Agency Information Collection Activities: Submission for OMB Review; Comment Request, 73336-73337 [E8-28541]
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Federal Register / Vol. 73, No. 232 / Tuesday, December 2, 2008 / Notices
Proposed Project: Maternal and Child
Health Bureau Performance Measures
for Discretionary Grants (OMB No.
0915–0298): Revision
continue using reporting requirements
for SPRANS projects, CISS projects, and
other grant programs administered by
MCHB, including national performance
measures, previously approved by OMB,
and in accordance with the
‘‘Government Performance and Results
Act (GPRA) of 1993’’ (Public Law 103–
62). This Act requires the establishment
of measurable goals for Federal
Programs that can be reported as part of
the budgetary process, thus linking
funding decisions with performance.
Performance measures for MCHB
discretionary grants were initially
The Maternal and Child Health
Bureau (MCHB) intends to continue to
collect performance data for Special
Projects of Regional and National
Significance (SPRANS), Community
Integrated Service Systems (CISS), and
other grant programs administered by
MCHB.
The Health Resources and Services
Administration (HRSA) proposes to
approved in January 2003. Approval
from OMB is being sought to continue
the use of these measures. Some of these
measures are specific to certain types of
programs, and will not apply to all
grantees. Furthermore, these measures
are based primarily on existing data,
thereby minimizing the response burden
consistent with program administration
and management needs. Through the
experience of utilizing these measures,
we are enhancing them to better reflect
program goals.
The estimated response burden is as
follows:
Form
Number of
respondents
Responses
per
respondent
Total
responses
Burden hours
per response
Total burden
hours
Grant Report ........................................................................
898
1
898
6
5,388
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: November 24, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E8–28540 Filed 12–1–08; 8:45 am]
Proposed Project: Maternal and Child
Health Services Title V Block Grant
Program Guidance and Forms for the
Title V Application/Annual Report
(OMB No. 0915–0172): Revision
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Health Resources and Services
Administration (HRSA) proposes to
revise the Maternal and Child Health
Services Title V Block Grant Program—
Guidance and Forms for the
Application/Annual Report. The
guidance is used annually by the 50
States and 9 jurisdictions to apply for
Block Grants under Title V of the Social
Security Act, and in preparing the
required annual report. The proposed
revisions follow and build on extensive
consultation received from a workgroup
convened to provide suggestions to
improve the guidance and forms.
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
Reporting document
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Responses
per
respondent
Number of
respondents
Total
responses
The changes in this edition of the
Maternal and Child Health Services
Title V Block Grant Program Guidance
and Forms for the Title V Application/
Annual Report are primarily revisions to
Section II—Needs Assessment. The
purpose of these revisions is: (1) To
provide more complete information on
the Background and Conceptual
Framework for the Needs Assessment
Process (Part A); (2) to clarify what State
grantees are to include in the Five Year
Needs Assessment Document (Part B);
(3) to better explain the information to
include in the Annual Needs
Assessment Summary/Update, both in
the year when the five year Needs
Assessment is conducted and in interim
years (Part C); and (4) to update Figure
2, the Needs Assessment diagram, to
reflect all aspects of the Needs
Assessment process. In addition, other
minor changes and clarifications are
included throughout the document to
make the instructions clearer for the
respondent. Such changes include the
clarification of headings and the types
of information that States may want to
include in a particular section.
The estimated average annual burden
is as follows:
Burden per
response
Total
burden
hours
Cost per
hour
Total hour
cost
jlentini on PROD1PC65 with NOTICES
Application and Report without
Needs Assessment (2009 &
2011) ....................................
Application with Needs Assessment (2010) ..........................
59
1
59
270
15,930
$30
$477,900
59
1
59
378.5
22,332
30
669,960
Total Average Annual Burden ................................
59
........................
59
306
18,064
30
541,920
The total estimate of annual burden is the average for the next three year period of Application submissions in which a Needs Assessment will
be required once. The Application submissions (with and without the Needs Assessment) are based on the calendar year.
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Federal Register / Vol. 73, No. 232 / Tuesday, December 2, 2008 / Notices
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA submission@omb.eop.gov
or by fax to 202–395–6974. Please direct
all correspondence to the ‘‘attention of
the desk officer for HRSA.’’
Dated: November 24, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E8–28541 Filed 12–1–08; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
jlentini on PROD1PC65 with NOTICES
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Method for Detection of Cancer Based
on Spatial Genome Organization in the
Cell Nucleus
Description of Technology: The
successful treatment of cancer is
correlated with the early detection of
the cancerous cells. Conventional
cancer diagnosis is largely based on
qualitative morphological criteria, but
more accurate quantitative tests could
greatly increase early detection of
malignant cells. It has been observed
that the spatial arrangement of DNA in
the nucleus is altered in cancer cells in
comparison to normal cells. Therefore,
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it is possible to distinguish malignant
cells by mapping the position of labeled
marker genes in the nucleus.
This NIH invention provides methods
of detecting abnormal cells in a sample
using the spatial position of one or more
genes within the nucleus of a cell, as
well as a kit for detecting abnormal cells
using such methods. The invention also
provides methods of identifying gene
markers for abnormal cells using the
spatial position of one or more genes
within the nucleus of a cell.
Applications: Diagnostic for cancer
from tumor biopsies after non-invasive
techniques such as a mammogram or
PSA assay have suggested cancer.
Advantages:
• Sensitive detection of cancer.
• Very small sample (100–200 cells)
reduces the need for invasive
procedures.
• Does not require mitotic
chromosomes.
• Applicable to solid tumors and
blood cancers.
• Single cell assay allows analysis of
subpopulations from biopsy.
• Probes to all genomic regions are
available.
• Alternative or complementary to
conventional diagnostics.
• Measures metastatic potential of
cancer cells.
• Determination of tumor type.
Market:
• This novel in vitro diagnostic test
for cancer has use in oncology
laboratories of hospitals and commercial
clinical laboratories.
• In the United States, almost 1.5
million new cancer cases are expected
to be diagnosed in 2008.
Development Status: Presently in the
process of validating the assay using a
larger set of tumor samples.
Inventors: Tom Misteli and Karen
Meaburn (NCI).
Publication: KJ Meaburn and T
Misteli. Locus-specific and activityindependent gene repositioning during
early tumorigenesis. J Cell Biol. 2008 Jan
14;180(1):39–50.
Patent Status: U.S. Provisional
Application No. 61/094,318 filed 04 Sep
2008 (HHS Reference No. E–283–2008/
0-US–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Whitney Hastings;
301–451–7337; hastingw@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute, Cell
Biology of Genomes Group, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize diagnostic methods for
detection of cancer using spatial genome
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73337
organization. Please contact John D.
Hewes, Ph.D. at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
A Novel, Non-Invasive and
Therapeutically Useful High
Throughput Technique To Isolate
Highly Enriched Tumor Reactive
Lymphocytes From Peripheral BloodPotential Use in Adoptive
Immunotherapy
Description of Technology: The
adoptive transfer of autologous antigen
reactive lymphocytes has been shown to
mediate significant tumor regression in
some patients with metastatic cancer.
However, the isolation of these T
lymphocytes requires invasive surgery,
which can lead to post-operative
complications and delays in initiating
adoptive immunotherapy with T cells.
This technology is directed to the use
of a novel high throughput technique to
isolate highly enriched tumor reactive
lymphocytes in a non-invasive manner
from the peripheral blood of cancer
patients for the purpose of cancer
immunotherapy. The technique utilizes
a highly sensitive PCR based screening
assay.
Applications: The isolated T
lymphocytes can be used in adoptive
immunotherapy for the treatment of
metastatic cancer.
Advantages:
• A rapid and non-invasive high
throughput method of isolating tumor
reactive T cells, which is otherwise
difficult with conventional peripheral
blood isolating techniques.
• The method is easy to use and
based on a highly sensitive PCR based
screening assay.
• The method can detect the presence
of extremely rare T cells in a bulk
population of peripheral blood cells.
Development Status: The method of
isolating tumor reactive T lymphocytes
has been established. The method was
successfully used to isolate tumor
reactive T cells from peripheral blood of
cancer patients.
Inventor: Udai S. Kammula (NCI).
Patent Status: U.S. Patent Application
No. 61/027,623 filed 11 Feb 2008 (HHS
Reference No. E–003–2008/0–US–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Sabarni K.
Chatterjee, PhD; 301–435–5587;
chatterjeesa@mail.nih.gov
Collaborative Research Opportunity:
The National Cancer Institute, Surgery
Branch, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize this high throughput T
E:\FR\FM\02DEN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 232 (Tuesday, December 2, 2008)]
[Notices]
[Pages 73336-73337]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28541]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources and Services Administration
(HRSA) publishes abstracts of information collection requests under
review by the Office of Management and Budget (OMB), in compliance with
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request
a copy of the clearance requests submitted to OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301)
443-1129.
The following request has been submitted to the Office of
Management and Budget for review under the Paperwork Reduction Act of
1995:
Proposed Project: Maternal and Child Health Services Title V Block
Grant Program Guidance and Forms for the Title V Application/Annual
Report (OMB No. 0915-0172): Revision
The Health Resources and Services Administration (HRSA) proposes to
revise the Maternal and Child Health Services Title V Block Grant
Program--Guidance and Forms for the Application/Annual Report. The
guidance is used annually by the 50 States and 9 jurisdictions to apply
for Block Grants under Title V of the Social Security Act, and in
preparing the required annual report. The proposed revisions follow and
build on extensive consultation received from a workgroup convened to
provide suggestions to improve the guidance and forms.
The changes in this edition of the Maternal and Child Health
Services Title V Block Grant Program Guidance and Forms for the Title V
Application/Annual Report are primarily revisions to Section II--Needs
Assessment. The purpose of these revisions is: (1) To provide more
complete information on the Background and Conceptual Framework for the
Needs Assessment Process (Part A); (2) to clarify what State grantees
are to include in the Five Year Needs Assessment Document (Part B); (3)
to better explain the information to include in the Annual Needs
Assessment Summary/Update, both in the year when the five year Needs
Assessment is conducted and in interim years (Part C); and (4) to
update Figure 2, the Needs Assessment diagram, to reflect all aspects
of the Needs Assessment process. In addition, other minor changes and
clarifications are included throughout the document to make the
instructions clearer for the respondent. Such changes include the
clarification of headings and the types of information that States may
want to include in a particular section.
The estimated average annual burden is as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Reporting document Number of Responses per Total Burden per burden Cost per Total hour
respondents respondent responses response hours hour cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application and Report without Needs Assessment 59 1 59 270 15,930 $30 $477,900
(2009 & 2011)...................................
Application with Needs Assessment (2010)......... 59 1 59 378.5 22,332 30 669,960
------------------------------------------------------------------------------------------------------
Total Average Annual Burden.................. 59 .............. 59 306 18,064 30 541,920
--------------------------------------------------------------------------------------------------------------------------------------------------------
The total estimate of annual burden is the average for the next three year period of Application submissions in which a Needs Assessment will be
required once. The Application submissions (with and without the Needs Assessment) are based on the calendar year.
[[Page 73337]]
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to
the desk officer for HRSA, either by e-mail to OIRA
submission@omb.eop.gov or by fax to 202-395-6974. Please direct all
correspondence to the ``attention of the desk officer for HRSA.''
Dated: November 24, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E8-28541 Filed 12-1-08; 8:45 am]
BILLING CODE 4165-15-P
