80 FR 30254 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 80, Issue 101 (May 27, 2015)

Page Range		30254-30255
FR Document		2015-12693

Federal Register, Volume 80 Issue 101 (Wednesday, May 27, 2015)

[Federal Register Volume 80, Number 101 (Wednesday, May 27, 2015)]
[Notices]
[Pages 30254-30255]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-12693]


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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

Federal Register / Vol. 80, No. 101 / Wednesday, May 27, 2015 / Notices 30255

the Administration for Children and 4730, Silver Spring, MD 20993–0002, II. Comments
Families. 301–796–5850. Interested persons may submit to the
Robert Sargis, I. Background Division of Dockets Management (see
Reports Clearance Officer. ADDRESSES) either electronic or written
In the Federal Register of June 11, comments regarding this document. It is
[FR Doc. 2015–12693 Filed 5–26–15; 8:45 am] 2010 (75 FR 33311), FDA announced the only necessary to send one set of
BILLING CODE 4184–01–P availability of a guidance for industry, comments. Identify comments with the
‘‘Bioequivalence Recommendations for docket number found in brackets in the
Specific Products,’’ which explained the heading of this document. Received
DEPARTMENT OF HEALTH AND process that would be used to make
HUMAN SERVICES comments may be seen in the Division
product-specific BE recommendations of Dockets Management between 9 a.m.
available to the public on FDA’s Web and 4 p.m., Monday through Friday.
Food and Drug Administration
site at http://www.fda.gov/Drugs/
[Docket No. FDA–2007–D–0369] GuidanceComplianceRegulatory III. Electronic Access
Information/Guidances/default.htm. As Persons with access to the Internet
Bioequivalence Recommendations for described in that guidance, FDA may obtain the document at either
Risperidone; Draft Guidance for adopted this process as a means to http://www.fda.gov/Drugs/Guidance
Industry; Availability develop and disseminate product- ComplianceRegulatoryInformation/
specific bioequivalence (BE) Guidances/default.htm or http://
AGENCY: Food and Drug Administration, recommendations and provide a www.regulations.gov.
HHS. meaningful opportunity for the public to
ACTION: Notice. Dated: May 21, 2015.
consider and comment on those
recommendations. This notice Leslie Kux,
SUMMARY: The Food and Drug announces the availability of a second Associate Commissioner for Policy.
Administration (FDA) is announcing the revision of draft BE recommendations [FR Doc. 2015–12847 Filed 5–26–15; 8:45 am]
availability of a draft guidance for for risperidone injection. BILLING CODE 4164–01–P
industry on risperidone injection
FDA initially approved new drug
entitled ‘‘Draft Guidance on
application 021346 for Risperdal Consta
Risperidone.’’ The recommendations DEPARTMENT OF HEALTH AND
Long-Acting Injection in October 2003.
provide specific guidance on the design HUMAN SERVICES
There are no approved ANDAs for this
of studies to support abbreviated new
product. In February 2010, FDA issued
drug applications (ANDAs) for Health Resources and Services
a draft guidance for industry on BE
risperidone injection. This draft Administration
recommendations for generic
guidance is the second revision of a
risperidone injection. In August 2013, Agency Information Collection
previously issued draft guidance on the
we issued a revised draft guidance on Activities: Proposed Collection: Public
same subject.
the same subject. We are now issuing a Comment Request
DATES: Although you can comment on second revision of the draft guidance for
any guidance at any time (see 21 CFR industry on BE recommendations for AGENCY: Health Resources and Services
10.115(g)(5)), to ensure that the Agency generic risperidone injection (Draft Administration, HHS.
considers your comments on this draft Guidance on Risperidone). ACTION: Notice.
guidance before it begins work on the In February 2011, Johnson & Johnson
final version of the guidance, submit Pharmaceutical Research and SUMMARY: In compliance with the
either electronic or written comments Development, LLC, manufacturer of requirement for opportunity for public
on the draft guidance by July 27, 2015. Risperdal Consta, the reference listed comment on proposed data collection
ADDRESSES: Submit written requests for drug, submitted a citizen petition projects (Section 3506(c)(2)(A) of the
single copies of the draft guidance to the requesting that FDA require that any Paperwork Reduction Act of 1995), the
Division of Drug Information, Center for ANDA referencing Risperdal Consta Health Resources and Services
Drug Evaluation and Research, Food meet certain requirements, including Administration (HRSA) announces
and Drug Administration, 10001 New requirements related to demonstrating plans to submit an Information
Hampshire Ave., Hillandale Building, BE (Docket No. FDA–2011–P–0086). Collection Request (ICR), described
4th Floor, Silver Spring, MD 20993– FDA is reviewing the issues raised in below, to the Office of Management and
0002. Send one self-addressed adhesive the petition. FDA will consider any Budget (OMB). Prior to submitting the
label to assist that office in processing comments on the revised draft BE ICR to OMB, HRSA seeks comments
your requests. See the SUPPLEMENTARY recommendations in responding to the from the public regarding the burden
INFORMATION section for electronic petition. estimate, below, or any other aspect of
access to the draft guidance document. the ICR.
This draft guidance is being issued
Submit electronic comments on the consistent with FDA’s good guidance DATES: Comments on this Information
draft guidance to http:// practices regulation (21 CFR 10.115). Collection Request must be received no
www.regulations.gov. Submit written The draft guidance, when finalized, will later than July 27, 2015.
comments to the Division of Dockets represent the Agency’s current thinking ADDRESSES: Submit your comments to
Management (HFA–305), Food and Drug paperwork@hrsa.gov or mail the HRSA
mstockstill on DSK4VPTVN1PROD with NOTICES

on the design of BE studies to support
Administration, 5630 Fishers Lane, Rm. ANDAs for risperidone injection. It does Information Collection Clearance
1061, Rockville, MD 20852. not create or confer any rights for or on Officer, Room 10–29, Parklawn
FOR FURTHER INFORMATION CONTACT: any person and does not operate to bind Building, 5600 Fishers Lane, Rockville,
Xiaoqiu Tang, Center for Drug FDA or the public. An alternative MD 20857.
Evaluation and Research (HFD–600), approach may be used if such approach FOR FURTHER INFORMATION CONTACT: To
Food and Drug Administration, 10903 satisfies the requirements of the request more information on the
New Hampshire Ave., Bldg. 75, Rm. applicable statutes and regulations. proposed project or to obtain a copy of

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Document Created: 2015-12-15 15:36:13
Document Modified: 2015-12-15 15:36:13

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		80 FR 30254

80 FR 30254 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESAdministration for Children and Families

Federal Register Volume 80, Issue 101 (May 27, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families