Proposed Information Collection Activity: Comment Request, 47854-47855 [2012-19665]
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47854
Federal Register / Vol. 77, No. 155 / Friday, August 10, 2012 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
regarding: (1) Pediatric research
conducted under sections 351, 409I, and
499 of the Public Health Service Act and
sections 501, 502, 505, 505A, and 505B,
510K, 515, and 520m of the Federal
Food, Drug, and Cosmetic Act; (2)
identification of research priorities
related to pediatric therapeutics
(including drugs and biological
products) and medical devices for
pediatric populations and the need for
additional diagnostics and treatments of
specific pediatric diseases or conditions,
(3) the ethics, design, and analysis of
clinical trials related to pediatric
therapeutics (including drugs and
biological products) and medical
devices, (4) pediatric labeling disputes
as specified in Public Law 107–109 and
Public Law 110–85, (5) pediatric
labeling changes as specified in Public
Law 107–109 and Public Law 110–85,
(6) adverse event reports for drugs
studied under Public Law 107–109 and
110–85 and labeled, (7) any safety issues
that may occur as specified Public Law
107–109 and Public Law 110–85, (8) any
other pediatric issue or pediatric
labeling dispute involving FDAregulated products, (9) pediatric ethical
issues including research involving
children as subjects as specified in 21
CFR 50.54; and (10) any other matter
involving pediatrics for which FDA has
regulatory responsibility.
The Committee also advises and
makes recommendations to the
Secretary directly or to the Secretary
through the Commissioner on research
involving children as subjects that is
conducted or supported by the
Department of Health and Human
Services as specified in 45 CFR 46.407.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for the committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
VerDate Mar<15>2010
18:02 Aug 09, 2012
Jkt 226001
selected within 60 days, the
Commissioner will select the nonvoting
member to represent industry interests.
III. Application Procedure
Individuals may self nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
contact person (see FOR FURTHER
INFORMATION CONTACT) within 30 days of
publication of this document (see
DATES). FDA will forward all
nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process).
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
Specifically, in this document,
nominations for nonvoting
representatives of industry interests are
encouraged from the pediatric
pharmaceutical research and
biotechnology manufacturing industry.
Authority: This notice is issued under the
Federal Advisory Committee Act (5 U.S.C.
app. 2) and 21 CFR part 14, relating to
advisory committees.
Dated: August 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–19639 Filed 8–9–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Proposed Information Collection
Activity: Comment Request
The Health Resources and Services
Administration (HRSA) periodically
publishes abstracts of information
collection submitted for review to the
Office of Management and Budget
(OMB) in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
clearance requests submitted to OMB for
review, email paperwork@hrsa.gov or
call the HRSA Reports Clearance Office
at (301) 443–1984.
The following request has been
submitted to the Office of Management
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Maternal, Infant, and
Early Childhood Home Visiting
Program Information System: Data
Collection Forms (OMB No. 0915–
xxxx)—[New]
On March 23, 2010, the President
signed into law the Patient Protection
and Affordable Care Act of 2010 (Pub.
L. 111–148), legislation designed to
make quality, affordable, health care
available to all Americans, reduce costs,
improve health care quality, enhance
disease prevention, and strengthen the
health care workforce. Through a
provision authorizing the creation of the
Maternal, Infant, and Early Childhood
Home Visiting (MIECHV) Program, the
Act responds to the diverse needs of
children and families in communities at
risk and provides an unprecedented
opportunity for collaboration and
partnership at the Federal, State, Tribal,
and community levels to improve health
and development outcomes for at-risk
children through evidence-based home
visiting programs. The MIECHV
Program is designed: (1) To strengthen
and improve the programs and activities
carried out under Title V; (2) to improve
coordination of services for at-risk
communities; and (3) to identify and
provide comprehensive services to
improve outcomes for families who
reside in at-risk communities. Formulabased and competitive grants have been
awarded to States, other eligible
jurisdictions, and, under a legislative
provision setting aside dedicated funds
for a Tribal MIECHV program, to eligible
Indian Tribes and consortia of Tribes,
Tribal Organizations, and Urban Indian
Organizations. Competitive grants to
non-profit organizations to provide
home visiting in certain States are
anticipated.
The Social Security Act, Title V,
Section 511 (42 U.S.C. 711), as amended
by the Patient Protection and Affordable
Care Act of 2010, requires that MIECHV
grantees collect both socio-demographic
data and data to measure improvements
for eligible families in six specified
areas (referred to as ‘‘benchmark areas’’)
that encompass the major goals for the
program. The Supplemental Information
Request for the Submission of the
Updated State Plan for a State Home
Visiting Program (SIR), published on
February 8, 2011, further listed a variety
of constructs under each benchmark
area for which grantees were to select
and submit relevant performance
measures. Per Section 511(d)(1)(B)(i) of
the legislation, no later than 30 days
after the end of the third year of the
program, grantees are required to
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10AUN1
47855
Federal Register / Vol. 77, No. 155 / Friday, August 10, 2012 / Notices
demonstrate improvement in at least
four of the six benchmark areas. The SIR
and subsequent MIECHV guidance
documents for both competitive and
formula grants also require that grantees
report annually on the constructs under
each benchmark area, as well as on
demographic, service utilization,
budgetary and other administrative data
related to program implementation.
The proposed data collection and
reporting forms were initially developed
by an internal MIECHV workgroup in
consultation with evidence-based home
visiting model developers and selected
grantees and further refined based on
comments received during the previous
60-day public comment period. The
data collected with the proposed forms
will be used to track grantees’ progress
in demonstrating improvement under
each benchmark area and provide an
overall picture of the population being
served. The proposed data collection
forms are as follows:
Home Visiting Form 1—Demographic
and Service Utilization Data for
Enrollees and Children
This form will be utilized by all
MIECHV program grantees (including
Tribal program grantees) and will
collect data to determine the
unduplicated number of participants
and of participant groups by primary
insurance coverage. This form will also
request data on the demographic
characteristics of program participants
as well as service utilization data.
Annual
number of
respondents
Reporting document
Number of
responses per
respondent
Home Visiting Form 2—Grantee
Performance Measures
States, the District of Columbia, and
territories participating in the MIECHV
program have already selected relevant
performance indicators for the
legislatively identified benchmark areas.
This form provides a template for these
jurisdictions and non-profit grantees
implementing home visiting programs
to report aggregate data on their already
selected and approved performance
measures.
While there will be variation in the
data collection and reporting burden to
grantees based on the number of
families served and data system
capabilities, the annual estimate of
burden is as follows:
Total
responses
Average
burden hours
per response
Total burden
hours
HV Form 1: Demographic and Service Utilization Data for
Enrollees and Children .....................................................
HV Form 2: Grantee Performance Measures .....................
1 81
2 56
1
1
81
56
731
313
59,211
17,528
Total ..............................................................................
81
........................
81
........................
76,739
1 In
addition to 56 jurisdictions and non-profit organizations, it is estimated that up to 25 Tribal MIECHV program grantees will utilize Form 1 to
report on demographic and service utilization data for all participant families.
2 Does not include Tribal program grantees.
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by
email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806. Please direct all
correspondence to the ‘‘attention of the
desk officer for HRSA.’’
the clearance requests submitted to
OMB for review, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office at (301) 443–
1984.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Dated: August 6, 2012.
Wendy Ponton,
Director, Office of Management.
Proposed Project: Maternal, Infant and
Early Childhood Home Visiting
Program FY 2012 Non-Competing
Continuation Progress Report (OMB No.
0915-xxxx)—[New] Activity Code: X02
[FR Doc. 2012–19665 Filed 8–9–12; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Health Resources and Services
Administration (HRSA) periodically
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
VerDate Mar<15>2010
18:02 Aug 09, 2012
Jkt 226001
On March 23, 2010, the President
signed into law the Patient Protection
and Affordable Care Act (ACA). Section
2951 of the Act amended Title V of the
Social Security Act by adding a new
section, 511, which authorized the
creation of the Maternal, Infant, and
Early Childhood Home Visiting
Program, (https://frwebgate.access.
gpo.gov/cgi-bin/getdoc.cgi?dbname=
111_cong_bills&docid=f:h3590enr.
txt.pdf, pages 216–225). The Act
responds to the diverse needs of
children and families in communities at
risk and provides an unprecedented
opportunity for collaboration and
partnership at the federal, state, and
community levels to improve health and
development outcomes for at-risk
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
children through evidence-based home
visiting programs.
Under this program, $125 million was
made available to states on a formula
basis in both fiscal years (FY) FY 2010
and 2011. This funding was awarded to
support states in implementing their
Updated State Plans. Additionally,
competitive funding was awarded in
June 2011 for Development Grants and
Expansion Grants. Development Grants
are intended to support states and
jurisdictions with modest evidencebased home visiting programs to expand
the depth and scope of these efforts,
with the intent to develop the
infrastructure and capacity needed to
seek an Expansion Grant in the future.
Expansion Grants are intended to
support states and jurisdictions that had
already made significant progress
towards a high-quality home visiting
program or embedding their home
visiting program into a comprehensive,
high-quality early childhood system.
Thirteen states were awarded
Development Grants, and nine states
were awarded Expansion Grants. These
competitive grants are for 2 years
(Development Grants) and 4 years
(Expansion Grants), respectively.
Grantees will be completing FY 2011
Progress Reports on activities conducted
since September 30, 2011, along with an
update on the activities to be conducted
E:\FR\FM\10AUN1.SGM
10AUN1
Agencies
[Federal Register Volume 77, Number 155 (Friday, August 10, 2012)]
[Notices]
[Pages 47854-47855]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19665]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Proposed Information Collection Activity: Comment Request
The Health Resources and Services Administration (HRSA)
periodically publishes abstracts of information collection submitted
for review to the Office of Management and Budget (OMB) in compliance
with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To
request a copy of clearance requests submitted to OMB for review, email
paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301)
443-1984.
The following request has been submitted to the Office of
Management and Budget for review under the Paperwork Reduction Act of
1995:
Proposed Project: Maternal, Infant, and Early Childhood Home Visiting
Program Information System: Data Collection Forms (OMB No. 0915-xxxx)--
[New]
On March 23, 2010, the President signed into law the Patient
Protection and Affordable Care Act of 2010 (Pub. L. 111-148),
legislation designed to make quality, affordable, health care available
to all Americans, reduce costs, improve health care quality, enhance
disease prevention, and strengthen the health care workforce. Through a
provision authorizing the creation of the Maternal, Infant, and Early
Childhood Home Visiting (MIECHV) Program, the Act responds to the
diverse needs of children and families in communities at risk and
provides an unprecedented opportunity for collaboration and partnership
at the Federal, State, Tribal, and community levels to improve health
and development outcomes for at-risk children through evidence-based
home visiting programs. The MIECHV Program is designed: (1) To
strengthen and improve the programs and activities carried out under
Title V; (2) to improve coordination of services for at-risk
communities; and (3) to identify and provide comprehensive services to
improve outcomes for families who reside in at-risk communities.
Formula-based and competitive grants have been awarded to States, other
eligible jurisdictions, and, under a legislative provision setting
aside dedicated funds for a Tribal MIECHV program, to eligible Indian
Tribes and consortia of Tribes, Tribal Organizations, and Urban Indian
Organizations. Competitive grants to non-profit organizations to
provide home visiting in certain States are anticipated.
The Social Security Act, Title V, Section 511 (42 U.S.C. 711), as
amended by the Patient Protection and Affordable Care Act of 2010,
requires that MIECHV grantees collect both socio-demographic data and
data to measure improvements for eligible families in six specified
areas (referred to as ``benchmark areas'') that encompass the major
goals for the program. The Supplemental Information Request for the
Submission of the Updated State Plan for a State Home Visiting Program
(SIR), published on February 8, 2011, further listed a variety of
constructs under each benchmark area for which grantees were to select
and submit relevant performance measures. Per Section 511(d)(1)(B)(i)
of the legislation, no later than 30 days after the end of the third
year of the program, grantees are required to
[[Page 47855]]
demonstrate improvement in at least four of the six benchmark areas.
The SIR and subsequent MIECHV guidance documents for both competitive
and formula grants also require that grantees report annually on the
constructs under each benchmark area, as well as on demographic,
service utilization, budgetary and other administrative data related to
program implementation.
The proposed data collection and reporting forms were initially
developed by an internal MIECHV workgroup in consultation with
evidence-based home visiting model developers and selected grantees and
further refined based on comments received during the previous 60-day
public comment period. The data collected with the proposed forms will
be used to track grantees' progress in demonstrating improvement under
each benchmark area and provide an overall picture of the population
being served. The proposed data collection forms are as follows:
Home Visiting Form 1--Demographic and Service Utilization Data for
Enrollees and Children
This form will be utilized by all MIECHV program grantees
(including Tribal program grantees) and will collect data to determine
the unduplicated number of participants and of participant groups by
primary insurance coverage. This form will also request data on the
demographic characteristics of program participants as well as service
utilization data.
Home Visiting Form 2--Grantee Performance Measures
States, the District of Columbia, and territories participating in
the MIECHV program have already selected relevant performance
indicators for the legislatively identified benchmark areas. This form
provides a template for these jurisdictions and non-profit grantees
implementing home visiting programs to report aggregate data on their
already selected and approved performance measures.
While there will be variation in the data collection and reporting
burden to grantees based on the number of families served and data
system capabilities, the annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Annual number Number of Average
Reporting document of responses per Total burden hours Total burden
respondents respondent responses per response hours
----------------------------------------------------------------------------------------------------------------
HV Form 1: Demographic and \1\ 81 1 81 731 59,211
Service Utilization Data for
Enrollees and Children.........
HV Form 2: Grantee Performance \2\ 56 1 56 313 17,528
Measures.......................
-------------------------------------------------------------------------------
Total....................... 81 .............. 81 .............. 76,739
----------------------------------------------------------------------------------------------------------------
\1\ In addition to 56 jurisdictions and non-profit organizations, it is estimated that up to 25 Tribal MIECHV
program grantees will utilize Form 1 to report on demographic and service utilization data for all participant
families.
\2\ Does not include Tribal program grantees.
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202-395-5806. Please direct all
correspondence to the ``attention of the desk officer for HRSA.''
Dated: August 6, 2012.
Wendy Ponton,
Director, Office of Management.
[FR Doc. 2012-19665 Filed 8-9-12; 8:45 am]
BILLING CODE 4165-15-P