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Federal Register / Vol. 71, No.

244 / Wednesday, December 20, 2006 / Notices 76349

some refinements in protein resolution ADDRESSES: Licensing information and Preliminary results shows the vaccine is
are still possible which may involve copies of the U.S. patent applications safe in 2 months old infants.
procedural, reagent or equipment listed below may be obtained by writing Inventors: Zuzana Kossaczka,
modifications. to the indicated licensing contact at the Shousun C. Szu, and John B. Robbins
Inventors: B. Alex Merrick (NIEHS), Office of Technology Transfer, National (NICHD).
Rachel Patterson (NIEHS), Robert Hall Institutes of Health, 6011 Executive Patent Status: U.S. Patent 6,797,275
(NIEHS), Chaoying He (NIEHS), James Boulevard, Suite 325, Rockville, issued 28 Sep 2004 (HHS Reference No.
Selkirk (NIEHS). Maryland 20852–3804; telephone: 301/ E–020–1999/0–US–02); U.S. Patent
Publication: BA Merrick, RM 496–7057; fax: 301/402–0220. A signed Application No. 10/866,343 filed 10 Jun
Patterson, LL Witcher, C He, JK Selkirk. Confidential Disclosure Agreement will 2004 (HHS Reference No. E–020–1999/
Separation and sequencing of familiar be required to receive copies of the 0–US–03).
and novel murine proteins using patent applications. Licensing Status: Available for non-
preparative two-dimensional gel exclusive licensing.
electrophoresis. Electrophoresis. 1994 A Method of Immunizing Humans Licensing Contact: Peter A. Soukas,
May;15(5):735–745. Against Salmonella Typhi Using a Vi- J.D.; 301/435–4646;
Patent Status: U.S. Patent No. rEPA Conjugate Vaccine soukasp@mail.nih.gov.
5,534,121 issued 09 July 1996, claiming Description of Technology: This Collaborative Research Opportunity:
priority to 16 May 1994 (HHS Reference invention is a method of immunization The National Institute of Child Health
No. E–066–1994/0–US–01). against typhoid fever using a conjugate and Human Development, Laboratory of
Licensing Status: Available for non- vaccine comprising the capsular Developmental and Molecular
exclusive or exclusive licensing. polysaccharide of Salmonella typhi, Vi, Immunity, is seeking statements of
Licensing Contact: Michael A. conjugated through an adipic capability or interest from parties
Shmilovich; 301/435–5019; dihydrazide linker to nontoxic interested in collaborative research to
shmilovm@mail.nih.gov. recombinant exoprotein A (rEPA) from further develop, evaluate, or
Collaborative Research Opportunity: Pseudomonas aeruginosa. The three commercialize A Method of Immunizing
The NIEHS National Center for licensed vaccines against typhoid fever, Humans Against Salmonella Typhi
Toxicogenomics, Proteomics Group, attenuated S. typhi Ty21a, killed whole Using a Vi-rEPA Conjugate Vaccine.
may consider statements of capability or cell vaccines and Vi polysaccharide, Please contact Betty Tong, PhD at 301–
interest from parties interested in have limited efficacy, in particular for 594–4263 for more information.
collaborative research to further children under 5 years of age, which
develop, evaluate, or commercialize this Vaccine Against Escherichia Coli
make an improved vaccine desirable. O157 Infection, Composed of Detoxified
preparative two-dimensional gel It is generally recognized that an
electrophoresis system. Please contact LPS Conjugated to Proteins
effective vaccine against Salmonella
John Penta, NIEHS Office of typhi is one that increases serum anti- Description of Technology: This
Translational Research, at 919/541–3696 Vi IgG eight-fold six weeks after invention is a conjugate vaccine to
or penta@niehs.nih.gov for additional immunization. The conjugate vaccine of prevent infection by E. coli O157:H7,
information. the invention increases anti-Vi IgG, 48- particularly in young children under 5
Dated: December 8, 2006. fold, 252-fold and 400-fold in adults, in years of age. E. coli O157:H7 is an
Steven M. Ferguson, 5–14 years old and 2–4 years old emerging human pathogen which causes
children, respectively. Thus this is a a spectrum of illnesses with high
Director, Division of Technology Development
and Transfer, Office of Technology Transfer, highly effective vaccine suitable for morbidity and mortality, ranging from
National Institutes of Health. children and should find utility in diarrhea to hemorrhagic colitis and
[FR Doc. E6–21665 Filed 12–19–06; 8:45 am] endemic regions and as a traveler’s hemolytic-uremic syndrome (HUS).
BILLING CODE 4140–01–P vaccine. The route of administration can Infection with E. coli O157:H7 occurs as
also be combined with routine a result of consumption of water,
immunization. In 2–5 years old, the vegetables, fruits or meat contaminated
DEPARTMENT OF HEALTH AND protection against typhoid fever is 90% by feces from infected animals, such as
HUMAN SERVICES for 4 years. In school age children and cattle. The most recent large outbreak in
in adults the protection could mount to the U.S. was from contaminated bag
National Institutes of Health completer protection according to the spinach. The conjugate is composed of
immunogenicity data. the O-specific polysaccharide isolated
Government-Owned Inventions; Application: Immunization against from E. coli O157, or other Shiga-toxin
Availability for Licensing Salmonella typhi for long term producing bacteria, conjugated to carrier
AGENCY: National Institutes of Health, prevention of typhoid fever in all ages. proteins, such as non-toxic P.
Public Health Service, HHS. Developmental Status: Conjugates aeruginosa exotoxin A or Shiga toxin 1.
ACTION: Notice. have been synthesized and clinical A Phase I clinical trial, involving adult
studies have been performed. The humans, showed the vaccine is safe and
SUMMARY: The inventions listed below synthesis of the conjugates is described highly immunogenic. Adults, after one
are owned by an agency of the U.S. by Kossaczka et al. in Infect Immun. injection containing 25 µg of antigen,
Government and are available for 1997 June;65(7):2088–2093. Phase III responded with high titers of
licensing in the U.S. in accordance with clinical studies are described by Mai et bactericidal antibodies. Similarly in a
35 U.S.C. 207 to achieve expeditious al. in N Engl J Med. 2003 October 2; phase II study, fifty 2 to 5 years-old
commercialization of results of 349(14):1390–1391. Dosage studies are children in U.S. were injected with the
federally-funded research and described by Canh et al. in Infect conjugate vaccines. There were only
sroberts on PROD1PC70 with NOTICES

development. Foreign patent Immun. 2004 Nov;72(11):6586–6588. mild local adverse reactions. More than
applications are filed on selected A safety and immunogenicity study in 90% children responded with greater
inventions to extend market coverage infants are underway. The aim is to than 10 fold rise of E. coli O157
for companies and may also be available administer the conjugate vaccine with antibodies of bactericidal ability. Thus
for licensing. routine infant immunization. the conjugates of the invention are

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76350 Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Notices

promising vaccines, especially for A portion of the meeting will be In the interest of security, NIH has
children and the elderly, who are most closed to the public in accordance with instituted stringent procedures for entrance
likely to suffer serious consequences the provisions set forth in sections into the building by nongovernment
employees. Persons without a government
from infection. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., I.D. will need to show a photo I.D. and sign-
Application: Prevention of E. coli as amended. The grant applications in at the security desk upon entering the
O157 infection. and/or contract proposals and the building.
Development Status: Clinical studies discussion could disclose confidential
have been performed and are described Dated: December 13, 2006.
trade secrets or commercial property
in Konadu et al., J Infect Dis. 1998 Anna Snouffer,
such as patentable material, and
Feb;177(2):383–387 and Ahmed et al., J personal information concerning Acting Director, Office of Federal Advisory
Infect Dis. 2006 Feb;193(2):515–526. Committee Policy.
individuals associated with the grant
Inventors: Shousun C. Szu, Edward applications and/or contract proposals, [FR Doc. 06–9773 Filed 12–19–06; 8:45 am]
Konadu, and John B. Robbins (NICHD). the disclosure of which would BILLING CODE 4140–01–M
Patent Status: U.S. Patent 6,858,211 constitute a clearly unwarranted
issued 22 Feb 2005 (HHS Reference No. invasion of personal privacy.
E–158–1998/0–US–06); U.S. Patent DEPARTMENT OF HEALTH AND
Application No. 10/987,428 filed 12 Name of Committee: National Advisory HUMAN SERVICES
Nov 2004 (HHS Reference No. E–158– Council for Complementary and Alternative
Medicine. National Institutes of Health
1998/0–US–07). Date: February 2, 2007.
Licensing Status: Available for non- Closed: 9 a.m. to 12 p.m.
exclusive or exclusive licensing. National Institute of Allergy and
Agenda: To review and evaluate grant Infectious Diseases; Notice of
Licensing Contact: Peter A. Soukas, applications and/or proposals.
J.D.; 301/435–4646; Meetings
Open: 1 p.m. to 4:30 p.m.
soukasp@mail.nih.gov. Agenda: Opening remarks by the Acting Pursuant to section 10(d) of the
Collaborative Research Opportunity: Director of National Center for Federal Advisory Committee Act, as
The National Institute of Child Health Complementary and Alternative Medicine, amended (5 U.S.C. Appendix 2), notice
and Human Development, Laboratory of presentations of new research initiatives, and
other council related business.
is hereby given of meetings of the
Developmental and Molecular National Advisory Allergy and
Immunity, is seeking statements of Place: National Institutes of Health,
Neuroscience Building, 6001 Executive Infectious Diseases Council.
capability or interest from parties Boulevard, Rooms C & D, Rockville, MD The meetings will be open to the
interested in collaborative research to 20852. public as indicated below, with
further develop, evaluate, or Contact Person: Martin H. Goldrosen, attendance limited to space available.
commercialize Vaccine for E. coli O157 Executive Secretary, National Center for Individuals who plan to attend and
for Children and Adults. Please contact Complementary and Alternative Medicine, need special assistance, such as sign
Betty Tong, PhD at 301–594–4263, National Institutes of Health, 6707 language interpretation or other
tongb@mail.nih.gov for more Democracy Blvd., Suite 401, Bethesda, MD
20892. (301) 594–2014. reasonable accommodations, should
information. notify the Contact Person listed below
The public comments session is scheduled
Dated: December 8, 2006.
from 4–4:30 p.m., but could change in advance of the meeting.
Steven M. Ferguson, depending on the actual time spent on each The meetings will be closed to the
Director, Division of Technology Development agenda item. Each speaker will be permitted public in accordance with the
and Transfer, Office of Technology Transfer, 5 minutes for their presentation. Interested provisions set forth in sections
National Institutes of Health. individuals and representatives of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
[FR Doc. E6–21666 Filed 12–19–06; 8:45 am] organizations are requested to notify Dr. as amended. The grant applications and
BILLING CODE 4140–01–P
Martin H. Goldrosen, National Center for the discussions could disclose
Complementary and Alternative Medicine, confidential trade secrets or commercial
NIH, 6707 Democracy Boulevard, Suite 401,
property such as patentable material,
Bethesda, Maryland 20892, 301–594–2014,
DEPARTMENT OF HEALTH AND Fax: 301–480–9970. Letters of intent to and personal information concerning
HUMAN SERVICES present comments, along with a brief individuals associated with the grant
description of the organization represented, applications, the disclosure of which
National Institutes of Health should be received no later than 5 p.m. on would constitute a clearly unwarranted
January 31, 2007. Only one representative of invasion of personal privacy.
National Center for Complementary & an organization may present oral comments. Name of Committee: National Advisory
Alternative Medicine; Notice of Meeting Any person attending the meeting who does Allergy and Infectious Diseases Council.
not request an opportunity to speak in Date: January 29, 2007.
Pursuant to Section 10(d) of the advance of the meeting may be considered
Federal Advisory Committee Act, as Open: 10:30 a.m. to 11:40 a.m.
for oral presentation, if time permits, and at Agenda: Report from the Institute Director
amended (5 U.S.C. Appendix 2), notice the discretion of the Chairperson. In and the Director of Center for Scientific
is hereby given of the National Advisory addition, written comments may be Research.
Council for Complementary and submitted to Dr. Martin H. Goldrosen at the Place: National Institutes of Health,
Alternative Medicine (NACCAM) address listed above up to ten calendar days Natcher Building, 45 Center Drive,
meeting. (February 12, 2007) following the meeting. Conference Rooms E1/E2, Bethesda, MD
The meeting will be open to the Copies of the meeting agenda and roster of 20892.
public as indicated below, with members will be furnished upon request by Closed: 11:40 a.m. to 12 p.m.
attendance limited to space available. contacting Dr. Martin H. Goldrosen, Agenda: To review and evaluate grant
Executive Secretary, NACCAM, National applications and/or proposals.
Individuals who plan to attend and
sroberts on PROD1PC70 with NOTICES

Center for Complementary and Alternative Place: National Institutes of Health,


need special assistance, such as sign Medicine, National Institutes of Health, 6707 Natcher Building, 45 Center Drive,
language interpretation or other Democracy Boulevard, Suite 401, Bethesda, Conference Rooms E1/E2, Bethesda, MD
reasonable accommodations, should Maryland 20892, 301–594–2014, Fax 301– 20892.
notify the Contact Person listed below 480–9970, or via e-mail at Contact Person: Paula S. Strickland,
in advance of the meeting. naccames@mail.nih.gov. Extramural Science Administrator for Special

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