[Federal Register Volume 78, Number 165 (Monday, August 26, 2013)]
[Notices]
[Pages 52774-52776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20710]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0973]
Agency Information Collection Activities; Proposed Collection;
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 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,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the paperwork burden to the
public of the Animal Feed Network, which includes the Pet Event
Tracking Network (PETNet) and LivestockNET, for reporting of pet food
or animal feed related instances, respectively.
DATES: Submit either electronic or written comments on the collection
of information by October 25, 2013.
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: Domini Bean, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400T, Rockville,
MD 20850, 301-796-5733, [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, 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--and Livestock.NET--21 U.S.C. 342,
21 U.S.C. 343, Section 1002(b) of the FDA Amendments Act of 2007 (Pub.
L. 110-85, 121 Stat. 823) (2007)--OMB Control Number 0910-0680
On August 1, 2011, the Pet Event Tracking Network (PETNet) was
launched by FDA and its partners in the
[[Page 52775]]
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 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 U.S.C. section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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21 U.S.C. 342, 21 U.S.C. 343, 20 5 100 0.25 (15 25
Section 1002(b) of the FDA minutes).
Amendments Act of 2007/PETNet.
Ibid./LivestockNET portal..... 20 5 100 0.25 (15 25
minutes).
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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 State 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 5 times per year for each portal. 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 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
[[Page 52776]]
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: August 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20710 Filed 8-23-13; 8:45 am]
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