Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tracking Network for PETNet, LivestockNet, and SampleNet, 17583-17584 [2020-06537]
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17583
Federal Register / Vol. 85, No. 61 / Monday, March 30, 2020 / Notices
ANNUAL BURDEN ESTIMATES
Total/annual
number of
respondents
Instrument
Survey of NSCAW Adopted Youth, Young Adults, and Adults .......................
Survey of NSCAW Adoptive Parents ..............................................................
Estimated Total Annual Burden
Hours: 571
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Authority: Child Abuse Prevention and
Treatment and Adoption Reform Act of 1978.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–06491 Filed 3–27–20; 8:45 am]
BILLING CODE 4184–25–P
588
554
meeting was announced in the Federal
Register on February 24, 2020.
FOR FURTHER INFORMATION CONTACT:
Kathleen Hayes, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6307,
Silver Spring, MD 20993–0002, 301–
796–7864, kathleen.hayes@fda.hhs.gov,
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), and follow the prompts to the
desired center or product area. Please
call the Information Line for up-to-date
information on this meeting, which was
announced in the Federal Register of
February 24, 2020, 85 FR 10451.
Dated: March 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–06513 Filed 3–27–20; 8:45 am]
Allergenic Products Advisory
Committee; Cancellation of Meeting
AGENCY:
HHS.
ACTION:
Notice.
The meeting of the Allergenic
Products Advisory Committee
scheduled for May 15, 2020, is canceled.
The Allergenic Products Advisory
Committee meeting scheduled for May
15, 2020, to discuss and make
recommendations on the safety and
efficacy of Peanut (Arachis hypogaea)
Allergen Extract manufactured by DBV
Technologies, S.A, has been canceled to
allow time for the FDA to review
outstanding issues. The Agency intends
to continue evaluating the product and
will schedule an Advisory Committee
meeting in the future, as needed. The
lotter on DSKBCFDHB2PROD with NOTICES
VerDate Sep<11>2014
18:05 Mar 27, 2020
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 April 29,
2020.
SUMMARY:
SUMMARY:
Jkt 250001
294
277
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:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
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
The Center for Veterinary Medicine
and the Partnership for Food Protection
developed a web-based tracking
network (the tracking network) to allow
Federal, State, and Territorial regulatory
and public health Agencies to share
safety information about animal food.
Information is submitted to the tracking
network by regulatory and public health
Agency employees with membership
rights. The efficient exchange of safety
information is necessary because it
improves early identification and
evaluation of a risk associated with an
animal food product. We use the
information to assist regulatory
Agencies to quickly identify and
evaluate a risk and take whatever action
is necessary to mitigate or eliminate
exposure to the risk. Earlier
identification and communication with
respect to emerging safety information
may also mitigate the potential adverse
economic impact for the impacted
parties associated with such safety
issues. The tracking network was
developed under the requirements set
forth under section 1002(b) of the Food
and Drug Administration Amendments
Act of 2007 (FDAAA) (Pub. L. 110–085).
Section 1002(b) of the FDAAA required
FDA, in relevant part, to establish a pet
food early warning alert system.
AGENCY:
Food and Drug Administration,
.5
.5
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Tracking Network
for PETNet, LivestockNet, and
SampleNet
[Docket No. FDA–2020–N–0008]
Annual
burden hours
OMB Control Number 0910–0680—
Extension
[Docket No. FDA–2016–N–0736]
Food and Drug Administration
1
1
Average
burden hours
per response
BILLING CODE 4164–01–P
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Number of
responses per
respondent
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–
ADDRESSES:
PO 00000
Frm 00056
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Sfmt 4703
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17584
Federal Register / Vol. 85, No. 61 / Monday, March 30, 2020 / Notices
The tracking network collects: (1)
reports of pet food-related illness and
product defects associated with dog
food, cat food, and food for other pets,
which are submitted via the Pet Event
Tracking Network (PETNet); (2) reports
of animal food-related illness and
product defects associated with animal
food for livestock animals, aquaculture
species, and horses (LivestockNet); and
(3) reports about animal food laboratory
samples considered adulterated by State
or FDA regulators (SampleNet).
PETNet and LivestockNet reports
share the following common data
elements, the majority of which are drop
down menu choices: product details
(product name, lot code, product form,
and the manufacturer or distributor/
packer (if known)), the species affected,
number of animals exposed to the
product, number of animals affected,
body systems affected, product
problem/defect, date of onset or the date
product problem was detected, the State
where the incident occurred, the origin
of the information, whether there are
supporting laboratory results, and
contact information for the reporting
member (i.e., name, telephone number
will be captured automatically when
member logs in to the system). For the
LivestockNet report, additional data
elements specific to livestock animals
are captured: product details (indication
of whether the product is a medicated
product, product packaging, and
intended purpose of the product), class
of the animal species affected, and
production loss. For PETNet reports, the
only additional data field is the animal
life stage. The SampleNet reports have
the following data elements, many of
which are drop down menu choices:
product information (product name, lot
code, guarantor information, date and
location of sample collection, and
product description); laboratory
information (sample identification
number, the reason for testing, whether
the food was reported to the Reportable
Food Registry, who performed the
analysis); and results information
(analyte, test method, analytical results,
whether the results contradict a label
claim or guarantee, and whether action
was taken as a result of the sample
analysis).
Description of Respondents:
Voluntary respondents to this collection
of information are Federal, State, and
Territorial regulatory and public health
Agency employees with membership
access to the Animal Feed Network.
In the Federal Register of November
22, 2019 (84 FR 64533), we published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was received
offering general support for the
information collection, but did not
suggest a change to our burden estimate.
At the same time, upon our own
reevaluation we have reduced the
number of respondents to the collection,
which results in an overall reduction of
225 responses and 57 hours annually.
We made this adjustment to better
reflect current use of the tracking
networks. We, therefore, estimate the
burden of the information collection as
follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Total annual
responses
Average burden per
response
Total hours
PETNet .............................................................
LivestockNet .....................................................
SampleNet ........................................................
5
5
5
5
5
5
25
25
25
0.25 (15 minutes) .......
0.25 (15 minutes) .......
0.25 (15 minutes) .......
6.25
6.25
6.25
Total ...........................................................
........................
..............................
75
.....................................
18.75
Dated: March 20, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–06537 Filed 3–27–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0451]
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
053
AGENCY:
Food and Drug Administration,
HHS.
lotter on DSKBCFDHB2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Activity
ACTION:
Electronic Submissions
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing a publication containing
modifications the Agency is making to
the list of standards FDA recognizes for
SUMMARY:
VerDate Sep<11>2014
18:05 Mar 27, 2020
use in premarket reviews (FDA
Recognized Consensus Standards). This
publication, entitled ‘‘Modifications to
the List of Recognized Standards,
Recognition List Number: 053’’
(Recognition List Number: 053), will
assist manufacturers who elect to
declare conformity with consensus
standards to meet certain requirements
for medical devices.
DATES: Submit either electronic or
written comments on the notice at any
time. These modifications to the list of
recognized standards are applicable
March 30, 2020.
ADDRESSES: You may submit comments
on the current list of FDA Recognized
Consensus Standards at any time as
follows:
Jkt 250001
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
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:
E:\FR\FM\30MRN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 61 (Monday, March 30, 2020)]
[Notices]
[Pages 17583-17584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06537]
-----------------------------------------------------------------------
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 April
29, 2020.
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 [email protected]. 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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
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--Extension
The Center for Veterinary Medicine and the Partnership for Food
Protection developed a web-based tracking network (the tracking
network) to allow Federal, State, and Territorial regulatory and public
health Agencies to share safety information about animal food.
Information is submitted to the tracking network by regulatory and
public health Agency employees with membership rights. The efficient
exchange of safety information is necessary because it improves early
identification and evaluation of a risk associated with an animal food
product. We use the information to assist regulatory Agencies to
quickly identify and evaluate a risk and take whatever action is
necessary to mitigate or eliminate exposure to the risk. Earlier
identification and communication with respect to emerging safety
information may also mitigate the potential adverse economic impact for
the impacted parties associated with such safety issues. The tracking
network was developed under the requirements set forth under section
1002(b) of the Food and Drug Administration Amendments Act of 2007
(FDAAA) (Pub. L. 110-085). Section 1002(b) of the FDAAA required FDA,
in relevant part, to establish a pet food early warning alert system.
[[Page 17584]]
The tracking network collects: (1) reports of pet food-related
illness and product defects associated with dog food, cat food, and
food for other pets, which are submitted via the Pet Event Tracking
Network (PETNet); (2) reports of animal food-related illness and
product defects associated with animal food for livestock animals,
aquaculture species, and horses (LivestockNet); and (3) reports about
animal food laboratory samples considered adulterated by State or FDA
regulators (SampleNet).
PETNet and LivestockNet reports share the following common data
elements, the majority of which are drop down menu choices: product
details (product name, lot code, product form, and the manufacturer or
distributor/packer (if known)), the species affected, number of animals
exposed to the product, number of animals affected, body systems
affected, product problem/defect, date of onset or the date product
problem was detected, the State where the incident occurred, the origin
of the information, whether there are supporting laboratory results,
and contact information for the reporting member (i.e., name, telephone
number will be captured automatically when member logs in to the
system). For the LivestockNet report, additional data elements specific
to livestock animals are captured: product details (indication of
whether the product is a medicated product, product packaging, and
intended purpose of the product), class of the animal species affected,
and production loss. For PETNet reports, the only additional data field
is the animal life stage. The SampleNet reports have the following data
elements, many of which are drop down menu choices: product information
(product name, lot code, guarantor information, date and location of
sample collection, and product description); laboratory information
(sample identification number, the reason for testing, whether the food
was reported to the Reportable Food Registry, who performed the
analysis); and results information (analyte, test method, analytical
results, whether the results contradict a label claim or guarantee, and
whether action was taken as a result of the sample analysis).
Description of Respondents: Voluntary respondents to this
collection of information are Federal, State, and Territorial
regulatory and public health Agency employees with membership access to
the Animal Feed Network.
In the Federal Register of November 22, 2019 (84 FR 64533), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received offering general
support for the information collection, but did not suggest a change to
our burden estimate. At the same time, upon our own reevaluation we
have reduced the number of respondents to the collection, which results
in an overall reduction of 225 responses and 57 hours annually. We made
this adjustment to better reflect current use of the tracking networks.
We, therefore, estimate the burden of the information collection as
follows:
Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
PETNet...................... 5 5 25 0.25 (15 6.25
minutes).
LivestockNet................ 5 5 25 0.25 (15 6.25
minutes).
SampleNet................... 5 5 25 0.25 (15 6.25
minutes).
-----------------------------------------------------------------------------------
Total................... .............. ................. 75 ............... 18.75
----------------------------------------------------------------------------------------------------------------
Dated: March 20, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06537 Filed 3-27-20; 8:45 am]
BILLING CODE 4164-01-P
