E7-8799. 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 [phone].

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—(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:

Form	Estimated number of respondents	Responses per respondent	Total Responses	Hours per response	Total burden hours
Baseline Pre-TED (Transplant Essential Data)	225	32	7,200	0.85	6,120
Product Form (includes Infusion, HLA, and Infectious Disease Marker inserts)	225	14	3,150	1.5	4,725
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
Total	225		30,825		32,040
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.