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availability of a draft guidance for FDA 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
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 1165 

specific draft guidances for industry 

entitled ‘‘Recommendations to Reduce 

the Risk of Transmission of Hepatitis B 

Virus (HBV) by Human Cells, Tissues, 

and Cellular and Tissue-Based Products 

(HCT/Ps);’’ ‘‘Recommendations to 

Reduce the Risk of Transmission of 

Hepatitis C Virus (HCV) by Human 

Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps);’’ and 

‘‘Recommendations to Reduce the Risk 

of Transmission of Human 

Immunodeficiency Virus (HIV) by 

Human Cells, Tissues, and Cellular and 

Tissue-Based Products (HCT/Ps).’’ 

These draft guidances are intended to 

update existing guidances and to assist 

establishments making donor eligibility 

determinations in understanding the 

requirements for determining donor 

eligibility, including donor screening 

and testing, for donors of HCT/Ps. These 

draft guidances are also intended to 

provide establishments making donor 

eligibility determinations with 

recommendations to reduce the risk of 

transmission of specific communicable 

disease agents and diseases, specifically, 

hepatitis B virus (HBV), hepatitis C 

virus (HCV), and human 

immunodeficiency virus (HIV), by HCT/ 

Ps. 

DATES: Submit either electronic or 

written comments on the draft 

guidances by February 6, 2025 to ensure 

that the Agency considers your 

comment on these draft guidances 

before it begins work on the final 

versions of the guidances. 

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 dockets 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–0465 for ‘‘Recommendations to 

Reduce the Risk of Transmission of 

Hepatitis B Virus (HBV) by Human 

Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps); Draft 

Guidance for Industry;’’ Docket No. 

FDA–2022–D–0466 for 

‘‘Recommendations to Reduce the Risk 

of Transmission of Hepatitis C Virus 

(HCV) by Human Cells, Tissues, and 

Cellular and Tissue-Based Products 

(HCT/Ps); Draft Guidance for Industry;’’ 

and Docket No. FDA–2022–D–0467 for 

‘‘Recommendations to Reduce the Risk 

of Transmission of Human 

Immunodeficiency Virus (HIV) by 

Human Cells, Tissues, and Cellular and 

Tissue-Based Products (HCT/Ps); Draft 

Guidance for Industry.’’ Received 

comments will be placed in the dockets 

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 dockets to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket numbers, 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 draft guidances to the 

Office of 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 label to 

assist the office in processing your 

requests. The draft guidances may also 

be obtained by phone by calling CBER 

at 1–800–835–4709 or 240–402–8010. 

See the SUPPLEMENTARY INFORMATION

section for electronic access to the draft 

guidances. 

FOR FURTHER INFORMATION CONTACT: 

Victoria Wagman, 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 

three draft guidances entitled: 

‘‘Recommendations to Reduce the Risk 

of Transmission of Hepatitis B Virus 

(HBV) by Human Cells, Tissues, and 

Cellular and Tissue-Based Products 

(HCT/Ps);’’ ‘‘Recommendations to 

Reduce the Risk of Transmission of 

Hepatitis C Virus (HCV) by Human 

Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps);’’ and 

‘‘Recommendations to Reduce the Risk 


ddrumheller on DSK120RN23PROD with NOTICES1
1166 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

of Transmission of Human 

Immunodeficiency Virus (HIV) by 

Human Cells, Tissues, and Cellular and 

Tissue-Based Products (HCT/Ps).’’ 

When finalized, these draft guidances 

will update existing guidance 

documents and assist establishments 

making donor eligibility determinations 

in understanding the requirements for 

determining donor eligibility, including 

donor screening and testing, for donors 

of HCT/Ps. When finalized, these 

specific draft guidances will also 

provide establishments making donor 

eligibility determinations with 

recommendations to reduce the risk of 

transmission of HBV, HCV, and HIV by 

HCT/Ps. Updates to existing guidance 

recommendations include but are not 

limited to: revising recommendations 

for donor screening that includes 

reducing certain time-based risk factors 

and conditions; assessing HCT/P donor 

eligibility using the same individual 

risk-based questions relevant to risk for 

every donor regardless of sex or gender, 

and for the draft guidance related to 

HIV, donor testing and screening for 

HIV–1 group O risk. 

Based on FDA review of the available 

science, adequacy of available test 

methods, studies used to evaluate risk 

behaviors, and experiences with 

updated blood donor screening 

questions, FDA also recommends 

eliminating the HCT/P donor screening 

questions specific to men who have sex 

with men (MSM) and women who have 

sex with MSM and, instead 

recommends assessing HCT/P donor 

eligibility using the same individual 

risk-based questions relevant to HBV, 

HCV, and HIV risk for every donor 

regardless of sex or gender. 

TABLE 1—THREE DRAFT GUIDANCES

ISSUED FOR PUBLIC COMMENT

Docket 

No. Draft guidance document title 

FDA– 

2022– 

D– 

0465.

Recommendations to Reduce the 

Risk of Transmission of Hepatitis 

B Virus (HBV) by Human Cells, 

Tissues, and Cellular and Tissue-Based Products (HCT/Ps); 

Draft Guidance for Industry. 

FDA– 

2022– 

D– 

0466.

Recommendations to Reduce the 

Risk of Transmission of Hepatitis 

C Virus (HCV) by Human Cells, 

Tissues, and Cellular and Tissue-Based Products (HCT/Ps); 

Draft Guidance for Industry. 

FDA– 

2022– 

D– 

0467.

Recommendations to Reduce the 

Risk of Transmission of Human 

Immunodeficiency Virus (HIV) by 

Human Cells, Tissues, and Cellular and Tissue-Based Products 

(HCT/Ps); Draft Guidance for Industry. 

At a later date, FDA intends to issue 

additional specific draft guidances with 

recommendations regarding specific 

communicable disease agents and 

diseases for donors of HCT/Ps as 

follows: (1) transmissible spongiform 

encephalopathy, (2) Treponema 

pallidum (syphilis), (3) Chlamydia 

trachomatis and Neisseria gonorrhoeae, 

(4) vaccinia virus, (5) West Nile virus, 

(6) human T-lymphotropic virus, (7) 

Cytomegalovirus, and (8) communicable 

disease risks associated with 

xenotransplantation. 

The draft guidances, when finalized, 

are intended to supersede information 

regarding HBV, HCV, and HIV risk in 

the document entitled ‘‘Eligibility 

Determination for Donors of Human 

Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps), Guidance for 

Industry,’’ dated August 2007. 

Regarding HBV risk, the draft guidance 

is also intended to supersede the 

document entitled ‘‘Use of Nucleic Acid 

Tests to Reduce the Risk of 

Transmission of Hepatitis B Virus from 

Donors of Human Cells, Tissues, and 

Cellular and Tissue-Based Products, 

Guidance for Industry’’ dated August 

2016. 

The three draft guidances are being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). These draft guidances, when 

finalized, will represent the current 

thinking of FDA on ‘‘Recommendations 

to Reduce the Risk of Transmission of 

Hepatitis B Virus (HBV) by Human 

Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps);’’ 

‘‘Recommendations to Reduce the Risk 

of Transmission of Hepatitis C Virus 

(HCV) by Human Cells, Tissues, and 

Cellular and Tissue-Based Products 

(HCT/Ps);’’ and ‘‘Recommendations to 

Reduce the Risk of Transmission of 

Human Immunodeficiency Virus (HIV) 

by Human Cells, Tissues, and Cellular 

and Tissue-Based Products (HCT/Ps).’’ 

They do not establish any rights for any 

person and are 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 these guidances contains no 

new collection of information, they do 

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 1271.50 have been approved under 

OMB control number 0910–0139. 

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 26, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–31523 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–0464] 

Recommendations for Determining 

Eligibility of Donors of Human Cells, 

Tissues, and Cellular and TissueBased Products; Draft 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 draft 

guidance document entitled 

‘‘Recommendations for Determining 

Eligibility of Donors of Human Cells, 

Tissues, and Cellular and Tissue-Based 

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

document includes general information 

on determining eligibility for donors of 

HCT/Ps. In addition, FDA intends to 

issue separate guidance documents with 

recommendations regarding reducing 

the risk of transmission of specific 

communicable disease agents and 

diseases for donors of HCT/Ps. These 

guidance documents are intended to 

update an existing guidance. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by February 6, 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 


ddrumheller on DSK120RN23PROD with NOTICES1