Proposed Information Collection Activity; Comment Request, 18857-18858 [2016-07359]
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18857
Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices
policy questions regarding this
collection contact Sarah Boehm at 301–
492–4429.)
Dated: March 29, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: ORR–3 Placement Report and
ORR–4 Progress Report for
Unaccompanied Refugee Minors (URM)
Program.
OMB No.: 0970–0034.
Description: As required by section
412(d) of the Immigration and
Nationality Act, the Administration for
Children and Families (ACF), Office of
Refugee Resettlement (ORR), is
requesting the information from report
Form ORR–3 and ORR–4 to administer
the Unaccompanied Refugee Minors
[FR Doc. 2016–07423 Filed 3–31–16; 8:45 am]
BILLING CODE 4120–01–P
(URM) program. The ORR–3 (Placement
Report) is submitted to ORR by the State
agency at the minor’s initial placement
in the resettlement State within 30 days
of the placement, and whenever there is
a change in the minor’s status, including
termination from the program, within 60
days of the change or closure of the
case. The ORR–4 (Progress Report) is
submitted every 12 months beginning
with 12 months from the date of the
initial placement to record outcomes of
the child’s progress toward the goals
listed in the child’s case plan. ORR–4 is
also submitted along with the initial
ORR–3 report for 17 years old or above
youth related to independent living
and/or educational plans. The ORR
regulations per 45 CFR 400.120 describe
specific URM program reporting
requirements.
Respondents: State governments.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
asabaliauskas on DSK3SPTVN1PROD with NOTICES
ORR–3 ...................................
ORR–4 ...................................
15
15
Estimated Total Annual Burden
Hours: 3,048.75.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW.,
Washington DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
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
VerDate Sep<11>2014
17:25 Mar 31, 2016
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Number of responses
per respondent
Average burden hours
per response
Estimated responses 178 ......
Estimated responses 127 ......
0.25 (15 min) .........................
1.25 (1 hour and 15 min) .......
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.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016–07361 Filed 3–31–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Low Income Home Energy
Assistance Program (LIHEAP)
Leveraging Report.
OMB No.: 0970–0121.
Description: The LIHEAP leveraging
incentive program rewards LIHEAP
grantees that have leveraged non-federal
home energy resources for low-income
households. The LIHEAP leveraging
report is the application for leveraging
incentive funds that the LIHEAP
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Total burden hours
Estimated 667.5.
Estimated 2,381.25.
grantees submit to the U.S. Department
of Health and Human Services (HHS) for
each fiscal year in which they leverage
countable resources. Participation in the
leveraging incentive program is
voluntary and is described at 45 CFR
96.87. The LIHEAP leveraging report
obtains information on the resources
leveraged by LIHEAP grantees each
federal fiscal year, e.g., as cash,
discounts, waivers, and in-kind; the
benefits provided to low-income
households by these resources, for
example, as fuel and payments for fuel,
as home heating and cooling equipment,
and as weatherization materials and
installation; and the fair market value of
these resources/benefits.
HHS needs this information in order
to carry out federal statutory
requirements for administering the
LIHEAP leveraging incentive program,
to determine accountability and
valuation of grantees’ leveraged nonfederal home energy resources, and to
determine grantees’ shares of leveraging
incentive funds. HHS proposes to
request a three-year clearance by OMB
for the LIHEAP leveraging report
information collection which has
received OMB approval in the past.
Respondents: State, Local or Tribal
Governments.
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01APN1
18858
Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
LIHEAP Leveraging Report .............................................................................
70
1
38
2,660
Estimated Total Annual Burden
Hours: 2,660.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW.,
Washington DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
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.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016–07359 Filed 3–31–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2015–N–2489]
Receipt of Notice That a Patent
Infringement Complaint Was Filed
Against a Biosimilar Applicant
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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17:25 Mar 31, 2016
Jkt 238001
The Food and Drug
Administration (FDA) is publishing
notice that an applicant for a proposed
biosimilar product notified FDA that a
patent infringement action was filed in
connection with the applicant’s
biologics license application (BLA).
Under the Public Health Service Act
(PHS Act), an applicant for a proposed
biosimilar product or interchangeable
product must notify FDA within 30 days
after the applicant was served with a
complaint in a patent infringement
action described under the PHS Act.
FDA is required to publish notice of the
complaint in the Federal Register.
SUMMARY:
FDA has received notice of the
following complaint under section
351(l)(6)(C) of the PHS Act:
Amgen, Inc., v. Apotex, Inc., 15–cv–
61631 (consolidated with 15–cv–62081,
S.D. Fla., filed October 2, 2015).
FDA has only a ministerial role in
publishing notice of a complaint
received under section 351(l)(6)(C) of
the PHS Act, and does not perform a
substantive review of the complaint.
Dated: March 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–07364 Filed 3–31–16; 8:45 am]
BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT:
Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6208, Silver Spring,
MD 20993–0002, 240–402–0979,
daniel.orr@fda.hhs.gov.
The
Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) was
enacted as part of the Patient Protection
and Affordable Care Act (Pub. L. 111–
148) on March 23, 2010. The BPCI Act
amended the PHS Act and created an
abbreviated licensure pathway for
biological products shown to be
biosimilar to, or interchangeable with,
an FDA-licensed biological reference
product. Section 351(k) of the PHS Act
(42 U.S.C. 262(k)), added by the BPCI
Act, describes the requirements for a
BLA for a proposed biosimilar product
or a proposed interchangeable product
(351(k) BLA). Section 351(l) of the PHS
Act, also added by the BPCI Act,
describes certain procedures for
exchanging patent information and
resolving patent disputes between a
351(k) BLA applicant and the holder of
the BLA reference product. If a 351(k)
applicant is served with a complaint for
a patent infringement described in
section 351(l)(6) of the PHS Act, the
applicant is required, under section
351(l)(6)(C) of the PHS Act, to provide
the FDA with notice and a copy of the
complaint within 30 days of service.
FDA is required to publish notice of a
complaint received under section
351(l)(6)(C) of the PHS Act in the
Federal Register.
SUPPLEMENTARY INFORMATION:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0031]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Clinical Laboratory
Improvement Amendments Act of 1988
Waiver Applications
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
collections of information associated
with Clinical Laboratory Improvement
Amendments of 1988 (CLIA) waiver
applications.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by May 31, 2016.
DATES:
ADDRESSES:
You may submit comments
as follows:
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]]>Agencies
[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)]
[Notices]
[Pages 18857-18858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07359]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Low Income Home Energy Assistance Program (LIHEAP)
Leveraging Report.
OMB No.: 0970-0121.
Description: The LIHEAP leveraging incentive program rewards LIHEAP
grantees that have leveraged non-federal home energy resources for low-
income households. The LIHEAP leveraging report is the application for
leveraging incentive funds that the LIHEAP grantees submit to the U.S.
Department of Health and Human Services (HHS) for each fiscal year in
which they leverage countable resources. Participation in the
leveraging incentive program is voluntary and is described at 45 CFR
96.87. The LIHEAP leveraging report obtains information on the
resources leveraged by LIHEAP grantees each federal fiscal year, e.g.,
as cash, discounts, waivers, and in-kind; the benefits provided to low-
income households by these resources, for example, as fuel and payments
for fuel, as home heating and cooling equipment, and as weatherization
materials and installation; and the fair market value of these
resources/benefits.
HHS needs this information in order to carry out federal statutory
requirements for administering the LIHEAP leveraging incentive program,
to determine accountability and valuation of grantees' leveraged non-
federal home energy resources, and to determine grantees' shares of
leveraging incentive funds. HHS proposes to request a three-year
clearance by OMB for the LIHEAP leveraging report information
collection which has received OMB approval in the past. Respondents:
State, Local or Tribal Governments.
[[Page 18858]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
LIHEAP Leveraging Report.................... 70 1 38 2,660
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 2,660.
In compliance with the requirements of Section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Planning, Research and Evaluation, 330 C Street SW., Washington DC
20201. Attn: ACF Reports Clearance Officer. Email address:
infocollection@acf.hhs.gov. All requests should be identified by the
title of the information collection.
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.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016-07359 Filed 3-31-16; 8:45 am]
BILLING CODE 4184-01-P
