[Federal Register Volume 75, Number 154 (Wednesday, August 11, 2010)]
[Notices]
[Page 48692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19752]


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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, e-mail 
[email protected] or call the HRSA Reports Clearance Office on (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:

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 the Department of Health and Human 
Services (HHS). The Act requires the Secretary of HHS 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 are 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 are 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 burden table for the 
year 2011 shows there will be approximately 12,800 annual follow-up 
assessments due for the Blood Stem Cell Transplantation Program's Stem 
Cell Therapeutic Outcomes Database. The 2007 30-Day Federal Register 
notice included total burden hours of 32,040 and 225 respondents. The 
burden table below includes 38,700 total burden hours and 200 
respondents. The increase in burden is due to an increase in the annual 
number of transplants. The number of respondents has decreased due to 
some centers no longer performing unrelated stem cell transplants and 
some centers are no longer in business.
    The estimate of burden is as follows:

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                                                                            Number of     Responses per        Total         Hours per     Total burden
                                  Form                                     respondents      respondent       responses       Response          hours
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Baseline Pre-TED (Transplant Essential Data)...........................             200             30             6,000            0.85           5,100
Product Forms (includes Infusion, HLA, and Infectious Disease Marker                200             20             4,000            1.5            6,000
 inserts)..............................................................
100-Day Post-TED.......................................................             200             30             6,000            0.85           5,100
6-Month Post-TED.......................................................             200             25             5,000            1.00           5,000
12-Month Post-TED......................................................             200             23.5           4,700            1.00           4,700
Annual Post-TED........................................................             200             64            12,800            1.00          12,800
                                                                        --------------------------------------------------------------------------------
    Total..............................................................             200  ...............          38,500  ..............          38,700
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to 
the desk officer for HRSA, either by e-mail to [email protected] or by fax to 202-395-6974. Please direct all 
correspondence to the ``attention of the desk officer for HRSA.''

    Dated: August 5, 2010.
Wendy Ponton,
Director, Office of Management.
[FR Doc. 2010-19752 Filed 8-10-10; 8:45 am]
BILLING CODE 4165-15-P