[Federal Register Volume 78, Number 189 (Monday, September 30, 2013)]
[Notices]
[Pages 59942-59943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23774]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request

AGENCY: Health Resources and Services Administration, HHS.

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 
the Paperwork Reduction Act of 1995), the Health Resources and Services 
Administration (HRSA) announces plans to submit an Information 
Collection Request (ICR), described below, to the Office of Management 
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks 
comments from the public regarding the burden estimate, below, or any 
other aspect of the ICR.

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

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 10-29, Parklawn 
Building, 5600 Fishers Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: 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 
Information Collection Clearance Officer at (301) 443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference.
    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

[[Page 59943]]

information. The total annual burden hours estimated for this 
Information Collection Request are summarized in the table below.

                                                         Total Estimated Annualized burden hours
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                                                                                         Number of                       Average burden
                             Form Nnme                                  Number of      responses per   Total responses    per response     Total burden
                                                                       respondents       respondent                        (in hours)         hours
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Baseline Pre-TED (Transplant Essential Data).......................             200               38            7,600                1            7,600
Product Form (includes Infusion, HLA, and Infectious Disease Marker             200               29            5,800                1            5,800
 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   ...............          52,260
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    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.

    Dated: September 20, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-23774 Filed 9-27-13; 8:45 am]
BILLING CODE 4165-15-P