Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 1133 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911; Terri 

Cornelison, Center for Devices and 

Radiological Health,10903 New 

Hampshire Ave., Bldg. 66, Rm. 5516, 

Silver Spring, MD 20993–0002, 301– 

796–5682; or Office of Women’s Health, 

10903 New Hampshire Ave., Bldg. 32, 

Rm. 2333, Silver Spring, MD 20993– 

0002, FDA-OWH@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Study of Sex Differences in the Clinical 

Evaluation of Medical Products.’’ 

Analyzing sex-related differences in 

medical product response is an 

important component of assessing 

product safety and effectiveness, to help 

understand safety and effectiveness 

across the intended patient population, 

and can inform what goes into product 

labeling to improve patient care. 

Differences in physiology between 

females and males can lead to 

differences in disease manifestation, 

pharmacokinetics, pharmacodynamics, 

and response to treatment, among other 

things. Topics addressed in this 

guidance include: (1) practices to 

improve the recruitment, enrollment, 

and retention of females in clinical 

trials, to help ensure the generalizability 

of research results to intended patient 

populations; (2) statistical 

considerations for analyzing sex 

differences; and (3) reporting results 

based on analyses of sex differences. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Study of Sex Differences in the 

Clinical Evaluation of Medical 

Products.’’ 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 

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 part 312 have 

been approved under OMB control 

number 0910–0014; the collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; the collections of 

information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338; and the collections 

of information in 21 CFR part 812 have 

been approved under OMB control 

number 0910–0078. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

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

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

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/guidance-documentsmedical-devices-and-radiation-emittingproducts, https://www.fda.gov/ 

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

www.regulations.gov. 

Dated: December 26, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–31537 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–0099] 

Questions and Answers Regarding 

Food Allergens, Including the Food 

Allergen Labeling Requirements of the 

Federal Food, Drug, and Cosmetic Act 

(Edition 5): 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 revised 

final guidance for industry entitled 

‘‘Questions and Answers Regarding 

Food Allergens, Including the Food 

Allergen Labeling Requirements of the 

Federal Food, Drug, and Cosmetic Act 

(Edition 5): Guidance for Industry.’’ The 

guidance explains FDA’s current 

thinking on a number of issues related 

to the labeling of food allergens, 

including requirements in the Food 

Allergen Labeling and Consumer 

Protection Act of 2004 (FALCPA) and 

the Food Allergy Safety, Treatment, 

Education, and Research Act of 2021 

(FASTER Act). 

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–0099 for ‘‘Questions and 

Answers Regarding Food Allergens, 

Including the Food Allergen Labeling 

Requirements of the Federal Food, Drug, 

and Cosmetic Act (Edition 5): 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 


ddrumheller on DSK120RN23PROD with NOTICES1
1134 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

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 

Nutrition and Food Labeling, 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: 

Carol D’Lima, Office of Nutrition and 

Food Labeling (HFS–800), Human 

Foods Program, Food and Drug 

Administration, 5001 Campus Dr., 

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

or Denise See, Office of Policy, 

Regulations, and Information, Human 

Foods Program, Food and Drug 

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 

‘‘Questions and Answers Regarding 

Food Allergens, Including the Food 

Allergen Labeling Requirements of the 

Federal Food, Drug, and Cosmetic Act 

(Edition 5): Guidance for Industry.’’ 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. 

FALCPA (Pub. L. 108–282) was 

enacted in August 2004 and, in part, 

amended the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) by 

defining the term ‘‘major food allergen’’ 

and requiring that the presence of any 

major food allergen be declared on the 

labels of FDA-regulated foods. FALCPA 

defined a major food allergen as milk, 

egg, fish (e.g., bass, flounder, or cod), 

Crustacean shellfish (e.g., crab, lobster, 

or shrimp), tree nuts (e.g., almonds, 

pecans, or walnuts), wheat, peanuts, 

and soybeans and as a food ingredient 

that contains protein derived from these 

foods (section 201(qq) of the FD&C Act 

(21 U.S.C. 321(qq))). In addition, the 

FASTER Act (Pub. L. 117–11) was 

enacted in April 2021 and, in part, 

amended the definition of major food 

allergen in the FD&C Act to include 

sesame. 

Since the passage of FALCPA, FDA 

has received numerous questions about 

food allergen labeling requirements. To 

explain FALCPA’s requirements as well 

as FDA’s current thinking on issues 

relating to the regulation of food 

allergens, on October 5, 2005, FDA 

issued the first edition of a guidance 

entitled ‘‘Guidance for Industry: 

Questions and Answers Regarding Food 

Allergens, including the Food Allergen 

Labeling and Consumer Protection Act 

of 2004.’’ We subsequently updated the 

guidance in December 2005 (Edition 2), 

April 2006 (Edition 3), and October 

2006 (Edition 4). 

In the Federal Register of November 

30, 2022 (87 FR 73561), FDA issued a 

draft guidance for industry entitled 

‘‘Questions and Answers Regarding 

Food Allergens, Including the Food 

Allergen Labeling Requirements of the 

Federal Food, Drug, and Cosmetic Act 

(Edition 5).’’ The draft guidance was a 

revision of Edition 4 originally entitled 

‘‘Questions and Answers Regarding 

Food Allergens, Including the Food 

Allergen Labeling and Consumer 

Protection Act of 2004’’ that contained 

revised and new questions and answers 

relating to food allergens, including 

questions and answers about FALCPA 

and the FASTER Act. We gave 

interested parties an opportunity to 

submit comments for us to consider 

before beginning work on the final 

version of the guidance. We received 

numerous comments on the draft 

guidance and have made modifications 

in this final guidance where 

appropriate. On November 30, 2022, 

FDA also issued a final guidance, 

‘‘Questions and Answers Regarding 

Food Allergens, Including the Food 

Allergen Labeling Requirements of the 

Federal Food, Drug, and Cosmetic Act 

(Edition 5),’’ that contained the 

questions and answers from Edition 4 

that remained unchanged, with the 

exception of editorial changes such as 

renumbering and organizational 

changes, and therefore were reissued as 

final guidance. The revised final 

guidance announced in this notice 

consolidates both the draft and final 

guidance that issued on November 30, 

2022. 

The revised final guidance contains 

questions and answers about food 

allergen labeling requirements, 

including the labeling of sesame, milk, 

eggs, incidental additives, highly 

refined oils, dietary supplement 

products, and certain specific packing 

and labeling situations (e.g., individual 

units within a multiunit package). We 

have made some changes from the draft 

guidance. For example, we have 

expanded our historical interpretation 

of the terms ‘‘milk’’ and ‘‘eggs;’’ for 

purposes of the definition of a ‘‘major 

food allergen’’ under section 201(qq) of 

the FD&C Act and for purposes of 

complying with the food allergen 

labeling requirements of the FD&C Act. 

FDA has historically interpreted ‘‘milk’’ 

as milk from the domesticated cow and 

‘‘eggs’’ as eggs from the domesticated 

chicken. However, the final guidance 

sets forth that for purposes of the 

definition of a ‘‘major food allergen’’ 

under section 201(qq) of the FD&C Act, 

FDA considers ‘‘milk’’ as milk from 

domesticated cows, goats, sheep, or 

other ruminants and FDA considers 

‘‘eggs’’ as eggs from domesticated 

chickens, ducks, geese, quail, and other 

fowl. In addition, the final guidance 


ddrumheller on DSK120RN23PROD with NOTICES1
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