[Federal Register Volume 75, Number 143 (Tuesday, July 27, 2010)]
[Notices]
[Pages 43990-43992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-18303]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2010-N-0368]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Pet Event Tracking Network--State, Federal Cooperation
to Prevent Spread of Pet Food Related Diseases
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the paperwork requirements for the proposed
Pet Event Tracking Network (PETNet) cooperative Federal and State
initiative.
DATES: Submit either electronic or written comments on the collection
of information by September 27, 2010.
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: Denver Presley, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-3793, [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
[[Page 43991]]
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 before submitting the
collection to OMB for approval. To comply with this requirement, FDA is
publishing notice of the proposed collection of information set forth
in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's 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.
Pet Event Tracking Network--State, Federal Cooperation to Prevent
Spread of Pet Food Related Diseases--21 U.S.C. 342 and 343, Section
1002(b) of the FDA Amendments Act of 2007. Stat. 823 (2007) (OMB
Control No. 0910-NEW)
In August, 2008, FDA sponsored the ``Gateway to Food Protection''
meeting, also known as the ``50-State'' meeting. The meeting included
representatives from other Federal agencies, the States, localities,
territories, and tribal partners, and was held to address the
challenges necessary to ensure the safety of the U.S. food supply. Work
groups were formed during the meeting which met and produced
recommendations in specific topic areas. One of the workgroups, the
Outbreaks/Food-Borne and Feed-Borne Investigations Workgroup, created a
subgroup consisting of veterinarians, animal feed regulators, and
others involved with animal health issues. This subgroup developed an
ambitious proposal for an early warning system to identify, track and
report disease outbreaks in companion animals or contamination
incidents concerning pet food or animals feed, which they named PETNet.
The PETNet proposal was developed in response to the 2007 outbreak that
occurred in companion animals that was associated with the deliberate
adulteration of pet food components, such as wheat gluten, with
melamine. As envisioned by the subgroup at that time, PETNet would
include a system for reporting outbreaks and would be supported by
adequate diagnostic laboratory facilities and an established mechanism
for conducting national epidemiological investigations.
The PETNet subgroup subsequently met twice in face-to-face
meetings, in May and November, 2009, during which time the proposed
scope of PETNet was streamlined to focus the program on information
sharing, rather than epidemiology or other aspects. One of the main
concerns of FDA's State regulatory partners regarding FDA's handling of
the melamine incident was that many States provided information to FDA,
but the information reported by the States to FDA and other information
in the possession of FDA was not shared by FDA with the States. States
believed that if they had received more information about what was
going on in a timely manner, they could perhaps have taken appropriate
action to safeguard animal and the public health by using their own
regulatory authorities and resources. The agency agreed with the
States, and thus decided to focus PETNet on being a system for sharing
information between FDA, other Federal agencies, and the States about
food-borne illness outbreaks in companion animals. By the end of the
November, 2009, meeting, this revised vision of PETNet was firmly
established with many of the details about the system in place.
FDA is planning to implement an initiative called ``The Pet Event
Tracking Network'' (PETNet) that will allow FDA and its State partners
to quickly and effectively exchange information about outbreaks of
illness in companion animals associated with pet food. FDA has worked
closely with its Federal and State partners to develop the PETNet, and
believes that it will serve an important function in protecting the
public and animal health.
PETNet will be a secure, internet-based network comprised of the
FDA, other Federal agencies, and State regulatory agencies/officials
that have authority over pet food. The Network will provide timely and
relevant information about pet food-related incidents to FDA, the
States, and other Federal Government agencies charged with protecting
animal and public health. FDA intends to identify and invite State
participants from all 50 States to participate in PETNet. Members of
the network will be able to both receive alerts about pet food
incidents, as well as create alerts when they are aware of a pet food
incident within their jurisdiction. The information will be used to
help State and Federal regulators determine how best to use
inspectional and other resources to either prevent or quickly limit the
adverse events caused by adulterated pet food. Many states have
regulatory authority beyond that of the FDA and often can be in a
position to act independently of FDA with the information they will
receive from the Pet Event Tracking Network.
Use of the system, including the reporting of incidents by States
to the FDA, will be entirely voluntary. The PETNet system will be
housed in Food Shield, a proprietary software system, and will be
accessible only to members via password. The system will make use of a
standardized electronic form housed on FoodShield to collect and
distribute basic information about pet food-related incidents. The form
contains the following data elements, almost all of which are drop down
menu choices: The species involved, clinical signs, number of animals
exposed, number of animals affected, animal ages, date of onset, name
and type of pet food involved, the manufacturer and distributor of the
pet food (if known), the State where the incident occurred, the origin
of the information, whether there are supporting laboratory results,
and contact information for the reporting PETNet member (i.e. name,
telephone number). The form would be filled out and submitted by a
PETNet member on FoodShield, at which time it will be available to
other PETNet members. Thus, the information will be entered and
received by PETNet members in as close to real time as possible. FDA
has designed the form itself to contain only the essential information
necessary to alert PETNet members about pet food-related incidents. For
further information, such as laboratory results, PETNet members can
contact the reporting PETNet member.
FDA estimates the burden of this collection of information as
follows:
[[Page 43992]]
Table 1.--Estimated Reporting Burden
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21 U.S.C. Section 342 & 343/Section 1002(b) 2007 No. of Annual Frequency Total Annual Hours per
Amendments / Form FDA Respondents per Response Responses Response Total Hours
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Form FDA 3756 50 10 500 20/60 167
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that each State will report (i.e., fill out the
PETNet form to alert other PETNet members about a pet food-related
incident) approximately 10 times per year. This estimate represents the
maximum number of reports that FDA expects a State to submit in a year,
and in many cases the number of reports submitted by a State will
probably be far less. FDA believes that, given the form only has 11
items and most are drop down fields, 20 minutes is a sufficient amount
of time to complete the form. State regulatory officials responsible
for pet food already possess computer systems and have the internet
access necessary to participate in PETNet, and thus there are no
capital expenditures associated with the reporting.
Regarding recordkeeping, State regulatory officials who report on
PETNet receive the reportable information from consumers in their
States in the course of their customary and regular duties. Further,
these individuals already maintain records of such consumer complaints
in the course of their duties which are sufficient for the purposes of
reporting on PETNet. Therefore, FDA believes that the proposed
collection of information does not have additional recordkeeping
requirements.
Dated: July 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-18303 Filed 7-26-10; 8:45 am]
BILLING CODE 4160-01-S