Notice2022-12225
Agency Information Collection Activities: Proposed Collection: Public Comment Request; The Stem Cell Therapeutic Outcomes Database OMB No. 0915-0310-Revision
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 7, 2022
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 109 (Tuesday, June 7, 2022)</title>
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[Federal Register Volume 87, Number 109 (Tuesday, June 7, 2022)]
[Notices]
[Pages 34692-34693]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-12225]
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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 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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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 <a href="/cdn-cgi/l/email-protection#334352435641445c4158735b4140521d545c45"><span class="__cf_email__" data-cfemail="304051405542475f425b70584243511e575f46">[email protected]</span></a> 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.
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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 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
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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)
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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.....
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Total...................... 177 ............... 75,106 .............. 51,526
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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
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