Discretionary Grant Program, 32557-32558 [2014-13002]
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32557
Federal Register / Vol. 79, No. 108 / Thursday, June 5, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section/activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
130.17(c)/Request for Permit ...............................................
130.17(i)/Request for Extension ..........................................
13
1
2
2
26
2
25
2
650
4
Total ..............................................................................
........................
........................
........................
........................
654
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated number of temporary
marketing permit applications and
hours per response is an average based
on our experience with applications
received for the past 3 years, and
information from firms that have
submitted recent requests for temporary
marketing permits. Based on this
information, we estimate that there will
be, on average, approximately 13 firms
submitting requests for 2 temporary
marketing permits per year over the next
3 years.
Thus, we estimate that 13 respondents
will submit 2 requests for temporary
marketing permits annually pursuant to
§ 130.17(c). The estimated number of
respondents for § 130.17(i) is minimal
because this section is seldom used by
the respondents; therefore, the Agency
estimates that there will be one or fewer
respondents annually with two or fewer
requests for extension of the marketing
permit under § 130.17(i). The estimated
number of hours per response is an
average based on the Agency’s
experience and information from firms
that have submitted recent requests for
temporary marketing permits. We
estimate that 13 respondents each will
submit 2 requests for temporary
marketing permits under § 130.17(c) and
that it will take a respondent 25 hours
per request to comply with the
requirements of that section, for a total
of 650 hours. We estimate that one
respondent will submit two requests for
extension of its temporary marketing
permits under § 130.17(i) and that it will
take a respondent 2 hours per request to
comply with the requirements of that
section, for a total of 4 hours.
rmajette on DSK2TPTVN1PROD with NOTICES
Dated: May 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–13041 Filed 6–4–14; 8:45 am]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Discretionary Grant Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of Class Deviation from
Competition Requirements for the
Maternal and Child Health Bureau’s
(MCHB) Autism Intervention Research
Network on Behavioral Health and
Autism Intervention Research Network
on Physical Health programs.
AGENCY:
HRSA will be issuing a 1-year
non-competitive continuation budget
period beyond the planned 3-year
project period for the Autism
Intervention Research Network on
Behavioral Health (AIR–B Network) and
the Autism Intervention Research
Network on Physical Health (AIR–P
Network) programs. Approximately
$1,500,000 in funding will be made
available in the form of a cooperative
agreement to the University of
California Los Angeles (UCLA),
Cooperative Agreement Number
UA3MC11055, during the budget period
of September 1, 2014, through August
31, 2015. Approximately $3,000,000 in
funding will be made available in the
form of a cooperative agreement to the
Massachusetts General Hospital (MGH),
Cooperative Agreement Number
UA3MC11054, during the budget period
of September 1, 2014, through August
31, 2015.
The AIR–B Network (UA3MC 11055)
and the AIR–P Network (UA3MC11054)
programs, CFDA No. 93.110, are
authorized by the Public Health Service
Act, § 399BB(f) (42 U.S.C. 280i-1(f)), as
amended by the Combating Autism
Reauthorization Act of 2011 (Pub. L.
112–32), which is scheduled to sunset
on September 30, 2014.
The AIR–B Network is an
interdisciplinary, multi-site network of
researchers working together with
communities to provide national
leadership in research to improve the
SUMMARY:
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
behavioral, mental, social, and/or
cognitive health and wellbeing of
children and adolescents with autism
spectrum disorders (ASD) and other
developmental disabilities. The AIR–B
Network conducts protocol-based
research to advance effective
intervention strategies aimed at
improving social and behavioral health
and well-being among underserved
children and adolescents with ASD, in
both home and school settings; provides
a research environment that is
supportive of the professional
development of emerging researchers
interested in autism intervention
research; disseminates critical
information on its research findings to
inform researchers, care providers,
policymakers, other stakeholders in the
field, and the public, including families
with children and adolescents with
ASD; and promotes the translation of
network findings into practice settings
and communities that will result in
improved care.
The AIR–P Network is an
interdisciplinary, multi-site research
network of clinicians and researchers
that provides national leadership in
research to improve the physical health
and well-being of children and
adolescents with autism spectrum
disorders (ASD) and other
developmental disabilities. The AIR–P
Network conducts protocol-based
research to advance effective treatment
strategies; develops and updates
evidence-based guidelines and validates
tools for interventions; provides a
research environment that supports the
professional development of emerging
researchers interested in autism
intervention research; disseminates
critical information on its research
findings to inform researchers, care
providers, policymakers, other
stakeholders in the field, and the public,
including families with children and
adolescents with ASD; and promotes the
translation of findings into practice
settings and communities that will
result in improved care.
SUPPLEMENTARY INFORMATION:
Intended Recipients of the Award:
The grantees of record (listed below).
E:\FR\FM\05JNN1.SGM
05JNN1
32558
Federal Register / Vol. 79, No. 108 / Thursday, June 5, 2014 / Notices
Amount of the Non-Competitive
Award:
• Up to $1,500,000 (AIR–B Network);
• Up to $3,000,000 (AIR–P Network).
CFDA Number: 93.110.
Current Project Period: 09/01/2011—
08/31/2014.
Period of Funding: 9/1/2014–8/31/
2015.
Authority: Public Health Service Act,
§ 399BB(f) (codified at 42 U.S.C. 280i–1(f))
and the Combating Autism Act of 2006 (Pub.
L. 109–416), as amended by the Combating
Autism Reauthorization Act of 2011 (Pub. L.
112–32), which is scheduled to sunset on 9/
30/2014.
Justification: MCHB is extending
funding for the currently funded AIR–B
Network on and AIR–P Network
programs by 1 year because the
authority for these programs is
scheduled to sunset on September 30,
2014, and a potential lapse in the
authorization would result in the
inability to continue to support them.
Should the legislation be
reauthorized, a 1-year extension,
beginning on September 1, 2014, will
allow the grantees to wrap up current
studies; strengthen dissemination efforts
to stakeholders including providers,
researchers, families, and partners in
schools and communities that regularly
serve children and adolescents with
ASD and their families; and strengthen
educational opportunities in
communities by enhancing partnerships
for community-based participatory
research. The networks will also
strengthen efforts in completing data
analyses, manuscript submissions, and
other products, and develop efforts
within the approved scope of work for
completion during the 1-year extension.
Because research networks are
planned and developed as multi-year
projects, without reauthorization, these
Grantee/organization name
Grant number
The University of California Los Angeles ...................
The Massachusetts General Hospital .........................
UA3MC11055 .................................
UA3MC11054 .................................
Dated: May 29, 2014.
Mary K. Wakefield,
Administrator.
[FR Doc. 2014–13002 Filed 6–4–14; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
rmajette on DSK2TPTVN1PROD with NOTICES
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications/
contract proposals and the discussions
could disclose confidential trade secrets
or commercial property such as
patentable material, and personal
information concerning individuals
associated with the grant applications/
contract proposals, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
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14:59 Jun 04, 2014
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FOR FURTHER INFORMATION CONTACT:
Robin Harwood, Ph.D. and Hae Young
Park, M.P.H., Division of Research,
Maternal and Child Health Bureau,
Health Resources and Services
Administration, 5600 Fishers Lane,
Room 18A–55, Rockville, Maryland
20857; rharwood@hrsa.gov, and
hpark@hrsa.gov.
Fiscal year
2013
authorized
funding level
State
CA
MA
Name of Committee: National Cancer
Institute Initial Review Group; Subcommittee
F, Institutional Training and Education.
Date: June 19, 2014.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Cancer Institute, Room 2W904, 9609
Medical Center Drive, Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Timothy C. Meeker, MD,
Ph.D., Scientific Review Officer, Resources
and Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, 9609 Medical Center Drive, Room
7W624, Bethesda, MD 20892–8329, 240–276–
6464, meekert@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Atomic
Bomb Survivors.
Date: June 19, 2014.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
National Cancer Institute, Room 7W102, 9609
Medical Center Drive, Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Thomas M. Vollberg,
Ph.D., Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, 9609 Medical Center Drive,
PO 00000
projects will be initiated but not
completed as planned. Should
reauthorization not occur, the programs
can be completed by the end of the 1year extension on August 31, 2015.
Delaying the competing cycle of the
programs by 1 year will also allow
MCHB to further examine these autism
research networks and develop more
effective programs, given the developing
science in autism intervention. This will
enable MCHB to better address emerging
needs from HRSA’s perspective and
respond to any legislative authority.
$1,850,000
3,997,517
Fiscal year
2014
estimated
funding
$1,500,000
3,000,000
Room 7W102, Rockville, MD 20850, 240–
276–6341, vollbert@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/sep/sep.htm
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: June 2, 2014.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–13099 Filed 6–4–14; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\05JNN1.SGM
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Agencies
[Federal Register Volume 79, Number 108 (Thursday, June 5, 2014)]
[Notices]
[Pages 32557-32558]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13002]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Discretionary Grant Program
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice of Class Deviation from Competition Requirements for the
Maternal and Child Health Bureau's (MCHB) Autism Intervention Research
Network on Behavioral Health and Autism Intervention Research Network
on Physical Health programs.
-----------------------------------------------------------------------
SUMMARY: HRSA will be issuing a 1-year non-competitive continuation
budget period beyond the planned 3-year project period for the Autism
Intervention Research Network on Behavioral Health (AIR-B Network) and
the Autism Intervention Research Network on Physical Health (AIR-P
Network) programs. Approximately $1,500,000 in funding will be made
available in the form of a cooperative agreement to the University of
California Los Angeles (UCLA), Cooperative Agreement Number UA3MC11055,
during the budget period of September 1, 2014, through August 31, 2015.
Approximately $3,000,000 in funding will be made available in the form
of a cooperative agreement to the Massachusetts General Hospital (MGH),
Cooperative Agreement Number UA3MC11054, during the budget period of
September 1, 2014, through August 31, 2015.
The AIR-B Network (UA3MC 11055) and the AIR-P Network (UA3MC11054)
programs, CFDA No. 93.110, are authorized by the Public Health Service
Act, Sec. 399BB(f) (42 U.S.C. 280i-1(f)), as amended by the Combating
Autism Reauthorization Act of 2011 (Pub. L. 112-32), which is scheduled
to sunset on September 30, 2014.
The AIR-B Network is an interdisciplinary, multi-site network of
researchers working together with communities to provide national
leadership in research to improve the behavioral, mental, social, and/
or cognitive health and wellbeing of children and adolescents with
autism spectrum disorders (ASD) and other developmental disabilities.
The AIR-B Network conducts protocol-based research to advance effective
intervention strategies aimed at improving social and behavioral health
and well-being among underserved children and adolescents with ASD, in
both home and school settings; provides a research environment that is
supportive of the professional development of emerging researchers
interested in autism intervention research; disseminates critical
information on its research findings to inform researchers, care
providers, policymakers, other stakeholders in the field, and the
public, including families with children and adolescents with ASD; and
promotes the translation of network findings into practice settings and
communities that will result in improved care.
The AIR-P Network is an interdisciplinary, multi-site research
network of clinicians and researchers that provides national leadership
in research to improve the physical health and well-being of children
and adolescents with autism spectrum disorders (ASD) and other
developmental disabilities. The AIR-P Network conducts protocol-based
research to advance effective treatment strategies; develops and
updates evidence-based guidelines and validates tools for
interventions; provides a research environment that supports the
professional development of emerging researchers interested in autism
intervention research; disseminates critical information on its
research findings to inform researchers, care providers, policymakers,
other stakeholders in the field, and the public, including families
with children and adolescents with ASD; and promotes the translation of
findings into practice settings and communities that will result in
improved care.
SUPPLEMENTARY INFORMATION:
Intended Recipients of the Award: The grantees of record (listed
below).
[[Page 32558]]
Amount of the Non-Competitive Award:
Up to $1,500,000 (AIR-B Network);
Up to $3,000,000 (AIR-P Network).
CFDA Number: 93.110.
Current Project Period: 09/01/2011--08/31/2014.
Period of Funding: 9/1/2014-8/31/2015.
Authority: Public Health Service Act, Sec. 399BB(f) (codified
at 42 U.S.C. 280i-1(f)) and the Combating Autism Act of 2006 (Pub.
L. 109-416), as amended by the Combating Autism Reauthorization Act
of 2011 (Pub. L. 112-32), which is scheduled to sunset on 9/30/2014.
Justification: MCHB is extending funding for the currently funded
AIR-B Network on and AIR-P Network programs by 1 year because the
authority for these programs is scheduled to sunset on September 30,
2014, and a potential lapse in the authorization would result in the
inability to continue to support them.
Should the legislation be reauthorized, a 1-year extension,
beginning on September 1, 2014, will allow the grantees to wrap up
current studies; strengthen dissemination efforts to stakeholders
including providers, researchers, families, and partners in schools and
communities that regularly serve children and adolescents with ASD and
their families; and strengthen educational opportunities in communities
by enhancing partnerships for community-based participatory research.
The networks will also strengthen efforts in completing data analyses,
manuscript submissions, and other products, and develop efforts within
the approved scope of work for completion during the 1-year extension.
Because research networks are planned and developed as multi-year
projects, without reauthorization, these projects will be initiated but
not completed as planned. Should reauthorization not occur, the
programs can be completed by the end of the 1-year extension on August
31, 2015. Delaying the competing cycle of the programs by 1 year will
also allow MCHB to further examine these autism research networks and
develop more effective programs, given the developing science in autism
intervention. This will enable MCHB to better address emerging needs
from HRSA's perspective and respond to any legislative authority.
FOR FURTHER INFORMATION CONTACT: Robin Harwood, Ph.D. and Hae Young
Park, M.P.H., Division of Research, Maternal and Child Health Bureau,
Health Resources and Services Administration, 5600 Fishers Lane, Room
18A-55, Rockville, Maryland 20857; rharwood@hrsa.gov, and
hpark@hrsa.gov.
----------------------------------------------------------------------------------------------------------------
Fiscal year Fiscal year
2013 2014
Grantee/organization name Grant number State authorized estimated
funding level funding
----------------------------------------------------------------------------------------------------------------
The University of California Los UA3MC11055............. CA $1,850,000 $1,500,000
Angeles.
The Massachusetts General Hospital... UA3MC11054............. MA 3,997,517 3,000,000
----------------------------------------------------------------------------------------------------------------
Dated: May 29, 2014.
Mary K. Wakefield,
Administrator.
[FR Doc. 2014-13002 Filed 6-4-14; 8:45 am]
BILLING CODE 4165-15-P