[Federal Register Volume 84, Number 163 (Thursday, August 22, 2019)]
[Notices]
[Pages 43814-43815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18088]


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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, OMB No. 0915-0310-Revision

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: In compliance with of the Paperwork Reduction Act of 1995, 
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 
23, 2019.

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 Lisa Wright-Solomon, 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 (Pub. L.) 109-129, as amended by the Stem Cell Therapeutic 
and Research Reauthorization Act of 2015, Public Law 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 has established the Stem Cell Therapeutic Outcomes Database. 
Operation of this database necessitates certain recordkeeping and 
reporting requirements to perform the functions related to 
hematopoietic stem cell transplantation under contract to 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, under contract, by 
the Medical College of Wisconsin's Center for International Blood and 
Marrow Transplant Research and is used for ongoing analysis of 
transplant outcomes. Over time, there is an expected increase in the 
number of recipients for whom data are reported as an increasing number 
of transplants are performed annually and survivorship after 
transplantation improves.
    A 60-day notice was published in the Federal Register on March 7, 
2019, vol. 84, No. 45; pp. 8334-8335. There were no public comments.
    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. Modifications of these forms fall into several 
categories: Consolidating questions and removing duplicate questions 
across the forms, implementing `check all that apply' formatting to 
reduce data entry time, and removing items no longer clinically 
significant (e.g., drugs). These modifications reduced the overall 
hours of burden inventory.
    Likely Respondents: Transplant Centers.
    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.

                                     Total Estimated Annualized Burden Hours
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                                     Number of       Number of                    Average burden
            Form name               respondents    responses per       Total        per response   Total burden
                                        \1\         respondent       responses      (in hours)         hours
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Baseline Pre-Transplant                      200              48           9,600        \2\ 0.68           6,560
 Essential Data (TED)...........
Disease Classification..........             200              48           9,600        \3\ 0.43           4,160
Product Form (includes Infusion,             200              45           9,000            1.00           9,000
 HLA, and Infectious Disease
 Marker inserts)................
100-day Post-TED................             200              48           9,600            0.85           8,160
6 month Post-TED................             200              43           8,600            0.85           7,310
1 year Post-TED.................             200              40           8,000            0.65           5,200
2 year Post-TED.................             200              34           6,800            0.65           4,420
3+ years Post-TED...............             200             172          34,400        \4\ 0.52          17,773
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    Total.......................             200  ..............          95,600  ..............          62,583
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\1\ The total of 200 is the number of centers completing the form; the same group will complete all of the
  forms.
\2\ The decimal is rounded down, and the actual number is .683333333.
\3\ The decimal is rounded down, and the actual number is .433333333.
\4\ The decimal is rounded up, and the actual number is .516667.



[[Page 43815]]

Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019-18088 Filed 8-21-19; 8:45 am]
 BILLING CODE 4165-15-P