Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Records Access Requirements for Food Facilities
| Published date | 30 July 2020 |
| Citation | 85 FR 45888 |
| Record Number | 2020-16546 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 85 Issue 147 (Thursday, July 30, 2020)
[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,
[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. 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
