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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Federal Register / Vol. 72, No. 86 / Friday, May 4, 2007 / Notices 25321 

3. U.S. Provisional Application No. 

60/895,912 filed 20 Mar 2007 (HHS 

Reference No. E–096–2007/2–US–01) 

Licensing Status: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: Jennifer Wong; 

301/435–4633; wongje@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute for Child Health 

and Human Development, Section on 

Cellular Neurobiology, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize CPE as a biomarker for 

predicting metastasis. Please contact 

John D. Hewes, Ph.D. at 301–435–3121 

or hewesj@mail.nih.gov for more 

information. 

Novel Diagnostics and Therapeutics for 

Various Hematologic Malignancies: 

Monoclonal Antibodies to Members of 

Fc receptor-like (FCRL) Proteins 

Description of Technology: Fc 

receptor-like (FCRL) is a gene family 

homologous to Fc receptors (alternative 

names, FcRH, IRTA, IFGP, SPAP). 

FCRL1–6 genes are located on human 

chromosome 1, where translocations 

and other abnormalities are frequently 

observed in certain B-cell lymphoma 

and multiple myeloma. Previous studies 

suggests that the FCRL proteins are 

differently expressed on various 

malignant cells from B-linage cells as 

well as normal B cells in different stage 

of the differentiation in adaptive 

immunity. Although the natural ligands 

are not known, FCRL proteins likely 

play roles in regulation of immunity. 

The members of the immunoglobulin 

superfamily receptor translocation 

associated (IRTA) genes 1–6 encode 

proteins homologous to Fc receptors. 

Previous studies suggest that each IRTA 

may play a different role in B-cell 

differentiation and immune responses. 

FCRL1–6 proteins possess 3–9 

extracellular immunoglobulin (Ig) 

domains, each of which exhibits a 

substantial homology to the same 

subtypes of Ig domains (up to 86% 

identity). Consequently there are some 

epitopes shared by FCRL1–6 

extracellular domains evidenced by the 

presence of many cross-reactive 

monoclonal antibodies (MAbs) with 

FCRL1–6. The invention relates to the 

development of novel MAbs specific to 

each members of the FCRL proteins, 

which show no cross-reactivity with 

other FCRL members. These antibodies 

could be used for studies on detailed 

expression studies of FCRLs in different 

cancer cells and on potential 

therapeutic use for FCRL-expressing 

hematological malignancies. 

Applications and Modality: 

1. Novel monoclonal antibodies to 

FCRL family members can help 

diagnose and treat B cell malignancies 

and RA. 

2. The antibodies can be used as 

research tools to detect cellular 

expression of FCRLs. 

Advantage: Monoclonal antibody 

clones are available that are specific to 

one member of the FCRL family with no 

cross-reactivity to other members. 

Development Status: The technology 

is in pre-clinical stage of development. 

Inventors: Ira Pastan (NCI) et al. 

Publications: 

1. A manuscript directly related to 

this technology will be available as soon 

as it is accepted for publication. 

2. T Ise, H Maeda, K Santora, L Xiang, 

RJ Kreitman, I Pastan, S Nagata. 

Immunoglobulin superfamily receptor 

translocation associated 2 protein on 

lymphoma cell lines and hairy cell 

leukemia cells detected by novel 

monoclonal antibodies. Clin Cancer Res. 

2005 Jan 1;11(1):87–96. 

3. T Ise, RJ Kreitman, I Pastan, S 

Nagata. Sandwich ELISAs for soluble 

immunoglobulin superfamily receptor 

translocation-associated 2 (IRTA2)/ 

FcRH5 (CD307) proteins in human sera. 

Clin Chem Lab Med. 2006;44(5):594– 

602. 

4. T Ise, S Nagata, RJ Kreitman, WH 

Wilson, AS Wayne, M StetlerStevenson, MR Bishop, DA Scheinberg, 

L Rassenti, TJ Kipps, RA Kyle, DF 

Jelinek, I Pastan. Elevation of soluble 

CD307 (IRTA2/FcRH5) protein in the 

blood and expression on malignant cells 

of patients with multiple myeloma, 

chronic lymphocytic leukemia, and 

mantle cell lymphoma. Leukemia. 2007 

Jan;21(1):169–174. Epub 2006 Oct 19. 

Patent Status: 

1. U.S. Provisional Application No. 

60/891,434, filed 23 Feb 2007, entitled 

‘‘Antibodies That Specifically Bind 

IRTA and Methods of Use’’ (HHS 

Reference No. E–016–2006/0–US–01) 

2. PCT Application No. PCT/US2005/ 

034444 filed 22 Sep 2005, entitled 

‘‘IRTA2 Antibodies and Methods of 

Use,’’ which published as WO 2006/ 

039238 on 25 Jan 2007 (HHS Reference 

No. E–287–2004/1–PCT–01) 

3. U.S. Patent Application filed 28 

Mar 2007 (HHS Reference No. E–287– 

2004/1–US–02) 

Licensing Status: Available for 

exclusive and non-exclusive licensing. 

Licensing Contact: Jesse S. Kindra, 

J.D.; 301–435–5559; 

kindraj@mail.nih.gov. 

High Speed Parallel Molecular Nucleic 

Acid Sequencing 

Description of Technology: Available 

for licensing and commercial 

development is a new system, methods 

and compositions for DNA sequencing, 

also known as Two Dye Sequencing 

(TDS). This invention is based on 

Fluorescence Resonance Energy 

Transfer (FRET), a technology 

increasingly in use for several molecular 

analysis purposes. In particular, the 

method consists of: 

(1) Attachment of engineered DNA 

polymerases labeled with a donor 

fluorophore to the surface (chamber) of 

a microscope field of view; 

(2) Addition to the chamber of DNA 

with an annealed oligonucleotide 

primer, which is bound by the 

polymerase; 

(3) Further addition of four nucleotide 

triphosphates, each labeled on the base 

with a different fluorescent acceptor 

dye; 

(4) Excitation of the donor 

fluorophore with light of a wavelength 

specific for the donor but not for any of 

the acceptors, resulting in the transfer of 

the energy associated with the excited 

state of the donor to the acceptor 

fluorophore for a given nucleotide, 

which is then radiated via FRET; 

(5) Identification of the nucleotides 

most recently added to the primer by 

recording the fluorescent spectrum of 

the individual dye molecules at specific 

locations in the microscope field, and 

(6) Converting the sequential 

spectrum into a DNA sequence for each 

DNA molecule in the microscope field 

of view. 

Application: Sequencing of single 

nucleic acid molecules on a substrate. 

Development Status: Early stage of 

development. 

Inventors: Thomas Schneider and 

Denise Rubens (NCI). 

Patent Status: U.S. Patent No. 

6,982,146 issued 03 Jan 2006 (HHS 

Reference No. E–033–1999/0–US–03); 

U.S. Patent Application No. 11/204,367 

filed 12 Aug 2005 (HHS Reference No. 

E–033–1999/0–US–04) 

Licensing Status: Available for coexclusive licensing. 

Licensing Contact: Cristina 

Thalhammer-Reyero, PhD, M.B.A.; 301/ 

435–4507; thalhamc@mail.nih.gov. 

Collaborative Research Opportunity: 

The NCI Nanobiology Program is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize 

nanoscale or molecular nucleic acid 

sequencing. Please contact John D. 

Hewes, PhD at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 


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25322 Federal Register / Vol. 72, No. 86 / Friday, May 4, 2007 / Notices 

Peptide Inhibitors of Fibronectin and 

Related Collagen-Binding Proteins 

Description of Technology: 

Fibronectin has been implicated in a 

variety of cell contact processes, 

including cell attachment and 

migration. Fibronectin interacts with 

collagen through its gelatin-binding 

domain and this interaction is 

fundamental to the organization of 

extracellular matrices and the behavior 

of these cells on substrates. Fibronectin 

is essential for the attachment and 

migration of many cells, including 

various tumor and cancer cells. 

The issued patents disclose peptide 

compositions having binding affinity for 

fibronectin, as well as methods for 

binding fibronectin with a fibronectinbinding peptide and methods for 

inhibiting fibronectin-mediated cell 

adhesion. The peptides disclosed are 

derived from the extracellular matrix 

protein thrombospondin, which is a 

modular adhesive glycoprotein that 

binds to the gelatin binding domain of 

fibronectin. These peptides are strong 

inhibitors of fibronectin-mediated cell 

adhesion. As such, they may be 

applicable to a variety of indications 

including cancer, wound healing, and 

connective tissue diseases. 

Applications: 

1. Potential therapeutic use for 

applications such as cancer, wound 

healing, and connective tissue disease. 

2. Research tools for study of cell 

adhesion and migration processes. 

Inventors: David D. Roberts et al. 

(NCI) 

Related Publications: 

1. JM Sipes, N Guo, E Ne`gre, T Vogel, 

HC Krutzsch, DD Roberts. Inhibition of 

fibronectin binding and fibronectinmediated cell adhesion to collagen by a 

peptide from the second type I repeat of 

thrombospondin. J Cell Biol. 1993 

Apr;121(2):469–477. 

2. S Schultz-Cherry, H Chen, DF 

Mosher, TM Misenheimer, HC Krutzsch, 

DD Roberts, JE Murphy-Ullrich. 

Regulation of TGFbeta activity by 

peptides from the type I repeats of 

thrombospondin-1. J Biol Chem. 1995 

Mar 31;270(13):7304–7310. 

3. C Daniel, J Wiede, Y Takabatake, M 

Mizui, Y Isaka, E Imai, H Rupprecht, E 

Schulze-Lohoff, HC Krutzsch, SMF 

Ribeiro, DD Roberts, JE Murphy-Ullrich, 

C Hugo. Thrombospondin-1 is a major 

activator of TGFbeta in fibrotic renal 

disease in the rat in vivo. Kidney Int. 

2004 Feb;65(2):459–468. 

Patent Status: 

1. U.S. Patent No. 5,491,130 issued 13 

Feb 1996 (HHS Reference No. E–219– 

1992/0–US–01). 

2. U.S. Patent No. 5,849,701 issued 15 

Dec 1998 (HHS Reference No. E–219– 

1992/0–US–10). 

3. Foreign counterparts issued in 

Australia, Great Britain, France, 

Germany, and Japan. 

Related Technologies: 

1. Heparin- and Sulfatide-Binding 

Peptides From the Type I Repeats of 

Human Thrombospondin. 

a. U.S. Patent No. 5,357,041 issued 18 

Oct 1994 (HHS Reference No. E–198– 

1991/0–US–01); 

b. U.S. Patent No. 5,770,563 issued 23 

Jun 1998 (HHS Reference No. E–198– 

1991/2–US–01); 

c. U.S. Patent No. 6,051,549 issued 18 

Apr 2000 (HHS Reference No. E–198– 

1991/2–US–03); and 

d. foreign counterparts. 

2. Compositions for Stimulating TGF 

Activity. 

a. U.S. Patent No. 6,384,189 issued 07 

May 2003 (HHS Reference No. E–019– 

1994/1–US–02) 

Licensing Availability: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: Tara Kirby, PhD; 

301/435–4426; tarak@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute, 

Laboratory of Pathology, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize these peptides. Please 

contact John D. Hewes, Ph.D. at (301) 

435–3121 or hewesj@mail.nih.gov for 

more information. 

Dated: April 27, 2007. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E7–8500 Filed 5–3–07; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the meeting of the 

President’s Cancer Panel. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(9)(b), Title 5 U.S.C., as 

amended, because the premature 

disclosure of information and the 

discussions would likely to significantly 

frustrate implementation of 

recommendations. 

Name of Committee: President’s Cancer 

Panel. 

Date: May 24, 2007. 

Time: 12:30 p.m. to 2:30 p.m. 

Agenda: The Panel will review the final 

draft of 2006/2007 Annual Report to the 

President. 

Place: National Cancer Institute, National 

Institutes of Health, Building 6116, Room 

212, 6116 Executive Boulevard, Bethesda, 

MD 20892, (Telephone Conference Call). 

Contact Person: Abby Sandler, PhD, 

Executive Secretary, Chief, Institute Review 

Office, Office of the Director, National Cancer 

Institute, National Institutes of Health, 

Building 6116, Room 212, MSC 8349, 6116 

Executive Boulevard, Bethesda, MD 20892– 

8349, 301/451–9399, sandlera@mail.nih.gov. 

Information is also available on the 

Institute’s/Center’s home page: 

deainfo.nci.nih.gov/advisory/pcp/pcp.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: April 26, 2007. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–2190 Filed 5–3–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel, NIDDK Diabetes 

Centers Applications. 


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