Agency Information Collection Activities; Proposed Collection; Comment Request; Tracking Network for PETNet, LivestockNet, and SampleNet, 13794-13796 [2016-05757]
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13794
Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices
Board of Governors of the Federal Reserve
System, March 10, 2016.
Michael J. Lewandowski,
Associate Secretary of the Board.
[FR Doc. 2016–05777 Filed 3–14–16; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2016–0029]
Proposed Revised Vaccine Information
Materials for Polio and Varicella
Vaccines
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
Under the National
Childhood Vaccine Injury Act (NCVIA)
(42 U.S.C. 300aa–26), the Centers for
Disease Control and Prevention (CDC)
within the Department of Health and
Human Services (HHS) develops
vaccine information materials that all
health care providers are required to
give to patients/parents prior to
administration of specific vaccines.
HHS/CDC seeks written comment on the
proposed updated vaccine information
statements for polio and varicella
vaccines.
SUMMARY:
Written comments must be
received on or before May 16, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2016–
0029, by any of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Written comments should be
addressed to Suzanne Johnson-DeLeon,
National Center for Immunization and
Respiratory Diseases, Centers for
Disease Control and Prevention,
Mailstop A–19, 1600 Clifton Road NE.,
Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
docket number. All relevant comments
received will be posted without change
to https://regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Skip
Wolfe (crw4@cdc.gov), National Center
for Immunization and Respiratory
Diseases, Centers for Disease Control
and Prevention, Mailstop A–19, 1600
asabaliauskas on DSK3SPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
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Clifton Road NE., Atlanta, Georgia
30329.
The
National Childhood Vaccine Injury Act
of 1986 (Pub. L. 99–660), as amended by
section 708 of Public Law 103–183,
added section 2126 to the Public Health
Service Act. Section 2126, codified at 42
U.S.C. 300aa–26, requires the Secretary
of Health and Human Services to
develop and disseminate vaccine
information materials for distribution by
all health care providers in the United
States to any patient (or to the parent or
legal representative in the case of a
child) receiving vaccines covered under
the National Vaccine Injury
Compensation Program (VICP).
Development and revision of the
vaccine information materials, also
known as Vaccine Information
Statements (VIS), have been delegated
by the Secretary to the Centers for
Disease Control and Prevention (CDC).
Section 2126 requires that the materials
be developed, or revised, after notice to
the public, with a 60-day comment
period, and in consultation with the
Advisory Commission on Childhood
Vaccines, appropriate health care
provider and parent organizations, and
the Food and Drug Administration. The
law also requires that the information
contained in the materials be based on
available data and information, be
presented in understandable terms, and
include:
(1) A concise description of the
benefits of the vaccine,
(2) A concise description of the risks
associated with the vaccine,
(3) A statement of the availability of
the National Vaccine Injury
Compensation Program, and
(4) Such other relevant information as
may be determined by the Secretary.
The vaccines initially covered under
the National Vaccine Injury
Compensation Program were diphtheria,
tetanus, pertussis, measles, mumps,
rubella and poliomyelitis vaccines.
Since April 15, 1992, any health care
provider in the United States who
intends to administer one of these
covered vaccines is required to provide
copies of the relevant vaccine
information materials prior to
administration of any of these vaccines.
Since then, the following vaccines have
been added to the National Vaccine
Injury Compensation Program, requiring
use of vaccine information materials for
them as well: hepatitis B, Haemophilus
influenzae type b (Hib), varicella
(chickenpox), pneumococcal conjugate,
rotavirus, hepatitis A, meningococcal,
human papillomavirus (HPV), and
seasonal influenza vaccines.
SUPPLEMENTARY INFORMATION:
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Instructions for use of the vaccine
information materials are found on the
CDC Web site at: https://www.cdc.gov/
vaccines/hcp/vis/.
HHS/CDC is proposing updated
versions of the polio and varicella
vaccine information statements.
The vaccine information materials
referenced in this notice are being
developed in consultation with the
Advisory Commission on Childhood
Vaccines, the Food and Drug
Administration, and parent and health
care provider groups.
We invite written comment on the
proposed vaccine information materials
entitled ‘‘Polio Vaccine: What You Need
to Know’’ and ‘‘Varicella Vaccine: What
You Need to Know.’’ Copies of the
proposed vaccine information materials
are available at https://
www.regulations.gov (see Docket
Number CDC–2016–0029). Comments
submitted will be considered in
finalizing these materials. When the
final materials are published in the
Federal Register, the notice will include
an effective date for their mandatory
use.
Dated: March 9, 2016.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2016–05776 Filed 3–14–16; 8:45 am]
BILLING CODE 4163–18–P
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.
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
SUMMARY:
E:\FR\FM\15MRN1.SGM
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Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices
safety information about animal food
from Federal, State, and Territorial
Agencies.
Submit either electronic or
written comments on the collection of
information by May 16, 2016.
ADDRESSES: You may submit comments
as follows:
DATES:
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
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’’).
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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
https://www.regulations.gov or at the
VerDate Sep<11>2014
17:40 Mar 14, 2016
Jkt 238001
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
https://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: https://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 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 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, PRAStaff@
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
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13795
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,
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Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices
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
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Average burden per
response
Total hours
PETNet .................................
LivestockNet .........................
SampleNet ............................
20
20
20
5
5
5
100
100
100
0.25 (15 minutes) .................
0.25 (15 minutes) .................
0.25 (15 minutes) .................
25
25
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSK3SPTVN1PROD with NOTICES
[Docket No. FDA–2016–N–0001]
Anesthetic and Analgesic Drug
Products Advisory Committee and the
Drug Safety and Risk Management
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
17:40 Mar 14, 2016
Jkt 238001
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committees: Anesthetic and
Analgesic Drug Products Advisory
Committee and the Drug Safety and Risk
Management Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 5, 2016, from 8 a.m. to 5
p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: Stephanie L.
Begansky, Center for Drug Evaluation
PO 00000
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and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, FAX:
301–847–8533, email: AADPAC@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committees will be
asked to discuss new drug application
(NDA) 208653, benzhydrocodone/
acetaminophen oral tablets, submitted
by KemPharm, Inc., with the proposed
indication of short-term (up to 14 days)
E:\FR\FM\15MRN1.SGM
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]]>Agencies
[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: 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 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 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 https://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 https://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: https://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 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 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, PRAStaff@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.
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\
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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.
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
