Alliance for Innovation on Maternal and Child Health Cooperative Agreement, 55859-55860 [2015-23357]
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Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Notices
For purposes of this extension
request, we are retaining our 2012
estimates. The PRA analysis for the
GRAS final rule will take into account
any changes to the GRAS notification
procedure as set forth in the final rule
and we will revise the collection
accordingly.
Dated: September 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–23334 Filed 9–16–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Pediatric Oncology Subcommittee of
the Oncologic Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Pediatric
Oncology Subcommittee of the
Oncologic Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on November 19, 2015, from 8 a.m.
to 1 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: Lauren D. Tesh,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, FAX:
301–847–8533, ODAC@fda.hhs.gov, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). A notice in
the Federal Register about last minute
modifications that impact a previously
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announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: Information will be
presented to gauge investigator interest
in exploring potential pediatric
development plans for two products in
various stages of development for adult
cancer indications. The subcommittee
will consider and discuss issues
concerning diseases to be studied,
patient populations to be included, and
possible study designs in the
development of these products for
pediatric use. The discussion will also
provide information to the Agency
pertinent to the formulation of written
requests for pediatric studies, if
appropriate. The products under
consideration are: (1) ABT–414,
application submitted by AbbVie, Inc.,
and (2) Lenvatinib, application
submitted by Eisai, Inc.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the subcommittee. Written
submissions may be made to the contact
person on or before November 4, 2015.
Oral presentations from the public will
be scheduled between approximately
9:05 a.m. to 9:35 a.m., and 11:30 a.m. to
12 noon. Those individuals interested in
making formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before October 27, 2015. Time
allotted for each presentation may be
limited. If the number of registrants
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55859
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
October 28, 2015.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Lauren D. Tesh
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 14, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–23366 Filed 9–16–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Alliance for Innovation on Maternal
and Child Health Cooperative
Agreement
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of Single-Case Deviation
from Competition Requirement for the
Alliance for Innovation on Maternal and
Child Health Cooperative Agreement at
the Association of State and Territorial
Health Officials, Grant Number
UC4MC28036.
AGENCY:
HRSA announces the award
of a program expansion supplement in
the amount of $100,000 for the Alliance
for Innovation on Maternal and Child
Health (AIM) cooperative agreement.
The purpose of the AIM cooperative
agreement, as stated in the funding
SUMMARY:
E:\FR\FM\17SEN1.SGM
17SEN1
55860
Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Notices
opportunity announcement (FOA), is to
expand access to care for the maternal
and child health (MCH) populations
through the following program focus
areas: (1) Ensuring continuity of
coverage and care for pregnant women
and children; (2) improving systems of
care for children with special health
care needs; and (3) promoting the use of
Bright Futures Guidelines for all
children. The program expansion
supplement will provide funds to the
Association of State and Territorial State
Health Officials (ASTHO), the
cooperative agreement awardee, during
the budget period of September 30,
2015, through September 29, 2016, to
provide targeted technical assistance to
two States at risk for rapid transmission
of HIV and Hepatitis C virus (HCV)
through injection drug use, to build
capacity and expand access to care,
document and share best practices with
other State Health Officials also seeking
to prevent HIV and HCV infection
through injection drug use.
SUPPLEMENTARY INFORMATION: Intended
Recipient of the Award: The Association
of State and Territorial Health Officials
Amount of the Non-Competitive Award:
$100,000
CFDA Number: 93.110
Current Project Period: 9/30/2014–9/29/
2017
Period of Supplemental Funding: 9/30/
2015–9/29/2016
Authority: Social Security Act, Title V,
§ 501(a)(2) (42 U.S.C. 701(a)(2)).
Justification: On April 24, 2015, the
Governor of Indiana declared a public
health disaster emergency in Scott
County, Indiana, attributable to the HIV
epidemic in that county. On the same
day, the Centers for Disease Control and
Prevention issued a Health Alert
Network Advisory to inform other
public health departments and
healthcare providers of the possibility of
HIV outbreaks among persons who
inject drugs and to provide guidance to
assist in the identification and
prevention of such outbreaks. As of
August 28, 2015, the Indiana outbreak is
now 181 (177 confirmed and 4
presumptive positive) adult and
adolescent HIV infections, including a
small number of pregnant women.
Though there are HIV prevention best
practices to inform States, additional
innovative practices are needed to reach
women of child-bearing age,
adolescents, and young adults within
high risk counties, which do not
routinely access health care.
As stated in the FOA, the Alliance for
Innovation on Maternal and Child
Health (AIM) is a Maternal and Child
Health Bureau (MCHB) collaborative
program of awardee organizations for
the purpose of expanding access to care
for the maternal and child health (MCH)
populations. Per the FOA, AIM
Collaborative Engagement awardees are
responsible for engaging key State
agencies and offices (i.e., Public Health
and Medicaid) in AIM activities and
raising awareness of best practices.
In 2014, following objective review of
its application, HRSA awarded the
Association of State and Territorial
Health Officials (ASTHO) cooperative
agreement funding as an AIM
Collaborative Engagement program. If
approved, this would be the first
program expansion supplement for this
cooperative agreement.
ASTHO is the national nonprofit
organization representing public health
agencies in the United States, the U.S.
Territories, the District of Columbia, and
over 100,000 public health professionals
these agencies employ. As part of its
AIM cooperative agreement, ASTHO
identifies and disseminates best
practices to meet the needs of MCH
populations. At the time of the FOA and
application, expanding access to care
among high risk populations to prevent
HIV infection through injection drug use
was not yet identified as a need of MCH
populations. As such, the FOA and
application did not address it.
To meet this emerging need, ASTHO
submitted a prior approval request to
expand the scope of its AIM cooperative
agreement award to work with States at
risk for rapid transmission of HIV and
HCV through injection drug use.
ASTHO, working with MCHB, would
provide targeted technical assistance to
two states to build capacity and expand
access to care among high risk
populations to prevent HIV and HCV
infection through injection drug use.
ASTHO would also document and share
best practices and other technical
assistance resources from the two
targeted states to its network of State
Health Officials.
FOR FURTHER INFORMATION CONTACT:
Sylvia Sosa, MSc, Office of Policy and
Planning, Maternal and Child Health
Bureau, Health Resources and Services
Administration, 5600 Fishers Lane,
Room 18W25D, Rockville, Maryland
20857; ssosa@hrsa.gov.
Grantee/organization name
Grant number
State
FY 2015
Authorized
funding level
FY 2015
Estimated
supplemental
funding
The Association of State and Territorial Health Officials ........
UC4MC28036 .........................
VA .................
$350,000
$100,000
Dated: September 11, 2015.
James Macrae,
Acting Administrator.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–23357 Filed 9–16–15; 8:45 am]
Health Resources and Services
Administration
BILLING CODE 4165–15–P
Centers of Excellence in Maternal and
Child Health in Education, Science,
and Practice Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of Single-Case Deviation
from Competition Requirements for
Program Expansion Supplement
Request for Centers of Excellence in
Maternal and Child Health in
tkelley on DSK3SPTVN1PROD with NOTICES
AGENCY:
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Education, Science, and Practice
program Award to the University of
Washington, Grant Number
T76MC00011.
HRSA announces the award
of a program expansion supplement in
the amount of $40,000 for the Centers of
Excellence in Maternal and Child
Health (MCH) in Education, Science,
and Practice grant. The purpose of the
Centers of Excellence in MCH program
is for the training of graduate and postgraduate public health professionals in
an interdisciplinary MCH setting. The
purpose of this notice is to award
supplemental funds to conduct a
rigorous evaluation of the Pediatric
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Notices]
[Pages 55859-55860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23357]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Alliance for Innovation on Maternal and Child Health Cooperative
Agreement
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice of Single-Case Deviation from Competition Requirement
for the Alliance for Innovation on Maternal and Child Health
Cooperative Agreement at the Association of State and Territorial
Health Officials, Grant Number UC4MC28036.
-----------------------------------------------------------------------
SUMMARY: HRSA announces the award of a program expansion supplement in
the amount of $100,000 for the Alliance for Innovation on Maternal and
Child Health (AIM) cooperative agreement. The purpose of the AIM
cooperative agreement, as stated in the funding
[[Page 55860]]
opportunity announcement (FOA), is to expand access to care for the
maternal and child health (MCH) populations through the following
program focus areas: (1) Ensuring continuity of coverage and care for
pregnant women and children; (2) improving systems of care for children
with special health care needs; and (3) promoting the use of Bright
Futures Guidelines for all children. The program expansion supplement
will provide funds to the Association of State and Territorial State
Health Officials (ASTHO), the cooperative agreement awardee, during the
budget period of September 30, 2015, through September 29, 2016, to
provide targeted technical assistance to two States at risk for rapid
transmission of HIV and Hepatitis C virus (HCV) through injection drug
use, to build capacity and expand access to care, document and share
best practices with other State Health Officials also seeking to
prevent HIV and HCV infection through injection drug use.
SUPPLEMENTARY INFORMATION: Intended Recipient of the Award: The
Association of State and Territorial Health Officials
Amount of the Non-Competitive Award: $100,000
CFDA Number: 93.110
Current Project Period: 9/30/2014-9/29/2017
Period of Supplemental Funding: 9/30/2015-9/29/2016
Authority: Social Security Act, Title V, Sec. 501(a)(2) (42
U.S.C. 701(a)(2)).
Justification: On April 24, 2015, the Governor of Indiana declared
a public health disaster emergency in Scott County, Indiana,
attributable to the HIV epidemic in that county. On the same day, the
Centers for Disease Control and Prevention issued a Health Alert
Network Advisory to inform other public health departments and
healthcare providers of the possibility of HIV outbreaks among persons
who inject drugs and to provide guidance to assist in the
identification and prevention of such outbreaks. As of August 28, 2015,
the Indiana outbreak is now 181 (177 confirmed and 4 presumptive
positive) adult and adolescent HIV infections, including a small number
of pregnant women. Though there are HIV prevention best practices to
inform States, additional innovative practices are needed to reach
women of child-bearing age, adolescents, and young adults within high
risk counties, which do not routinely access health care.
As stated in the FOA, the Alliance for Innovation on Maternal and
Child Health (AIM) is a Maternal and Child Health Bureau (MCHB)
collaborative program of awardee organizations for the purpose of
expanding access to care for the maternal and child health (MCH)
populations. Per the FOA, AIM Collaborative Engagement awardees are
responsible for engaging key State agencies and offices (i.e., Public
Health and Medicaid) in AIM activities and raising awareness of best
practices.
In 2014, following objective review of its application, HRSA
awarded the Association of State and Territorial Health Officials
(ASTHO) cooperative agreement funding as an AIM Collaborative
Engagement program. If approved, this would be the first program
expansion supplement for this cooperative agreement.
ASTHO is the national nonprofit organization representing public
health agencies in the United States, the U.S. Territories, the
District of Columbia, and over 100,000 public health professionals
these agencies employ. As part of its AIM cooperative agreement, ASTHO
identifies and disseminates best practices to meet the needs of MCH
populations. At the time of the FOA and application, expanding access
to care among high risk populations to prevent HIV infection through
injection drug use was not yet identified as a need of MCH populations.
As such, the FOA and application did not address it.
To meet this emerging need, ASTHO submitted a prior approval
request to expand the scope of its AIM cooperative agreement award to
work with States at risk for rapid transmission of HIV and HCV through
injection drug use. ASTHO, working with MCHB, would provide targeted
technical assistance to two states to build capacity and expand access
to care among high risk populations to prevent HIV and HCV infection
through injection drug use. ASTHO would also document and share best
practices and other technical assistance resources from the two
targeted states to its network of State Health Officials.
FOR FURTHER INFORMATION CONTACT: Sylvia Sosa, MSc, Office of Policy and
Planning, Maternal and Child Health Bureau, Health Resources and
Services Administration, 5600 Fishers Lane, Room 18W25D, Rockville,
Maryland 20857; ssosa@hrsa.gov.
----------------------------------------------------------------------------------------------------------------
FY 2015
FY 2015 Estimated
Grantee/organization name Grant number State Authorized supplemental
funding level funding
----------------------------------------------------------------------------------------------------------------
The Association of State and UC4MC28036.......... VA.................. $350,000 $100,000
Territorial Health Officials.
----------------------------------------------------------------------------------------------------------------
Dated: September 11, 2015.
James Macrae,
Acting Administrator.
[FR Doc. 2015-23357 Filed 9-16-15; 8:45 am]
BILLING CODE 4165-15-P
