
[Federal Register Volume 84, Number 34 (Wednesday, February 20, 2019)]
[Notices]
[Pages 5087-5089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02751]



[[Page 5087]]

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

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.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) 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, including 
each proposed extension of an existing 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 March 22, 2019.

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 22, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 22, 2019. 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     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 https://www.regulations.gov. 
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 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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.

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: Under the PRA (44 U.S.C. 3501-3520), 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

[[Page 5088]]

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 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, 
as well as procedures for respondents who wish to request a waiver for 
any requirement.
    We estimate the burden of the information collection 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 hours, 
consistent with the estimate found in our 2016 Final Regulatory Impact 
Analysis 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.

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                      21 CFR section; activity                          Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.908; Disclosure of sanitary specifications; operating temperature             226                1              226         * 0.5833              132
 conditions........................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
* ~35 mins.


[[Page 5089]]

    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: February 13, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02751 Filed 2-19-19; 8:45 am]
 BILLING CODE 4164-01-P


