Submission for OMB Review; Comment Request, 34953-34954 [2012-14185]
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34953
Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices
risk populations; (6) Advocate the needs
for priority setting and budget allocation
for hepatitis prevention.
Funded sites will use HEPTLC data
for the following purposes:
(1) Understand targeted populations
(demographics, risk behaviors,
vaccination histories, etc.) and assess
the extent to which the targeted
populations have been reached;
(2) Document how well the project is
progressing in meeting goals/objectives
set forth by CDC (e.g. who delivered
what to whom, how many, where,
when, and how well), as well as
performance indicators related to
testing, counseling and linkage to care;
(3) Highlight opportunities for local
Qualified Health Centers (FQHCs). They
will routinely collect, enter, and report
information about the test site, client
demographics and behaviors, testing
results and linkage to care follow up
information within the web-based
HEPTLC system.
CDC anticipates that routine
information collection will begin
immediately after OMB approval. CDC
intends for grantees to bear minimum
burdens with minimal standardized
data variables, while fulfilling
mandatory reporting requirements.
There are no costs to respondents other
than their time.
program collaboration and service
integration (PCSI) to prevent hepatitis:
(4)Fulfill data collection and reporting
requirements outlined in the
cooperative agreements.
The total estimated annualized hourly
burden anticipated for all data
collections and training would be
approximately 6,080 hours.
Respondents will be testing sites at
multiple settings, including health
departments, community based
organizations (CBOs), community health
centers (CHCs), person who inject drugs
(PWID) treatment centers, and other
settings, e.g. human immunodeficiency
virus (HIV) or sexually transmitted
disease (STD) clinics, Federally
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondents
Form name
HBV—CBOs/Health Jurisdictions .....
HCV—multiple sites (IDU, CHCs,
Others, ECHO).
HBV—CBOs/Health Jurisdictions .....
HCV—multiple sites (IDU, CHCs,
Others, ECHO).
Training .............................................
HEPTLC Data Variables & Values
(test-level monthly reporting).
40
12
12
5,760
HEPTLC Template (program-level
reporting/quarterly).
40
4
1.5
240
HEPTLC System ..............................
40
1
2
80
Total ...........................................
...........................................................
........................
........................
........................
6,080
Kimberly S. Lane,
Deputy Director, Office of Science Integrity,
Office of the Associate Director for Science,
Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2012–14209 Filed 6–11–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
srobinson on DSK4SPTVN1PROD with NOTICES
Submission for OMB Review;
Comment Request
Title: Affordable Care Act Tribal
Maternal, Infant and Early Childhood
Home Visiting Program Annual Report.
OMB No.: 0970–NEW.
Description: Section 511(h)(2)(A) of
Title V of the Social Security Act, as
added by Section 2951 of the Patient
Protection and Affordable Care Act of
2010 (Pub. L. 111–148, Affordable Care
Act or ACA), authorizes the Secretary of
HHS to award grants to Indian Tribes (or
a consortium of Indian Tribes), Tribal
Organizations, or Urban Indian
Organizations to conduct an early
childhood home visiting program.
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22:42 Jun 11, 2012
Jkt 226001
The legislation sets aside 3 percent of
the total ACA Maternal, Infant, and
Early Childhood Home Visiting
(MIECHV) Program appropriation
(authorized in Section 511(j)) for grants
to Tribal entities and requires that the
Tribal grants, to the greatest extent
practicable, be consistent with the
requirements of the Maternal, Infant,
and Early Childhood Home Visiting
Program grants to States and territories
(authorized in Section 511(c)), and
include (1) Conducting a needs
assessment similar to the assessment
required for all States under the
legislation and (2) establishing
quantifiable, measurable 3- and 5-year
benchmarks consistent with the
legislation.
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 MIECHV). The Tribal
MIECHV grant awards support 5-year
cooperative agreements to conduct
community needs assessments, plan for
and implement (in accordance with an
Implementation Plan submitted at the
end of Year 1) high-quality, culturally-
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Fmt 4703
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relevant, evidence-based and promising
home visiting programs in at-risk Tribal
communities, and participate in
research and evaluation activities to
build the knowledge base on home
visiting among Native populations.
Section 511(e)(8)(A) of the Social
Security Act, as added by Section 2951
of the Affordable Care Act, requires that
grantees under the MIECHV program for
States and Jurisdictions submit an
annual 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. As described above, 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. In the Tribal
Maternal, Infant, and Early Childhood
Home Visiting Program Guidance for
Submitting a Needs Assessment and
Plan for Responding to Identified Needs
(Phase 2 Implementation Plan) (OMB
Control No. 0970–0389, Expiration Date
6/30/14), Tribal MIECHV grantees were
notified that in Years 2–5 of their grant
E:\FR\FM\12JNN1.SGM
12JNN1
34954
Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices
they must comply with the requirement
for submission of an Annual Report to
the Secretary regarding the program and
activities carried out under the program.
This report shall be submitted to HHS
by Tribal MIECHV grantees 90 days
following the end of Years 2–5 of the
grant.
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).
Progress toward Meeting Legislatively
Mandated Benchmark Requirements.
Update on Rigorous Evaluation
Activities.
Home Visiting Program Continuous
Quality Improvement (CQI) Efforts.
Administration of Home Visiting
Program.
Technical Assistance Needs.
Respondents: Affordable Care Act
Tribal Maternal, Infant, and Early
Childhood Home Visiting Program Year
2–5 Grantees.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Affordable Care Act Tribal Maternal, Infant, and Early Childhood Home Visiting Program Guidance for Submitting an Annual Report to the Secretary
25
1
50
1,250
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 the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–14185 Filed 6–11–12; 8:45 am]
srobinson on DSK4SPTVN1PROD with NOTICES
BILLING CODE 4184–01–P
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22:42 Jun 11, 2012
Jkt 226001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0560]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance on
Informed Consent for In Vitro
Diagnostic Device Studies Using
Leftover Human Specimens That Are
Not Individually Identifiable
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
the guidance on informed consent for in
vitro diagnostic device studies using
leftover human specimens that are not
individually identifiable.
DATES: Submit either electronic or
written comments on the collection of
information by August 13, 2012.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
SUMMARY:
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comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@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
E:\FR\FM\12JNN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 113 (Tuesday, June 12, 2012)]
[Notices]
[Pages 34953-34954]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14185]
-----------------------------------------------------------------------
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.
OMB No.: 0970-NEW.
Description: Section 511(h)(2)(A) of Title V of the Social Security
Act, as added by Section 2951 of the Patient Protection and Affordable
Care Act of 2010 (Pub. L. 111-148, Affordable Care Act or ACA),
authorizes the Secretary of HHS to award grants to Indian Tribes (or a
consortium of Indian Tribes), Tribal Organizations, or Urban Indian
Organizations to conduct an early childhood home visiting program.
The legislation sets aside 3 percent of the total ACA Maternal,
Infant, and Early Childhood Home Visiting (MIECHV) Program
appropriation (authorized in Section 511(j)) for grants to Tribal
entities and requires that the Tribal grants, to the greatest extent
practicable, be consistent with the requirements of the Maternal,
Infant, and Early Childhood Home Visiting Program grants to States and
territories (authorized in Section 511(c)), and include (1) Conducting
a needs assessment similar to the assessment required for all States
under the legislation and (2) establishing quantifiable, measurable 3-
and 5-year benchmarks consistent with the legislation.
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
MIECHV). The Tribal MIECHV grant awards support 5-year cooperative
agreements to conduct community needs assessments, plan for and
implement (in accordance with an Implementation Plan submitted at the
end of Year 1) high-quality, culturally-relevant, evidence-based and
promising home visiting programs in at-risk Tribal communities, and
participate in research and evaluation activities to build the
knowledge base on home visiting among Native populations.
Section 511(e)(8)(A) of the Social Security Act, as added by
Section 2951 of the Affordable Care Act, requires that grantees under
the MIECHV program for States and Jurisdictions submit an annual 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. As described above, 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. In the Tribal Maternal, Infant, and Early Childhood Home
Visiting Program Guidance for Submitting a Needs Assessment and Plan
for Responding to Identified Needs (Phase 2 Implementation Plan) (OMB
Control No. 0970-0389, Expiration Date 6/30/14), Tribal MIECHV grantees
were notified that in Years 2-5 of their grant
[[Page 34954]]
they must comply with the requirement for submission of an Annual
Report to the Secretary regarding the program and activities carried
out under the program. This report shall be submitted to HHS by Tribal
MIECHV grantees 90 days following the end of Years 2-5 of the grant.
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).
Progress toward Meeting Legislatively Mandated Benchmark
Requirements.
Update on Rigorous Evaluation Activities.
Home Visiting Program Continuous Quality Improvement (CQI) Efforts.
Administration of Home Visiting Program.
Technical Assistance Needs.
Respondents: Affordable Care Act Tribal Maternal, Infant, and Early
Childhood Home Visiting Program Year 2-5 Grantees.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Affordable Care Act Tribal Maternal, Infant, 25 1 50 1,250
and Early Childhood Home Visiting Program
Guidance for Submitting an Annual Report to
the Secretary..............................
----------------------------------------------------------------------------------------------------------------
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 the
Administration for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012-14185 Filed 6-11-12; 8:45 am]
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