Federal Register / Vol. 72, No. 86 / Friday, May 4, 2007 / Notices 25319 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: The Medicare 

and Medicaid Programs: Programs of 

All-inclusive Care for the Elderly 

(PACE); Form Number: CMS–R–244 

(OMB#: 0938–0790); Use: PACE 

organizations must demonstrate their 

ability to provide quality communitybased care for the frail elderly who meet 

their State’s nursing home eligibility 

standards using capitated payments 

from Medicare and the State. PACE 

programs must provide all Medicare and 

Medicaid covered services including 

hospital, nursing home, home health, 

and other specialized services. This 

collection is necessary to ensure that 

only appropriate organizations are 

selected to become PACE organizations 

and that CMS has the information 

necessary to monitor the care they 

provide; Frequency: Reporting—Once 

and On occasion; Affected Public: Notfor-profit institutions and State, Local, 

or Tribal Governments; Number of 

Respondents: 54; Total Annual 

Responses: 108; Total Annual Hours: 

44131.50. 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Application for 

Hospital Insurance Benefits; Form 

Number: CMS–18F5 (OMB#: 0938– 

0251); Use: The CMS–18F5 form is used 

to establish entitlement to and 

enrollment in Part A of Medicare for 

beneficiaries who are not automatically 

entitled to Medicare Part A under Title 

XVIII of the Social Security Act and 

must file an application. Sections 

226(a), 227 and 1818A of the Social 

Security Act and sections 42 CFR 

406.10, 406.11 and 406.20 outline the 

requirements for entitlement to 

Medicare hospital insurance (Part A). 

Section 42 CFR 406.6 provides 

information about who needs to file an 

application for Part A and who does not. 

Section 42 CFR 406.7 lists the CMS– 

18F5 form as the application to be used 

by individuals applying for Part A of 

Medicare. The CMS–18F5 form was 

designed to capture all the information 

needed to make a determination of an 

individual’s entitlement to hospital 

insurance (Part A); Frequency: 

Reporting—Once; Affected Public: 

Individuals or households; Number of 

Respondents: 50,000; Total Annual 

Responses: 50,000; Total Annual Hours: 

12,495. 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Hospice Request 

for Certification in the Medicare 

Program; Form Number: CMS–417 

(OMB#: 0938–0313); Use: The Hospice 

Request for Certification Form is the 

identification and screening form used 

to initiate the certification process and 

to determine if the provider has 

sufficient personnel to participate in the 

Medicare program; Frequency: 

Reporting—Yearly; Affected Public: 

Private Sector: Business or other forprofits; Number of Respondents: 2,286; 

Total Annual Responses: 2,286; Total 

Annual Hours: 572. 

4. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Psychiatric 

Hospital Survey Data and Supporting 

Regulations at 42 CFR 482.60, 482.61, 

and 482.62; Form Number: CMS–724 

(OMB#: 0938–0378); Use: The 

Medicare/Medicaid Psychiatric Hospital 

Survey is used to collect data that is not 

collected elsewhere and assists CMS in 

program planning and evaluation of 

survey needs. In addition, the survey 

assists CMS in maintaining an accurate 

data base on providers participating in 

the Medicare psychiatric hospital 

program; Frequency: Reporting—Yearly; 

Affected Public: Private Sector: Business 

or other for-profits; Number of 

Respondents: 420; Total Annual 

Responses: 200; Total Annual Hours: 

100. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received at the address below, no 

later than 5 p.m. on July 3, 2007. 

CMS, Office of Strategic Operations 

and Regulatory Affairs, Division of 

Regulations Development—C, Attention: 

Bonnie L Harkless, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: April 27, 2007. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E7–8423 Filed 5–3–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS-R–245] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Revision of the currently 

approved collection; Title of 

Information Collection: Medicare and 

Medicaid Programs OASIS Collection 

Requirements as Part of the Conditions 

of Participation for Home Health 

Agencies and Supporting Regulations in 

42 CFR 484.55, 484.205, 484.245, 

484.250; Form No.: CMS–R–245 (OMB# 

0938–0760) Use: The Outcome and 

Assessment Information Set (OASIS) is 

a requirement for one of the Conditions 

of Participation (CoPs) that Home 

Health Agencies (HHAs) must meet in 


cprice-sewell on DSK89S0YB1PROD with NOTICES
25320 Federal Register / Vol. 72, No. 86 / Friday, May 4, 2007 / Notices 

order to participate in the Medicare 

program. Specifically, the CoP at 

§ 484.55 requires that each patient 

receive from an HHA a patient-specific, 

comprehensive assessment that 

identifies a patient’s continuing need for 

home care and meets the patient’s 

medical, nursing, rehabilitative, social 

and discharge planning needs. In 

addition, the regulation requires that as 

part of the comprehensive assessment, 

HHAs use a standard core assessment 

data set, the OASIS, to evaluate, nonmaternity patients. The data collected 

using OASIS is used for three main 

purposes: assessing and improving the 

quality of care provided by an HHA, 

submitting and paying claims for 

Medicare home health services, and 

surveying the HHAs in accordance with 

Section 1891 of the Social Security Act 

(the Act). 

We have made several modifications 

to this information collection without 

increasing the burden. The 

modifications include but are not 

limited to the following items. In order 

for the OASIS to have the information 

necessary to allow the grouper to priceout the claim, we propose to make the 

following changes to the OASIS to 

capture whether an episode is an early 

or later episode. In addition, for the 

purposes of payment, we propose to 

make changes to the OASIS in order to 

enable agencies to report secondary case 

mix diagnosis codes. The proposed 

changes clarify how to appropriately fill 

out OASIS items M0230 and M0240, 

using ICD–9–CM sequencing 

requirements if multiple coding is 

indicated for any diagnosis. The 

proposed OASIS revisions also include 

incorporating previously revised 

instructions regarding diagnosis coding 

in items M0190, M0210, and M0230/ 

M0240/M0246 (previously M0245). The 

burden associated with these proposed 

changes includes possible training of 

staff, the time and effort associated with 

downloading a new form and replacing 

previously pre-printed versions of the 

OASIS, and utilizing updated vendor 

software. However, CMS will be 

removing or modifying existing 

questions in the OASIS data set to 

accommodate the requirements 

referenced above. Therefore, CMS 

believes the burden increase associated 

with these changes is negated by the 

removal or modification of several 

current data items. Frequency: 

Recordkeeping and Reporting—upon 

patient assessment; Affected Public: 

Business or other for-profit and Not-forprofit institutions; Number of 

Respondents: 8,277; Total Annual 

Responses: 10,105,827; Total Annual 

Hours: 11,977,601. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

Written comments and 

recommendations for the proposed 

information collections must be mailed 

or faxed within 30 days of this notice 

directly to the OMB desk officer: OMB 

Human Resources and Housing Branch, 

Attention: Carolyn Lovett, New 

Executive Office Building, Room 10235, 

Washington, DC 20503, Fax Number: 

(202) 395–6974. 

Dated: April 27, 2007. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E7–8424 Filed 5–3–07; 8:45 am] 

BILLING CODE 4120–01–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. 

Method for Predicting and Detecting 

Tumor Metastasis 

Description of Technology: Detecting 

cancer prior to metastasis greatly 

increases the efficacy of treatment and 

the chances of patient survival. 

Although numerous biomarkers have 

been reported to identify aggressive 

tumor types and predict prognosis, each 

biomarker is specific for a particular 

type of cancer, and no universal marker 

that can predict metastasis in a number 

of cancers have been identified. In 

addition, due to a lack of reliability, 

several markers are typically required to 

determine the prognosis and course of 

therapy. 

Available for licensing are 

carboxypeptidase E (CPE) inhibitor 

compositions and methods to progonose 

and treat cancer as well as methods to 

determine the stage of cancer. The 

inventors discovered that CPE 

expression levels increase according to 

the presence of cancer and metastasis 

wherein CPE is upregulated in tumors 

and CPE levels are further increased in 

metastatic cancer. This data has been 

demonstrated both in vitro and in vivo 

experiments and in liver, breast, 

prostate, colon, and head and neck 

cancers. Metastatic liver cells treated 

with CPE siRNA reversed the cells from 

being metastatic and arrested cells from 

further metastasis. Thus, CPE as a 

biomarker for predicting metastasis and 

its inhibitors have an enormous 

potential to increase patient survival. 

Applications: 

1. Method to prognose multiple types 

of cancer and determine likelihood of 

metastasis. 

2. Compositions that inhibit CPE such 

as siRNA. 

3. Method to prevent and treat cancer 

with CPE inhibitors. 

Market: 

1. 600,000 cancer related deaths in 

2006; 

2. Global cancer market is worth more 

than eight percent of total global 

pharmaceutical sales; 

3. Cancer industry is predicted to 

expand to $85.3 billion by 2010. 

Development Status: The technology 

is currently in the pre-clinical stage of 

development. 

Inventors: Y. Peng Loh (NICHD) et al. 

Publication: Manuscript in 

preparation. 

Patent Status: 

1. U.S. Provisional Application No. 

60/885,809 filed 19 Jan 2007 (HHS 

Reference No. E–096–2007/0–US–01) 

2. U.S. Provisional Application No. 

60/887,061 filed 29 Jan 2007 (HHS 

Reference No. E–096–2007/1–US–01) 


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