Notice2023-27018
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Allergen Labeling and Reporting
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 8, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 235 (Friday, December 8, 2023)</title>
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[Federal Register Volume 88, Number 235 (Friday, December 8, 2023)]
[Notices]
[Pages 85640-85642]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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-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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#49191b081a3d282f2f092f2d286721213a672e263f"><span class="__cf_email__" data-cfemail="69393b283a1d080f0f290f0d084701011a470e061f">[email protected]</span></a>.
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
[[Page 85641]]
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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-food-allergen-labeling-exemption-petitions-and-notifications">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-food-allergen-labeling-exemption-petitions-and-notifications</a>, 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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-questions-and-answers-regarding-food-allergen-labeling-edition-5">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-questions-and-answers-regarding-food-allergen-labeling-edition-5</a>, 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
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