[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, Denver.presley@fda.hhs.gov.

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
   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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 3756                                                          50                    10                500              20/60                167
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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