Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Feed Network (Pet Event Tracking Network and LivestockNET)-State, Federal Cooperation To Prevent Spread of Pet Food and Animal Feed Related Diseases, 52774-52776 [2013-20710]
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Federal Register / Vol. 78, No. 165 / Monday, August 26, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours) 2
Total hours
190.6 ....................................................................................
55
1
55
20
1,100
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
ehiers on DSK2VPTVN1PROD with NOTICES
We believe that there will be minimal
burden on the industry to generate data
to meet the requirements of the
premarket notification program because
we are requesting only that information
that the manufacturer or distributor
should already have developed to
satisfy itself that a dietary supplement
containing a new dietary ingredient is in
full compliance with the FD&C Act. In
the past, commenters argued that our
burden estimate is too low. We revisited
this issue and believe their burden
estimate included the time it takes to
research and generate safety data for a
new dietary ingredient. However, sec.
190.6(a) requires each manufacturer or
distributor of a dietary supplement
containing a new dietary ingredient, or
of a new dietary ingredient, to submit
notification of the basis for their
conclusion that said supplement or
ingredient will reasonably be expected
to be safe. Section 190.6 requests simply
the extraction and summarization of the
safety data that should have already
been developed by the manufacturer or
distributor. Thus, we estimate that
extracting and summarizing the relevant
information from the company’s files,
and presenting it in a format that will
meet the requirements of section 413 of
the FD&C Act will require a burden of
approximately 20 hours of work per
submission.
We estimate that 55 respondents will
submit one premarket notification each
and that it will take a respondent 20
hours to prepare the notification, for a
total of 1,100 hours. The estimated
number of premarket notifications and
hours per response is an average based
on our experience with notifications
received during the last 3 years and
information from firms that have
submitted recent premarket
notifications.
Dated: August 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–20711 Filed 8–23–13; 8:45 am]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0973]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Animal Feed
Network (Pet Event Tracking Network
and LivestockNET)—State, Federal
Cooperation To Prevent Spread of Pet
Food and Animal Feed Related
Diseases
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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
the paperwork burden to the public of
the Animal Feed Network, which
includes the Pet Event Tracking
Network (PETNet) and LivestockNET,
for reporting of pet food or animal feed
related instances, respectively.
DATES: Submit either electronic or
written comments on the collection of
information by October 25, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, 1350
Piccard Dr., PI50–400T, Rockville, MD
SUMMARY:
PO 00000
Frm 00017
Fmt 4703
Sfmt 4703
20850, 301–796–5733, domini.bean@
fda.hhs.gov.
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.
Pet Event Tracking Network—State,
Federal Cooperation To Prevent Spread
of Pet Food Related Diseases—and
Livestock.NET—21 U.S.C. 342, 21
U.S.C. 343, Section 1002(b) of the FDA
Amendments Act of 2007 (Pub. L. 110–
85, 121 Stat. 823) (2007)—OMB Control
Number 0910–0680
On August 1, 2011, the Pet Event
Tracking Network (PETNet) was
launched by FDA and its partners in the
E:\FR\FM\26AUN1.SGM
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Federal Register / Vol. 78, No. 165 / Monday, August 26, 2013 / Notices
Partnership for Food Protection (PFP).
PETNet is a secure, Web-based network
that allows information to be exchanged
more freely and efficiently between FDA
and other Federal and State regulatory
agencies. PETNet allows the exchange of
information about pet food related
incidents, such as illness associated
with the consumption of pet food or pet
food product defects. PETNet is only
accessible by government employees
with membership rights, and each
member has equal access to the data in
the system. At its launch, the system
had over 200 members representing 4
Federal agencies, all 50 states, and 3
U.S. territories. Using the shared
information, State and Federal agencies
can work together to quickly determine
if regulatory actions are needed to
prevent or quickly limit adverse effects
associated with pet food products.
Since its launch, PETNet has seen
increased usage among members. Two
years following the launch of the
system, there have been reports entered
by two Federal agencies and multiple
states. Approximately 60 percent of the
entries are from Federal agency
members and 40 percent by State agency
members. The majority of entries in
PETNet are associated with dog food
products, followed by cat food products,
products affecting species ‘‘other’’ than
those available in the drop down menu
choices, and small mammal products.
As familiarity with PETNet has
increased, there has been increased
usage and entries from members.
PETNet was originally developed for
pet animals only, but after its initial
launch in 2011, there have been ongoing
requests to expand the system to
include livestock animals, aquaculture
species, and horses. Such an early alert
system does not currently exist to share
information related to illness associated
with consumption of adulterated food or
product defects for these species.
LivestockNET has been developed to
serve as a similar early alert system for
feed-related illness and product defects
associated with feed for livestock
animals, aquaculture species, and
horses.
LivestockNET and PETNet will be
Web-based portals with the same
functionality, but the questions asked
for each portal will be specific for each.
Users of the individual portals are
expected to be the same officials from
Federal, State, and Territorial agencies.
Because of the similarity of the portals
and the intended audience for both, the
two individual portals will be housed in
an overall system titled the Animal Feed
Network. PETNet and LivestockNET
will be able to be accessed individually
in the Animal Feed Network, once the
user logs in to the system.
Use of the Animal Feed Network,
including the reporting of incidents by
non-FDA members, will continue to be
voluntary. The Animal Feed Network is
a Web-based system, based in a
proprietary system using CORESHIELD
technology, and will be accessible only
to members via password. PETNet and
LivestockNET will make use of
standardized electronic forms that have
been custom developed for the
individual portals. The two forms share
the following common data elements,
the majority of which are drop down
52775
menu choices: Product details (name of
feed, 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 form, additional data
elements specific to livestock animals
will be captured: Product details
(indication of whether the feed is a
medicated feed, product packaging, and
intended purpose of the feed), class of
the animal species affected, and
production loss. For PETNet, the only
additional data field is the animal life
stage. The form would be filled out and
submitted by a member in the specified
portal of the Animal Feed Network.
Once the entry is submitted, it will be
available to other members. Thus, the
information will be entered and
received by Animal Feed Network
members in as close to real time as
possible. FDA and the PFP have
designed the form itself to contain only
the essential information necessary to
alert Animal Feed Network members
about animal feed and pet food related
incidents.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 U.S.C. section
Total annual
responses
Average burden per response
Total hours
21 U.S.C. 342, 21 U.S.C. 343, Section 1002(b) of the FDA Amendments Act of 2007/PETNet.
Ibid./LivestockNET portal ...................
20
5
100
0.25 (15 minutes) ............................
25
20
5
100
0.25 (15 minutes) ............................
25
Total Hours .................................
........................
........................
........................
..........................................................
50
ehiers on DSK2VPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that each State will
report to the Animal Feed Network (i.e.,
fill out the PETNet or LivestockNET
form to alert other members about a pet
food or animal food related incident,
respectively) approximately 5 times per
year for each portal. This estimate
represents the maximum number of
reports that FDA expects a State to
submit in a year, and in many cases the
number of reports submitted by a State
VerDate Mar<15>2010
13:45 Aug 23, 2013
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will probably be far less. FDA believes
that, given the PETNet form has 15
items and the LivestockNET form has 19
items, with most being drop down fields
and not all fields being required for
submission, 15 minutes is a sufficient
amount of time to complete the form.
State regulatory officials responsible for
animal feed and pet food already
possess computer systems and have the
Internet access necessary to participate
PO 00000
Frm 00018
Fmt 4703
Sfmt 4703
in the Animal Feed Network, and thus
there are no capital expenditures
associated with the reporting.
Regarding recordkeeping, State
regulatory officials who report in the
Animal Feed Network receive the
reportable information from consumers
in their States in the course of their
customary and regular duties. Further,
these individuals already maintain
records of such consumer complaints in
the course of their duties, which are
E:\FR\FM\26AUN1.SGM
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Federal Register / Vol. 78, No. 165 / Monday, August 26, 2013 / Notices
sufficient for the purposes of reporting
in the PETNet and LivestockNET portals
of the Animal Feed Network. Therefore,
FDA believes that the proposed
collection of information does not have
additional recordkeeping requirements.
Dated: August 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–20710 Filed 8–23–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0724]
Documents to Support Submission of
an Electronic Common Technical
Document; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability on the Agency Web site of
revised final versions of the following
four documents that support making
regulatory submissions in electronic
format using the electronic Common
Technical Document (eCTD)
specifications: ‘‘The eCTD Backbone
Files Specification for Module 1,’’
version 2.2 (which includes the U.S.
regional document type definition
(DTD), version 3.2); ‘‘The
Comprehensive Table of Contents
Headings and Hierarchy,’’ version 2.2;
‘‘Specifications for eCTD Validation
Criteria,’’ version 3.0; and ‘‘Example
Submissions using eCTD Backbone Files
Specification for Module 1,’’ version
1.2. Technical files that support these
documents are also available on the
Agency Web site. A complete summary
of the revisions made is included in the
updated documents. FDA estimates it
will be able to receive submissions
utilizing Module 1 Specifications 2.2 by
June 2014, and will give 30 days’
advance notice to industry.
ADDRESSES: Submit written requests for
single copies of the documents to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002 or Office
of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448. Send one self-
ehiers on DSK2VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
13:45 Aug 23, 2013
Jkt 229001
addressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the documents.
FOR FURTHER INFORMATION CONTACT:
Constance Robinson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1105,
Silver Spring, MD 20993, 301–796–
1065, email: constance.robinson@
fda.hhs.gov; or Joseph Montgomery,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 11400 Rockville Pike,
HFM–165, Rm. 4155, Rockville, MD
20857, 301–827–1332, email:
joseph.montgomery@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The eCTD is an International
Conference on Harmonisation (ICH)
standard based on specifications
developed by ICH and its member
parties. FDA’s Center for Drug
Evaluation and Research (CDER) and
Center for Biologics Evaluation and
Research (CBER) have been receiving
submissions in the eCTD format since
2003, and the eCTD has been the
standard for electronic submissions to
CDER and CBER since January 1, 2008.
The majority of new electronic
submissions are now received in eCTD
format. Since adoption of the eCTD
standard, it has become necessary to
update the administrative portion of the
eCTD (Module 1) to reflect regulatory
changes, provide clarification of
business rules for submission
processing and review, refine the
characterization of promotional
marketing and advertising material, and
facilitate automated processing of
submissions. FDA previously
announced availability of final versions
of technical documentation in a Federal
Register notice dated February 13, 2013
(Docket No. FDA–2011–N–0724). The
Agency has revised the final
documentation and is making available
revised versions of the following
documents:
• ‘‘The eCTD Backbone Files
Specification for Module 1, version
2.2,’’ which provides specifications for
creating the eCTD backbone file for
Module 1 for submission to CDER and
CBER (This document should be used in
conjunction with the guidance for
industry Providing Regulatory
Submissions in Electronic Format––
Human Pharmaceutical Applications
and Related Submissions Using the
eCTD Specifications, which will be
revised as part of the implementation of
the updated eCTD backbone files
PO 00000
Frm 00019
Fmt 4703
Sfmt 4703
specification (https://www.fda.gov/
downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/
UCM072349.pdf )).
• ‘‘The Comprehensive Table of
Contents Headings and Hierarchy,’’
version 2.2, which reflects updated
headings that are specified in the
document entitled ‘‘The eCTD Backbone
Files Specification for Module 1,’’
version 2.2
• ‘‘Specifications for eCTD Validation
Criteria,’’ version 3.0
• ‘‘Example Submissions using eCTD
Backbone Files Specification for Module
1,’’ version 1.2
Supporting technical files are being
made available on the Agency Web site.
A complete summary of the revisions
made are included in the updated
documents. The revisions include the
following:
eCTD Backbone Files Specification for
Module I
Æ changed DTD version references
from 3.1 to 3.2, where applicable
Æ replaced the copy of DTD Version
3.1 in Appendix I with DTD
Version 3
Æ revised text, revised Table 1, and
added Table 13 to indicate the new
required attribute material-id and
the new optional attribute issuedate which applies to m1–15–2–1
The Comprehensive Table of Contents
Headings and Hierarchy
Æ added two new attributes for
1.15.2.1
Specifications for eCTD Validation
Criteria
Æ incorporated changes to US eCTD
Module 1
Example Submissions using eCTD
Backbone Files Specification for
Module 1
Æ modified example 7 to reference the
Form FDA 356h in the Admin
section
Æ modified examples 13 through 17
to reference the material-id and
issue date attributes as applicable,
and include the Promotional
Labeling and Advertising
Regulatory Contact
FDA is not prepared at present to
accept submissions utilizing this new
version of the eCTD Backbone Files
Specification for Module 1, version 2.2,
because eCTD software vendors need
time to update their software to
accommodate this information and
because its use will require software
upgrades within the Agency. FDA
estimates it will be able to receive
submissions utilizing Module 1
Specifications 2.2 by June 2014, and
will give 30 days advance notice to
industry.
E:\FR\FM\26AUN1.SGM
26AUN1
]]>Agencies
[Federal Register Volume 78, Number 165 (Monday, August 26, 2013)]
[Notices]
[Pages 52774-52776]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20710]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0973]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Animal Feed Network (Pet Event Tracking Network and
LivestockNET)--State, Federal Cooperation To Prevent Spread of Pet Food
and Animal Feed Related Diseases
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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 the paperwork burden to the
public of the Animal Feed Network, which includes the Pet Event
Tracking Network (PETNet) and LivestockNET, for reporting of pet food
or animal feed related instances, respectively.
DATES: Submit either electronic or written comments on the collection
of information by October 25, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400T, Rockville,
MD 20850, 301-796-5733, domini.bean@fda.hhs.gov.
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.
Pet Event Tracking Network--State, Federal Cooperation To Prevent
Spread of Pet Food Related Diseases--and Livestock.NET--21 U.S.C. 342,
21 U.S.C. 343, Section 1002(b) of the FDA Amendments Act of 2007 (Pub.
L. 110-85, 121 Stat. 823) (2007)--OMB Control Number 0910-0680
On August 1, 2011, the Pet Event Tracking Network (PETNet) was
launched by FDA and its partners in the
[[Page 52775]]
Partnership for Food Protection (PFP). PETNet is a secure, Web-based
network that allows information to be exchanged more freely and
efficiently between FDA and other Federal and State regulatory
agencies. PETNet allows the exchange of information about pet food
related incidents, such as illness associated with the consumption of
pet food or pet food product defects. PETNet is only accessible by
government employees with membership rights, and each member has equal
access to the data in the system. At its launch, the system had over
200 members representing 4 Federal agencies, all 50 states, and 3 U.S.
territories. Using the shared information, State and Federal agencies
can work together to quickly determine if regulatory actions are needed
to prevent or quickly limit adverse effects associated with pet food
products.
Since its launch, PETNet has seen increased usage among members.
Two years following the launch of the system, there have been reports
entered by two Federal agencies and multiple states. Approximately 60
percent of the entries are from Federal agency members and 40 percent
by State agency members. The majority of entries in PETNet are
associated with dog food products, followed by cat food products,
products affecting species ``other'' than those available in the drop
down menu choices, and small mammal products. As familiarity with
PETNet has increased, there has been increased usage and entries from
members.
PETNet was originally developed for pet animals only, but after its
initial launch in 2011, there have been ongoing requests to expand the
system to include livestock animals, aquaculture species, and horses.
Such an early alert system does not currently exist to share
information related to illness associated with consumption of
adulterated food or product defects for these species. LivestockNET has
been developed to serve as a similar early alert system for feed-
related illness and product defects associated with feed for livestock
animals, aquaculture species, and horses.
LivestockNET and PETNet will be Web-based portals with the same
functionality, but the questions asked for each portal will be specific
for each. Users of the individual portals are expected to be the same
officials from Federal, State, and Territorial agencies. Because of the
similarity of the portals and the intended audience for both, the two
individual portals will be housed in an overall system titled the
Animal Feed Network. PETNet and LivestockNET will be able to be
accessed individually in the Animal Feed Network, once the user logs in
to the system.
Use of the Animal Feed Network, including the reporting of
incidents by non-FDA members, will continue to be voluntary. The Animal
Feed Network is a Web-based system, based in a proprietary system using
CORESHIELD technology, and will be accessible only to members via
password. PETNet and LivestockNET will make use of standardized
electronic forms that have been custom developed for the individual
portals. The two forms share the following common data elements, the
majority of which are drop down menu choices: Product details (name of
feed, 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 form, additional data elements specific to livestock
animals will be captured: Product details (indication of whether the
feed is a medicated feed, product packaging, and intended purpose of
the feed), class of the animal species affected, and production loss.
For PETNet, the only additional data field is the animal life stage.
The form would be filled out and submitted by a member in the specified
portal of the Animal Feed Network. Once the entry is submitted, it will
be available to other members. Thus, the information will be entered
and received by Animal Feed Network members in as close to real time as
possible. FDA and the PFP have designed the form itself to contain only
the essential information necessary to alert Animal Feed Network
members about animal feed and pet food related incidents.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 U.S.C. section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
21 U.S.C. 342, 21 U.S.C. 343, 20 5 100 0.25 (15 25
Section 1002(b) of the FDA minutes).
Amendments Act of 2007/PETNet.
Ibid./LivestockNET portal..... 20 5 100 0.25 (15 25
minutes).
------------------------------------------------ ---------------
Total Hours............... .............. .............. .............. ................ 50
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA estimates that each State will report to the Animal Feed
Network (i.e., fill out the PETNet or LivestockNET form to alert other
members about a pet food or animal food related incident, respectively)
approximately 5 times per year for each portal. This estimate
represents the maximum number of reports that FDA expects a State to
submit in a year, and in many cases the number of reports submitted by
a State will probably be far less. FDA believes that, given the PETNet
form has 15 items and the LivestockNET form has 19 items, with most
being drop down fields and not all fields being required for
submission, 15 minutes is a sufficient amount of time to complete the
form. State regulatory officials responsible for animal feed and pet
food already possess computer systems and have the Internet access
necessary to participate in the Animal Feed Network, and thus there are
no capital expenditures associated with the reporting.
Regarding recordkeeping, State regulatory officials who report in
the Animal Feed Network receive the reportable information from
consumers in their States in the course of their customary and regular
duties. Further, these individuals already maintain records of such
consumer complaints in the course of their duties, which are
[[Page 52776]]
sufficient for the purposes of reporting in the PETNet and LivestockNET
portals of the Animal Feed Network. Therefore, FDA believes that the
proposed collection of information does not have additional
recordkeeping requirements.
Dated: August 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20710 Filed 8-23-13; 8:45 am]
BILLING CODE 4160-01-P
