Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Allergen Labeling and Reporting, 25635-25636 [2024-07663]
Download as PDF
<![CDATA[
Federal Register / Vol. 89, No. 71 / Thursday, April 11, 2024 / Notices
has submitted the following proposed
collection of information to OMB for
review and clearance.
website at https://www.access
data.fda.gov/scripts/cder/daf/.
Dated: April 8, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
Food Allergen Labeling and Reporting
OMB Control Number 0910–0792—
Revision
[FR Doc. 2024–07657 Filed 4–10–24; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
SUMMARY:
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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
khammond on DSKJM1Z7X2PROD with NOTICES
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.
In
compliance with 44 U.S.C. 3507, FDA
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:50 Apr 10, 2024
Jkt 262001
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
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
25635
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.
In the Federal Register of December 8,
2023 (88 FR 85640), we published a 60day 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:
E:\FR\FM\11APN1.SGM
11APN1
25636
Federal Register / Vol. 89, No. 71 / Thursday, April 11, 2024 / Notices
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
Average
burden per
disclosure
Total annual
disclosures
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
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
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
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
FD&C act section; information collection activity
VerDate Sep<11>2014
16:50 Apr 10, 2024
Jkt 262001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Availability of Draft Health
Center Program Policy Guidance
Regarding Services To Support
Transitions in Care for JusticeInvolved Individuals Reentering the
Community
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for public comment on
draft Health Center Program policy
guidance regarding services to support
transitions in care for Justice-involved
individuals reentering the community.
AGENCY:
HRSA is inviting public
comment on the draft Health Center
Program Policy Guidance Regarding
Services to Support Transitions in Care
for Justice-Involved Individuals
Reentering the Community. The
purpose of the draft Policy Information
Notice (PIN) is to propose Health Center
Program policy guidance for all health
centers that apply for and receive
federal award funds under the Health
Center Program, as authorized by
section 330 of the Public Health Service
(PHS) Act (including sections 330(e),
(g), (h), and (i)), as well as section 330
subrecipient organizations and Health
Center Program look-alikes, to clarify
the conditions under which they may
provide certain health services as part of
SUMMARY:
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
the Health Center Program scope of
project to certain incarcerated/detained
individuals. This draft PIN establishes
policy guidance that identifies a set of
health services that a health center may
provide, the locations at which such
services may be provided, the target
population for such services
(specifically, incarcerated/detained
individuals who are scheduled for
release from a carceral setting within 90
days), and other pertinent
circumstances under which the health
center may, on its own behalf and
subject to all section 330 requirements,
provide such services to justiceinvolved individuals reentering the
community to support their care
transition from the carceral setting to
the community within the scope of their
Health Center Program project.
DATES: Submit comments on or before
June 14, 2024.
ADDRESSES: Electronic comments
should be submitted through the HRSA
Bureau of Primary Health Care Contact
Form (https://hrsa.my.site.com/support/
s/), ‘‘Comment on Draft Policy’’ under
the ‘‘Policy’’ section. Comments should
be submitted no later than 60 days after
the publication date.
FOR FURTHER INFORMATION CONTACT:
Jennifer Joseph, Office of Policy and
Program Development Director, HRSA,
at jjoseph@hrsa.gov and 301–594–4300.
SUPPLEMENTARY INFORMATION: HRSA
provides grants to eligible applicants
under section 330 of the PHS Act, as
amended (42 U.S.C. 254b), to support
the delivery of preventive and primary
E:\FR\FM\11APN1.SGM
11APN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 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
