Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 1135 

revises the list of tree nuts that FDA 

considers as major food allergens. 

We also have revised several 

questions and answers to update and 

clarify information presented in 

previous editions, including questions 

related to the labeling of fish and 

Crustacean shellfish. 

II. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3521). The collections of information in 

section 403(w) of the FD&C Act (21 

U.S.C. 343(w)) have been approved 

under OMB control number 0910–0792. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance document at 

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. 2024–31533 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–0278] 

Action Levels for Lead in Processed 

Food Intended for Babies and Young 

Children; Guidance for Industry; 

Availability 

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 final 

guidance for industry entitled ‘‘Action 

Levels for Lead in Processed Food 

Intended for Babies and Young 

Children.’’ The guidance establishes 

action levels for lead in certain 

processed foods intended for babies and 

young children less than 2 years old. 

The guidance is intended to set 

achievable action levels that will help 

further reduce lead in the food supply. 

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 FDA 

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– 

2022–D–0278 for ‘‘Action Levels for 

Lead in Processed Food Intended for 

Babies and Young Children; Guidance 

for Industry.’’ 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 the Office of 

Food Chemical Safety, Dietary 

Supplements, and Innovation, 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: 

Eileen Abt, Office of Food Chemical 

Safety, Dietary Supplements, and 

Innovation, Human Foods Program, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740, 

240–402–1700; or Holli Kubicki, Office 

of Policy, Regulations, and Information, 

Human Foods Program, Food and Drug 


ddrumheller on DSK120RN23PROD with NOTICES1
1136 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

Administration, 5001 Campus Dr., 

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

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a guidance for industry entitled ‘‘Action 

Levels for Lead in Processed Food 

Intended for Babies and Young 

Children.’’ We are issuing this guidance 

consistent with our good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents 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. 

In the Federal Register of January 25, 

2023 (88 FR 4749), we made available 

a draft guidance for industry entitled 

‘‘Action Levels for Lead in Food 

Intended for Babies and Young 

Children’’ and gave interested parties an 

opportunity to submit comments by 

March 27, 2023, for us to consider 

before beginning work on the final 

version of the guidance. In the Federal 

Register of April 6, 2023 (88 FR 20525), 

we announced that we were reopening 

the comment period until May 8, 2023, 

to allow interested parties additional 

time to submit comments. We received 

several comments on the draft guidance 

and have modified the final guidance 

where appropriate. Changes to the 

guidance include clarifications to the 

foods that the guidance addresses, 

including the age range of the foods’ 

intended consumers. We added 

information about the method that FDA 

uses to test for lead in food and made 

several editorial changes to improve 

clarity of the guidance. We also 

collected and analyzed additional 

samples from our Toxic Elements 

Program and special FDA surveys to 

inform our exposure and achievability 

assessments. The guidance announced 

in this notice finalizes the draft 

guidance dated January 2023. 

In accordance with § 109.6 (21 CFR 

109.6), this guidance establishes the 

following action levels for lead in 

processed food intended for babies and 

young children less than 2 years old: 10 

parts per billion (ppb) for fruits, 

vegetables (excluding single-ingredient 

root vegetables), mixtures (including 

grain- and meat-based mixtures), 

yogurts, custards/puddings, and singleingredient meats; 20 ppb for singleingredient root vegetables; and 20 ppb 

for dry infant cereals. Consistent with 

§ 109.6(d), these action levels reflect 

levels of lead at which FDA may regard 

the food as adulterated within the 

meaning of section 402(a)(1) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 342(a)(1)). We intend to 

consider these action levels, in addition 

to other factors, when considering 

whether to bring enforcement action in 

a particular case. 

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/FoodGuidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, 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. 2024–31534 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–2015–D–3517] 

Interim Policy on Compounding Using 

Bulk Drug Substances Under Section 

503A of the Federal Food, Drug, and 

Cosmetic Act; 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 entitled ‘‘Interim 

Policy on Compounding Using Bulk 

Drug Substances Under Section 503A of 

the Federal Food, Drug, and Cosmetic 

Act.’’ This guidance describes FDA’s 

interim policy concerning compounding 

by human drug product compounders 

that are not outsourcing facilities using 

bulk drug substances while FDA 

develops the list of bulk drug substances 

that can be used in compounding under 

the applicable section of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act). This guidance finalizes the draft 

guidance of the same title issued in 

December 2023 and replaces the final 

guidance of the same title issued in 

January 2017. 

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– 

2015–D–3517 for ‘‘Interim Policy on 

Compounding Using Bulk Drug 

Substances Under Section 503A of the 

Federal Food, Drug, and Cosmetic Act.’’ 

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. 


ddrumheller on DSK120RN23PROD with NOTICES1