[Federal Register Volume 87, Number 53 (Friday, March 18, 2022)]
[Notices]
[Pages 15439-15440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05718]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
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 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 17, 
2022.

ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#7707160712050018051c371f05041659101801"><span class="__cf_email__" data-cfemail="d8a8b9a8bdaaafb7aab398b0aaabb9f6bfb7ae">[email protected]</span></a> or mail the HRSA 
Information Collection Clearance Officer, Room 14N136B, 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 <a href="/cdn-cgi/l/email-protection#4f3f2e3f2a3d38203d240f273d3c2e61282039"><span class="__cf_email__" data-cfemail="9dedfcedf8efeaf2eff6ddf5efeefcb3faf2eb">[email protected]</span></a> or call Samantha Miller, 
the acting HRSA Information Collection Clearance Officer at (301) 443-
9094.

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 TRANSPLANT Act of 2021, 
Public Law 117-15 (the Act), provides for the collection and 
maintenance of human blood stem cells for the treatment of patients and 
for 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 an 
electronic format. HRSA's Health Systems Bureau has established the 
Stem Cell Therapeutic Outcomes Database (SCTOD), one component of the 
C.W. Bill Young Cell Transplantation Program (Program) which 
necessitates certain electronic record keeping and reporting 
requirements to perform the functions related to hematopoietic stem 
cell transplantation (HCT) 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 to improve the treatment, survival and quality of 
life for patients who may benefit from cellular therapies. Over time, 
there is an expected increase in the information reported as the number 
of transplants performed annually increases, and survivorship after 
transplantation improves. Similarly, because of ongoing rapid evolution 
in transplant indications, methods to establish diagnoses, disease 
prognostic factors, treatments provided before HCT, methods to 
determine donor matching, and transplantation techniques, the Program 
anticipates incremental changes in information collected by the SCTOD 
to reflect current clinical care and facilitate statistical modeling 
throughout the approval period to fulfill the requirements of the 
Program. Such small incremental changes will not significantly affect 
the burden.
    Need and Proposed Use of the Information: Per statutory 
responsibilities, the collection of information outlined in the ``Total 
Estimated Annualized Burden Hours'' section below is needed to collect, 
analyze, and publish stem cell transplantation related data including 
patient outcomes data and provide the Secretary with an annual report 
of transplant center-specific survival data. The proposed revisions of 
this information collection reflect the most up-to-date medical 
evidence while simultaneously reducing HCT facility burden. Revisions 
fall into several categories: Consolidating questions, implementing 
interactive requests (electronic check boxes, check all that apply, and 
pull-down menus) to reduce data entry time, adding necessary 
information fields, adding clarity to information requests and removing 
items no longer clinically significant (e.g., drugs). These revisions 
also

[[Page 15440]]

incorporate COVID-19 vaccine questions currently under emergency 
approval. From time to time, there may be refinements in the 
information collection to keep pace with changes in the field or to 
enhance the ability to collect information in an automated fashion from 
respondent source systems, such as electronic health records.
    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. The estimated total annual 
burden hours for this submission are 56,768 compared to 62,583 
estimated in the 30-day Federal Register notice posted on August 22, 
2019.

                                     Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of         Total        burden per     Total burden
          Form name \1\             respondents    responses per   responses \4\   response  (in       hours
                                        \2\       respondent \3\                      hours)
----------------------------------------------------------------------------------------------------------------
Pre-Transplant Information                   177            46.4       \6\ 8,207         \7\ 1.1           9,028
 Collection \5\.................
Transplant Procedure and Product             177            46.4       \9\ 8,207             1.0           8,207
 Information \8\................
Post-Transplant Periodic                     177           319.1     \11\ 56,476        \12\ 0.7          39,533
 Information Collection based on
 Predetermined Schedule \10\....
                                 -------------------------------------------------------------------------------
    Total.......................             177  ..............          72,890  ..............          56,768
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\1\ This burden estimate table refers to data collections at different time periods consistent with approved
  practice. The SCTOD contractor is working with respondents to reduce burden by submitting data using
  interoperability standards. These data collections may include OMB-approved forms.
\2\ The Number of Responses the total number of transplant centers that submit data to the SCTOD is equal to
  177.
\3\ The Number of Responses per Respondent was calculated by dividing the Total Responses by the Number of
  Respondents and rounding to the nearest tenth.
\4\ The Total Responses is less than previous calculations because of improvements in estimation. Previous
  estimates assumed all years had the same number of transplants. This improved estimate includes accurate
  transplant counts from prior years, which are often less than the current year leading to less follow-up
  activity.
\5\ Pre-Transplant Data includes baseline recipient data including patient demographics, pertinent medical
  history, disease characteristics and status, and co-morbidities, transplant data procedure characteristics,
  including preparative regimen, and donor data.
\6\ Total Responses for Pre-Transplant Information Collection equals number of new transplant patients in 2020.
\7\ This number is rounded to nearest tenth. The actual burden estimate for these data is 1.11666666.
\8\ Transplant Procedure and Product Information includes Graft-vs-Host Disease (GVHD) prophylaxis, graft
  source, donor type and degree of human leukocyte antigen matching and graft manipulation; graft characteristic
  data for cord blood units, including infused cell dose; and product information.
\9\ Total Responses for Transplant Procedure and Product Information equals number of new transplant patients in
  2020.
\10\ Post-Transplant Data Collection includes hematopoietic recovery and engraftment, serious complications
  including GVHD and second cancers, disease status, survival status, and cause of death; and subsequent
  procedures.
\11\ Total Responses for Post-Transplant Periodic Information Collection is based on a predetermined schedule:
  100 days after transplant, 6 months after transplant, 1 year after transplant, annually for 6 years after
  transplant and then biennially thereafter. In any given year the number of responses is a function of the
  number of transplants in that year, the number of transplants in previous years, and expected patient survival
  between the time of transplant and any follow-up activity.
\12\ This number is rounded to nearest tenth. The actual burden estimate is 0.74.

    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.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022-05718 Filed 3-17-22; 8:45 am]
BILLING CODE 4165-15-P


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