103838 Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices 

2Totals may not sum due to rounding. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 2

21 CFR section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per 

recordkeeping Total hours 

§ 1.1113; recordkeeping associated with ISO/IEC 

17011:2017.

8 2 8 22 ............................ 176 

§ 1.1124; ABs—additional recordkeeping requirements a recognized accreditation body must 

maintain, for 5 years after the date of creation of 

the records, records created while it is recognized 

demonstrating its compliance with this subpart.

§ 1.1138; laboratories—becoming accredited to ISO/ 

IEC 17025:2017 (one-time); Laboratories adding 

ISO 17025 to become LAAF-accredited.

9 1 9 91.06 (91 hours and 

4 minutes).

820 

§ 1.1138; laboratories—maintaining ISO/IEC 17025: 

2017 accreditation.

160 2 320 450.765 (450 hours 

and 46 minutes).

144,245 

§ 1.1154; laboratories—additional recordkeeping requirements; a LAAF-accredited laboratory must 

maintain, for 5 years after the date of creation, 

records created and received while it is LAAF-accredited that relate to compliance with this subpart.

Total .................................................................... ........................ ........................ 345 ................................. 145,241 

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

2Totals may not sum due to rounding. 

The burden we attribute to reporting 

and recordkeeping activities is assumed 

to be distributed among the individual 

elements of the respective information 

collection activities. Although we have 

not received a notice of intent to 

relinquish records since the last 

approval of this information collection, 

we include one response for the purpose 

of estimating burden. 

We calculate the number of food 

testing laboratories seeking 

accreditation based on the number of 

applicants. As a result, the number of 

respondents to the information 

collection decreased (from 170 

respondents in the currently approved 

collection to 160 respondents). 

Consequently, we have adjusted our 

burden estimate, which results in a 

decrease of 227 responses and 9,303 

burden hours from the currently 

approved information collection. 

Dated: December 11, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–30230 Filed 12–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5581] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food Additives 

Intended for Use in Animal Food, Food 

Additive Petitions, Investigational 

Food Additive Files Exemptions, and 

Declaration on Animal Food Labels 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, 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 associated with 

food additives intended for use in 

animal food, food additive petitions, 

investigational food additive files 

exemptions, and declaration of color 

additives on animal food labels. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

February 18, 2025. 

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 

February 18, 2025. 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 


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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– 

2024–N–5581 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Food 

Additives Intended For Use In Animal 

Food, Food Additive Petitions, 

Investigational Food Additive Files 

Exemptions, and Declaration on Animal 

Food Labels.’’ 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 

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: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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. 

Food Additives Intended For Use in 

Animal Food, Food Additive Petitions, 

Investigational Food Additive Files 

Exemptions, and Declarations on 

Animal Food Labels 

OMB Control Number 0910–0546— 

Revision 

This information collection helps 

support implementation of FDA’s 

authority over food additives intended 

for use in animal food. Misbranded 

foods are prohibited under section 403 

of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 343); food 

additives are covered in section 409 of 

the FD&C Act (21 U.S.C. 348), which 

provides, at section 409(a) of the FD&C 

Act, that a food additive shall be 

deemed to be unsafe unless its use is 

permitted by a regulation that prescribes 

the condition(s) under which it may 

safely be used, or unless it is exempted 

by regulation for investigational use. 

Section 409(b) of the FD&C Act provides 

for petitions to establish safety of food 

additives and specifies information that 

must be submitted to FDA before a 

regulation permitting its use may be 

issued. Agency regulation in 21 CFR 

part 570 sets forth general provisions 

applicable to food additives intended 

for use in animal food; provides relevant 

definitions; establishes principles for 

determining safety; and explains 

prescribed elements to be included in a 

Generally Recognized as Safe (GRAS) 

notice. The regulation also provides for 

certain exemptions for investigational 

use and discusses related procedures. 

Agency regulation in 21 CFR part 571 

establishes procedural requirements 

applicable to the submission of petitions 

filed under section 409(b) of the FD&C 

Act, including content and format 

elements to facilitate FDA processing of 

a food additive petition. Finally, Agency 

regulation in 21 CFR part 501 

establishes disclosure requirements for 

animal food labeling, including the 

disclosure of the presence of certified 

and noncertified color additives (21 CFR 

501.22(k)). Additional disclosure 

requirements are found in 21 CFR parts 

573 (food additives permitted in feed 

and drinking water of animals) and 579 

(irradiation in the production, 

processing, and handling of animal 

food), and are included in the scope of 

coverage for the information collection. 

We are revising the information 

collection to include related authority 

established through enactment of the 

Animal Drug and Animal Generic Drug 


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103840 Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices 

User Fee Amendments of 2018 (2018 

Amendments) (Pub. L. 115–234). 

Intending to help ensure the safety of 

pet food, section 306(c) of the 2018 

Amendments provides for the issuance 

of guidance on pre-petition 

consultations for animal food additives. 

We have issued the following guidance 

documents to assist respondents in this 

regard: 

Guidance for Industry (GFI) #262, 

‘‘Pre-Submission Consultation Process 

for Animal Food Additive Petitions or 

Generally Recognized as Safe (GRAS) 

Notices’’ (December 2020), available for 

download from our website at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/cvmgfi-262-pre-submission-consultationprocess-animal-food-additive-petitionsor-generally. The guidance document 

describes the types of information our 

Center for Veterinary Medicine 

recommends be included in: 

1. pre-petition consultations prior to 

submission of food additive petitions 

(FAP) for food additives intended for 

use in animal food; 

2. pre-submission consultations 

regarding an animal food substance for 

which an entity plans to provide notice 

of its conclusion that the intended use 

of the substance is GRAS under FDA’s 

animal food GRAS Notification 

program; or 

3. a Food Use Authorization request 

to permit the use, in human or animal 

foods, of animal products derived from 

animals that have been administered an 

investigational substance intended for 

use in animal food. 

Additionally, GFI #294, ‘‘Animal 

Food Ingredient Consultation (AFIC)’’ 

(August 2024), available for download at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/cvm-gfi-294-animal-foodingredient-consultation-afic, describes 

the AFIC process, which provides for a 

way, within the regulatory framework, 

for firms that are developing animal 

food ingredients to consult with FDA, 

and for FDA to review information from 

developers and the public regarding the 

ingredients and any relevant safety 

concerns. The AFIC process includes 

opportunities for public awareness of, 

and input on, the ingredients for which 

FDA is providing consultation. The 

guidance document also explains that 

FDA generally would not intend to take 

enforcement action against an 

ingredient for being an unapproved 

animal food additive if FDA has sent an 

AFIC ‘‘consultation complete’’ letter, 

provided the ingredient is used in 

accordance with the terms described in 

the letter and there continues to be no 

questions or concerns about the safety of 

the ingredient. 

Description of Respondents: 

Respondents to this collection of 

information are animal food 

manufacturers or animal food additive 

manufactures. With regard to 

submission activities, we assume 2,508 

respondents based on the number of 

registrants who identify as animal food 

additive manufacturers. With regard to 

labeling activities under 21 CFR 

501.22(k), we assume 3,120 respondents 

based on information found in previous 

Agency rulemaking (RIN–0910AG02) 

regarding declarations for animal food 

product labels. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Regulatory authority; submission of information Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

Food Additive Petitions 

21 CFR 571.1(c) Moderate Category .......................... 3 1 3 3,000 ...................... 9,000 

21 CFR 571.1(c) Complex Category ........................... 3 1 3 10,000 .................... 30,000 

21 CFR 571.6 Amendment of Petition ........................ 5 1 5 1,300 ...................... 6,500 

Investigational Food Additive Files 

21 CFR 570.17 Moderate Category ............................ 8 1 8 1,500 ...................... 12,000 

21 CFR 570.17 Complex Category ............................. 10 1 10 5,000 ...................... 50,000 

Animal Food Ingredient Consultation 

Consultation Category ................................................. 12 1 12 3,000 ...................... 36,000 

Amendment of Consultation ........................................ 12 1 12 1,300 ...................... 15,600 

Color Additives 

21 CFR 501.22(k); labeling of color additive or lake 

of color additive; labeling of color additives not 

subject to certification.

3,120 0.8292 2,587 0.25 (15 minutes) ... 647 

Total Hours ........................................................... ........................ ........................ ........................ ................................ 159,747 

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

We have determined that food 

additive petitions and investigational 

food additive files that are submitted, 

fall into one of two categories of 

complexity. Fluctuations in the number 

and types of food and color additive 

petitions received in any given year are 

governed by market forces. 

§ 571.1(c) Moderate Category: For a 

food additive petition without complex 

chemistry, manufacturing, efficacy and/ 

or safety issues, the estimated time 

requirement per petition is 

approximately 3,000 hours. We estimate 

that, annually, 3 respondents will 

submit 1 such petition, for a total of 

9,000 hours. 

§ 571.1(c) Complex Category: For a 

food additive petition with complex 

chemistry, manufacturing, efficacy and/ 

or safety issues, the estimated time 

requirement per petition is 

approximately 10,000 hours. We 

estimate that, annually, 3 respondents 

will each submit 1 such petition, for a 

total of 30,000 hours. 


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§ 571.6 Amendment of Petition: For a 

food additive petition amendment, the 

estimated time requirement per petition 

is approximately 1,300 hours. We 

estimate that, annually, 5 respondents 

will each submit 1 such amendment, for 

a total of 6,500 hours. 

§ 570.17 Moderate Category: For an 

investigational food additive file 

without complex chemistry, 

manufacturing, efficacy and/or safety 

issues, the estimated time requirement 

per file is approximately 1,500 hours. 

We estimate that, annually, 8 

respondents will each submit 1 such 

file, for a total of 12,000 hours. 

§ 570.17 Complex Category: For an 

investigational food additive file with 

complex chemistry, manufacturing, 

efficacy and/or safety issues, the 

estimated time requirement per file is 

approximately 5,000 hours. We estimate 

that, annually, 10 respondents will each 

submit 1 such file, for a total of 50,000 

hours. 

Consultation Category: We estimate 

developers of animal food ingredients 

will spend 3,000 hours consulting with 

FDA on an ingredient. We estimate that, 

annually, 12 respondents will consult 

with FDA, for a total of 36,000 hours. 

The labeling requirements for food 

and color additives were designed to 

specify the minimum information 

needed for labeling in order that food 

and color manufacturers may comply 

with all applicable provisions of the 

FD&C Act and other specific labeling 

acts administered by FDA. Label 

information does not require any 

additional information gathering beyond 

what is already required to assure 

conformance with all specifications and 

limitations in any given food or color 

additive regulation. Label information 

does not have any specific 

recordkeeping requirements unique to 

preparing the label. Therefore, because 

labeling requirements for a particular 

color additive or food additive involve 

information required as part of the 

safety review process, the burden hours 

for labeling are included in the estimate 

for 21 CFR 501.22(k) and 571.1. 

We base our estimate of the total 

annual responses on submissions 

received over the last 3 years. We base 

our estimate of the hours per response 

on our experience with the labeling, 

food additive petition, and filing 

processes. 

Based on review of the information 

collection, there was a decrease of food 

additive petition (FAP) responses and a 

corresponding decrease in burden hours 

for FAPs. We attribute this adjustment 

to an increase in the number of GRAS 

notices (21 CFR part 570, subpart E) 

received, which tend to substitute for 

FAP submissions due to a similar 

quantity and quality of data and 

information requirement. These 

numbers can fluctuate year to year. We 

also note that investigational food 

additive file responses have increased 

due to more respondents providing 

information during the pre-market 

process prior to providing a more formal 

regulatory response (e.g., FAP or GRAS 

notice). We did not adjust the number 

of responses received for the declaration 

of color additives on animal food labels 

from the previous collection. 

Our estimated burden for the 

information collection reflects an 

overall increase of 40,600 total hours 

and 24 responses. We attribute this to 

accounting for the consultation process 

for firms developing animal food 

ingredients. 

Dated: December 12, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–30227 Filed 12–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–1055] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request Data To Support 

Social and Behavioral Research as 

Used by the Food and Drug 

Administration 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, us, 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 January 21, 

2025. 

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 0910–0847. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, 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. 

Data To Support Social and Behavioral 

Research as Used by the Food and Drug 

Administration 

OMB Control Number 0910–0847— 

Extension 

This information collection is 

intended to support FDA-conducted 

research. Understanding patients, 

consumers, and healthcare 

professionals’ perceptions and 

behaviors plays an important role in 

improving FDA’s regulatory decisionmaking processes and communications 

that affect various stakeholders. FDA 

uses the following methodology to 

achieve these goals: (1) creation and 

validation of survey instruments; (2) use 

of techniques to evaluate sampling and 

recruitment methods; (3) evaluation of 

the validity and reliability of survey 

instruments; (4) individual in-depth 

interviews, (5) general public focus 

group interviews, (6) intercept 

interviews, (7) self-administered 

surveys, (8) gatekeeper surveys, and (9) 

focus group interviews. These methods 

serve the narrowly defined need for 

direct and informal opinion on a 

specific topic and serve as a qualitative 

and quantitative research tool having 

two major purposes: 

• Obtaining useful, valid, and reliable 

information for the development of 

variables and measures for formulating 

the basic objectives of social and 

behavioral research and 

• Successfully communicating and 

addressing behavioral changes with 

intended audiences to assess the 

potential effectiveness of FDA 

communications, behavioral 

interventions, and other materials. 

While FDA will use these methods to 

test and refine its ideas and help 

develop communication and behavioral 

strategies research, the Agency will 

generally conduct further research 

before making important decisions 

(such as adopting new policies and 

allocating or redirecting significant 

resources to support these policies). 


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