[Federal Register Volume 73, Number 27 (Friday, February 8, 2008)]
[Notices]
[Page 7564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-2324]



[[Page 7564]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0056] (formerly Docket No. 2007N-0444)


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 March 
10, 2008.

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: 202-395-6974, or e-mailed to <a href="/cdn-cgi/l/email-protection#b4d6d5d3c1ddd8d5c6f4dbd9d69ad1dbc49ad3dbc2"><span class="__cf_email__" data-cfemail="4e2c2f293b27222f3c0e21232c602b213e60292138">[email protected]</span></a>. 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: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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 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 
(21 CFR 1.326 through 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 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 November 19, 2007 (72 FR 65033), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                                       Annual Frequency
  21 CFR Section         No. of              per            Total Annual    Hours per  Record     Total Hours
                     Recordkeepers      Recordkeeping         Records
----------------------------------------------------------------------------------------------------------------
1.337, 1.345, and            379,493                  1            379,493             13.228          5,020,000
 1.352 (records
 maintenance)
----------------------------------------------------------------------------------------------------------------
1.337, 1.345, and             18,975                  1             18,975              4.790             90,890
 1.352 (learning
 for new firms)
----------------------------------------------------------------------------------------------------------------
Total              .................  .................  .................  .................          5,110,890
----------------------------------------------------------------------------------------------------------------
\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 (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 30, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-2324 Filed 2-7-08; 8:45 am]
BILLING CODE 4160-01-S


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