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41336 Federal Register / Vol. 72, No.

144 / Friday, July 27, 2007 / Notices

DEPARTMENT OF HEALTH AND Louis D. Coccodrilli, Designated Federal production of an efficient anthrax
HUMAN SERVICES Official for the ACICBL, Bureau of vaccine is an ultimate goal, the benefits
Health Professions, Health Resources of vaccination can be expected only if
Health Resources and Services and Services Administration, Parklawn a large proportion of the population at
Administration Building, Rm 9–05, 5600 Fishers Lane, risk is immunized. The low incidence of
Rockville, Maryland 20857; (301) 443– anthrax suggests that large-scale
Advisory Committee on 6950 or lcoccodrilli@hrsa.gov. Vanessa vaccination may not be the most
Interdisciplinary, Community-Based Saldanha, Public Health Fellow can also efficient means of controlling this
Linkages; Notice of Meeting be contacted for inquiries at (301) 443– disease. In contrast, passive
In accordance with section 10(a)(2) of 6529 or vsaldanha@hrsa.gov. administration of neutralizing human or
the Federal Advisory Committee Act Dated: July 24, 2007. chimpanzee monoclonal antibody to a
(Pub. L. 92–463), notice is hereby given Alexandra Huttinger, subject at risk for anthrax or exposed to
of the following meeting: anthrax could provide immediate
Acting Director, Division of Policy Review
and Coordination. efficacy for emergency prophylaxis
Name: Advisory Committee on
Interdisciplinary, Community-Based against or treatment of anthrax.
[FR Doc. E7–14528 Filed 7–26–07; 8:45 am]
Linkages (ACICBL). Four monoclonal antibodies (mAbs)
Dates and Times: August 13, 2007, 1 p.m.- against PA, three mAbs against LF and
5 p.m., EST. four mAbs specific for EF of anthrax
Place: (Audio Conference Call). were isolated from a phage display
The ACICBL will meet on Monday, August DEPARTMENT OF HEALTH AND
library generated from immunized
13, 2007 from 1 p.m. to 5 p.m. (EST). The HUMAN SERVICES
chimpanzees. Two mAbs recognizing
public can join the meeting via audio
National Institutes of Health PA (W1 and W2), two anti-LF mAbs
conference by dialing 1–888–697–8510 and
providing the following information: efficiently neutralized the cytotoxicity
Leader’s Name: Mr. Lou Coccodrilli. Government-Owned Inventions; of lethal toxin in a macrophage lysis
Passcode: 43495. Availability for Licensing assay. One anti-EF mAb efficiently
Status: The meeting will be open to the neutralized edema toxin in cell culture.
public; teleconference access limited only by AGENCY: National Institutes of Health, All five neutralizing mAbs protected
availability of telephone ports. Public Health Service, HHS. animals from anthrax toxin challenge.
Purpose: The Committee will continue to ACTION: Notice. Application: Prophylactics or
focus on issues related to Health Information therapeutics against B. anthracis.
Technology/Electronic Medical Records SUMMARY: The inventions listed below
Developmental Status: Preclinical
(HIT/EMR) and its potential impact on Title are owned by an agency of the U.S.
VII Interdisciplinary, Community-Based studies have been performed.
Government and are available for
Training Grant Programs identified under Inventors: Zhaochun Chen, Robert
licensing in the U.S. in accordance with
sections 751–756, Part D of the Public Health Purcell, Suzanne Emerson, Stephen
35 U.S.C. 207 to achieve expeditious
Service Act. The Committee may invite Leppla, Mahtab Moyeri (NIAID).
commercialization of results of federally Publication: Z Chen et al. Efficient
speakers to highlight various topics related to
HIT/EMR including, but not limited to funded research and development. neutralization of anthrax toxin by
benefits and barriers; consumer privacy and Foreign patent applications are filed on chimpanzee monoclonal antibodies
confidentiality; implications on underserved selected inventions to extend market against protective antigen. J Infect Dis.
and unserved populations, rural, geriatric coverage for companies and may also be 2006 Mar 1;193(5):625–633. Epub 2006
and other populations; implementation and available for licensing.
use of EMRs across various settings, i.e.,
Feb 2.
ADDRESSES: Licensing information and Patent Status: U.S. Provisional
hospitals, inpatient settings and ambulatory
copies of the U.S. patent applications Application No. 60/903,022 filed 23 Feb
care sites (Health Centers, Rural Health
Clinics); academic settings, i.e., listed below may be obtained by writing 2007 (HHS Reference No. E–123–2007/
interdisciplinary and community-based to the indicated licensing contact at the 0–US–01); U.S. Patent Application filed
education and training of health Office of Technology Transfer, National 22 Jun 2007 (HHS Reference No. E–146–
professionals; health literacy and patient Institutes of Health, 6011 Executive 2004/0–US–03).
education; as well as the future of HIT/EMR Boulevard, Suite 325, Rockville, Licensing Status: Available for
as an interoperable system to enhance health Maryland 20852–3804; telephone: 301/ exclusive or non-exclusive licensing.
care delivery. The meeting will allow 496–7057; fax: 301/402–0220. A signed Licensing Contact: Peter A. Soukas,
committee members the opportunity to
Confidential Disclosure Agreement will J.D.; 301/435–4646;
identify and discuss current efforts involving
HIT/EMR and formulate appropriate be required to receive copies of the soukasp@mail.nih.gov.
recommendations for the Secretary and the patent applications. Collaborative Research Opportunity:
Congress regarding the use of advanced The National Institute of Allergy and
Monoclonal Antibodies that Neutralize
technology to enhance interdisciplinary and Infectious Diseases, Laboratory of
community-based training of health
B. anthracis Protective Antigen (PA),
Infectious Diseases is seeking statements
professions students and practicing health Lethal Factor (LF) and Edema Factor
of capability or interest from parties
professionals. (EF)
interested in collaborative research to
Agenda: The agenda includes an overview Description of Technology: Anthrax, further develop, evaluate, or
of the Committee’s general business whether resulting from natural or
activities, presentations by experts on HIT/ commercialize Chimpanzee/human
EMR related topics, and discussion sessions
bioterrorist-associated exposure, is a neutralizing monoclonal antibodies
for the development of recommendations to constant threat to human health. The against anthrax toxins. Please contact
be addressed in the Seventh Annual ACICBL lethality of anthrax is primarily the Dr. Robert Purcell at 301–496–5090 for
Report. result of the effects of anthrax toxin, more information.
jlentini on PROD1PC65 with NOTICES

Agenda items are subject to change as which has 3 components: a receptor-

dictated by the priorities of the Committee. binding protein known as ‘‘protective Use of Amyloid Proteins as Vaccine
FOR FURTHER INFORMATION CONTACT: antigen’’ (PA) and 2 catalytic proteins Scaffolds
Anyone requesting information known as ‘‘lethal factor’’ (LF) and Description of Technology: Amyloid
regarding the Committee should contact ‘‘edema factor’’ (EF). Although proteins are composed of peptides

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Federal Register / Vol. 72, No. 144 / Friday, July 27, 2007 / Notices 41337

whose chemical properties are such that Collaborative Research Opportunity: the level of overexpression. As the
they spontaneously aggregate in vitro or The FDA, Division of Therapeutic pathology in these mice results from the
in vivo, assuming parallel or antiparallel Proteins (CDER) and Office of Vaccines, overexpression of a single gene, it
beta sheet configurations. Amyloid Division of Bacterial Products (CBER) is represents a superior model for lupus
proteins can arise from peptides which, seeking statements of capability or and other autoimmune diseases
though differing in primary amino acid interest from parties interested in compared to other existing mouse
sequences, assume the same tertiary and collaborative research to further models that dysregulate multiple genes
quaternary structures. The amyloid develop, evaluate, or commercialize to achieve the same pathologic
structure presents a regular array of amyloid based vaccines for prevention syndrome.
accessible N-termini of the peptide of infectious disease or treatment of Two strains are currently available.
molecules. malignant states. Please contact Amy The TLR7.Tg1 strain overexpresses
Claimed in this application are Rosenberg at TLR7 at approximately 16 times the
compositions and methods for use of amy.rosenberg@fda.hhs.gov or (301) wild-type level. The TLR7.Tg6 strain
amyloid proteins as vaccine scaffolds, 827–1794 for more information. overexpresses TLR7 at approximately 4
on which peptide determinants from times the level of a wild-type mouse;
Dated: July 19, 2007.
microorganisms or tumors may be additionally, the transgene for this
presented to more efficiently generate Steven M. Ferguson,
strain is located on the Y chromosome,
and produce a sustained neutralizing Director, Division of Technology Development which would be advantageous for cross-
antibody response to prevent infectious and Transfer, Office of Technology Transfer,
National Institutes of Health.
breeding to other mouse lines.
diseases or treat tumors. The inventors Inventors: Jonathan Deane et al.
have arrayed peptides to be optimally [FR Doc. E7–14500 Filed 7–26–07; 8:45 am] (NIAID).
immunogenic on the amyloid protein BILLING CODE 4140–01–P Related Publication: P. Pisitkun et al.
scaffold by presenting antigen using Autoreactive B cell responses to RNA-
three different approaches. First, the N- related antigens due to TLR7 gene
terminal ends of the amyloid forming DEPARTMENT OF HEALTH AND duplication. Science 2006 Jun
peptides can be directly modified with HUMAN SERVICES 16;312(5780):1669–1672.
the peptide antigen of interest; second, Patent Status: HHS Reference No. E–
National Institutes of Health
the N-termini of the amyloid forming 128–2007/0—Research Tool.
peptides are modified with a linker to Government-Owned Inventions; Licensing Status: This technology is
which the peptide antigens of interest Availability for Licensing available for nonexclusive licensing.
are linked; and third, the scaffold Licensing Contact: Tara L. Kirby,
amyloid may be modified to create a AGENCY: National Institutes of Health, Ph.D.; 301/435–4426;
chimeric molecule. Public Health Service, HHS. tarak@mail.nih.gov.
Aside from stability and enhanced ACTION: Notice.
Dysphagia Rehabilitation (Swallowing
immunogenicity, the major advantages Recovery): Vibro-Tactile Stimulation
of this approach are the synthetic nature SUMMARY: The inventions listed below
are owned by an agency of the U.S. Device and Method for Motor Control
of the vaccine and its low cost. Thus, Recovery
concerns regarding contamination of Government and are available for
vaccines produced from cellular licensing in the U.S. in accordance with Description of Technology: Available
substrates, as are currently employed for 35 U.S.C. 207 to achieve expeditious for licensing and/or commercial
some vaccines, are eliminated; the commercialization of results of development under a scientific
robust stability allows the amyloid federally-funded research and collaboration, are device and method
based vaccine to be stored at room development. Foreign patent patents for volitional swallowing with a
temperature for prolonged periods of applications are filed on selected substitute sensory system. The
time; and the inexpensive synthetic inventions to extend market coverage inventions are potentially applicable to
amino acid starting materials, and their for companies and may also be available a wide variety of indications, including
rapid spontaneous aggregation in vitro for licensing. recovery post-stroke and post ex-
should provide substantial cost savings ADDRESSES: Licensing information and tubation for example, after coronary
over the resource and labor-intensive copies of the U.S. patent applications bypass surgery. The device is being
current vaccine production platforms. listed below may be obtained by writing tested in dysphagic patients in two, on-
Application: Immunization to prevent to the indicated licensing contact at the going clinical trials at the National
infectious diseases or treat chronic Office of Technology Transfer, National Institutes of Health. A collaborator or
conditions or cancer. Institutes of Health, 6011 Executive licensee is needed to support further
Developmental Status: Vaccine Boulevard, Suite 325, Rockville, clinical trials, validation studies, and
candidates have been synthesized and Maryland 20852–3804; telephone: 301/ final package development.
preclinical studies have been 496–7057; fax: 301/402–0220. A signed Device: For the device patent, upon
performed. Confidential Disclosure Agreement will activation a vibrator moves and vibrates
Inventors: Amy Rosenberg (CDER/ be required to receive copies of the the larynx. Patients can initiate sensory
FDA), James E. Keller (CBER/FDA), patent applications. stimulation immediately prior to the
Robert Tycko (NIDDK). patient’s own initiation of a swallow.
Transgenic Mouse Model for Lupus and Specifically, the device allows the
Patent Status: U.S. Provisional
Other Autoimmune Diseases patient to coordinate muscular
Application No. 60/922,131 filed 06 Apr
2007 (HHS Reference No. E–106–2007/ Description of Technology: The movement with a button press to permit
0–US–01). inventors have developed a series of volitional swallowing. The device can
jlentini on PROD1PC65 with NOTICES

Licensing Status: Available for transgenic mice that overexpress Toll- also include a movement sensor for
exclusive or non-exclusive licensing. Like Receptor 7 (TLR7) at different monitoring pressure on the patient’s
Licensing Contact: Peter A. Soukas, levels. Overexpression of TLR7 in these larynx and a swallowing detector. The
J.D.; 301/435–4646; mice results in a lupus-like syndrome, swallowing detector includes a
soukasp@mail.nih.gov. the intensity of which correlates with piezoelectric stretch receptor and a

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