Federal Register / Vol. 72, No. 25 / Wednesday, February 7, 2007 / Notices 5725 

influenza vaccine manufactured by 

Sanofi Pasteur. In the afternoon, the 

committee will hear presentations and 

have discussions on clinical 

development of influenza vaccines for 

pre-pandemic uses. On February 28, 

2007, in the morning, the committee 

will hear presentations and make 

recommendations on strain selections 

for the influenza virus vaccine for the 

2007–2008 season. In the afternoon, the 

committee will hear presentations and 

have discussions on circulating lineages 

of influenza type B virus. 

FDA intends to make background 

material available to the public no later 

than 1 business day before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2007 and scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before February 13, 2007. 

Oral presentations from the public will 

be scheduled between approximately 

10:45 and 11:15 a.m. and 2:45 and 3:15 

p.m. on February 27, 2007, and between 

approximately 10:40 and 11:10 a.m. and 

2:50 and 3:20 p.m. on February 28, 

2007. Those desiring to make formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before February 5, 2007. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

February 6, 2007. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Christine 

Walsh or Denise Royster at least 7 days 

in advance of the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 1, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E7–1899 Filed 2–6–07; 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, HHS. 

ACTION: Notice. 

SUMMARY: The invention listed below is 

owned by an agency of the U.S. 

Government and is 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. 

Metal Chelators and Target-Moiety 

Complexes for Imaging 

Available for licensing and 

commercial development are 

bifunctional metal chelators, metal 

chelator-targeting moiety complexes, 

metal chelator-targeting moiety-metal 

conjugates, kits, and methods of 

preparing them in a non-aqueous, 

automated peptide synthesizer system. 

These bifunctional chelators are useful 

for radiolabeling targeting moieties with 

SPECT and PET radioisotopes for 

molecular imaging for diagnosis and/or 

treatment of cancer. The metal chelators 

may be used in conventional synthetic 

methods to form targeting moieties [e.g., 

peptides, proteins, and Starburst 

polyamidoamine dendrimers 

(PAMAM)], capable of conjugating 

diagnostic and/or therapeutic metals. 

The formulae for two such chelators are 

shown below: 


sroberts on PROD1PC70 with NOTICES
5726 Federal Register / Vol. 72, No. 25 / Wednesday, February 7, 2007 / Notices 

Inventors: Martin Wade Brechbiel and 

Thomas Clifford (NCI). 

Publications: 

1. T Clifford et al. Validation of a 

novel CHX-A’’ derivative suitable for 

peptide conjugation: small animal PET/ 

CT imaging using yttrium–86–CHX–A’’–

octreotide. J Med Chem. 2006 Jul 

13;49(14):4297–4304. 

2. HS Chong et al. Synthesis and 

evaluation of novel macrocyclic and 

acyclic ligands as contrast enhancement 

agents for magnetic resonance imaging. 

J Med Chem. 2006 Mar 23;49(6):2055–

2062. 

Licensing Status: Available for 

exclusive or non-exclusive licensing or 

collaborative research opportunity. 

Patent Status: U.S. Provisional 

Application No. 60/603,781 filed 23 

Aug 2004 (HHS Reference No. E–317–

2004/1–US–01); International Patent 

Application PCT/US2005/028125 filed 

09 Aug 2005 (HHS Reference No. E–

317–2004/1–PCT–02). 

Licensing Contact: Michael A. 

Shmilovich, Esq.; 301/435–5019; 

shmilovm@mail.nih.gov. 

Dated: January 30, 2007. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 07–526 Filed 2–6–07; 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. 

Extended Transgene Expression for a 

Non-Integrating Adenoviral Vector 

Containing Retroviral Elements 

Description of Technology: Anthrax 

lethal toxin (LeTx) consists of two 

components: The protective antigen 

(PrAg) and the lethal factor (LF). PrAg 

binds to the cell surface where it is 

activated by furin protease, followed by 

the formation of a PrAg heptamer. LF is 

then translocated into the cytosol of a 

cell via this heptamer, where it acts as 

a metalloprotease on all but one 

mitogen-activated protein kinase kinase 

(MAPKK). Approximately 70% of 

human melanomas contain a mutation 

(B–RAF V600E) that constitutively 

activates a MAPKK pathway, and LeTx 

has been shown to have significant 

toxicity towards cells which have this 

mutation. This suggested a potential use 

for LeTx in cancer therapy. 

Unfortunately, native LeTx is toxic to 

normal cells, detracting from its in vivo 

applicability. 

PrAg has been engineered to be 

activated by a matrix metalloprotease 

(MMP), instead of by furin protease. 

Because MMPs are highly expressed in 

tumor cells, this modification increases 

selectivity towards cancer cells. 

Surprisingly, mouse data shows that the 

modified LeTx (denoted PrAg-L1/LF) is 

less cytotoxic to ‘‘normal’’ cells in vivo, 

when compared to wild-type LeTx. 

Significantly, PrAg-L1/LF maintained 

its high toxicity toward human tumors 

in mouse xenograft models of human 

tumors, including melanomas. However, 

this toxicity applied not only to tumors 

having mutations that constitutively 

activate MAPKKs, but also to other 

tumor types such as lung and colon 

carcinomas. The absence of toxicity to 

‘‘normal’’ cells coupled to its 

effectiveness on a wide range of cancer 


sroberts on PROD1PC70 with NOTICESEN07FE07.015</GPH>