Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 70663 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1119] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Food Canning 

Establishment Registration, Process 

Filing, and Recordkeeping for Acidified 

Foods and Thermally Processed LowAcid Foods in Hermetically Sealed 

Containers 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or us) 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 

13, 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 0910–0037. 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. 

Food Canning Establishment 

Registration, Process Filing, and 

Recordkeeping for Acidified Foods and 

Thermally Processed Low-Acid Foods 

in Hermetically Sealed Containers—21 

CFR 108.25 and 108.35, and 21 CFR 

Parts 113 and 114 

OMB Control Number 0910–0037— 

Extension 

Section 402 of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

342) deems a food to be adulterated, in 

part, if the food bears or contains any 

poisonous or deleterious substance that 

may render it injurious to health. 

Section 301(a) of the FD&C Act (21 

U.S.C. 331(a)) prohibits the introduction 

or delivery for introduction into 

interstate commerce of adulterated food. 

Under section 404 of the FD&C Act (21 

U.S.C. 344), our regulations require 

registration of food processing 

establishments, filing of process or other 

data, and maintenance of processing 

and production records for acidified 

foods and thermally processed low-acid 

foods in hermetically sealed containers. 

These requirements are intended to 

ensure safe manufacturing, processing, 

and packing procedures and to permit 

us to verify that these procedures are 

being followed. Improperly processed 

low-acid foods present life-threatening 

hazards if contaminated with foodborne 

microorganisms, especially Clostridium 

botulinum. The spores of C. botulinum 

need to be destroyed or inhibited to 

avoid production of the deadly toxin 

that causes botulism. This is 

accomplished with good manufacturing 

procedures, which must include the use 

of adequate heat processes or other 

means of preservation. 

To protect the public health, our 

regulations require that each firm that 

manufactures, processes, or packs 

acidified foods or thermally processed 

low-acid foods in hermetically sealed 

containers for introduction into 

interstate commerce register the 

establishment with us using Form FDA 

2541 (§§ 108.25(c)(1) and 108.35(c)(1) 

(21 CFR 108.25(c)(1) and 108.35(c)(1)). 

In addition to registering the plant, each 

firm is required to provide data on the 

processes used to produce these foods, 

using Forms FDA 2541d, FDA 2541e, 

and FDA 2541f for all methods except 

aseptic processing, or Form FDA 2541g 

for aseptic processing of low-acid foods 

in hermetically sealed containers 

(§§ 108.25(c)(2) and 108.35(c)(2)). Plant 

registration and process filing may be 

accomplished simultaneously. Process 

data must be filed prior to packing any 

new product, and operating processes 

and procedures must be posted near the 

processing equipment or made available 

to the operator (21 CFR 113.87(a)). 

Regulations in parts 108, 113, and 114 

(21 CFR parts 108, 113, and 114) require 

firms to maintain records showing 

adherence to the substantive 

requirements of the regulations. These 

records must be made available to FDA 

on request. Firms also must document 

corrective actions when process controls 

and procedures do not fall within 

specified limits (§§ 113.89, 114.89, and 

114.100(c)); to report any instance of 

potential health-endangering spoilage, 

process deviation, or contamination 

with microorganisms where any lot of 

the food has entered distribution in 

commerce (§§ 108.25(d) and 108.35(d) 

and (e)); and to develop and keep on file 

plans for recalling products that may 

endanger the public health (§§ 108.25(e) 

and 108.35(f)). To permit lots to be 

traced after distribution, acidified foods 

and thermally processed low-acid foods 

in hermetically sealed containers must 

be marked with an identifying code 

(§ 113.60(c) (thermally processed lowacid foods) and § 114.80(b) (acidified 

foods)). 

The records of processing information 

are periodically reviewed during factory 

inspections by FDA to verify fulfillment 

of the requirements in parts 113 or 114. 

Scheduled thermal processes are 

examined and reviewed to determine 

their adequacy to protect public health. 

In the event of a public health 

emergency, records are used to pinpoint 

potentially hazardous foods rapidly and 

thus limit recall activity to affected lots. 

As described in FDA regulations, 

processors may obtain the paper version 

of Forms FDA 2541, FDA 2541d, FDA 

2541e, FDA 2541f, and FDA 2541g at 

https://www.fda.gov/Food/Guidance

Regulation/FoodFacilityRegistration/ 

AcidifiedLACFRegistration/ 

ucm2007436.htm. Processors mail 

completed paper forms to us. However, 

processors who are subject to § 108.25 

and/or § 108.35 have an option to 

submit Forms FDA 2541, FDA 2541d, 

FDA 2541e, FDA 2541f, and FDA 2541g 

electronically. 

Although we encourage commercial 

processors to use the electronic 

submission system for plant registration 

and process filing, we will continue to 

make paper-based forms available. To 

standardize the burden associated with 

process filing, regardless of whether the 

process filing is submitted electronically 

or using a paper form, we are offering 

the public the opportunity to use four 

forms, each of which pertains to a 

specific type of commercial processing 

and is available both on the electronic 

submission system and as a paper-based 

form. The electronic submission system 


ddrumheller on DSK120RN23PROD with NOTICES1
70664 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 

and paper-based form ‘‘mirror’’ each 

other to the extent practicable. The four 

process filing forms are as follows: 

• Form FDA 2541d (Food Process 

Filing for Low-Acid Retorted Method); 

• Form FDA 2541e (Food Process 

Filing for Acidified Method); 

• Form FDA 2541f (Food Process 

Filing for Water Activity/Formulation 

Control Method); and 

• Form FDA 2541g (Food Process 

Filing for Low-Acid Aseptic Systems). 

Description of Respondents: The 

respondents to this information 

collection are commercial processors 

and packers of acidified foods and 

thermally processed low-acid foods in 

hermetically sealed containers. 

In the Federal Register of March 21, 

2023 (88 FR 16990), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Form FDA No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

108.25(c)(1) and 108.35(c)(2); Food 

canning establishment registration.

2541 1,218 1 1,218 0.17 (10 minutes) 207 

108.25(c)(2); Food process filing for 

acidified method.

2541e 2,078 7 14,546 0.33 (20 minutes) 4,800 

108.35(c)(2); Food process filing for 

low-acid retorted method.

2541d 842 7 5,894 0.33 (20 minutes) 1,945 

108.35(c)(2); Food process filing for 

water activity/formulation control 

method.

2541f 111 4 444 0.33 (20 minutes) 147 

108.35(c)(2); Food process filing for 

low-acid aseptic systems.

2541g 168 11 1,848 0.75 (45 minutes) 1,386 

108.25(d), 108.35(d) and (e); Report 

of any instance of potential healthendangering spoilage, process deviation, or contamination with 

microorganisms where any lot of 

the food has entered distribution in 

commerce.

N/A 1 1 1 4 ........................... 4 

Total ............................................ ........................ ........................ ........................ ........................ .............................. 8,489 

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

We base our estimates in table 1 on 

registrations, process filings, and reports 

received. The estimates for hours per 

response are based on our experience 

with similar programs and information 

received from industry. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

113.100 and 114.100 ........................................................... 10,392 1 10,392 250 2,598,000 

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

Our regulations require that 

processors mark thermally processed 

low-acid foods in hermetically sealed 

containers (§ 113.60(c)) and acidified 

foods (§ 114.80(b)) with an identifying 

code to permit lots to be traced after 

distribution. No burden has been 

estimated for the third-party disclosure 

requirements in §§ 113.60(c) and 

114.80(b) because the coding process is 

done as a usual and customary part of 

normal business activities. Coding is a 

business practice in foods for liability 

purposes, inventory control, and 

process control in the event of a 

problem. Under 5 CFR 1320.3(b)(2), the 

time, effort, and financial resources 

necessary to comply with a collection of 

information are excluded from the 

burden estimate if the reporting, 

recordkeeping, or disclosure activities 

needed to comply are usual and 

customary because they would occur in 

the normal course of activities. 

Since the publication of the 60-day 

notice we have adjusted our burden 

estimate. Our estimated burden for the 

information collection reflects an 

increase of 3,606 total burden hours and 

a corresponding increase of 10,141 total 

annual responses. This increase 

corresponds with data obtained from 

past submissions. 

Dated: October 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22461 Filed 10–11–23; 8:45 am] 

BILLING CODE 4164–01–P 


ddrumheller on DSK120RN23PROD with NOTICES1