Request for Public Comment on Proposed Funding Opportunity Announcement for Special Initiative Concerning the Assets for Independence Program, 18225-18226 [2011-7649]
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Federal Register / Vol. 76, No. 63 / Friday, April 1, 2011 / Notices
lawyers as specialist is child welfare,
develops and implements child
representation research and
demonstration projects to promote
evidence-based, evidence-informed
practice improvements and effective
child representation, establishes and
maintains a national information
sharing network to disseminate
information on promising practices;
evaluates the impact of selected projects
implementing the child representation
models on outcomes for children and
families who have competent and
effective child representation, and
identifies barriers and recommends
need changes in laws, policies,
procedures and/or practice. The
supplemental funds will be used to
provide additional training, technical
assistance, and support to each research
and demonstration site to fully
implement and maintain rigorous onsite and cross-site evaluation plans.
FOR FURTHER INFORMATION CONTACT: Gail
Collins, Children’s Bureau, 1250
Maryland Avenue, SW., Washington,
DC 20047. Telephone: 202–205–8552,
e-mail: gail.collins@acf.hhs.gov.
Dated: March 23, 2011.
Bryan Samuels,
Commissioner, Administration on Children,
Youth and Families.
[FR Doc. 2011–7648 Filed 3–31–11; 8:45 am]
BILLING CODE 4184–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Request for Public Comment on
Proposed Funding Opportunity
Announcement for Special Initiative
Concerning the Assets for
Independence Program
Office of Community Services,
ACF, HHS.
ACTION: Request for Public Comment.
AGENCY:
mstockstill on DSKH9S0YB1PROD with NOTICES
C.F.D.A. Number: 93.602
Statutory Authority: The Assets for
Independence Act (Title IV of the
Community Opportunities, Accountability,
and Training and Educational Services Act of
1998, as amended, Pub. L. 105–285, 42 U.S.C.
604 note) authorizes the Department of
Health and Human Services to award grants
to support Assets for Independence (AFI)
projects and to research and evaluate the
effectiveness of the AFI program and
Individual Development Accounts (IDAs).
In FY 2011, the Office of
Community Services (OCS) will
coordinate with the Administration on
Native Americans (ANA) to implement
SUMMARY:
VerDate Mar<15>2010
20:09 Mar 31, 2011
Jkt 223001
the Native Asset Building Initiative,
through which the two offices will
support Tribes and Native organizations
in planning and implementing
comprehensive asset-building projects.
The initiative will feature special grants
through the Assets for Independence
(AFI) program. These grants will be in
addition to the annual AFI grants that
OCS will award in FY 2011. In contrast
to the annual awards, though, the
eligibility criteria to be listed for these
AFI grants in the ‘‘Native Asset Building
Initiative’’ will vary from the annual AFI
awards’ eligibility criteria. This is
because the criteria used to determine
eligibility for these special initiative
awards will be more consistent with
those used to determine eligibility in the
ANA grant program with which OCS is
coordinating. Consequently, the
eligibility for the special AFI grants will
be limited to Native 501(c)(3) nonprofits serving Native Americans;
Federally recognized Tribal
governments or Alaska Native Villages,
as defined in the Alaska Native Claims
Settlement Act, that are joint applicants
with a 501(c)(3) Native non-profit
organization; and Native non-profit
organizations designated by the
Secretary of the Treasury as Community
Development Financial Institutions and
Native non-profit credit unions
designated by the National Credit Union
Administration as low-income credit
unions that demonstrate a collaborative
relationship with a local community
based organization whose activities are
designed to address poverty and the
needs of community members for
economic independence and stability.
Other entities will not be eligible for
awards under this initiative, but will
continue to be eligible for awards under
the annual AFI funding opportunity
announcement that was published
issued for FY 2011 through FY 2013 on
February 24, 2011 on https://
www.acf.hhs.gov/grants/open/foa/view/
HHS-2011-ACF-OCS-EI-0137.
It is estimated that OCS will award up
to 10 AFI program grants under Native
Asset Building Initiative, with overall
funding of approximately $2,500,000
toward the initiative. It is anticipated
that each recipient of these special AFI
grants will also receive a separate ANA
award for their project.
In addition to these special AFI
awards, we estimate that $15,000,000 in
grants will be awarded in FY 2011
under the annual AFI funding
opportunity announcement published
on February 24, 2011.
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
18225
Proposed Funding Opportunity
Announcement; Native Asset Building
Initiative
In FY 2011, OCS will coordinate with
the Administration on Native
Americans (ANA) on the Native Asset
Building Initiative to support Tribes and
Native organizations in planning and
implementing comprehensive asset
building projects. OCS and ANA are
providing this support through a joint
funding opportunity and training and
technical assistance.
The OCS component of the joint
funding opportunity will feature special
Assets for Independence (AFI) program
grants the eligibility for which will be
limited to entities that are eligible for
ANA grants. Therefore, eligibility for the
special AFI grants will be limited to
Native 501(c)(3) non-profits serving
Native Americans; Federally recognized
Tribal governments or Alaska Native
Villages, as defined in the Alaska Native
Claims Settlement Act, that are joint
applicants with a 501(c)(3) Native nonprofit organization; Native non-profit
organizations designated by the
Secretary of the Treasury as Community
Development Financial Institutions and
Native non-profit credit unions
designated by the National Credit Union
Administration as low-income credit
unions that demonstrate a collaborative
relationship with a local communitybased organization whose activities are
designed to address poverty and the
needs of community members for
economic independence and stability.
Other entities will not be eligible to
submit applications for the AFI grants
under the Native Asset Building
Initiative. It is estimated that OCS will
award up to ten AFI program grants
under the initiative, with overall
funding of approximately $2,500,000.
The ANA component of the Native
Asset Building Initiative will feature a
new funding opportunity through the
Social and Economic Development
Strategies (SEDS) program as well. The
SEDS grants will provide funding for
each project’s operational and staffing
costs, as well as support for financial
literacy education training, capacity
building, and other asset building
activities.
The OCS AFI grants will provide
funding to support the provision of
Individual Development Accounts
(IDA), or matched savings accounts,
component of each selected applicant’s
comprehensive asset building project.
The AFI grantees will also provide
funding to support limited
administrative costs related to the IDA
component. AFI is a demonstration of
the use of IDAs and related strategies
E:\FR\FM\01APN1.SGM
01APN1
18226
Federal Register / Vol. 76, No. 63 / Friday, April 1, 2011 / Notices
using an asset-based approach for
assisting individuals and families with
low incomes out of poverty. The
program supports grantee organizations
that provide financial literacy education
and other training to families, along
with access to IDAs. Every dollar in
savings deposited into an IDA by a
participant will be matched with AFI
grant funds and non-federal funds. The
program promotes savings and enables
participants to acquire an economic
asset that will appreciate over the longterm. Participants use their IDA savings
to acquire a first home, capitalize a
small business, or enroll in
postsecondary education or training.
The Native Asset Building Initiative is
designed to create synergies between the
SEDS program and the AFI program,
and to provide enhanced funding
opportunities for Native communities.
OCS and ANA anticipate that the Native
Asset Building Initiative funding
opportunity announcement will be
published in April 2011. Upon
publication, the Native Asset Building
Initiative funding opportunity
announcement will be made available at
https://www.Grants.gov and at ACF
Funding Opportunities https://
www.acf.hhs.gov/grants/.
Information on the planned
announcement may now be accessed at
the HHS Grants Forecast Web site at
https://www.acf.hhs.gov/
hhsgrantsforecast/.
OCS will publish a synopsis of
comments received as a result of this
notice, along with the agency’s
responses.
The deadline for receipt of
comments is 30 days from the date of
publication of this notice in the Federal
Register.
DATES:
Comments in response to
this notice should be addressed to James
Gatz, Manager, Assets for Independence
Program, Office of Community Services,
370 L’Enfant Promenade, SW., Mailstop
Aerospace 5–West, Washington, DC
20447. Comments will be available for
inspection by members of the public at
the Office of Community Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447.
ADDRESSES:
mstockstill on DSKH9S0YB1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Jennifer Medina, Program Specialist,
(866) 778–6037.
Dated: March 23, 2011.
Yolanda Butler,
Acting Director, Office of Community
Services.
[FR Doc. 2011–7649 Filed 3–31–11; 8:45 am]
BILLING CODE 4184–26–P
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20:09 Mar 31, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0283]
Guidance for Industry on
Postmarketing Studies and Clinical
Trials—Implementation of Section
505(o)(3) of the Federal Food, Drug,
and Cosmetic Act; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Postmarketing Studies and
Clinical Trials—Implementation of
Section 505(o)(3) of the Federal Food,
Drug, and Cosmetic Act.’’ The Food and
Drug Administration Amendments Act
of 2007 (FDAAA) added new provisions
to the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) authorizing FDA to
require certain postmarketing studies
and clinical trials for prescription drugs
approved under the FD&C Act and
biological products approved under the
Public Health Service Act (the PHS Act).
This guidance provides information on
the implementation of the new
provisions and a description of the
types of postmarketing studies and
clinical trials that will generally be
required under the new legislation
(postmarketing requirements (PMRs))
and the types that will generally be
agreed-upon commitments
(postmarketing commitments (PMCs))
because they do not meet the new
statutory criteria for required
postmarketing studies and clinical
trials.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002; or the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. The
guidance may also be obtained by mail
by calling CBER at 1–800–835–4709 or
301–827–1800. Send one self-addressed
adhesive label to assist the office in
processing your requests.
Submit electronic comments to
https://www.regulations.gov. Submit
SUMMARY:
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
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:
Nancy Dickinson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–5400; or
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852–
1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Postmarketing Studies and Clinical
Trials—Implementation of Section
505(o)(3) of the Federal Food, Drug, and
Cosmetic Act.’’ In the past, FDA has
used the term ‘‘PMC’’ to refer to studies
(including clinical trials), conducted by
an applicant after FDA has approved a
drug for marketing or licensing, that
were intended to further refine the
safety, efficacy, or optimal use of a
product, or to ensure consistency and
reliability of product quality. These
commitments were either agreed upon
by FDA and the applicant or, in certain
circumstances, required by FDA. Prior
to the passage of FDAAA, FDA required
PMCs in the following situations:
• Subpart H and subpart E
accelerated approvals, which require
postmarketing studies to demonstrate
clinical benefit (21 CFR 314.510 and
601.41);
• Deferred pediatric studies, where
studies are required under the Pediatric
Research Equity Act (section 505, FD&C
Act); and
• Animal Efficacy Rule approvals,
where studies to demonstrate safety and
efficacy in humans are required at the
time of use (21 CFR 314.610(b)(1) and
601.91(b)(1)).
Title IX, section 901 of FDAAA (Pub.
L. 110–85) amended the FD&C Act by
adding new section 505(o) (21 U.S.C.
355(o)). Section 505(o)(3) of the FD&C
Act authorizes FDA to require certain
postmarketing studies or clinical trials
for prescription drugs approved under
section 505(b) of the FD&C Act and
biological products approved under
section 351 of the PHS Act (42 U.S.C.
262). Section 505(o)(3)(B) of the FD&C
Act states that postmarketing studies
and clinical trials may be required for
one of three purposes:
• To assess a known serious risk
related to the use of the drug;
E:\FR\FM\01APN1.SGM
01APN1
Agencies
[Federal Register Volume 76, Number 63 (Friday, April 1, 2011)]
[Notices]
[Pages 18225-18226]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7649]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Request for Public Comment on Proposed Funding Opportunity
Announcement for Special Initiative Concerning the Assets for
Independence Program
AGENCY: Office of Community Services, ACF, HHS.
ACTION: Request for Public Comment.
-----------------------------------------------------------------------
C.F.D.A. Number: 93.602
Statutory Authority: The Assets for Independence Act (Title IV
of the Community Opportunities, Accountability, and Training and
Educational Services Act of 1998, as amended, Pub. L. 105-285, 42
U.S.C. 604 note) authorizes the Department of Health and Human
Services to award grants to support Assets for Independence (AFI)
projects and to research and evaluate the effectiveness of the AFI
program and Individual Development Accounts (IDAs).
SUMMARY: In FY 2011, the Office of Community Services (OCS) will
coordinate with the Administration on Native Americans (ANA) to
implement the Native Asset Building Initiative, through which the two
offices will support Tribes and Native organizations in planning and
implementing comprehensive asset-building projects. The initiative will
feature special grants through the Assets for Independence (AFI)
program. These grants will be in addition to the annual AFI grants that
OCS will award in FY 2011. In contrast to the annual awards, though,
the eligibility criteria to be listed for these AFI grants in the
``Native Asset Building Initiative'' will vary from the annual AFI
awards' eligibility criteria. This is because the criteria used to
determine eligibility for these special initiative awards will be more
consistent with those used to determine eligibility in the ANA grant
program with which OCS is coordinating. Consequently, the eligibility
for the special AFI grants will be limited to Native 501(c)(3) non-
profits serving Native Americans; Federally recognized Tribal
governments or Alaska Native Villages, as defined in the Alaska Native
Claims Settlement Act, that are joint applicants with a 501(c)(3)
Native non-profit organization; and Native non-profit organizations
designated by the Secretary of the Treasury as Community Development
Financial Institutions and Native non-profit credit unions designated
by the National Credit Union Administration as low-income credit unions
that demonstrate a collaborative relationship with a local community
based organization whose activities are designed to address poverty and
the needs of community members for economic independence and stability.
Other entities will not be eligible for awards under this initiative,
but will continue to be eligible for awards under the annual AFI
funding opportunity announcement that was published issued for FY 2011
through FY 2013 on February 24, 2011 on https://www.acf.hhs.gov/grants/open/foa/view/HHS-2011-ACF-OCS-EI-0137.
It is estimated that OCS will award up to 10 AFI program grants
under Native Asset Building Initiative, with overall funding of
approximately $2,500,000 toward the initiative. It is anticipated that
each recipient of these special AFI grants will also receive a separate
ANA award for their project.
In addition to these special AFI awards, we estimate that
$15,000,000 in grants will be awarded in FY 2011 under the annual AFI
funding opportunity announcement published on February 24, 2011.
Proposed Funding Opportunity Announcement; Native Asset Building
Initiative
In FY 2011, OCS will coordinate with the Administration on Native
Americans (ANA) on the Native Asset Building Initiative to support
Tribes and Native organizations in planning and implementing
comprehensive asset building projects. OCS and ANA are providing this
support through a joint funding opportunity and training and technical
assistance.
The OCS component of the joint funding opportunity will feature
special Assets for Independence (AFI) program grants the eligibility
for which will be limited to entities that are eligible for ANA grants.
Therefore, eligibility for the special AFI grants will be limited to
Native 501(c)(3) non-profits serving Native Americans; Federally
recognized Tribal governments or Alaska Native Villages, as defined in
the Alaska Native Claims Settlement Act, that are joint applicants with
a 501(c)(3) Native non-profit organization; Native non-profit
organizations designated by the Secretary of the Treasury as Community
Development Financial Institutions and Native non-profit credit unions
designated by the National Credit Union Administration as low-income
credit unions that demonstrate a collaborative relationship with a
local community-based organization whose activities are designed to
address poverty and the needs of community members for economic
independence and stability. Other entities will not be eligible to
submit applications for the AFI grants under the Native Asset Building
Initiative. It is estimated that OCS will award up to ten AFI program
grants under the initiative, with overall funding of approximately
$2,500,000.
The ANA component of the Native Asset Building Initiative will
feature a new funding opportunity through the Social and Economic
Development Strategies (SEDS) program as well. The SEDS grants will
provide funding for each project's operational and staffing costs, as
well as support for financial literacy education training, capacity
building, and other asset building activities.
The OCS AFI grants will provide funding to support the provision of
Individual Development Accounts (IDA), or matched savings accounts,
component of each selected applicant's comprehensive asset building
project. The AFI grantees will also provide funding to support limited
administrative costs related to the IDA component. AFI is a
demonstration of the use of IDAs and related strategies
[[Page 18226]]
using an asset-based approach for assisting individuals and families
with low incomes out of poverty. The program supports grantee
organizations that provide financial literacy education and other
training to families, along with access to IDAs. Every dollar in
savings deposited into an IDA by a participant will be matched with AFI
grant funds and non-federal funds. The program promotes savings and
enables participants to acquire an economic asset that will appreciate
over the long-term. Participants use their IDA savings to acquire a
first home, capitalize a small business, or enroll in postsecondary
education or training.
The Native Asset Building Initiative is designed to create
synergies between the SEDS program and the AFI program, and to provide
enhanced funding opportunities for Native communities. OCS and ANA
anticipate that the Native Asset Building Initiative funding
opportunity announcement will be published in April 2011. Upon
publication, the Native Asset Building Initiative funding opportunity
announcement will be made available at https://www.Grants.gov and at ACF
Funding Opportunities https://www.acf.hhs.gov/grants/.
Information on the planned announcement may now be accessed at the
HHS Grants Forecast Web site at https://www.acf.hhs.gov/hhsgrantsforecast/.
OCS will publish a synopsis of comments received as a result of
this notice, along with the agency's responses.
DATES: The deadline for receipt of comments is 30 days from the date of
publication of this notice in the Federal Register.
ADDRESSES: Comments in response to this notice should be addressed to
James Gatz, Manager, Assets for Independence Program, Office of
Community Services, 370 L'Enfant Promenade, SW., Mailstop Aerospace 5-
West, Washington, DC 20447. Comments will be available for inspection
by members of the public at the Office of Community Services, 370
L'Enfant Promenade, SW., Washington, DC 20447.
FOR FURTHER INFORMATION CONTACT: Jennifer Medina, Program Specialist,
(866) 778-6037.
Dated: March 23, 2011.
Yolanda Butler,
Acting Director, Office of Community Services.
[FR Doc. 2011-7649 Filed 3-31-11; 8:45 am]
BILLING CODE 4184-26-P