocations 

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 of Life 

Technologies Corp. (a part of Thermo 

Fisher Scientific Inc.)’s TaqPath 

Monkeypox/Orthopox Virus DNA Kit, 

and Becton, Dickinson and Co.’s 

VIASURE Monkeypox virus Real Time 

PCR Reagents for BD MAX System. The 

revocations in their entirety follow and 

provide an explanation of the reasons 

for revocations, as required by section 

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

BILLING CODE 4164–01–P 


ddrumheller on DSK120RN23PROD with NOTICES1
69934 Federal Register / Vol. 88, No. 194 / Tuesday, October 10, 2023 / Notices 


ddrumheller on DSK120RN23PROD with NOTICES1EN10OC23.020</GPH>

April 18, 2023. 

$tacey M()ltch®.ott 

Reguiatory•.AfIIUl'S Manager 

file Techno1ogies.•.Corporation(apiiitBf'.Themi◊ F1shet:Scientific,Jnc.} 

5781 V:anA.llen\Vay 

C!ltlsbad; GA92Q0$ 

Re: Revocation ofEUA:220461 

ThisJeUer is lll resp<>nsefo therequeslfromLffeTechnologies Corporation (a part of Thermo 

FishetScientific Inc), in .aJetter receiy<:dApril B, 2023, that theU.S. Food and Dntg 

Administration.(FDA)re:voke the EUAfofTaqPath M()nkeyi,ox/Ortho~ox V'irus DNA I<.it 

issued on De~mber 13, 2Q22. Thermo Fisher Scientific Inc; hl:t& decided not.Jo comtneI"cially 

support the EUA product and requested that the ~UA be re~oked, FDA understands that, as of 

the date of:thisJetter,noTaqPathMonke:ypox/Orthopox Vin.I$ DNAKttreagents wete 

distributed m the United States. 

The authorizationofa deviceforemergency use undersectfon 564 ofthe Federal Food, Drug, 

and Cosmetic Act (the,Act) (21 U.S.C. 360bbb•3) may,pursuanFto section 564(g)(2) oftheAct, 

be revoked-when circumstiirices tnake sttchrevocation appropriate to. ptotectthe.public health. or 

safety (section $64(g)(2)(C} ofthe0Act), Because Toenno Fisher Scientificlnc. has,requested 

thiltFl)Are:vokt}the El.J.Aforthe TaqPilthMonkeypox/Orlhopox Vir:tlS DNAKit, FDAhas. 

determined that ifis appt:~priate, to protect the pubHo health or safe~; i~ t'e~ke this 

authqrization: Accordingly. FI)J\ here~y revokes EUA220Mit for the TaqPath 

MonkeyPoXl'.OrthopoxVirus DNA Kit, pursuanU<>: section S64(gX2)(C) qfthe A¢{ As ofilie 

4* ofthisJetter; the TaqPilth Monkeypox/Orth()pux Vi~ DNA Kitis no lon~r attthgrized,for 

emergency use by FDA 

Notice ofthisrevocatiortwill·t;e··published mtlieftedeti'ttRegister,putsuant tosectfort564(h)(l) 

oftheAct 

JeffreyE. Shuren, M.D., J~D. 

Director 

Centerfor Devi~ an.41flldi<>fogical aeatttx 

Food an<l't>rugA,d,:nt.iμistr~timt • 
Federal Register / Vol. 88, No. 194 / Tuesday, October 10, 2023 / Notices 69935 

Dated: October 4, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22390 Filed 10–6–23; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Closed Meeting 

Pursuant to section 1009 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 Institute on 

Drug Abuse Special Emphasis Panel; 

Implementing Comprehensive HIV Services 

in Syringe Service Program Settings. 

Date: November 17, 2023. 

Time: 12:00 to 2:00 p.m. 


ddrumheller on DSK120RN23PROD with NOTICES1EN10OC23.021</GPH>

May24,2023 

Melissa Barhoover, Ph.D., RAC 

Sen:ior Regulatory Affairs Manager 

BectQn, Dickinson and Company 

7 Loveton Circle, 

Sparks, MD 21152-0999 

Re: Revocation ofEUA220453 

Dear Dr. Barhoover: 

This letter is ill response to the request from Becton, Dickinson and Company ("BD')~ ill a ktter 

received May 22, 2023, that the U.S. Food and Drug Admillistration (FDA) withdraw the EUA 

for the VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System issued on 

December 23, 2022. BD has decided not to manufacture or sell these kits moving forward and 

requested that the EU A be withdrawn. FDA understands that, as of the date of this letter, no 

VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System reagents were 

distributed ill the United States. 

The authorization of a device for. emergency use under section 564 of the Federal Food, Drug, 

and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuantto section 564(gX2) oftlie Act, 

be revoked. when circumstam:es make such revocation appropriate to pr-0tect ihe public health Qr 

safety (section 564(g)(2)(C) of the Act). Because BD has requested that FDA withdraw the EUA 

for the VIASURE Monkeypox vnus Real Time PCR Reagents for BD MA,X System, FDA has 

determined that itis appropriate, to protect the public health or safety, to revoke this 

authorization. Accordingly, FDA hereby revokes EUA220453 for the VIASURE MonkeYPox 

virus Real Time PCR Reagents for BD MA,XSystem, pursuant to.section 564(g)(2XC) of the 

Act. As of the date ofthis letter, the VIASURE Monkeypox virus Real Time PCR Reagents for 

BD MA,X System is no longer authorized for emergency use by FDA. 

Notice of this tevoc.ation wiil be published in the Federal Regzs.tet, p0rsu:ant to section 564(hXl) 

oftheAct. • 

Sincerely~ 

Jeffrey E. Shuren, M.D., J.D. 

Director 

Center for Devices and Radiological Health 

Food and Drug Admillistration •