Submission for OMB Review; Comment Request; Women's Health Initiative Observational Study, 10944-10945 [E9-5521]
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10944
Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices
[FR Doc. E9–5492 Filed 3–12–09; 8:45 am]
BILLING CODE 4160–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Clinical Trials Endpoints for Acute
Graft-Versus-Host Disease After
Allogeneic Hematopoietic Stem Cell
Transplantation; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) and National Institutes of Health
(NIH) in co-sponsorship with the Center
for International Blood and Marrow
Transplantation Research (CIBMTR) and
the American Society for Blood and
Marrow Transplantation (ASBMT) are
announcing a public workshop entitled
‘‘Clinical Trials Endpoints for Acute
Graft-Versus-Host Disease (GVHD) After
Allogeneic Hematopoietic Stem Cell
Transplantation.’’ This is a 1-day
workshop for academics, government
researchers, clinical trial experts,
government regulators, and industry
representatives. The purpose of the
public workshop is to review the data
that will serve as the foundation for
protocol design and clinical trial
evidence-based endpoints intended to
support the approval of new drugs or
biologics to prevent or treat acute
GVHD. The public workshop also will
inform FDA and assist investigators in
facilitating clinical development
programs for products to prevent or treat
acute GVHD indications.
Date and Time: The public workshop
will be held on May 19, 2009, from 8:30
a.m. to 5 p.m.
Location: The public workshop will
be held at the Hilton Washington DC/
Rockville Executive Meeting Center,
1750 Rockville Pike, Rockville, MD
20852.
Overnight accommodations can be
booked at the Hilton under group code
‘‘MCW’’ for the conference rate by
calling 1–800–445–8667 or by using the
Reservation Web site athttps://
www.hilton.com/en/hi/groups/
personalized/IADMRHF–MCW–
20090518/index.jhtml. Accommodation
agreement courtesy of CIBMTR. (FDA
has verified the Web site address, but is
not responsible for subsequent changes
to the Web site after this document
publishes in the Federal Register).
Contact Person: Leslie Haynes, Center
for Biologics Evaluation and Research
VerDate Nov<24>2008
17:55 Mar 12, 2009
Jkt 217001
(HFM–43), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–2000, FAX: 301–827–3079; email: CBERTraining@fda.hhs.gov
(Subject line: Acute GVHD Workshop).
Registration: Mail or fax your
registration information (including
name, title, firm name, address,
telephone and fax numbers) to the
Contact Person by April 18, 2009. There
is no registration fee for the public
workshop. Early registration is
recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space available basis beginning at 8:15
a.m.
If you need special accommodations
due to a disability, please contact Leslie
Haynes at least 7 days in advance.
SUPPLEMENTARY INFORMATION: At the
present time, there are no drugs or
biologics approved for prevention or
treatment of acute GVHD. Development
of products to prevent or treat acute
GVHD poses several challenges. First,
the market is not very big, so there is
little incentive for investment if the
process is cumbersome; second,
analyses of these studies are
complicated by confounding factors;
and third, there is a lack of evidencebased endpoints that can be used to
demonstrate a clinically meaningful
benefit of any therapy.
The Center for Biologics Evaluation
and Research is the FDA Center with
regulatory responsibility for vaccines,
blood and blood products, allergenic
products, and therapies involving cells,
tissues, and genes. The mission of FDA
is to protect and enhance the public
health including the safety and purity of
medical products and the Nation’s
blood supply. The purpose of this event
is to review the data that can be used
to develop evidence-based endpoints for
clinical trials targeting acute GVHD.
ASBMT is a professional organization
that promotes advancement of the field
of blood and bone marrow
transplantation. Its members are both in
clinical practice and in research.
CIBMTR is a research network
comprised of the National Marrow
Donor Program© and the International
Bone Marrow Transplant Registry and
Autologous Blood and Marrow
Transplant Registry. Its activities
include support for the National Heart,
Lung and Blood Institute (NHLBI)funded Blood and Marrow
Transplantation Clinical Trials Network
and Health Resources and Services
Administration’s C.W. Bill Young Cell
Transplantation Program. The goals of
the CIBMTR include defining key areas
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for future research in collaboration with
leading scientists, physicians, and
others in the blood and marrow
transplant community; the design and
implementation of clinical studies; and
making available research resources
including a clinical database of related
blood and marrow transplants, along
with repositories of matched tissue
samples from transplant recipients and
their donors.
The NHLBI, National Institute of
Allergy and Infectious Diseases (NIAID),
National Cancer Institute (NCI), and
Office of Rare Diseases (ORD) are at the
National Institutes of Health (NIH), the
primary Federal agency for conducting
and supporting medical research. NIH’s
mission is science in pursuit of
fundamental knowledge about the
nature and behavior of living systems
and the application of that knowledge to
extend healthy life and reduce the
burdens of illness and disability.
The public workshop will feature
presentations by FDA, CIBMTR, and
members of ASBMT. The topics to be
discussed include the following: (1)
Regulatory requirements for clinical
trials, (2) extant data which support the
endpoints currently used in clinical
trials, (3) data analyses to support the
validity of the proposed endpoints, (4)
statistical approaches to minimize
confounding factors in stem cell
transplantation study analysis, (5)
biomarkers for acute GVHD, and (6)
patient-reported outcomes for acute
GVHD prevention and treatment trials.
Presentations: Presentations from the
public workshop will be maintained on
the CIBMTR’s Web site for at least 1
year.
Dated: March 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–5496 Filed 3–12–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Women’s Health
Initiative Observational Study
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Director, the National Heart, Lung, and
Blood Institute (NHLBI), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
E:\FR\FM\13MRN1.SGM
13MRN1
10945
Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices
listed below. This proposed information
collection was previously published in
the Federal Register on December 30,
2008, page 79889–79890 and allowed
60-days for public comment. One
comment was received and appropriate
response was made. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institutes of Health may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised or implemented on or after
October 1, 1995 unless it displays a
current valid OMB control number.
Proposed Collection: Title: Women’s
Health Initiative (WHI) Observational
Study. Type of Information Collection
Request: REVISION: OMB No. 0925–
0414, Expiration date: 05/31/2009. Need
and Use of Information Collection: This
study will be used by the NIH to
evaluate risk factors for chronic disease
among older women by developing and
following a large cohort of
postmenopausal women and relating
subsequent disease development to
baseline assessments of historical,
physical, psychosocial, and physiologic
characteristics. In addition, the
observational study will complement
the clinical trial (which has received
clinical exemption) and provide
additional information on the common
causes of frailty, disability and death for
postmenopausal women, namely,
coronary heart disease, breast and
colorectal cancer, and osteoporotic
fractures. Continuation of follow-up
years for ascertainment of medical
history update forms will provide
essential data for outcomes assessment
for this population of aging women.
Frequency of Response: Annually.
Affected Public: Individuals and
physicians. Type of Respondents:
Women, next-of-kin, and physician’s
office staff. The annual reporting burden
is as follows:
ESTIMATE OF ANNUAL HOUR BURDEN
Number of
respondents
Type of response
Frequency of
response
Average hours
per response
Annual hour
burden
Observational Study Participants
Next of Kin1
Health Care Providers1
63,230
1,163
9
1.1
1
1
.3383
.083
.083
23,509
97
.77
Total
64,402
............................
............................
23,607
1 Annual
sroberts on PROD1PC70 with NOTICES
burden is placed on health care providers and respondent relatives/informants through requests for information which will help in the
compilation of the number and nature of new fatal and nonfatal events.
The annualized cost burden to
respondents is estimated at $377,725.
There are no Capital Costs, Operating
Costs and/or Maintenance Costs to
report.
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 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 the 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.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
VerDate Nov<24>2008
17:55 Mar 12, 2009
Jkt 217001
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plan and instruments, contact: Shari
Eason Ludlam, Project Officer, Women’s
Health Initiative Program Office, 6701
Rockledge Drive, 2 Rockledge Centre,
Suite 10018, MSC 7936, Bethesda, MD
20892–7936, or call (301) 402–2900 or
E-mail your request, including your
address to: ludlams@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
Dated: March 2, 2009.
Michael S. Lauer,
Director, Division of Prevention and
Population Sciences, NHLBI, National
Institutes of Health.
Dated: March 3, 2009.
Suzanne Freeman,
Chief, FOIA, NHLBI, National Institutes of
Health.
[FR Doc. E9–5521 Filed 3–12–09; 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
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION:
Notice.
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.
E:\FR\FM\13MRN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 48 (Friday, March 13, 2009)]
[Notices]
[Pages 10944-10945]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5521]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Women's Health
Initiative Observational Study
Summary: Under the provisions of Section 3507(a)(1)(D) of the
Paperwork Reduction Act of 1995, the Office of the Director, the
National Heart, Lung, and Blood Institute (NHLBI), the National
Institutes of Health (NIH) has submitted to the Office of Management
and Budget (OMB) a request for review and approval of the information
collection
[[Page 10945]]
listed below. This proposed information collection was previously
published in the Federal Register on December 30, 2008, page 79889-
79890 and allowed 60-days for public comment. One comment was received
and appropriate response was made. The purpose of this notice is to
allow an additional 30 days for public comment. The National Institutes
of Health may not conduct or sponsor, and the respondent is not
required to respond to, an information collection that has been
extended, revised or implemented on or after October 1, 1995 unless it
displays a current valid OMB control number.
Proposed Collection: Title: Women's Health Initiative (WHI)
Observational Study. Type of Information Collection Request: REVISION:
OMB No. 0925-0414, Expiration date: 05/31/2009. Need and Use of
Information Collection: This study will be used by the NIH to evaluate
risk factors for chronic disease among older women by developing and
following a large cohort of postmenopausal women and relating
subsequent disease development to baseline assessments of historical,
physical, psychosocial, and physiologic characteristics. In addition,
the observational study will complement the clinical trial (which has
received clinical exemption) and provide additional information on the
common causes of frailty, disability and death for postmenopausal
women, namely, coronary heart disease, breast and colorectal cancer,
and osteoporotic fractures. Continuation of follow-up years for
ascertainment of medical history update forms will provide essential
data for outcomes assessment for this population of aging women.
Frequency of Response: Annually. Affected Public: Individuals and
physicians. Type of Respondents: Women, next-of-kin, and physician's
office staff. The annual reporting burden is as follows:
Estimate of Annual Hour Burden
------------------------------------------------------------------------
Annual
Type of Number of Frequency of Average hours hour
response respondents response per response burden
------------------------------------------------------------------------
Observational 63,230 1.1 .3383 23,509
Study
Participants
Next of Kin\1\ 1,163 1 .083 97
Health Care 9 1 .083 .77
Providers\1\
--------------------------------------------------------
Total...... 64,402 .............. .............. 23,607
------------------------------------------------------------------------
\1\ Annual burden is placed on health care providers and respondent
relatives/informants through requests for information which will help
in the compilation of the number and nature of new fatal and nonfatal
events.
The annualized cost burden to respondents is estimated at $377,725.
There are no Capital Costs, Operating Costs and/or Maintenance Costs to
report.
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 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 the
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.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: Desk Officer for NIH. To request more information on the
proposed project or to obtain a copy of the data collection plan and
instruments, contact: Shari Eason Ludlam, Project Officer, Women's
Health Initiative Program Office, 6701 Rockledge Drive, 2 Rockledge
Centre, Suite 10018, MSC 7936, Bethesda, MD 20892-7936, or call (301)
402-2900 or E-mail your request, including your address to:
ludlams@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
Dated: March 2, 2009.
Michael S. Lauer,
Director, Division of Prevention and Population Sciences, NHLBI,
National Institutes of Health.
Dated: March 3, 2009.
Suzanne Freeman,
Chief, FOIA, NHLBI, National Institutes of Health.
[FR Doc. E9-5521 Filed 3-12-09; 8:45 am]
BILLING CODE 4140-01-P
