Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tracking Network for PETNet, LivestockNet, and SampleNet, 18293-18294 [2017-07769]
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Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices
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Dated: March 28, 2017.
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[FR Doc. 2017–07817 Filed 4–17–17; 8:45 am]
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Secretary of the Board.
[FR Doc. 2017–07737 Filed 4–17–17; 8:45 am]
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VerDate Sep<11>2014
16:55 Apr 17, 2017
Jkt 241001
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.
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.
SUMMARY:
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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Cappezzuto, Office of
Operations, Food and Drug
PO 00000
Frm 00017
Fmt 4703
Sfmt 4703
18293
Administration, Three White Flint
North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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
E:\FR\FM\18APN1.SGM
18APN1
18294
Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices
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
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
PETNet .................................................................................
LivestockNet .........................................................................
SampleNet ...........................................................................
20
20
20
5
5
5
100
100
100
* 0.25
* 0.25
* 0.25
25
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
sradovich on DSK3GMQ082PROD with NOTICES
[Docket No. FDA–2010–N–0062]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices;
Exception From General Requirements
for Informed Consent
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
VerDate Sep<11>2014
16:55 Apr 17, 2017
Jkt 241001
Submit either electronic or
written comments on the collection of
information by June 19, 2017.
ADDRESSES: You may submit comments
as follows:
DATES:
Food and Drug Administration
AGENCY:
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 the information
collection regarding exception from the
general requirements for informed
consent.
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,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
PO 00000
Frm 00018
Fmt 4703
Sfmt 4703
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): 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
E:\FR\FM\18APN1.SGM
18APN1
Agencies
[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