Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices 83021 

Dated: October 8, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–23646 Filed 10–11–24; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0335] 

Revocation of Emergency Use of a 

Biological Product During the COVID– 

19 Pandemic; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the revocation of the 

Emergency Use Authorization (EUA) 

(the Authorization) issued to Janssen 

Biotech, Inc. (Janssen), for the Janssen 

COVID–19 Vaccine. FDA revoked the 

Authorization on June 1, 2023, 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 is revoked as 

of June 1, 2023. 

ADDRESSES: Submit written requests for 

a single copy of the revocation to the 

Office of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

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 

Authorization. 

FOR FURTHER INFORMATION CONTACT: 

Tami Belouin, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

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 

February 27, 2021, FDA issued an 

Authorization (EUA 27205) to Janssen 

for the Janssen COVID–19 Vaccine, 

subject to the terms of the 

Authorization. Notice of the issuance of 

the Authorization was published in the 

Federal Register on May 27, 2021 (86 

FR 28608), as required by section 

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

updates to the Authorization were made 

available on FDA’s website. The 

authorization of a biological product 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. EUA Revocation Request 

In a request received by FDA on May 

22, 2023, Janssen requested withdrawal 

of, and on June 1, 2023, FDA revoked, 

the Authorization for the Janssen 

COVID–19 Vaccine. Janssen notified 

FDA that the last lots of the Janssen 

COVID–19 Vaccine purchased by the 

U.S. Government have expired, that 

there is no demand for new lots of the 

Janssen COVID–19 Vaccine in the 

United States, and that it does not 

intend to update the strain composition 

of this vaccine to address emerging 

variants. Based on FDA’s understanding 

that Janssen does not intend to offer the 

Janssen COVID–19 Vaccine in the 

United States under the EUA anymore 

and Janssen’s request that FDA revoke 

the EUA for the Janssen COVID–19 

Vaccine, FDA has determined that it is 

appropriate to revoke this Authorization 

to protect the public health or safety. 

III. 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 

Janssen COVID–19 Vaccine. Although 

FDA revoked the Authorization for the 

Janssen COVID–19 Vaccine on June 1, 

2023, as was publicly announced on the 

Agency’s website, publication of notice 

of this revocation in the Federal 

Register was inadvertently delayed. 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. 

IV. Electronic Access 

An electronic version of this 

document and the full text of the 

Authorizations and revocation are 

available on the internet at https://

www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization. 

BILLING CODE 4164–01–P 


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83022 Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices 


khammond on DSKJM1Z7X2PROD with NOTICESEN15OC24.037</GPH>

FOOD DRUG 

June 1, 2023 

Janssen Biotech, Inc. 

Attention: Ms. Ruta Walawalkar 

92.0 Route 202 

Raritan, NJ 08869 

Re: Revocation of EUA 27205 ~ Janssen COVID-19 Vaccine 

Dear Ms. Walawalkar: 

This letter is in response to the request from Janssen Biotech, Inc. received on May 22, 

2023, that the U.S. Food and Drug Administration (FDA) withdraw the EUA for the 

Janssen COVID-19 Vaccine issued on February 27, 2021, as subsequently amended. 

Janssen Biotech, Inc has informed the FDA that the last lots of the Janssen COVID-19 

Vaccine purchased by the United States Government have. expired, that there is no 

demand for new lots of the Janssen COVID-19 Vaccine in the United States, and that 

Janssen Biotech, Inc does not intend to update the strain composition of this vaccine to 

address emerging variants. 

The authorization of a biological product for emergency use under section 564 of the 

Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb~3) may, pursuant to 

section 564(g)(2) of the Act, be revoked when circumstances make such revocation 

appropriate to protect the public health or safety (section 564(g)(2)(C) of the Act). 

Because FDA understands that Janssen Biotech, Inc. no longer intends to offer the 

Janssen COVID-19 Vaccine in the United States under the EUA and because Janssen 

Biotech, Inc. has requested that FDA withdraw the EUA for the Janssen COVID-19 

Vaccine, FDA has determined that it is appropriate to protect the public health or safety 

to revoke this authorization. 

Accordingly, FDA hereby revokes EUA 27205 for the Janssen COVID-19 Vaccine, 

pursuant to section 564(g)(2)(C) of the Act As of the date of this letter, the Janssen 

COVID-19 Vaccine is no longer authorized for emergency use by FDA.. 

Notice of this revocation will be published in the Federal Register, pursuant to section 

564(h)(1) of the Act. 

Sincerely, 

Peter W, Marks-, 

s o, .. , "''''"''"' 

Peter Marks, M.D, Ph.D. 

Director 

Center for Biologics Evaluation and Research 
Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices 83023 

Dated: September 27, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–23637 Filed 10–11–24; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0026] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product; 

AQNEURSA (Levacetylleucine) 

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 rare pediatric disease 

product application. The Federal Food, 

Drug, and Cosmetic Act (FD&C Act) 

authorizes FDA to award priority review 

vouchers to sponsors of approved rare 

pediatric disease product applications 

that meet certain criteria. FDA is 

required to publish notice of the award 

of the priority review voucher. FDA has 

determined that AQNEURSA 

(levacetylleucine), approved on 

September 24, 2024, manufactured by 

IntraBio Inc., meets the criteria for a 

priority review voucher. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn Lee, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–1394. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a priority 

review voucher to the sponsor of an 

approved rare pediatric disease product 

application. Under section 529 of the 

FD&C Act (21 U.S.C. 360ff), FDA will 

award priority review vouchers to 

sponsors of approved rare pediatric 

disease product applications that meet 

certain criteria. FDA has determined 

that AQNEURSA (levacetylleucine), 

manufactured by IntraBio Inc., meets 

the criteria for a priority review 

voucher. AQNEURSA (levacetylleucine) 

is indicated for the treatment of 

neurological manifestations of 

Niemann-Pick disease type C in adults 

and pediatric patients weighing ≥15 kg. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to https://www.fda.gov/ForIndustry/ 

DevelopingProductsforRareDiseases

Conditions/RarePediatricDiseasePriority

VoucherProgram/default.htm. For 

further information about AQNEURSA 

(levacetylleucine), go to the ‘‘Drugs@

FDA’’ website at http://

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

daf/. 

Dated: October 8, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–23712 Filed 10–11–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Statement of Organization, Functions, 

and Delegations of Authority 

This notice amends Part R of the 

Statement of Organization, Functions, 

and Delegations of Authority of the 

Department of Health and Human 

Services (HHS), Health Resources and 

Services Administration (HRSA) (60 FR 

56605, as amended November 6, 1995; 

as last amended at 89 FR 19832 dated 

March 20, 2024) to reorganize sections 

of the Maternal and Child Health 

Bureau (MCHB). 

This reorganization updates and/or 

realigns functions, including 

delegations of authority for MCHB (RM). 

Chapter RM—Maternal and Child 

Health Bureau (RM) 

Section RM.10 Organization 

Establish the Office of Strategy, 

Innovation, and External Affairs and the 

Division of Women’s Health. 

Following this realignment, MCHB 

includes the following components: 

• Office of the Associate 

Administrator (RM), 

• Office of Policy and Planning 

(RMA), 

• Office of Strategy, Innovation, and 

External Affairs (RMB), 

• Office of Operations and 

Management (RM1), 

• Division of Services for Children 

with Special Health Needs (RM2), 

• Division of Child, Adolescent, and 

Family (RM3), 

• Division of Maternal and Child 

Health Workforce Development (RM4), 

• Division of Healthy Start and 

Perinatal Services (RM5), 

• Division of State and Community 

Health (RM6), 

• Division of Home Visiting and Early 

Childhood Systems (RM8), 

• Office of Epidemiology and 

Research (RM9), and 

• Division of Women’s Health (RMC). 

Section RM.20 Function 

Update the functional statements for 

the Office of the Associate 

Administrator, Office of Policy and 

Planning, Division of Healthy Start and 

Perinatal Services, and Division of 

Home Visiting and Early Childhood 

Systems and add the functional 

statement for the Office of Strategy, 

Innovation, and External Affairs and 

Division of Women’s Health: 

Office of the Associate Administrator 

(RM) 

The Office of the Associate 

Administrator provides national 

leadership and policy direction for 

MCHB programs. These programs are 

designed to improve the health of 

women of childbearing age, infants, 

children, adolescents and their families, 

children with special health needs, and 

persons with hemophilia. Specifically, 

the Office: (1) coordinates the planning, 

development, implementation, and 

evaluation of MCHB’s programs and 

activities; (2) facilitates effective, 

collaborative relationships with other 

health and related programs; (3) 

establishes program mission, goals, 

objectives, and policy with broad 

Administration guidelines; (4) arranges 

and provides technical assistance to 

ensure that grantees meet program 

expectations; (5) serves as principal 

contact point across HRSA, HHS, and 

other agencies on matters concerning 

the health status of America’s mothers 

and children; and (6) provides 

information and reports on MCHB’s 

programs to Congress, other federal 

agencies, the public, and other 

stakeholders. 

Office of Policy and Planning (RMA) 

The Office of Policy and Planning 

serves as MCHB’s focal point for the 

development of MCHB policy and 

program planning. Specifically, the 

Office: (1) supports the Office of the 

Associate Administrator in identifying, 

planning, and implementing policy and 

program priorities across MCHB; (2) 

advises and assists in the development, 

coordination, and management of 

program and policy documents and 

responses to departmental and HRSA 

initiatives; and (3) coordinates with 

other components within HRSA, HHS, 

federal agencies, state and local 

governments, and other public and 

private organizations on issues affecting 

MCHB programs and policies. 

Office of Strategy, Innovation, and 

External Affairs (RMB) 

The Office of Strategy, Innovation, 

and External Affairs serves as MCHB’s 

focal point for strategic planning, 


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