[Federal Register Volume 85, Number 67 (Tuesday, April 7, 2020)]
[Notices]
[Pages 19489-19491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07275]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0016]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Recordkeeping and Records Access Requirements for Food 
Facilities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 provisions of 
our recordkeeping and records access requirements for food facilities.

DATES: Submit either electronic or written comments on the collection 
of information by June 8, 2020.

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 June 8, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 8, 2020. 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-2011-N-0016 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Recordkeeping and Records Access 
Requirements for Food Facilities.'' 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.govinfo.gov/content/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

[[Page 19490]]

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. 3501-3521), 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.

Recordkeeping and Records Access Requirements for Food Facilities--21 
CFR 1.337, 1.345, and 1.352

OMB Control Number 0910-0560--Extension

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 added section 414 of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 350c), which requires that persons 
who manufacture, process, pack, hold, receive, distribute, transport, 
or import food in the United States establish and maintain records 
identifying the immediate previous sources and immediate subsequent 
recipients of food. Sections 1.326 through 1.363 of our regulations (21 
CFR 1.326 through 1.363) set forth the requirements for recordkeeping 
and records access. The requirement to establish and maintain records 
improves our ability to respond to, and further contain, threats of 
serious adverse health consequences or death to humans or animals from 
accidental or deliberate contamination of food.
    Information maintained under these regulations helps us identify 
and quickly locate contaminated or potentially contaminated food and 
inform the appropriate individuals and food facilities of specific 
terrorist threats. Our regulations require that records for non-
transporters include the name and full contact information of sources, 
recipients, and transporters; an adequate description of the food, 
including the quantity and packaging; and the receipt and shipping 
dates (Sec. Sec.  1.337 and 1.345). Required records for transporters 
include the names of consignor and consignee, points of origin and 
destination, date of shipment, number of packages, description of 
freight, route of movement and name of each carrier participating in 
the transportation, and transfer points through which shipment moved 
(Sec.  1.352). Existing records may be used if they contain all the 
required information and are retained for the required time period.
    Section 101 of the FDA Food Safety Modernization Act (FSMA) (Pub. 
L. 111-353) amended section 414(a) of the FD&C Act and expanded our 
access to records. Specifically, FSMA expanded our access to records 
beyond records relating to the specific suspect article of food to 
records relating to any other article of food that we reasonably 
believe is likely to be affected in a similar manner. In addition, we 
can access records if we believe that there is a reasonable probability 
that the use of or exposure to an article of food, and any other 
article of food that we reasonably believe is likely to be affected in 
a similar manner, will cause serious adverse health consequences or 
death to humans or animals. To gain access to these records, our 
officer or employee must present appropriate credentials and a written 
notice, at reasonable times and within reasonable limits and in a 
reasonable manner.
    The information collection provisions of Sec.  1.361 are exempt 
from OMB review under 44 U.S.C. 3518(c)(1)(B)(ii) and 5 CFR 
1320.4(a)(2) as collections of information obtained during the conduct 
of an administrative action, investigation, or audit involving an 
agency against specific individuals or entities. The regulations at 5 
CFR 1320.3(c) provide that the exception in 5 CFR 1320.4(a)(2) applies 
during the entire course of the investigation, audit, or action, but 
only after a case file or equivalent is opened with respect to a 
particular party. Such a case file would be opened as part of the 
request to access records under Sec.  1.361. Accordingly, we have not 
included an estimate of burden hours associated with Sec.  1.361 in 
table 1.
    Description of Respondents: Respondents to this collection of 
information are persons that manufacture, process, pack, hold, receive, 
distribute, transport, or import food in the United States who are 
required to establish and maintain records, including persons that 
engage in both interstate and intrastate commerce.
    We estimate the burden of this collection of information 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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1.337, 1.345, and 1.352 (Records         379,493               1         379,493            6.61       2,508,449
 maintenance)...................
1.337, 1.345, and 1.352                   18,975               1          18,975             4.5          85,388
 (Learning for new firms).......
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    Total.......................  ..............  ..............  ..............  ..............       2,593,837
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 19491]]

    Based on a review of the information collection since our last 
request for OMB approval, we have made adjustments to our burden 
estimate to account for advances in information and communication 
technology that have occurred in the last decade. Because the 
transition from paper-based to electronic records systems is 
widespread, we estimate that the average burden per recordkeeping has 
decreased by 50 percent. With regards to records maintenance, we 
estimate that approximately 379,493 facilities each spend half the 
amount of time from the 13.228 hours previously reported to 6.61 hours 
collecting, recording, and checking for accuracy of the limited amount 
of additional information required by the regulations, for a total of 
2,508,449 hours annually. In addition, we estimate that new firms 
entering the affected businesses incur a burden from learning the 
regulatory requirements and understanding the records required for 
compliance. In this regard, we estimate the number of new firms 
entering the affected businesses is 5 percent of 379,493, or 18,975 
firms. Thus, we estimate that approximately 18,975 facilities each 
spend, on average, 4.5 hours learning about the recordkeeping and 
records access requirements, for a total of 85,388 hours annually. This 
estimate reflects a reduction from 4.79 to 4.5 average hours per 
facility to account for the increase in facilities using internet, 
which increased from 71 to 99 percent. We estimate that approximately 
the same number of firms (18,975) exit the group of affected businesses 
in any given year, resulting in no growth in the number of total firms 
reported on line 1 of table 1.

    Dated: April 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-07275 Filed 4-6-20; 8:45 am]
BILLING CODE 4164-01-P


