[Federal Register: February 8, 2008 (Volume 73, Number 27)]
[Notices]
[Page 7564]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08fe08-58]
[[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 baguilar@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: 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\
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Annual Frequency
21 CFR Section No. of per Total Annual Hours per Record Total Hours
Recordkeepers Recordkeeping Records
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1.337, 1.345, and 379,493 1 379,493 13.228 5,020,000
1.352 (records
maintenance)
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1.337, 1.345, and 18,975 1 18,975 4.790 90,890
1.352 (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 (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