25644 Federal Register / Vol. 87, No. 84 / Monday, May 2, 2022 / Notices 

notice, (Differences Between TJC’s 

Standards and Requirements for 

Accreditation and Medicare Conditions 

and Survey Requirements) as authorized 

under § 488.8, we will continue ongoing 

review of TJC’s hospital survey. In 

keeping with CMS’s initiative to 

increase AO oversight broadly, and 

ensure that our requested revisions by 

TJC are completed, CMS expects more 

frequent review of TJC’s activities in the 

future. 

VI. Collection of Information 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Lynette Wilson, who is the 

Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Dated: April 27, 2022. 

Lynette Wilson, 

Federal Register Liaison, Center for Medicare 

& Medicaid Services. 

[FR Doc. 2022–09361 Filed 4–29–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–3427] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by June 1, 2022. 

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. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address at: https://

www.cms.gov/Regulations-andGuidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: End Stage Renal 

Disease Application and Survey and 

Certification Report; Use: The Form 

CMS–3427 is required for each new 

ESRD facility seeking initial 

certification and for each existing 

facility seeking recertification, 

relocation, expansion/change of 

service(s), or change of ownership. The 

form is also used for information 

collection purposes related to a 

complaint survey of an ESRD facility. 

The Form CMS–3427 information is 

currently collected on paper as a 

manual option or may be completed in 

an online fillable format based on 

facility preference. This online form is 

a step in the direction towards 

electronic submission. Form Number: 

CMS–3427 (OMB control number: 

0938–0360); Frequency: Every three 

years; Affected Public: Private sector 

(Business or other for-profit and Not-for 

profit institutions); Number of 

Respondents: 7,883; Total Annual 

Responses: 2,601; Total Annual Hours: 

866. (For policy questions regarding this 

collection contact Jennifer Milby at 410– 

786–8828). 

Dated: April 27, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–09388 Filed 4–29–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0354] 

Acrotech Biopharma LLC; Withdrawal 

of Approval of New Drug Application 

for MARQIBO (VinCRIStine Sulfate 

LIPOSOME Injection), 5 milligrams/5 

milliliters 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of new drug 

application (NDA) for MARQIBO 

(vinCRIStine sulfate LIPOSOME 

injection), 5 milligrams (mg)/5 

milliliters (mL), held by Acrotech 

Biopharma LLC (Acrotech), 29 

Princeton Hightstown Rd., East 

Windsor, NJ 08520. Acrotech has 

voluntarily requested that FDA 

withdraw approval of this application 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 84 / Monday, May 2, 2022 / Notices 25645 

and has waived its opportunity for a 

hearing. 

DATES: Approval is withdrawn as of 

May 2, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Lehrfeld, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–3137, Kimberly.Lehrfeld@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On August 

9, 2012, FDA approved NDA 202497 for 

MARQIBO (vinCRIStine sulfate 

LIPOSOME injection), 5 mg/5 mL, for 

the treatment of adult patients with 

Philadelphia chromosome-negative

(Ph-) acute lymphoblastic leukemia 

(ALL) in second or greater relapse or 

whose disease has progressed following 

two or more anti-leukemia therapies, 

under the Agency’s accelerated approval 

regulations, 21 CFR part 314, subpart H. 

The accelerated approval of MARQIBO 

(vinCRIStine sulfate LIPOSOME 

injection) for Ph-ALL included a 

required postmarketing clinical trial 

intended to verify the clinical benefit of 

MARQIBO (vinCRIStine sulfate 

LIPOSOME injection). 

On September 24, 2021, FDA 

published the Federal Register notice 

‘‘Oncologic Drugs Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments,’’ 

announcing that MARQIBO 

(vinCRIStine sulfate LIPOSOME 

injection) would be discussed at an 

Oncologic Drug Advisory Committee 

Meeting (ODAC) scheduled for 

December 2, 2021 (86 FR 53067). On 

October 27, 2021, FDA met with 

Acrotech to discuss the planned ODAC 

meeting. At that meeting, the Agency 

recommended the applicant voluntarily 

request withdrawal of approval for 

MARQIBO (vinCRIStine sulfate 

LIPOSOME injection), 5 mg/5mL, due to 

the lack of verification of clinical 

benefit. The postmarketing trial required 

to verify clinical benefit had not been 

completed, and patient recruitment to 

fulfill the PMR appeared to be 

significantly challenging due to the 

treatment options that are currently 

available. 

On November 19, 2021, Acrotech 

submitted a letter asking FDA to 

withdraw approval of NDA 202497 for 

MARQIBO (vinCRIStine sulfate 

LIPOSOME injection), 5 mg/5mL, 

pursuant to § 314.150(d) (21 CFR 

314.150(d)) and waiving its opportunity 

for a hearing. On November 23, 2021, 

FDA acknowledged Acrotech’s request 

for withdrawal of approval of the NDA 

and waiver of its opportunity for 

hearing. FDA also cancelled the ODAC 

meeting scheduled for December 2, 

2021, since Acrotech’s withdrawal 

request made discussion at an advisory 

committee meeting moot. 

For the reasons discussed above, and 

in accordance with the applicant’s 

request, approval of NDA 202497 for 

MARQIBO (vinCRIStine sulfate 

LIPOSOME injection), 5 mg/5mL, and 

all amendments and supplements 

thereto, is withdrawn under 

§ 314.150(d). Distribution of MARQIBO 

(vinCRIStine sulfate LIPOSOME 

injection) 5 mg/5mL, into interstate 

commerce without an approved 

application is illegal and subject to 

regulatory action (see sections 505(a) 

and 301(d) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355(a) and 

331(d)). 

Dated: April 26, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09235 Filed 4–29–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–0895] 

Issuance of Priority Review Voucher; 

Material Threat Medical 

Countermeasure Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a material threat medical 

countermeasure (MCM) product 

application. The Federal Food, Drug, 

and Cosmetic Act (FD&C Act), as 

amended by the 21st Century Cures Act 

(Cures Act), authorizes FDA to award 

priority review vouchers to sponsors of 

approved material threat MCM product 

applications that meet certain criteria. 

FDA is required to publish notice of the 

award of the priority review voucher. 

FDA has determined that INMAZEB 

(atoltivimab, maftivimab, and 

odesivimab-ebgn), manufactured by 

Regeneron Pharmaceuticals, Inc., meets 

the criteria for a material threat MCM 

priority review voucher. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Sadove, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–8515, Fax: 301– 

796–8615, email: EUA.OCET@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a material 

threat MCM priority review voucher to 

the sponsor of an approved material 

threat MCM product application. Under 

section 565A of the FD&C Act (21 U.S.C. 

360bbb–4a), which was added by the 

Cures Act (Pub. L. 114–255), FDA will 

award priority review vouchers to 

sponsors of approved material threat 

MCM product applications that meet 

certain criteria upon approval of those 

applications. FDA has determined that 

INMAZEB (atoltivimab, maftivimab, and 

odesivimab-ebgn), manufactured by 

Regeneron Pharmaceuticals, Inc., meets 

the criteria for a material threat MCM 

priority review voucher. INMAZEB was 

approved on October 14, 2020. 

mINMAZEB is a mixture of three 

monoclonal antibodies indicated for the 

treatment of infection caused by Zaire 

ebolavirus (Ebola virus) in adult and 

pediatric patients. 

For further information about the 

material threat MCM Priority Review 

Voucher Program and for a link to the 

full text of section 565A of the FD&C 

Act, go to https://www.fda.gov/

emergency-preparedness-and-response/

mcm-legal-regulatory-and-policyframework/mcm-relatedcounterterrorism-legislation. For further 

information about INMAZEB 

(atoltivimab, maftivimab, and 

odesivimab-ebgn), go to the Drugs@FDA 

website at https://

www.accessdata.fda.gov/scripts/cder/

daf/. 

Dated: April 26, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09315 Filed 4–29–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–New] 

Agency Information Collection 

Request; 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before June 1, 2022. 


jspears on DSK121TN23PROD with NOTICES1