72486 Federal Register / Vol. 88, No. 202 / Friday, October 20, 2023 / Notices 

NOTIFICATION PROCEDURES: 

An individual who wishes to know if 

this system of records contains a record 

about him or her must submit a written 

notification request to the relevant 

System Manager at the address 

indicated in the ‘‘System Manager(s)’’ 

section above, in accordance with the 

Department’s Privacy Act 

implementation regulations in 45 CFR. 

The request must contain the requester’s 

full name, address, date of birth, and 

signature. The individual must verify 

his or her identity in the same manner 

required for an access request. 

EXEMPTIONS PROMULGATED FOR THE SYSTEM: 

None. 

HISTORY: 

83 FR 11213 (Mar. 14, 2018). 

[FR Doc. 2023–23147 Filed 10–19–23; 8:45 am] 

BILLING CODE 4184–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–1272] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Third Party 

Disclosure and Recordkeeping 

Requirements for Reportable Food 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by November 

20, 2023. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0643. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Third Party Disclosure and 

Recordkeeping Requirements for 

Reportable Food—21 U.S.C. 350f 

OMB Control Number 0910–0643— 

Extension 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act), as amended by the 

Food and Drug Administration 

Amendments Act of 2007 (FDAAA) 

(Pub. L. 110–85), requires the 

establishment of a Reportable Food 

Registry (the Registry) by which 

instances of reportable food must be 

submitted to FDA by responsible parties 

and may be submitted by public health 

officials. Section 417 of the FD&C Act 

(21 U.S.C. 350f) defines ‘‘reportable 

food’’ as an article of food (other than 

infant formula) for which there is a 

reasonable probability that the use of, or 

exposure to, such article of food will 

cause serious adverse health 

consequences or death to humans or 

animals. (See section 417(a)(2) of the 

FD&C Act.) We believe that the most 

efficient and cost-effective means to 

implement the Registry is by utilizing 

our electronic Safety Reporting Portal. 

The information collection provisions 

associated with the submission of 

reportable food reports has been 

approved under OMB control number 

0910–0291. 

In conjunction with the reportable 

foods requirements, section 417 of the 

FD&C Act also establishes third-party 

disclosure and recordkeeping burdens. 

Specifically, we may require the 

responsible party to notify the 

immediate previous source(s) and/or 

immediate subsequent recipient(s) of a 

reportable food (sections 417(d)(6)(B)(i) 

to (ii) of the FD&C Act). Similarly, we 

may also require the responsible party 

that is notified (i.e., the immediate 

previous source and/or immediate 

subsequent recipient) to notify their 

own immediate previous source(s) and/ 

or immediate subsequent recipient(s) of 

a reportable food (sections 

417(d)(7)(C)(i) to (ii) of the FD&C Act). 

Notification to the immediate 

previous source(s) and immediate 

subsequent recipient(s) of the article of 

food may be accomplished by electronic 

communication methods such as email, 

fax, or text messaging or by telegrams, 

mailgrams, or first-class letters. 

Notification may also be accomplished 

by telephone call or other personal 

contacts, but we recommend that such 

notifications also be confirmed by one 

of the previous methods and/or 

documented in an appropriate manner. 

We may require that the notification 

include any or all of the following data 

elements: (1) the date on which the 

article of food was determined to be a 

reportable food; (2) a description of the 

article of food including the quantity or 

amount; (3) the extent and nature of the 

adulteration; (4) the results of any 

investigation of the cause of the 

adulteration if it may have originated 

with the responsible party, if known; (5) 

the disposition of the article of food, 

when known; (6) product information 

typically found on packaging including 

product codes, use-by dates, and the 

names of manufacturers, packers, or 

distributors sufficient to identify the 

article of food; (7) contact information 

for the responsible party; (8) contact 

information for parties directly linked in 

the supply chain and notified under 

section 417(d)(6)(B) or 417(d)(7)(C) of 

the FD&C Act, as applicable; (9) the 

information required by FDA to be 

included in the notification provided by 

the responsible party involved under 

section 417(d)(6)(B) or 417(d)(7)(C) of 

the FD&C Act or required to report 

under section 417(d)(7)(A) of the FD&C 

Act; and (10) the unique number 

described in section 417(d)(4) of the 

FD&C Act (section 417(d)(6)(B)(iii)(I), 

(d)(7)(C)(iii)(I), and (e) of the FD&C Act). 

We may also require that the 

notification provides information about 

the actions that the recipient of the 

notification will perform and/or any 

other information we may require 

(section 417(d)(6)(B)(iii)(II) and (III) and 

(d)(7)(C)(iii)(II) and (III) of the FD&C 

Act). 

Section 417(g) of the FD&C Act 

requires that responsible persons 

maintain records related to reportable 

foods for a period of 2 years. 

The congressionally-identified 

purpose of the Registry is to provide a 

reliable mechanism to track patterns of 

adulteration in food which would 

support efforts by FDA to target limited 

inspection resources to protect the 

public health (see FDAAA, section 

1005(a)(4)). The reporting and 

recordkeeping requirements described 

previously are designed to enable FDA 

to quickly identify and track an article 

of food (other than infant formula) for 

which there is a reasonable probability 

that the use of or exposure to such 

article of food will cause serious adverse 

health consequences or death to humans 

or animals. We use the information 


ddrumheller on DSK120RN23PROD with NOTICES1
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