Office of the Director Notice of Charter Renewal, 73087 [2014-28750]
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Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making 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
December 17, 2014. 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 December 18, 2014.
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 Stephanie L.
Begansky (see Contact Person) at least 7
days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: December 2, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
Medicine (BOR) was renewed for an
additional two-year period on
November 20, 2014.
It is determined that the BOR is in the
public interest in connection with the
performance of duties imposed on the
Department of Health and Human
Services by law, and that these duties
can best be performed through the
advice and counsel of this group.
Inquires may be directed to Jennifer S.
Spaeth, Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail Code 4875), Telephone (301) 496–
2123, or spaethj@od.nih.gov.
Dated: December 3, 2014.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–28750 Filed 12–8–14; 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,
HHS.
ACTION:
Notice.
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. 209 and 37 CFR part 404 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.
SUMMARY:
[FR Doc. 2014–28702 Filed 12–8–14; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4164–01–P
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
rljohnson on DSK3VPTVN1PROD with NOTICES
National Institutes of Health
Office of the Director Notice of Charter
Renewal
In accordance with Title 41 of the
U.S. Code of Federal Regulations,
Section 102–3.65(a), notice is hereby
given that the Charter for the Board of
Regents of the National Library of
VerDate Sep<11>2014
14:48 Dec 08, 2014
Jkt 235001
SUPPLEMENTARY INFORMATION:
Technology descriptions follow.
PO 00000
Frm 00062
Fmt 4703
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73087
Vaccine for Protection Against
Shigella sonnei Disease
Description of Technology:
Shigellosis is a global human health
problem. Transmission usually occurs
by contaminated food and water or
through person-to-person contact. The
bacterium is highly infectious by the
oral route, and ingestion of as few as 10
organisms can cause an infection in
volunteers. An estimated 200 million
people worldwide suffer from
shigellosis, with more than 650,000
associated deaths annually. A recent
CDC estimate indicates the occurrence
of over 440,000 annual shigellosis cases
in the United States alone,
approximately eighty percent (80%) of
which are caused by Shigella sonnei.
Shigella sonnei is more active in
developed countries. Shigella infections
are typically treated with a course of
antibiotics. However, due to the
emergence of multidrug resistant
Shigella strains, a safe and effective
vaccine is highly desirable. No vaccines
against Shigella infection currently
exist. Immunity to Shigellae is mediated
largely by immune responses directed
against the serotype specific Opolysaccharide. Claimed in the
invention are compositions and
methods for inducing an
immunoprotective response against S.
sonnei. Specifically, an attenuated
bacteria capable of expressing an S.
sonnei antigen comprised of the S.
sonnei form I O-polysaccharide
expressed from the S. sonnei rfb/rfc
gene cluster is claimed. The inventors
have shown that the claimed vaccine
compositions showed one hundred
percent (100%) protection against
parenteral challenge with virulent S.
sonnei in mice.
Potential Commercial Applications:
• Shigella/Typhoid vaccine for
travelers, military
• Shigella/Typhoid vaccine for
developing countries
• Shigella/Typhoid diagnostics
Competitive Advantages:
• Low cost of production
• Temperature stable formulation
• Safety/efficacy of Ty21a established
in humans
Development Stage: In vivo data
available (animal)
Inventors: Dennis J. Kopecko (FDA),
De Qi Xu (NIDCR), John O. Cisar
(NICHD)
Publication: Kopecko DJ, et al.
Molecular cloning and characterization
of genes for Shigella sonnei form I O
polysaccharide: proposed biosynthetic
pathway and stable expression in a live
salmonella vaccine vector. Infect
Immun. 2002 Aug;70(8):4414–23.
[PMID: 12117952]
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[Federal Register Volume 79, Number 236 (Tuesday, December 9, 2014)]
[Notices]
[Page 73087]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28750]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Office of the Director Notice of Charter Renewal
In accordance with Title 41 of the U.S. Code of Federal
Regulations, Section 102-3.65(a), notice is hereby given that the
Charter for the Board of Regents of the National Library of Medicine
(BOR) was renewed for an additional two-year period on November 20,
2014.
It is determined that the BOR is in the public interest in
connection with the performance of duties imposed on the Department of
Health and Human Services by law, and that these duties can best be
performed through the advice and counsel of this group.
Inquires may be directed to Jennifer S. Spaeth, Director, Office of
Federal Advisory Committee Policy, Office of the Director, National
Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda,
Maryland 20892 (Mail Code 4875), Telephone (301) 496-2123, or
spaethj@od.nih.gov.
Dated: December 3, 2014.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2014-28750 Filed 12-8-14; 8:45 am]
BILLING CODE 4140-01-P
