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notice of availability for a draft guidance 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comment on the draft guidance.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draft guidance, including comments 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finalizes the draft guidance dated 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
1140 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

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– 

2022–D–1102 for ‘‘Labeling of PlantBased Alternatives to Animal-Derived 

Foods: Draft Guidance for Industry; 

Availability; Agency Information 

Collection Activities; Proposed 

Collection; Comment Request.’’ 

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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

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 Office of 

Nutrition and Food Labeling (HFS–800), 

Human Foods Program, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740. Send two selfaddressed adhesive labels to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the draft guidance: 

Andrea Krause, Office of Nutrition and 

Food Labeling (HFS–820), Human 

Foods Program, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2371; 

or Lauren Kleinman, Office of Policy, 

Regulations, and Information, Human 

Foods Program, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2378. 

With regard to the proposed collection 

of information: 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: 

I. Background 

We are announcing the availability of 

a draft guidance for industry entitled 

‘‘Labeling of Plant-Based Alternatives to 

Animal-Derived Foods.’’ This draft 

guidance is intended to 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. 

Consumer demand for plant-based 

alternative foods has increased and FDA 

is committed to helping ensure 

consumers understand the foods they 

buy, to help them make informed 

dietary choices. The scope of this draft 

guidance includes plant-based 

alternatives to eggs, seafood, poultry, 

meat, and dairy (excluding plant-based 

milk alternatives) that fall under FDA 

jurisdiction. (In the Federal Register of 

February 23, 2023 (88 FR 11449), we 

announced the availability of a draft 

guidance entitled ‘‘Labeling of Plantbased Milk Alternatives and Voluntary 

Nutrient Statements: Draft Guidance for 

Industry.’’ When finalized, the guidance 

will provide FDA’s view on the naming 

of plant-based food products that are 

marketed and sold as alternatives to 

milk (plant-based milk alternatives) and 

our recommendations on the use of 

voluntary nutrient statements. The draft 

guidance entitled ‘‘Labeling of Plantbased Milk Alternatives and Voluntary 

Nutrient Statements: Draft Guidance for 

Industry’’ is available online at https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/draftguidance-industry-labeling-plant-basedmilk-alternatives-and-voluntarynutrient-statements.) 

We are issuing the draft guidance 

consistent with our good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on this topic. 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. 

‘‘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 

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. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 1141 

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. 

Labeling of Plant-Based Alternatives to 

Animal-Derived Foods: Draft Guidance 

for Industry 

OMB Control Number 0910–0381— 

Revision 

The draft guidance, once finalized, 

will provide recommendations on best 

practices for naming and labeling of 

certain plant-based alternative foods. 

Industry’s use of these 

recommendations for naming and 

labeling plant-based alternative foods 

will help ensure consumers understand 

the nature of individual plant-based 

alternative foods, including differences 

among these products, and have the 

information they need to make informed 

purchasing decisions. 

Standards of identity have not been 

established for plant-based alternative 

foods. As such, plant-based alternative 

foods are non-standardized foods and 

must be labeled with their common or 

usual name, or in the absence thereof, 

a statement of identity that accurately 

describes the food. See 21 CFR 101.3(b). 

Many plant-based alternative foods are 

novel foods and do not have common or 

usual names established by common 

usage. Currently, products appear to be 

identified in multiple ways, sometimes 

inconsistently across the category. Thus, 

the purpose of this guidance is to 

provide our recommendations on best 

practices for naming and labeling of 

certain plant-based foods that are 

marketed and sold as alternatives for 

animal-derived foods. 

Description of respondents: 

Respondents to this information 

collection are manufacturers, packers, 

and distributors of plant-based 

alternative foods that are marketed and 

sold in the United States. Respondents 

are from the private sector (for-profit 

businesses). 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED THIRD-PARTY DISCLOSURE BURDEN

Activity Number of 

respondents 

Number of 

disclosures 

per respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours Total capital 

costs 1 2

Labeling recommendations in ‘‘Labeling of 

Plant-Based Alternatives to Animal-Derived 

Foods’’ .......................................................... 160 5 800 1 800 $1,231,200

1One-time relabeling costs. 

2There are no operating and maintenance costs associated with this collection of information. 

The estimates in table 1 are based on 

our experience with similar labeling 

programs. We estimate that each year 

160 manufacturers will relabel their 

products following recommendations 

found in the draft guidance. We 

estimate that each manufacturer will 

relabel 5 products for 800 total annual 

disclosures (160 manufacturers × 5 

labels). Each disclosure will take an 

estimated 1 hour to complete for an 

annual third-party disclosure burden of 

800 hours (800 disclosures × 1 hour). 

We estimate that there will be an annual 

capital cost of $1,231,200 associated 

with relabeling. This is the cost of 

designing a revised label and 

incorporating it into the manufacturing 

process. We believe that this will be a 

one-time burden per respondent. 

III. Electronic Access

Persons with access to the internet

may obtain the guidance at either 

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

FoodGuidances, or https://

www.regulations.gov. Use the FDA 

website listed in the previous sentence 

to find the most current version of the 

guidance. 

Dated: December 27, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–31535 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–3067] 

Recommendations To Reduce the Risk 

of Transmission of Disease Agents 

Associated With Sepsis by Human 

Cells, Tissues, and Cellular and 

Tissue-Based Products; Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the availability of a 

final guidance for immediate 

implementation entitled 

‘‘Recommendations To Reduce the Risk 

of Transmission of Disease Agents 

Associated with Sepsis by Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps).’’ FDA is issuing this 

guidance to provide establishments 

making donor eligibility determinations 

with recommendations to reduce the 

risk of transmission of infections due to 

sepsis by HCT/Ps. This notice is being 

issued to respond to a public health 

safety concern and to address the urgent 

need for updated recommendations in 

making a donor eligibility determination 

when screening a donor for clinical 

evidence of sepsis and clinical signs to 

consider. 

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 


ddrumheller on DSK120RN23PROD with NOTICES1