Government-Owned Inventions; Availability for Licensing, 47257-47258 [E9-22223]
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Federal Register / Vol. 74, No. 177 / Tuesday, September 15, 2009 / Notices
response for a total screener burden of
4,000 (respondents) + 6,000 (ineligibles
screened) x .0167 hours = 167 hours.
The survey will require an average of 20
minutes (0.33 hours) per respondent
and we expect that the variation in
burden across respondents will be
small. This estimate is based on average
interview time for the 2006 Food Safety
Survey. The proposed number of
respondents is 4,000, each of whom will
be asked to complete a one-time
telephone interview that requires no
preparation time. Additionally, 200
initial nonrespondents will be asked to
participate in a short version of the
survey to conduct a nonresponse
analysis. This is expected to take 6
minutes (0.10 hours). Therefore, the
total estimated public reporting burden
is 1,541 hours.
We have revised the burden table. In
the 60-day notice published on
September 17, 2008, we estimated the
total burden to be 1,421 hours. The total
burden of 1,541 hours estimated in table
1 of this document includes an
additional 120 hours, which resulted
from correcting a typographical error in
line 4 of the table. The hours per
response in line 4 of table 1 changed
from 0.3 to 0.33.
Dated: September 1, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–22121 Filed 9–14–09; 8:45 am]
BILLING CODE 4160–01–S
Food and Drug Administration
[Docket No. FDA–2009–N–0406]
Agency Emergency Processing Under
the Office of Management and Budget
Review; Tobacco Product
Establishment Registration and
Submission of Certain Health
Information; Correction
AGENCY:
Food and Drug Administration,
HHS.
sroberts on DSKD5P82C1PROD with NOTICES
ACTION:
Notice; correction.
SUMMARY: The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of September 1, 2009 (74 FR
45219). The document announced the
proposed collection of information
concerning the submission of tobacco
product establishment registration and
submission of certain health
information, including ingredient listing
and health related documents, as
required by the Family Smoking
VerDate Nov<24>2008
19:12 Sep 14, 2009
Jkt 217001
Prevention and Tobacco Control Act.
The document was published with an
incorrect date for submitting written or
electronic comments on the proposed
collection. This document corrects that
error.
Dated: September 4, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–22140 Filed 9–14–09; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4163–18–P
Jonna Capezzuto, Office of Information
Management (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794,
Jonnalynn.Capezzuto@fda.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In FR Doc.
E9–21099, appearing on page 45219, in
the Federal Register of Tuesday,
September 1, 2009, the following
correction is made:
On page 45219, in the second column,
in the ‘‘DATES’’ section, beginning in the
second line, ‘‘September 16, 2009’’ is
corrected to read ‘‘October 1, 2009’’.
SUPPLEMENTARY INFORMATION:
Dated: September 8, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–22120 Filed 9–14–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Center for Injury Prevention
and Control Initial Review Group:
Notice of Charter Renewal
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
47257
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the
National Center for Injury Prevention
and Control Initial Review Group,
Department of Health and Human
Services, has been renewed for a 2-year
period through August 20, 2011.
For information, contact Dr. Richard
Waxweiler, Executive Secretary,
National Center for Injury Prevention
and Control Initial Review Group,
Department of Health and Human
Services, 1600 Clifton Road, M/S F63,
Atlanta, Georgia 30341, telephone 770/
488–4850, or fax 770/488–4422.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and othercommittee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
PO 00000
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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.
Purified Saxitoxin for Food Safety
Applications
Description of Technology: Available
for licensing as a biological material for
research purposes is purified saxitoxin.
Saxitoxin is the parent compound in a
family of natural toxins that can occur
in seafood and can cause food borne
illness. Highly purified saxitoxin is vital
for the development, validation, and
calibration of detection methods for
these toxins, as well as for fundamental
studies in physiology and pain
management. Interested parties may
license the compound for conjugation
chemistry and radiolabeling with the
end goal of generating a research
reagent.
E:\FR\FM\15SEN1.SGM
15SEN1
Federal Register / Vol. 74, No. 177 / Tuesday, September 15, 2009 / Notices
Applications:
• Investigation of food borne illness.
• Monitoring of seafood for
contamination.
• Detection of food poisons.
Inventor: Sherwood Hall (FDA).
Relevant Publication: EJ Schantz et al.
Paralytic shellfish poison. VI. A
procedure for the isolation and
purification of the poison from toxic
clam and mussel tissues. J Am Chem
Soc. 1957 Oct;79(19):5230–5235, doi:
10.1021/ja01576a044.
Patent Status: HHS Reference No. E–
278–2009/0—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Status: Available for
licensing.
Licensing Contact: Michael A.
Shmilovich, Esq.; 301–435–5019;
shmilovm@mail.nih.gov.
sroberts on DSKD5P82C1PROD with NOTICES
Identification of Recent HIV–I Infection
by Genotypic Analysis for Treatment
Strategy
Description of Technology: This
invention describes a bioinformatics
algorithm capable of distinguishing
between recently infected and
chronically infected HIV–I patients
based on the genetic diversity of HIV
pro-pol sequences. Directly after
infection with HIV–I, genetic diversity
is extremely low. Previously, single
genome sequencing was used to
demonstrate that HIV–I genetic diversity
accumulates after infection in a linear
and predictable fashion during the first
8–10 months of infection (Kearney et
al., 2009). Using single genome
sequencing, it is possible to determine
whether a person had been infected
with HIV–1 in the recent past. Single
genome sequencing is, however, a
research technique that is relatively
labor intensive and somewhat
expensive, making it less feasible for
routine use. The invention improves on
this analysis in both ease and cost, and
is capable of estimating genetic diversity
using a population-based sequence that
is obtained by routine, commercially
available genotyping through the
determination of genotype sequence
ambiguity, which resulted in both
sensitive and specific identification of
acute versus chronic infection. The
algorithm is also capable of
simultaneously determining drug
resistance profiles, further representing
significant improvement over current
VerDate Nov<24>2008
19:12 Sep 14, 2009
Jkt 217001
antibody-based methods. Since recent
data have shown that patients in the
primary infection stage are estimated to
be 26 times more infective than patients
in the chronic stage of infection
(Hollingsworth et al., 2008), and
epidemiological models of immediate
antiretroviral therapy (ART) predict a
shift from the endemic phase to the
elimination phase within five years
(Granich et al., 2009), this invention
represents a potentially valuable
diagnostic tool for clinicians as well as
an improvement over the current
antibody-based methods of
epidemiological research for
determining HIV incidence.
Applications:
• HIV Diagnostics capable of
distinguishing between a recent HIV
infection and a chronic one. This feature
will assist clinicians in the design of
HIV treatment regimen and strategy.
• Analysis and prediction of patient’s
HIV drug resistance. Facilitating
devising a treatment strategy.
• Epidemiological application due to
ability of the test to report HIV
incidence.
Advantages: The method offers
important public health benefits with
regards to HIV/AIDS as elaborated
below:
• The method adds important value
to conventional HIV genotyping and
enhances the diagnostic usefulness of
genotyping.
• The method offers an inexpensive
and convenient way to distinguish
recently infected from chronically
infected subjects and thus provides
important information regarding HIV
drug management.
• The method can, simultaneously
with the above, provide information
regarding drug resistance mutations.
• The method is based on
commercially available HIV–1 genotype
sequence information and thus offers
simplicity and convenience.
• The method can provide important
and useful epidemiological information.
Market: A favorable market potential
for the method exists, and it may in the
future be routinely used in every
clinical laboratory that provides
genotyping services and by
manufacturers and laboratories that
provide tests for drug resistance
patterns.
Development Status: Early stage.
Inventors: Frank Maldarelli et al.
(NCI).
Patent Status: HHS Reference No. E–
238–2009/0—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Status: Available for
licensing.
PO 00000
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Fmt 4703
Sfmt 4703
Licensing Contacts: Uri Reichman,
PhD, MBA, 301–435–4616,
UR7a@nih.gov; John Stansberry, PhD,
301–435–5236, js852e@nih.gov.
Collaborative Research Opportunity:
The NCI HIV Drug Resistance Program,
Host Virus Interaction Branch, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize this
technology. Please contact John D.
Hewes, PhD at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Dated: September 9, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–22223 Filed 9–14–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
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 meetings.
The meetings 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: Center for Scientific
Review Special Emphasis Panel Tachycardias
and Arrhythmias.
Date: September 22, 2009.
Time: 11 a.m. to 1 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Telephone Conference Call).
Contact Person: Olga A. Tjurmina, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4138,
MSC 7814 Bethesda, MD 20892. (301) 451–
1375. ot3d@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
E:\FR\FM\15SEN1.SGM
15SEN1
EN15SE09.032</GPH>
47258
]]>Agencies
[Federal Register Volume 74, Number 177 (Tuesday, September 15, 2009)]
[Notices]
[Pages 47257-47258]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22223]
-----------------------------------------------------------------------
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.
Purified Saxitoxin for Food Safety Applications
Description of Technology: Available for licensing as a biological
material for research purposes is purified saxitoxin. Saxitoxin is the
parent compound in a family of natural toxins that can occur in seafood
and can cause food borne illness. Highly purified saxitoxin is vital
for the development, validation, and calibration of detection methods
for these toxins, as well as for fundamental studies in physiology and
pain management. Interested parties may license the compound for
conjugation chemistry and radiolabeling with the end goal of generating
a research reagent.
[[Page 47258]]
[GRAPHIC] [TIFF OMITTED] TN15SE09.032
Applications:
Investigation of food borne illness.
Monitoring of seafood for contamination.
Detection of food poisons.
Inventor: Sherwood Hall (FDA).
Relevant Publication: EJ Schantz et al. Paralytic shellfish poison.
VI. A procedure for the isolation and purification of the poison from
toxic clam and mussel tissues. J Am Chem Soc. 1957 Oct;79(19):5230-
5235, doi: 10.1021/ja01576a044.
Patent Status: HHS Reference No. E-278-2009/0--Research Tool.
Patent protection is not being pursued for this technology.
Licensing Status: Available for licensing.
Licensing Contact: Michael A. Shmilovich, Esq.; 301-435-5019;
shmilovm@mail.nih.gov.
Identification of Recent HIV-I Infection by Genotypic Analysis for
Treatment Strategy
Description of Technology: This invention describes a
bioinformatics algorithm capable of distinguishing between recently
infected and chronically infected HIV-I patients based on the genetic
diversity of HIV pro-pol sequences. Directly after infection with HIV-
I, genetic diversity is extremely low. Previously, single genome
sequencing was used to demonstrate that HIV-I genetic diversity
accumulates after infection in a linear and predictable fashion during
the first 8-10 months of infection (Kearney et al., 2009). Using single
genome sequencing, it is possible to determine whether a person had
been infected with HIV-1 in the recent past. Single genome sequencing
is, however, a research technique that is relatively labor intensive
and somewhat expensive, making it less feasible for routine use. The
invention improves on this analysis in both ease and cost, and is
capable of estimating genetic diversity using a population-based
sequence that is obtained by routine, commercially available genotyping
through the determination of genotype sequence ambiguity, which
resulted in both sensitive and specific identification of acute versus
chronic infection. The algorithm is also capable of simultaneously
determining drug resistance profiles, further representing significant
improvement over current antibody-based methods. Since recent data have
shown that patients in the primary infection stage are estimated to be
26 times more infective than patients in the chronic stage of infection
(Hollingsworth et al., 2008), and epidemiological models of immediate
antiretroviral therapy (ART) predict a shift from the endemic phase to
the elimination phase within five years (Granich et al., 2009), this
invention represents a potentially valuable diagnostic tool for
clinicians as well as an improvement over the current antibody-based
methods of epidemiological research for determining HIV incidence.
Applications:
HIV Diagnostics capable of distinguishing between a recent
HIV infection and a chronic one. This feature will assist clinicians in
the design of HIV treatment regimen and strategy.
Analysis and prediction of patient's HIV drug resistance.
Facilitating devising a treatment strategy.
Epidemiological application due to ability of the test to
report HIV incidence.
Advantages: The method offers important public health benefits with
regards to HIV/AIDS as elaborated below:
The method adds important value to conventional HIV
genotyping and enhances the diagnostic usefulness of genotyping.
The method offers an inexpensive and convenient way to
distinguish recently infected from chronically infected subjects and
thus provides important information regarding HIV drug management.
The method can, simultaneously with the above, provide
information regarding drug resistance mutations.
The method is based on commercially available HIV-1
genotype sequence information and thus offers simplicity and
convenience.
The method can provide important and useful
epidemiological information.
Market: A favorable market potential for the method exists, and it
may in the future be routinely used in every clinical laboratory that
provides genotyping services and by manufacturers and laboratories that
provide tests for drug resistance patterns.
Development Status: Early stage.
Inventors: Frank Maldarelli et al. (NCI).
Patent Status: HHS Reference No. E-238-2009/0--Research Tool.
Patent protection is not being pursued for this technology.
Licensing Status: Available for licensing.
Licensing Contacts: Uri Reichman, PhD, MBA, 301-435-4616,
UR7a@nih.gov; John Stansberry, PhD, 301-435-5236, js852e@nih.gov.
Collaborative Research Opportunity: The NCI HIV Drug Resistance
Program, Host Virus Interaction Branch, is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize this
technology. Please contact John D. Hewes, PhD at 301-435-3121 or
hewesj@mail.nih.gov for more information.
Dated: September 9, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E9-22223 Filed 9-14-09; 8:45 am]
BILLING CODE 4140-01-P
