Agency Information Collection Activities; Proposed Collection; Comment Request; Food Allergen Labeling and Reporting, 85640-85642 [2023-27018]
Download as PDF
<![CDATA[
85640
Federal Register / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices
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.
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.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
16:50 Dec 07, 2023
Jkt 262001
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
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
‘‘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-201509-18/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, PRAStaff@
fda.hhs.gov.
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
E:\FR\FM\08DEN1.SGM
08DEN1
85641
Federal Register / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices
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/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-foodallergen-labeling-exemption-petitionsand-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-fdaguidance-documents/draft-guidanceindustry-questions-and-answersregarding-food-allergen-labelingedition-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
FD&C Act Section; information collection
activity
403; review product labeling for compliance with applicable statutory requirements ....................................................
403; redesign/modifications to product labeling for compliance with applicable
statutory requirements ..........................
Total ..................................................
1 There
Number of
disclosures
per
respondent
Number of
respondents
Total
annual
disclosures
Average
burden per
disclosure
Total hours
Total capital
costs
77,500
1
77,500
1
77,500
0
775
1
775
16
12,400
$1,414,375
........................
........................
........................
........................
89,900
1,414,375
are no operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
FD&C Act Section; information collection activity
Average
burden per
response
Total annual
responses
Total hours
403(w)(6); petition for exemptions .......................................
403(w)(7); notification submissions .....................................
6
6
1
1
6
6
100
68
600
408
Total ..............................................................................
........................
........................
........................
........................
1,008
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
VerDate Sep<11>2014
16:50 Dec 07, 2023
Jkt 262001
allergen labeling under section
403(w)(1) of the FD&C Act includes the
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
time we assume respondents need to
review the labels of new or reformulated
E:\FR\FM\08DEN1.SGM
08DEN1
85642
Federal Register / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices
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.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Time and Extent Applications for
Nonprescription Drug Products
[FR Doc. 2023–27018 Filed 12–7–23; 8:45 am]
BILLING CODE 4164–01–P
OMB Control Number 0910–0688—
Revision
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
I. Background
Food and Drug Administration
[Docket No. FDA–2023–N–2851]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Time and Extent
Applications for Nonprescription Drug
Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) 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 January 8,
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
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
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 0910–0688. Also include
the FDA docket number found in
brackets in the heading of this
document.
VerDate Sep<11>2014
16:50 Dec 07, 2023
Jkt 262001
This information collection supports
certain Agency regulations in part 330
(21 CFR part 330) regarding over-thecounter (OTC) human drugs and
associated guidance. Specifically, FDA
regulations in §§ 330.14 and 330.15 (21
CFR 330.14 and 330.15) establish
additional criteria and procedures for
classifying OTC drugs as generally
recognized as safe and effective and not
misbranded. These regulations provide
that OTC drug products introduced into
the U.S. market after the OTC drug
review began in 1972 and OTC drug
products without any marketing
experience in the United States can be
evaluated under the OTC monograph
system if the conditions (e.g., active
ingredients) meet certain ‘‘time and
extent’’ criteria outlined in the
regulations. The regulations in § 330.14
allow a sponsor to submit certain
information to the Agency in a time and
extent application (TEA) for use to
determine eligibility of a condition for
consideration in the OTC monograph
system.
We developed the final guidance
document entitled ‘‘Time and Extent
Applications for Nonprescription Drug
Products’’ (September 2011) (available
from our website at https://
www.fda.gov/regulatory-information/
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
search-fda-guidance-documents/timeand-extent-applicationsnonprescription-drug-products) to assist
respondents with the information
collection provisions found in the
regulations. The guidance was issued
consistent with our good guidance
practice regulations at 21 CFR 10.115,
which provide for comment at any time.
The guidance explains what information
an applicant should submit to the
Agency to request that a drug product be
included in the OTC drug monograph
system. The guidance also discusses
format and content elements, and the
process for submitting information,
consistent with the applicable
regulations.
II. OTC Monograph Reform in the
Coronavirus Aid, Relief, and Economic
Security Act
The Coronavirus Aid, Relief, and
Economic Security Act (CARES Act
(Pub. L. 116–136, Stat. 281)) signed
March 27, 2020, included provisions
that govern the way certain OTC drugs
are regulated in the United States. The
CARES Act added section 505G to the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355h), which
reforms and modernizes the OTC drug
review process, including establishing
new procedures for consideration of
additions or changes to conditions
covered in OTC monographs. As a result
of these revised statutory provisions, we
anticipate no submissions under
§ 330.14. Our OTC Monographs@FDA
portal (https://dps.fda.gov/omuf)
provides additional information about
OTC monograph drugs and the OTC
drug review process.
Consistent with section 505G(k)(3) of
the FD&C Act, we plan to withdraw the
regulations supporting the TEA
provisions in part 330 and discontinue
the related guidance document. When
these actions occur, we will also request
discontinuation of the information
collection approved under OMB control
number 0910–0688.
In the Federal Register of August 8,
2023 (88 FR 53497), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\08DEN1.SGM
08DEN1
]]>Agencies
[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]
[[Page 85640]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[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 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
FD&C Act Section; information Number of responses per Total annual Average burden Total hours
collection activity respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
403(w)(6); petition for 6 1 6 100 600
exemptions.....................
403(w)(7); notification 6 1 6 68 408
submissions....................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,008
----------------------------------------------------------------------------------------------------------------
\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
[[Page 85642]]
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
