Document ID: FDA-2011-N-0016-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Recordkeeping and Records Access Requirements for Food Facilities
Posted Date: 2011-03-28T04:00Z

[Federal Register Volume 76, Number 59 (Monday, March 28, 2011)]
[Notices]
[Pages 17131-17132]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7188]

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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 April 
27, 2011.

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

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 FDA's 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 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 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 required information and 
are retained for the required time period.
    In the Federal Register of January 13, 2011 (76 FR 2396), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one letter containing multiple 
comments in response to the notice.
    (Comment 1) One comment was generally supportive of the necessity 
of the information collection and its practical utility.
    (Response) FDA agrees. As discussed previously in this document, 
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.
    (Comment 2) Another comment stated that accurate recordkeeping is 
integral to the effective and timely tracing of food products through 
the supply chain and, to support effective product tracing, suggested 
that industry should determine the Critical Tracking Events (CTEs) and 
the Key Data Elements (KDEs) necessary for product tracing; FDA should 
encourage the adoption of standard ways to express this

[[Page 17132]]

information as well as the adoption of electronic recordkeeping and 
electronic submission of data to the agency; and, review of product 
tracing procedures should be part of standard audits.
    (Response) FDA agrees that recordkeeping is key to effective 
product tracing. However, to the extent that the comments suggest 
changes to the requirements of the recordkeeping regulations in 
sections 1.326 through 1.363, such requests are outside the scope of 
the four collection of information topics on which the notice solicits 
comments. Such changes to the current recordkeeping requirements can 
only be accomplished by notice and comment rulemaking.
    FDA estimates the burden of this collection of information as 
follows:

                               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 (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 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 of 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 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: March 23, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-7188 Filed 3-25-11; 8:45 am]
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