06-8020. 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, call the HRSA Reports Clearance Officer at [phone].

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (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—(New)

The Stem Cell Therapeutic and Research Act of 2005 provides for the collection and maintenance of human blood stem cells for the treatment of patients and research. The Health Resources and Services Administration's (HRSA), Healthcare Systems Bureau (HSB), is establishing the Stem Cell Therapeutic Outcomes Database. Operation of this database necessitates certain record keeping 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 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 conducted by The 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:

Record keeping	Number of responses	Responses per respondent	Total responses	Hours per response	Total burden hours
Baseline Patient/Day of Transplant Data	250	40	8,000	2.25	18,000
Product Receipt/Analysis/Preparation Data	250	40	8,000	1	8,000
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 (year two and beyond)	250	40	8,000	2.25	18,000
Death Information	250	25	4,923	0.5	2,461.5
Total	250		46,769		86,615

Send comments to Susan G. Queen, Ph.D., 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: September 15, 2006.

Cheryl R. Dammons,

Director, Division of Policy Review and Coordination.