Prospective Grant of Exclusive License: FDA Approvable Human DNA Diagnostic Test for Endometriosis, 5345-5346 [E6-1277]
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Federal Register / Vol. 71, No. 21 / Wednesday, February 1, 2006 / Notices
postulates that passively transferred
anti-leukocyte antibodies from blood
donors are responsible for TRALI. The
donor antibodies implicated in TRALI
include antibodies directed towards
HLA class I and class II antigens, and
anti-neutrophil antibodies. The LAP
Study is a cross-sectional multi-center
study to measure the prevalence of HLA
and neutrophil antibodies in blood
donors with or without a history of
blood transfusion or pregnancy, and the
development of a repository of blood
samples obtained from these donors.
Specifically, 7,900 adult blood donors
across six blood centers participating in
the Retrovirus Epidemiology Donor
Study II (REDS–II) will be enrolled in
the study. Eligible donors will be asked
to complete a short questionnaire on
their transfusion history (ever, and date
of last transfusion) and, for female
donors, questions on pregnancy history
(ever, number and outcome of
pregnancies, last pregnancy). Each
donor will also be asked to provide a
sample of blood which will be tested for
the presence of HLA class I and class II
antibodies. This data will help us
evaluate variations in HLA antibody
prevalence based on blood transfusion
and pregnancy history and time since
the last immunizing event. Further,
neutrophil specific antibodies will be
measured in those blood donors who
have HLA antibodies. Also, donors with
neutrophil antibodies will be tested to
determine their neutrophil phenotype
using routine serologic and DNA
methods, since individuals homozygous
for certain neutrophil antigens are more
prone to develop certain neutrophil
antibodies. The results from testing HLA
positive donors for neutrophil
antibodies in this primary study could
be used to develop an optimal testing
strategy for large number of donors
using the stored repository samples.
These data will provide the basis for
calculating donor loss in the event that
a TRALI prevention strategy is
implemented that includes deferring
donors with a history of transfusion or
pregnancy or those with HLA or
neutrophil antibodies. The second major
goal of this study is to develop a
repository of blood samples from well
characterized blood donors whose
detailed transfusion and pregnancy
histories are known. Repository samples
will be stored indefinitely. Although
future research on repository samples is
yet to be determined, they may be tested
for studies designed to help transfusion
safety and transfusion biology.
Frequency of Response: Once. Affected
Public: Individuals. Type of
Respondents: Adult Blood Donors. The
annual reporting burden is a follows:
Estimated Number of Respondents:
7,900; Estimated Number of Responses
per Respondent: 1; Average Burden of
Hours per Response: 0.17; and
Estimated Total Annual Burden Hours
Requested: 1343. The annualized cost to
respondents is estimated at: $24,174
(based on $18 per hour). There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
Estimated
number of
respondents
Estimated
number of
responses per
respondent
Average
burden hours
per response
Estimated total
annual burden
hours
requested
Adult Blood Donors ..........................................................................................
cchase on PROD1PC60 with NOTICES
Type of respondents
7,900
1
0.17
1343
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and the assumptions used;
(3) Ways to enhance the quality, utility,
and clarity of the information collected;
and (4) Ways to minimize the burden of
the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Dr. George Nemo,
Project Officer, NHLBI, Two Rockledge
Center, Room 10142, 6701 Rockledge
Drive, MSC 7950, Bethesda, MD 20892–
7950, or call 301–435–0075, or e-mail
your request to nemog@nih.gov.
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17:49 Jan 31, 2006
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Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: January 20, 2006.
Charles M. Peterson,
Director, DBDR, National Institutes of Health.
[FR Doc. E6–1269 Filed 1–31–06; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: FDA Approvable Human DNA
Diagnostic Test for Endometriosis
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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 (NIH), Department
of Health and Human Services, is
contemplating the grant of an exclusive
license worldwide to practice the
invention embodied in U.S. Patent
PO 00000
Frm 00114
Fmt 4703
Sfmt 4703
Application Number 60/654,331 filed
February 18, 2005, entitled
‘‘Identification of Molecular Markers for
Endometriosis in Blood Lymphocytes
Using DNA Microarrays,’’ to OrthoClinical Diagnostics, having a place of
business in Raritan, NJ 08869. The
contemplated exclusive license may be
limited to an FDA approvable human
DNA diagnostic test for endometriosis.
The United States of America is the
assignee of the patent rights in this
invention.
Only written comments and/or
application for a license which are
received by the National Institutes of
Health on or before April 3, 2006 will
be considered.
ADDRESSES: Requests for a copy of the
patent, inquires, comments, and other
materials relating to the contemplated
license should be directed to: Marlene
Astor, Technology Licensing Specialist,
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: 301–435–4426;
Facsimile: 301–402–0220; e-mail:
ms482m@nih.gov.
DATES:
SUPPLEMENTARY INFORMATION:
Endometriosis is a common, nonmalignant gynecological disease that
E:\FR\FM\01FEN1.SGM
01FEN1
5346
Federal Register / Vol. 71, No. 21 / Wednesday, February 1, 2006 / Notices
affects up to twenty percent (20%) of
women during their reproductive years.
Endometriosis is characterized by the
growth of endometrial tissue outside the
uterus. This growth of tissue causes
recurring severe pain and can lead to
infertility. As the current procedure
used for diagnosis is invasive and not
entirely accurate, there is a need for a
fast, accurate, and minimally invasive
test to test for endometriosis.
Using DNA microarray analysis of
blood lymphocytes, the inventors have
identified two gene markers expressed
in blood that are able to discriminate
between those women who have
endometriosis and those that don’t. This
new technology would be minimally
invasive and quick using a blood sample
from a patient.
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 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.
Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response 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: January 23, 2006.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E6–1277 Filed 1–31–06; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
cchase on PROD1PC60 with NOTICES
AGENCY:
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
VerDate Aug<31>2005
17:49 Jan 31, 2006
Jkt 208001
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:
Rapid Anti-Depressant Response
Produced by Low Dose Treatment with
Anti-Muscarinic Drugs
Maura Furey and Wayne Drevets
(NIMH).
U.S. Patent Application No. 11/137,114
filed 25 May 2005 (HHS Reference
No. E–175–2004/0–US–01).
Licensing Contact: Norbert Pontzer; 301/
435–5502; pontzern@mail.nih.gov.
Available for licensing are new
methods of rapidly treating depression.
The drugs currently used to treat
depression work by increasing the
activity at serotonin, norepinephrine
and perhaps dopamine receptors in the
CNS. However these drugs are effective
in only 60–70% of patients, require 3–
4 weeks of treatment before clinical
improvement and have many side
effects. These inventors have shown that
in human patients, the administration of
anti-muscarinic agents produces a rapid,
prolonged alleviation of depressive
symptoms. Beginning the day following
administration of the anti-muscarinic
agent, a majority of patients show
significant improvements in mood,
anxiety, sleep and other depressive
symptoms that last days or weeks. The
very slow dissociation of some
muscarinic agents from their receptors
may account for the prolonged
therapeutic effects.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Dated: January 23, 2006.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E6–1286 Filed 1–31–06; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
State-of-the-Science Conference:
Cesarean Delivery on Maternal
Request; Notice
Notice is hereby given of the National
Institutes of Health (NIH) ‘‘State-of-theScience Conference: Cesarean Delivery
on Maternal Request’’ to be held March
27–29, 2006, in the NIH Natcher
Conference Center, 45 Center Drive,
Bethesda, Maryland 20892. The
conference will begin at 8:30 a.m. on
March 27 and 28, and at 9 a.m. on
March 29, and will be open to the
public.
Despite the national goal of reducing
rates of cesarean delivery to 15 percent
of births established as part of Healthy
People 2010, cesarean delivery rates
have continued to increase. In 2003, 1.1
million or 27.5 percent of births in the
U.S. were by cesarean delivery. An
estimated 2.5 percent of births that year
were cesarean deliveries performed on
request, in the absence of medical
necessity, and the rate of cesareans on
request appears to be growing rapidly
over time.
The potential benefits of elective
cesarean delivery as compared to
vaginal delivery are not fully
understood but are thought to include
decreased risk of urinary incontinence,
pelvic organ prolapse, anal sphincter
damage and fecal incontinence. Elective
cesarean delivery also has the benefit of
flexible timing for mother and
physician. However, like any major
surgical procedure, there are risks
associated with cesarean delivery. Risks
that are known to be higher for cesarean
deliveries than for vaginal delivery
include adverse reactions to anesthesia,
breathing problems, bleeding, infection,
urinary tract injury, and injury to the
baby. In addition, recovery time
following cesarean delivery is typically
longer than for vaginal delivery.
Given these risks, any decision to
deliver by cesarean delivery when
vaginal delivery is also available should
be informed by the best possible
information regarding potential health
outcomes, good and bad, for both
mother and baby. Toward that end, the
National Institute of Child Health and
Human Development and the Office of
Medical Applications of Research of the
National Institutes of Health will
convene a State-of-the-Science
Conference from March 27 to 29, 2006,
to assess the available scientific
evidence relevant to the following
questions:
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]]>Agencies
[Federal Register Volume 71, Number 21 (Wednesday, February 1, 2006)]
[Notices]
[Pages 5345-5346]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1277]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: FDA Approvable Human DNA
Diagnostic Test for Endometriosis
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 (NIH),
Department of Health and Human Services, is contemplating the grant of
an exclusive license worldwide to practice the invention embodied in
U.S. Patent Application Number 60/654,331 filed February 18, 2005,
entitled ``Identification of Molecular Markers for Endometriosis in
Blood Lymphocytes Using DNA Microarrays,'' to Ortho-Clinical
Diagnostics, having a place of business in Raritan, NJ 08869. The
contemplated exclusive license may be limited to an FDA approvable
human DNA diagnostic test for endometriosis. The United States of
America is the assignee of the patent rights in this invention.
DATES: Only written comments and/or application for a license which are
received by the National Institutes of Health on or before April 3,
2006 will be considered.
ADDRESSES: Requests for a copy of the patent, inquires, comments, and
other materials relating to the contemplated license should be directed
to: Marlene Astor, Technology Licensing Specialist, Office of
Technology Transfer, National Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: 301-435-
4426; Facsimile: 301-402-0220; e-mail: ms482m@nih.gov.
SUPPLEMENTARY INFORMATION: Endometriosis is a common, non-malignant
gynecological disease that
[[Page 5346]]
affects up to twenty percent (20%) of women during their reproductive
years. Endometriosis is characterized by the growth of endometrial
tissue outside the uterus. This growth of tissue causes recurring
severe pain and can lead to infertility. As the current procedure used
for diagnosis is invasive and not entirely accurate, there is a need
for a fast, accurate, and minimally invasive test to test for
endometriosis.
Using DNA microarray analysis of blood lymphocytes, the inventors
have identified two gene markers expressed in blood that are able to
discriminate between those women who have endometriosis and those that
don't. This new technology would be minimally invasive and quick using
a blood sample from a patient.
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 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.
Properly filed competing applications for a license filed in
response to this notice will be treated as objections to the
contemplated license. Comments and objections submitted in response 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: January 23, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E6-1277 Filed 1-31-06; 8:45 am]
BILLING CODE 4140-01-P
