Prospective Grant of Exclusive License: Food Quality Indicator Device, 31590-31591 [E7-10963]
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Federal Register / Vol. 72, No. 109 / Thursday, June 7, 2007 / Notices
have been approved under OMB control
number 0910–0485; and the collections
of information in 21 CFR part 820 have
been approved under OMB control
number 0910–0073.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
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. Comments
received may be seen in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: May 31, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E7–10996 Filed 6–6–07; 8:45 am]
I. Background
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0212]
Draft Guidance for Industry on Malaria:
Developing Drug and Nonvaccine
Biological Products for Treatment and
Prophylaxis; Availability
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Malaria: Developing
Drug and Nonvaccine Biological
Products for Treatment and
Prophylaxis.’’ This draft guidance
addresses issues regarding the
development of therapy for prophylaxis
and treatment of malaria. Specific topics
include recommendations for
preclinical development, clinical trial
study design, the use of microbiological
testing during clinical trials, and
statistical considerations.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by September 5, 2007.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
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20:59 Jun 06, 2007
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Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the draft
guidance 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.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Leonard Sacks, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6178,
Silver Spring, MD 20993–0002, 301–
796–1600.
SUPPLEMENTARY INFORMATION:
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Malaria: Developing Drug and
Nonvaccine Biological Products for
Treatment and Prophylaxis.’’ Malaria is
a major global problem with the greatest
burden of disease and mortality
occurring in developing countries.
Although cases of malaria are
uncommon in the United States,
antimalarial drugs have significant
public health importance in the United
States: Antimalarial prophylaxis is used
extensively by U.S. travelers and by U.S.
citizens residing in or deployed to
endemic areas (e.g., military personnel).
This guidance addresses the
development of therapy for the
prophylaxis and treatment of malaria.
Overall aspects of a developmental
program for antimalarial therapy are
discussed. Specific topics include
recommendations for preclinical
development, clinical trial study design,
the use of microbiological testing during
clinical trials, and statistical
considerations.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on developing drug and nonvaccine
biological products for the treatment
and prophylaxis of malaria. 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.
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II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
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. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/ohrms/dockets/
default.htm or https://www.fda.gov/cder/
guidance/index.htm.
Dated: May 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–11001 Filed 6–6–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Food Quality Indicator Device
Food and Drug Administration,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
part 404.7(a)(1)(i), that the Food and
Drug Administration, Department of
Health and Human Services, is
contemplating the grant of an exclusive
patent license to practice the invention
embodied in U.S. Patent 7,014,816,
issued March 21, 2006, entitled ‘‘Food
Quality Indicator Device’’ [E–093–1997/
0–US–03] and foreign counterparts; to
Litmus, LLC, having a place of business
in Little Rock, AR. 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
manufacture, use, distribution and sale
of the Food Quality Indicator Device as
claimed in the licensed patent rights.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
August 6, 2007 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
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Federal Register / Vol. 72, No. 109 / Thursday, June 7, 2007 / Notices
and other materials relating to the
contemplated exclusive license should
be directed to: Adaku Nwachukwu, J.D.,
Technology Licensing Specialist, Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
5560; Facsimile: (301) 402–0220; E-mail:
madua@mail.nih.gov.
The
technology relates to an effective way to
monitor food quality and freshness in
real time. The major factor for food
spoilage is the release of volatile bases
due to the action of enzymes contained
within the food or produced by
microorganisms, such as bacteria, yeasts
and molds growing in the food. The rate
of release of such bases depends on
food’s storage history. In this
technology, a reactive dye locked in a
water-repellent material reacts with the
bases released during food
decomposition, and changes color. Thus
a rapid and informed decision can be
made about quality of food and its shelf
life under the storage conditions used.
Since the detection is based on
biological processes that are the root
cause for food spoilage, these indicators
are much more reliable.
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.
rwilkins on PROD1PC63 with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: May 21, 2007.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E7–10963 Filed 6–6–07; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substances Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMSHA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMSHA Reports
Clearance Officer on (240) 276–1243.
Project: Community Mental Health
Services Block Grant Application
Guidance and Instruction, FY 2008–
2010 (OMB No. 0930–0168)—Revisions
Sections 1911 through 1920 of the
Public Health Service Act (42 U.S.C.
300x through 300x–9) provide for
annual allotments to assist States to
establish or expand an organized,
community-based system of care for
adults with serious mental illnesses and
children with serious emotional
disturbances. Under these provision of
the law, States may receive allotments
only after an application is submitted
and approved by the Secretary of the
Department of Health and Human
Services.
For the FY 2008–2010 Community
Mental Health Services Block Grant
application cycle, SAMSHA will
provide States guidance and
instructions to guide development of
comprehensive State applications/plans
and implementation reports. Proposed
revisions to the guidance include:
(1) The integration of mental health
transformation as a guiding principle in
the development of State mental health
plans. State plans for FY 2008–2010 will
describe State mental health
transformation efforts and activities
within the context of the five (5)
legislative criteria, identify mental
health transformation activities funded
by the MHBG and other State funding
sources, identify activities of the State
mental health planning council that
contribute to and support State
transformation efforts, include one State
transformation performance indicator in
the plan, and include a description of
the services provided to older adults
under criterion 4 of the State’s plan.
(2) The introduction of the Web Block
Grant Application System (WebBGAS).
WebBGAS enables States to submit
applications/plans, and implementation
reports electronically thus reducing the
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31591
burden of paperwork required for
submission, revision, and reporting
purposes. In FY 2008, all States and
Territories will be encouraged to submit
State plans using WebBGAS. Other
advantages to using WebBGAS include:
• Eliminating redundancy in data
entry by pre-populating the States’
previous year data in the current year’s
plans and implementation reports.
• Standardizing Mental Health Block
Grant data for reporting and quantitative
analysis.
• Allowing the States’ mental health
planning councils to have access to state
plans and implementation reports
throughout the FY as a means to enable
councils to meet their Federal mandate
of reviewing the plans and providing
recommendations to the State.
• Adhering to the Federal
Government’s e-governments and egrants initiatives, where applicable.
(3) A requirement for States to report
nine CMHS National Outcome Measures
(NOMS) for mental health. All nine
measures are derived from tables in the
Uniform Reporting System (URS) which
was developed in collaboration with the
States. Four (4) of the nine measures
were established, in concert with OMB
PART, to support the long-term goals of
the Mental Health Block Grant program
and SAMSHA’s Government Results
and Performance Act (GPRA) measures.
The nine CMHS measures are:
• Increased access to services
• Reduced utilization of psychiatric
inpatient beds for 30 and 180 days
• Number of evidenced-based
practices and number of persons served
in these programs
• Client perception of care
• Increased/retained employment or
returned to/stayed in school
• Decreased criminal justice
involvement
• Increased stability in housing
• Increased social supports and social
connectedness, and
• Improved level of functioning.
Two of the NOMS, Increased Social
Supports and Social Connectedness,
and Improved Functioning, are
currently under development at
SAMSHA. States that are unable to
report data on these or other indicators
will be required to describe their current
reporting capacity and efforts underway
to make collection of the data possible.
(4) Revisions to tables in the Uniform
Reporting System (URS). Since FY 2001,
States have reported annual data on the
public mental health system to the
MHBG Program through 21 tables in the
URS. For the past three years, CMHS
worked collaboratively with States,
using the Data Infrastructure Grant (DIG)
process, to refine the data and make
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]]>Agencies
[Federal Register Volume 72, Number 109 (Thursday, June 7, 2007)]
[Notices]
[Pages 31590-31591]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10963]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Food Quality Indicator
Device
AGENCY: Food and Drug Administration, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
CFR part 404.7(a)(1)(i), that the Food and Drug Administration,
Department of Health and Human Services, is contemplating the grant of
an exclusive patent license to practice the invention embodied in U.S.
Patent 7,014,816, issued March 21, 2006, entitled ``Food Quality
Indicator Device'' [E-093-1997/0-US-03] and foreign counterparts; to
Litmus, LLC, having a place of business in Little Rock, AR. 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 manufacture, use, distribution
and sale of the Food Quality Indicator Device as claimed in the
licensed patent rights.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
August 6, 2007 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments,
[[Page 31591]]
and other materials relating to the contemplated exclusive license
should be directed to: Adaku Nwachukwu, J.D., Technology Licensing
Specialist, Office of Technology Transfer, National Institutes of
Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804;
Telephone: (301) 435-5560; Facsimile: (301) 402-0220; E-mail:
madua@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The technology relates to an effective way
to monitor food quality and freshness in real time. The major factor
for food spoilage is the release of volatile bases due to the action of
enzymes contained within the food or produced by microorganisms, such
as bacteria, yeasts and molds growing in the food. The rate of release
of such bases depends on food's storage history. In this technology, a
reactive dye locked in a water-repellent material reacts with the bases
released during food decomposition, and changes color. Thus a rapid and
informed decision can be made about quality of food and its shelf life
under the storage conditions used. Since the detection is based on
biological processes that are the root cause for food spoilage, these
indicators are much more reliable.
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 21, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer,Office of
Technology Transfer,National Institutes of Health.
[FR Doc. E7-10963 Filed 6-6-07; 8:45 am]
BILLING CODE 4140-01-P
