Agency Information Collection Activities: Proposed Collection; Comment Request, 21435-21436 [05-8275]
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Federal Register / Vol. 70, No. 79 / Tuesday, April 26, 2005 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Nitroxides as Protectors
Against Oxidative Stress
National Institutes of Health,
Public Health Service, DHHS.
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
5,792,775, issued on August 11, 1998,
entitled ‘‘Nitroxides as Protectors
Against Oxidative Stress,’’ to Mitos, Inc.
having a place of business in the State
of California. The field of use may be
limited to therapeutics for the treatment
and/or protection of tissue damage
caused by ionization radiation. The
United States of America is the assignee
of the patent rights in this invention.
This announcement is the first notice to
grant an exclusive license to this
technology.
DATES: Only written comments and/or
application for a license which are
received by the NIH Office of
Technology Transfer on or before June
27, 2005 will be considered.
ADDRESSES: Requests for a copy of the
patent, inquiries, comments and other
materials relating to the contemplated
license should be directed to: Pradeep
Ghosh, J.D., Ph.D., M.B.A., Technology
Licensing Specialist, Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
telephone: (301) 435–5282; Facsimile:
(301) 402–0220; e-mail:
ghoshpr@mail.nih.gov.]
This
technology relates to to the use of a
biologically compatible composition
containing an effective amount of a
metal independent nitroxide compound
as an antioxidant capable of protecting
cells, tissues, organs, and whole
organisms against deleterious effects of
harmful oxygen-derived species
generated during oxidative stress
SUPPLEMENTARY INFORMATION:
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induced by ionizing radiations.
Nitroxides are low molecular weight
molecules and easily soluble in aqueous
solutions. They are active within the
biological pH range of 5–8, non-toxic at
effective concentrations and can be
easily attached to several organic
molecules that may facilitate targeting of
the molecules to specific organs or
organelles. These properties of
nitroxides make them ideal for
treatment and protection of radiation
induced cellular and tissue damages.
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, 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: April 18, 2005.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 05–8299 Filed 4–25–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration will publish
periodic summaries of proposed
projects. To request more information
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21435
on the proposed projects or to obtain a
copy of the information collection
plans, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: 2005 Client/Patient
Sample Survey—New
The Substance Abuse and Mental
Health Services Administration
(SAMHSA), Center for Mental Health
Services (CMHS) will conduct a sample
survey of mental health programs (i.e.,
inpatient, residential, and less than 24hour care) within specialty mental
health organizations. These
organizations include psychiatric
hospitals, general hospitals with
separate psychiatric services,
multiservice mental health
organizations, residential treatment
centers, and freestanding outpatient
clinics and partial care organizations.
A sample of approximately 2,500
mental health organizations/programs
will provide information on an average
sample of 8 admissions and 8 persons
under care in the programs. National
estimates will be generated on the
number of persons admitted to and
under care in these organizations, and
on the sociodemographic, clinical, and
service use characteristics of these
persons. This survey will update a
previous sample survey conducted in
1997 (OMB No. 0930–0114).
In addition, the 2005 survey will
include a consumer survey for the
sampled adults under care in the less
than 24-hour programs to obtain
consumers’ perceptions of care received.
Respondents will have the option of
responding electronically.
The annual burden estimate is shown
below:
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Federal Register / Vol. 70, No. 79 / Tuesday, April 26, 2005 / Notices
No. of
responses per
respondent
No. of
respondents
Respondent
Average burden/response
(hrs.)
Total annual
burden
(hrs.)
Mental Health Organization/Program ..............................................................
Consumer ........................................................................................................
2,500
8,000
1
1
5.25
0.25
13,125
2,000
Total ..........................................................................................................
10,500
........................
........................
15,125
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 7–1044, 1 Choke Cherry Road,
Rockville, MD 20850. Written comments
should be received by June 27, 2005.
Dated: April 12, 2005.
Anna Marsh,
Executive Officer, SAMHSA.
[FR Doc. 05–8275 Filed 4–25–05; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance 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
(SAMHSA) 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 SAMHSA Reports
Clearance Officer on (240) 276–1243.
Proposed Project: Emergency Response
Grants Regulations—42 CFR Part 51—
(OMB No. 0930–0229)—Extension
This rule implements section 501(m)
of the Public Health Service Act (42
U.S.C. 290aa), which authorizes the
Secretary to make noncompetitive
grants, contracts or cooperative
agreements to public entities to enable
such entities to address emergency
substance abuse or mental health needs
in local communities. The rule
establishes criteria for determining that
a substance abuse or mental health
emergency exists, the minimum content
for an application, and reporting
requirements for recipients of such
funding. SAMHSA will use the
information in the applications to make
a determination that the requisite need
exists; that the mental health and/or
substance abuse needs are a direct result
of the precipitating event; that no other
local, State, tribal or Federal funding
sources are available to address the
need; that there is an adequate plan of
services; that the applicant has
appropriate organizational capability;
and, that the budget provides sufficient
justification and is consistent with the
documentation of need and the plan of
services. Eligible applicants may apply
to the Secretary for either of two types
of substance abuse and mental health
emergency response grants: Immediate
awards and Intermediate awards. The
Number of respondents
42 CFR citation
former are designed to be funded up to
$50,000, or such greater amount as
determined by the Secretary on a caseby-case basis, and are to be used over
the initial 90-day period commencing as
soon as possible after the precipitating
event; the latter awards require more
documentation, including a needs
assessment, other data and related
budgetary detail. The Intermediate
awards have no predefined budget limit.
Typically, Intermediate awards would
be used to meet systemic mental health
and/or substance abuse needs during
the recovery period following the
Immediate award period. Such awards
may be used for up to one year, with a
possible second year supplement based
on submission of additional required
information and data. This program is
an approved user of the PHS–5161
application form, approved by OMB
under control number 0920–0428. The
quarterly financial status reports in
51d.10(a)(2) and (b)(2) are as permitted
by 45 CFR 92.41(b); the final program
report, financial status report and final
voucher in 51d.10(a)(3) and in
51d.10(b)(3–4) are in accordance with
45 CFR 92.50(b). Information collection
requirements of 45 CFR part 92 are
approved by OMB under control
number 0990–0169. The following table
presents annual burden estimates for the
information collection requirements of
this regulation.
Responses
per respondent
Hours per response
Annual burden
hours
Immediate award application:
51d.4(a) and 51d.6(a)(2) ..............................................................................
51d.4(b) and 51d.6(a)(2), Immediate Awards ..............................................
51d.10(a)(1)—Immediate awards—mid-program report if applicable ..........
Final report content for both types of awards:
51d.10(c) ......................................................................................................
3
3
3
1
1
1
3
10
2
*9
* 30
*6
6
1
3
18
Total ......................................................................................................
6
........................
........................
18
* This burden is carried under OMB No. 0920–0428.
Written comments and
recommendations concerning the
proposed information collection should
be sent by May 26, 2005 to: SAMHSA
Desk Officer, Human Resources and
Housing Branch, Office of Management
and Budget, New Executive Office
Building, Room 10235, Washington, DC
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20503; due to potential delays in OMB’s
receipt and processing of mail sent
through the U.S. Postal Service,
respondents are encouraged to submit
comments by fax to: (202) 395–6974.
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Dated: April 14, 2005.
Anna Marsh,
Executive Officer, SAMHSA.
[FR Doc. 05–8278 Filed 4–25–05; 8:45 am]
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Agencies
[Federal Register Volume 70, Number 79 (Tuesday, April 26, 2005)]
[Notices]
[Pages 21435-21436]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8275]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection;
Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995 concerning opportunity for public comment on proposed
collections of information, the Substance Abuse and Mental Health
Services Administration will publish periodic summaries of proposed
projects. To request more information on the proposed projects or to
obtain a copy of the information collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276-1243.
Comments are invited on: (a) Whether the proposed collections of
information are necessary for the proper performance of the functions
of the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology.
Proposed Project: 2005 Client/Patient Sample Survey--New
The Substance Abuse and Mental Health Services Administration
(SAMHSA), Center for Mental Health Services (CMHS) will conduct a
sample survey of mental health programs (i.e., inpatient, residential,
and less than 24-hour care) within specialty mental health
organizations. These organizations include psychiatric hospitals,
general hospitals with separate psychiatric services, multiservice
mental health organizations, residential treatment centers, and
freestanding outpatient clinics and partial care organizations.
A sample of approximately 2,500 mental health organizations/
programs will provide information on an average sample of 8 admissions
and 8 persons under care in the programs. National estimates will be
generated on the number of persons admitted to and under care in these
organizations, and on the sociodemographic, clinical, and service use
characteristics of these persons. This survey will update a previous
sample survey conducted in 1997 (OMB No. 0930-0114).
In addition, the 2005 survey will include a consumer survey for the
sampled adults under care in the less than 24-hour programs to obtain
consumers' perceptions of care received. Respondents will have the
option of responding electronically.
The annual burden estimate is shown below:
[[Page 21436]]
----------------------------------------------------------------------------------------------------------------
No. of Average burden/
Respondent No. of responses per response Total annual
respondents respondent (hrs.) burden (hrs.)
----------------------------------------------------------------------------------------------------------------
Mental Health Organization/Program.............. 2,500 1 5.25 13,125
Consumer........................................ 8,000 1 0.25 2,000
---------------- -----------------
Total....................................... 10,500 .............. .............. 15,125
----------------------------------------------------------------------------------------------------------------
Send comments to Summer King, SAMHSA Reports Clearance Officer,
Room 7-1044, 1 Choke Cherry Road, Rockville, MD 20850. Written comments
should be received by June 27, 2005.
Dated: April 12, 2005.
Anna Marsh,
Executive Officer, SAMHSA.
[FR Doc. 05-8275 Filed 4-25-05; 8:45 am]
BILLING CODE 4162-20-P