Notice2022-12914
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
June 15, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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 87 Issue 115 (Wednesday, June 15, 2022)</title>
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[Federal Register Volume 87, Number 115 (Wednesday, June 15, 2022)]
[Notices]
[Pages 36133-36135]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-12914]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0013]
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.
[[Page 36134]]
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 July 15, 2022.
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: 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#247476657750454242644240450a4c4c570a434b52"><span class="__cf_email__" data-cfemail="6e3e3c2f3d1a0f08082e080a0f4006061d40090118">[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. The regulations are
intended to focus on preventing food safety problems throughout the
food chain and were issued under the Sanitary Food Transportation Act
of 2005 (2005 SFTA), and the FDA Food Safety Modernization Act, enacted
in 2011. The 2005 SFTA amended the Federal Food, Drug, and Cosmetic Act
(FD&C Act), in part, by creating section 416 (21 U.S.C. 350e), which
directs us to issue regulations to require 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.
In addition, the 2005 SFTA created section 402(i) of the FD&C Act
(21 U.S.C. 342(i)), which provides 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 and section 301(hh) of the FD&C
Act (21 U.S.C. 331(hh)), which prohibits the failure by a shipper,
carrier by motor vehicle or rail vehicle, receiver, or any other person
engaged in the transportation of food to comply with the regulations
issued under section 416 of the FD&C Act.
The 2005 SFTA also amended section 703 of the FD&C Act (21 U.S.C.
373) by providing that a shipper, carrier by motor vehicle or rail
vehicle, receiver, or other person subject to section 416 shall, 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 of the FD&C Act.
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. For additional information regarding Agency implementation
of the 2005 SFTA, visit our website at <a href="https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/sanitation-transportation-guidance-documents-regulatory-information">https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/sanitation-transportation-guidance-documents-regulatory-information</a>.
In the Federal Register of February 24, 2022 (87 FR 10369), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the information collection topics solicited.
FDA estimates the burden of this collection of information as
follows:
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 hours
recordkeepers recordkeeper records
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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.
We estimate an annual recordkeeping burden of 124,669, which
assumes 1,502,032 workers will spend an average of 5 minutes on
activities related to the record retention requirements under Sec.
1.912. We expect these activities will likely include documenting
procedures and training, as well as sanitary transportation operations
and specification requirements.
[[Page 36135]]
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.
We estimate one waiver petition from each of two firms will be
submitted and respondents will spend 24 hours to prepare and submit the
petition to FDA.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
21 CFR section; activity Number of disclosures Total annual Average burden per disclosure Total hours
respondents per respondent disclosures
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1.908; Disclosure of sanitary 226 1 226 0.5833 (~35 minutes)................... 132
specifications; operating temperature
conditions.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Finally, we estimate an annual third-party disclosure burden of 132
hours, assuming each of 226 firms will spend an average of 35 minutes,
annually, disclosing written records as required under Sec. 1.908.
Based on an evaluation of the information collection, we have made
no adjustments to our burden estimate.
Dated: June 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12914 Filed 6-14-22; 8:45 am]
BILLING CODE 4164-01-P
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