[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)]
[Notices]
[Pages 18293-18294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07769]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0736]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Tracking Network for
PETNet, LivestockNet, and SampleNet
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 May 18,
2017.
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: JonnaLynn Cappezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.
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.
Tracking Network for PETNet, LivestockNet, and SampleNet OMB Control
Number 0910-0680--Revision
The Center for Veterinary Medicine and the Partnership for Food
Protection developed a Web-based tracking network (the tracking
network) to allow Federal, State, and Territorial regulatory and public
health Agencies to share safety information about animal food.
Information is submitted to the tracking network by regulatory and
public health Agency employees with membership rights. The efficient
exchange of safety information is necessary because it improves early
identification and evaluation of a risk associated with an animal food
product. We use the information to assist regulatory Agencies to
quickly identify and evaluate a risk and take whatever action is
necessary to mitigate or eliminate exposure to the risk. Earlier
identification and communication with respect to emerging safety
information may also mitigate the potential adverse economic impact for
the impacted parties associated with such safety issues. The tracking
network was developed under the requirements set forth under section
1002(b) of the Food and Drug Administration Amendments Act of 2007
(FDAAA) (Pub. L. 110-085). Section 1002(b) of FDAAA required FDA, in
relevant part, to establish a pet food early warning alert system.
Currently we receive two types of reports via the tracking network:
(1) Reports of pet food-related illness and product defects associated
with dog food, cat food, and food for other pets, which are submitted
via the Pet Event Tracking Network (PETNet); and (2) reports of animal
food-related illness and product defects associated with animal food
for livestock animals, aquaculture species, and horses, which are
submitted via LivestockNet. We are revising the collection to include a
third type of report that would be submitted via ``SampleNet.''
SampleNet will collect reports about animal food laboratory samples
considered adulterated by State or FDA regulators. SampleNet will allow
Federal, State, and Territorial regulatory and public health Agencies
to share laboratory data related to adulterated samples for
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purposes of surveillance, mitigation, work planning, and supporting the
animal food standard requirements.
PETNet and LivestockNet reports share the following common data
elements, the majority of which are drop down menu choices: Product
details (product name, 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 report, additional data elements specific
to livestock animals will be captured: Product details (indication of
whether the product is a medicated feed under 21 CFR 558.3(b)(8),
product packaging, and intended purpose of the product), class of the
animal species affected, and production loss. For PETNet reports, the
only additional data field is the animal life stage. The proposed
SampleNet reports will have the following data elements, many of which
are drop down menu choices: Product information (product name, lot
code, guarantor information, date and location of sample collection,
and product description); laboratory information (sample identification
number, the reason for testing, whether the food was reported to the
Reportable Food Registry, who performed the analysis); and results
information (analyte, test method, analytical results, whether the
results contradict a label claim or guarantee, and whether action was
taken as a result of the sample analysis).
Description of Respondents: Respondents to the collection of
information are Federal, State, and Territorial regulatory and public
health Agency employees with membership access to the Animal Feed
Network.
In the Federal Register of March 15, 2016 (81 FR 13794), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
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PETNet.......................... 20 5 100 * 0.25 25
LivestockNet.................... 20 5 100 * 0.25 25
SampleNet....................... 20 5 100 * 0.25 25
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Total....................... 75 .............. .............. .............. ..............
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
* 15 minutes.
Our estimate is based on our experience with the tracking network
over the past 3 years. We estimate that we will receive an average of 5
submissions from 20 respondents for each type of report, and that it
will take 15 minutes (0.25 hour) per response.
Dated: April 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-07769 Filed 4-17-17; 8:45 am]
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