50830 Federal Register / Vol. 73, No. 168 / Thursday, August 28, 2008 / Notices 

a reduction of toxicity by more than 

100,000-fold. Sandwich ELISA analysis 

indicated that the featured toxoids were 

two- to three-fold less antigenic than the 

native neurotoxin compared to 

commercially available toxoids, which 

were about 100-fold less antigenic. 

Preclinical studies have been 

performed using the toxoids of the 

invention. Mice were immunized twice, 

on Day Zero (0) and Day Fourteen (14). 

By Day Twenty-Eight (28), relatively 

high toxin-specific IgG titers were 

detected in animals that had received 

any of the in-house toxoids, with greater 

than 99% being IgG1 and the remainder 

IgG2. These immunized mice remained 

asymptomatic after being challenged 

with Fifty (50) to One Million 

(1,000,000) median lethal dose (LD50) 

units of the 900 kDa neurotoxin. In 

contrast, animals immunized with 

several different batches of 

commercially available toxoids did not 

develop measurable toxin-specific 

antibody titers; however, these mice did 

survive neurotoxin challenges with Two 

(2) LD50 units, but died when 

challenged with Six (6) LD50 units. 

This application claims the formalindetoxified botulinum compositions 

described above and an in vitro method 

for characterizing the toxoids. Also 

claimed are methods of making the 

botulinum compositions, and methods 

of producing antitoxin to botulinum 

toxin. 

Applications: ELISA development, 

production of equine or human-derived 

botulinum antitoxin, development of 

next generation botulism vaccines. 

Development Status: Toxoids have 

been prepared and preclinical studies 

have been performed. Standard 

antibody reagents for ELISA assay 

development have been prepared. 

Inventors: James E. Keller (FDA/ 

CBER). 

Publication: JE Keller. 

Characterization of New Formalin 

Botulinum Neurotoxin Toxoids. Clin 

Vaccine Immunol. 2008 Jul 30; Epub 

ahead of print, doi:10.1128/CVI.00117–

08. 

Patent Status: U.S. Provisional 

Application No. 61/036,904 filed 14 Mar 

2008 (HHS Reference No. E–325–2007/ 

0–US–01). 

Licensing Status: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301–435–4646; 

soukasp@mail.nih.gov. 

Collaborative Research Opportunity: 

The FDA Center for Biologics 

Evaluation and Research is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize botulinum toxoids. 

Please contact Alice Welch, PhD at 301–

827–0359 or Alice.Welch@fda.hhs.gov 

for more information. 

Magnetic Resonance Imaging Methods 

and Systems for Estimating Cone of 

Uncertainty 

Description of Technology: In 

diffusion tensor MRI imaging it is 

desirable to determine and display the 

fiber tract dispersion, e.g., the 

eigenvectors and the associated 

uncertainties. For example, the unit 

eigenvector may be displayed with a 

cone of uncertainty around its tip. This 

conveys the notion that the direction of 

fiber is not known precisely. However, 

the known methods are directed to 

computation and visualization of a 

circular cone of uncertainty. These 

methods are suitable for practical 

computation and visualization of an 

elliptical cone of uncertainty. The 

current invention overcomes this 

problem by providing (1) a 

reconstruction procedure to construct 

the covariance matrix of a major 

eigenvector for each voxel of a region of 

interest of a subject, (2) a visualization 

technique to visualize the elliptical cone 

of uncertainty of the eigenvector, and (3) 

two reconstruction procedures to 

compute the normalized areal and 

circumferential measures of the 

elliptical cone of uncertainty. The 

methods can be used to diagnose 

medical disorders associated with 

anomalous changes in water diffusion. 

The methods can also be used in 

applications in material science and 

earth science (geomagnetism). 

Applications: Magnetic Resonance 

Imaging; Diagnostics; Material science; 

Earth science (Geomagnetism). 

Inventor: Cheng Guan Koay (NICHD). 

Publications: 

1. CG Koay et al. The elliptical cone 

of uncertainty and its normalized 

measures in diffusion tensor imaging. 

IEEE Trans Med Imaging. 2008 

Jun;27(6):834–846. 

2. CG Koay et al. Error propagation 

framework for diffusion tensor imaging 

via diffusion tensor representations. 

IEEE Trans Med Imaging. 2007 

Aug;26(8):1017–1034. 

3. CG Koay et al. A unifying 

theoretical and algorithmic framework 

for least squares methods of estimation 

in diffusion tensor imaging. J Magn 

Reson. 2006 Sep;182(1):115–125. 

Patent Status: U.S. Provisional 

Application No. 60/996,169 filed 05 

Nov 2007 (HHS Reference No. E–273–

2007/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Michael A. 

Shmilovich, Esq.; 301–435–5019; 

shmilovm@mail.nih.gov. 

Collaborative Research Opportunity: 

The NICHD, Section on Tissue 

Biophysics and Biomimetics, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize this technology. Please 

contact Alan E. Hubbs, PhD at 301–594–

4263 or hubbsa@mail.nih.gov for more 

information. 

Dated: August 18, 2008. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E8–19915 Filed 8–27–08; 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. 

Radiotracers for Imaging Cannabinoid 

Sub-Type1 (CB1) Receptor 

Description of Technology: The 

present invention relates to novel 

radiolabeled compounds for imaging 

cannabinoid sub-type 1 (CB1) receptors 

in brains of mammals, particularly 

humans, using positron emission 

tomography (PET) or single photon 

emission computed tomography 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 168 / Thursday, August 28, 2008 / Notices 50831 

(SPECT). These radioligands can be 

used in clinical research, diagnostics, or 

drug discovery and development, in 

that, they permit understanding of the 

role of CB1 receptors in 

neuropsychiatric disorders such as 

Parkinson’s disease, Huntington’s 

disease, Alzheimer’s disease, multiple 

sclerosis, depression, mood disorder, 

anxiety, schizophrenia, drug addiction, 

alcohol disorder, obesity and anorexia. 

Applications: 

• In vivo imaging of CB1 receptor in 

mammals, particularly humans 

• Diagnostic imaging of CB1 receptors 

in subjects having a neurological, 

neuropsychiatric, neurodegenerative or 

other condition and treatment 

• Pharmaceutical composition 

• Diagnostic kits 

Advantages: The principal 

radioligand under the claim is effective 

for imaging CB1 receptors in vivo with 

PET. 

Development Status: Primary 

radioligand has been evaluated in nonhuman primates with PET. 

Market: Radioligands may be useful 

for performing drug occupancy studies 

of CB1 receptors, and for 

neuropsychiatric studies and 

investigations with imaging techniques 

(e.g., PET or SPECT). 

Patent Status: U.S. Provisional 

Application No. 61/052,581 filed 12 

May 2008 (HHS Reference No. E–155–

2008/0–US–01). 

Inventors: Victor W. Pike (NIMH), 

Sean R. Donohue (NIMH), et al. 

Relevant Publications: 

1. SR Donohue, C Halldin, VW Pike. 

Synthesis and structure-activity 

relationships (SARs) of 1,5- 

diarylpyrazole cannabinoid type-1 (CB1) 

receptor ligands for potential use in 

molecular imaging. Bioorg Med Chem. 

2006 Jun 1;14(11):3712–3720. 

2. SR Donohue, VW Pike, SJ Finnema, 

P Truong, J Andersson, B Gulya ́s, C 

Halldin. Discovery and labeling of high 

affinity 3,4-diarylpyrazolines as 

candidate radioligands for in vivo 

imaging of cannabinoid subtype-1 (CB1) 

receptors. J Med Chem., in press. 

Licensing Status: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: RC Tang, JD, LLM; 

301–435–5031; tangrc@mail.nih.gov. 

HIV Immunogen and Method of Making 

and Using Same 

Description of Technology: The 

invention describes composition and 

methods of preventing HIV infection 

using a truncated version of the HIV 

gp41 subunit of Env fused to human Fc 

through a flexible linker as a vaccine 

immunogen. This immunogen binds 

several broadly cross-reactive HIV–1 

neutralizing human monoclonal 

antibodies recently identified and 

developed by the inventor’s laboratory, 

including m44. m44 does not react with 

self-antigen suggesting that this 

immunogen may elicit antibodies which 

are not regulated by tolerance 

mechanisms, a problem suggested as the 

cause of failure for some of the gp41- 

based immunogens previously tested. 

Rabbits immunized with this fusion 

construct developed broad-neutralizing 

antibodies against several HIV-isolates 

from different clades in a cell line/ 

pseudovirus assay with high titer. 

Preclinical testing of these novel 

immunogens in primate models is 

currently being planned. 

Applications: Treatment and 

prevention of HIV infection. 

Advantages: 

• Has potential to elicit broad 

neutralizing antibodies against several 

HIV isolates from different clades. 

• Immunogen is based on the gp41 

subunit of the HIV Env, a region more 

conserved than the gp120 subunit of 

Env and fusion to Fc increases the 

stability and half-life of the immunogen. 

• Potentially elicits antibodies that 

are not regulated by tolerance 

mechanisms. 

Development Status: Data can be 

provided upon request. 

Market: Preventative or treatment for 

HIV infection. 

Inventors: Dimiter S. Dimitrov and 

Mei-yun Zhang (NCI). 

Publications: 

1. M–Y Zhang, V Choudhry, IA 

Sidorov, V Tenev, BK Vu, A Choudhary, 

H Lu, GM Stiegler, HWD Katinger, S 

Jiang, CC Broder, DS Dimitrov. Selection 

of a novel gp41-specific HIV–1 

neutralizing human antibody by 

competitive antigen panning. J Immunol 

Methods 2006 Dec 20;317(1–2):21–30. 

2. M–Y Zhang, DS Dimitrov. Novel 

approaches for identification of broadly 

cross-reactive HIV–1 neutralizing 

human monoclonal antibodies and 

improvement of their potency. Curr 

Pharm Des. 2007;13(2):203–212. 

3. V Choudhry, M–Y Zhang, IA 

Sidorov, JM Louis, I Harris, AS 

Dimitrov, P Bouma, F Cham, A 

Choudhary, SM Rybak, T Fouts, DC 

Montefiori, CC Broder, GV Quinnan, DS 

Dimitrov. Cross-reactive HIV–1 

neutralizing monoclonal antibodies 

selected by screening of an immune 

human phage library against an 

envelope glycoprotein (gp140) isolated 

from a patient (R2) with broadly HIV–

1 neutralizing antibodies. Virology 2007 

Jun 20;363(1):79–90. 

4. M–Y Zhang, BK Vu, A Choudhary, 

H Lu, M Humbert, H Ong, M Alam, RM 

Ruprecht, G Quinnan, S Jiang, DC 

Montefiori, JR Mascola, CC Broder, BF 

Haynes, DS Dimitrov. Cross-reactive 

human immunodeficiency virus type 1- 

neutralizing human monoclonal 

antibody that recognizes a novel 

conformational epitope on gp41 and 

lacks reactivity against self-antigens. J 

Virol. 2008 Jul;82(14):6869–6879. 

Patent Status: U.S. Provisional 

Application No. 61/126,662 filed 06 

May 2008 (HHS Reference No. E–072–

2008/0–US–01). 

Licensing Status: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: Sally Hu, Ph.D.; 

301–435–5606, HuS@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute CCR 

Nanobiology Program is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize this technology. Please 

contact John D. Hewes, Ph.D. at 301–

435–3121 or hewesj@mail.nih.gov for 

more information. 

Cross-Reactive Neutralizing Human 

Domain Antibody Against HIV–1 

Description of Technology: The 

invention describes the first identified 

anti-HIV human domain antibody 

(m36), which can potentially be used 

alone or synergistically with other antiHIV antibodies and antiretroviral drugs 

as a therapeutic and/or preventative for 

HIV infection. It targets an epitope 

whose exposure is enhanced by binding 

of the HIV receptor CD4 to the HIV 

envelope glycoprotein (Env). M36 was 

identified by sequential panning of a 

newly developed large human VH 

library against Envs from different HIV–

1 isolates. The antibody can neutralize 

HIV–1 primary isolates from different 

clades at low (nM) concentrations and 

due to its small size (14 kDa) is 

potentially able to efficiently penetrate 

lymphoid tissues where the virus 

replicates. The antibody is fairly well 

characterized and the inventors are 

generating derivatives of this antibody 

to improve the half-life and increase its 

potency and cross-reactivity. 

Applications: Treatment and 

prevention of HIV infections. 

Advantages: 

• Human monoclonal antibody, thus 

eliminating some of the issues 

associated with humanized or murine 

monoclonal antibodies. 

• Potential neutralization of HIV–1 

primary isolates from different clades at 

nM concentrations. 

• Relatively small size allows for 

potential efficient penetration into 

lymphoid tissues. 

Development Status: In vitro data is 

available. 


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50832 Federal Register / Vol. 73, No. 168 / Thursday, August 28, 2008 / Notices 

Market: HIV therapeutics and 

preventatives. 

Inventors: Dimiter Dimitrov and 

Weizao Chen (NCI). 

Publications: 

1. MY Zhang et al. Identification of a 

Novel CD4i human monoclonal 

antibody Fab that neutralizes HIV–1 

primary isolates from different clades. 

Antiviral Res. 2004 Mar;61(3):161–164. 

2. MY Zhang et al. Improved breath 

and potency of an HIV–1 neutralizing 

human single-chain antibody by random 

mutagenesis and sequential antigen 

panning. J Mol Biol. 2004 Jan 

2;335(1):209–219. 

3. CC Huang et al. Structure of a V3- 

containing HIV–1 gp120 core. Science 

2005 Nov 11; 310(5750):1025–1028. 

4. W Chen et al. Construction of a 

large phage-displayed human antibody 

domain library with a scaffold based on 

a newly identified highly soluble, stable 

heavy chain variable domain. J. Mol 

Biol. 2008, in press. 

5. W Chen et al. Human domain 

antibodies to conserved sterically 

restricted regions on gp120 as 

exceptionally potent cross-reactive HIV–

1 neutralizers. Proc Natl Acad Sci USA., 

under review. 

Patent Status: U.S. Patent Application 

No. 61/019,426 filed 07 Jan 2008 (HHS 

Reference No. E–043–2008/0–US–01). 

Licensing Status: This invention is 

available for exclusive or non-exclusive 

licensing. 

Licensing Contact: Sally Hu, Ph.D.; 

301–435–5606, HuS@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute CCR 

Nanobiology Program is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize domain antibodies and 

nanoantibodies against HIV. Please 

contact John D. Hewes, Ph.D. at 301–

435–3121 or hewesj@mail.nih.gov for 

more information. 

Monodisperse and Modified Yersinia 

pestis Capsular F1–V Antigen Fusion 

Proteins for Vaccination Against 

Bubonic and Pneumonic Plague 

Description of Technology: An 

effective plague vaccine against Yersinia 

pestis is currently unavailable in the 

U.S. The F1–V (fusion of two Y. pestis 

proteins, the Fraction 1 capsular antigen 

and a second immunogen called the Vantigen) vaccine of this invention is a 

monodispersed, mutated form of F1–V 

fusion protein. This is a promising 

candidate for commercialization. 

Features and benefits include: 

• The vaccine is substantially 

monomeric but does not tend to selfassociate and form aggregates. 

• The antigen fusion proteins retain 

immunogenicity. 

• The associated, new manufacturing 

process provides an inexpensive means 

of making an effective vaccine. 

• The method eliminates the need for 

mixing components that is the case with 

competitive technology. 

Applications: 

• An effective vaccine is needed 

where plague is endemic. 

• An important biodefense 

countermeasure against dissemination 

of weaponized plague is sought. 

Inventors: David F. Nellis and Steven 

L. Giardina (NIAID). 

Relevant Publication: JL Goodin et al. 

Purification and protective efficacy of 

monomeric and modified Yersinia 

pestis capsular F1–V antigen fusion 

proteins for vaccination against plague. 

Protein Expr Purif. 2007 May;53(1):63–

79. 

Patent Status: U.S. Patent Application 

No. 11/944,230 filed 21 Nov 2008 (HHS 

Reference No. E–189–2007/0–US–01). 

Development Status: The technology 

is in pre-clinical stage of development. 

Licensing Status: Available for nonexclusive or exclusive licensing. 

Licensing Contact: Cristina 

Thalhammer-Reyero, Ph.D., M.B.A.; 

301–435–4507; thalhamc@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIAID is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize this plague vaccine. 

Please contact Marguerite J. Miller at 

301–435–8619 /or 

millermarg@niaid.nih.gov for more 

information. 

Dated: August 18, 2008. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E8–19917 Filed 8–27–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

[Docket No. DHS–2008–0087] 

Data Privacy and Integrity Advisory 

Committee 

AGENCY: Office of the Secretary, DHS. 

ACTION: Notice of Federal Advisory 

Committee Meeting. 

SUMMARY: The Data Privacy and 

Integrity Advisory Committee will meet 

on September 17, 2008 in Las Vegas, 

NV. This meeting will be open to the 

public. 

DATES: The Data Privacy and Integrity 

Advisory Committee will meet on 

Wednesday, September 17, 2008 from 9 

a.m. to 12 p.m. and 1 p.m. to 4:20 p.m. 

Please note that the meeting may close 

early if the committee has completed its 

business. 

ADDRESSES: The meeting will be held in 

a conference room in the Hampton Inn 

Tropicana and Southwest Event Center, 

4975 Dean Martin Drive, Las Vegas, NV 

89118. Send written materials, 

comments, and requests to make oral 

presentations to Ken Hunt, Executive 

Director, Data Privacy and Integrity 

Advisory Committee, Department of 

Homeland Security, Washington, DC 

20528. Written materials, comments, 

and requests to make oral presentations 

at the meeting should reach the contact 

person listed by September 8, 2008. 

Requests to have a copy of your material 

distributed to each member of the 

committee prior to the meeting should 

reach the persons listed under FOR

FURTHER INFORMATION CONTACT, below, 

by September 8, 2008. Persons wishing 

to make comments or who are unable to 

attend or speak at the meeting may 

submit comments at any time. All 

submissions received must include the 

docket number DHS–2008–0087 and 

may be submitted by any one of the 

following methods: 

• Federal Rulemaking Portal: http:// 

www.regulations.gov. Follow 

instructions for submitting comments 

on the Web site. 

• E-mail: PrivacyCommittee@dhs.gov. 

Include docket number in the subject 

line of the message. 

• Fax: (866) 466–5370. 

• Mail: Mr. Ken Hunt, Executive 

Director, Data Privacy and Integrity 

Advisory Committee, Department of 

Homeland Security, Washington, DC 

20528. 

Instructions: All submissions received 

must include the words ‘‘Department of 

Homeland Security Data Privacy and 

Integrity Advisory Committee’’ and the 

docket number: DHS–2008–0087. 

Comments received will also be posted 

without alteration at http:// 

www.regulations.gov, including any 

personal information provided. 

Docket: For access to the docket to 

read background documents or 

comments received by the DHS Data 

Privacy and Integrity Committee, go to 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Hugo Teufel III, Chief Privacy Officer, or 

Ken Hunt, Executive Director, Data 

Privacy and Integrity Advisory 

Committee, Department of Homeland 


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