[Federal Register Volume 85, Number 61 (Monday, March 30, 2020)]
[Notices]
[Pages 17583-17584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06537]


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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 April 
29, 2020.

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 oira_submission@omb.eop.gov. 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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@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.

Tracking Network for PETNet, LivestockNet, and SampleNet

OMB Control Number 0910-0680--Extension

    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 the FDAAA required FDA, 
in relevant part, to establish a pet food early warning alert system.

[[Page 17584]]

    The tracking network collects: (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); (2) reports of animal food-related illness and 
product defects associated with animal food for livestock animals, 
aquaculture species, and horses (LivestockNet); and (3) reports about 
animal food laboratory samples considered adulterated by State or FDA 
regulators (SampleNet).
    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 are captured: product details (indication of 
whether the product is a medicated product, 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 SampleNet reports 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: Voluntary respondents to this 
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 November 22, 2019 (84 FR 64533), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received offering general 
support for the information collection, but did not suggest a change to 
our burden estimate. At the same time, upon our own reevaluation we 
have reduced the number of respondents to the collection, which results 
in an overall reduction of 225 responses and 57 hours annually. We made 
this adjustment to better reflect current use of the tracking networks. 
We, therefore, estimate the burden of the information collection as 
follows:

                                   Table 1--Estimated Annual Reporting Burden
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                                                  Number of
          Activity               Number of      responses per     Total annual    Average burden    Total hours
                                respondents       respondent        responses      per response
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PETNet......................               5                  5              25  0.25 (15                   6.25
                                                                                  minutes).
LivestockNet................               5                  5              25  0.25 (15                   6.25
                                                                                  minutes).
SampleNet...................               5                  5              25  0.25 (15                   6.25
                                                                                  minutes).
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    Total...................  ..............  .................              75  ...............           18.75
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    Dated: March 20, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06537 Filed 3-27-20; 8:45 am]
 BILLING CODE 4164-01-P


