[Federal Register Volume 85, Number 147 (Thursday, July 30, 2020)]
[Notices]
[Pages 45888-45889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16546]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 August 31, 2020.

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 0910-0560. 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. 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: (1) The name and full contact information of 
sources, recipients, and transporters; (2) an adequate description of 
the food, including the quantity and packaging; and (3) 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

[[Page 45889]]

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.
    In the Federal Register of April 7, 2020 (85 FR 19489), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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.

    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: July 24, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16546 Filed 7-29-20; 8:45 am]
BILLING CODE 4164-01-P


