Proposed Collection; Comment Request; Quality of Life Outcomes in Neurological Disorders, 54269-54270 [E7-18772]
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Federal Register / Vol. 72, No. 184 / Monday, September 24, 2007 / Notices
Committee (NVAC) will hold a meeting.
The meeting is open to the public.
DATES: The meeting will be held on
October 22, 2007, from 9 a.m. to 5 p.m.,
and on October 23, 2007, from 9 a.m. to
1:30 p.m.
ADDRESSES: Department of Health and
Human Services; Hubert H. Humphrey
Building, Room 800; 200 Independence
Avenue, SW., Washington, DC 20201.
FOR FURTHER INFORMATION, CONTACT: Ms.
Emma English, Program Analyst,
National Vaccine Program Office,
Department of Health and Human
Services, Room 443–H Hubert H.
Humphrey Building, 200 Independence
Avenue, SW., Washington, DC 20201;
(202) 690–5566, nvpo@hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to section 2101 of the Public Service Act
(42 U.S.C. section 300aa–1), the
Secretary of Health and Human Services
was mandated to establish the National
Vaccine Program to achieve optimal
prevention of human infectious diseases
through immunization and to achieve
optimal prevention against adverse
reactions to vaccines. The National
Vaccine Advisory Committee was
established to provide advice and make
recommendations to the Assistant
Secretary for Health, as the Director of
the National Vaccine Program, on
matters related to the program’s
responsibilities.
Topics to be discussed at the meeting
include adult and adolescent
immunization, pandemic vaccine
prioritization, vaccine financing,
vaccine stockpiles, and other
Departmental vaccine priorities.
Subcommittee meetings will be held on
the afternoon of October 22, 2007. A
tentative agenda is currently available
on the NVAC Web site: https://
www.hhs.gov/nvpo/nvac.
In anticipation of a discussion
regarding the Committee’s draft
document ‘‘Mandates for Adolescent
Immunizations,’’ developed by the
Adolescent Immunization Working
Group, the Committee invites the public
to submit written comments to the
Executive Secretary, NVAC, through the
contact person listed above. Written
comment must be received by close of
business on October 9, 2007.
Additionally, members of the public
will be given the opportunity to
participate in the discussion on October
22, 2007. Public comment will be
limited to five minutes per speaker. A
copy of this draft document can be
found at (https://www.hhs.gov/nvpo) or
by contacting the contact person
identified above.
Public attendance at the meeting is
limited to space available. Individuals
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must provide a photo ID for entry into
the Humphrey Building. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
designated contact person. Members of
the public will have the opportunity to
provide comments at the meeting.
Public comment will be limited to five
minutes per speaker. Any members of
the public who wish to have printed
material distributed to NVAC members
should submit materials to the
Executive Secretary, NVAC, through the
contact person listed above prior to
close of business October 16, 2007. Preregistration is required for both public
attendance and comment. Any
individual who wishes to attend the
meeting and/or participate in the public
comment session should e-mail
nvpo@hhs.gov or call 202–690–5566.
Dated: September 19, 2007.
Bruce Gellin,
Director, National Vaccine Program Office.
[FR Doc. E7–18758 Filed 9–21–07; 8:45 am]
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54269
Dated: September 17, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–18748 Filed 9–21–07; 8:45 am]
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This gives notice under the Federal
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The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: September 17, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–18749 Filed 9–21–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Quality of Life Outcomes in
Neurological Disorders
SUMMARY: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Neurological
Disorders and Stroke (NINDS), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
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54270
Federal Register / Vol. 72, No. 184 / Monday, September 24, 2007 / Notices
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: Quality of
Life Outcomes in Neurological
Disorders; Type of Information
Collection Request: New; Form Number:
NA; Need and Use of Information
Collection: In order to improve outcome
measurement in clinical trials of
neurological conditions, NINDS is
developing a health-related quality of
life (HRQL) measurement system for
major neurological diseases that affect
the United States population. This
measurement system must be consistent
enough across the selected conditions to
allow for cross-disease comparison, and
yet flexible enough to capture
condition-specific HRQL issues. The
primary end users of this measurement
system will be clinical trialists and
other clinical neurology researchers;
however the measurement system will
Number of
respondents
Type of respondents
also be appropriate for clinical practice.
The proposed information collection
will support psychometric testing of
HRQL item banks and testing of Spanish
translation of the final questionnaires.
Frequency of Response: Once; Affected
Public: Individuals; Type of
Respondent: Adults and children. The
annual reporting burden is shown in the
following table. There are no Capital
Costs, Operating Costs or Maintenance
Costs to report.
Frequency of
response
Average time
per response
Annual hour
burden
Adults ...............................................................................................................
Children ............................................................................................................
6000
3000
1
1
0.5
0.5
3,000
1,500
Totals ........................................................................................................
9000
........................
........................
4,500
rfrederick on PROD1PC67 with NOTICES
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points; (1) Evaluate 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) Evaluate the
accuracy of the agency’s estimate of the
burden of proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) 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. Claudia Moy,
Program Director, Clinical Trials Group,
NINDS, NIH, Neuroscience Center, 6001
Executive Boulevard, Room 2214,
Bethesda, MD 20892, or call non-tollfree number 301–496–2789 or e-mail
your request, including your address to:
moyc@ninds.nih.gov.
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: September 6, 2007.
Joellen Harper Austin,
Executive Officer, NINDS, National Institutes
of Health.
[FR Doc. E7–18772 Filed 9–21–07; 8:45 am]
BILLING CODE 4140–01–P
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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.
Method for Predicting and Detecting
Tumor Metastasis
Description of Technology: Detecting
cancer prior to metastasis greatly
increases the efficacy of treatment and
the chances of patient survival.
Although numerous biomarkers have
been reported to identify aggressive
tumor types and predict prognosis, each
biomarker is specific for a particular
type of cancer, and no universal marker
PO 00000
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that can predict metastasis in a number
of cancers have been identified. In
addition, due to a lack of reliability,
several markers are typically required to
determine the prognosis and course of
therapy.
Available for licensing are
carboxypeptidase E (CPE) inhibitor
compositions and methods to prognose
and treat cancer as well as methods to
determine the stage of cancer. The
inventors discovered that CPE
expression levels increase according to
the presence of cancer and metastasis
wherein CPE is upregulated in tumors
and CPE levels are further increased in
metastatic cancer. This data has been
demonstrated both in vitro and in vivo
experiments and in liver, breast,
prostate, colon, and head and neck
cancers. Metastatic liver cells treated
with CPE siRNA reversed the cells from
being metastatic and arrested cells from
further metastasis. Thus, CPE as a
biomarker for predicting metastasis and
its inhibitors have an enormous
potential to increase patient survival.
Applications: Method to prognose
multiple types of cancer and determine
likelihood of metastasis; Compositions
that inhibit CPE such as siRNA; Method
to prevent and treat cancer with CPE
inhibitors.
Market: 600,000 cancer related deaths
in 2006; Global cancer market is worth
more than eight percent of total global
pharmaceutical sales; Cancer industry is
predicted to expand to $85.3 billion by
2010.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Inventors: Y. Peng Loh (NICHD) et al.
Publication: Manuscript in
preparation.
Patent Status: U.S. Provisional
Application No. 60/885,809 filed 19 Jan
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[Federal Register Volume 72, Number 184 (Monday, September 24, 2007)]
[Notices]
[Pages 54269-54270]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18772]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; Quality of Life Outcomes in
Neurological Disorders
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Institute of
Neurological Disorders and Stroke (NINDS), the National Institutes of
Health (NIH) will publish periodic summaries of proposed
[[Page 54270]]
projects to be submitted to the Office of Management and Budget (OMB)
for review and approval.
Proposed Collection: Title: Quality of Life Outcomes in
Neurological Disorders; Type of Information Collection Request: New;
Form Number: NA; Need and Use of Information Collection: In order to
improve outcome measurement in clinical trials of neurological
conditions, NINDS is developing a health-related quality of life (HRQL)
measurement system for major neurological diseases that affect the
United States population. This measurement system must be consistent
enough across the selected conditions to allow for cross-disease
comparison, and yet flexible enough to capture condition-specific HRQL
issues. The primary end users of this measurement system will be
clinical trialists and other clinical neurology researchers; however
the measurement system will also be appropriate for clinical practice.
The proposed information collection will support psychometric testing
of HRQL item banks and testing of Spanish translation of the final
questionnaires. Frequency of Response: Once; Affected Public:
Individuals; Type of Respondent: Adults and children. The annual
reporting burden is shown in the following table. There are no Capital
Costs, Operating Costs or Maintenance Costs to report.
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average time Annual hour
Type of respondents respondents response per response burden
----------------------------------------------------------------------------------------------------------------
Adults.......................................... 6000 1 0.5 3,000
Children........................................ 3000 1 0.5 1,500
---------------------------------------------------------------
Totals...................................... 9000 .............. .............. 4,500
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points; (1) Evaluate 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) Evaluate the accuracy of the agency's estimate of the
burden of proposed collection of information, including the validity of
the methodology and assumptions used; (3) Enhance the quality, utility,
and clarity of the information to be collected; and (4) 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. Claudia Moy, Program Director, Clinical
Trials Group, NINDS, NIH, Neuroscience Center, 6001 Executive
Boulevard, Room 2214, Bethesda, MD 20892, or call non-toll-free number
301-496-2789 or e-mail your request, including your address to:
moyc@ninds.nih.gov.
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: September 6, 2007.
Joellen Harper Austin,
Executive Officer, NINDS, National Institutes of Health.
[FR Doc. E7-18772 Filed 9-21-07; 8:45 am]
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