[Federal Register Volume 75, Number 75 (Tuesday, April 20, 2010)]
[Notices]
[Pages 20602-20603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9066]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. To request more
information on the proposed project or to obtain a copy of the data
collection plans and draft instruments, e-mail [email protected] or
call the HRSA Reports Clearance Officer at (301) 443-1129.
Comments are invited on: (a) The proposed collection of information
for the proper performance of the functions of the agency; (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: The Stem Cell Therapeutic Outcomes Database (OMB No.
0915-0310)--Extension
The Stem Cell Therapeutic and Research Act of 2005 provides for the
collection and maintenance of human cord blood stem cells for the
treatment of patients and research. The Health Resources and Services
Administration's (HRSA) Healthcare Systems Bureau (HSB) has established
the Stem Cell Therapeutic Outcomes Database. Operation of this database
necessitates certain recordkeeping and reporting requirements in order
to perform the functions related to hematopoietic stem cell
transplantation under contract to HHS. The Act requires the Secretary
to contract for the establishment and maintenance of information
related to patients who have received stem cell therapeutic products
and to do so using a standardized, electronic format. Data is collected
from transplant centers in a manner similar to the data collection
activities conducted by the Center for International Blood and Marrow
Transplant Research (CIBMTR) and is used for ongoing analysis of
transplant outcomes. HRSA uses the information in order to carry out
its statutory responsibilities. Information is needed to monitor the
clinical status of transplantation and to provide the Secretary with an
annual report of transplant center-specific survival data.
The estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Reporting respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Baseline Patient/Day of 250 40 8,000 2.25 18,000
Transplant Data...............
Product Receipt/Analysis/ 250 40 8,000 1 8,000
Preparation Data..............
100-Day Post-Transplant Data... 250 40 8,000 2.25 18,000
6-Month Post-Transplant Data... 250 28 5,538 2.25 12,460.5
12-Month Post-Transplant Data.. 250 22 4,308 2.25 9,693
Annual Post-Transplant Data 250 40 8,000 2.25 18,000
(year two and beyond).........
Death Information.............. 250 25 4,923 0.5 2,461.5
--------------------------------------------------------------------------------
Total...................... 250 .............. 46,769 .............. 86,615
----------------------------------------------------------------------------------------------------------------
[[Page 20603]]
E-mail comments to [email protected] or mail the HRSA Reports
Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments should be received within 60 days
of this notice.
Dated: April 14, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information Coordination.
[FR Doc. 2010-9066 Filed 4-19-10; 8:45 am]
BILLING CODE 4165-15-P