Agency Information Collection Activities: Proposed Collection: Comment Request, 10373-10374 [2011-4162]
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10373
Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Notices
samples) and an average of 0.25 hour
per response is required for
recordkeeping.
FDA’s Web-based color certification
information system allows certifiers to
request color certification online, follow
their submissions through the process,
and obtain information on account
status. The system sends back the
certification results electronically,
allowing certifiers to sell their certified
color before receiving hard copy
certificates. Any delays in the system
result only from shipment of color
additive samples to FDA’s Office of
Cosmetics and Colors for analysis. FDA
has estimated a reduction in the hour
burden for reporting from use of the
Web-based system.
Dated: February 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–4155 Filed 2–23–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
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 at (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.
Proposed Project: Patient Navigator
Outreach and Chronic Disease
Prevention Demonstration Program
(OMB No. 0915–NEW)—[NEW]
The Patient Navigator Outreach and
Chronic Disease Prevention
Number of
respondents
Form
Responses
per
respondent
Demonstration Program (PNDP)
authorizes funds for the development
and operation of projects to provide
patient navigator services to improve
health outcomes for individuals with
cancer and other chronic diseases, with
a specific emphasis on health disparities
populations. Award recipients are to use
grant funds to recruit, assign, train, and
employ patient navigators who have
direct knowledge of the communities
they serve to facilitate the care of those
who are at risk for or who have cancer
or other chronic diseases, including
conducting outreach to health
disparities populations.
As authorized by the statute, an
evaluation of the outcomes of the
program must be submitted to Congress.
The purpose of these data collection
instruments, including navigated
patient data intake, VR–12 health status,
patient navigator survey, patient
navigator encounter/tracking log,
patient medical record and clinic data,
clinic rates (baseline measures), and
quarterly reports is to provide data to
inform and support the Report to
Congress for: the quantitative analysis of
baseline and benchmark measures;
aggregate information about the patients
served and program activities, and;
recommendations on whether patient
navigator programs could be used to
improve patient outcomes in other
public health areas.
Total
responses
Hours per
response
Total burden
hours
Navigated Patient Data Intake Form .......................................
VR–12 Health Status Form ......................................................
6,327
6,327
1
2
6,327
12,654
0.5
.12
3,163.5
1,519
SubTotal—Patient Burden ................................................
6,327
3
18,981
.62
4,682.5
The annual estimate of burden is as follows:
46
46
1
825.3
46
37,962
0.2
0.2
9.2
7,592.4
SubTotal—Patient Navigator Burden .......................................
Patient Medical Record and Clinic Data ..................................
Clinic Rates (Baseline Measures) ...........................................
Quarterly Report ......................................................................
46
10
10
10
826.3
632.7
1
4
38,008
6,327
10
40
0.4
.17
10
1
7,601.6
2,151.2
100
40
SubTotal—Grantee Burden ..............................................
30
637.7
6,377
11.17
2,291.2
Totals ................................................................................
6,403
......................
63,366
......................
14,575.3
Total Average Annual Burden ...................................
emcdonald on DSK2BSOYB1PROD with NOTICES
Patient Navigator Survey .........................................................
Patient Navigator Encounter/Tracking Log ..............................
........................
......................
........................
......................
14,575.3
Anticipated Number of Patients per
Site:
Over 3 years
Over 3 years
Clinica Sierra Vista ...............
VerDate Mar<15>2010
17:21 Feb 23, 2011
2,280
Jkt 223001
CMAP ...................................
New River .............................
Project Concern ....................
Queens Medical Center ........
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
1,000
7,200
450
500
Over 3 years
South County ........................
Texas Tech ...........................
University of Utah .................
Vista ......................................
E:\FR\FM\24FEN1.SGM
24FEN1
600
200
1,350
3,000
10374
Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Notices
by medical professionals for medical
imaging.
William F. Ryan .............
2,400
Thanks to its swiftly improved
display quality, the smartphone has
Total ...............................
18,980 been advocated by the medical imaging
vendors for viewing medical images in
E-mail comments to
specific conditions that require urgency
paperwork@hrsa.gov or mail the HRSA
of the read or when full-size workstation
Reports Clearance Officer, Room 10–33, displays are not readily available.
Parklawn Building, 5600 Fishers Lane,
However, as a hand-held device, the
Rockville, MD 20857. Written comments viewing conditions of a smartphone (e.g.
should be received within 60 days of
ambient light and hand shaking) are not
this notice.
predictable and may adversely affect the
perceived image quality. The present
Dated: February 17, 2011.
invention proposes the use of the builtReva Harris,
in sensors in iPhone-like mobile devices
Acting Director, Division of Policy and
to detect and adapt to the viewing
Information Coordination.
conditions and hand shaking. The built[FR Doc. 2011–4162 Filed 2–23–11; 8:45 am]
in camera can be used to capture the
BILLING CODE 4165–15–P
ambient light for determining the
adaptation level, which affects the
brightness, contrast and color
DEPARTMENT OF HEALTH AND
perception. The built-in accelerometers
HUMAN SERVICES
can be used to detect orientation and
moving velocity of the display, which
National Institutes of Health
affect the perceived spatial resolution.
Government-Owned Inventions;
The execution of critical tasks can be
Availability for Licensing
then censored based on the detected
scenario. If the viewing conditions are
AGENCY: National Institutes of Health,
not suitable for reading medical images,
Public Health Service, HHS.
for example, then the program could
ACTION: Notice.
halt until the viewing conditions
improve.
SUMMARY: The inventions listed below
This invention can be used by
are owned by an agency of the U.S.
consumer-grade mobile devices which
Government and are available for
were not originally designed for medical
licensing in the U.S. in accordance with purposes to show medical images with
35 U.S.C. 207 to achieve expeditious
improved perceived image quality.
commercialization of results of
Applications
Federally-funded research and
development. Foreign patent
• Biomedical imaging.
applications are filed on selected
• Radiology.
inventions to extend market coverage
Advantages: Improved image quality
for companies and may also be available of mobile devices that minimizes issues
for licensing.
related to inadequate light conditions or
hand movement.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
Development Status
listed below may be obtained by writing
• Algorithm developed.
to the indicated licensing contact at the
• Prototype is being built.
Office of Technology Transfer, National
Inventors: Wei-Chung Cheng and
Institutes of Health, 6011 Executive
Aldo G. Badano (FDA).
Boulevard, Suite 325, Rockville,
Patent Status: HHS Reference No. E–
Maryland 20852–3804; telephone: 301/
284–2010/0—Research Tool/Software.
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will Patent protection is not being pursued
for this technology.
be required to receive copies of the
Licensing Status: Available for
patent applications.
licensing.
LightCensor: A Detecting and Control
Licensing Contacts
Program That Guarantees That a
• Uri Reichman, PhD, MBA; 301–
Mobile Device Be Used Only in
Appropriate Lighting Conditions When 435–4616; UR7a@nih.gov.
• Michael Shmilovich, Esq.; 301–
Displaying Medical Images
435–5019; ShmilovichM@mail.nih.gov.
Description of Invention: The
invention provides algorithm that when A Novel MRI Phantom for Breast
Imaging
used in a mobile device (e.g.
smartphone) can enhance the
Description of Invention: The
capabilities of mobile devices to be used invention offered for licensing is in the
emcdonald on DSK2BSOYB1PROD with NOTICES
Over 3 years
VerDate Mar<15>2010
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field of breast cancer imaging. More
specifically it relates to novel breast
phantoms that can be used as reference
in breast imaging. The anthropomorphic
breast phantoms described in the
invention comprise a combination of
adipose tissue mimicking components
and fibroglandular tissue mimicking
components. Typically, x-ray
attenuation coefficients or magnetic
resonance relaxation times T1 and T2
are selected that are sufficiently similar
to actual patient tissues. The mimicking
components are distributed within the
phantom such that images of the
phantom contain features similar to
those of patient tissues. A breast
phantom can be based on a lard/egg
white combination that is shaped to
approximate a human breast, or a
compressed human breast as prepared
for mammography. The phantoms can
include lesion chambers that permit the
introduction of contrast agents to
simulate benign or malignant lesions,
and contrast agent concentration can be
time varied to produce washout curves.
Applications: Imaging of breast cancer
as well as calibration and optimization
of related instrumentation.
Advantages: The breast phantoms of
the invention precisely mimics human
breast in several of their characteristics
as mentioned above. Furthermore, they
can be utilized in conjunction with xray mammography and/or with MRI.
The phantoms may therefore be used to
enhance the accuracy and quality of
diagnostic breast imaging, and thus
avoid unnecessary procedures. In
addition, wide-spread use of the breast
phantoms will lead to improved
standardization in the field of breast
imaging.
Development Status: The methods of
making the phantoms have been
established. Clinical usefulness has to
be established.
Inventors: Melanie Freed and Aldo
Badano (FDA).
Patent Status
• U.S. Provisional Application No.
61/385,929 filed 23 Sep 2010 (HHS
Reference No. E–126–2010/0–US–01),
entitled ‘‘Evaluation of Breast Dynamic
Contrast-enhanced Magnetic Resonance
Imaging’’.
• U.S. Provisional Application No.
61/424,495 filed 17 Dec 2010 (HHS
Reference No. E–126–2010/1–US–01),
entitled ‘‘Anthropomorphic, X-ray and
Dynamic Contrast-Enhanced Magnetic
Resonance Imaging Phantom for
Quantitative Evaluation of Breast
Imaging Techniques’’.
Licensing Status: Available for
licensing.
E:\FR\FM\24FEN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 37 (Thursday, February 24, 2011)]
[Notices]
[Pages 10373-10374]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4162]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
In compliance with the requirement for opportunity for public
comment on 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 at (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.
Proposed Project: Patient Navigator Outreach and Chronic Disease
Prevention Demonstration Program (OMB No. 0915-NEW)--[NEW]
The Patient Navigator Outreach and Chronic Disease Prevention
Demonstration Program (PNDP) authorizes funds for the development and
operation of projects to provide patient navigator services to improve
health outcomes for individuals with cancer and other chronic diseases,
with a specific emphasis on health disparities populations. Award
recipients are to use grant funds to recruit, assign, train, and employ
patient navigators who have direct knowledge of the communities they
serve to facilitate the care of those who are at risk for or who have
cancer or other chronic diseases, including conducting outreach to
health disparities populations.
As authorized by the statute, an evaluation of the outcomes of the
program must be submitted to Congress. The purpose of these data
collection instruments, including navigated patient data intake, VR-12
health status, patient navigator survey, patient navigator encounter/
tracking log, patient medical record and clinic data, clinic rates
(baseline measures), and quarterly reports is to provide data to inform
and support the Report to Congress for: the quantitative analysis of
baseline and benchmark measures; aggregate information about the
patients served and program activities, and; recommendations on whether
patient navigator programs could be used to improve patient outcomes in
other public health areas.
----------------------------------------------------------------------------------------------------------------
Responses
Form Number of per Total Hours per Total burden
respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Navigated Patient Data Intake Form.. 6,327 1 6,327 0.5 3,163.5
VR-12 Health Status Form............ 6,327 2 12,654 .12 1,519
---------------------------------------------------------------------------
SubTotal--Patient Burden........ 6,327 3 18,981 .62 4,682.5
----------------------------------------------------------------------------------------------------------------
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Patient Navigator Survey............ 46 1 46 0.2 9.2
Patient Navigator Encounter/Tracking 46 825.3 37,962 0.2 7,592.4
Log................................
---------------------------------------------------------------------------
SubTotal--Patient Navigator Burden.. 46 826.3 38,008 0.4 7,601.6
Patient Medical Record and Clinic 10 632.7 6,327 .17 2,151.2
Data...............................
Clinic Rates (Baseline Measures).... 10 1 10 10 100
Quarterly Report.................... 10 4 40 1 40
---------------------------------------------------------------------------
SubTotal--Grantee Burden........ 30 637.7 6,377 11.17 2,291.2
---------------------------------------------------------------------------
Totals.......................... 6,403 ............ 63,366 ............ 14,575.3
===========================================================================
Total Average Annual Burden. .............. ............ .............. ............ 14,575.3
----------------------------------------------------------------------------------------------------------------
Anticipated Number of Patients per Site:
------------------------------------------------------------------------
Over 3 years
------------------------------------------------------------------------
Clinica Sierra Vista.................................... 2,280
CMAP.................................................... 1,000
New River............................................... 7,200
Project Concern......................................... 450
Queens Medical Center................................... 500
South County............................................ 600
Texas Tech.............................................. 200
University of Utah...................................... 1,350
Vista................................................... 3,000
[[Page 10374]]
William F. Ryan..................................... 2,400
---------------
Total.............................................. 18,980
------------------------------------------------------------------------
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 17, 2011.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2011-4162 Filed 2-23-11; 8:45 am]
BILLING CODE 4165-15-P
