[Federal Register Volume 81, Number 50 (Tuesday, March 15, 2016)]
[Notices]
[Pages 13794-13796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05757]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, 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
(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 our use of a tracking network
to collect and share
[[Page 13795]]
safety information about animal food from Federal, State, and
Territorial Agencies.
DATES: Submit either electronic or written comments on the collection
of information by May 16, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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 will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, [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.
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. 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,
[[Page 13796]]
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 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
------------------
Total................................... ................. ................. ................. .............................. 75
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
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: March 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05757 Filed 3-14-16; 8:45 am]
BILLING CODE 4164-01-P