
[Federal Register Volume 79, Number 123 (Thursday, June 26, 2014)]
[Notices]
[Pages 36321-36322]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14977]


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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 July 
28, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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) (Pub. L. 107-188) 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 to 
identify and locate quickly contaminated or potentially contaminated 
food and to 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 of the

[[Page 36322]]

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 regulations in 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 April 17, 2014 (79 FR 21767) FDA 
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              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          13.228       5,020,000
 maintenance)...................
1.337, 1.345, and 1.352                   18,975               1          18,975           4.790          90,890
 (Learning for new firms).......
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    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 of 
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, the Agency estimates 
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: June 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14977 Filed 6-25-14; 8:45 am]
BILLING CODE 4164-01-P


