[Federal Register Volume 79, Number 37 (Tuesday, February 25, 2014)]
[Notices]
[Pages 10529-10530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-04012]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0973]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Animal Feed Network 
(Pet Event Tracking Network and LivestockNet)--State, Federal 
Cooperation To Prevent Spread of Pet Food and Animal Feed 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 March 
27, 2014.

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 emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0680. 
Also include the FDA 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: 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--State, Federal Cooperation To Prevent 
Spread of Pet Food Related Diseases--and Livestock.Net; OMB Control 
Number 0910-0680--Revision

    On August 1, 2011, the Pet Event Tracking Network (PETNet) was 
launched by FDA and its partners in the Partnership for Food Protection 
(PFP). PETNet is a secure, Web-based network that allows information to 
be exchanged more freely and efficiently between FDA and other Federal 
and State regulatory Agencies. PETNet allows the exchange of 
information about pet food related incidents, such as illness 
associated with the consumption of pet food or pet food product 
defects. PETNet is only accessible by government employees with 
membership rights, and each member has equal access to the data in the 
system. At its launch, the system had over 200 members representing 4 
Federal Agencies, all 50 States, and 3 U.S. territories. Using the 
shared information, State and Federal Agencies can work together to 
quickly determine if regulatory actions are needed to prevent or 
quickly limit adverse effects associated with pet food products.
    Since its launch, PETNet has seen increased usage among members. 
Two years following the launch of the system, there have been reports 
entered by two Federal Agencies and multiple states. Approximately 60 
percent of the entries are from Federal Agency members and 40 percent 
by State Agency members. The majority of entries in PETNet are 
associated with dog food products, followed by cat food products, 
products affecting species ``other'' than those available in the drop-
down menu choices, and small mammal products. As familiarity with 
PETNet has increased, there has been increased usage and entries from 
members.
    PETNet was originally developed for pet animals only, but after its 
initial launch in 2011, there have been ongoing requests to expand the 
system to include livestock animals, aquaculture species, and horses. 
Such an early alert system does not currently exist to share 
information related to illness associated with consumption of 
adulterated food or product defects for these species. LivestockNet has 
been developed to serve as a similar early alert system for

[[Page 10530]]

feed-related illness and product defects associated with feed for 
livestock animals, aquaculture species, and horses.
    LivestockNet and PETNet will be Web-based portals with the same 
functionality, but the questions asked for each portal will be specific 
for each. Users of the individual portals are expected to be the same 
officials from Federal, State, and Territorial Agencies. Because of the 
similarity of the portals and the intended audience for both, the two 
individual portals will be housed in an overall system titled the 
Animal Feed Network. PETNet and LivestockNet will be able to be 
accessed individually in the Animal Feed Network, once the user logs in 
to the system.
    Use of the Animal Feed Network, including the reporting of 
incidents by non-FDA members, will continue to be voluntary. The Animal 
Feed Network is a Web-based system, based in a proprietary system using 
CORESHIELD technology, and will be accessible only to members via 
password. PETNet and LivestockNet will make use of standardized 
electronic forms that have been custom developed for the individual 
portals. The two forms share the following common data elements, the 
majority of which are drop down menu choices: Product details (name of 
feed, lot code, product form, and the manufacturer or distributor/
packer (if known)), the species affected, number of animals exposed to 
the product, number of animals affected, body systems affected, product 
problem/defect, date of onset or the date product problem was detected, 
the State where the incident occurred, the origin of the information, 
whether there are supporting laboratory results, and contact 
information for the reporting member (i.e., name, telephone number will 
be captured automatically when member logs in to the system). For the 
LivestockNet form, additional data elements specific to livestock 
animals will be captured: Product details (indication of whether the 
feed is a medicated feed, product packaging, and intended purpose of 
the feed), class of the animal species affected, and production loss. 
For PETNet, the only additional data field is the animal life stage. 
The form would be filled out and submitted by a member in the specified 
portal of the Animal Feed Network. Once the entry is submitted, it will 
be available to other members. Thus, the information will be entered 
and received by Animal Feed Network members in as close to real time as 
possible. FDA and the PFP have designed the form itself to contain only 
the essential information necessary to alert Animal Feed Network 
members about animal feed and pet food-related incidents.
    In the Federal Register of August 26, 2013 (78 FR 52774), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although four comments were received, none 
were responsive to the four collection of information topics solicited 
and therefore will not be discussed in this document.
    FDA estimates the burden of this collection of information as 
follows:

                                                         Table 1--Estimated Reporting Burden \1\
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                                                                   Number of
               21 U.S.C. Section                   Number of     responses per   Total annual          Average burden per response          Total hours
                                                  respondents     respondent       responses
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21 U.S.C. 342, 21 U.S.C. 343, Section 1002(b)               20               5             100  0.25 (15 minutes).......................              25
 of the FDA Amendments Act of 2007/PETNet.
Ibid./LivestockNet portal.....................              20               5             100  0.25 (15 minutes).......................              25
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    Total Hours...............................  ..............  ..............  ..............  ........................................              50
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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 member will report to the Animal Feed 
Network (i.e., fill out the PETNet or LivestockNet form to alert other 
members about a pet food or animal food-related incident, respectively) 
approximately five times per year for each portal. This estimate 
represents the maximum number of reports that FDA expects will be 
submitted in a year, and in many cases the number of reports submitted 
by a member will probably be far less. FDA believes that, given the 
PETNet form has 15 items and the LivestockNet form has 19 items, with 
most being drop down fields and not all fields being required for 
submission, 15 minutes is a sufficient amount of time to complete the 
form. State regulatory officials responsible for animal feed and pet 
food already possess computer systems and have the Internet access 
necessary to participate in the Animal Feed Network, and thus there are 
no capital expenditures associated with the reporting.
    Regarding recordkeeping, State regulatory officials who report in 
the Animal Feed Network 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 in the PETNet and LivestockNet portals of 
the Animal Feed Network. Therefore, FDA believes that the proposed 
collection of information does not have additional recordkeeping 
requirements.

    Dated: February 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04012 Filed 2-24-14; 8:45 am]
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