[Federal Register Volume 72, Number 88 (Tuesday, May 8, 2007)]
[Notices]
[Pages 26136-26137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8799]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Health Resources and Services Administration 
(HRSA) publishes abstracts of information collection requests under 
review by the Office of Management and Budget (OMB), in compliance with 
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request 
a copy of the clearance requests submitted to OMB for review, call the 
HRSA Reports Clearance Office at (301) 443-1129.
    The following request has been submitted to the Office of 
Management and Budget for review under the Paperwork Reduction Act of 
1995:

[[Page 26137]]

Proposed Project: The Stem Cell Therapeutic Outcomes Database--(New)

    The Stem Cell Therapeutic and Research Act of 2005 establishes the 
C.W. Bill Young Cell Transplantation Program and provides for the 
collection and maintenance of human blood stem cells for the treatment 
of patients and for research. The Health Resources and Services 
Administration's (HRSA), Healthcare Systems Bureau (HSB), is 
establishing the Stem Cell Therapeutic Outcomes Database as one 
component of the C.W. Bill Young Cell Transplantation Program. 
Operation of this database necessitates certain 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 collection and maintenance of information related 
to patients who have received stem cell therapeutic products and to do 
so using a standardized, electronic format. Data will be collected from 
transplant centers in a manner similar to the data collection 
activities historically conducted by the Medical College of Wisconsin's 
Center for International Blood and Marrow Transplant Research (CIBMTR) 
and will be used for ongoing analysis of transplant outcomes. HRSA will 
use 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:

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                                     Estimated
              Form                   number of     Responses per       Total         Hours per     Total  burden
                                    respondents     respondent       Responses       response          hours
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Baseline Pre-TED (Transplant                 225              32           7,200            0.85           6,120
 Essential Data)................
Product Form (includes Infusion,             225              14           3,150            1.5            4,725
 HLA, and Infectious Disease
 Marker inserts)................
100-Day Post-TED................             225              32           7,200            0.85           6,120
6-Month Post-TED................             225              23           5,175            1.00           5,175
12-Month Post-TED...............             225              20           4,500            1.00           4,500
Annual Post-TED.................             225              16           3,600            1.50           5,400
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    Total.......................             225  ..............          30,825  ..............         32,040
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The Pre-TED, Product Form, 100-Day Post-TED, 6-Month Post-TED, and 12-Month Post-TED will be collected on all
  patients during their first year of transplant. In subsequent years, patient outcomes will be reported on the
  Annual Post-TED form. There will be a gradual increase in the cumulative reporting burden over time
  commensurate with the number of survivors for which transplant centers must submit an Annual Post-TED.

    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to: 
Karen Matsuoka, Human Resources and Housing Branch, Office of 
Management and Budget, New Executive Office Building, Room 10235, 
Washington, DC 20503.

    Dated: May 2, 2007.
Caroline Lewis,
Associate Administrator for Management.
[FR Doc. E7-8799 Filed 5-7-07; 8:45 am]
BILLING CODE 4165-15-P