[Federal Register Volume 89, Number 71 (Thursday, April 11, 2024)]
[Notices]
[Pages 25635-25636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07663]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by May 13, 2024.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0792. Also include the FDA docket 
number found in brackets in the heading of this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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.
    In the Federal Register of December 8, 2023 (88 FR 85640), we 
published a 60-day notice soliciting comment on the proposed collection 
of information. Although one comment was received, we believe it was 
misdirected. The comment pertained to neither the topic of this notice, 
nor the four information collection topics solicited.
    We estimate the burden of this collection of information as 
follows:

[[Page 25636]]



                                               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......
                                                         -----------------------------------------------------------------------------------------------
    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 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: April 8, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-07663 Filed 4-10-24; 8:45 am]
BILLING CODE 4164-01-P