Notice2022-03916
Agency Information Collection Activities; Proposed Collection; 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
February 24, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements associated with the sanitary transportation of human and animal food.
Full Text
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<title>Federal Register, Volume 87 Issue 37 (Thursday, February 24, 2022)</title>
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[Federal Register Volume 87, Number 37 (Thursday, February 24, 2022)]
[Notices]
[Pages 10369-10371]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03916]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0013]
Agency Information Collection Activities; Proposed Collection;
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, 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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection requirements
associated with the sanitary transportation of human and animal food.
DATES: Submit either electronic or written comments on the collection
of information by April 25, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 25, 2022. 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 April 25, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is 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-2013-N-0013 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Sanitary Transportation of Human
and Animal Food.'' 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
[[Page 10370]]
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#f2a2a0b3a186939494b2949693dc9a9a81dc959d84"><span class="__cf_email__" data-cfemail="346466756740555252745250551a5c5c471a535b42">[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 these 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 on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 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.
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.
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 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>.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Recordkeeping Burden 1
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Number of Average burden
21 CFR section; activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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1.912; Record retention....... 1,502,032 1 1,502,032 0.083 (5 124,669
minutes).
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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 21 CFR
1.912. We expect these activities will likely include documenting
procedures and training, as well as sanitary transportation operations
and specification requirements.
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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 hours
respondents respondent responses per response
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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 Total hours
respondents per respondent disclosures per disclosure
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1.908; Disclosure of sanitary 226 1 226 0.5833 (~35 132
specifications; operating minutes).
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 21 CFR 1.908.
Based on an evaluation of the information collection, we have made
no adjustments to our burden estimate.
Dated: February 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03916 Filed 2-23-22; 8:45 am]
BILLING CODE 4164-01-P
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