[Federal Register Volume 87, Number 115 (Wednesday, June 15, 2022)]
[Notices]
[Pages 36133-36135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12914]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 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 0910-0773. 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, 
[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.

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 https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/sanitation-transportation-guidance-documents-regulatory-information.
    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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
          21 CFR section; activity              Number of       records per      Total annual       Average burden per recordkeeping       Total hours
                                              recordkeepers     recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.912; Record retention....................       1,502,032                1        1,502,032   0.083 (5 minutes)......................         124,669
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                                                      Number of
    21 CFR section; activity         Number of      responses per     Total annual   Average  burden     Total
                                    respondents       respondent       responses      per  response      hours
----------------------------------------------------------------------------------------------------------------
1.914; Waiver petitions.........               2                1                2               24          48
----------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
          21 CFR section; activity              Number of       disclosures      Total annual       Average  burden per  disclosure        Total hours
                                               respondents     per respondent    disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.908; Disclosure of sanitary                           226                1              226   0.5833 (~35 minutes)...................             132
 specifications; operating temperature
 conditions.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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