This PDF is the current document as it appeared on Public Inspection on 03/06/2013 at 08:45 am.
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, email email@example.com or call the HRSA Reports Clearance Officer at (301) 443-1984.
HRSA specifically requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Information Collection Request Title: The Stem Cell Therapeutic Outcomes Database (OMB No. 0915-0310)—[Revision]
Abstract: The Stem Cell Therapeutic and Research Act of 2005, Public Law (Pub. L.) 109-129, as amended by the Stem Cell Therapeutic and Research Reauthorization Act of 2010, Public Law 111-264 (the Act), provides for the collection and maintenance of human blood stem cells for the treatment of patients and research. HRSA's Healthcare Systems Bureau has established 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 the U.S. Department of Health and Human Services (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 by the Center for International Blood and Marrow Transplant Research 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 of HHS with an annual report of transplant center-specific survival data. The increase in burden is due to an increase in the annual number of transplants and increasing survivorship after transplantation.
Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below.
The annual estimate of burden is as follows:
|Form name||Number of respondents||Number of responses per respondent||Total responses||Average burden per response (in hours)||Total burden hours|
|Baseline Pre-TED (Transplant Essential Data)||200||38||7,600||0.9||6,840|
|Product Form (includes Infusion, HLA, and Infectious Disease Marker inserts)||200||29||5,800||1.5||8,700|
Submit your comments to firstname.lastname@example.org or mail the HRSA Reports Clearance Officer, Room 10-29, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857.Start Printed Page 14806
Deadline: Comments on this Information Collection Request must be received within 60 days of this notice.Start Signature
Dated: February 28, 2013.
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-05302 Filed 3-6-13; 8:45 am]
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