Submission for OMB Review; Comment Request, 30254-30255 [2015-12693]
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30254
Federal Register / Vol. 80, No. 101 / Wednesday, May 27, 2015 / Notices
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
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. 2015–12695 Filed 5–26–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Affordable Care Act Tribal
Maternal, Infant and Early Childhood
Home Visiting Program Annual Report
Guidance.
OMB No.: 0970–0409.
Tribal Home Visiting grantees have
been notified that in every year of their
grant, after the first year, they must
comply with the requirement for
submitting an Annual Report to the
Secretary that should feature activities
carried out under the program during
the past reporting period. In order to
assist grantees with meeting the
requirements of the Annual Report to
the Secretary, ACF created guidance for
grantees to use when writing their
annual reports. ACF is requesting
approval to renew and update the
existing Tribal Home Visiting Guidance
for Submitting an Annual Report to the
Secretary (OMB Control No. 0970–0409)
that will include instructions for
grantees to submit either an annual or
final report (in the final year of the
grant) on the progress of their program
to the Secretary, depending on the
reporting period.
This Report Shall Address the
Following:
• Update on Home Visiting Program
Goals and Objectives
• Update on the Implementation of
Home Visiting Program in Targeted
Community(ies)
• Update on progress toward meeting
Legislatively Mandated Benchmark
Requirements
• Update on Rigorous Evaluation
Activities
• Update on Home Visiting Program
Continuous Quality Improvement
(CQI) Efforts
• Update on Dissemination Activities
• Update on Technical Assistance
Needs
Respondents: Tribal Maternal, Infant,
and Early Childhood Home Visiting
Program Managers (The information
collection does not include direct
interaction with individuals or families
that receive the services).
Description: Section 511(e)(8)(A) of
the Social Security Act, as added by
Section 2951 of the Affordable Care Act
and amended by the Protecting Access
to Medicare Act of 2014 and the
Medicare Access and CHIP
Reauthorization Act of 2015, requires
that grantees under the Maternal, Infant,
and Early Childhood Home Visiting
(MIECHV) program for states and
jurisdictions submit an annual and final
report to the Secretary of Health and
Human Services regarding the program
and activities carried out under the
program, including such data and
information as the Secretary shall
require. Section 511 (h)(2)(A) further
states that the requirements for the
MIECHV grants to tribes, tribal
organizations, and urban Indian
organizations are to be consistent, to the
greatest extent practicable, with the
requirements for grantees under the
MIECHV program for states and
jurisdictions.
The Administration for Children and
Families, Office of Child Care, in
collaboration with the Health Resources
and Services Administration, Maternal
and Child Health Bureau, has awarded
grants for the Tribal Maternal, Infant,
and Early Childhood Home Visiting
Program (Tribal Home Visiting). The
Tribal Home Visiting discretionary
grants support cooperative agreements
to conduct community needs
assessments; plan for and implement
high-quality, culturally-relevant,
evidence-based home visiting programs
in at-risk tribal communities; establish,
measure, and report on progress toward
meeting performance measures in six
legislatively-mandated benchmark
areas; and participate in rigorous
evaluation activities to build the
knowledge base on home visiting among
Native populations.
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Number of
responses per
respondent
Total
responses
Average burden
hours per
response
Total annual
burden hours
Annual/Final Report to the Secretary (depending on reporting period) ................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
25
1
1
50
1250
Estimated Total Annual Burden
Hours: 1,250.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
VerDate Sep<11>2014
16:45 May 26, 2015
Jkt 235001
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
PO 00000
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within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
E:\FR\FM\27MYN1.SGM
27MYN1
Federal Register / Vol. 80, No. 101 / Wednesday, May 27, 2015 / Notices
the Administration for Children and
Families.
4730, Silver Spring, MD 20993–0002,
301–796–5850.
Robert Sargis,
Reports Clearance Officer.
I. Background
[FR Doc. 2015–12693 Filed 5–26–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Bioequivalence Recommendations for
Risperidone; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry on risperidone injection
entitled ‘‘Draft Guidance on
Risperidone.’’ The recommendations
provide specific guidance on the design
of studies to support abbreviated new
drug applications (ANDAs) for
risperidone injection. This draft
guidance is the second revision of a
previously issued draft guidance on the
same subject.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by July 27, 2015.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Xiaoqiu Tang, Center for Drug
Evaluation and Research (HFD–600),
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:45 May 26, 2015
Jkt 235001
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry,
‘‘Bioequivalence Recommendations for
Specific Products,’’ which explained the
process that would be used to make
product-specific BE recommendations
available to the public on FDA’s Web
site at https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm. As
described in that guidance, FDA
adopted this process as a means to
develop and disseminate productspecific bioequivalence (BE)
recommendations and provide a
meaningful opportunity for the public to
consider and comment on those
recommendations. This notice
announces the availability of a second
revision of draft BE recommendations
for risperidone injection.
FDA initially approved new drug
application 021346 for Risperdal Consta
Long-Acting Injection in October 2003.
There are no approved ANDAs for this
product. In February 2010, FDA issued
a draft guidance for industry on BE
recommendations for generic
risperidone injection. In August 2013,
we issued a revised draft guidance on
the same subject. We are now issuing a
second revision of the draft guidance for
industry on BE recommendations for
generic risperidone injection (Draft
Guidance on Risperidone).
In February 2011, Johnson & Johnson
Pharmaceutical Research and
Development, LLC, manufacturer of
Risperdal Consta, the reference listed
drug, submitted a citizen petition
requesting that FDA require that any
ANDA referencing Risperdal Consta
meet certain requirements, including
requirements related to demonstrating
BE (Docket No. FDA–2011–P–0086).
FDA is reviewing the issues raised in
the petition. FDA will consider any
comments on the revised draft BE
recommendations in responding to the
petition.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on the design of BE studies to support
ANDAs for risperidone injection. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
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30255
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: May 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–12847 Filed 5–26–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than July 27, 2015.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
SUMMARY:
E:\FR\FM\27MYN1.SGM
27MYN1
]]>Agencies
[Federal Register Volume 80, Number 101 (Wednesday, May 27, 2015)]
[Notices]
[Pages 30254-30255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12693]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Affordable Care Act Tribal Maternal, Infant and Early
Childhood Home Visiting Program Annual Report Guidance.
OMB No.: 0970-0409.
Description: Section 511(e)(8)(A) of the Social Security Act, as
added by Section 2951 of the Affordable Care Act and amended by the
Protecting Access to Medicare Act of 2014 and the Medicare Access and
CHIP Reauthorization Act of 2015, requires that grantees under the
Maternal, Infant, and Early Childhood Home Visiting (MIECHV) program
for states and jurisdictions submit an annual and final report to the
Secretary of Health and Human Services regarding the program and
activities carried out under the program, including such data and
information as the Secretary shall require. Section 511 (h)(2)(A)
further states that the requirements for the MIECHV grants to tribes,
tribal organizations, and urban Indian organizations are to be
consistent, to the greatest extent practicable, with the requirements
for grantees under the MIECHV program for states and jurisdictions.
The Administration for Children and Families, Office of Child Care,
in collaboration with the Health Resources and Services Administration,
Maternal and Child Health Bureau, has awarded grants for the Tribal
Maternal, Infant, and Early Childhood Home Visiting Program (Tribal
Home Visiting). The Tribal Home Visiting discretionary grants support
cooperative agreements to conduct community needs assessments; plan for
and implement high-quality, culturally-relevant, evidence-based home
visiting programs in at-risk tribal communities; establish, measure,
and report on progress toward meeting performance measures in six
legislatively-mandated benchmark areas; and participate in rigorous
evaluation activities to build the knowledge base on home visiting
among Native populations.
Tribal Home Visiting grantees have been notified that in every year
of their grant, after the first year, they must comply with the
requirement for submitting an Annual Report to the Secretary that
should feature activities carried out under the program during the past
reporting period. In order to assist grantees with meeting the
requirements of the Annual Report to the Secretary, ACF created
guidance for grantees to use when writing their annual reports. ACF is
requesting approval to renew and update the existing Tribal Home
Visiting Guidance for Submitting an Annual Report to the Secretary (OMB
Control No. 0970-0409) that will include instructions for grantees to
submit either an annual or final report (in the final year of the
grant) on the progress of their program to the Secretary, depending on
the reporting period.
This Report Shall Address the Following:
Update on Home Visiting Program Goals and Objectives
Update on the Implementation of Home Visiting Program in
Targeted Community(ies)
Update on progress toward meeting Legislatively Mandated
Benchmark Requirements
Update on Rigorous Evaluation Activities
Update on Home Visiting Program Continuous Quality Improvement
(CQI) Efforts
Update on Dissemination Activities
Update on Technical Assistance Needs
Respondents: Tribal Maternal, Infant, and Early Childhood Home
Visiting Program Managers (The information collection does not include
direct interaction with individuals or families that receive the
services).
Annual Burden Estimates
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Annual number of responses per Total responses hours per Total annual
respondents respondent response burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual/Final Report to the Secretary (depending on 25 1 1 50 1250
reporting period).......................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 1,250.
Additional Information: Copies of the proposed collection may be
obtained by writing to the Administration for Children and Families,
Office of Planning, Research and Evaluation, 370 L'Enfant Promenade
SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All
requests should be identified by the title of the information
collection. Email address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this document in the Federal Register. Therefore, a comment is best
assured of having its full effect if OMB receives it within 30 days of
publication. Written comments and recommendations for the proposed
information collection should be sent directly to the following: Office
of Management and Budget, Paperwork Reduction Project, Fax: 202-395-
7285, Email: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for
[[Page 30255]]
the Administration for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015-12693 Filed 5-26-15; 8:45 am]
BILLING CODE 4184-01-P
