Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 1163 

21 CFR Part or guidance Topic OMB control No. 

50, 56 .......................................................................................................................... Protection of Human Subjects 

and Institutional Review 

Boards.

0910–0130 

Dated: December 26, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–31526 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–2021–N–0553] 

Evaluating the Public Health 

Importance of Food Allergens Other 

Than the Major Food Allergens Listed 

in the Federal Food, Drug, and 

Cosmetic Act; Guidance for FDA Staff 

and Interested Parties; 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 FDA staff and interested 

parties entitled ‘‘Evaluating the Public 

Health Importance of Food Allergens 

Other Than the Major Food Allergens 

Listed in the Federal Food, Drug, and 

Cosmetic Act.’’ This guidance document 

provides our current thinking on the 

approach we generally intend to take 

when we evaluate the public health 

importance of a food allergen other than 

one of the major food allergens (i.e., 

milk, eggs, fish, Crustacean shellfish, 

tree nuts, wheat, peanuts, soybean, and 

sesame) listed in the Federal Food, 

Drug, and Cosmetic Act (FD&C 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– 

2021–N–0553 for ‘‘Evaluating the Public 

Health Importance of Food Allergens 

Other Than the Major Food Allergens 

Listed in 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. 

• 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 Division of 

Chemical Contaminants, Office of PostMarket Assessment, 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: 

Stefano Luccioli, Office of Post-Market 

Assessment, Human Foods Program, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740, 

240–402–1283; or Alexandra Beliveau, 

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: 


ddrumheller on DSK120RN23PROD with NOTICES1
1164 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

I. Background 

We are announcing the availability of 

a guidance for FDA staff and interested 

parties entitled ‘‘Evaluating the Public 

Health Importance of Food Allergens 

Other Than the Major Food Allergens 

Listed in the Federal Food, Drug, and 

Cosmetic Act.’’ 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 April 19, 

2022 (87 FR 23181), we announced the 

availability of a draft guidance for FDA 

staff and stakeholders entitled 

‘‘Evaluating the Public Health 

Importance of Food Allergens Other 

Than the Major Food Allergens Listed in 

the Federal Food, Drug, and Cosmetic 

Act.’’ We gave interested parties until 

August 17, 2022, to submit comments 

for us to consider before beginning work 

on the final version of the guidance. 

This guidance finalizes the approach 

we generally intend to take when 

evaluating the public health importance 

of a non-listed food allergen. The 

guidance specifies the scientific factors 

and other information relevant to the 

labeling and production of food 

containing the food allergen that we 

generally intend to consider when 

evaluating the public health importance 

of a non-listed food allergen. It also 

describes our recommendations for how 

to identify and evaluate the body of 

evidence applicable to an evaluation of 

the public health importance of a nonlisted food allergen. 

Food allergy can be broadly defined 

as an adverse health effect arising from 

a specific immune response that occurs 

reproducibly on exposure to a given 

food. A food allergen is the food or 

component(s) (often a protein) of a food 

that elicits specific immunologic 

reactions. While many different types of 

food allergies have been identified, food 

allergies that are most studied and 

understood clinically are those due to 

immunoglobulin E antibodies (IgE) that 

cause the body to release inflammatory 

chemicals. The most severe and 

immediately life-threatening food 

allergies are those that are mediated by 

IgE and are capable of triggering 

anaphylaxis, which can be fatal. The 

focus of this guidance is primarily IgEmediated food allergy. However, we 

recognize that food allergens acting 

through other mechanisms may raise 

public health concerns. We intend to 

evaluate the public health importance of 

these allergens on a case-by-case basis. 

We will also continue gathering 

scientific data and other information on 

food allergens acting through other 

mechanisms to help inform possible 

future action on these allergens, which 

may include future guidance or 

communications to the public. 

In general, the regulatory framework 

of the FD&C Act and our regulations 

implementing the FD&C Act broadly 

apply to the production of food that is 

or contains a food allergen through 

statutory and regulatory provisions 

regarding: (1) food labeling; (2) food 

production (e.g., manufacturing, 

processing, packing, and holding food); 

and (3) the safety of substances added 

to food. Under section 403(w) of the 

FD&C Act (21 U.S.C. 343(w)), a food is 

misbranded if it contains a major food 

allergen and fails to declare that major 

food allergen as specified on its label 

using the major food allergen’s common 

or usual name. Section 201(qq)(1) of the 

FD&C Act (21 U.S.C. 321(qq)(1)) defines 

a ‘‘major food allergen,’’ in part, as any 

of the following: milk, eggs, fish (e.g., 

bass, flounder, or cod), Crustacean 

shellfish, tree nuts (e.g., almonds, 

pecans, or walnuts), wheat, peanuts, 

soybeans, and sesame. 

We considered all comments received 

during the comment period before 

developing the final guidance. Some 

comments on the draft guidance 

requested that we expand the scope of 

the guidance to cover non-IgE-mediated 

food allergies and to describe the 

potential regulatory options available to 

FDA. Other comments recommended 

that FDA define specific targets for each 

evaluation factor laid out in the 

framework. We have modified the final 

guidance where appropriate. Changes to 

the guidance include: 

• Clarifying that evidence of non-IgEmediated reactions can be useful as 

supplemental data in an evaluation of 

the public health importance of a food 

allergen; 

• Incorporating updated text and a 

revised reference to reflect the recent 

publication of the Food and Agricultural 

Organization of the United Nations and 

World Health Organization’s Expert 

Committee meeting report; and 

• Expanding the discussion regarding 

prevalence data when a food is not 

regularly consumed in the United 

States. 

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 (44 U.S.C. 3501– 

3521). The collections of information in 

21 CFR part 10 have been approved 

under OMB control number 0910–0191. 

The collections of information in 21 

CFR part 101 have been approved under 

OMB control number 0910–0381. The 

collections of information in section 

403(w) of the FD&C Act have been 

approved under OMB control number 

0910–0792. The collections of 

information in 21 CFR part 117 have 

been approved under OMB control 

number 0910–0751. The collections of 

information for Form FDA 3800 have 

been approved under OMB control 

number 0910–0645. The collections of 

information for Form FDA 3500 have 

been approved under OMB control 

number 0910–0291. The collections of 

information in 21 CFR 70.25, 71.1, 

170.36, 171.1, 172, 173, 179, and 180 

have been approved under OMB control 

number 0910–0016. 

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 websites 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. 2024–31529 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–0465, FDA–2022– 

D–0466, and FDA–2022–D–0467] 

Draft Guidances Relating to 

Recommendations To Reduce the Risk 

of Transmission of Relevant 

Communicable Disease Agents and 

Diseases by Human Cells, Tissues, 

and Cellular and Tissue-Based 

Products; Draft Guidances 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 three 


ddrumheller on DSK120RN23PROD with NOTICES1