[Federal Register Volume 84, Number 107 (Tuesday, June 4, 2019)]
[Notices]
[Pages 25816-25817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11532]



[[Page 25816]]

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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.

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: Fax written comments on the collection of information by July 5, 
2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 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, 
PRAStaff@fda.hhs.gov.

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 1.900

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 1.900 that establish 
requirements for the sanitary transportation of human and animal food. 
The regulations include certain recordkeeping requirements, procedures 
and information collection for respondents who wish to request a waiver 
for any requirement, as well as third-party disclosures regarding 
sanitary specifications.
    In the Federal Register of February 20, 2019 (84 FR 5087), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of the information collection 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 hours, 
consistent with the estimate found in the Final Regulatory Impact 
Analysis for the 2016 final rule and used to establish the information 
collection. This 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.

[[Page 25817]]



                                                     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 per disclosure          Total hours
                                                 respondents   per respondent    disclosures
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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.

    Finally, we estimate an annual third-party disclosure burden of 132 
hours, consistent with the currently approved burden estimate for this 
collection of information. We assume each of 226 firms will spend an 
average of 35 minutes, annually, disclosing written records as required 
under 21 CFR 1.908.
    Cumulatively, we have reduced our burden estimate for the 
information collection. We made this adjustment to reflect the removal 
of one-time burden associated with implementation of the new regulatory 
requirements. Because these provisions have since become effective, the 
one-time estimates previously included have been removed.

    Dated: May 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11532 Filed 6-3-19; 8:45 am]
BILLING CODE 4164-01-P


