[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