Agency Information Collection Activities: Proposed Collection: Comment Request, 10373-10374 [2011-4162]

Download as PDF 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 17:21 Feb 23, 2011 Jkt 223001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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 24FEN1

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