[Federal Register Volume 79, Number 74 (Thursday, April 17, 2014)]
[Notices]
[Pages 21767-21768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-08707]
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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 or we) is announcing an
opportunity for public comment on our proposed collection of certain
information. Under the Paperwork Reduction Act of 1995 (the PRA),
Federal Agencies must publish a notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension of an existing collection of information, and allow
60 days for public comment. This notice solicits comments on the
information collection provisions of our recordkeeping and records
access requirements for food facilities.
DATES: Submit either electronic or written comments on the collection
of information by June 16, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, [email protected].
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, we are publishing this notice of the proposed
collection of information set forth in this document.
With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of our functions,
including whether the information will have practical utility; (2) the
accuracy of our 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
through 1.363 of our 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 our 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.
Information maintained under these regulations will help us to
identify and locate quickly contaminated or potentially contaminated
food and to inform the appropriate individuals and food facilities of
specific terrorist threats. Our 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
[[Page 21768]]
(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.
Section 101 of the FDA Food Safety Modernization Act (FSMA) (Pub.
L. 111-353) amended section 414(a) of the FD&C Act and expanded our
access to records. Specifically, FSMA expanded our access to records
beyond records relating to the specific suspect article of food to
records relating to any other article of food that we reasonably
believe is likely to be affected in a similar manner. In addition, we
can access records if we believe that there is a reasonable probability
that the use of or exposure to an article of food, and any other
article of food that we reasonably believe is likely to be affected in
a similar manner, will cause serious adverse health consequences or
death to humans or animals. To gain access to these records, our
officer or employee must present appropriate credentials and a written
notice, at reasonable times and within reasonable limits and in a
reasonable manner.
On February 23, 2012, we issued an interim final rule in the
Federal Register (77 FR 10658) (the 2012 IFR) amending Sec. 1.361 to
be consistent with the current statutory language in section 414(a) of
the FD&C Act, as amended by section 101 of FSMA. In the 2012 IFR, we
concluded that the information collection provisions of Sec. 1.361
were exempt from OMB review under 44 U.S.C. 3518(c)(1)(B)(ii) and 5 CFR
1320.4(a)(2) as collections of information obtained during the conduct
of a civil action to which the United States or any official or agency
thereof is a party, or during the conduct of an administrative action,
investigation, or audit involving an agency against specific
individuals or entities (77 FR at 10661). The regulations in 5 CFR
1320.3(c) provide that the exception in 5 CFR 1320.4(a)(2) applies
during the entire course of the investigation, audit, or action, but
only after a case file or equivalent is opened with respect to a
particular party. Such a case file would be opened as part of the
request to access records under Sec. 1.361. Accordingly, we have not
included an estimate of burden hours associated with Sec. 1.361 in
table 1.
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.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
21 CFR Section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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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 our 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 71650). With regard to records
maintenance, we estimate 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, we
estimate 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, we estimate 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. We estimate that approximately the same number
of firms (18,975) will exit the affected businesses in any given year,
resulting in no growth in the number of total firms reported on line 1
of table 1. Therefore, the total annual recordkeeping burden is
estimated to be 5,110,890 hours.
Dated: April 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08707 Filed 4-16-14; 8:45 am]
BILLING CODE 4160-01-P