Federal Register / Vol. 88, No. 202 / Friday, October 20, 2023 / Notices 72489 

apply to: (1) statutory and regulatory 

standards that are legally binding, such 

as certain provisions of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

301 et seq.) and the Public Health 

Service Act (42 U.S.C. 6A); (2) standards 

developed by Standards Development 

Organizations that do not follow 

consensus mechanisms; or (3) electronic 

data exchange standards for 

submissions to CBER. 

In the Federal Register of Thursday, 

June 16, 2022 (87 FR 36327), FDA 

announced the availability of the draft 

guidance of the same title dated June 

2022. FDA received a few comments on 

the draft guidance and those comments 

were considered as the guidance was 

finalized. A summary of changes 

includes minor edits to improve clarity 

and the addition of information 

regarding information collection 

provisions under the Paperwork 

Reduction Act of 1995. The guidance 

announced in this notice finalizes the 

draft guidance dated June 2022. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Voluntary 

Consensus Standards Recognition 

Program for Regenerative Medicine 

Therapies.’’ 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 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3521). The collections of information 

have been approved under OMB control 

number 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/ 

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

www.regulations.gov. 

Dated: October 17, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–23156 Filed 10–19–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–1137] 

Development and Licensure of 

Vaccines To Prevent COVID–19; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a revised 

guidance for industry entitled 

‘‘Development and Licensure of 

Vaccines to Prevent COVID–19.’’ This 

guidance revises the guidance of the 

same name, which was announced in 

the Federal Register on August 3, 2020. 

FDA is issuing this guidance to assist 

the Agency and sponsors in the clinical 

development and licensure of vaccines 

for the prevention of COVID–19. 

Additionally, this guidance provides an 

overview of key considerations to satisfy 

regulatory requirements set forth in the 

investigational new drug application 

(IND) regulations and in the licensing 

regulations for chemistry, 

manufacturing, and controls (CMC), and 

nonclinical and clinical data through 

development and licensure, and for 

post-licensure safety evaluation of 

COVID–19 preventive vaccines. FDA is 

also announcing the withdrawal of an 

FDA guidance document related to 

COVID–19. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 20, 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–1137 for ‘‘Development and 

Licensure of Vaccines to Prevent 

COVID–19.’’ 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 


ddrumheller on DSK120RN23PROD with NOTICES1
72490 Federal Register / Vol. 88, No. 202 / Friday, October 20, 2023 / Notices 

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 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance 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 

two self-addressed adhesive labels to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Jessica Gillum, 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 

We are announcing the availability of 

a revised guidance for industry entitled 

‘‘Development and Licensure of 

Vaccines to Prevent COVID–19.’’ The 

recommendations described in the 

guidance are expected to assist the 

Agency and sponsors in the clinical 

development and licensure of vaccines 

for the prevention of COVID–19. 

Due to the COVID–19 public health 

emergency, there was an urgent need to 

develop safe and effective vaccines to 

prevent COVID–19 and work 

collaboratively with industry and other 

partners to accelerate those efforts. To 

help address those needs, in June 2020, 

FDA issued a guidance entitled 

‘‘Development and Licensure of 

Vaccines to Prevent COVID–19’’ (the 

‘‘June 2020 guidance’’) to assist 

sponsors in the clinical development 

and licensure of vaccines for the 

prevention of COVID–19. The June 2020 

guidance, which was announced in the 

Federal Register on August 3, 2020 (85 

FR 46641), explained that we expected 

the recommendations would continue to 

apply outside the context of the COVID– 

19 public health emergency, and that 

FDA would replace that guidance with 

any appropriate changes based on 

public comments and our experience 

with implementation. In addition, in the 

Federal Register of March 13, 2023 (88 

FR 15417), FDA listed the June 2020 

guidance as one of the guidances the 

Agency was revising to continue in 

effect for 180 days after the COVID–19 

public health emergency declaration 

issued under the Public Health Service 

Act expired on May 11, 2023, during 

which time FDA planned to further 

revise those guidances. Consistent with 

what we said in the Federal Register of 

March 13, 2023, FDA is issuing this 

revised final guidance. 

We are issuing this revised guidance 

consistent with our good guidance 

practices (GGP) regulation (§ 10.115 (21 

CFR 10.115)). We are implementing this 

guidance without prior public comment 

because we have determined that prior 

public participation is not feasible or 

appropriate (see § 10.115(g)(2) and 

section 701(h)(1)(C) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 371(h)(1)(C)). We made this 

determination because the revisions to 

the guidance acknowledge the current 

epidemiology of COVID–19 or reflect 

current recommendations provided to 

sponsors and immediate 

implementation is required to facilitate 

the development of vaccines to protect 

the public health. Specifically, we are 

issuing this guidance to ensure that 

sponsors are aware of our current 

recommendations to expedite the timely 

development of vaccines to prevent 

COVID–19. In addition, we note that 

interested parties have had the 

opportunity to comment on the June 

2020 guidance. Although this guidance 

document is being implemented 

immediately, it remains subject to 

comment in accordance with FDA’s 

GGP regulation (§ 10.115(g)(3)(D)). 

The revised guidance provides an 

overview of key considerations to satisfy 

regulatory requirements set forth in the 

IND regulations in part 312 (21 CFR part 

312) and licensing regulations in part 

601 (21 CFR part 601) for CMC, and 

nonclinical and clinical data through 

development and licensure, and for 

post-licensure safety evaluation of 

COVID–19 preventive vaccines. FDA is 

committed to supporting all 

scientifically sound approaches to 

attenuating the clinical impact of 

COVID–19. There are many candidate 

COVID–19 vaccines currently in 

development, and FDA recognizes that 

the considerations presented do not 

represent all the considerations 

necessary to satisfy statutory and 

regulatory requirements applicable to 

the licensure of vaccines intended to 

prevent COVID–19. The nature of a 

particular vaccine and its intended use 

may impact specific data needs. 

We received numerous comments on 

the June 2020 guidance. Those 

comments were considered and the 

revisions in this guidance reflect the 

responses to the comments as 

appropriate. Changes to the guidance 

from the June 2020 guidance include 

removal of reference to the COVID–19 

public health emergency and revisions 

to the nonclinical data section to take 

into consideration that enhanced 

respiratory disease has not occurred 

with clinical use of COVID–19 vaccines. 

The clinical trials section has been 

revised to reflect that at this stage of the 

pandemic only very young children are 

likely to be serologically naı ̈ve and, in 

recognition of the available data on 

vaccine effectiveness, to recommend 

that sponsors provide appropriate 

justification for statistical criteria for 

clinical disease efficacy studies. In 

addition, editorial changes were made 

to improve clarity. The revised guidance 

announced in this notice replaces the 

June 2020 guidance. 

The revised guidance represents the 

current thinking of FDA on the 

development and licensure of vaccines 

to prevent COVID–19. 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 part 312 have been 

approved under OMB control number 

0910–0014; the collections of 

information in 21 CFR part 58 regarding 

good laboratory practice for nonclinical 

laboratory studies have been approved 

under OMB control number 0910–0119; 

the collections of information in 21 CFR 

part 50 have been approved under OMB 

control number 0910–0130; the 

collections of information in 21 CFR 

parts 210, 211 and 610 have been 

approved under OMB control number 

0910–0139; the collections of 

information in 21 CFR part 600 have 

been approved under OMB control 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 202 / Friday, October 20, 2023 / Notices 72491 

numbers 0910–0308 and 0910–0291 

(Form FDA 3500A); the collections of 

information in part 601 have been 

approved under OMB control number 

0910–0338; the collections of 

information in FDA’s guidance entitled 

‘‘Establishment and Operation of 

Clinical Trial Data Monitoring 

Committees’’ have been approved under 

OMB control number 0910–0581; and, 

the collections of information in FDA’s 

guidance entitled ‘‘Emergency Use 

Authorization of Medical Products and 

Related Authorities’’ have been 

approved under OMB control number 

0910–0595. 

III. Emergency Use Authorization for 

Vaccines To Prevent COVID–19 

Guidance 

In October 2020, FDA first issued a 

guidance entitled ‘‘Emergency Use 

Authorization for Vaccines to Prevent 

COVID–19’’ (Vaccine EUA guidance) to 

provide sponsors of requests for 

emergency use authorization (EUA) for 

COVID–19 vaccines with 

recommendations regarding the data 

and information needed to support the 

issuance of an EUA under section 564 

of the FD&C Act (21 U.S.C. 360bbb–3) 

for an investigational vaccine to prevent 

COVID–19. Although, the guidance 

stated that it was intended to remain in 

effect only for the duration of the public 

health emergency related to COVID–19 

declared under the Public Health 

Service Act, in the Federal Register of 

March 13, 2023 (88 FR 15417 at 15421), 

FDA listed the guidance as one of the 

COVID–19-related guidances the 

Agency was revising to continue in 

effect for 180 days after the COVID–19 

public health emergency declared under 

the PHS Act expired on May 11, 2023, 

during which time FDA planned to 

further revise those guidances. 

However, circumstances have changed 

since the end of the declared public 

health emergency on May 11, 2023. FDA 

has reviewed the Vaccine EUA guidance 

and determined that the guidance is no 

longer needed, as the Agency has 

shifted its focus toward communicating 

directly with individual manufacturers. 

Accordingly, the EUA guidance will no 

longer be in effect after the publication 

of the guidance for immediate 

implementation announced in this 

notice, ‘‘Development and Licensure of 

Vaccines to Prevent COVID–19.’’ 

IV. Electronic Access 

Persons with access to the internet 

may obtain the document at https://

www.fda.gov/emergency-preparednessand-response/coronavirus-disease-2019- 

covid-19/covid-19-related-guidancedocuments-industry-fda-staff-and-otherstakeholders, https://www.fda.gov/ 

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

www.regulations.gov. Use the FDA 

website listed in the previous sentence 

to find the most current version of the 

guidance. 

Dated: October 17, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–23162 Filed 10–19–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–2316] 

Benefit-Risk Assessment for New Drug 

and Biological Products; 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 ‘‘BenefitRisk Assessment for Human Drug and 

Biological Products.’’ FDA has 

developed this guidance document in 

accordance with goals associated with 

the sixth authorization of the 

Prescription Drug User Fee Act (PDUFA 

VI) under Title I of the FDA 

Reauthorization Act of 2017 and 

requirements under the 21st Century 

Cures Act. The intent of this guidance 

is to provide drug sponsors and other 

stakeholders with better clarity on how 

considerations about a drug’s benefits, 

risks, and risk management options 

factor into FDA’s pre- and postmarket 

regulatory decisions about new drug 

applications (NDAs) or biologics license 

applications (BLAs). This guidance 

finalizes the draft guidance of the same 

title issued in September 2021. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 20, 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–2316 for ‘‘Benefit-Risk 

Assessment for New Drug and 

Biological Products.’’ 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 


ddrumheller on DSK120RN23PROD with NOTICES1