
[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Pages 44427-44428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20239]


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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: Fax written comments on the collection of information by October 
23, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0560. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
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 (the Bioterrorism Act) added section 414 of the 
Federal Food, Drug, and Cosmetic Act (the 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 will help us 
identify and locate quickly 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

[[Page 44428]]

be used if they contain all of 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.
    On February 23, 2012, we issued an interim final rule in the 
Federal Register (77 FR 10658) (the 2012 IFR) amending Sec.  1.361 to 
be consistent with the current statutory language in section 414(a) of 
the FD&C Act, as amended by section 101 of FSMA. In the 2012 IFR, we 
concluded that the information collection provisions of Sec.  1.361 
were 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 a civil action to which the United States or any official or agency 
thereof is a party, or during the conduct of an administrative action, 
investigation, or audit involving an agency against specific 
individuals or entities (77 FR 10658 at 10661). The interim final rule 
was made final, without change, on April 4, 2014 (79 FR 18799). 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: Persons that manufacture, process, 
pack, hold, receive, distribute, transport, or import food in the 
United States are required to establish and maintain records, including 
persons that engage in both interstate and intrastate commerce.
    In the Federal Register of June 14, 2017 (82 FR 27263), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment. The comment was 
supportive of the information collection but requested that FDA 
coordinate with the U.S. Department of Agriculture. FDA addresses 
issues regarding duplication of information collection in question 4 of 
the Agency's supporting statement.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                               Number of      Number of records     Total annual      Average burden
                      21 CFR section                         recordkeepers     per recordkeeper       records       per recordkeeping     Total hours
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1.337, 1.345, and 1.352 (Records maintenance)............            379,493                  1            379,493             13.228          5,020,000
1.337, 1.345, and 1.352 (Learning for new firms).........             18,975                  1             18,975              4.790             90,890
                                                          ----------------------------------------------------------------------------------------------
    Total................................................  .................  .................  .................  .................          5,110,890
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    This estimate is based on our estimate of the number of facilities 
affected by the final rule entitled ``Establishment and Maintenance of 
Records Under the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002,'' published in the Federal Register of 
December 9, 2004 (69 FR 71562 at 71650). With regard to records 
maintenance, we estimate that approximately 379,493 facilities will 
spend 13.228 hours collecting, recording, and checking for accuracy the 
limited amount of additional information required by the regulations, 
for a total of 5,020,000 hours annually. In addition, we estimate that 
new firms entering the affected businesses will 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 to be 5 percent of 379,493, or 
18,975 firms. Thus, we estimate that approximately 18,975 facilities 
will spend 4.790 hours learning about the recordkeeping and records 
access requirements, for a total of 90,890 hours annually. We estimate 
that approximately the same number of firms (18,975) will exit the 
affected businesses in any given year, resulting in no growth in the 
number of total firms reported on line 1 of table 1. Therefore, the 
total annual recordkeeping burden is estimated to be 5,110,890 hours.

    Dated: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20239 Filed 9-21-17; 8:45 am]
 BILLING CODE 4164-01-P


