Notice2025-18614
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sanitary Transportation of Human and Animal Food
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
September 25, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 184 (Thursday, September 25, 2025)</title>
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[Federal Register Volume 90, Number 184 (Thursday, September 25, 2025)]
[Notices]
[Pages 46228-46229]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18614]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5944]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Sanitary
Transportation of Human and Animal Food
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 October 27, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 0910-0773. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#89d9dbc8dafde8efefc9efede8a7e1e1faa7eee6ff"><span class="__cf_email__" data-cfemail="cb9b998a98bfaaadad8badafaae5a3a3b8e5aca4bd">[email protected]</span></a>.
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.
Sanitary Transportation of Human and Animal Food--21 CFR Part 1,
Subpart O
OMB Control Number 0910-0773--Extension
This information collection supports FDA regulations regarding the
sanitary transportation of human and animal food. Section 402(i) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(i)),
establishes that food that is transported or offered for transport by a
shipper, carrier by motor vehicle or rail vehicle, receiver, or any
other person engaged in the transportation of food under conditions
that are not in compliance with the regulations issued under section
416 is adulterated. Section 416 (21 U.S.C. 350e) of the FD&C Act,
requires shippers, carriers by motor vehicle or rail vehicle,
receivers, and other persons engaged in the transportation of food to
use prescribed sanitary transportation practices to ensure that food is
not transported under conditions that may render the food adulterated.
Section 416 of the FD&C Act also directs that we prescribe appropriate
human and animal food transportation practice requirements relating to:
(1) sanitation; (2) packaging, isolation, and other protective
measures; (3) limitations on the use of vehicles; (4) information to be
disclosed to carriers and to manufacturers; and (5) recordkeeping.
Additionally, section 703 of the FD&C Act (21 U.S.C. 373) provides
that a shipper, carrier by motor vehicle or rail vehicle, receiver, or
other person subject to section 416 of the FD&C Act must, on request of
an officer or employee designated by FDA, permit the officer or
employee, at reasonable times, to have access to and to copy all
records that are required to be kept under the regulations issued under
section 416.
Accordingly, we issued regulations in 21 CFR part 1, subpart O (21
CFR 1.900 through 1.934) that establish requirements for the sanitary
transportation of human and animal food, as well as prescribe
procedures for respondents who wish to request a waiver for any
requirement. Under section 1.924 of 21 CFR part 1, subpart O, waivers
are requested in the same manner as prescribed in Sec. 10.30 (21 CFR
10.30). Electronic submissions are accepted via <a href="http://www.regulations.gov">www.regulations.gov</a> as
prescribed in Sec. 10.30(b)(1). The collections of information in
Sec. 10.30 have been approved under OMB control number 0910-0191. For
additional information regarding Agency implementation of sections
402(i), 416, and 703 of the FD&C Act, visit our website at <a href="https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-sanitary-transportation-human-and-animal-food">https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-sanitary-transportation-human-and-animal-food</a>.
Description of Respondents: Respondents to this collection of
information are domestic shippers and carriers, and in certain
circumstances, foreign shippers of human and animal food. Respondents
are from the private sector (for-profit businesses).
In the Federal Register of June 27, 2025 (90 FR 27628), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received in support of the
information collection.
FDA estimates the burden of this collection of information as
follows:
[[Page 46229]]
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of
21 CFR section; activity Number of records per Total annual Average burden per recordkeeping Total
recordkeepers recordkeeper records hours
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1.912; Record retention........................ 1,502,032 1 1,502,032 0.083 (5 minutes)............................ 124,669
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section; activity Number of responses per Total annual Average burden Total
respondents respondent responses per response hours
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1.914; Waiver petitions.......... 2 1 2 24 48
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
21 CFR section; activity Number of disclosures per Total annual Average burden per disclosure Total
respondents respondent disclosures hours
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1.908; Disclosure of sanitary specifications; 226 1 226 0.5833 (~35 mins.).......................... 132
operating temperature conditions.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. However, we note that due to rounding, the number of total
burden hours recorded by OMB (124,848 hours) has increased by one hour
(now 124,849 hours).
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18614 Filed 9-24-25; 8:45 am]
BILLING CODE 4164-01-P
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