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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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41338 Federal Register / Vol. 72, No. 144 / Friday, July 27, 2007 / Notices

stimulator, coupled to the movement Licensing Contact: Michael A. Dated: July 19, 2007.
sensor, for applying pressure to a Shmilovich, Esq.; 301/435–5019; Jennifer Spaeth,
patient’s larynx prior to swallowing. shmilovm@mail.nih.gov. Director, Office of Federal Advisory
The device can also be used to Collaborative Research Opportunity: Committee Policy.
automatically trigger and retrain For research and development [FR Doc. 07–3668 Filed 7–26–07; 8:45 am]
swallowing to prevent aspiration collaborations with inventors, contact BILLING CODE 4140–01–M
pneumonia post stroke or post Heather Gunas at 301–435–3944 or e-
extubation. mail at gunash@mail.nih.gov.
Method: For the method patent, the
Dated: July 19, 2007. DEPARTMENT OF HEALTH AND
instant device has also been claimed in
a patent application asserting rights for Steven M. Ferguson, HUMAN SERVICES
improving voluntary initiation of Director, Division of Technology Development National Institutes of Health
swallowing in neurologically impaired and Transfer, Office of Technology Transfer,
patients. Swallowing recovery alleviates National Institutes of Health.
National Institute on Alcohol Abuse
the risk of aspiration by augmenting [FR Doc. E7–14501 Filed 7–26–07; 8:45 am] and Alcoholism; Notice of Closed
volitional control using a simultaneous BILLING CODE 4140–01–P Meeting
motor act (e.g., such as pressing a button
to indicate when they are ready to Pursuant to section 10(d) of the
swallow). It is believed that such motor DEPARTMENT OF HEALTH AND Federal Advisory Committee Act, as
training also initiates sensory HUMAN SERVICES amended (5 U.S.C. Appendix 2), notice
stimulation, immediately preceding the
motor act, and that such sensory National Institutes of Health is hereby given of the following
stimulation enhances excitation of a meeting.
central pattern generator in the brain National Heart, Lung, and Blood The meeting will be closed to the
stem that augments the volitional Institute; Notice of Closed Meeting public in accordance with the
control of swallowing. This principle is provisions set forth in sections
applicable to other neurological Pursuant to section 10(d) of the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
impairments; their associated Federal Advisory Committee Act, as as amended. The grant applications and
enhancement of voluntary motor act amended (5 U.S.C. Appendix 2), notice the discussions could disclose
control by the patient initiating is hereby given of the following confidential trade secrets or commercial
immediately concurrent and related meeting. property such as patentable material,
sensory stimulations. Neurological The meeting will be closed to the and personal information concerning
impairments that are contemplated public in accordance with the individuals associated with the grant
include reflex actions involving provisions set forth in sections applications, the disclosure of which
interactions between afferent and 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., would constitute a clearly unwarranted
efferent paths (at the spinal cord or in as amended. The grant applications and
the brain stem) as well as higher order invasion of personal privacy.
the discussions could disclose
interactions. This invention includes confidential trade secrets or commercial Name of Committee: National Institute on
methods for treating neurologically property such as patentable material, Alcohol Abuse and Alcoholism Special
impaired humans using devices such as and personal information concerning Emphasis Panel, Review of SBIR/STTIR
those that produce vibratory individuals associated with the grant Applications; RFA AA–07–009/10.
stimulation, pressure stimulation, applications, the disclosure of which Date: August 13, 2007.
auditory stimulation, temperature Time: 2 p.m. to 5 p.m.
would constitute a clearly unwarranted
stimulation, visual stimulation, Agenda: To review and evaluate grant
invasion of personal privacy.
olfactory stimulation, taste stimulation, applications.
or a combination of these. Combinations Name of Committee: National Heart, Lung, Place: National Institutes of Health, 5635
of two or more stimulation types are and Blood Institute Special Emphasis Panel, Fishers Lane, Bethesda, MD 20892,
particularly useful. For example, the Mentored Patient Oriented Research Career (Telephone Conference Call).
Development Award (K23’s). Contact Person: Philippe Marmillot, PhD,
combined use of button press training
Date: August 23, 2007. Scientific Review Administrator, National
with simultaneous vibratory and
Time: 11 a.m. to 12 p.m. Institutes of Health, National Institute on
pressure stimulation on the neck to
Agenda: To review and evaluate grant Alcohol Abuse and Alcoholism, 5635 Fishers
augment feedback to the brain stem applications.
swallowing centers to facilitate Lane, RM 3045, Bethesda, MD 20892, 301–
Place: National Institutes of Heart,
voluntary control of swallowing 443–2861, marmillotp@mail.nih.gov.
Rockledge Center 2, 6701 Rockledge Drive,
(thought to be largely an involuntary Bethesda, MD 20892, (Telephone Conference (Catalogue of Federal domestic Assistance
brain stem function) is particularly Call). Program Nos. 93.271, Alcohol Research
useful for treating dysphagic patients. Contact Person: Mark Roltsch, PhD, Career Development Awards for Scientists
Alternatively automatic cycles of Scientific Review Administrator, Review and Clinicians; 93.272, Alcohol National
stimulation at intervals during the day Branch/DERA, National Heart, Lung, and Research Service Awards for Research
can be used for intensive retraining of Blood Institute, 6701 Rockledge Drive, Room Training; 93.273, Alcohol Research Programs;
swallowing post stroke or post- 7192, Bethesda, MD 20892–7924, 301–435– 93.891, Alcohol Research Center Grants,
extubation to prevent aspiration. 0287, roltschm@nhibi.nih.gov. National Institutes of Health, HHS)
Inventors: Christy Ludlow (NINDS), (Catalogue of Federal Domestic Assistance Dated: July 20, 2007.
Christopher Poletto (NINDS), Ianessa Program Nos. 92.233, National Center for
jlentini on PROD1PC65 with NOTICES

Anna Snouffer,
Humbert (NINDS), Newlin Morgan Sleep Disorders Research; 93.837, Heart and
(NIMH). Vascular Diseases Research; 93.838, Lung Acting Director, Office of Federal Advisory
Patent Status: PCT Application No. Diseases Research; 93.839, Blood Diseases Committee Policy.
PCT/US2006/025535 (HHS Reference and Resources Research, National Institutes [FR Doc. 07–3667 Filed 7–26–07; 8:45 am]
No. E–251–2005/1–PCT–02). of Health, HHS) BILLING CODE 4140–01–M

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