[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Pages 64533-64535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25327]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0736]
Agency Information Collection Activities; Proposed Collection;
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, the Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (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 our use of a tracking network
to collect and share safety information about animal food from Federal,
State, and Territorial Agencies.
DATES: Submit either electronic or written comments on the collection
of information by January 21, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 21, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 21, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically,
[[Page 64534]]
including attachments, to https://www.regulations.gov will be posted to
the docket unchanged. Because your comment will be made public, you are
solely responsible for ensuring that your comment does not include any
confidential information that you or a third party may not wish to be
posted, such as medical information, your or anyone else's Social
Security number, or confidential business information, such as a
manufacturing process. Please note that if you include your name,
contact information, or other information that identifies you in the
body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-N-0736 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Tracking Network for PETNet,
LivestockNet, and SampleNet.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jonnalynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.
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.
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).
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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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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PETNet.................................... 20 5 100 0.25 (15 minutes)........................... 25
LivestockNET.............................. 20 5 100 0.25 (15 minutes)........................... 25
SampleNet................................. 20 5 100 0.25 (15 minutes)........................... 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.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: November 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25327 Filed 11-21-19; 8:45 am]
BILLING CODE 4164-01-P