
[Federal Register Volume 88, Number 235 (Friday, December 8, 2023)]
[Notices]
[Pages 85640-85642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27018]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4849]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Allergen Labeling and Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
associated with statutory provisions applicable to ingredients derived 
from major food allergens.

DATES: Either electronic or written comments on the collection of 
information must be submitted by February 6, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 6, 2024. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

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-2023-N-4849 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Food Allergen Labeling and 
Reporting.'' Received comments, those filed in a timely manner (see 
ADDRESSES), 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.'' 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 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.

FOR FURTHER INFORMATION CONTACT: 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, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the 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, including 
each proposed extension of an existing 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 the following 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

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on respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 
technology.

Food Allergen Labeling and Reporting

OMB Control Number 0910-0792--Revision

    This information collection helps support implementation of 
statutory requirements pertaining to ingredients derived from major 
food allergens. The Federal Food, Drug, and Cosmetic Act (FD&C Act) 
defines the term ``major food allergen'' (section 201(qq) of the FD&C 
Act (21 U.S.C. 321(qq))) and provides that foods are misbranded unless 
they declare the presence of each major food allergen on the product 
label using the name of the food source from which the major food 
allergen is derived or are exempt from the requirement. Under sections 
403(w)(6) and (7) of the FD&C Act (21 U.S.C. 343(w)(6) and (7)), 
respondents may request an FDA determination that an ingredient is 
exempt from the labeling requirement of section 403(w)(1) of the FD&C 
Act. Alternatively, an ingredient may become exempt through submission 
of a notification containing scientific evidence showing that the 
ingredient ``does not contain allergenic protein'' or that there has 
been a previous determination through a premarket approval process 
under section 409 of the FD&C Act (21 U.S.C. 348) that the ingredient 
``does not cause an allergic response that poses a risk to human 
health'' (section 403(w)(7) of the FD&C Act).
    To assist respondents with the information collection in this 
regard, the document entitled ``Guidance for Industry: Food Allergen 
Labeling Exemption Petitions and Notifications'' (June 2015), available 
on our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-food-allergen-labeling-exemption-petitions-and-notifications, communicates information we 
recommend respondents include in petitions submitted under sections 
403(w)(6) and (7) of the FD&C Act or notifications submitted under 
section 409 of the FD&C Act. We use the information submitted in the 
petition or notification to determine whether the ingredient satisfies 
the criteria of section 403(w)(6) and (7) of the FD&C Act for granting 
the exemption. The allergen information disclosed on the label or 
labeling of a food product benefits consumers who purchase that food 
product. Because even small exposure to a food allergen can potentially 
cause an adverse reaction, consumers rely upon food labeling 
information to help determine their product choices.
    On April 23, 2021, the definition of the term major food allergen 
was amended by the Food Allergy Safety, Treatment, Education, and 
Research Act of 2021 (FASTER Act) (Pub. L. 117-11) to include sesame. 
Accordingly, we are revising the information collection to account for 
burden attributable to required declarations and/or associated requests 
for exemption as they pertain to foods that include sesame. We issued 
the draft guidance document entitled ``Questions and Answers Regarding 
Food Allergens, Including the Food Allergen Labeling Requirements of 
the Federal Food, Drug, and Cosmetic Act (Edition 5)'' (November 2022), 
available on our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-questions-and-answers-regarding-food-allergen-labeling-edition-5, that once 
finalized, will communicate our current thinking regarding the labeling 
of food allergens, including sesame in food products regulated under 
section 403 of the FD&C Act. The guidance was issued consistent with 
our good guidance practice regulations in 21 CFR 10.115, which provide 
for public comment at any time.
    Description of Respondents: The respondents to this collection of 
information are manufacturers and packers of packaged foods sold in the 
United States subject to the labeling requirements and prohibitions 
found in section 403 of the FD&C Act.
    We estimate the burden of this collection of information as 
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                             Number of
    FD&C Act Section; information collection activity        Number of      disclosures    Total annual   Average burden    Total hours    Total capital
                                                            respondents   per respondent    disclosures   per disclosure                       costs
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403; review product labeling for compliance with                  77,500               1          77,500               1          77,500               0
 applicable statutory requirements......................
403; redesign/modifications to product labeling for                  775               1             775              16          12,400      $1,414,375
 compliance with applicable statutory requirements......
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    Total...............................................  ..............  ..............  ..............  ..............          89,900       1,414,375
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\1\ There are no operating and maintenance costs associated with this collection of information.


                                 Table 2--Estimated Annual Reporting Burden \1\
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                                                     Number of
  FD&C Act Section; information      Number of     responses per   Total annual   Average burden    Total hours
       collection activity          respondents     respondent       responses     per response
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403(w)(6); petition for                        6               1               6             100             600
 exemptions.....................
403(w)(7); notification                        6               1               6              68             408
 submissions....................
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    Total.......................  ..............  ..............  ..............  ..............           1,008
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimate of the third-party disclosure burden associated with 
food allergen labeling under section 403(w)(1) of the FD&C Act includes 
the time we assume respondents need to review the labels of new or 
reformulated

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products for compliance with the requirements of section 403(w)(1) of 
the FD&C Act, along with the time needed to make any needed 
modifications to the labels of those products. We believe firms have 
already redesigned their labels to comply with requirements under the 
Food Allergen Labeling and Consumer Protection Act of 2004. However, 
this estimate accounts for firms that will redesign their label to 
comply with requirements under the FASTER Act. Our estimated reporting 
burden is based on our past experience with these submissions. We have 
increased our cumulative estimate by 12,552 hours and 776 responses 
annually to reflect the inclusion of sesame as a major food allergen.

    Dated: December 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27018 Filed 12-7-23; 8:45 am]
BILLING CODE 4164-01-P


