88402 Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Notices 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Maria Clary, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4638, Silver Spring, 

MD 20993–0002, 240–402–8615. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance for industry entitled 

‘‘Development of Monoclonal Antibody 

Products Targeting SARS–CoV–2 for 

Emergency Use Authorization.’’ This 

guidance provides recommendations to 

sponsors on the development of 

monoclonal antibody products targeting 

SARS–CoV–2 intended for the 

prevention or treatment of COVID–19. 

The recommendations focus on the data 

and information that may be used to 

support a request for EUA under section 

564 of the FD&C Act (21 U.S.C. 360bbb– 

3). Specifically, the guidance discusses 

the manufacturing, pharmacology/ 

toxicology, virologic, and clinical 

considerations to support EUA. 

This guidance supersedes the 

guidance for industry entitled 

‘‘Development of Monoclonal Antibody 

Products Targeting SARS–CoV–2, 

Including Addressing the Impact of 

Emerging Variants, During the COVID– 

19 Public Health Emergency,’’ which 

was published in February 2021. FDA 

issued the guidance to communicate its 

policy for the duration of the COVID–19 

public health emergency (PHE) declared 

by the Secretary of Health and Human 

Services (HHS) on January 31, 2020, 

including any renewals made by the 

HHS Secretary in accordance with 

section 319(a)(2) of the Public Health 

Service Act (42 U.S.C. 247d(a)(2)). In the 

Federal Register of March 13, 2023 (88 

FR 15417), FDA listed certain guidance 

documents that FDA was revising to 

continue in effect for 180 days after the 

expiration of the COVID–19 PHE 

declaration, during which time FDA 

planned to further revise the guidances. 

The February 2021 guidance on 

development of monoclonal antibody 

products targeting SARS–CoV–2 is 

included in this list. 

Although circumstances have 

improved, SARS–CoV–2 remains in 

broad circulation throughout the United 

States. The virus has and continues to 

evolve over time, and in certain 

instances, mutations in the virus have 

greatly reduced the activity of 

monoclonal antibody therapies available 

for the prevention or treatment of 

COVID–19, resulting in vulnerable 

populations having limited preventative 

and therapeutic options. FDA retains 

the ability to issue an EUA under 

section 564 of the FD&C Act for 

products to treat or prevent COVID–19, 

so the recommendations in this 

guidance are still pertinent (88 FR 

16644). This guidance is intended to 

remain in effect only for the duration of 

the declaration by the Secretary of HHS 

under section 564 of the FD&C Act 

effective March 27, 2020, that 

circumstances exist justifying the 

authorization of emergency use of drugs 

and biological products during the 

COVID–19 pandemic (85 FR 18250). In 

revising this guidance, FDA considered 

comments received on the 2021 

guidance as well as the Agency’s 

experience issuing COVID–19-related 

EUAs. In addition, editorial changes 

were made to improve clarity. 

Given the need to ensure that 

sponsors are aware of our current 

recommendations to facilitate timely 

development of monoclonal antibody 

products targeting SARS–CoV–2, FDA is 

issuing this guidance for immediate 

implementation without initially 

seeking prior comment because the 

Agency has determined that prior public 

participation is not feasible or 

appropriate (see § 10.115(g)(2) and 

section 701(h)(1)(C)(i) of the FD&C Act 

(21 U.S.C. 371(h)(1)(C)(i))). This 

guidance document is being 

implemented immediately, but it 

remains subject to comment in 

accordance with the Agency’s good 

guidance practices (see § 10.115(g)(3)). 

The guidance represents the current 

thinking of FDA on ‘‘Development of 

Monoclonal Antibody Products 

Targeting SARS–CoV–2 for Emergency 

Use Authorization.’’ It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR part 314 

pertaining to new drug applications 

have been approved under 0910–0001. 

The collections of information 

pertaining to EUA of medical products 

have been approved under OMB control 

number 0910–0595. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: December 15, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28092 Filed 12–20–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Advisory Committee on 

Minority Health 

AGENCY: Office of Minority Health, 

Office of the Secretary, U.S. Department 

of Health and Human Services. 

ACTION: Notice of meeting. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the U.S. 

Department of Health and Human 

Services (HHS) is hereby giving notice 

that the Advisory Committee on 

Minority Health (ACMH) will hold a 

meeting. This meeting will be open to 

the public. Preregistration is required 

for the public to attend the meeting, 

provide comments, and/or distribute 

printed material(s) to ACMH members. 

Information about the meeting is 

available from the designated contact 

person and will be posted on the HHS 

Office of Minority Health (OMH) 

website: www.minorityhealth.hhs.gov. 

Information about ACMH activities can 

be found on the OMH website under the 

heading About OMH, Committees and 

Working Groups. 

DATES: The ACMH meeting will be held 

on February 13–14, 2024 from 8:30 a.m. 

to 5:30 p.m. EST each day. If the 

Committee completes its work before 

5:30 p.m., the meeting will adjourn 

early. 

ADDRESSES: The meeting will be held at 

the Tower Building at 1101 Wootton 

Parkway, Lower Level Conference 

Room, Rockville, Maryland 20852 and 

will be accessible by webcast. Members 

of the public must register for the 

meeting by 5:00 p.m. EST on January 30, 

2024. Registered webcast participants 

will receive webcast access information 

prior to the meeting. 

FOR FURTHER INFORMATION CONTACT: 

Violet Woo, Designated Federal Officer, 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Notices 88403 

Advisory Committee on Minority 

Health, OMH, HHS, Tower Building, 

1101 Wootton Parkway, Suite 100, 

Rockville, Maryland 20852. Phone: 240– 

453–6816; email: OMH-ACMH@hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

accordance with Public Law 105–392, 

the ACMH was established to provide 

advice to the Deputy Assistant Secretary 

for Minority Health on the development 

of goals and program activities related to 

OMH’s duties. The topic to be discussed 

during the meeting is the 

implementation of the anticipated 

updates to the Office of Management 

and Budget (OMB) federal race and 

ethnicity data collection standards. The 

focus will be on opportunities for 

supporting community awareness of 

and engagement in future efforts to 

implement the revised race and 

ethnicity data collection standards, 

anticipated to be published by the OMB 

no later than Summer 2024. The 

recommendations will be given to the 

Deputy Assistant Secretary for Minority 

Health to inform efforts related to 

implementation of the revised OMB 

standards. Information on OMB’s 

Interagency Technical Working Group 

on Race and Ethnicity Standards can be 

found on this website: 

spd15revision.gov. 

The meeting is open to the public. 

Any individual who wishes to attend 

the meeting must register by sending an 

email to OMH-ACMH@hhs.gov by 5:00 

p.m. EST on January 30, 2024. Each 

registrant should provide their name, 

affiliation, phone number, email 

address, days attending, and if 

participation is in-person or via 

webcast. Registrants will receive 

webcast access information via email. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

contact OMH-ACMH@hhs.gov and 

reference this meeting. Requests for 

special accommodation should be made 

during registration or at least ten (10) 

business days prior to the meeting. 

Registered members of the public will 

have an opportunity to provide 

comments at the meeting. Public 

comments will be limited to two 

minutes per speaker during the time 

allotted. Individuals of the public may 

also submit and distribute electronic or 

printed statements or material(s) related 

to this meeting’s topic. Written 

comments should not exceed two pages 

in length. Individuals planning to 

submit material should email the 

material to OMH-ACMH@hhs.gov at 

least five (5) business days prior to the 

meeting. 

Violet Woo, 

Designated Federal Officer, Advisory 

Committee on Minority Health. 

[FR Doc. 2023–28101 Filed 12–20–23; 8:45 am] 

BILLING CODE 4150–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; 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 

Aging Special Emphasis Panel; Role of Tau 

Oligomer Polymorphism in Alzheimer’s 

Disease and Related Disorders. 

Date: March 6, 2024. 

Time: 11:30 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Nesar Uddin Akanda, 

Ph.D., M.D., Scientific Review Officer, 

Scientific Review Branch, National Institute 

on Aging, 7201 Wisconsin Avenue, Gateway 

Bldg., Suite 2E405, Bethesda, MD 20892, 

(301) 594–8984, nesar.akanda@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: December 15, 2023. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–28023 Filed 12–20–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Library of Medicine; Notice of 

Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

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 materials, 

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 Library of 

Medicine Special Emphasis Panel; Conflicted 

and Other Applications (R01, R13 and K99 

and Curation). 

Date: March 28, 2024. 

Time: 11:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Library of Medicine, 8600 

Rockville Pike, Bethesda, MD 20892 (Video 

Assisted Meeting). 

Contact Person: Ali Sharma, Ph.D., 

Scientific Review Officer, National Library of 

Medicine, NIH, 6705 Rockledge Drive, Suite 

500, Bethesda, MD 20892–7968, ali.sharma@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program No. 93.879, Medical Library 

Assistance, National Institutes of Health, 

HHS) 

Dated: December 15, 2023. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–28071 Filed 12–20–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; 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 


khammond on DSKJM1Z7X2PROD with NOTICES