[Federal Register Volume 76, Number 59 (Monday, March 28, 2011)]
[Notices]
[Pages 17131-17132]
From the Federal Register Online via the Government Publishing 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 [email protected]. 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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