Leadership Education in Neurodevelopmental and Other Related Disabilities MCH Training Program, 4040-4041 [E9-1236]
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Federal Register / Vol. 74, No. 13 / Thursday, January 22, 2009 / Notices
rmajette on PRODPC74 with NOTICES
availability of Compliance Policy Guide
Sec. 540.370—Fish and Fishery
Products—Decomposition (the CPG).
The CPG provides guidance for FDA
staff on decomposition in fish and
fishery products.
DATES: Submit written or electronic
comments on the CPG at any time.
ADDRESSES: Submit written comments
on the CPG to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. Submit written
requests for single copies of the CPG to
the Division of Compliance Policy
(HFC–230), Office of Enforcement, Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send two
self-addressed adhesive labels to assist
that office in processing your request, or
fax your request to 240–632–6861. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the CPG.
FOR FURTHER INFORMATION CONTACT:
Robert D. Samuels, Center for Food
Safety and Applied Nutrition (HFS–
325), Food and Drug Administration,
100 Paint Branch Pkwy., College Park,
MD 20740, 301–436–2300.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 18,
2008 (73 FR 41361), FDA announced the
availability of draft CPG Sec. 540.370—
Fish and Fishery Products—
Decomposition and gave interested
parties an opportunity to submit
comments. The agency received no
comments on the draft CPG but on its
own initiative made a few editorial
changes for clarification purposes. The
CPG provides guidance for FDA staff on
decomposition in fish and fishery
products. The CPG also contains
information that may be useful to the
regulated industry and to the public.
FDA is issuing this CPG as a level 1
guidance consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The CPG represents the
agency’s current thinking on FDA’s
direct reference enforcement criteria
related to decomposition in fish and
fishery products. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
VerDate Nov<24>2008
14:47 Jan 21, 2009
Jkt 217001
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. The CPG and
received comments may be seen in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the CPG at https://www.fda.
gov/ora/compliance_ref/cpg/
default.htm.
Dated: January 12, 2009.
Michael A. Chappell,
Acting Associate Commissioner for
Regulatory Affairs.
[FR Doc. E9–1142 Filed 1–21–09; 8:45 am]
non-competitively extend with funds
the 5-year project periods for those
LEND grantees ending on June 30, 2009,
for 2 additional budget periods at the
same level of support for the same scope
of activities which they received in FY
2008.
SUPPLEMENTARY INFORMATION:
Intended Recipients of the Award
Seventeen programs in the LEND
cohort are expected to compete in FY
2009. These programs presently have
active LEND grants: University of Iowa,
Johns Hopkins University, University of
Missouri, University of Nebraska,
Dartmouth Hitchcock Medical Center,
Albert Einstein College of Medicine,
Children’s Hospital of Pittsburgh,
University of South Dakota, University
of Vermont, Virginia Commonwealth
University, West Virginia University,
University of Massachusetts Medical
School, Ohio State University,
Vanderbilt University, Children’s
Research Institute, Indiana University,
University of Oklahoma.
Amount of Individual Supplemental
Awards: Note: These funding levels are
expected to continue in FYs 2009 and
2010.
Grantee
FY 2008
award
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Leadership Education in
Neurodevelopmental and Other
Related Disabilities MCH Training
Program
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notice of Class Deviation from
Project/Budget Period Funding Policies.
AGENCY:
SUMMARY: HRSA will provide 2
additional years of support in the
absence of competition for one cohort of
grants under the Leadership Education
in Neurodevelopmental and Other
Related Disabilities (LEND) MCH
Training Program. HRSA will extend the
project period to June 30, 2011, for the
cohort of the LEND program expected to
compete in fiscal year (FY) 2009, which
would correspond to the sunset of the
Combating Autism Act. Currently, there
are 34 LEND grants split into two
cohorts (17 each) with different end
dates; one group is scheduled to
compete in FY 2009 (Cohort A), and the
other in FY 2011 (Cohort B). HRSA will
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University of Iowa .....................
Johns Hopkins University .........
University of Missouri ...............
University of Nebraska .............
Dartmouth Hitchcock Medical
Center ...................................
Albert Einstein College of Medicine ........................................
Children’s Hospital of Pittsburgh .....................................
University of South Dakota .......
University of Vermont ...............
Virginia Commonwealth University .........................................
West Virginia University ...........
University of Massachusetts
Medical School ......................
Ohio State University ................
Vanderbilt University .................
Children’s Research Institute ...
Indiana University .....................
University of Oklahoma ............
$491,265
884,277
393,012
412,663
451,964
491,265
393,012
432,313
451,964
451,964
439,825
604,256
393,011
393,012
393,012
481,440
442,139
Current Project Periods: 7/1/04
through 6/30/09.
Period of Supplemental Funding:
7/1/09 through 6/30/11.
Authority: Combating Autism Act of 2006,
Public Law No. 109–416, § 399BB(e)(1)(A),
120 Stat 2821, 2826 (2006).
CFDA Number: 93.110.
FOR FURTHER INFORMATION CONTACT:
Laura Kavanagh; Branch Chief, MCH
Training Program, Division of Research,
Training and Education; Maternal and
Child Health Bureau; (301) 443–2254.
E:\FR\FM\22JAN1.SGM
22JAN1
Federal Register / Vol. 74, No. 13 / Thursday, January 22, 2009 / Notices
Justification for the Exception to
Competition: HRSA is ending the two
cohort system for the following reason:
The Combating Autism Act of 2006 is
scheduled to sunset in September of 2011.
With this legislation, it is critical to have
sufficient and accurate data to evaluate the
progress of screening and diagnosing a
greater number of children with autism
spectrum disorder (ASD) and other
developmental disabilities and assuring that
they receive evidenced based services. A
national evaluation will be conducted to
contribute to the HHS Secretary’s Report to
Congress on progress related to ASD and
other developmental disabilities as required
by the Combating Autism Act. From a
programmatic perspective, it is imperative to
collect data from the same group of grantees
over the project period to assess program
goals as requested in the National Evaluation.
By extending the project period for two
additional years for the LEND cohort with the
current project period ending date of June 30,
2009, MCHB will be able to collect common
data elements from both LEND cohorts
through the end of Combating Autism Act
which sunsets in 2011. Doing so will help
ensure that there will be a more cohesive and
uniform collection of data being gathered and
analyzed across both cohorts which will
increase sample size and ultimately, data
validity and study power. If it becomes
necessary to hold a competition for the LEND
cohort in FY 2009 and new applicants were
to apply and be successful, there would be
the potential for less uniformity in the data
collection. It is crucial that there is as much
meaningful data gathered in the remaining
time available from both cohorts to ensure
that the National Evaluation is an accurate
reflection of the program activities.
Under this deviation, MCHB will
provide the LEND grantees in LEND
Cohort A, currently expected to compete
in FY 2009, with the same amount of
funds for the same scope of activities
that they received in FY 2008 for both
the FY2009 and 2010 budget periods.
Dated: January 13, 2009.
Elizabeth M. Duke,
Administrator.
[FR Doc. E9–1236 Filed 1–21–09; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
rmajette on PRODPC74 with NOTICES
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), 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
VerDate Nov<24>2008
14:47 Jan 21, 2009
Jkt 217001
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications 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, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Multiscale
Models of the Physiome.
Date: January 29–30, 2009.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Virtual Meeting)
Contact Person: Malgorzata Klosek, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4188,
MSC 7849, Bethesda, MD 20892, (301) 435–
2211, klosekm@csr.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: Surgical Sciences,
Biomedical Imaging and Bioengineering,
Integrated Review Group Biomedical Imaging
Technology Study Section.
Date: February 2–3, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Guest Suites Doheny
Beach, 34402 Pacific Coast Highway, Dana
Point, CA 92629.
Contact Person: Lee Rosen, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5116,
MSC 7854, Bethesda, MD 20892, (301) 435–
1171, rosenl@csr.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: Oncological Sciences
Integrated Review Group, Tumor
Microenvironment Study Section.
Date: February 2–3, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Fairmont Washington, DC, 2401
M Street, NW., Washington, DC 20037.
Contact Person: Eun Ah Cho, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6202,
MSC 7804, Bethesda, MD 20892, (301) 451–
4467, choe@csr.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: Musculoskeletal, Oral
and Skin Sciences, Integrated Review Group,
Musculoskeletal Tissue Engineering Study
Section.
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Date: February 2–3, 2009.
Time: 8 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bahia Resort Hotel, 998 West
Mission Bay Drive, San Diego, CA 92109.
Contact Person: Jean D. Sipe, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4106,
MSC 7814, Bethesda, MD 20892, 301/435–
1743, sipej@csr.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: Biology of
Development and Aging Integrated Review
Group, Development—2 Study Section.
Date: February 5, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: The River Inn, 924 25th Street, NW.,
Washington, DC 20037.
Contact Person: Neelakanta Ravindranath,
Ph.D., MVSC, Scientific Review Officer,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Room 5140, MSC 7843, Bethesda, MD 20892,
301–435–1034, ravindrn@csr.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: Immunology
Integrated Review Group, Innate Immunity
and Inflammation Study Section.
Date: February 5–6, 2009.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Westin St. Francis, 335 Powell
Street, San Francisco, CA 94102.
Contact Person: Tina Mcintyre, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4202,
MSC 7812, Bethesda, MD 20892, 301–594–
6375, mcintyrt@csr.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: Infectious Diseases
and Microbiology, Integrated Review Group,
Clinical Research and Field Studies of
Infectious Diseases Study Section.
Date: February 6, 2009.
Time: 8:30 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: St. Gregory Hotel, 2033 M Street,
NW., Washington, DC 20036.
Contact Person: Soheyla Saadi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3211,
MSC 7808, Bethesda, MD 20892, 301–435–
0903, saadisoh@csr.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience, Integrated Review
Group, Clinical Neuroplasticity and
Neurotransmitters Study Section.
Date: February 9–10, 2009.
E:\FR\FM\22JAN1.SGM
22JAN1
]]>Agencies
[Federal Register Volume 74, Number 13 (Thursday, January 22, 2009)]
[Notices]
[Pages 4040-4041]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-1236]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Leadership Education in Neurodevelopmental and Other Related
Disabilities MCH Training Program
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Notice of Class Deviation from Project/Budget Period Funding
Policies.
-----------------------------------------------------------------------
SUMMARY: HRSA will provide 2 additional years of support in the absence
of competition for one cohort of grants under the Leadership Education
in Neurodevelopmental and Other Related Disabilities (LEND) MCH
Training Program. HRSA will extend the project period to June 30, 2011,
for the cohort of the LEND program expected to compete in fiscal year
(FY) 2009, which would correspond to the sunset of the Combating Autism
Act. Currently, there are 34 LEND grants split into two cohorts (17
each) with different end dates; one group is scheduled to compete in FY
2009 (Cohort A), and the other in FY 2011 (Cohort B). HRSA will non-
competitively extend with funds the 5-year project periods for those
LEND grantees ending on June 30, 2009, for 2 additional budget periods
at the same level of support for the same scope of activities which
they received in FY 2008.
SUPPLEMENTARY INFORMATION:
Intended Recipients of the Award
Seventeen programs in the LEND cohort are expected to compete in FY
2009. These programs presently have active LEND grants: University of
Iowa, Johns Hopkins University, University of Missouri, University of
Nebraska, Dartmouth Hitchcock Medical Center, Albert Einstein College
of Medicine, Children's Hospital of Pittsburgh, University of South
Dakota, University of Vermont, Virginia Commonwealth University, West
Virginia University, University of Massachusetts Medical School, Ohio
State University, Vanderbilt University, Children's Research Institute,
Indiana University, University of Oklahoma.
Amount of Individual Supplemental Awards: Note: These funding
levels are expected to continue in FYs 2009 and 2010.
------------------------------------------------------------------------
FY 2008
Grantee award
------------------------------------------------------------------------
University of Iowa......................................... $491,265
Johns Hopkins University................................... 884,277
University of Missouri..................................... 393,012
University of Nebraska..................................... 412,663
Dartmouth Hitchcock Medical Center......................... 451,964
Albert Einstein College of Medicine........................ 491,265
Children's Hospital of Pittsburgh.......................... 393,012
University of South Dakota................................. 432,313
University of Vermont...................................... 451,964
Virginia Commonwealth University........................... 451,964
West Virginia University................................... 439,825
University of Massachusetts Medical School................. 604,256
Ohio State University...................................... 393,011
Vanderbilt University...................................... 393,012
Children's Research Institute.............................. 393,012
Indiana University......................................... 481,440
University of Oklahoma..................................... 442,139
------------------------------------------------------------------------
Current Project Periods: 7/1/04 through 6/30/09.
Period of Supplemental Funding: 7/1/09 through 6/30/11.
Authority: Combating Autism Act of 2006, Public Law No. 109-416,
Sec. 399BB(e)(1)(A), 120 Stat 2821, 2826 (2006).
CFDA Number: 93.110.
FOR FURTHER INFORMATION CONTACT: Laura Kavanagh; Branch Chief, MCH
Training Program, Division of Research, Training and Education;
Maternal and Child Health Bureau; (301) 443-2254.
[[Page 4041]]
Justification for the Exception to Competition: HRSA is ending the
two cohort system for the following reason:
The Combating Autism Act of 2006 is scheduled to sunset in
September of 2011. With this legislation, it is critical to have
sufficient and accurate data to evaluate the progress of screening
and diagnosing a greater number of children with autism spectrum
disorder (ASD) and other developmental disabilities and assuring
that they receive evidenced based services. A national evaluation
will be conducted to contribute to the HHS Secretary's Report to
Congress on progress related to ASD and other developmental
disabilities as required by the Combating Autism Act. From a
programmatic perspective, it is imperative to collect data from the
same group of grantees over the project period to assess program
goals as requested in the National Evaluation. By extending the
project period for two additional years for the LEND cohort with the
current project period ending date of June 30, 2009, MCHB will be
able to collect common data elements from both LEND cohorts through
the end of Combating Autism Act which sunsets in 2011. Doing so will
help ensure that there will be a more cohesive and uniform
collection of data being gathered and analyzed across both cohorts
which will increase sample size and ultimately, data validity and
study power. If it becomes necessary to hold a competition for the
LEND cohort in FY 2009 and new applicants were to apply and be
successful, there would be the potential for less uniformity in the
data collection. It is crucial that there is as much meaningful data
gathered in the remaining time available from both cohorts to ensure
that the National Evaluation is an accurate reflection of the
program activities.
Under this deviation, MCHB will provide the LEND grantees in LEND
Cohort A, currently expected to compete in FY 2009, with the same
amount of funds for the same scope of activities that they received in
FY 2008 for both the FY2009 and 2010 budget periods.
Dated: January 13, 2009.
Elizabeth M. Duke,
Administrator.
[FR Doc. E9-1236 Filed 1-21-09; 8:45 am]
BILLING CODE 4165-15-P
