[Federal Register Volume 78, Number 45 (Thursday, March 7, 2013)]
[Notices]
[Pages 14805-14806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-05302]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities; Proposed Collection; 
Comment Request

ACTION: Notice.

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SUMMARY: 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 protected] 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:

                                                 2013--Estimated
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                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
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Baseline Pre-TED (Transplant                 200              38           7,600             0.9           6,840
 Essential Data)................
Product Form (includes Infusion,             200              29           5,800             1.5           8,700
 HLA, and Infectious Disease
 Marker inserts)................
100-Day Post-TED................             200              38           7,600            0.85           6,460
6-Month Post-TED................             200              31           6,200               1           6,200
12-Month Post-TED...............             200              27           5,400               1           5,400
Annual Post-TED.................             200             104          20,800               1          20,800
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    Total.......................             200  ..............          53,400  ..............          54,400
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ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Reports Clearance Officer, Room 10-29, Parklawn Building, 5600 Fishers 
Lane, Rockville, MD 20857.

[[Page 14806]]

    Deadline: Comments on this Information Collection Request must be 
received within 60 days of this notice.

    Dated: February 28, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-05302 Filed 3-6-13; 8:45 am]
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