[Federal Register Volume 84, Number 45 (Thursday, March 7, 2019)]
[Notices]
[Pages 8334-8335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04117]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request Information Collection Request Title: 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 the requirement for an opportunity for 
public comment on proposed data collection projects of the Paperwork 
Reduction Act of 1995, HRSA announces plans to submit an Information 
Collection Request (ICR), described below, to the Office of Management 
and Budget (OMB). Before 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 ICR should be received no later than May 6, 
2019.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14N39, 5600 Fishers 
Lane, Rockville, Maryland 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

[[Page 8335]]

instruments, email [email protected] or call Lisa Wright-Solomon, 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 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. 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. HRSA's 
Healthcare Systems Bureau has established the Stem Cell Therapeutic 
Outcomes Database, which necessitates certain electronic record keeping 
and reporting requirements to perform the functions related to 
hematopoietic stem cell transplantation under contract to HHS. 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. Over time, there is an expected increase in the 
number of recipients for whom data are reported as the increasing 
number of transplants are performed annually and survivorship after 
transplantation improves.
    Need and Proposed Use of the Information: Per statutory 
responsibilities, information collected on the forms outlined in the 
``Total Estimated Annualized Burden Hours'' section below is needed to 
monitor the clinical status of transplantation and provide the 
Secretary with an annual report of transplant center-specific survival 
data. The proposed revisions of these data collection 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 proposed revisions are not 
anticipated to affect total burden hours.
    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              44           8,800            1.00           8,800
 Essential Data (TED)...........
Disease Classification..........             200              44           8,800            0.15           1,320
Product Form (includes Infusion,             200              33           6,600            1.00           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  ..............          68,600  ..............          68,660
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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.

    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.

Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2019-04117 Filed 3-6-19; 8:45 am]
BILLING CODE 4165-15-P