Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices 66445 

sense of alarm among patients and 

practitioners. 

Response: The purpose of the 

November 17, 2003, Federal Register 

notice was to describe the proposed 

study and offer an opportunity for 

comment by the sponsors of marketed 

triptans. The responses to the comments 

in this notice also provide additional 

explanation and another opportunity for 

all interested parties to participate 

through additional comments. In 

addition, FDA has responded in this 

document to those comments expressing 

concern with the study methods. 

References 

The following references have been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20857, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. (FDA has verified the 

Web site address, but FDA is not 

responsible for any subsequent changes 

to the Web site after this document 

publishes in the Federal Register.) 

1. Who Online: Pew Internet & American 

Life Project, February–March 2005 Tracking 

Survey, 2005. 

2. Dorgan, J.F., M.E. Reichman, J.T. Judd, 

C. Brown, C. Longcope, A. Schatzkin, et al., 

‘‘The relation of reported alcohol ingestion to 

plasma levels of estrogens and androgens in 

premenopausal women (Maryland, United 

States),’’ Cancer Causes Control, 5(1):53–60, 

1994. 

3. Kushi, L.H., J. Finnegan, B. Martinson, 

J. Rightmyer, C. Vachon, L. Yochum, 

‘‘Epidemiology and the Internet,’’ [letter; 

comment], Epidemiology 1997;8 (6):689–90, 

1997. 

4. Soetikno, R.M., R. Mrad, V. Pao, L.A. 

Lenert, ‘‘Quality-of-life research on the 

Internet: feasibility and potential biases in 

patients with ulcerative colitis,’’ Journal of 

the American Medical Informatics 

Association, 4(6):426–35, 1997. 

5. Soetikno, R.M., D. Provenzale, L.A. 

Lenert, ‘‘Studying ulcerative colitis over the 

World Wide Web, [see comments], American 

Journal of Gastroenterology, 92(3):457–60, 

1997. 

6. L. Lenert, R.F. Munoz, J. Stoddard, K. 

Delucchi, A. Bansod, S. Skoczen, et al., 

‘‘Design and pilot evaluation of an internet 

smoking cessation program,’’ Journal of the 

American Medical Informatics Association, 

10(1):16–20, 2003. 

7. Lorig, K.R., D.D. Laurent, R.A. Deyo, 

M.E. Marnell, M.A. Minor, P.L. Ritter, ‘‘Can 

a Back Pain E-mail Discussion Group 

improve health status and lower health care 

costs?: A randomized study,’’ Archives of 

Internal Medicine, 162(7):792–6, 2002. 

8. Lenert, L.A., ‘‘Use of willingness to pay 

to study values for pharmacotherapies for 

migraine headache, Medical Care, 41(2):299–

308, 2003. 

9. Lenert, L.A., T. Looman, T. Agoncillo, 

M. Nguyen, A. Sturley, C.M. Jackson, 

‘‘Potential validity of conducting research on 

headache in internet populations,’’

Headache, 42(3):200–3, 2002. 

10. Athale, N., A. Sturley, S. Skoczen, A. 

Kavanaugh, L. Lenert, ‘‘A web-compatible 

instrument for measuring self-reported 

disease activity in arthritis,’’ Journal of 

Rheumatology, 31:223/8, 2004. 

11. McAlindon, T., M. Formica, M. 

LaValley, M. Lehmer, K. Kabbara, 

‘‘Effectiveness of glucosamine for symptoms 

of knee osteoarthritis: results from an 

internet-based randomized double-blind 

controlled trial,’’ American Journal of 

Medicine, 117(9):643–9, 2004. 

12. McAlindon, T., M. Formica, K. 

Kabbara, M. LaValley, M. Lehmer, 

‘‘Conducting clinical trials over the internet: 

feasibility study,’’ The British Medical 

Journal, 327(7413):484–7, 2003. 

13. McAlindon, T.E., M.K. Formica, C.E. 

Chaisson, R. Woods, J. Fletcher, ‘‘Feasibility 

Of An Internet-Based Case-Control Study Of 

Recent-Onset SLE,’’ Arthritis Rheum, 50(9 

(Suppl)):682, 2004. 

FDA estimates that approximately 500 

persons will voluntarily complete the 

questionnaire. The estimated time for 

completing each questionnaire is 

approximately 2 hours, resulting in a 

total burden of 1,000 hours per year. 

The burden of this collection of 

information is estimated as follows: 

TABLE 1.—ESTIMATED ONE-TIME REPORTING BURDEN1

No. of Respondents Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

500 1 500 2 1,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: October 26, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21807 Filed 11–1–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, DHHS. 

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. 

Antibodies Against Insulin-Like 

Growth Factor II and Uses Thereof 

Dimiter S. Dimitrov et al. (NCI). 

U.S. Provisional Application No. 60/ 

709,226 filed 17 Aug 2005 (HHS 

Reference No. E–217–2005/0–US–01). 

Licensing Contact: Michelle A. Booden; 

301/451–7337; 

boodenm@mail.nih.gov. 

The type 1 insulin-like growth factor 

(IGF) receptor (IGF1R) is over-expressed 

by many tumors and mediates 

proliferation, motility, and protection 

from apoptosis. Agents that inhibit 

IGF1R expression or function can 

potentially block tumor growth and 

metastasis. Its major ligand, IGF–II, is 

over-expressed by multiple tumor types. 

Previous studies indicate that inhibition 

of IGF–II binding to its cognizant 

receptor negatively modulates signal 

transduction through the IGF pathway 

and concomitant cell growth. 

The present invention relates to the 

identification of multiple, novel fully 

human monoclonal antibodies that are 

specific for IGF–II and do not cross-react 

with IGF–1 or insulin. The present 

invention also describes methods 

employing these novel antibodies to 

inhibit IGF–1R phosphorylation and 

66446 Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices 

concomitant cell growth and motility. 

The invention also encompasses other 

IGF–II antibodies or derivatives of the 

original antibodies and methods of 

using said antibodies to block binding of 

ligands. Additional embodiments 

describe methods for treating various 

human diseases associated with 

aberrant cell growth and motility 

including breast, prostate, and leukemia 

carcinomas. Thus, these novel IGF–II 

antibodies may provide a therapeutic 

intervention for multiple carcinomas 

without the negative side effects 

associated with IGF I and insulin 

inhibition. 

This technology is available for 

licensing under an exclusive or nonexclusive patent license. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

Compositions and Methods for 

Diagnosis and Treatment of 

Chemotherapy-Resistant Neoplastic 

Disease 

John Park (NINDS). 

U.S. Provisional Application No. 60/ 

571,296 filed 15 May 2004 (HHS 

Reference No. E–192–2004/0–US–01); 

PCT Application No. PCT/US2005/ 

016924 filed 13 May 2005 (HHS 

Reference No. E–192–2004/0–PCT–

02). 

Licensing Contact: Jesse S. Kindra; 301/ 

435–5559; kindraj@mail.nih.gov. 

The present invention relates to 

compositions and methods for the 

treatment of a neoplastic disease state 

(i.e. tumors) using RNA interferencemediated down regulation of stathmin 

expression. This invention also 

discloses methods for determining the 

presence or predisposition to a 

neoplastic disease state. 

Stathmin is a cytoplasmic protein that 

is highly expressed in many different 

types of tumors such as leukemias, lung 

cancers and brain tumors. Stathmin is 

believed to be involved in the regulation 

of the cell cycle via its interactions with 

microtubules. Lowering the expression 

of stathmin in tumor cells using RNA 

interference (RNAi) technology causes a 

decrease in tumor cell growth and also 

causes such cells to become more 

sensitive to the effects of standard 

chemotherapeutic agents. 

Accordingly, the delivery of stathmin 

RNAi oligonucleotides either alone or in 

combination with standard 

chemotherapies may be used to treat 

patients with various tumors. For 

example, retroviruses or adenoassociated viruses containing stathmin 

RNAi oligonucleotides could be 

delivered to brain tumors in order to 

decrease cell growth and increase 

sensitivity to standard chemotherapies. 

Serine Protease Inhibitors 

Peter P. Roller, Peng Li (NCI). 

PCT Patent Application No. PCT/ 

US2004/34108 filed 15 Oct 2004 

(HHS Reference No. E–272–2002/1–

PCT–01). 

Licensing Contact: Mojdeh Bahar; 301/ 

435–2950; baharm@mail.nih.gov. 

This disclosure concerns novel serine 

protease inhibitors and methods for 

using the inhibitors to reduce tumor 

progression and/or metastasis. 

Embodiments of the inhibitors are 

highly effective, selective inhibitors of 

matriptase, which has been implicated 

in tissue remodeling associated with the 

growth of cancerous tumors and cancer 

metastasis. 

Angiogenesis and tumor invasion 

require that the normal tissue 

surrounding the tumor be broken down 

in a process referred to as tissue 

remodeling. Tissue remodeling is 

accomplished by a host of enzymes that 

break down the proteins in the normal 

tissue barriers comprising the 

extracellular matrix. Among the 

enzymes associated with degradation of 

the extracellular matrix and tissue 

remodeling are a number of proteases. 

The expression of some of these 

proteases has been correlated with 

tumor progression. 

The disclosed compounds can be 

used to inhibit matriptase, MTSP1, or 

both, in vitro and in vivo and thus can 

be used in the prevention or treatment 

of conditions characterized by abnormal 

or pathological serine protease activity. 

For example, the compounds are useful 

for prevention or treatment of 

conditions characterized by the 

pathological degradation of the 

extracellular matrix, such as conditions 

characterized by neovascularization or 

angiogenesis, including cancerous 

conditions, particularly metastatic 

cancerous conditions where matriptase 

is implicated. The disclosed compounds 

can be used to decrease the degradation 

of the cellular matrix and thereby 

reduce concomitant tumor progression 

and metastasis. Conditions 

characterized by abnormal or 

pathological serine protease activity that 

can be treated according to the disclosed 

method include those characterized by 

abnormal cell growth and/or 

differentiation, such as cancers and 

other neoplastic conditions. Typical 

examples of cancers that may be treated 

according to the disclosed inhibitors 

and method include colon, pancreatic, 

prostate, head and neck, gastric, renal, 

and brain cancers. 

Dated: October 25, 2005. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 05–21831 Filed 11–1–05; 8:45 am] 

BILLING CODE 4140–01–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 To Disrupt Protein-Protein 

Interactions and Its Use To Identify 

Compounds Able To Inhibit HIV–1 Rev 

Protein Multimerization 

George Pavlakis and Leonid Suvoroz 

(NCI). 

HHS Reference No. E–303–2005/0—

Research Tool. 

Licensing Contact: Sally Hu; 301/435–

5606; hus@mail.nih.gov. 

The invention provides a FRET-based 

assay for the study of Rev-Rev 

interaction in vitro, based on YFP and 

CFP expression constructs for Rev. 

Using this assay, Rev-derived small 

peptides that can inhibit Rev-Rev 

interactions and disrupt dimerization 

were discovered. This assay can be used 

as an in vitro assay for studying proteinprotein interactions in general, and for 

the discovery of inhibitors or agonists of 

such interactions as potential drugs 

against HIV infections, as well as for the