Proposed Collection; Comment Request; Physicians' Experience of Ethical Dilemmas and Resource Allocation, 27817-27818 [E7-9543]
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Federal Register / Vol. 72, No. 95 / Thursday, May 17, 2007 / Notices
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Dated: May 8, 2007.
David A. Schwartz,
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Health Sciences and National Toxicology
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Dated: May 10, 2007.
Elaine L. Baker,
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and Prevention.
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Centers for Disease Control and
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Healthcare Infection Control Practices
Advisory Committee (HICPAC):
Meeting
Disease, Disability, and Injury
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Emphasis Panel: Evaluation of
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Opportunity Announcement (FOA)
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In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces a meeting of the
aforementioned Special Emphasis
Panel.
Time and Date: 12 p.m.–4 p.m., June 18,
2007 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters to be Discussed: The meeting will
include the review, discussion, and
evaluation of research grant applications in
response to FOA IP07–007, ‘‘Evaluation of
Vaccination Reminder/Recall Systems for
Adolescent Patients,’’ FOA IP07–010,
‘‘Strategies to Reach the ‘‘Unreachable’’
Through Immunization Registries,’’ and FOA
IP07–012, ‘‘Using Provider Reminder/Recall
to Enhance Up-to-Date Coverage of 18-Month
Olds.’’
For Further Information Contact: Trudy
Messmer, Ph.D., Designated Federal Official,
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The Director, Management Analysis and
Services Office, has been delegated the
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Dated: May 10, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–9479 Filed 5–16–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4140–01–P
Centers for Disease Control and
Prevention
27817
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting.
Times and Dates: 8:30 a.m.–5 p.m., June
11, 2007. 8:30 a.m.–3 p.m., June 12, 2007.
Place: CDC Roybal Campus, Bldg 19,
Auditorium B3, 1600 Clifton Road, NE.,
Atlanta, GA 30333.
Status: Open to the public, limited only by
the space available.
Purpose: The Committee is charged with
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Secretary, the Assistant Secretary for Health,
the Director, CDC, and the Director, National
Center for Infectious Diseases (NCID),
regarding (1) the practice of hospital
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(3) periodic updating of guidelines and other
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healthcare-related conditions.
Matters to be Discussed: Agenda items will
include: Guideline Planning, Discussion of
Norovirus Guideline, Discussion of Urinary
Track Infection Guideline, Healthcare
Infection Control Information Technology
follow up and Surveillance Definitions
discussion.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information:
Angela B. Scott, Committee Management
Specialist, HICPAC, Division of Healthcare
Quality Promotion, NCID, CDC, l600 Clifton
Road, NE., M/S A–07, Atlanta, GA 30333,
telephone 404/639–1526.
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.
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Proposed Collection; Comment
Request; Physicians’ Experience of
Ethical Dilemmas and Resource
Allocation
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 Dental and
Craniofacial Research (NIDCR), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection
Title: Physicians’ Experience of
Ethical Dilemmas and Resource
Allocation.
Type of Information Collection
Request: New.
Need and Use of Information
Collection: Health care costs are rising
ceaselessly and there are currently no
generally accepted way of controlling
them. This study will access the
experience of physicians regarding
resource allocation in clinical practice,
and how allocation decisions made at
other levels shapes this experience. The
primary objectives of the study are to
determine if physicians make decisions
to withhold interventions on the basis of
cost, how often they report doing so,
what types of care are withheld, and
what criteria are used in making such
decisions. The findings will provide
valuable information concerning: (1)
The practice of resource allocation in
clinical practice, (2) the possible effects
of perceived constraints on this practice,
and (3) international comparisons on
these two aspects.
Frequency of Response: Once.
Affected Public: Individuals or
households; Businesses or other forprofit; Not-for-profit institutions.
Type of Respondents: Physicians.
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Federal Register / Vol. 72, No. 95 / Thursday, May 17, 2007 / Notices
Capital Costs, Operating Costs and/or
Maintenance Costs to report.
Average Burden Hours Per Response:
.0.3674; and
Estimated Total Annual Burden
Hours Requested: 91.85.
The annualized cost to respondents is
estimated at: $5,218. There are no
The annual reporting burden is as
follows:
Estimated Number of Respondents:
250;
Estimated Number of Responses per
Respondent: 1;
A.12–1.—ESTIMATES OF HOUR BURDEN
Type of
respondents
Number of
respondents
Average time
per
response
Frequency of
response
Annual hour
burden
Physicians (internists) ......................................................................................
250
1
0.3674
91.85
Total ..........................................................................................................
250
........................
........................
91.85
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on 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
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be 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.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Dr. Marion Danis,
Department of Clinical Bioethics,
Building 10, room 1C118, National
Institutes of Health, Bethesda, MD
20892, or call non-toll-free number 301–
435–8727 or e-mail your request,
including your address to:
mdanis@cc.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.
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FOR FURTHER INFORMATION CONTACT:
David K. Henderson,
Deputy Director, Warren G. Magnuson
Clinical Center, National Institutes of Health.
Ezekiel J. Emanuel,
Director, Department of Clinical Bioethics,
Warren G. Magnuson Clinical Center,
National Institutes of Health.
[FR Doc. E7–9543 Filed 5–16–07; 8:45 am]
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Government-Owned Inventions;
Availability for Licensing
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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
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inventions to extend market coverage
for companies and may also be available
for licensing.
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to the indicated licensing contact at the
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Maryland 20852–3804; telephone: 301/
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patent applications.
Humanized Anti-Carcinoma CC49
Monoclonal Antibodies
Description of Technology: The
technology describes the humanization
of a murine anti-carcinoma antibody
CC49 which has been shown to react
with Tumor Associated Glycoprotein 72
(TAG–72), an antigen which is
expressed on human breast, ovarian,
colorectal, and other carcinomas.
The invention includes a new method
of humanization of a rodent antibody
which is based on grafting all the
Complementarity Determining Residues
(CDRs) of a rodent antibody onto a
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human antibody framework.
Additionally, the method identifies
Specificity Determining Residues
(SDRs), the amino acid residues in the
hypervariable regions of an antibody
that are most critical for antigen binding
activity and of rendering any antibody
minimally immunogenic in humans by
transferring the SDRs of the antibody to
a human antibody framework. The
resulting humanized antibodies,
including CDR variants thereof
(including a CH2 deleted version), are
also embodied in the invention, as are
methods of using the antibodies for
therapeutic and diagnostic purposes.
Furthermore, these antibodies are
suitable for radiolabeling for the
application in radioimmunotherapy
(RIT) based treatment of several cancers.
Phase I results of radioimmunotherapy
for ovarian cancer using 90Yttrium-CC49
murine monoclonal antibodies have
shown promising results and confirms
feasibility of the use of these antibodies
for RIT. Promising pharmacokinetic data
for the radiolabeled humanized
antibodies in colon carcinoma xenograft
models were recently published.
Applications and Modality
1. A humanized anti-cancer CC49
monoclonal antibody has been
developed.
2. New methods of humanization of
rodent antibodies have been identified.
3. The antibody(s) has been shown to
react with Tumor Associated
Glycoprotein 72 (TAG–72), an antigen
which is expressed on human breast,
ovarian, colorectal, and other
carcinomas.
4. These antibodies are suitable for
radiolabeling for the application in
radioimmunotherapy (RIT) based
treatment of several cancers.
5. These antibodies can be useful in
diagnosis and treatment of several
cancers.
Development Status: The technology
is currently in the pre-clinical stage of
development. Phase I results of
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]]>Agencies
[Federal Register Volume 72, Number 95 (Thursday, May 17, 2007)]
[Notices]
[Pages 27817-27818]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9543]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; Physicians' Experience of
Ethical Dilemmas and Resource Allocation
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 Dental
and Craniofacial Research (NIDCR), the National Institutes of Health
(NIH) will publish periodic summaries of proposed projects to be
submitted to the Office of Management and Budget (OMB) for review and
approval.
Proposed Collection
Title: Physicians' Experience of Ethical Dilemmas and Resource
Allocation.
Type of Information Collection Request: New.
Need and Use of Information Collection: Health care costs are
rising ceaselessly and there are currently no generally accepted way of
controlling them. This study will access the experience of physicians
regarding resource allocation in clinical practice, and how allocation
decisions made at other levels shapes this experience. The primary
objectives of the study are to determine if physicians make decisions
to withhold interventions on the basis of cost, how often they report
doing so, what types of care are withheld, and what criteria are used
in making such decisions. The findings will provide valuable
information concerning: (1) The practice of resource allocation in
clinical practice, (2) the possible effects of perceived constraints on
this practice, and (3) international comparisons on these two aspects.
Frequency of Response: Once.
Affected Public: Individuals or households; Businesses or other
for-profit; Not-for-profit institutions.
Type of Respondents: Physicians.
[[Page 27818]]
The annual reporting burden is as follows:
Estimated Number of Respondents: 250;
Estimated Number of Responses per Respondent: 1;
Average Burden Hours Per Response: .0.3674; and
Estimated Total Annual Burden Hours Requested: 91.85.
The annualized cost to respondents is estimated at: $5,218. There
are no Capital Costs, Operating Costs and/or Maintenance Costs to
report.
A.12-1.--Estimates of Hour Burden
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average time Annual hour
Type of respondents respondents response per response burden
----------------------------------------------------------------------------------------------------------------
Physicians (internists)......................... 250 1 0.3674 91.85
---------------------------------------------------------------
Total....................................... 250 .............. .............. 91.85
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on 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 assumptions used; (3) Ways to enhance the quality, utility, and
clarity of the information to be 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. Marion Danis, Department of Clinical
Bioethics, Building 10, room 1C118, National Institutes of Health,
Bethesda, MD 20892, or call non-toll-free number 301-435-8727 or e-mail
your request, including your address to: mdanis@cc.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.
David K. Henderson,
Deputy Director, Warren G. Magnuson Clinical Center, National
Institutes of Health.
Ezekiel J. Emanuel,
Director, Department of Clinical Bioethics, Warren G. Magnuson Clinical
Center, National Institutes of Health.
[FR Doc. E7-9543 Filed 5-16-07; 8:45 am]
BILLING CODE 4140-01-P
