Federal Register / Vol. 88, No. 202 / Friday, October 20, 2023 / Notices 72487 

collected under these authorities to help 

ensure that such products are quickly 

and efficiently removed from the 

market. 

As required under section 1005(f) of 

FDAAA and to assist industry, we have 

issued the guidance entitled, ‘‘Guidance 

for Industry: Questions and Answers 

Regarding the Reportable Food Registry 

as Established by the Food and Drug 

Administration Amendments Act of 

2007,’’ which is available at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

guidance-industry-questions-andanswers-regarding-reportable-foodregistry-established-food-and-drug. The 

guidance contains questions and 

answers relating to the requirements 

under section 417 of the FD&C Act, 

including: (1) how, when, and where to 

submit reports to FDA; (2) who is 

required to submit reports to FDA; (3) 

what is required to be submitted to 

FDA; and (4) what may be required 

when providing notifications to other 

persons in the supply chain of an article 

of food. The guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR 7.46 of FDA’s regulations have 

been approved under OMB control 

number 0910–0249. 

Description of Respondents: 

Mandatory respondents to this 

collection of information are the 

owners, operators, or agents in charge of 

a domestic or foreign facility engaged in 

manufacturing, processing, packing, or 

holding food for consumption in the 

United States (‘‘responsible parties’’) 

who have information on a reportable 

food. Voluntary respondents to this 

collection of information are Federal, 

State, and local public health officials 

who have information on a reportable 

food. 

In the Federal Register of May 22, 

2023 (88 FR 32775), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total 

annual 

disclosures 

Average 

burden per 

disclosure 

Total 

hours 

Notifying immediate previous source of the article of food under section 

417(d)(6)(B)(i) of the FD&C Act (mandatory reporters only).

1,200 1 1,200 0.6 (36 minutes) ......... 720 

Notifying immediate subsequent recipient of the article of food under 

section 417(d)(6)(B)(ii) of the FD&C Act (mandatory reporters only).

1,200 1 1,200 0.6 (36 minutes) ......... 720 

Notifying immediate previous source of the article of food under section 

417(d)(7)(C)(i) of the FD&C Act (mandatory reporters only).

1,200 1 1,200 0.6 (36 minutes) ......... 720 

Notifying immediate subsequent recipient of the article of food under 

section 417(d)(7)(C)(ii) of the FD&C Act (mandatory reporters only).

1,200 1 1,200 0.6 (36 minutes) ......... 720 

Total .................................................................................................. ........................ ........................ ........................ ..................................... 2,880 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Third Party Disclosure: Although it is 

not mandatory under section 1005 of 

FDAAA that responsible persons notify 

the sources and recipients of instances 

of reportable food, for purposes of the 

burden estimate we are assuming FDA 

would exercise its authority and require 

such notifications in all such instances 

for mandatory reporters. This 

notification burden does not affect 

voluntary reporters of reportable food 

events. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeping 

Total 

hours 

Maintenance of reportable food records under section 417(g) of the 

FD&C Act—mandatory reports.

1,200 1 1,200 0.25 (15 minutes) ....... 300 

Maintenance of reportable food records under section 417(g) of the 

FD&C Act—voluntary reports.

4 1 4 0.25 (15 minutes) ....... 1 

Total .................................................................................................. ........................ ........................ ........................ ..................................... 301 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Recordkeeping: As noted previously, 

section 417(g) of the FD&C Act requires 

that responsible persons maintain 

records related to reportable foods 

reports and notifications for a period of 

2 years. However, we do not expect that 

records will always be kept in relation 

to voluntary reportable food reports. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: October 16, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–23117 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–2022–D–0745] 

Voluntary Consensus Standards 

Recognition Program for Regenerative 

Medicine Therapies; Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 


ddrumheller on DSK120RN23PROD with NOTICES1
72488 Federal Register / Vol. 88, No. 202 / Friday, October 20, 2023 / Notices 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance entitled ‘‘Voluntary Consensus 

Standards Recognition Program for 

Regenerative Medicine Therapies; 

Guidance for Industry.’’ The guidance 

document describes a standards 

recognition program for regenerative 

medicine therapies (SRP–RMT) at FDA’s 

Center for Biologics Evaluation and 

Research (CBER) designed to identify 

Voluntary Consensus Standards (VCS) 

that might be used in the preparation 

and evaluation of submissions for 

Regenerative Medicine Therapy (RMT) 

products regulated by CBER when such 

standards are appropriate. The use of 

recognized VCS can assist stakeholders 

in more efficiently meeting regulatory 

requirements and increasing regulatory 

predictability for RMT products. This 

program is modeled after the formal 

standards and conformity assessment 

program (S–CAP) for medical devices 

where the term ‘‘recognize’’ refers to 

FDA’s formal identification of a 

standard after the determination that the 

standard is appropriate to meet relevant 

requirements as defined by law. CBER 

encourages the use of appropriate 

standards in the development of CBERregulated products. The guidance 

announced in this notice finalizes the 

draft guidance of the same title dated 

June 2022. 

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. [insert 

docket number FDA–2022–D–0745] for 

‘‘Voluntary Consensus Standards 

Recognition Program for Regenerative 

Medicine Therapies.’’ 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 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 (CBER), 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 the office in processing your 

requests. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

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

FDA is announcing the availability of

a document entitled ‘‘Voluntary 

Consensus Standards Recognition 

Program for Regenerative Medicine 

Therapies; Guidance for Industry.’’ The 

guidance describes a program at FDA’s 

CBER for recognition of VCS relevant to 

RMT products regulated in CBER. The 

SRP–RMT is designed to identify and 

recognize VCS to facilitate the 

development and assessment of RMT 

products. The voluntary use of 

recognized VCS can assist stakeholders 

in more efficiently meeting regulatory 

requirements and increasing regulatory 

predictability for RMT products. The 

program parallels the S–CAP for 

medical devices. 

The guidance describes the purpose of 

the program, how the SRP–RMT is 

expected to facilitate RMT development, 

and describes how the Office of 

Therapeutic Products in CBER generally 

intends to evaluate VCS for recognition 

in the SRP–RMT. This program will not 


ddrumheller on DSK120RN23PROD with NOTICES1
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