[Federal Register Volume 78, Number 238 (Wednesday, December 11, 2013)]
[Notices]
[Pages 75355-75356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-29510]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission to OMB for 
Review and Approval; Public Comment Request

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the Health Resources and Services Administration 
(HRSA) has submitted an Information Collection Request (ICR) to the 
Office of Management and Budget (OMB) for review and approval. Comments 
submitted during the first public review of this ICR will be provided 
to OMB. OMB will accept further comments from the public during the 
review and approval period.

DATES: Comments on this ICR should be received within 30 days of this 
notice.

ADDRESSES: Submit your comments, including the Information Collection 
Request Title, to the desk officer for HRSA, either by email to [email protected] or by fax to 202-395-5806.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email the HRSA Information 
Collection Clearance Officer at [email protected] or call (301) 443-
1984.

SUPPLEMENTARY INFORMATION:
    Information Collection Request Title: Stem Cell Therapeutic 
Outcomes Database.
    OMB 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

[[Page 75356]]

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, as reflected in this 
revised submission request, 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 ICR are summarized in the table below.

                                   Estimates of Average Annualized Hour Burden
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                                     Number of     Responses per       Total         Hours per     Total burden
            Form name               respondents     respondent       responses       response          hours
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Baseline Pre-Transplant                      200              38           7,600               1           7,600
 Essential Data (TED)...........
Product Form (includes Infusion,             200              29           5,800               1           5,800
 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  ..............          52,260
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    Dated: December 5, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-29510 Filed 12-10-13; 8:45 am]
BILLING CODE 4165-15-P