Agency Information Collection Activities: Submission for OMB Review; Comment Request, 9251-9252 [E9-4460]
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9251
Federal Register / Vol. 74, No. 40 / Tuesday, March 3, 2009 / Notices
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information related to the content and
format of labeling have been approved
under OMB control no. 0910–0572; the
collections of information related to
pharmacogenomic data have been
approved under OMB control no. 0910–
0557.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/cder/guidance/index.htm,
https://www.fda.gov/cber/
guidelines.htm, or https://
www.regulations.gov.
Dated: February 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–4372 Filed 3–2–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer on (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
In compliance with the requirement
for opportunity for public comment on
Number of
respondents
Form
Responses
per
respondent
Proposed Project: HRSA Office of
Performance Review (OPR) Leading
Practices Data Collection Initiative—
NEW
HRSA conducts performance reviews
to assure that HRSA-funded grantees are
successfully accomplishing their
program purposes. While the Office of
Performance Review’s (OPR) primary
function is to conduct performance
reviews, another core function is to
identify leading practices through the
performance review process. The
purpose of this submission is to collect
qualitative information from diverse
grantees across HRSA and identify a
program component (activity, strategy,
process, or intervention) that has been
shown to work effectively, and produce
successful outcomes, supported by
objective and/or subjective data sources.
Some characteristics of the program
components that grantees will be asked
to describe are their ability to be
replicable and adaptable, ability to be
documented, and ability to lead to
successful program outcomes.
In order to document and evaluate
leading practices, grantees with
potential leading practices will be asked
to complete both the Data Collection
Tool and the Narrative. The information
collected through these documents will
be submitted to OPR. The estimated
annual burden is as follows:
Total
responses
Hours per
response
Total burden
hours
Data Collection Tool ............................................................
Narrative ...............................................................................
40
40
1
1
40
40
3
3
120
120
Total ..............................................................................
........................
........................
........................
........................
240
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: February 24, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E9–4459 Filed 3–2–09; 8:45 am]
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BILLING CODE 4165–15–P
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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
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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: Health Centers
Patient Survey—New.
The Health Center program supports
Community Health Centers (CHCs),
Migrant Health Centers (MHCs), Health
Care for the Homeless (HCH) projects,
and Public Housing Primary Care
(PHPC) programs. Health Centers
receive grants from HRSA to provide
primary and preventive health care
services to medically underserved
populations.
The proposed Patient Survey will
collect in-depth information about
health center patients, their health
E:\FR\FM\03MRN1.SGM
03MRN1
9252
Federal Register / Vol. 74, No. 40 / Tuesday, March 3, 2009 / Notices
status, the reasons they seek care at
health centers, their diagnoses, the
services they utilize at health centers
and elsewhere, the quality of those
services, and their satisfaction with the
care they receive, through personal
interviews of a stratified random sample
of health center patients. Interviews are
planned to take approximately 1 hour
and six minutes each.
The Patient Survey builds on previous
periodic User-Visit Surveys which were
conducted to learn about the process
and outcomes of care in CHCs and HCH
projects. The original survey questions
were derived from the National Health
Interview Survey (NHIS) and the
National Hospital Ambulatory Medical
Care Survey (NHAMCS) conducted by
the National Center for Health Statistics
(NCHS). Conformance with the NHIS
and NHAMCS allowed comparisons
between these NCHS surveys and the
previous CHC and HCH User-Visit
Surveys. The new Patient Survey was
developed using a questionnaire
methodology similar to that used in the
past, and will also allow some
longitudinal comparisons for CHCs and
HCH projects with the previous UserVisit survey data, including monitoring
of process outcomes over time. In
addition, this survey will include
interviews of patients drawn from
migrant populations and from residents
of public housing; these populations
were not included in the previous
surveys.
The annual estimate of burden is as
follows:
The estimated response burden for the
survey is as follows:
SURVEY
Number of
respondents
Responses
per
respondent
Grantee/Site Recruitment and Site Training ..........................................
Patient Recruitment ...............................................................................
Patient Survey .......................................................................................
115
5,658
4,526
3
1
1
345
5,658
4,526
3.75
.167
1.1
1,294
945
4,979
Total ................................................................................................
5,773
....................
10,529
......................
7,218
Type of respondent; activity involved
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: February 24, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E9–4460 Filed 3–2–09; 8:45 am]
Prevention of Head and Neck Cancer
Using Rapamycin and Its Analogs
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY: National Institutes of Health,
Public Health Service, HHS.
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ACTION:
Notice.
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.
VerDate Nov<24>2008
16:42 Mar 02, 2009
Jkt 217001
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.
ADDRESSES:
Description of Technology: It is
frequently observed in head and neck
squamous cell carcinoma (HNSCC), a
cancer occurring mostly in the mouth,
that the Akt/mTOR pathway is
abnormally activated. Therefore,
inhibiting this signaling pathway may
help in treating this disease. Rapamycin
and its analogs are known to inhibit the
activity of mTOR so in principle they
could serve as therapeutics for treating
HNSCC.
Researchers at the NIH have
developed a method of potentially
preventing or treating HNSCC through
the inhibition of mTOR activity. The
proof of this principle was
demonstrated by rapid regression of
mouth tumors in mice afflicted with
Cowden syndrome with the
administration of rapamycin. Like
HNSCC, development of this disease is
linked to over activation of the Akt/
mTOR pathway. Furthermore, the
therapeutic potential of rapamycin was
demonstrated using mice in
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Total
number of
responses
Burden per
response
(hours)
Total hour
burden
experiments that model chronic
exposure to tobacco, which promotes
the development of HNSCC. Therefore,
inhibitors of mTOR have considerable
potential in the prevention and
treatment of HNSCC.
Applications: Preventing the
development of oral cancer using mTOR
inhibitors to halt progression of precancerous lesions.
Market: Approximately 500,000 new
cases of squamous cell carcinomas of
the head and neck arise every year
making it the 6th most common cancer
in the world.
Frequently, prognosis is poor due to
late detection of cancer.
Development Status: Pre-clinical
proof of principle.
Inventors: J. Silvio Gutkind et al.
(NIDCR).
Publications: 1. CH Squarize, RM
Castilho, JS Gutkind. Chemoprevention
and treatment of experimental Cowden’s
disease by mTOR inhibition with
rapamycin. Cancer Res. 2008 Sep
1;68(17):7066–7072.
2. R Czerninski, P Amornphimoltham,
V Patel, AA Molinolo, JS Gutkind.
Targeting mTOR by rapamycin prevents
tumor progression in an oral-specific
chemical carcinogenesis model. Cancer
Prevention Res. 2009 Jan;2(1):27–36.
Patent Status: U.S. Patent Application
No. 61/090/414 filed 20 Aug 2008 (HHS
Reference No. E–302–2008/0-US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Whitney Hastings;
301–451–7337; hastingw@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Dental and
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03MRN1
]]>Agencies
[Federal Register Volume 74, Number 40 (Tuesday, March 3, 2009)]
[Notices]
[Pages 9251-9252]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4460]
-----------------------------------------------------------------------
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: Health Centers Patient Survey--New.
The Health Center program supports Community Health Centers (CHCs),
Migrant Health Centers (MHCs), Health Care for the Homeless (HCH)
projects, and Public Housing Primary Care (PHPC) programs. Health
Centers receive grants from HRSA to provide primary and preventive
health care services to medically underserved populations.
The proposed Patient Survey will collect in-depth information about
health center patients, their health
[[Page 9252]]
status, the reasons they seek care at health centers, their diagnoses,
the services they utilize at health centers and elsewhere, the quality
of those services, and their satisfaction with the care they receive,
through personal interviews of a stratified random sample of health
center patients. Interviews are planned to take approximately 1 hour
and six minutes each.
The Patient Survey builds on previous periodic User-Visit Surveys
which were conducted to learn about the process and outcomes of care in
CHCs and HCH projects. The original survey questions were derived from
the National Health Interview Survey (NHIS) and the National Hospital
Ambulatory Medical Care Survey (NHAMCS) conducted by the National
Center for Health Statistics (NCHS). Conformance with the NHIS and
NHAMCS allowed comparisons between these NCHS surveys and the previous
CHC and HCH User-Visit Surveys. The new Patient Survey was developed
using a questionnaire methodology similar to that used in the past, and
will also allow some longitudinal comparisons for CHCs and HCH projects
with the previous User-Visit survey data, including monitoring of
process outcomes over time. In addition, this survey will include
interviews of patients drawn from migrant populations and from
residents of public housing; these populations were not included in the
previous surveys.
The annual estimate of burden is as follows:
The estimated response burden for the survey is as follows:
Survey
----------------------------------------------------------------------------------------------------------------
Responses Total Burden per
Type of respondent; activity involved Number of per number of response Total hour
respondents respondent responses (hours) burden
----------------------------------------------------------------------------------------------------------------
Grantee/Site Recruitment and Site Training.... 115 3 345 3.75 1,294
Patient Recruitment........................... 5,658 1 5,658 .167 945
Patient Survey................................ 4,526 1 4,526 1.1 4,979
-----------------------------------------------------------------
Total..................................... 5,773 ........... 10,529 ............ 7,218
----------------------------------------------------------------------------------------------------------------
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: February 24, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E9-4460 Filed 3-2-09; 8:45 am]
BILLING CODE 4165-15-P
