Government-Owned Inventions; Availability for Licensing, 20956-20957 [E9-10452]
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20956
Federal Register / Vol. 74, No. 86 / Wednesday, May 6, 2009 / Notices
mstockstill on PROD1PC66 with NOTICES
Customs and Border Protection’s (CBP’s)
staff on enforcement of the Public
Health Security and Bioterrorism
Preparedness and Response Act of 2002
(the Bioterrorism Act) and the agency’s
implementing regulations, which
require prior notice for food imported or
offered for import into the United
States.
DATES: Submit written or electronic
comments concerning the CPG at any
time.
ADDRESSES: Submit written comments
on the CPG to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the CPG.
Submit written requests for single
copies of the CPG to the Division of
Compliance Policy (HFC–230), Office of
Enforcement, Food and Drug
Administration, 5600 Fishers Lane,
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office in processing your request, or fax
your request to 240–632–6861.
FOR FURTHER INFORMATION CONTACT:
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Affairs (HFC–100), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 866–521–2297.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of November
7, 2008 (73 FR 66411), FDA announced
the availability of a draft CPG entitled
‘‘Sec. 110.310 Prior Notice of Imported
Food Under the Public Health Security
and Bioterrorism Preparedness and
Response Act of 2002.’’ After
considering the one comment received,
FDA revised the CPG, with CBP
concurrence, where appropriate. The
revised CPG provides written guidance
to FDA’s and CBP’s staff on enforcement
of section 307 of the Bioterrorism Act
and the agency’s implementing
regulations, which require prior notice
for food imported or offered for import
into the United States.
FDA is issuing this CPG as level 1
guidance consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The CPG represents the
agency’s current thinking on its
enforcement policy concerning prior
notice. It does not create or confer any
rights for or on any person and does not
operate to bind FDA, or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
VerDate Nov<24>2008
18:36 May 05, 2009
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II. Comments
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ADDRESSES) written or electronic
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Submit a single copy of electronic
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Comments are to be identified with the
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III. Electronic Access
An electronic version of the CPG is
available on the Internet at https://
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References.’’
Dated: April 29, 2009.
Michael A. Chappell,
Acting Associate Commissioner for
Regulatory Affairs.
[FR Doc. E9–10556 Filed 5–4–09; 4:15 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION:
Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
ADDRESSES:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Small Molecule Activators of Human
Pyruvate Kinase for Treatment of
Cancer and Enzyme-Deficient
Hemolytic Anemia
Description of Technology: NIH
investigators have discovered a series of
small compounds with the potential to
treat a variety of cancers as well as
hemolytic anemia. Contrary to most
cancer medications, these molecules can
be non-toxic to normal cells because
they target a protein specific to the
metabolic pathways in tumors, thus
representing a significant clinical
advantage over less-specific
chemotherapeutics.
The invention described here is a
series of small molecules that activate
pyruvate kinase (PK) isoform M2. PK–
M2 is a critical metabolic enzyme that
is affected in all forms of cancer.
Inactivation of PK–M2 leads to a
buildup of metabolic intermediates
inside the cell. Tumor cells require a
buildup of metabolic intermediates in
order to undergo rapid cell growth and
proliferation. Hence, activation of PK–
M2 in tumor cells may prevent the
buildup of metabolic intermediates and
thereby stall tumor cell proliferation or
destroy the tumor cells. Further, while
in normal adult cells only PK isoforms
R, L, or M1 are active, in all tumors only
PK–M2 is active. Therefore, PK–M2
activation would affect only tumor cells,
and small-molecule PK–M2 activators
are not expected to be toxic to healthy
cells.
In addition, in patients with PK–R
deficiency the buildup of metabolic
intermediates in red blood cells
ultimately leads to the loss of water
from the cells and cell death. Smallmolecule induced activation of PK–R in
PK-deficient red blood cells may
enhance vitality of these cells and
decrease or eliminate enzyme-deficient
hemolytic anemia in a patient.
Applications: Therapeutic for cancer;
Therapeutic for enzyme-deficient
hemolytic anemia.
Development Status: Early stage.
Market: In the United States in 2008,
approximately 1.4 million people were
diagnosed with cancer. In addition,
approximately 12,000 people in the
United States are chronically affected by
PK-deficient hemolytic anemia.
Inventors: Craig J. Thomas et al.
(NHGRI).
Publications: In preparation.
Patent Status: U.S. Provisional
Application No. 61/104,091 filed 09 Oct
2008 (HHS Reference No. E–326–2008/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Steve Standley,
PhD; 301–435–4074; sstand@od.nih.gov.
E:\FR\FM\06MYN1.SGM
06MYN1
Federal Register / Vol. 74, No. 86 / Wednesday, May 6, 2009 / Notices
Collaborative Research Opportunity:
The NIH Chemical Genomics Center is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
appropriate lead compounds described
in U.S. Provisional Application No. 61/
199,763. Please contact Dr. Craig J.
Thomas via e-mail
(craigt@nhgri.nih.gov) for more
information.
Polyclonal Antibodies to the Kidney
Protein Sodium-Hydrogen Exchanger 3
(NHE3)
Description of Technology:
Antibodies to NHE3, useful for
immunoblotting and
immunocytochemistry, are available to
resell for research purposes. NHE3 is a
membrane Na+/H+ exchanger involved
in maintenance of fluid volume
homeostasis in the kidney. It is
expressed on the apical membrane of
the renal proximal tubule and plays a
major role in NaCl and HCO3
absorption. The inventor has developed
rabbit polyclonal antibodies directed
against a peptide sequence common to
human, rat and mouse NHE3.
Applications: Western blotting and
immunocytochemistry.
Inventor: Mark A. Knepper (NHLBI).
Related Publication: Unpublished.
Patent Status: HHS Reference No. E–
253–2008/0—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Status: This technology is
available as a research tool under a
Biological Materials License.
Licensing Contact: Steve Standley,
Ph.D.; 301–435–4074;
sstand@od.nih.gov.
mstockstill on PROD1PC66 with NOTICES
Polyclonal Antibodies to ThiazideSensitive Sodium-Chloride
Cotransporter (NCC)
Description of Technology:
Antibodies to thiazide-sensitive sodiumchloride cotransporter (NCC), useful for
immunoblotting and
immunocytochemistry, are available to
resell for research purposes. NCC is
found on the apical membrane of the
distal convoluted tubule, where it is the
principal mediator of Na+ and CI
reabsorption in this segment of the
nephron. NCC is the target of thiazide
diuretics used in the treatment of
hypertension. The inventors have
developed rabbit polyclonal antibodies
directed against a peptide sequence in
the C-terminal region of NCC.
Applications: Western blotting and
immunohistochemistry.
Inventor: Mark A. Knepper (NHLBI).
VerDate Nov<24>2008
18:36 May 05, 2009
Jkt 217001
Related Publication: HL Biner, MP
Arpin-Bott, J Loffing, X Wang, M
Knepper, SC Hebert, B Kaissling.
Human cortical distal nephron:
distribution of electrolyte and water
transport pathways. J Am Soc Nephrol.
2002 Apr;13(4):836–847.
Patent Status: HHS Reference No. E–
254–2008/0—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Status: This technology is
available as a research tool under a
Biological Materials License.
Licensing Contact: Steve Standley,
Ph.D.; 301–435–4074;
sstand@od.nih.gov.
Polyclonal Antibodies to NKCC2, a
Kidney-Specific Member of the Cation
Chloride Co-transporter Family,
SLC12A1
Description of Technology:
Antibodies to NKCC2, useful for
immunoblotting and
immunocytochemistry, are available to
resell for research purposes. NKCC2 is
found on the apical surface of the thick
ascending limb of the loop of Henle,
where it facilitates transport of sodium,
potassium, and chloride ions from the
lumen of the renal thick ascending limb
into the cell. Transport of sodium
dilutes the luminal fluid, decreasing its
osmolality creating an osmotic driving
force for water reabsorption in the
connecting tubule and cortical
collecting duct under the influence of
the hormone vasopressin. NKCC2 is
blocked by loop diuretics such as
furosemide. The inventor has developed
rabbit polyclonal antibodies directed
against a peptide sequence in the Nterminal tail of NKCC2.
Applications: Western blotting and
immunocytochemistry.
Inventor: Mark A. Knepper (NHLBI).
Related Publications:
1. GH Kim, CA Ecelbarger, C Mitchell,
RK Packer, JB Wade, MA Knepper.
Vasopressin increases Na-K–2CI
cotransporter expression in thick
ascending limb of Henle’s loop. Am J
Physiol. 1999 Jan;276(1 Pt 2):F96–F103.
2. HL Brooks, AJ Allred, KT Beutler,
TM Cofiman, MA Knepper. Targeted
proteomic profiling of renal Na+
transporter and channel abundances in
angiotensin II type 1a receptor knockout
mice. Hypertension. 2002 Feb;39(2 Pt
2):470–473.
Patent Status: HHS Reference No. E–
255–2008/0—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Status: This technology is
available as a research tool under a
Biological Materials License.
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
20957
Licensing Contact: Steve Standley,
Ph.D.; 301–435–4074;
sstand@od.nih.gov.
Polyclonal Antibodies to the Kidney
Protein Urea Transporter 1 (UTA1)
Description of Technology:
Antibodies to UTA1, useful for
immunoblotting and
immunocytochemistry, are available to
resell for research purposes. Urea
Transporter 1 (UTA1) is activated by
vasopressin and is responsible for urea
transport across the apical membrane
into the intracellular space within the
renal inner medullary collecting duct.
The inventor has developed rabbit
polyclonal antibodies directed against a
peptide sequence in human UTA1.
Antibody also recognizes UTA3, another
product of the same gene.
Applications: Western blotting and
immunocytochemistry.
Inventor: Mark A. Knepper (NHLBI).
Related Publication: S Nielsen, J
Terris, CP Smith, MA Hediger, CA
Ecelbarger, MA Knepper. Cellular and
subcellular localization of the
vasopressin-regulated urea transporter
in rat kidney. Proc Natl Acad Sci USA.
1996 May 28;93(11):5495–500.
Patent Status: HHS Reference No. E–
268–2008/0—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Status: This technology is
available as a research tool under a
Biological Materials License.
Licensing Contact: Steve Standley,
Ph.D.; 301–435–4074;
sstand@od.nih.gov.
Dated: April 28, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–10452 Filed 5–5–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
E:\FR\FM\06MYN1.SGM
06MYN1
]]>Agencies
[Federal Register Volume 74, Number 86 (Wednesday, May 6, 2009)]
[Notices]
[Pages 20956-20957]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10452]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of federally-funded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
for companies and may also be available for licensing.
ADDRESSES: Licensing information and copies of the U.S. patent
applications listed below may be obtained by writing to the indicated
licensing contact at the Office of Technology Transfer, National
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville,
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A
signed Confidential Disclosure Agreement will be required to receive
copies of the patent applications.
Small Molecule Activators of Human Pyruvate Kinase for Treatment of
Cancer and Enzyme-Deficient Hemolytic Anemia
Description of Technology: NIH investigators have discovered a
series of small compounds with the potential to treat a variety of
cancers as well as hemolytic anemia. Contrary to most cancer
medications, these molecules can be non-toxic to normal cells because
they target a protein specific to the metabolic pathways in tumors,
thus representing a significant clinical advantage over less-specific
chemotherapeutics.
The invention described here is a series of small molecules that
activate pyruvate kinase (PK) isoform M2. PK-M2 is a critical metabolic
enzyme that is affected in all forms of cancer. Inactivation of PK-M2
leads to a buildup of metabolic intermediates inside the cell. Tumor
cells require a buildup of metabolic intermediates in order to undergo
rapid cell growth and proliferation. Hence, activation of PK-M2 in
tumor cells may prevent the buildup of metabolic intermediates and
thereby stall tumor cell proliferation or destroy the tumor cells.
Further, while in normal adult cells only PK isoforms R, L, or M1 are
active, in all tumors only PK-M2 is active. Therefore, PK-M2 activation
would affect only tumor cells, and small-molecule PK-M2 activators are
not expected to be toxic to healthy cells.
In addition, in patients with PK-R deficiency the buildup of
metabolic intermediates in red blood cells ultimately leads to the loss
of water from the cells and cell death. Small-molecule induced
activation of PK-R in PK-deficient red blood cells may enhance vitality
of these cells and decrease or eliminate enzyme-deficient hemolytic
anemia in a patient.
Applications: Therapeutic for cancer; Therapeutic for enzyme-
deficient hemolytic anemia.
Development Status: Early stage.
Market: In the United States in 2008, approximately 1.4 million
people were diagnosed with cancer. In addition, approximately 12,000
people in the United States are chronically affected by PK-deficient
hemolytic anemia.
Inventors: Craig J. Thomas et al. (NHGRI).
Publications: In preparation.
Patent Status: U.S. Provisional Application No. 61/104,091 filed 09
Oct 2008 (HHS Reference No. E-326-2008/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Steve Standley, PhD; 301-435-4074;
sstand@od.nih.gov.
[[Page 20957]]
Collaborative Research Opportunity: The NIH Chemical Genomics
Center is seeking statements of capability or interest from parties
interested in collaborative research to further develop, evaluate, or
commercialize appropriate lead compounds described in U.S. Provisional
Application No. 61/199,763. Please contact Dr. Craig J. Thomas via e-
mail (craigt@nhgri.nih.gov) for more information.
Polyclonal Antibodies to the Kidney Protein Sodium-Hydrogen Exchanger 3
(NHE3)
Description of Technology: Antibodies to NHE3, useful for
immunoblotting and immunocytochemistry, are available to resell for
research purposes. NHE3 is a membrane Na+/H+ exchanger involved in
maintenance of fluid volume homeostasis in the kidney. It is expressed
on the apical membrane of the renal proximal tubule and plays a major
role in NaCl and HCO3 absorption. The inventor has developed
rabbit polyclonal antibodies directed against a peptide sequence common
to human, rat and mouse NHE3.
Applications: Western blotting and immunocytochemistry.
Inventor: Mark A. Knepper (NHLBI).
Related Publication: Unpublished.
Patent Status: HHS Reference No. E-253-2008/0--Research Tool.
Patent protection is not being pursued for this technology.
Licensing Status: This technology is available as a research tool
under a Biological Materials License.
Licensing Contact: Steve Standley, Ph.D.; 301-435-4074;
sstand@od.nih.gov.
Polyclonal Antibodies to Thiazide-Sensitive Sodium-Chloride
Cotransporter (NCC)
Description of Technology: Antibodies to thiazide-sensitive sodium-
chloride cotransporter (NCC), useful for immunoblotting and
immunocytochemistry, are available to resell for research purposes. NCC
is found on the apical membrane of the distal convoluted tubule, where
it is the principal mediator of Na+ and CI reabsorption in this segment
of the nephron. NCC is the target of thiazide diuretics used in the
treatment of hypertension. The inventors have developed rabbit
polyclonal antibodies directed against a peptide sequence in the C-
terminal region of NCC.
Applications: Western blotting and immunohistochemistry.
Inventor: Mark A. Knepper (NHLBI).
Related Publication: HL Biner, MP Arpin-Bott, J Loffing, X Wang, M
Knepper, SC Hebert, B Kaissling. Human cortical distal nephron:
distribution of electrolyte and water transport pathways. J Am Soc
Nephrol. 2002 Apr;13(4):836-847.
Patent Status: HHS Reference No. E-254-2008/0--Research Tool.
Patent protection is not being pursued for this technology.
Licensing Status: This technology is available as a research tool
under a Biological Materials License.
Licensing Contact: Steve Standley, Ph.D.; 301-435-4074;
sstand@od.nih.gov.
Polyclonal Antibodies to NKCC2, a Kidney-Specific Member of the Cation
Chloride Co-transporter Family, SLC12A1
Description of Technology: Antibodies to NKCC2, useful for
immunoblotting and immunocytochemistry, are available to resell for
research purposes. NKCC2 is found on the apical surface of the thick
ascending limb of the loop of Henle, where it facilitates transport of
sodium, potassium, and chloride ions from the lumen of the renal thick
ascending limb into the cell. Transport of sodium dilutes the luminal
fluid, decreasing its osmolality creating an osmotic driving force for
water reabsorption in the connecting tubule and cortical collecting
duct under the influence of the hormone vasopressin. NKCC2 is blocked
by loop diuretics such as furosemide. The inventor has developed rabbit
polyclonal antibodies directed against a peptide sequence in the N-
terminal tail of NKCC2.
Applications: Western blotting and immunocytochemistry.
Inventor: Mark A. Knepper (NHLBI).
Related Publications:
1. GH Kim, CA Ecelbarger, C Mitchell, RK Packer, JB Wade, MA
Knepper. Vasopressin increases Na-K-2CI cotransporter expression in
thick ascending limb of Henle's loop. Am J Physiol. 1999 Jan;276(1 Pt
2):F96-F103.
2. HL Brooks, AJ Allred, KT Beutler, TM Cofiman, MA Knepper.
Targeted proteomic profiling of renal Na+ transporter and channel
abundances in angiotensin II type 1a receptor knockout mice.
Hypertension. 2002 Feb;39(2 Pt 2):470-473.
Patent Status: HHS Reference No. E-255-2008/0--Research Tool.
Patent protection is not being pursued for this technology.
Licensing Status: This technology is available as a research tool
under a Biological Materials License.
Licensing Contact: Steve Standley, Ph.D.; 301-435-4074;
sstand@od.nih.gov.
Polyclonal Antibodies to the Kidney Protein Urea Transporter 1 (UTA1)
Description of Technology: Antibodies to UTA1, useful for
immunoblotting and immunocytochemistry, are available to resell for
research purposes. Urea Transporter 1 (UTA1) is activated by
vasopressin and is responsible for urea transport across the apical
membrane into the intracellular space within the renal inner medullary
collecting duct. The inventor has developed rabbit polyclonal
antibodies directed against a peptide sequence in human UTA1. Antibody
also recognizes UTA3, another product of the same gene.
Applications: Western blotting and immunocytochemistry.
Inventor: Mark A. Knepper (NHLBI).
Related Publication: S Nielsen, J Terris, CP Smith, MA Hediger, CA
Ecelbarger, MA Knepper. Cellular and subcellular localization of the
vasopressin-regulated urea transporter in rat kidney. Proc Natl Acad
Sci USA. 1996 May 28;93(11):5495-500.
Patent Status: HHS Reference No. E-268-2008/0--Research Tool.
Patent protection is not being pursued for this technology.
Licensing Status: This technology is available as a research tool
under a Biological Materials License.
Licensing Contact: Steve Standley, Ph.D.; 301-435-4074;
sstand@od.nih.gov.
Dated: April 28, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E9-10452 Filed 5-5-09; 8:45 am]
BILLING CODE 4140-01-P
