Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Notices 88401 

samples in the pretest and main study 

of the experimental phase and conjoint 

analysis phase. 

II. References 

The following references are on 

display with the Dockets Management 

Staff (see ADDRESSES) and are available 

for viewing by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday; these are not available 

electronically at https://

www.regulations.gov as these references 

are copyright protected. Some may be 

available at the website address, if 

listed. FDA has verified the website 

addresses, as of the date this document 

publishes in the Federal Register, but 

websites are subject to change over time. 

1. Harris, R.J., M.L. Trusty, J.I. Bechtold, et 

al. ‘‘Memory for Implied Versus Directly 

Stated Advertising Claims,’’ Psychology 

& Marketing, vol. 6, issue 2, pp. 87–96, 

1989, https://doi.org/10.1002/ 

mar.4220060202. 

2. Burke, R.R., W.S. DeSarbo, R.L. Oliver, et 

al. ‘‘Deception By Implication: An 

Experimental Investigation,’’ Journal of 

Consumer Research, vol. 14, issue 4, pp. 

483–494, 1988, https://doi.org/10.1086/ 

209130. 

3. Louviere, J.J., T.N. Flynn, and A.A.J. 

Marley, Best-Worst Scaling: Theory, 

Methods, and Applications. Cambridge: 

Cambridge University Press, 2015. 

Dated: December 15, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28093 Filed 12–20–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–1136] 

Development of Monoclonal Antibody 

Products Targeting SARS–CoV–2 for 

Emergency Use Authorization; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 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, 

including addressing the impact of 

emerging variants. The 

recommendations focus on the data and 

information that may be used to support 

a request for emergency use 

authorization (EUA) under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act). This guidance supersedes the 

guidance entitled ‘‘Development of 

Monoclonal Antibody Products 

Targeting SARS–CoV–2, Including 

Addressing the Impact of Emerging 

Variants, During the COVID–19 Public 

Health Emergency’’ issued on February 

22, 2021. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 21, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2020–D–1136 for ‘‘Development of 

Monoclonal Antibody Products 

Targeting SARS–CoV–2 for Emergency 

Use Authorization.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see § 10.115(g)(5) 

(21 CFR 10.115(g)(5))). 

Submit written requests for single 

copies of the guidance to the Division of 

Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 


khammond on DSKJM1Z7X2PROD with NOTICES
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, 


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