NIH Consensus Development Conference: Hydroxyurea Treatment for Sickle Cell Disease; Notice, 65970-65971 [E7-22907]
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Federal Register / Vol. 72, No. 226 / Monday, November 26, 2007 / Notices
Frequency of Response: Once. Affected
Public: Individuals or households.
Projects
Questionnaire Development
Volunteers.
General Volunteers ...................
Household Interview Volunteers
(1) Survey questionnaire development.
(2) Research on the cognitive
aspects of survey methodology.
(3) Research on computer-user
interface design.
(4) Pilot Household interviews ..
Total ...................................
...................................................
mstockstill on PROD1PC66 with NOTICES
Computer User Volunteers .......
The estimated total annual burden
hours requested is 600. There are no
annualized costs to respondents. The
annualized costs to the Federal
Government are estimated at $264,000
and include cost of NCI staff to plan,
conduct, and analyze outcomes of
questionnaire development, $50
payment of pretest participants,
contracting for pretesting activities and
research, travel costs, and additional
materials needed to conduct and recruit
participants for the research.
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. Gordon Willis,
PhD., Cognitive Psychologist, Applied
Research Program, DCCPS, NCI/NIH,
6130 Executive Blvd, MSC 7344, EPN
4005, Bethesda, MD 20892 or call nontoll-free number 301–594–6652 or email your request, including your
address to: willis@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
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Frequency of
responses/
participant
Number of
respondents
Type of respondents
200
1
100
1
100
1
200
600
250.0
125.0
1
1.25
(75 minutes)
0.5
(30 minutes)
............................
............................
600.0
Dated: November 13, 2007.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. E7–22905 Filed 11–23–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
NIH Consensus Development
Conference: Hydroxyurea Treatment
for Sickle Cell Disease; Notice
Notice is hereby given of the National
Institutes of Health (NIH) ‘‘NIH
Consensus Development Conference:
Hydroxyurea Treatment for Sickle Cell
Disease’’ to be held February 25–27,
2008, in the NIH Natcher Conference
Center, 45 Center Drive, Bethesda,
Maryland 20892. The conference will
begin at 8:30 a.m. on February 25 and
26, at 9 a.m. on February 27, and will
be open to the public.
Sickle cell disease is an inherited
blood disorder that affects between
50,000 and 75,000 people in the United
States. It is most common among people
whose ancestors come from sub-Saharan
Africa, South and Central America, the
Middle East, India, and the
Mediterranean basin. Sickle cell disease
occurs when an infant inherits the gene
for sickle hemoglobin from both parents
(Hb SS, or sickle cell anemia) or the
gene for sickle hemoglobin from one
parent and another abnormal
hemoglobin gene from the other parent.
Each year, approximately 2,000 babies
with sickle cell disease are born in the
United States. The condition is chronic
and lifelong and is associated with a
decreased lifespan. In addition,
Frm 00034
Fmt 4703
Sfmt 4703
Response
burden
1.25
(75 minutes)
1.25
(75 minutes)
best assured of having their full effect if
received within 60 days of the date of
this publication.
PO 00000
Average hours
per response
125.0
100.0
approximately 2 million Americans
carry the sickle cell trait, which
increases the public health burden as
this disorder is passed on to future
generations.
The red blood cells in people with
sickle cell disease become deoxygenated
(or depleted of oxygen) and crescentshaped or ‘‘sickled.’’ The cells become
sticky and adhere to blood vessel walls,
thereby blocking blood flow within
limbs and organs. These changes lead to
acute painful episodes, chronic pain,
and chronic damage to the brain, heart,
lungs, kidneys, liver, and spleen.
Infections and lung disease are leading
causes of death.
Pain crises are responsible for most
emergency room visits and
hospitalizations of people with sickle
cell disease. Standard treatments for
acute pain crises include painkilling
medications, fluid replacement, and
oxygen. In the mid-1990s, researchers
began investigating the potential of
hydroxyurea to reduce the number and
severity of pain crises in sickle cell
patients. Hydroxyurea is in a class of
anticancer drugs and it acts to increase
the overall percentage of normally
structured red blood cells in the
circulation. By diluting the number of
cells that ‘‘sickle,’’ it may, if taken on a
daily basis, reduce their damaging
effects. Hydroxyurea was approved by
the Food and Drug Administration for
use in adults with sickle cell anemia in
1998. However, there are a number of
unresolved issues about the use of
hydroxyurea, including a lack of
knowledgeable providers who treat
sickle cell disease, and patient and
practitioner questions about safety and
effectiveness, including concerns
regarding potential long-term
carcinogenesis.
In order to take a closer look at this
important topic, the National Heart,
Lung, and Blood Institute and the Office
of Medical Applications of Research of
E:\FR\FM\26NON1.SGM
26NON1
Federal Register / Vol. 72, No. 226 / Monday, November 26, 2007 / Notices
mstockstill on PROD1PC66 with NOTICES
the NIH will convene a Consensus
Development Conference from February
25–27, 2008, to assess the available
scientific evidence related to the
following questions:
• What is the efficacy (results from
clinical studies) of hydroxyurea
treatment for patients who have sickle
cell disease in three groups: Infants,
preadolescents, and adolescents/adults?
• What is the effectiveness (in
everyday practice) of hydroxyurea
treatment for patients who have sickle
cell disease?
• What are the short- and long-term
harms of hydroxyurea treatment?
• What are the barriers to
hydroxyurea treatment (i.e., health care
system factors and patient-related
factors) for patients who have sickle cell
disease and what are the potential
solutions?
• What are the future research needs?
An impartial, independent panel will
be charged with reviewing the available
published literature in advance of the
conference, including a systematic
literature review commissioned through
the Agency for Healthcare Research and
Quality. The first day and a half of the
conference will consist of presentations
by expert researchers and practitioners
and open public discussions. On
Wednesday, February 27, the panel will
present a statement of its collective
assessment of the evidence to answer
each of the questions above. The panel
will also hold a press conference to
address questions from the media. The
draft statement will be published online
later that day, and the final version will
be released approximately six weeks
later. The primary sponsors of this
meeting are the NIH National Heart,
Lung, and Blood Institute and the NIH
Office of Medical Applications of
Research.
Advance information about the
conference and conference registration
materials may be obtained from
American Institutes for Research of
Silver Spring, Maryland, by calling 888–
644–2667 or by sending e-mail to
consensus@mail.nih.gov. American
Institutes for Research’s mailing address
is 10720 Columbia Pike, Silver Spring,
MD 20901. Registration information is
also available on the NIH Consensus
Development Program Web site at
https://consensus.nih.gov.
Please Note: The NIH has instituted
security measures to ensure the safety of NIH
employees and property. All visitors must be
prepared to show a photo ID upon request.
Visitors may be required to pass through a
metal detector and have bags, backpacks, or
purses inspected or x-rayed as they enter NIH
buildings. For more information about the
new security measures at NIH, please visit
VerDate Aug<31>2005
22:03 Nov 23, 2007
Jkt 214001
65971
the Web site at https://www.nih.gov/about/
visitorsecurity.htm.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: November 14, 2007.
Raynard S. Kington,
Deputy Director, National Institutes of Health.
[FR Doc. E7–22907 Filed 11–23–07; 8:45 am]
National Institutes of Health
National Center on Minority Health and
Health Disparities; Notice of Closed
Meeting
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center on Minority Health and
Health Disparities; 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 grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center on
Minority Health and Health Disparities
Special Emphasis Panel, R13 Conference
Grant Review.
Date: December 19, 2007.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6707
Democracy Blvd., Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Lorrita Watson, PhD.,
National Center on Minority Health and
Health Disparities, National Institutes of
Health, 6707 Democracy Blvd, Suite 800,
Bethesda, MD 20892–5465, (301) 402–1366,
watsonl@mail.nih.gov.
Dated: November 16, 2007.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 07–5810 Filed 11–23–07; 8:45 am]
BILLING CODE 4140–01–M
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
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 grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center on
Minority Health and Health Disparities
Special Emphasis Panel, Community Based
Participatory Research (CBPR) Meeting.
Date: December 16–18, 2007.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road, NW.,
Washington DC 20015.
Contact Person: Robert Nettey, MD.,
Scientific Review Administrator, National
Institute on Minority Health and Health
Disparities, 6707 Democracy Blvd., Suite 800,
Bethesda, MD 20892, (301)–496–3996.
Dated: November 16, 2007.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 07–5811 Filed 11–23–07; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Eye Institute; Notice of Closed
Meetings
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
meetings.
The meetings 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
E:\FR\FM\26NON1.SGM
26NON1
]]>Agencies
[Federal Register Volume 72, Number 226 (Monday, November 26, 2007)]
[Notices]
[Pages 65970-65971]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22907]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
NIH Consensus Development Conference: Hydroxyurea Treatment for
Sickle Cell Disease; Notice
Notice is hereby given of the National Institutes of Health (NIH)
``NIH Consensus Development Conference: Hydroxyurea Treatment for
Sickle Cell Disease'' to be held February 25-27, 2008, in the NIH
Natcher Conference Center, 45 Center Drive, Bethesda, Maryland 20892.
The conference will begin at 8:30 a.m. on February 25 and 26, at 9 a.m.
on February 27, and will be open to the public.
Sickle cell disease is an inherited blood disorder that affects
between 50,000 and 75,000 people in the United States. It is most
common among people whose ancestors come from sub-Saharan Africa, South
and Central America, the Middle East, India, and the Mediterranean
basin. Sickle cell disease occurs when an infant inherits the gene for
sickle hemoglobin from both parents (Hb SS, or sickle cell anemia) or
the gene for sickle hemoglobin from one parent and another abnormal
hemoglobin gene from the other parent. Each year, approximately 2,000
babies with sickle cell disease are born in the United States. The
condition is chronic and lifelong and is associated with a decreased
lifespan. In addition, approximately 2 million Americans carry the
sickle cell trait, which increases the public health burden as this
disorder is passed on to future generations.
The red blood cells in people with sickle cell disease become
deoxygenated (or depleted of oxygen) and crescent-shaped or
``sickled.'' The cells become sticky and adhere to blood vessel walls,
thereby blocking blood flow within limbs and organs. These changes lead
to acute painful episodes, chronic pain, and chronic damage to the
brain, heart, lungs, kidneys, liver, and spleen. Infections and lung
disease are leading causes of death.
Pain crises are responsible for most emergency room visits and
hospitalizations of people with sickle cell disease. Standard
treatments for acute pain crises include painkilling medications, fluid
replacement, and oxygen. In the mid-1990s, researchers began
investigating the potential of hydroxyurea to reduce the number and
severity of pain crises in sickle cell patients. Hydroxyurea is in a
class of anticancer drugs and it acts to increase the overall
percentage of normally structured red blood cells in the circulation.
By diluting the number of cells that ``sickle,'' it may, if taken on a
daily basis, reduce their damaging effects. Hydroxyurea was approved by
the Food and Drug Administration for use in adults with sickle cell
anemia in 1998. However, there are a number of unresolved issues about
the use of hydroxyurea, including a lack of knowledgeable providers who
treat sickle cell disease, and patient and practitioner questions about
safety and effectiveness, including concerns regarding potential long-
term carcinogenesis.
In order to take a closer look at this important topic, the
National Heart, Lung, and Blood Institute and the Office of Medical
Applications of Research of
[[Page 65971]]
the NIH will convene a Consensus Development Conference from February
25-27, 2008, to assess the available scientific evidence related to the
following questions:
What is the efficacy (results from clinical studies) of
hydroxyurea treatment for patients who have sickle cell disease in
three groups: Infants, preadolescents, and adolescents/adults?
What is the effectiveness (in everyday practice) of
hydroxyurea treatment for patients who have sickle cell disease?
What are the short- and long-term harms of hydroxyurea
treatment?
What are the barriers to hydroxyurea treatment (i.e.,
health care system factors and patient-related factors) for patients
who have sickle cell disease and what are the potential solutions?
What are the future research needs?
An impartial, independent panel will be charged with reviewing the
available published literature in advance of the conference, including
a systematic literature review commissioned through the Agency for
Healthcare Research and Quality. The first day and a half of the
conference will consist of presentations by expert researchers and
practitioners and open public discussions. On Wednesday, February 27,
the panel will present a statement of its collective assessment of the
evidence to answer each of the questions above. The panel will also
hold a press conference to address questions from the media. The draft
statement will be published online later that day, and the final
version will be released approximately six weeks later. The primary
sponsors of this meeting are the NIH National Heart, Lung, and Blood
Institute and the NIH Office of Medical Applications of Research.
Advance information about the conference and conference
registration materials may be obtained from American Institutes for
Research of Silver Spring, Maryland, by calling 888-644-2667 or by
sending e-mail to consensus@mail.nih.gov. American Institutes for
Research's mailing address is 10720 Columbia Pike, Silver Spring, MD
20901. Registration information is also available on the NIH Consensus
Development Program Web site at https://consensus.nih.gov.
Please Note: The NIH has instituted security measures to ensure
the safety of NIH employees and property. All visitors must be
prepared to show a photo ID upon request. Visitors may be required
to pass through a metal detector and have bags, backpacks, or purses
inspected or x-rayed as they enter NIH buildings. For more
information about the new security measures at NIH, please visit the
Web site at https://www.nih.gov/about/visitorsecurity.htm.
Dated: November 14, 2007.
Raynard S. Kington,
Deputy Director, National Institutes of Health.
[FR Doc. E7-22907 Filed 11-23-07; 8:45 am]
BILLING CODE 4140-01-P
