Government-Owned Inventions; Availability for Licensing, 33467-33468 [E6-9018]
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Federal Register / Vol. 71, No. 111 / Friday, June 9, 2006 / Notices
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Sakineh Walther, Center for Drug
Evaluation and Research (HFD–316),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–8964.
SUPPLEMENTARY INFORMATION:
I. Background
In the United States, as many as
several thousand drug products are
marketed illegally without required
FDA approval. The manufacturers of
these drugs have neither received FDA
approval to legally market their drugs,
nor have the drugs been marketed in
accordance with a final OTC drug
monograph. The drug approval and OTC
monograph processes play an essential
role in ensuring that all drugs are both
safe and effective. Manufacturers of new
drugs that lack required approval,
including those that are not marketed in
accordance with an OTC drug
monograph, have not provided FDA
with evidence demonstrating that their
products are safe and effective.
Therefore, FDA has an interest in taking
steps to encourage the manufacturers of
these products either to obtain the
required evidence and comply with the
approval provisions of the Federal Food,
Drug, and Cosmetic Act or to remove the
products from the market. FDA wants to
achieve these goals without adversely
affecting public health, imposing undue
burdens on consumers, or unnecessarily
disrupting the market.
In general, in recent years, FDA has
employed a risk-based enforcement
approach to marketed unapproved drugs
that includes efforts to identify illegally
marketed drugs, prioritization of those
drugs according to potential public
health concerns or other impacts on the
public health, and subsequent
regulatory followup. Some of the
specific actions the agency has taken
have been precipitated by evidence of
safety or effectiveness problems that has
come to our attention either during
inspections or through outside sources.
jlentini on PROD1PC65 with NOTICES
II. The Guidance
FDA is announcing the availability of
a guidance entitled ‘‘Marketed
Unapproved Drugs—Compliance Policy
Guide.’’ In the Federal Register of
October 23, 2003 (62 FR 60702), FDA
announced the availability of a draft
guidance of the same title and gave
interested persons an opportunity to
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16:01 Jun 08, 2006
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submit comments by December 22,
2003. In response to comments received,
the agency revised the guidance to
include editorial corrections and
clarification of policies, including
clarification of when and how we
intend to exercise our enforcement
discretion. The revisions also clarify the
discussion of ‘‘grandfather’’ status and
expressly state that no part of the
guidance is a finding as to the legal
status of any particular drug product.
This document supersedes section
440.100 entitled ‘‘Marketed New Drugs
Without Approved NDAs or ANDAs’’
(CPG 7132c.02) of the CPG. It applies to
any new drug required to have FDA
approval for marketing, including new
drugs covered by the OTC review.
The goals of the guidance are to
address the following issues: (1) Clarify
for FDA personnel and the regulated
industry how the FDA intends to
exercise its enforcement discretion
regarding unapproved drugs and (2)
emphasize that illegally marketed drugs
must obtain FDA approval.
The guidance reflects the agency’s
desire to address these issues with
policies that are predictable, reasonable,
and supportive of the public health. The
agency’s approach encourages
companies to comply with the drug
approval process, but it also seeks to
minimize disruption to the marketplace
and to safeguard consumer health when
there are potential safety risks. The
guidance explains that FDA will
continue to give priority to enforcement
actions involving unapproved drugs
with potential safety risks, that lack
evidence of effectiveness, and that
constitute health fraud. It also explains
how the agency intends to address those
situations in which a firm obtains FDA
approval to sell a drug that other firms
have long been selling without FDA
approval. It confirms that the agency
will continue longstanding policies
regarding firms making unapproved
drugs who are violating the act in other
respects and clarifies how the agency
plans to address formulation changes
made to evade an enforcement action.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on this topic. 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.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
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33467
ADDRESSES)
written or electronic
comments on the guidance. Submit a
single copy of electronic comments or
two paper copies of any mailed
comments, except that individuals may
submit one paper copy. Comments are
to be identified with the docket number
found in brackets in the heading of this
document. The guidance and received
comments are available for public
examination in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: June 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–9032 Filed 6–8–06; 8:45 am]
BILLING CODE 4160–01–S
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.
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
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.
DNA Influenza Vaccine
Description of Technology: The FDA
is pleased to announce a single vector
DNA vaccine against influenza as
available for licensing. The single vector
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33468
Federal Register / Vol. 71, No. 111 / Friday, June 9, 2006 / Notices
jlentini on PROD1PC65 with NOTICES
expresses both hemagglutinin (HA) and
matrix (M) proteins, generating both
humoral and cellular immune
responses. The vaccine candidate
completely protected mice against
homologous virus challenge and
significantly improved survival against
heterologous virus challenge. A robust
and reliable vaccine supply is widely
recognized as critical for seasonal or
pandemic influenza preparedness. The
advantages offered by this vaccine make
it an excellent candidate for further
development.
Advantages: (1) DNA vaccines are
easy to produce and store; (2) Vaccine
candidate improved survival against
heterologous virus challenge; (3) No risk
of reversion to pathogenic strain as with
live-attenuated virus vaccines; (4) Can
be administered to immunocompromised individuals, increasing
potential market size; (5) HA and M
proteins encoded by single vector,
ensuring uniform delivery of
immunogen; (6) More efficient to boost
synergistic effects on both HA and M
specific immune responses than a
mixture of individual plasmids; (7) M
protein not subject to antigenic drift,
which allows advanced manufacturing
and overcomes the need for strain
monitoring; (8) DNA vaccines elicit
cellular immune response, essential for
efficient virus clearance.
Inventors: Zhiping Ye et al. (FDA).
Patent Status: U.S. Provisional
Application No. 60/786,747 filed 27 Mar
2006 (HHS Reference No. E–300–2005/
0–US–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Susan Ano, Ph.D.;
301/435–5515; anos@mail.nih.gov.
Collaborative Research Opportunity:
The Food and Drug Administration is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize this
technology. Please contact the inventor,
Zhiping Ye at 301/435–5197 or Beatrice
Droke at 301/827–7008 for more
information.
Method for Improved Phase Contrast
MRI Resolution
Description of Technology: This
invention is a method to significantly
improve the temporal or spatial
resolution in a phase contrast MRI (PC–
MRI) study. In general, conventional
PC–MRI involves encoding the motion
information of spins in the phase of the
image. The velocity of the spin motion
can be extracted by calculating the
phase difference between two
consecutive images acquired with two
different bipolar encoding gradients.
VerDate Aug<31>2005
16:01 Jun 08, 2006
Jkt 208001
Two scans are required in order to
reconstruct flow velocity data, resulting
in an increase in image acquisition and
reconstruction time by a factor of two
compared to that of a standard
anatomical image. As a means of
reducing the PC–MRI scan time, the
inventors propose a method of acquiring
only a fraction of k-space data. The kspace is sampled using an undersampled spiral or single projection,
radial scheme. Subsequently, the two
data sets in the PC–MRI are subtracted
to extract the motion information from
undersampled data without any aliasing
artifacts. This method of partial-field of
view acquisition and reconstruction of
PC-MRI results in an increased temporal
resolution, while maintaining high
spatial resolution. The increase in image
acquisition efficiency could be used to
increase the spatial resolution while
maintaining the temporal resolution.
Inventors: Reza Nezafat et al. (NHLBI).
Patent Status: U.S. Patent Application
No. 11/227,406 filed 14 Sep 2005 (HHS
Reference No. E–134–2005/0-US–01).
Licensing Status: Available for nonexclusive or exclusive licensing.
Licensing Contact: Chekesha
Clingman, PhD; 301/435–5018;
clingmac@mail.nih.gov.
Image Guided Systems and Methods for
Organ Viability Assessment
Description of Technology: The
number of patients for organ transplants
continues to grow, without an increase
in the number of organs available for
transplant. This has increased interest
in transplanting organs from nontraditional sources, such as donations
after cardiac death. However, there are
currently no methods to objectively
measure the effects of resuscitation and
ischemia damage on organ viability.
The present invention relates to
systems and methods for evaluating the
status and characterization of organs,
determining their suitability for
transplants, as well as restoring the
viability of organs intended for
transplants. Particularly, this method is
based on using optical (infrared or near
infrared) imaging to guide the
resuscitation of the donor organs and
predict the recovery of grafts challenged
with several hours of preservation. This
method allows for localization of
ischemic areas and guiding targeted
resuscitation of the organ.
For example, the inventors have
shown that by combining a kidney
reperfusion system with infrared
imaging equipment, it is possible to
differentiate between ischemic and nonischemic tissue and restore the viability
of the kidney. This method can
potentially be used to evaluate the
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
viability of any body part or organ
intended for transplantation, such as
extremities, heart, lungs, and liver. This
approach can lead to the utilization of
donation-after-cardiac-death organs and
can substantially increase the donor
pool of organs. Hence, this new method
can identify organs that may be
considered unsuitable for transplant,
and help prevent transplantation of
organs whose function may be
considered impaired, as well as help
guide resuscitation efforts.
Inventors: Alexander M. Gorbach
(ORS), Allan D. Kirk (NIDDK), Eric
Elster (NIDDK).
Patent Status: U.S. Provisional
Application No. 60/778,785 filed 03 Mar
2006 (HHS Reference No. E–098–2005/
0–US–01).
Licensing Status: Available for nonexclusive or exclusive licensing.
Licensing Contact: Chekesha
Clingman, PhD; 301/435–5018;
clingmac@mail.nih.gov.
Dated: June 5, 2006.
David R. Sadowski,
Acting Director, Division of Technology
Development and Transfer, Office of
Technology Transfer, National Institutes of
Health.
[FR Doc. E6–9018 Filed 6–8–06; 8:45 am]
BILLING CODE 4140–01–P
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. Appendix 2), 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 rant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Small
Grants for Behavioral Research in Cancer
Control.
Date: June 26–27, 2006.
Time: 9 a.m. to 5 p.m.
Agenda: To review an evaluate grant
applications.
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]]>Agencies
[Federal Register Volume 71, Number 111 (Friday, June 9, 2006)]
[Notices]
[Pages 33467-33468]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9018]
-----------------------------------------------------------------------
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.
DNA Influenza Vaccine
Description of Technology: The FDA is pleased to announce a single
vector DNA vaccine against influenza as available for licensing. The
single vector
[[Page 33468]]
expresses both hemagglutinin (HA) and matrix (M) proteins, generating
both humoral and cellular immune responses. The vaccine candidate
completely protected mice against homologous virus challenge and
significantly improved survival against heterologous virus challenge. A
robust and reliable vaccine supply is widely recognized as critical for
seasonal or pandemic influenza preparedness. The advantages offered by
this vaccine make it an excellent candidate for further development.
Advantages: (1) DNA vaccines are easy to produce and store; (2)
Vaccine candidate improved survival against heterologous virus
challenge; (3) No risk of reversion to pathogenic strain as with live-
attenuated virus vaccines; (4) Can be administered to immuno-
compromised individuals, increasing potential market size; (5) HA and M
proteins encoded by single vector, ensuring uniform delivery of
immunogen; (6) More efficient to boost synergistic effects on both HA
and M specific immune responses than a mixture of individual plasmids;
(7) M protein not subject to antigenic drift, which allows advanced
manufacturing and overcomes the need for strain monitoring; (8) DNA
vaccines elicit cellular immune response, essential for efficient virus
clearance.
Inventors: Zhiping Ye et al. (FDA).
Patent Status: U.S. Provisional Application No. 60/786,747 filed 27
Mar 2006 (HHS Reference No. E-300-2005/0-US-01).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Susan Ano, Ph.D.; 301/435-5515;
anos@mail.nih.gov.
Collaborative Research Opportunity: The Food and Drug
Administration is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate, or commercialize this technology. Please contact the
inventor, Zhiping Ye at 301/435-5197 or Beatrice Droke at 301/827-7008
for more information.
Method for Improved Phase Contrast MRI Resolution
Description of Technology: This invention is a method to
significantly improve the temporal or spatial resolution in a phase
contrast MRI (PC-MRI) study. In general, conventional PC-MRI involves
encoding the motion information of spins in the phase of the image. The
velocity of the spin motion can be extracted by calculating the phase
difference between two consecutive images acquired with two different
bipolar encoding gradients. Two scans are required in order to
reconstruct flow velocity data, resulting in an increase in image
acquisition and reconstruction time by a factor of two compared to that
of a standard anatomical image. As a means of reducing the PC-MRI scan
time, the inventors propose a method of acquiring only a fraction of k-
space data. The k-space is sampled using an under-sampled spiral or
single projection, radial scheme. Subsequently, the two data sets in
the PC-MRI are subtracted to extract the motion information from
undersampled data without any aliasing artifacts. This method of
partial-field of view acquisition and reconstruction of PC-MRI results
in an increased temporal resolution, while maintaining high spatial
resolution. The increase in image acquisition efficiency could be used
to increase the spatial resolution while maintaining the temporal
resolution.
Inventors: Reza Nezafat et al. (NHLBI).
Patent Status: U.S. Patent Application No. 11/227,406 filed 14 Sep
2005 (HHS Reference No. E-134-2005/0-US-01).
Licensing Status: Available for non-exclusive or exclusive
licensing.
Licensing Contact: Chekesha Clingman, PhD; 301/435-5018;
clingmac@mail.nih.gov.
Image Guided Systems and Methods for Organ Viability Assessment
Description of Technology: The number of patients for organ
transplants continues to grow, without an increase in the number of
organs available for transplant. This has increased interest in
transplanting organs from non-traditional sources, such as donations
after cardiac death. However, there are currently no methods to
objectively measure the effects of resuscitation and ischemia damage on
organ viability.
The present invention relates to systems and methods for evaluating
the status and characterization of organs, determining their
suitability for transplants, as well as restoring the viability of
organs intended for transplants. Particularly, this method is based on
using optical (infrared or near infrared) imaging to guide the
resuscitation of the donor organs and predict the recovery of grafts
challenged with several hours of preservation. This method allows for
localization of ischemic areas and guiding targeted resuscitation of
the organ.
For example, the inventors have shown that by combining a kidney
reperfusion system with infrared imaging equipment, it is possible to
differentiate between ischemic and non-ischemic tissue and restore the
viability of the kidney. This method can potentially be used to
evaluate the viability of any body part or organ intended for
transplantation, such as extremities, heart, lungs, and liver. This
approach can lead to the utilization of donation-after-cardiac-death
organs and can substantially increase the donor pool of organs. Hence,
this new method can identify organs that may be considered unsuitable
for transplant, and help prevent transplantation of organs whose
function may be considered impaired, as well as help guide
resuscitation efforts.
Inventors: Alexander M. Gorbach (ORS), Allan D. Kirk (NIDDK), Eric
Elster (NIDDK).
Patent Status: U.S. Provisional Application No. 60/778,785 filed 03
Mar 2006 (HHS Reference No. E-098-2005/0-US-01).
Licensing Status: Available for non-exclusive or exclusive
licensing.
Licensing Contact: Chekesha Clingman, PhD; 301/435-5018;
clingmac@mail.nih.gov.
Dated: June 5, 2006.
David R. Sadowski,
Acting Director, Division of Technology Development and Transfer,
Office of Technology Transfer, National Institutes of Health.
[FR Doc. E6-9018 Filed 6-8-06; 8:45 am]
BILLING CODE 4140-01-P
