1138 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

thinking of FDA on ‘‘Interim Policy on 

Compounding Using Bulk Drug 

Substances Under Section 503A of the 

Federal Food, Drug, and Cosmetic Act.’’ 

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 no collection 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: December 27, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–31546 Filed 1–6–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–2978] 

Food and Drug Administration Animal 

Food Ingredient Consultation; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry #294 entitled 

‘‘Animal Food Ingredient Consultation 

(AFIC).’’ This guidance describes FDA’s 

interim AFIC process and explains one 

way FDA will work with firms that are 

developing animal food ingredients now 

that the Memorandum of Understanding 

(MOU) with the Association of 

American Feed Control Officials 

(AAFCO) expired on October 1, 2024, 

and while FDA evaluates the animal 

Food Additive Petition and Generally 

Recognized as Safe (GRAS) Notification 

programs. The AFIC process provides an 

additional way for engagement with 

FDA regarding ingredients for which 

firms may otherwise have used the 

AAFCO ingredient definition process. 

AFIC will help FDA identify any 

potential safety concerns associated 

with such ingredients. The AFIC 

process also allows for public awareness 

of and input on such ingredients. In 

addition, this guidance describes FDA’s 

enforcement policy for certain 

ingredients assessed using the AFIC 

process. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 7, 2025. 

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– 

2024–D–2978 for ‘‘Animal Food 

Ingredient Consultation (AFIC).’’ 

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 Policy and 

Regulations Staff, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 1139 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Charlotte Conway, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–6768, 

Charlotte.Conway@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of August 9, 

2024 (89 FR 65368), FDA published the 

notice of availability for a draft guidance 

#294 entitled ‘‘Animal Food Ingredient 

Consultation (AFIC),’’ giving interested 

persons until September 9, 2024, to 

comment on the draft guidance. FDA 

received numerous comments on the 

draft guidance, including comments 

from the animal food and drug 

industries, AAFCO, a veterinary 

association, a State food and agriculture 

department, and private citizens, and 

those comments were considered as the 

guidance was finalized. In response to 

comments, the guidance was revised. 

First, we clarified the scope of the AFIC 

process as including any animal food 

ingredient for which firms may have 

otherwise utilized the AAFCO 

ingredient definition process. We also 

clarified that a proposed ingredient 

name and definition should be included 

in the consultation for FDA’s 

consideration. We removed the 

recommendation to submit a statement 

of environmental risk. In addition, we 

clarified that firms participating in the 

AFIC process should not resubmit 

information they have already provided 

to FDA and added clarification 

regarding what information interested 

parties should include when providing 

comments on pending AFICs through 

the docket. Lastly, editorial changes 

were made to improve clarity. The 

guidance announced in this notice 

finalizes the draft guidance dated 

August 9, 2024. 

This level 1 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 ‘‘Animal Food 

Ingredient Consultation (AFIC).’’ 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 

Under the Paperwork Reduction Act 

of 1995 (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. 

FDA is issuing this guidance, as final, 

that includes information collection 

recommendations regarding animal food 

ingredient consultations with FDA, 

which are subject to review and 

approval by OMB under the PRA. FDA 

will implement the information 

collection recommendations upon OMB 

approval and will announce OMB 

approval in the Federal Register. 

Information collection pertaining to 

animal food ingredient safety is 

currently provided for in FDA 

regulations in 21 CFR parts 570 and 571, 

currently approved in OMB control 

numbers 0910–0342 and 0910–0546, 

respectively. Disclosures under 21 CFR 

501.22 requiring animal food 

manufacturers to declare the presence of 

certified and noncertified color 

additives in animal food product 

labeling are also currently approved in 

OMB control number 0910–0546. 

However, upon our review of the latter 

information collection, we note that 

while we account for general reporting 

activities applicable to animal food 

ingredient regulations, we do not 

discuss activities that may be 

specifically attributable to animal food 

ingredient consultations with FDA. We 

also acknowledge that discontinuation 

of the MOU with AAFCO may result in 

an adjustment for some respondents 

with regard to how they engage in 

consultation with FDA. On December 

19, 2024, FDA published a notice (89 FR 

103838) under the PRA of its intent to 

revise the information collection to 

explicitly discuss animal food 

ingredient consultations that we believe 

are implicitly contemplated by the 

existing regulations in 21 CFR parts 570 

and 571 specifically to invite comment 

on the associated burden. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm, 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://

www.regulations.gov. 

Dated: December 27, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–31525 Filed 1–6–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–1102] 

Labeling of Plant-Based Alternatives to 

Animal-Derived Foods: Draft Guidance 

for Industry; Availability; Agency 

Information Collection Activities; 

Proposed Collection; Comment 

Request 

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 draft 

guidance for industry entitled ‘‘Labeling 

of Plant-Based Alternatives to AnimalDerived Foods.’’ This draft guidance, 

when finalized, will provide our 

recommendations on best practices for 

naming and labeling of certain plantbased foods that are marketed and sold 

as alternatives for animal-derived foods 

(plant-based alternative foods), 

especially in the absence of a common 

or usual name for the product. This 

draft guidance does not address the 

naming and labeling of plant-based milk 

alternatives; FDA is providing 

recommendations regarding these 

products in a separate guidance 

document. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by May 7, 2025 to ensure that we 

consider your comment on the draft 

guidance before we begin work on the 

final version of the guidance. Submit 

electronic or written comments on the 

proposed collection of information in 

the draft guidance by March 10, 2025. 

ADDRESSES: You may submit comments 

on any guidance 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 


ddrumheller on DSK120RN23PROD with NOTICES1