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Animal-Derived Foods: Draft Guidance 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The draft guidance, once finalized, 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
1142 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

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–3067 for ‘‘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).’’ 

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 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive labels to 

assist that office in processing your 

requests. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jessica Gillum, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA 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 the guidance to 

provide establishments making donor 

eligibility determinations with 

recommendations to reduce the risk of 

transmission of disease agents 

associated with sepsis for donors of 

human cells, tissues, and cellular and 

tissue-based products. This guidance 

supersedes the information regarding 

sepsis in the August 2007 guidance 

entitled ‘‘Eligibility Determination for 

Donors of Human Cells, Tissues, and 

Cellular and Tissue-Based Products 

(HCT/Ps).’’ The August 2007 guidance 

identified sepsis as a relevant 

communicable disease agent or disease 

under 21 CFR 1271.3(r)(2). 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of another guidance for 

immediate implementation entitled 

‘‘Recommendations To Reduce the Risk 

of Transmission of Mycobacterium 

Tuberculosis (Mtb) by Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps).’’ This guidance is 

being issued to assist establishments 

that make donor eligibility 

determinations for donors of human 

cells, tissues, and cellular and tissuebased products, with recommendations 

for screening donors for evidence of, 

and risk factors for, infection with Mtb, 

the organism that causes tuberculosis, 

which can be a cause of sepsis. 

We are issuing this guidance 

consistent with our good guidance 

practices (GGP) regulation (§ 10.115 (21 

CFR 10.115)). We are implementing this 

guidance without prior public comment 

because we have determined that prior 

public participation is not feasible or 

appropriate (§ 10.115(g)(2)). We made 

this determination because of the urgent 

need to update recommendations to 

industry for screening a donor for risk 

factors and conditions, and clinical and 

physical evidence, associated with the 

disease agents that cause sepsis. 

Although this guidance document is 

immediately in effect, it remains subject 

to comment in accordance with FDA’s 

GGP regulation. 

The guidance represents the current 

thinking of FDA on ‘‘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).’’ 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. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 1143 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR 1271 relating to 

HCT/Ps, including establishing and 

maintaining records, investigation and 

reporting of adverse actions and 

documentation of methods used in 

facilities related to HCT/Ps, which, 

includes but not limited to donor 

screening, donor testing, and labeling 

have been approved under OMB control 

number 0910–0543. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, 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. 2024–31538 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–5376] 

Type VII Veterinary Master File for 

Research and Development and Risk 

Reviews; Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a draft 

guidance for industry (GFI) #260 

entitled ‘‘Type VII Veterinary Master 

File for Research and Development and 

Risk Reviews.’’ This draft guidance, 

when finalized, will describe FDA’s 

current thinking regarding the use of 

Type VII Veterinary Master Files (Type 

VII VMFs). Type VII VMFs are 

appropriate for research and 

development of animal cells, tissues, 

and cell- and tissue-based products 

(ACTPs), gene therapies, and heritable 

intentional genomic alterations (IGAs) 

in animals. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 10, 2025 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

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 

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–5376 for ‘‘Type VII Veterinary 

Master File for Research and 

Development and Risk Reviews.’’ 

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 (HFV–6), 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 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Lynne Boxer, Center for Veterinary 

Medicine, Food and Drug 


ddrumheller on DSK120RN23PROD with NOTICES1