Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Notices 10373 

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 

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. 

Form Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

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 Log .............................. 46 825 .3 37,962 0 .2 7,592.4 

SubTotal—Patient Navigator Burden ....................................... 46 826 .3 38,008 0 .4 7,601.6 

Patient Medical Record and Clinic Data .................................. 10 632 .7 6,327 .17 2,151.2 

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 

Over 3 years 

CMAP ................................... 1,000 

New River ............................. 7,200 

Project Concern .................... 450 

Queens Medical Center ........ 500 

Over 3 years 

South County ........................ 600 

Texas Tech ........................... 200 

University of Utah ................. 1,350 

Vista ...................................... 3,000 


emcdonald on DSK2BSOYB1PROD with NOTICES
10374 Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Notices 

Over 3 years 

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 

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. 

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. 

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. 

LightCensor: A Detecting and Control 

Program That Guarantees That a 

Mobile Device Be Used Only in 

Appropriate Lighting Conditions When 

Displaying Medical Images 

Description of Invention: The 

invention provides algorithm that when 

used in a mobile device (e.g. 

smartphone) can enhance the 

capabilities of mobile devices to be used 

by medical professionals for medical 

imaging. 

Thanks to its swiftly improved 

display quality, the smartphone has 

been advocated by the medical imaging 

vendors for viewing medical images in 

specific conditions that require urgency 

of the read or when full-size workstation 

displays are not readily available. 

However, as a hand-held device, the 

viewing conditions of a smartphone (e.g. 

ambient light and hand shaking) are not 

predictable and may adversely affect the 

perceived image quality. The present 

invention proposes the use of the builtin sensors in iPhone-like mobile devices 

to detect and adapt to the viewing 

conditions and hand shaking. The builtin camera can be used to capture the 

ambient light for determining the 

adaptation level, which affects the 

brightness, contrast and color 

perception. The built-in accelerometers 

can be used to detect orientation and 

moving velocity of the display, which 

affect the perceived spatial resolution. 

The execution of critical tasks can be 

then censored based on the detected 

scenario. If the viewing conditions are 

not suitable for reading medical images, 

for example, then the program could 

halt until the viewing conditions 

improve. 

This invention can be used by 

consumer-grade mobile devices which 

were not originally designed for medical 

purposes to show medical images with 

improved perceived image quality. 

Applications 

• Biomedical imaging. 

• Radiology. 

Advantages: Improved image quality 

of mobile devices that minimizes issues 

related to inadequate light conditions or 

hand movement. 

Development Status 

• Algorithm developed. 

• Prototype is being built. 

Inventors: Wei-Chung Cheng and 

Aldo G. Badano (FDA). 

Patent Status: HHS Reference No. E– 

284–2010/0—Research Tool/Software. 

Patent protection is not being pursued 

for this technology. 

Licensing Status: Available for 

licensing. 

Licensing Contacts 

• Uri Reichman, PhD, MBA; 301– 

435–4616; UR7a@nih.gov. 

• Michael Shmilovich, Esq.; 301– 

435–5019; ShmilovichM@mail.nih.gov. 

A Novel MRI Phantom for Breast 

Imaging 

Description of Invention: The 

invention offered for licensing is in the 

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. 


emcdonald on DSK2BSOYB1PROD with NOTICES