Agency Information Collection Activities: Proposed Collection: Public Comment Request; The Stem Cell Therapeutic Outcomes Database OMB No. 0915-0310-Revision, 15439-15440 [2022-05718]
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15439
Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Notices
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
SHIP COVID–19 Testing and
Mitigation Data Reporting.
Total ..................................
Number of responses
per respondent
1,540 .......................................
Number of unique organizations funded through the
program.
6 ..............................................
Reported on a quarterly basis
during the 18 month program or until the end of the
public health emergency
(whichever is first).
9,240
.25
1,540 .......................................
..................................................
9,240
........................
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. 2022–05717 Filed 3–17–22; 8:45 am]
BILLING CODE 4165–15–P
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
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
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.
jspears on DSK121TN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
Average
burden per
response
(in hours)
Number of respondents
Form name
18:27 Mar 17, 2022
Jkt 256001
Total
responses
Submit your comments to
paperwork@hrsa.gov 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 paperwork@hrsa.gov
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
ADDRESSES:
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
Total burden hours
2,310
Total hours spent on responses for all funded organization over a 2-year period.
2,310
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
E:\FR\FM\18MRN1.SGM
18MRN1
15440
Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Notices
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
Number of
respondents 2
Form name 1
Number of
responses per
respondent 3
Average
burden per
response
(in hours)
Total
responses 4
Total burden
hours
Pre-Transplant Information Collection 5 ...............................
Transplant Procedure and Product Information 8 ................
Post-Transplant Periodic Information Collection based on
Predetermined Schedule 10 ..............................................
177
177
46.4
46.4
6 8,207
7 1.1
9 8,207
1.0
9,028
8,207
177
319.1
11 56,476
12 0.7
39,533
Total ..............................................................................
177
........................
72,890
........................
56,768
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.
jspears on DSK121TN23PROD with NOTICES1
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.
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; Rural Health Clinic COVID–19
Reporting Portal, OMB No. 0906–
0056—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022–05718 Filed 3–17–22; 8:45 am]
BILLING CODE 4165–15–P
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
SUMMARY:
VerDate Sep<11>2014
18:27 Mar 17, 2022
Jkt 256001
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
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.
Comments on this ICR should be
received no later than April 18, 2022.
DATES:
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
ADDRESSES:
E:\FR\FM\18MRN1.SGM
18MRN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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 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 [email protected] 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 [email protected] 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
----------------------------------------------------------------------------------------------------------------
\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
