Document ID: FDA-2016-N-0736-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Tracking Network
for PETNet, LivestockNet, and SampleNet
Posted Date: 2017-04-18T04:00Z

[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]

=======================================================================
-----------------------------------------------------------------------

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.

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

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 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: 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

[[Page 18294]]

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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
PETNet..........................              20               5             100          * 0.25              25
LivestockNet....................              20               5             100          * 0.25              25
SampleNet.......................              20               5             100          * 0.25              25
                                 -------------------------------------------------------------------------------
    Total.......................              75  ..............  ..............  ..............  ..............
----------------------------------------------------------------------------------------------------------------
\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]
 BILLING CODE 4164-01-P