Announcement of the Award of a Single-Source Expansion Supplement Grant to National Safe Place in Louisville, KY, 69856 [2014-27738]
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69856
Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[CFDA Number: 93.623]
Announcement of the Award of a
Single-Source Expansion Supplement
Grant to National Safe Place in
Louisville, KY
Family and Youth Services
Bureau (FYSB), ACYF, ACF, DHHS.
ACTION: Notice of the award.
AGENCY:
The Administration for
Children and Families (ACF),
Administration on Children, Youth and
Families (ACYF), Family and Youth
Services Bureau (FYSB), Division of
Adolescent Development and Support
(DADS) announces the award of a
single-source expansion supplement
grant of $610,000 to Safe Place in
Louisville, KY, to support costs
associated with the expansion of the
scope of approved activities under their
award for the Runaway and Homeless
Youth Training and Technical
Assistance Center (RHYTTAC).
DATES: The award will support activities
from August 1, 2014 through September
29, 2014.
FOR FURTHER INFORMATION CONTACT:
Christopher Holloway, Central Office
Program Manager, Runaway and
Homeless Youth Program, Division of
Adolescent Development and Support,
Family and Youth Services Bureau,
1250 Maryland Avenue SW., Suite 800,
Washington, DC 20024; Telephone:
202–205–9560; Email:
Christopher.Holloway@acf.hhs.gov
SUPPLEMENTARY INFORMATION: The
expansion supplement award will allow
National Safe Place to:
• Assist runaway and homeless youth
(RHY) organizations with understanding
and responding to the impact of toxic
stress in the workplace through the
creation of an annotated resource
directory and distribution of other
materials related to Toxic Stress
Awareness and Response.
• Provide training and technical
assistance (T & TA) to RHY grantees on
enhancing sustainability and for the
development of an RHY Sustainability
Toolkit containing an extensive
compilation of generalized information
for sustainability of RHY organizations.
• Extend the Human Trafficking
(HTR3) project to build upon and
expand efforts in assisting programs
with making the transition from
understanding how to recognize and
respect the victims of human trafficking
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SUMMARY:
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20:32 Nov 21, 2014
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to responding to the diverse needs of
victims through the development of
effective organizational practices and
community collaborations.
Using evidence-based practices
derived from the best available research,
professional expertise, and input from
youth and families, the Runaway and
Homeless Youth Training and Technical
Assistance Center (RHYTTAC), operated
by the National Safe Place, serves as the
centralized national resource for FYSBfunded RHY grantees. Training and
technical assistance services are
directed to assisting RHY grantees in
engaging in continuous quality
improvement of their services and to
assist them in building their
organizational capacity to effectively
serve RHY with a focus on helping the
nation’s network of RHY service
providers boost ‘‘protective factors’’ for
their clients.
Statutory Authority: Runaway and
Homeless Youth Act, 42 U.S.C. 5701 through
5752, amended by the Reconnecting
Homeless Youth Act of 2008, Public Law
110–378.
Christopher Beach,
Senior Grants Policy Specialist, Office of
Administration, Division of Grants Policy.
[FR Doc. 2014–27738 Filed 11–21–14; 8:45 am]
BILLING CODE 4184–04–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0329]
Fees for Human Drug Compounding
Outsourcing Facilities Under the FD&C
Act; Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a final guidance for
industry entitled ‘‘Fees for Human Drug
Compounding Outsourcing Facilities
Under Sections 503B and 744K of the
FD&C Act.’’ The guidance is intended
for entities that compound human drugs
and elect to register as outsourcing
facilities under the Federal Food, Drug,
and Cosmetic Act (FD&C Act), as added
by the Drug Quality and Security Act
(DQSA). Entities that elect to register as
outsourcing facilities must pay certain
fees to be considered outsourcing
facilities. This guidance describes the
annual establishment fee, the
reinspection fee, annual adjustments to
fees required by law, how to submit
payment, the effect of failure to pay fees,
SUMMARY:
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
and how to qualify as a small business
to obtain a reduction of the annual
establishment fee.
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. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
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.
FOR FURTHER INFORMATION CONTACT:
Jonathan Gil, Food and Drug
Administration, 10001 New Hampshire
Ave., Silver Spring, MD 20903, 301–
796–7900.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a final guidance for industry entitled
‘‘Fees for Human Drug Compounding
Outsourcing Facilities Under Sections
503B and 744K of the FD&C Act.’’ On
November 27, 2013, President Obama
signed the DQSA (Pub. L. 113–54) into
law. The DQSA added a new section
503B to the FD&C Act (21 U.S.C. 353B)
that created a category of entities called
‘‘outsourcing facilities.’’ Section
503B(d)(4) of the FD&C Act defines an
outsourcing facility, in part, as a facility
that complies with all of the
requirements of section 503B, including
registering with FDA as an outsourcing
facility and paying associated fees. If the
conditions outlined in section 503B(a)
of the FD&C Act are satisfied, a drug
compounded by or under the direct
supervision of a licensed pharmacist in
an outsourcing facility is exempt from
certain sections of the FD&C Act,
including section 502(f)(1) (21 U.S.C.
352(f)(1)) (concerning the labeling of
drugs with adequate directions for use)
and section 505 (21 U.S.C. 355)
(concerning the approval of human drug
products under new drug applications
(NDAs) or abbreviated new drug
applications (ANDAs)). Drugs
compounded in outsourcing facilities
are not exempt from the requirements of
section 501(a)(2)(B) of the FD&C Act (21
U.S.C. 351(a)(2)(B)) (concerning current
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]]>Agencies
[Federal Register Volume 79, Number 226 (Monday, November 24, 2014)]
[Notices]
[Page 69856]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27738]
[[Page 69856]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
[CFDA Number: 93.623]
Announcement of the Award of a Single-Source Expansion Supplement
Grant to National Safe Place in Louisville, KY
AGENCY: Family and Youth Services Bureau (FYSB), ACYF, ACF, DHHS.
ACTION: Notice of the award.
-----------------------------------------------------------------------
SUMMARY: The Administration for Children and Families (ACF),
Administration on Children, Youth and Families (ACYF), Family and Youth
Services Bureau (FYSB), Division of Adolescent Development and Support
(DADS) announces the award of a single-source expansion supplement
grant of $610,000 to Safe Place in Louisville, KY, to support costs
associated with the expansion of the scope of approved activities under
their award for the Runaway and Homeless Youth Training and Technical
Assistance Center (RHYTTAC).
DATES: The award will support activities from August 1, 2014 through
September 29, 2014.
FOR FURTHER INFORMATION CONTACT: Christopher Holloway, Central Office
Program Manager, Runaway and Homeless Youth Program, Division of
Adolescent Development and Support, Family and Youth Services Bureau,
1250 Maryland Avenue SW., Suite 800, Washington, DC 20024; Telephone:
202-205-9560; Email: Christopher.Holloway@acf.hhs.gov
SUPPLEMENTARY INFORMATION: The expansion supplement award will allow
National Safe Place to:
Assist runaway and homeless youth (RHY) organizations with
understanding and responding to the impact of toxic stress in the
workplace through the creation of an annotated resource directory and
distribution of other materials related to Toxic Stress Awareness and
Response.
Provide training and technical assistance (T & TA) to RHY
grantees on enhancing sustainability and for the development of an RHY
Sustainability Toolkit containing an extensive compilation of
generalized information for sustainability of RHY organizations.
Extend the Human Trafficking (HTR3) project to build upon
and expand efforts in assisting programs with making the transition
from understanding how to recognize and respect the victims of human
trafficking to responding to the diverse needs of victims through the
development of effective organizational practices and community
collaborations.
Using evidence-based practices derived from the best available
research, professional expertise, and input from youth and families,
the Runaway and Homeless Youth Training and Technical Assistance Center
(RHYTTAC), operated by the National Safe Place, serves as the
centralized national resource for FYSB-funded RHY grantees. Training
and technical assistance services are directed to assisting RHY
grantees in engaging in continuous quality improvement of their
services and to assist them in building their organizational capacity
to effectively serve RHY with a focus on helping the nation's network
of RHY service providers boost ``protective factors'' for their
clients.
Statutory Authority: Runaway and Homeless Youth Act, 42 U.S.C.
5701 through 5752, amended by the Reconnecting Homeless Youth Act of
2008, Public Law 110-378.
Christopher Beach,
Senior Grants Policy Specialist, Office of Administration, Division of
Grants Policy.
[FR Doc. 2014-27738 Filed 11-21-14; 8:45 am]
BILLING CODE 4184-04-P
