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DATES: Approval is withdrawn as of 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