[Federal Register Volume 87, Number 109 (Tuesday, June 7, 2022)]
[Notices]
[Pages 34692-34693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12225]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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. OMB may act on HRSA's ICR only after the 
30-day comment period for this Notice has closed.

DATES: Comments on this ICR should be received no later than July 7, 
2022.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under Review--Open for 
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email Samantha Miller, the acting 
HRSA Information Collection Clearance Officer at [email protected] or 
call (301) 443-9094.

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 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 
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 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 
frequent incremental changes in information

[[Page 34693]]

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. Changes from the prior data collection 
spreadsheet include addition of a response option for pre-transplant 
information collection and three questions to collect donor lymphocyte 
infusion for post-transplant information collection. The burden has 
decreased due to better estimates of the number of responses and use of 
burden testing results to estimate the time required.
    A 60-day Notice published in the Federal Register, Volume 87, 
Number 53, FR 15439-15440 (March 18, 2022). There were no public 
comments.
    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 of HHS 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 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. The 
contractor requests OMB approval by June 30, 2022.
    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 revised total annual burden hours 
estimated for this ICR are summarized in the table below. The total 
hours decreased from 56,786 to 51,526 due to minor changes in the ICR.
---------------------------------------------------------------------------

    \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 total number of transplant centers that submit data to 
the SCTOD is 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 number of 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\ Total responses for Pre-Transplant Information Collection 
equals estimated number of new transplant patients in 2021.
    \6\ 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. This number is rounded to nearest tenth. The actual burden 
estimate for these data is 1.4175.
    \7\ Transplant Procedure and Product Information equals 
estimated number of new transplant patients in 2021.
    \8\ Transplant Procedure and Product Information includes Graft-
vs-Host Disease (GVHD) prophylaxis, graft source, donor type and 
degree of HLA matching and graft manipulation; graft characteristic 
data for cord blood units, including infused cell dose; and product 
information. This number is rounded to nearest tenth. The actual 
burden estimate for these data is 1.0616.
    \9\ The number of 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.
    \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. This number is rounded to nearest tenth. 
The actual burden estimate is 0.5247.

                                    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             52.6       \5\ 9,315         \6\ 1.4          13,041
 Collection....................
Transplant Procedure and                    177             52.6       \7\ 9,315         \8\ 1.1          10,247
 Product Information...........
Post-Transplant Periodic                    177            319.1      \9\ 56,476        \10\ 0.5          28,238
 Information Collection based
 on Predetermined Schedule.....
                                --------------------------------------------------------------------------------
    Total......................             177  ...............          75,106  ..............          51,526
----------------------------------------------------------------------------------------------------------------

    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. 2022-12225 Filed 6-6-22; 8:45 am]
BILLING CODE 4165-15-P