Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices 28511 

with the docket number found in 

brackets in the heading of this 

document. FDA will consider any 

comments received in determining 

whether to amend the current listing of 

modifications to the list of recognized 

standards, Recognition List Number: 

017. These modifications to the list or 

recognized standards are effective upon 

publication of this notice in the Federal 

Register. 

Dated: May 10, 2007. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. E7–9718 Filed 5–18–07; 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 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. 

A Method With Increased Yield for 

Production of Polysaccharide-Protein 

Conjugate Vaccines Using Hydrazide 

Chemistry 

Description of Technology: Current 

methods for synthesis and 

manufacturing of polysaccharideprotein conjugate vaccines employ 

conjugation reactions with low 

efficiency (about twenty percent). This 

means that up to eighty percent of the 

added activated polysaccharide (PS) is 

lost. In addition, inclusion of a 

chromatographic process for 

purification of the conjugates from 

unconjugated PS is required. 

The present invention utilizes the 

characteristic chemical property of 

hydrazide groups on one reactant to 

react with aldehyde groups or cyanate 

esters on the other reactant with an 

improved conjugate yield of at least 

sixty percent. With this conjugation 

efficiency the leftover unconjugated 

protein and polysaccharide would not 

need to be removed and thus the 

purification process of the conjugate 

product can be limited to diafiltration to 

remove the by-products of small 

molecules. The new conjugation 

reaction can be carried out within one 

or two days with reactant 

concentrations between 1 and 25 mg/mL 

at PS/protein ratios from 1:2 to 3:1, at 

temperatures between 4 and 40 degrees 

Centigrade, and in a pH range of 5.5 to 

7.4, optimal conditions varying from PS 

to PS. 

Application: Cost effective and 

efficient manufacturing of conjugate 

vaccines. 

Inventors: Che-Hung Robert Lee and 

Carl E. Frasch (CBER/FDA). 

Patent Status: U.S. Patent Application 

No. 10/566,899 filed 01 Feb 2006, 

claiming priority to 06 Aug 2003 (HHS 

Reference No. E–301–2003/0–US–10); 

U.S. Patent Application No. 10/566,898 

filed 01 Feb 2006, claiming priority to 

06 Aug 2003 (HHS Reference No. E–

301–2003/1–US–02); International 

rights available. 

Licensing Status: Available for nonexclusive licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301/435–4646; 

soukasp@mail.nih.gov. 

A Method of Immunizing Humans 

Against Salmonella Typhi Using a VirEPA Conjugate Vaccine 

Description of Technology: This 

invention is a method of immunization 

against typhoid fever using a conjugate 

vaccine comprising the capsular 

polysaccharide of Salmonella typhi, Vi, 

conjugated through an adipic 

dihydrazide linker to nontoxic 

recombinant exoprotein A (rEPA) from 

Pseudomonas aeruginosa. The three 

licensed vaccines against typhoid fever, 

attenuated S. typhi Ty21a, killed whole 

cell vaccines and Vi polysaccharide, 

have limited efficacy, in particular for 

children under 5 years of age, which 

make an improved vaccine desirable. 

It is generally recognized that an 

effective vaccine against Salmonella 

typhi is one that increases serum antiVi IgG eight-fold six weeks after 

immunization. The conjugate vaccine of 

the invention increases anti-Vi IgG, 48- 

fold, 252-fold and 400-fold in adults, in 

5–14 years-old and 2–4 years-old 

children, respectively. Thus this is a 

highly effective vaccine suitable for 

children and should find utility in 

endemic regions and as a traveler’s 

vaccine. The route of administration can 

also be combined with routine 

immunization. In 2–5 years old, the 

protection against typhoid fever is 90% 

for 4 years. In school age children and 

in adults the protection could mount to 

completer protection according to the 

immunogenicity data. 

Application: Immunization against 

Salmonella typhi for long term 

prevention of typhoid fever in all ages. 

Developmental Status: Conjugates 

have been synthesized and clinical 

studies have been performed. The 

synthesis of the conjugates is described 

by Kossaczka et al. in Infect Immun. 

1997 June;65(7):2088–2093. Phase III 

clinical studies are described by Mai et 

al. in N Engl J Med. 2003 October 2; 

349(14):1390–1391. Dosage studies are 

described by Canh et al. in Infect 

Immun. 2004 Nov;72(11):6586–6588. 

A safety and immunogenicity study in 

infants are underway. The aim is to 

administer the conjugate vaccine with 

routine infant immunization. 

Preliminary results show the vaccine is 

safe in 2 months old infants. 

Inventors: Zuzana Kossaczka, 

Shousun C. Szu, and John B. Robbins 

(NICHD). 

Patent Status: U.S. Patent 6,797,275 

issued 28 Sep 2004 (HHS Reference No. 

E–020–1999/0–US–02); U.S. Patent 

Application No. 10/866,343 filed 10 Jun 

2004 (HHS Reference No. E–020–1999/ 

0–US–03); U.S. Patent Application No. 

11/726,304 filed 20 Mar 2007 (HHS 

Reference No. E–020–1999/0–US–04). 

Licensing Status: Available for nonexclusive licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301/435–4646; 

soukasp@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Child Health 

and Human Development, Laboratory of 

Developmental and Molecular 

Immunity, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize A Method of Immunizing 

Humans Against Salmonella Typhi 

Using a Vi-rEPA Conjugate Vaccine. 

Please contact John D. Hewes, Ph.D., at 

301–435–3121 or hewesj@mail.nih.gov 

for more information. 


pwalker on PROD1PC71 with NOTICES
28512 Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices 

Vaccine Against Escherichia Coli 

0157 Infection, Composed of Detoxified 

LPS Conjugated to Proteins 

Description of Technology: This 

invention is a conjugate vaccine to 

prevent infection by E. coli 0157:H7, 

particularly in young children under 5 

years of age. E. coli 0157:H7 is an 

emerging human pathogen which causes 

a spectrum of illnesses with high 

morbidity and mortality, ranging from 

diarrhea to hemorrhagic colitis and 

hemolytic-uremic syndrome (HUS). 

Infection with E. coli 0157:H7 occurs as 

a result of consumption of water, 

vegetables, fruits or meat contaminated 

by feces from infected animals, such as 

cattle. The most recent large outbreak in 

the U.S. was from contaminated bag 

spinach. The conjugate is composed of 

the O-specific polysaccharide isolated 

from E. coli 0157, or other Shiga-toxin 

producing bacteria, conjugated to carrier 

proteins, such as non-toxic P. 

aeruginosa exotoxin A or Shiga toxin 1. 

A Phase I clinical trial, involving adult 

humans, showed the vaccine is safe and 

highly immunogenic. Adults, after one 

injection containing 25 μg of antigen, 

responded with high titers of 

bactericidal antibodies. Similarly in a 

phase II study, fifty 2-to-5- years old 

children in U.S. were injected with the 

conjugate vaccines. There were only 

mild local adverse reactions. More than 

90% of the children responded with 

greater than 10 fold rise of E. coli O157 

antibodies of bactericidal ability. Thus 

the conjugates of the invention are 

promising vaccines, especially for 

children and the elderly, who are most 

likely to suffer serious consequences 

from infection. 

Application: Prevention of E. coli 

O157 infection. 

Development Status: Clinical studies 

have been performed and are described 

in Konadu et al., J Infect Dis. 1998 Feb; 

177(2):383–387 and Ahmed et al., J 

Infect Dis. 2006 Feb; 193(2):515–526. 

Inventors: Shousun C. Szu, Edward 

Konadu, and John B. Robbins (NICHD). 

Patent Status: U.S. Patent 6,858,211 

issued 22 Feb 2005 (HHS Reference No. 

E–158–1998/0–US–06); U.S. Patent 

Application No. 10/987,428 filed 12 

Nov 2004 (HHS Reference No. E–158–

1998/0–US–07); U.S. Patent Application 

No. 11/015,436 filed 16 Dec 2004 (HHS 

Reference No. E–158–1998/0–US–08). 

Licensing Status: Available for nonexclusive or exclusive licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301/435–4646; 

soukasp@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Child Health 

and Human Development, Laboratory of 

Developmental and Molecular 

Immunity, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize Vaccine for E. coli O157 

for Children and Adults. Please contact 

John D. Hewes, Ph.D., at 301–435–3121 

or hewesj@mail.nih.gov for more 

information. 

Dated: May 11, 2007. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E7–9656 Filed 5–18–07; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN 

National Institutes of Health 

National Cancer Institute; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Cancer 

Advisory Board, June 14, 2007, 2 p.m. 

to June 15, 2007, 12 p.m., National 

Institutes of Health, Building 31, 31 

Center Drive, Bethesda, MD 20892, 

which was published in the Federal 

Register on May 2, 2007, 72 FR 24319. 

The notice is being amended to 

change the open session start and end 

times on June 14, 2007 to 1:15 p.m.—

4:20 p.m. and the end time on June 15, 

2007 to 11:45 a.m. The meeting is 

partially Closed to the public. 

Dated: May 14, 2007. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–2495 Filed 5–18–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

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 following 

meeting. 

The meeting will be closed to the 

public in accordance with the provision 

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: Heart, Lung, and 

Blood Initial Review Group; Clinical Trials 

Review Committee. 

Date: June 25, 2007. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Intercontinental Harbor Court, 550 

Light Street, Baltimore, MD 21202. 

Contact Person: Patricia A Haggerty, PhD, 

Section Chief, Clinical Studies and Training 

Scientific Review Group, Review Branch, 

Division of Extramural Research Activities, 

National Heart, Lung, and Blood Institute, 

NIH, 6701 Rockledge Drive, Room 7194, MSC 

7924, Bethesda, MD 20892, 301/435–0288, 

haggertp@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: May 14, 2007. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–2488 Filed 5–18–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung and Blood 

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 give 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 Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Mentored Scientist Award (K99). 

Date: June 28–29, 2007. 

Time: June 28, 2007, 12 p.m. to 10 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Washington Plaza, 10 Thomas Circle 

NW., Washington, DC 20005. 


pwalker on PROD1PC71 with NOTICES