[Federal Register Volume 79, Number 74 (Thursday, April 17, 2014)]
[Notices]
[Pages 21767-21768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-08707]


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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 we) is announcing an 
opportunity for public comment on our proposed collection of certain 
information. Under the Paperwork Reduction Act of 1995 (the PRA), 
Federal Agencies must publish a notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension of an existing collection of information, and allow 
60 days for public comment. 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 16, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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, we are publishing this notice of the proposed 
collection of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of our functions, 
including whether the information will have practical utility; (2) the 
accuracy of our 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 (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 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

[[Page 21768]]

(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 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 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.
    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: April 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08707 Filed 4-16-14; 8:45 am]
BILLING CODE 4160-01-P