Prospective Grant of Exclusive License: Use of N-Acetyl-Mannosamine and Derivatives Thereof to Treat Muscle Wasting Diseases and Kidney Diseases Related to Hyposialylation, 26714-26715 [E9-12858]
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Federal Register / Vol. 74, No. 105 / Wednesday, June 3, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Cancer
Prevention Research Small Grant Program.
Date: June 15–16, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance M Street Hotel, 1143
New Hampshire Avenue, NW., Washington,
DC 20037.
Contact Person: Irina Gordienko, PhD,
Scientific Review Officer, Scientific Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
6116 Executive Blvd., Rm. 7073, Bethesda,
MD 20892, 301–594–1566,
gordienkoiv@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control; 93.701, ARRA Related
Biomedical Research and Research Support
Awards, National Institutes of Health, HHS)
Dated: May 26, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–12879 Filed 6–2–09; 8:45 am]
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PWALKER on PROD1PC71 with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Clinical Center; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
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hereby given of a meeting of the Board
of Scientific Counselors of the NIH
Clinical Center. The meeting will be
closed to the public as indicated below
in accordance with the provisions set
forth in section 552b(c)(6), Title 5
U.S.C., as amended for the review,
discussion, and evaluation of individual
intramural programs and projects
conducted by the Clinical Center,
including consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors of the NIH Clinical Center.
Date: June 18, 2009.
Time: 8:15 a.m. to 5:30 p.m.
Agenda: To review and evaluate the
Clinical Center’s Nursing Department.
Place: National Institutes of Health,
Building 10, 10 Center Drive, Room 4–2551,
Bethesda, MD 20892.
Contact Person: David K Henderson, MD,
Deputy Director for Clinical Care, Office of
the Director, Clinical Center, National
Institutes of Health, Building 10, Room 6–
1480, Bethesda, MD 20892, (301) 496–3515.
Dated: May 26, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–12877 Filed 6–2–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel—Health Disparities.
Date: June 25, 2009.
Time: 8 a.m. to 5 p.m.
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Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Blvd., Bethesda, MD 20817.
Contact Person: Ruth Grossman, DDS,
Scientific Review Officer, National Institutes
of Biomedical Imaging and Bioengineering,
6707 Democracy Boulevard, Room 960,
Bethesda, MD 20892, 301–496–8775,
grossmanrs@mail.nih.gov.
Dated: May 26, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–12875 Filed 6–2–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Use of N-AcetylMannosamine and Derivatives Thereof
to Treat Muscle Wasting Diseases and
Kidney Diseases Related to
Hyposialylation
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
SUMMARY: This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
patent license to practice the inventions
embodied in U.S. Patent Application
No. 60/932,451, filed May 31, 2007, now
abandoned, [HHS Ref. No. E–217–2007/
0–US–01]; PCT Patent Application No.
PCT/US2008/006895, filed May 30,
2008, [HHS Ref. No. E–217–2007/0–
PCT–02], both of which are entitled, ‘‘NAcetyl-Mannosamine as a Therapeutic
Agent’’ (Inventors: Drs. Marjan Huizing,
William A. Gahl, Irini Manoli, and
Enriko Klootwijk, NHGRI) to New
Zealand Pharmaceuticals, Ltd., having
an office in at Palmerston North, New
Zealand. The patent rights in these
inventions have been assigned to the
United States of America.
The prospective exclusive license
territory may be worldwide, and the
field of use may be limited to the use
of N-Acetyl-Mannosamine or derivatives
thereof for the treatment of muscle
wasting diseases and kidney diseases
related to hyposialylation.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
August 3, 2009 will be considered.
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Federal Register / Vol. 74, No. 105 / Wednesday, June 3, 2009 / Notices
Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Steven Standley, PhD,
Licensing and Patenting Manager, Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
4074; Facsimile: (301) 402–0220; E-mail:
sstand@od.nih.gov.
ADDRESSES:
N-Acetyl
Mannosamine is a precursor for the
synthesis of sugar molecules known as
sialic acids which play an important
role in specific biological processes
such as cellular adhesion, cellular
communication and signal transduction.
Lack of sialic acids also play an
important role in disease processes such
as cancer, inflammation and immunity.
This invention relates to methods of
administering N-Acetyl Mannosamine
or its derivative (to produce sialic acid
in patients who are deficient in the
sugar molecule) to treat muscular
atrophy including hereditary inclusion
body myopathy (HIBM) and distal
myopathy with rimmed vacuoles
(DMRV, or Nonaka myopathy). Certain
kidney conditions such as those arising
from hyposialytion of kidney
membranes may be treated by this
method as well.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR 404.7. The prospective
exclusive license may be granted unless
within sixty (60) days from the date of
this published notice, the NIH receives
written evidence and argument that
establishes that the grant of the license
would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR 404.7.
Applications for a license in the field
of use filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive license.
Comments and objections submitted to
this notice will not be made available
for public inspection and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
PWALKER on PROD1PC71 with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: May 27, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–12858 Filed 6–2–09; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
[Docket No. DHS–2009–0012]
Privacy Act of 1974, as Amended;
Computer Matching Program
(Department of Homeland Security
United States Citizenship and
Immigration Services (DHS/USCIS)New Jersey Department of Labor and
Workforce Development (NJLWD))
AGENCY: United States Citizenship and
Immigration Services, DHS.
ACTION: Notice of the renewal of an
existing computer matching program,
which is scheduled to expire on July 6,
2009.
SUMMARY: In accordance with the
provisions of the Privacy Act, as
amended, this notice announces the
renewal of a computer matching
program that Department of Homeland
Security United States Citizenship and
Immigration Services (DHS/USCIS) is
currently conducting with New Jersey
Department of Labor and Workforce
Development.
DATES: The matching program will
become effective 30 days after
publication of this notice in the Federal
Register. The matching program will
continue for 18 months from the
effective date and may be extended for
an additional 12 months thereafter, if
certain conditions are met.
ADDRESSES: Interested parties may
comment on this notice by either
telefaxing to (703) 483–2999 or writing
to the Privacy Office, Department of
Homeland Security, Washington, DC
20528. All comments received will be
available for public inspection at this
address.
FOR FURTHER INFORMATION CONTACT: For
general questions please contact Donald
Hawkins (202–272–8000), USCIS
Privacy Officer, 20 Massachusetts
Avenue, NW., Washington, DC 20529.
For privacy issues please contact: Mary
Ellen Callahan (703–235–0780), Chief
Privacy Officer, Privacy Office, U.S.
Department of Homeland Security,
Washington, DC 20528.
SUPPLEMENTARY INFORMATION:
A. General
The Computer Matching and Privacy
Protection Act of 1988 (Public Law
(Pub. L.) 100–503), amended the Privacy
Act (5 U.S.C. 552a) by describing the
conditions under which computer
matching involving the Federal
government could be performed and
adding certain protections for
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26715
individuals applying for, and receiving,
Federal benefits. Section 7201of the
Omnibus Budget Reconciliation Act of
1990 (Pub. L. 101–508) further amended
the Privacy Act regarding protections for
such individuals.
The Privacy Act, as amended,
regulates the use of computer matching
by Federal agencies when records in a
system of records are matched with
other Federal, State, or local government
records. It requires Federal agencies
involved in computer matching
programs to:
(1) Negotiate written agreements with
the other agency or agencies
participating in the matching programs;
(2) Obtain the approval of the
matching agreement by the Data
Integrity Boards (DIB) of the
participating Federal agencies;
(3) Publish notice of the computer
matching program in the Federal
Register;
(4) Furnish detailed reports about
matching programs to Congress and
OMB;
(5) Notify applicants and beneficiaries
that their records are subject to
matching; and
(6) Verify match findings before
reducing, suspending, terminating, or
denying an individual’s benefits or
payments.
B. DHS Computer Matches Subject to
the Privacy Act
DHS/USCIS has taken action to
ensure that all of DHS’s computer
matching programs comply with the
requirements of the Privacy Act, as
amended.
C. Purpose of the Matching Program
The purpose of this agreement is to
provide the NJLWD with electronic
access to immigration status information
contained within DHS/USCIS’
Verification Information System (VIS).
This access will enable the NJLWD to
determine whether an applicant is
eligible for benefits under the
Unemployment Compensation (UC)
program administered by NJLWD.
D. Authority for Conducting the
Matching Program
NJLWD seeks access to the
information contained in the DHS–
USCIS VIS database to execute its
obligations under Section 1137 of the
Social Security Act and New Jersey
Statute 43:21–4.
USCIS maintains the VIS database
pursuant to Section 121 of the
Immigration Reform and Control Act
(IRCA) of 1986, Public Law 99–603, as
amended by the Personal Responsibility
and Work Opportunity Reconciliation
E:\FR\FM\03JNN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 105 (Wednesday, June 3, 2009)]
[Notices]
[Pages 26714-26715]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-12858]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Use of N-Acetyl-
Mannosamine and Derivatives Thereof to Treat Muscle Wasting Diseases
and Kidney Diseases Related to Hyposialylation
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
CFR 404.7(a)(1)(i), that the National Institutes of Health, Department
of Health and Human Services, is contemplating the grant of an
exclusive patent license to practice the inventions embodied in U.S.
Patent Application No. 60/932,451, filed May 31, 2007, now abandoned,
[HHS Ref. No. E-217-2007/0-US-01]; PCT Patent Application No. PCT/
US2008/006895, filed May 30, 2008, [HHS Ref. No. E-217-2007/0-PCT-02],
both of which are entitled, ``N-Acetyl-Mannosamine as a Therapeutic
Agent'' (Inventors: Drs. Marjan Huizing, William A. Gahl, Irini Manoli,
and Enriko Klootwijk, NHGRI) to New Zealand Pharmaceuticals, Ltd.,
having an office in at Palmerston North, New Zealand. The patent rights
in these inventions have been assigned to the United States of America.
The prospective exclusive license territory may be worldwide, and
the field of use may be limited to the use of N-Acetyl-Mannosamine or
derivatives thereof for the treatment of muscle wasting diseases and
kidney diseases related to hyposialylation.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
August 3, 2009 will be considered.
[[Page 26715]]
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
license should be directed to: Steven Standley, PhD, Licensing and
Patenting Manager, Office of Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-4074; Facsimile: (301) 402-0220; E-mail:
sstand@od.nih.gov.
SUPPLEMENTARY INFORMATION: N-Acetyl Mannosamine is a precursor for the
synthesis of sugar molecules known as sialic acids which play an
important role in specific biological processes such as cellular
adhesion, cellular communication and signal transduction. Lack of
sialic acids also play an important role in disease processes such as
cancer, inflammation and immunity.
This invention relates to methods of administering N-Acetyl
Mannosamine or its derivative (to produce sialic acid in patients who
are deficient in the sugar molecule) to treat muscular atrophy
including hereditary inclusion body myopathy (HIBM) and distal myopathy
with rimmed vacuoles (DMRV, or Nonaka myopathy). Certain kidney
conditions such as those arising from hyposialytion of kidney membranes
may be treated by this method as well.
The prospective exclusive license will be royalty bearing and will
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.
The prospective exclusive license may be granted unless within sixty
(60) days from the date of this published notice, the NIH receives
written evidence and argument that establishes that the grant of the
license would not be consistent with the requirements of 35 U.S.C. 209
and 37 CFR 404.7.
Applications for a license in the field of use filed in response to
this notice will be treated as objections to the grant of the
contemplated exclusive license. Comments and objections submitted to
this notice will not be made available for public inspection and, to
the extent permitted by law, will not be released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: May 27, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E9-12858 Filed 6-2-09; 8:45 am]
BILLING CODE 4140-01-P
