[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
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Total.............................................................. 200 ............... 38,500 .............. 38,700
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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]
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