81 FR 59641 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The Stem Cell Therapeutic Outcomes Database

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 81, Issue 168 (August 30, 2016)

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.

[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Notices]
[Pages 59641-59642]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-20758]


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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; The Stem Cell Therapeutic 
Outcomes Database

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 no later than September 
29, 2016.

ADDRESSES: Submit your comments, including the ICR 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: The Stem Cell Therapeutic 
Outcomes Database OMB No. 0915-0310--Revision.
    Abstract: The Stem Cell Therapeutic and Research Act of 2005, 
Public Law (P.L.) 109-129, as amended by the Stem Cell Therapeutic and 
Research Reauthorization Act of 2015, P.L. 114-104 (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 
established the Stem Cell Therapeutic Outcomes Database. Operation of 
this database necessitates certain record keeping and reporting 
requirements 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 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. Post-
Transplant Essential Data (TED) forms are being revised in this 
submission. The portion of the Product Form related to confirmation of 
human leukocyte antigen (HLA) typing has minor changes to the 
identification and date fields to allow this form to more flexibly 
capture HLA typing data for expanding indications of cellular therapy. 
The Pre-TED form remains unchanged from the previously approved OMB 
submission.
    The increase in burden is due to an increase in the annual number 
of transplants and increasing survivorship after transplantation.
    Need and Proposed Use of the Information: HRSA uses the information 
to carry out its statutory responsibilities. Information is needed to 
monitor the clinical status of transplantation and provide the 
Secretary of HHS with an annual report of transplant center specific 
survival data.
    Likely Respondents: Transplant Centers.

[[Page 59642]]

    Burden Statement: Burden in this context means the time expended by 
persons to generate, maintain, retain, disclose or provide the 
information requested. This includes (1) the time needed to review 
instructions; (2) to develop, acquire, install and utilize technology 
and systems for the purpose of collecting, validating and verifying 
information; (3) processing and maintaining information; (4) disclosing 
and providing information; (5) training personnel to be able to respond 
to a collection of information; (6) searching data sources; (7) 
completing and reviewing the collection of information; and (8) 
transmitting or otherwise disclosing the information. The total annual 
burden hours estimated for this ICR are summarized in the table below.

                                    Total Estimated Annualized Burden--Hours
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                                                                                      Average
                                     Number of       Number of         Total        burden per     Total burden
            Form name               respondents    responses per     responses     response (in        hours
                                                    respondent                        hours)
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Baseline Pre-TED (Transplant                 200              44           8,800            1.15          10,120
 Essential Data)................
Product Form (includes Infusion,             200              33           6,600               1           6,600
 HLA, and Infectious Disease
 Marker inserts)................
100-Day Post-TED................             200              44           8,800            1.25          11,000
6-Month Post-TED................             200              36           7,200            1.15           8,280
12-Month Post-TED...............             200              32           6,400            1.15           7,360
Annual Post-TED.................             200             110          22,000            1.15          25,300
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    * Total.....................             200  ..............          59,800  ..............          68,660
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* The Total of 200 is the number of centers completing the form. The same group of 200 centers completes each of
  the forms.


Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-20758 Filed 8-29-16; 8:45 am]
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