
[Federal Register Volume 76, Number 9 (Thursday, January 13, 2011)]
[Notices]
[Pages 2396-2397]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-592]


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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) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
provisions of FDA's recordkeeping and records access requirements for 
food facilities.

DATES: Submit either electronic or written comments on the collection 
of information by March 14, 2011.

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: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's 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 to 
1.363 (21 CFR 1.326 to 1.363) of FDA's regulations set forth the 
requirements for recordkeeping and records access. The requirement to 
establish and maintain records improves FDA's 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.
    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.
    FDA's regulations require that records for nontransporters 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 required information and 
are retained for the required time period.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 2397]]



                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                      Annual
        21 CFR section             Number of      frequency per    Total annual      Hours per      Total hours
                                 recordkeepers    recordkeeping       records         record
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1.337, 1.345, and 1.352                 379,493                1         379,493          13.228       5,020,000
 (Records 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 FDA's 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 71630). With 
regard to records maintenance, FDA estimates 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, 
FDA estimates 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 (5%) of 379,493, or 18,975 firms. Thus, FDA 
estimates 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. Therefore, the total annual 
recordkeeping burden is estimated to be 5,110,890 hours.

    Dated: January 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-592 Filed 1-12-11; 8:45 am]
BILLING CODE 4160-01-P


