Announcement of Five Single Source Grant Awards, 44934-44935 [2011-18960]
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44934
Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Notices
Strategic Plan goals and objectives
related to improving minority health
and eliminating health disparities.
• Develops an Agency-wide data
collection infrastructure for minority
health activities and initiatives.
• Implements activities to increase
the availability of data to monitor the
impact of CMS programs in improving
minority health and eliminating health
disparities.
• Participates in the formulation of
CMS goals, policies, legislative
proposals, priorities and strategies as
they affect health professional
organizations and others involved in or
concerned with the delivery of
culturally and linguisticallyappropriate, quality health services to
minorities and disadvantaged
populations.
• Consults with HHS Federal
agencies and other public and private
sector agencies and organizations to
collaborate in addressing health equity.
• Establishes short-term and longrange objectives and participates in the
focus of activities and objectives in
assuring equity of access to resources
and health careers for minorities and
disadvantaged populations.
Authority: 44 U.S.C. 3101.
Dated: July 12, 2011.
Donald Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2011–19000 Filed 7–26–11; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Child Care Quarterly Case
Record Report—ACF–801.
OMB No.: 0970–0167.
Description: Section 658K of the Child
Care and Development Block Grant Act
of 1990 (Pub. L. 101–508, 42 U.S.C.
9858) requires that States and
Territories submit monthly case-level
data on the children and families
receiving direct services under the Child
Care and Development Fund. The
implementing regulations for the
statutorily required reporting are at
45 CFR 98.70. Case-level reports,
submitted quarterly or monthly (at
grantee option, include monthly sample
or full population case-level data. The
data elements to be included in these
reports are represented in the ACF–801.
ACF uses disaggregate data to determine
program and participant characteristics
as well as costs and levels of child care
services provided. This provides ACF
with the information necessary to make
reports to Congress, address national
child care needs, offer technical
assistance to grantees, meet performance
measures, and conduct research.
Consistent with the statute and
regulations, ACF requests extension of
the ACF–801. With this extension, ACF
is proposing to add several new data
elements as well as some minor changes
and clarifications to the existing
reporting requirements and instructions.
These proposed revisions to the ACF–
801 would allow OCC to capture childlevel data on provider quality for each
child receiving a child care subsidy.
Respondents: States, the District of
Columbia, and Territories including
Puerto Rico, Guam, the Virgin Islands,
American Samoa, and the Northern
Marianna Islands.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ACF–801 ..........................................................................................................
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Instrument
56
4
25
5,600
Estimated Total Annual Burden
Hours: 5,600.
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 proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Planning Research and
Evaluation, 370 L’Enfant Promenade,
SW., Washington, DC 20447, Attn: ACF
Reports Clearance Officer. e-mail
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
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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.
Dated: July 20 2011.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2011–18787 Filed 7–26–11; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children And
Families
Announcement of Five Single Source
Grant Awards
AGENCY:
Office of Child Care, ACF,
HHS.
Award of five single source
grants under the Tribal Home Visiting
Program to the Eastern Band of
Cherokee Indians, Cherokee, NC; Native
American Health Center, Inc., Oakland,
CA; Riverside-San Bernardino County
Indian Health, Inc., Banning, CA; Taos
Pueblo, Taos, NM; and United Indians
of All Tribes Foundation, Seattle, WA.
ACTION:
BILLING CODE 4184–01–M
PO 00000
CFDA Number: 93.508.
Statutory Authority: Section
511(h)(2)(A) of Title V of the Social
Security Act, as added by Section 2951
of the Affordable Care Act of 2010 (Pub.
L. 111–148, ACA), authorizes the
Secretary of HHS to award grants to
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Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Notices
Indian Tribes (or a consortium of Indian
Tribes), Tribal Organizations, or Urban
Indian Organizations to conduct an
early childhood home visiting program.
Specifically, the legislation provides for
a 3 percent set-aside of the total
Maternal, Infant, and Early Childhood
Home Visiting Program appropriation
(authorized in Section 511(j)) for
discretionary competitive grants to
Tribal entities.
Summary: The Administration for
Children and Families (ACF), Office of
Child Care (OCC) announces the award
of five Fiscal Year 2011 Tribal Maternal,
Infant, and Early Childhood Home
Visiting single source grants to the
following:
Eastern Band of Cherokee Indians:
$205,000. Cherokee, NC.
Eastern Band of Cherokee Indians will
provide home visiting services to
children under the age of 5 and their
families on the Qualla Boundary.
Native American Health Center, Inc.:
$227,000. Oakland, CA.
Native American Health Center, Inc.
is an urban Tribal organization that will
provide home visiting services to the
American Indian and Alaska Native
(AIAN) population in a five-county
region in Northern California, which
includes Oakland and San Francisco.
Riverside-San Bernardino County
Indian Health, Inc.: $348,000. Banning,
CA.
Riverside-San Bernardino County
Indian Health, Inc. is a tribally
controlled health care organization that
will provide home visiting services to
approximately 2,000 families on 10
tribal reservations in Riverside and San
Bernardino Counties.
Taos Pueblo: $340,000. Taos, NM.
At the Taos Pueblo, there are
currently no services for infants under
the age of 18 months and their parents.
The award will allow the Taos Pueblo
to provide home visiting services for up
to 300 families in order to complete the
continuum of services for children, aged
birth to age 5, and their families.
United Indians of All Tribes
Foundation: $182,000. Seattle, WA.
This is an urban Indian organization
that will provide home visiting services
to the AIAN population in King County,
WA, which represents more than 100
different Tribal entities.
The Tribal Maternal, Infant, and Early
Childhood Home Visiting single source
awards will support the grantees in
conducting community needs
assessments; planning for and
implementation of high-quality,
culturally relevant, evidence-based
home visiting programs in at-risk Tribal
communities for pregnant women and
families with young children aged birth
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17:08 Jul 26, 2011
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to kindergarten entry; and participate in
research and evaluation activities to
build the knowledge base on home
visiting among American Indian and
Alaska Native populations.
It is expected that the five grantees
will continue with their projects for the
remainder of a projected five-year
project period by implementing home
visiting activities for which grantees
may receive noncompetitive
continuation awards. Home visiting
programs are intended to promote
outcomes such as improvements in
maternal and prenatal health, infant
health, and child health and
development; reduced child
maltreatment; improved parenting
practices related to child development
outcomes; improved school readiness;
improved family socio-economic status;
improved coordination of referrals to
community resources and supports; and
reduced incidence of injuries, crime,
and domestic violence.
Dates: July 1, 2011–June 30, 2016.
FOR FURTHER INFORMATION CONTACT:
Carol Gage, Office of Child Care, 370
L’Enfant Promenade SW., Washington,
DC 20047, Telephone: 202–690–6243,
e-mail: carol.gage@acf.hhs.gov.
Dated: July 21, 2011.
Shannon L. Rudisill,
Director, Office of Child Care.
[FR Doc. 2011–18960 Filed 7–26–11; 8:45 am]
BILLING CODE 4184–43–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0453]
Draft Guidance for Industry and Food
and Drug Administration Staff; 510(k)
Device Modifications: Deciding When
To Submit a 510(k) for a Change to an
Existing Device; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘510(k) Device Modifications:
Deciding When To Submit a 510(k) for
a Change to an Existing Device.’’ The
recommendations in this guidance
document are intended to describe
when a new 510(k) should be submitted
for a change or modification to a legally
marketed device. This draft guidance is
not final nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
SUMMARY:
PO 00000
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44935
10.115(g)(5)), to ensure that the Agency
considers your comment 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 October 25,
2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘510(k) Device
Modifications: Deciding When To
Submit a 510(k) for a Change to an
Existing Device’’ to the Division of
Small Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4613,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 301–847–
8149. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
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. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Michael J. Ryan, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1615, Silver Spring,
MD 20993–0002, 301–796–6283.
SUPPLEMENTARY INFORMATION:
I. Background
Since the amendment of the Federal
Food, Drug, and Cosmetic Act by the
Medical Device Amendments of 1976,
FDA has attempted to define with
greater clarity when a modification to an
existing medical device would trigger
the requirement that a new premarket
notification (510(k)) be submitted to the
Agency and cleared prior to marketing.
FDA regulations state in 21 CFR
807.81(a)(3) when a 510(k) must be
submitted, but the language used in this
regulation sometimes leads to varying
interpretations of when a 510(k) is
required for a device modification. In
order to address this issue, FDA issued
in 1997 the guidance document entitled
‘‘Deciding When To Submit a 510(k) for
a Change to an Existing 510(k)’’;
however, regulatory changes such as the
implementation of the Quality System
Regulation have occurred since that
time, and medical device technology
has evolved.
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]]>Agencies
[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Notices]
[Pages 44934-44935]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18960]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children And Families
Announcement of Five Single Source Grant Awards
AGENCY: Office of Child Care, ACF, HHS.
ACTION: Award of five single source grants under the Tribal Home
Visiting Program to the Eastern Band of Cherokee Indians, Cherokee, NC;
Native American Health Center, Inc., Oakland, CA; Riverside-San
Bernardino County Indian Health, Inc., Banning, CA; Taos Pueblo, Taos,
NM; and United Indians of All Tribes Foundation, Seattle, WA.
-----------------------------------------------------------------------
CFDA Number: 93.508.
Statutory Authority: Section 511(h)(2)(A) of Title V of the Social
Security Act, as added by Section 2951 of the Affordable Care Act of
2010 (Pub. L. 111-148, ACA), authorizes the Secretary of HHS to award
grants to
[[Page 44935]]
Indian Tribes (or a consortium of Indian Tribes), Tribal Organizations,
or Urban Indian Organizations to conduct an early childhood home
visiting program. Specifically, the legislation provides for a 3
percent set-aside of the total Maternal, Infant, and Early Childhood
Home Visiting Program appropriation (authorized in Section 511(j)) for
discretionary competitive grants to Tribal entities.
Summary: The Administration for Children and Families (ACF), Office
of Child Care (OCC) announces the award of five Fiscal Year 2011 Tribal
Maternal, Infant, and Early Childhood Home Visiting single source
grants to the following:
Eastern Band of Cherokee Indians: $205,000. Cherokee, NC.
Eastern Band of Cherokee Indians will provide home visiting
services to children under the age of 5 and their families on the
Qualla Boundary.
Native American Health Center, Inc.: $227,000. Oakland, CA.
Native American Health Center, Inc. is an urban Tribal organization
that will provide home visiting services to the American Indian and
Alaska Native (AIAN) population in a five-county region in Northern
California, which includes Oakland and San Francisco.
Riverside-San Bernardino County Indian Health, Inc.: $348,000.
Banning, CA.
Riverside-San Bernardino County Indian Health, Inc. is a tribally
controlled health care organization that will provide home visiting
services to approximately 2,000 families on 10 tribal reservations in
Riverside and San Bernardino Counties.
Taos Pueblo: $340,000. Taos, NM.
At the Taos Pueblo, there are currently no services for infants
under the age of 18 months and their parents. The award will allow the
Taos Pueblo to provide home visiting services for up to 300 families in
order to complete the continuum of services for children, aged birth to
age 5, and their families.
United Indians of All Tribes Foundation: $182,000. Seattle, WA.
This is an urban Indian organization that will provide home
visiting services to the AIAN population in King County, WA, which
represents more than 100 different Tribal entities.
The Tribal Maternal, Infant, and Early Childhood Home Visiting
single source awards will support the grantees in conducting community
needs assessments; planning for and implementation of high-quality,
culturally relevant, evidence-based home visiting programs in at-risk
Tribal communities for pregnant women and families with young children
aged birth to kindergarten entry; and participate in research and
evaluation activities to build the knowledge base on home visiting
among American Indian and Alaska Native populations.
It is expected that the five grantees will continue with their
projects for the remainder of a projected five-year project period by
implementing home visiting activities for which grantees may receive
noncompetitive continuation awards. Home visiting programs are intended
to promote outcomes such as improvements in maternal and prenatal
health, infant health, and child health and development; reduced child
maltreatment; improved parenting practices related to child development
outcomes; improved school readiness; improved family socio-economic
status; improved coordination of referrals to community resources and
supports; and reduced incidence of injuries, crime, and domestic
violence.
Dates: July 1, 2011-June 30, 2016.
FOR FURTHER INFORMATION CONTACT: Carol Gage, Office of Child Care, 370
L'Enfant Promenade SW., Washington, DC 20047, Telephone: 202-690-6243,
e-mail: carol.gage@acf.hhs.gov.
Dated: July 21, 2011.
Shannon L. Rudisill,
Director, Office of Child Care.
[FR Doc. 2011-18960 Filed 7-26-11; 8:45 am]
BILLING CODE 4184-43-P
