[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......
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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 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