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56774 Federal Register / Vol. 72, No.

192 / Thursday, October 4, 2007 / Notices

requirements, cost data, and fiscal year (due in July of each year) also The quarterly report represents the
coordination with Medicaid. Each requests information that only changes best method for HRSA to determine how
quarterly report requests updates from annually (e.g., State funding, drug ADAP grants are being expended and to
programs on number of patients served, formulary, eligibility criteria for provide answers to requests from
type of pharmaceuticals prescribed, and enrollment, and cost-saving strategies Congress and other organizations.
prices paid to provide medication. The including coordinating with Medicaid). The estimated annual burden is as
first quarterly report of each ADAP follows:

Responses
Number of Total Hours per Total burden
Form per
respondents responses response hours
respondent

1st Quarterly Report ........................................................ 57 1 57 3 171


2nd, 3rd, & 4th Quarterly Reports ................................... 57 3 171 1.5 256.5
Total .......................................................................... 57 ........................ 228 .......................... 427.5

Send comments to Susan G. Queen, Hepatitis C Virus Cell Culture System Use of CpG Oligodeoxynucleotides To
PhD, HRSA Reports Clearance Officer, Description of Technology: Hepatitis Induce Epithelial Cell Growth
Room 10–33, Parklawn Building, 5600 C virus (HCV) infection causes chronic
Fishers Lane, Rockville, MD 20857. Description of Invention: Wound
liver disease and is a major global health repair is the result of complex
Written comments should be received problem with an estimated 170 million
within 60 days of this notice. interactions and biologic processes.
people affected worldwide and 3–4
Three phases have been described in
Dated: September 28, 2007. million new cases every year.
normal wound healing: acute
Alexandra Huttinger, Therapeutic advances will be greatly
inflammatory phase, extracellular
aided by the ability of researchers to
Acting Director, Division of Policy Review matrix and collagen synthesis, and
and Coordination. successfully replicate and characterize
remodeling. The process involves the
the virus in vitro. The study of HCV
[FR Doc. E7–19599 Filed 10–3–07; 8:45 am] interaction of keratinocytes, fibroblasts
replication has, however, been hindered
BILLING CODE 4165–15–P and inflammatory cells at the wound
by the lack of an efficient virus culture
system. One approach, using cell site. The sequence of the healing
culture adaptive mutations in the viral process is initiated during an acute
DEPARTMENT OF HEALTH AND RNA has been found to significantly inflammatory phase with the deposition
HUMAN SERVICES enhance HCV virus production, but it of provisional tissue. This is followed
has been difficult to define which stage by re-epithelialization, collagen
National Institutes of Health synthesis and deposition, fibroblast
of the viral lifecycle is affected by a
given adaptive mutation. proliferation, and neovascularization,
Government-Owned Inventions; all of which ultimately define the
Availability for Licensing NIH researchers have now developed
a single-cycle virus production system remodeling phase. These events are
that allows the stage of the viral influenced by growth factors and
AGENCY: National Institutes of Health, cytokines secreted by inflammatory
Public Health Service, HHS. lifecycle affected by a specific adaptive
mutation to be determined. They have cells or by the cells localized at the
ACTION: Notice. isolated a unique subclone of Huh 7 edges of the wound.
Hepatoma cells, S29, that permits HCV Tissue regeneration is believed to be
SUMMARY: The inventions listed below replication and infectious virion release, controlled by specific peptide factors
are owned by an agency of the U.S. but is resistant to infection by HCV. which regulate the migration and
Government and are available for This permits the use of single cycle proliferation of cells involved in the
licensing in the U.S. in accordance with growth studies, and removes the repair process. Thus, it has been
35 U.S.C. 207 to achieve expeditious confounding effects of virus re-infection proposed that growth factors will be
commercialization of results of allowing progress to be made on useful therapeutics in the treatment of
federally-funded research and structure/function studies, or on studies wounds, burns and other skin disorders.
development. Foreign patent of the effects of drugs on replication and However, there still remains a need for
applications are filed on selected virus assembly. additional methods to accelerate wound
inventions to extend market coverage Applications: HCV drug discovery; healing and tissue repair.
for companies and may also be available HCV single-cycle virus studies; HCV
structure/function studies. This application claims methods of
for licensing. increasing epithelial cell growth. The
Market: HCV research.
ADDRESSES: Licensing information and Inventors: Suzanne U. Emerson, methods include administering a
copies of the U.S. patent applications Robert H. Purcell, Rodney Russell therapeutically effective amount of a
listed below may be obtained by writing (NIAID). CpG oligodeoxynucleotide (ODN) to
to the indicated licensing contact at the Patent Status: HHS Reference No. E– induce epithelial cell division. Also
Office of Technology Transfer, National 324–2007/0—Research Tool. Patent claimed are methods of inducing wound
Institutes of Health, 6011 Executive protection is not being sought for this healing. The method includes treating
Boulevard, Suite 325, Rockville, technology. the wound with a CpG oligonucleotide,
pwalker on PROD1PC71 with NOTICES

Maryland 20852–3804; telephone: 301/ Licensing Status: Available for thereby inducing wound healing. The
496–7057; fax: 301/402–0220. A signed licensing. wound can be any type of wound,
Confidential Disclosure Agreement will Licensing Contact: Chekesha S. including trauma or surgical wounds.
be required to receive copies of the Clingman, Ph.D.; 301/435–5018; The CpG ODN can be applied
patent applications. clingmac@mail.nih.gov. systemically or locally.

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Federal Register / Vol. 72, No. 192 / Thursday, October 4, 2007 / Notices 56775

Application: Induction of wound highly conserved coreceptor binding resistant to currently available
healing through use of CpG site epitopes; (3) indefinite control of antiretroviral drugs.
oligodeoxynucleotides. HIV viral replication, without the need Applications: Research tool.
Developmental Status: CpG for combination therapy, arising from Development Status: In vitro data
oligonucleotides have been synthesized properties (1) and (2); (4) improved HIV available .
and preclinical studies have been viral replication control when used in Inventors: Carol D. Weiss and Russell
performed. combination with other Highly Active A. Vassell (CBER/FDA).
Inventors: Dennis Klinman and Antiretroviral Therapy (HAART); (5) Related Publication: S Jiang et al. A
Takahashi Sato (NCI). improved prevention of seroconversion screening assay for antiviral compounds
Patent Status: U.S. Provisional when used in combination with other targeted to the HIV–1 gp41 core
Application filed 06 Sep 2007 (HHS HAART shortly following known structure using a conformation-specific
Reference No. E–242–2007/0–US–01). exposure to HIV. monoclonal antibody. J Virol Methods.
Licensing Status: Available for Applications: Novel therapeutics for 1999 Jun;80(1):85–96.
exclusive or nonexclusive licensing. the treatment and prevention of HIV Patent Status: HHS Reference No. E–
Licensing Contact: Peter A. Soukas, 124–2007/0—Research Tool. Patent
infection.
J.D.; 301/435–4646; protection not being pursued for this
soukasp@mail.nih.gov. Development Status: Synthesis and
characterization in progress. technology.
Collaborative Research Opportunity: Licensing Status: Available for non-
The Laboratory of Experimental Inventors: Sriram Subramaniam and
Adam Bennett (NCI). exclusive licensing as biological
Immunology of the National Cancer material.
Institute is seeking statements of Publication: AE Bennett et al. Cryo
Licensing Contact: Sally Hu, Ph.D.;
capability or interest from parties electron tomographic analysis of an HIV
301/435–5606; HuS@mail.nih.gov.
interested in collaborative research to neutralizing protein and its complex
with native viral gp 120. J Biol Chem., Dated: September 27, 2007.
further develop, evaluate, or
commercialize methods of increasing in press; published online ahead of Steven M. Ferguson,
epithelial cell growth. Please contact print June 28, 2007. Director, Division of Technology Development
John D. Hewes, Ph.D. at 301–435–3121 Patent Status: U.S. Provisional and Transfer, Office of Technology Transfer,
Application No. 60/932,464 filed 31 National Institutes of Health.
or hewesj@mail.nih.gov for more
information. May 2007 (HHS Reference No. E–213– [FR Doc. E7–19649 Filed 10–3–07; 8:45 am]
2007/0–US–01). BILLING CODE 4140–01–P
Flexible, Polyvalent Antiviral Dendritic Licensing Status: Available for
Conjugates for the Treatment of HIV/ licensing.
AIDS Licensing Contact: Sally Hu, Ph.D.; DEPARTMENT OF HEALTH AND
Description of Technology: This 301/435–5606; HuS@mail.nih.gov. HUMAN SERVICES
technology describes the design and Collaborative Research Opportunity:
synthesis of flexible, polyvalent, National Institutes of Health
The Laboratory of Cell Biology of the
antiviral conjugates of less than 200 kDa National Cancer Institute is seeking Office of Portfolio Analysis and
for the treatment of HIV/AIDS. These statements of capability or interest from Strategic Initiatives, Office of the
conjugates are mimetic of D1D2-Igatp, a parties interested in collaborative Director, National Institutes of Health;
high-molecular-weight (1 MDa) CD4- research to further develop, evaluate, or Notice of Meeting
immunoglobulin fusion construct with commercialize Flexible, Polyvalent
extreme HIV neutralizing potency. Cryo Antiviral Dendritic Conjugates for the Notice is hereby given of a planning
electron microscopy suggests that the Treatment of HIV/AIDS. Please contact meeting for the proposed Council of
extreme potency of D1D2-Igatp is due to John D. Hewes, Ph.D. at 301–435–3121 Councils, an external advisory panel to
polyvalent presentation of a gp120- or hewesj@mail.nih.gov for more the NIH IC Directors and the Office of
binding ligand on a flexible scaffold. information. Portfolio Analysis and Strategic
The current prototype for the Initiatives (OPASI).
technology is a conjugate comprising Monoclonal Antibodies to Fusion- The meeting will be open to the
soluble, two-domain human CD4 Active Conformations of GP41 public, with attendance limited to space
covalently linked to a flexible Description of Technology: This available. individuals who plan to
poly(ethylene glycol)-PAMAM technology describes three novel attend and need special assistance, such
dendrimer scaffold. The construct is monoclonal antibodies, 2F12, 9C5 and as sign language interpretation or other
designed to retain a high degree of 11B8, which were derived against an reasonable accommodations, should
flexibility and polyvalence, and, at less HIV gp41 heptad-repeat entry inhibitor notify the Contact Person listed below
than 200 kDa, is similar in size to that mimics a structure of the HIV in advance of the meeting.
successful antibody therapeutics envelope protein fusion intermediate. Name of Committee: Council of Councils
currently on the market. Because it These antibodies recognize the fusion- Planning Group.
retains the key determinants of potency intermediate and six-helix Date: November 8, 2007.
and the human CD4 moieties of D1D2- conformations of gp41 and are useful Time: 8:30 a.m. to 5:00 p.m.
Igatp, this conjugate is expected to have tools for high-throughput screening Agenda: Among the topics proposed for
the following unique set of HIV antiviral assays (HTS) to identify novel HIV–1 discussion are: Role of the Council and
properties: (1) IC90 infectivity inhibitors. Since the drugs identified in timeline.
Place: National Institutes of Health,
neutralization values in the nanomolar the assays using these monoclonal are Building 31, Conference Room 6, 9000
range against HIV primary isolates; (2) expected to inhibit HIV infection in a
pwalker on PROD1PC71 with NOTICES

Rockville Pike, Bethesda, MD 20892.


lack of susceptibility to viable escape different manner than current Contact Person: Robert D. Hammond, PhD,
mutations, because the ligand is CD4, antiretroviral drugs, these antibodies Consultant To OPASI, 301–977–9307,
and because CD4-independence evolves may serve as valuable tools for bhammond@thehillgroup.com.
concomitantly with constitutive screening for new drugs that may have Any interested person may file written
exposure of neutralization-sensitive, activity against HIV strains that are comments with the committee by forwarding

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