
[Federal Register Volume 75, Number 246 (Thursday, December 23, 2010)]
[Notices]
[Pages 80825-80826]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32275]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0368]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 January 
24, 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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-new and 
title Pet Event Tracking Network--State, Federal Cooperation to Prevent 
Spread of Pet Food Related Diseases. Also include the FDA docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7651, Juanmanuel.vilela@fda.hhs.gov.

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.

Pet Event Tracking Network (PETNet)--State, Federal Cooperation To 
Prevent Spread of Pet Food Related Diseases--(OMB Control Number 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 ``The 
Pet Event Tracking Network'' (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 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 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 FDA and often can be in a position 
to act independently of FDA with the information they will receive from 
the PetNet.
    Use of the system, including the reporting of incidents by States 
to 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

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can contact the reporting PETNet member.
    In the Federal Register of July 27, 2010 (75 FR 43990), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received 12 comments on the 60-day 
notice, 11 from private citizens and one from a veterinary association. 
None of the comments addressed paperwork issues. Ten of the comments 
generally supported the PETNet concept, while two comments generally 
did not support it.
    Several comments suggested that it be mandatory, rather than 
voluntary, for all 50 States to participate in PETNet. FDA declines to 
follow the comments' suggestion, but we note that invitations have been 
sent to all 50 States requesting their participation in PETNet, and at 
this time 35 States have responded that they will participate in the 
program.
    Several comments stated that the information in PETNet should be 
publicly available and not just available to Federal and State pet food 
regulators. FDA disagrees with this comment. Much of the information 
shared through PETNet will be preliminary reports of potential pet food 
problems that turn out to be false or to otherwise have no public 
health significance. FDA and State Agencies routinely receive these 
types of reports and followup on them without notifying the public. FDA 
believes that State and Federal regulators can decide how to best use 
the information in PETNet, including how to use their resources to 
determine if a pet food incident warranting public notification exists.
    One comment recommended that FDA ``closely assess reported 
incidents as soon as possible to ensure no confounding factors bias any 
determination of a need for a pet food recall.'' To assist in this 
effort, the comment recommended that FDA incorporate drop down menus in 
the PETNet reporting form to collect information about whether the 
adverse event was confirmed (versus suspected) to have been caused by 
pet food, if the exposure was acute or chronic, and the clinical 
outcome of the case.
    PETNet will be an additional information resource used by FDA, but 
will not change FDA's current process for determining the need for pet 
food recalls. The information the American Veterinary Medical 
Association recommends FDA collect will be considered by pet food 
regulatory professional in deciding whether to enter a report into 
PETNet. Some of the recommended information may also be derived from 
the current PETNet form. For example, question 11 asks if the reporter 
has laboratory results available to share. Laboratory results are key 
factors in confirming whether an adverse event is caused by a pet food. 
Answers to question 8 will provide an indication about duration of 
exposure, and some clinical outcomes can be derived form question 6.
    One comment stated that the focus of PETNet is wrong and that the 
U.S. Department of Agriculture (USDA) should be involved because it is 
their responsibility to inspect pet food plants. FDA notes that it is 
FDA, not USDA that is responsible for ensuring the safety of pet food, 
and that FDA conducts inspections of pet food manufacturing 
establishments. However, USDA is a Federal Agency that can contribute 
to PETNet and USDA has been invited/will participate in PETNet. Another 
comment stated that PETNet ``lacks data security'' and is a 
``needlessly invasive project'' whose object to ``identify tainted 
doggie food'' is of questionable value. With respect to data security, 
the data shared through PETNet is contained on a database limited to 
State and Federal Government officials, and the data collection form 
has been designed such that it is highly unlikely to contain 
confidential or trade secret information that requires additional data 
protection measures. Additionally, the Agency disagrees that the 
project is invasive since it is just a method of sharing existing 
information among State and Federal regulators. Finally, the objective 
of the project is to protect animal health is valid and consistent with 
FDA's mission.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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   21 U.S.C. 342 & 343/Section                        Annual
     1002(b) of the 2007 FDA         Number of     frequency per   Total annual      Hours per      Total hours
     amendments act/form FDA        respondents      response        responses       response
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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: December 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-32275 Filed 12-22-10; 8:45 am]
BILLING CODE 4160-01-P


