54394 Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual 

Frequency per 

Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

100.2(d) 1 1 1 10 10 

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

The reporting burden for § 100.2(d) is 

insignificant because enforcement 

notifications are seldom used by States. 

During the last 3 years, FDA has not 

received any enforcement notifications. 

Since the enactment of section 403A(b) 

of the act (21 U.S.C. 343–1(b)) as part of 

the Nutrition Labeling and Education 

Act of 1990, FDA has received only a 

few enforcement notifications. Although 

FDA believes that the burden will be 

insignificant, it believes these 

information collection provisions 

should be extended to provide for the 

potential future need of a State 

government to submit enforcement 

notifications informing FDA when it 

intends to take enforcement action 

under the act against a particular food 

located in the State. 

Dated: September 7, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–18223 Filed 9–13–05; 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. 

Soluble Fragments of the IGF1R 

Ectodomain 

Dimiter S. Dimitrov et al. (NCI) 

HHS Reference No. E–144–2005/0—

Research Tool 

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. 

The present invention relates to the 

identification of soluble fragments of the 

IGF1R ectodomain, where these 

fragments bind IGF-I, IGF-II, or the 

various other ligands of IFG1R. The 

identified fragment may be useful for 

identifying agents that block IGF1R and 

may act as a strong dominant negative 

inhibitor of tumor growth by blocking 

the IGF1R pathway. The invention also 

encompasses other IGF1R fragments or 

derivatives of the original fragments, 

methods of identifying IGF1R fragments 

or other similar fragments in the IGF1R 

ectodomain, methods of using said 

fragments to block binding of ligands, 

and methods of producing antibodies 

against the IGF1R fragments. 

The technology is available for 

licensing under a biological material 

license. In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

Polymer-Linked Pseudomonas Exotoxin 

Immunotoxin 

Ira Pastan (NCI) et al. 

U.S. Provisional Application No. 60/ 

636,007 filed 12 Dec 2004 (HHS 

Reference No. E–121–2005/0-US–01) 

Licensing Contact: Jesse Kindra; 301/ 

435–5559; kindraj@mail.nih.gov. 

Molecules based on monoclonal 

antibodies hold the promise of highly 

selective therapeutics. However, their 

efficacy can be limited by poor tissue 

penetration, rapid renal clearance and 

an immune response to the antibody. 

The present technology provides an 

immunotoxin that is modified to 

overcome such limitations. 

The technology relates to polymerconjugated immunotoxins targeted to 

the mesothelin tumor cell antigen. 

These polymer-immunotoxin conjugates 

possess an enhanced therapeutic index 

and may provide improved methods of 

treating tumors and cancers expressing 

the mesothelin antigen. 

Tumor Suppressor Gene Caliban 

Mark A. Mortin et al. (NICHD) 

U.S. Provisional Application filed 06 

Jun 2005 (DHHS Reference No. E–

118–2005/0-US–01) 

Licensing Contact: Jesse S. Kindra; 301/ 

435–5559; kindraj@mail.nih.gov. 

This invention relates to the 

identification of a tumor suppressor 

gene named Caliban from Drosophila 

melanogaster. The inventors have 

demonstrated that Caliban is very 

similar to the corresponding human 

gene and they have shown that the 

human gene is inactive in human lung 

cancer cells but active in normal lung 

cells. For the first time, it has been 

shown that when full length Caliban is 

expressed in human lung cancer cells 

they lose many of their tumorigenic 

properties. Hence, using gene therapy to 

replace the inactive gene with full 

length Caliban may treat cancer. Details 

of this were published in Bi et al., 

‘‘Drosophila caliban, a nuclear export 

mediator, can function as a tumor 

suppressor in human lung cancer cells,’’

Oncogene advance online publication, 

August 15, 2005; doi:10.1038/ 

sj.onc.1208962. 

This invention also provides a 

biomarker assay that can be used to 

determine if the fly or human tumor 

suppressor Caliban gene product is 

functioning in cells. This assay uses a 

peptide from the fly gene Prospero, 

named HDA, which when fused to a 

reporter such as green fluorescent 

protein, is exported from the nucleus 

when Caliban is working. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices 54395 

SIPA–1 Gene and SIPA–1 Inhibitor for 

the Treatment, Prevention and 

Diagnosis of Cancer 

Kent Hunter et al. (NCI) 

U.S. Provisional Application No. 60/ 

649,365 filed 02 Feb 2005 (HHS 

Reference No. E–082–2005/0-US–01); 

U.S. Provisional Application No. 60/ 

657,943 filed 02 Mar 2005 (HHS 

Reference No. E–082–2005/1–US–01); 

U.S. Provisional Application No. 60/ 

695,024 filed 29 Jun 2005 (HHS 

Reference No. E–216–2005/0–US–01) 

Licensing Contact: Mojdeh Bahar; 301/ 

435–2950; baharm@mail.nih.gov. 

The technology relates to methods 

and compositions of matter used to 

identify and treat metastatic cancer. 

Using genetics, the inventors identified 

the mouse Sipa-1 gene as a possible 

metastasis modifying gene. Further 

analyses revealed that Sipa-1 expression 

levels correlate with metastasis. The 

inventors developed compounds that 

modulate Sipa-1 expression and reduce 

metastasis in animal models. The 

inventors also identified single 

nucleotide polymorphisms (SNPs) 

present in the mouse Sipa-1 gene that, 

if also present in humans, could serve 

as the basis for diagnosing cancer and 

metastasis. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

Diagnostic Tool for Diagnosing Benign 

Versus Malignant Thyroid Lesions 

Steven K. Libutti et al. (NCI) 

PCT Patent Application No. PCT/US05/ 

12289 filed 11 Apr 2005 (HHS 

Reference No. E–124–2004/2–PCT–

01) 

Licensing Contact: Mojdeh Bahar; 301/ 

435–2950; baharm@mail.nih.gov. 

The present invention relates to 

methods for the diagnosis and staging of 

thyroid cancer. The invention employs 

analysis of gene expression using 

microarrays or quantitative RT-PCR to 

distinguish between malignant and 

benign tumors. Primer and probe 

sequences are described that represent a 

six gene or ten gene model for 

diagnosing benign and malignant 

thyroid cancer. Analysis of the 

expression of these genes in thyroid 

lesions taken from patients could be 

used for molecular classification of the 

lesions. As analysis of thyroid lesions 

by traditional means, such as fine 

needle biopsy with cytologic 

examination, can result in 

indeterminate results, the current 

invention may provide a superior 

method for molecular diagnoses of 

thyroid cancer. 

This research is described, in part, in 

Mazzanti et al., ‘‘Using gene expression 

profiling to differentiate benign versus 

malignant thyroid tumors,’’ Cancer Res. 

2004 Apr 15 64(8):2898–2903. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

Recombinant Vaccinia Viruses 

Expressing IL–15 and Methods of Using 

the Same 

Liyanage Perera et al. (NCI) 

U.S. Provisional Application No. 60/ 

433,703 filed 16 Dec 2002 (HHS 

Reference No. E–243–2002/0–US–01); 

PCT Application No. PCT/US03/ 

39967 filed 15 Dec 2003, which 

published as WO 2004/058278A1 on 

15 Jul 2004 (HHS Reference No. E–

243–2002/1–PCT–01); U.S. Patent 

Application filed 14 Jun 2005 (HHS 

Reference No. E–243–2002/1–US–02) 

Licensing Contact: John Stansberry; 301/ 

435–5236; stansbej@mail.nih.gov. 

Vaccinia-based vaccines have a 

proven record of being effective 

vaccines in humans as well as in 

animals. However, accumulating 

evidence reveals the need for 

technology to improve the immune 

responses such vaccines generate. 

The present invention discloses 

recombinant vaccinia viruses capable of 

expressing interleukin 15 (IL–15), and 

methods for modulating immune 

responses using such viruses. This 

invention shows that by inserting the 

human IL–15 gene into the vaccinia 

genome, more effective vaccines can be 

generated against infectious agents and 

cancer. Currently, IL–2 has been 

approved by the FDA for use in the 

treatment of patients with metastatic 

renal cell carcinoma or with metastatic 

melanoma. It has been used as a 

component of cancer vaccines and in 

various approaches for the treatment of 

AIDS. However, administration of IL–2 

is associated with activation-induced 

cell death (AICD), and may lead to death 

of T-cells that recognize the antigens 

expressed in the tumor cells. Thus, IL–

15 may be a superior agent in the 

treatment of cancer, or as a component 

of a vaccine directed towards cancer or 

infectious agents. Co-expression of IL–

15 with antigens during the 

immunization process, according to the 

current invention, leads to induction of 

CD8+ memory T cells with higher 

avidity that proliferate more effectively 

in vivo and persist much longer in the 

immunized individual in addition to 

enhancing the levels and persistence of 

antigen specific antibodies thus 

providing substantially longer lasting 

cellular and humoral immunity. 

This invention has the potential to be 

used in a variety of ways, including: (i) 

an improved, more efficacious vaccine 

candidate for smallpox, (ii) for 

incorporation into existing vaccinia 

based vaccines to enhance and confer 

superior long lasting immune response 

to viral and cancer antigens, or (iii) as 

a valuable source material for IL–15 

production, especially should IL–15 be 

proven as an alternate of more 

efficacious cytokine than IL–2. 

This research has been described, in 

part, in SK Oh et al., ‘‘Coadministration 

of HIV vaccine vectors with vaccinia 

viruses expressing IL–15 but not IL–2 

induces long-lasting cellular 

immunity,’’ Proc. Natl. Acad. Sci USA 

2003 Mar 18;100(6):3392–3397, online 

publication 10.1073/pnas.0630592100. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

Amelioration of Inflammatory Arthritis 

Targeting the Pre-ligand Assembly 

Domain (PLAD) of Tumor Necrosis 

Factor Receptors 

Michael J. Lenardo et al. (NIAID) 

U.S. Provisional Application No. 60/ 

694,015 filed 24 Jun 2005 (HHS 

Reference No. E–095–2000/2–US–01) 

Licensing Contact: Mojdeh Bahar; 301/ 

435–2950; baharm@mail.nih.gov. 

The invention relates to compositions 

of matter and methods for treating 

arthritis by modulating Tumor Necrosis 

Factor Alpha (TNFalpha) signaling. 

TNFalpha plays a key role in the 

pathogenesis of numerous diseases 

including rheumatoid and septic 

arthritis, and other autoimmune and 

inflammatory diseases. TNFalpha 

mediates its effects through receptors 

that contain a Pre-ligand Assembly 

Domain (PLAD). The inventors have 

discovered compounds that interfere 

with PLAD can block the effects of 

TNFalpha in vitro. Treatment of mice 

with these compounds in vivo 

ameliorated disease in several models of 

arthritis. Therefore, the compositions 

and methods of the current invention 

may lead to novel arthritis treatments. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

54396 Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices 

Disubstituted Levendustin A Analogs 

(Including Adaphostin) and 

Pharmaceutical Compositions 

Comprising the Analogs 

Venkatacha L. Narayanan et al. (NCI) 

U.S. Patent Application No. 09/623,000 

filed 25 Aug 2000 (DHHS Reference 

No. E–013–1998/0–US–07) 

Licensing Contact: John Stansberry; 

(301) 435–5236; 

stansbej@mail.nih.gov. 

Chronic myelogenous leukemia (CML) 

is almost universally associated with a 

translocation that juxtaposes the Bcr 

and Abl genes. Because the resulting 

kinase, p210 Brc/Abl, is found exclusively 

in malignant hematopoietic cells there 

has been considerable interest in 

identifying inhibitors of this enzyme. 

Adaphostin induces cytotoxicity in 

human leukemia cells by downregulating p210 Bcr/Abl, inducing DNA 

damage and initiating apoptosis. 

Adaphostin exhibits selectivity for CML 

myeloid progenitors in vitro and 

retained its catholicity when 

cytotoxicity mesylate-resistant K562 

cells were examined. Adaphostin may 

kill a wide range of human leukemia 

cells and may be effective against other 

cancer types. The present invention 

provides pharmaceutical compositions 

comprising effective amounts of 

adaphostin. The compound and 

composition of the present invention 

may be used for treating human 

leukemia and other proliferative 

diseases. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

Heterologous Boosting Immunizations 

Ronald S. Chamberlain et al. (NCI) 

U.S. Patent Application No. 09/171,086 

filed 22 Jan 1999 (HHS Reference No. 

E–087–1996/0-US–04); U.S. Patent 

Application No. 09/838,987 filed 20 

Apr 2001 (HHS Reference No. E–087–

1996/0–US–05); U.S. Patent 

Application No. 11/007,115 filed 08 

Dec 2004 (HHS Reference No. E–087–

1996/0–US–06); PCT Application No. 

PCT/US97/06632 filed 21 Apr 1997, 

which published as WO 97/39771 on 

30 Oct 1997 (HHS Reference No. E–

087–1996/0–PCT–02); and Canadian 

Patent Application Serial No. 

2,252,406 (HHS Reference No. E–087–

1996/0–CA–03) 

Licensing Contact: Michelle A. Booden; 

301/451–7337; 

boodenm@mail.nih.gov. 

The identification of tumor-associated 

antigens and the cloning of DNA 

sequences encoding them have enabled 

the development of anticancer vaccines. 

Such vaccines target tumors by 

stimulating an immune response against 

the antigens. One method of vaccination 

involves the delivery of antigenencoding DNA sequences, and a number 

of recombinant vectors have been used 

for this purpose. To optimize the 

efficacy of recombinant vaccines, Dr. 

Steve Rosenberg and colleagues at the 

NCI have developed treatment regimens 

that use two different vectors (i.e., 

heterologous boosting). 

The present invention describes the 

method of heterologous boosting 

immunizations, which in essence is the 

use of a priming vaccination and a 

boosting vaccination using two different 

recombinant vectors that contain a 

similar or different tumor associated 

antigen (TAA). The use of different 

recombinant vectors unexpectedly 

increases and maintains the immune 

response to most tumor-associated 

antigens included in the vectors. The 

claims are directed, but not limited to, 

various recombinant viral vectors: 

poxvirus, vaccine, adenovirus, etc. 

Additional embodiments and claims are 

directed, but not limited to, melanoma 

tumor antigens such as Mart1, gp100, or 

Hep B surface antigen. These tumor 

antigen expressing recombinant vectors 

are coupled with distinctly different 

recombinant vectors, which express 

various cytokines and co-stimulatory 

and accessory molecules such as B7–1, 

B7–2, ICAM–1, etc. This therapeutic 

intervention could be directed toward 

multiple human carcinomas but, with 

respect to this technology, has been 

customized as a therapeutic 

intervention for melanoma. 

This technology is available under an 

exclusive or non-exclusive license. In 

addition to licensing, the technology is 

available for further development 

through collaborative research 

opportunities with the inventors. 

Dated: September 2, 2005. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 05–18168 Filed 9–13–05; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Alternative Medicine; 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 Center for 

Complementary and Alternative Medicine 

Special Emphasis Panel, Clinical Science. 

Date: October 20–21, 2005. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Park Hotel, 8400 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Jeanette M. Hosseini, 

Scientific Review Administrator, National 

Center For Complementary and Alternative 

Medicine, 6707 Democracy Blvd., Suite 401, 

Bethesda, MD 20892, 301–594–9096. 

Dated: September 6, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–18171 Filed 9–13–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Library of Medicine; Notice of 

Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

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

is hereby given of the tenth and final 

meeting of the Commission on Systemic 

Interoperability. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The mission of the Commission on 

Systemic Interoperability is to submit a 

report to the Secretary of Health and 

Human Services and to Congress on a 

comprehensive strategy for the adoption 

and implementation of health care 

information technology standards that 

includes a timeline and prioritization 

for such adoption and implementation. 

In developing that strategy, the