Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices 4311 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

101.82; Soy protein/CHD health claim ................................ 25 1 25 1 25 

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

The records currently required to be 

retained under § 101.82(c)(2)(ii)(B) are 

the records, e.g., the formulation or 

recipe, that a manufacturer has and 

maintains as a normal course of its 

doing business. Thus, the burden to the 

food manufacturer is limited to 

assembling and retaining the records. 

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: January 18, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01239 Filed 1–22–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0073] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Irradiation in the 

Production, Processing, and Handling 

of Food 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, us, or 

we) is announcing an opportunity for 

public comment on the proposed 

collection of certain information by the 

Agency. Under the Paperwork 

Reduction Act of 1995 (PRA), Federal 

agencies are required to publish notice 

in the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection provisions of our 

requirements for food irradiation 

processors. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

March 25, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

March 25, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

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– 

2018–N–0073 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Irradiation in the Production, 

Processing, and Handling of Food.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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 


khammond on DSKJM1Z7X2PROD with NOTICES
4312 Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices 

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. 

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: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Irradiation in the Production, 

Processing, and Handling of Food 

OMB Control Number 0910–0186— 

Extension 

This information collection supports 

FDA regulations. Under sections 201(s) 

and 409 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 321(s) and 348), 

food irradiation is subject to regulation 

by FDA under the food additive 

premarket approval provisions. The 

regulations providing for uses of 

irradiation in the production, 

processing, and handling of food are 

found in part 179 (21 CFR part 179). To 

ensure safe use of a radiation source, 

§ 179.21(b)(1) requires that the label of 

sources bear appropriate and accurate 

information identifying the source of 

radiation and the maximum (or 

minimum and maximum) energy of the 

emitted radiation. Section 179.21(b)(2) 

requires that the label or accompanying 

labeling bear adequate directions for 

installation and use and a statement 

supplied by us that indicates maximum 

dose of radiation allowed. Section 

179.26(c) requires that the label or 

accompanying labeling bear a logo and 

a radiation disclosure statement. Section 

179.25(e) requires that food processors 

who treat food with radiation make and 

retain, for 1 year past the expected shelf 

life of the products up to a maximum of 

3 years, specified records relating to the 

irradiation process (e.g., the food 

treated, lot identification, scheduled 

process, etc.). The records required by 

§ 179.25(e) are used by our inspectors to 

assess compliance with the regulation 

that establishes limits within which 

radiation may be safely used to treat 

food. We cannot ensure safe use without 

a method to assess compliance with the 

dose limits, and there are no practicable 

methods for analyzing most foods to 

determine whether they have been 

treated with ionizing radiation and are 

within the limitations set forth in part 

179. Records inspection is the only way 

to determine whether firms are 

complying with the regulations for 

treatment of foods with ionizing 

radiation. 

Description of Respondents: 

Respondents to the information 

collection are businesses engaged in the 

irradiation of food. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

179.25(e), large processors ............................................... 4 300 1,200 1 1,200 

179.25(e), small processors .............................................. 4 30 120 1 120 

Total ............................................................................ ........................ ........................ ........................ .......................... 1,320 

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

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. Our 

estimate of the recordkeeping burden 

under § 179.25(e) is based on our 

experience regulating the safe use of 

radiation as a direct food additive. The 

number of firms who process food using 

irradiation is extremely limited. We 

estimate that there are four irradiation 

plants whose business is devoted 

primarily (i.e., approximately 100 

percent) to irradiation of food and other 

agricultural products. Four other firms 

also irradiate small quantities of food. 

We estimate that this irradiation 

accounts for no more than 10 percent of 

the business for each of these firms. 

Therefore, the average estimated burden 

is based on four facilities devoting 100 

percent of their business to food 

irradiation, and four facilities devoting 

10 percent of their business to food 

irradiation. 

No burden has been estimated for the 

labeling requirements in §§ 179.21(b)(1), 

179.21(b)(2), and 179.26(c) because the 

disclosures are supplied by FDA. Under 

5 CFR 1320.3(c)(2), the public 

disclosure of information originally 

supplied by the Federal Government to 

the recipient for the purpose of 

disclosure to the public is not subject to 

review by OMB under the PRA. 

Dated: January 18, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01240 Filed 1–22–24; 8:45 am] 

BILLING CODE 4164–01–P 


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