Mandatory Guidelines Effect. Date

75122

Federal Register / Vol. 73, No. 238 / Wednesday, December 10, 2008 / Notices

Collaborative Research Opportunity:
The NIAID, OTD, is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize this ‘‘Discovery of Novel
Pharmacophores Inhibiting the Growth
of Mycobacterium Tuberculosis’’. Please
contact Anna Amar at 301–451–3525 for
more information.

mstockstill on PROD1PC66 with NOTICES

A Varicella-Zoster Virus Mutant That Is
Markedly Impaired for Latent Infection
Available for the Development of
Shingles Vaccines and Diagnostics
Description of Technology:
Reactivation of latent Varicella-Zoster
virus (VZV) infection is the cause of
shingles, which is prominent in adults
over the age of 60 and individuals who
have compromised immune systems,
due to HIV infection, cancer treatment
and/or transplant. Shingles is a
worldwide health concern that affects
approximately 600,000 Americans each
year. The incidence of shingles is also
high in Europe, South America, and
India; the latter having an estimated two
million individuals affected, yearly.
Recent research studies show that VZV
vaccines have a significant effect on
decreasing the incidence of shingles in
elderly.
The current technology describes
compositions, cells and methods related
to the production and use of a mutant
VZV and the development of vaccines
against the infectious agent. Latent VZV
expresses a limited repertoire of viral
genes including the following six open
reading frames (ORFs): 4, 21, 29, 62, 63,
and 66. The present invention describes
an ORF29 mutant VZV that
demonstrates a weakened ability to
establish latency in animal studies. The
current technology provides methods
for using the mutant in the development
of live vaccines and diagnostic tools. A
related invention is described in PCT/
US05/021788 (publication number
WO2006012092).
Applications: Development of
vaccines and diagnostics for prevention
of shingles.
Development Status: Pre-clinical
studies have been performed to
demonstrate the reduced latency of the
ORF29 mutant VZV in animals.
Inventors: Jeffrey Cohen (NIAID) and
Lesley Pesnicak (NIAID).
Patent Status: U.S. Provisional
Application No. 60/857,766 filed 09
Nov 2006 (HHS Reference No. E–029–
2007/0–US–01); PCT Application No.
PCT/US2007/084331 filed 09 Nov 2007,
which published as WO 2008/079539
on 03 Jul 2008 (HHS Reference No. E–
029–2007/0–PCT–02).

VerDate Aug<31>2005

16:49 Dec 09, 2008

Jkt 217001

Licensing Status: Available for
licensing and commercial development.
Licensing Contact: Kevin W. Chang,
Ph.D.; 301–435–5018;
[email protected].
Collaborative Research Opportunity:
The NIAID Laboratory of Clinical
Infectious Diseases is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize vaccine strains of VZV
vaccine with impaired latency. Please
contact Kelly Murphy, J.D., M.S., at 301/
451–3523 or [email protected]
for more information.
Anti-Plasmodium Compositions and
Methods of Use
Description of Technology: The
present invention comprises peptides/
antibodies specific for the binding
proteins of Plasmodium, a parasite
responsible for malaria, hence in effect
blocking the parasite’s binding to the
erythrocytes. Also included are methods
for their use in preventing, diagnosing
or treating the related infections.
Although malaria is virtually
eradicated in the United States, it
continues to be one of the most serious
infectious diseases in the world, killing
millions of people each year in the
countries throughout Africa, Asia and
Latin America. In fact, over 41% of the
world population lives in the regions
affected by malaria. In vitro studies
using the antibodies described in the
current technology showed ∼80%
reduction in the number of blood cells
infected with Plasmodium parasite.
Infectivity studies using peptides
demonstrated that they are also
specifically able to prevent binding of
parasites to blood cells. The claimed
antibodies and peptides can also be
used for immunization of humans and
animals, or for development of
diagnostic kits capable of detecting the
presence, localization and quantity of
the Plasmodium parasites in tissues and
cells.
Applications: Diagnostics
development; Vaccines development.
Inventors: David L. Narum and Kim
Lee Sim (NIAID).
Relevant Publications:
1. Sim BK, Narum DL, Liang H,
Fuhrmann SR, Obaldia N 3rd,
Gramzinski R, Aguiar J, Haynes JD,
Moch JK, Hoffman SL. Induction of
biologically active antibodies in mice,
rabbits, and monkeys by Plasmodium
falciparum EBA–175 region II DNA
vaccine. Mol Med. 2001 Apr;7(4):247–
254.
2. Narum DL, Haynes JD, Fuhrmann
S, Moch K, Liang H, Hoffman SL, Sim
BK. Antibodies against the Plasmodium

PO 00000

Frm 00046

Fmt 4703

Sfmt 4703

falciparum receptor binding domain of
EBA–175 block invasion pathways that
do not involve sialic acids. Infect
Immun. 2000 Apr;68(4):1964–1966.
3. Liang H, Narum DL, Fuhrmann SR,
Luu T, Sim BK. A recombinant
baculovirus-expressed Plasmodium
falciparum receptor-binding domain of
erythrocyte binding protein EBA–175
biologically mimics native protein.
Infect Immun. 2000 Jun;68(6):3564–
3568.
Patent Status: HHS Reference No. E–
004–2004/2—
• U.S. Patent No. 7,025,961 issued 11
Apr 2006
• Australian Patent No. 20042011615
issued 11 May 2007
• Canadian Application No.
CA236247
• Japanese Application No. JP2000–
602280 (published as JP,2002–
540770,A)
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: RC Tang, JD, LLM;
301–435–5031; [email protected]
Dated: December 1, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–29146 Filed 12–9–08; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Mandatory Guidelines for Federal
Workplace Drug Testing Programs
Correction
In notice document E8–26726
beginning on page 71858 in the issue
ofTuesday, November 25, 2008, make
the following correction:
On page 71858, in the first column,
under the DATES heading, in the first
line, ‘‘Effective Date: March 25, 2008’’
shouldread ‘‘Effective Date: May 1,
2010’’.
[FR Doc. Z8–26726 Filed 12–9–08; 8:45 am]
BILLING CODE 1505–01–D

E:\FR\FM\10DEN1.SGM

10DEN1