[Federal Register Volume 87, Number 75 (Tuesday, April 19, 2022)]
[Notices]
[Pages 23181-23184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08303]


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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Cosmetic Act; Draft Guidance for FDA Staff and Stakeholders; 
Availability; Agency Information Collection Activities; Proposed 
Collection; Comment Request

AGENCY: Food and Drug Administration, HHS.

[[Page 23182]]


ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 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availability of a draft guidance for FDA staff and stakeholders 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.'' This draft guidance, when finalized, will explain 
our current thinking on the approach we generally intend to take when 
we evaluate the public health importance of a food allergen other than 
milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, 
soybean, and sesame (non-listed food allergen). (In April 2021, the 
Food Allergy Safety, Treatment, Education, and Research Act of 2021 
amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add 
sesame to the definition of ``major food allergen.'' This statutory 
requirement goes into effect on January 1, 2023). We are also 
announcing an opportunity for public comment on our proposed collection 
of information. This draft guidance is not final nor is it in effect at 
this time.

DATES: Submit either electronic or written comments on the draft 
guidance by August 17, 2022 to ensure that we consider your comment on 
this draft guidance before we begin work on the final version of the 
guidance. Submit electronic or written comments on the proposed 
collection of information in the draft guidance by August 17, 2022.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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 draft guidance to 
the Compliance Policy Staff, Office of Compliance (HFS-605), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740. Send two self-addressed adhesive 
labels 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: 
    With regard to the draft guidance: Stefano Luccioli, Office of 
Compliance (HFS-605), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 
240-402-1283, <a href="/cdn-cgi/l/email-protection#eba8adb8aaa5a884869b87828a85888e9b8487828892ab8d8f8ac5838398c58c849d"><span class="__cf_email__" data-cfemail="ffbcb9acbeb1bc90928f93969e919c9a8f9093969c86bf999b9ed197978cd1989089">[email protected]</span></a>; or Alexandra Jurewitz, 
Office of Regulations and Policy (HFS-024), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-2378.
    With regard to the proposed collection of information: Domini Bean, 
Office of Operations, Food and Drug Administration, Three White Flint 
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
5733, <a href="/cdn-cgi/l/email-protection#5e0e0c1f0d2a3f38381e383a3f7036362d70393128"><span class="__cf_email__" data-cfemail="b8e8eaf9ebccd9dedef8dedcd996d0d0cb96dfd7ce">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    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

[[Page 23183]]

IgE and are capable of triggering anaphylaxis, which can be fatal. The 
focus of the draft guidance is IgE-mediated food allergy.
    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. The Food Allergen Labeling and 
Consumer Protection Act of 2004 amended the FD&C Act to provide us with 
additional, specific authority regarding the labeling of a food (other 
than a raw agricultural commodity) that bears or contains a ``major 
food allergen.'' 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, and soybean. In April 
2021, the Food Allergy Safety, Treatment, Education, and Research Act 
of 2021 amended section 201(qq) of the FD&C Act to add sesame to the 
definition of ``major food allergen.'' This amendment applies to ``any 
food that is introduced or delivered for introduction into interstate 
commerce on or after January 1, 2023'' (Pub. L. 117-11).
    We are announcing 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 are issuing the draft 
guidance consistent with our good guidance practices regulation (21 CFR 
10.115). The draft guidance, when finalized, will represent 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.
    The draft guidance discusses: (1) The scientific factors that we 
would generally intend to consider when evaluating the public health 
importance of a non-listed food allergen; (2) other information, 
relevant to the labeling and production of food containing the food 
allergen, that we would generally intend to consider when evaluating 
the public health importance of a non-listed food allergen; and (3) our 
tentative recommendations for how to identify and evaluate the body of 
evidence applicable to an evaluation of the public health importance of 
a non-listed food allergen.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501-3521), 
Federal Agencies must obtain approval from the Office of Management and 
Budget (OMB) for each collection of information they conduct or 
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) 
and 5 CFR 1320.3(c) and includes Agency requests or requirements that 
members of the public submit reports, keep records, or provide 
information to a third party. Section 3506(c)(2)(A) of the PRA (44 
U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day 
notice in the Federal Register concerning each proposed collection of 
information before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing notice of the proposed 
collection of information set forth in this document.
    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.

Evaluating the Public Health Importance of Food Allergens Other Than 
the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic 
Act

OMB Control Number 0910-0191--Revision

    The draft guidance, when finalized, will describe our current 
thinking on the approach we generally intend to take when we evaluate 
the public health importance of a non-listed food allergen. Respondents 
who are interested in asking FDA to evaluate a food or component of 
food as a food allergen of public health importance may submit 
information relevant to their request in accordance with Sec.  10.30 
(21 CFR 10.30). We recommend that the submitted information include 
data demonstrating that the food allergy is IgE-mediated and data for 
prevalence, severity, and potency, as described in the draft guidance.
    Description of respondents: The respondents to this collection of 
information are any persons who file citizen petitions under 21 CFR 
10.30, which may include manufacturers and packers of packaged foods 
sold in the United States that may contain a non-listed food allergen 
and individuals and organizations interested in evaluating a food or 
component of food as a food allergen of public health importance. 
Respondents are from the private sector (for-profit businesses and non-
profit entities).
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                      Activity; 21 CFR section                          Number of      responses per     Total annual   Avg. burden per    Total hours
                                                                       respondents       respondent       responses         response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting data for evidence of IgE-mediated food allergy,                        1                1                1               80               80
 prevalence, severity, and potency; 10.30..........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We base these estimates on our experience with reviewing and 
evaluating data for food allergens. We estimate that one respondent 
will spend approximately 80 hours developing and

[[Page 23184]]

submitting the information to FDA each year.
    This draft guidance also refers to previously approved collections 
of information found in FDA regulations. 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 draft guidance 
at either 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: April 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08303 Filed 4-18-22; 8:45 am]
BILLING CODE 4164-01-P


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