Agency Information Collection Activities: Proposed Collection: Public Comment Request; The Stem Cell Therapeutic Outcomes Database, OMB No. 0915-0310-Extension, 67478-67479 [2021-25786]
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Federal Register / Vol. 86, No. 225 / Friday, November 26, 2021 / Notices
detection systems; and training
personnel in Privacy Act and
information security requirements. After
the records have been scheduled with
NARA, records that are eligible for
destruction will be disposed of in
accordance with the applicable
schedule, using secure destruction
methods prescribed by NIST SP 800–88.
RECORD ACCESS PROCEDURES:
An individual seeking access to
records about that individual in this
system of records must submit a written
access request to the applicable System
Manager identified in the ‘‘System
Manager’’ section of this System of
Records Notice (SORN). The request
must contain the requester’s full name,
address, and signature. The request
should also contain sufficient
identifying particulars (such as, the
provider’s National Provider Identifier,
TIN, or patient medical record number,
or the patient’s patient identifier or SSN
to enable HHS to locate the requested
records. So that HHS may verify the
requester’s identity, the requester’s
signature must be notarized or the
request must include the requester’s
written certification that the requester is
the individual who the requester claims
to be and that the requester understands
that the knowing and willful request for
or acquisition of a record pertaining to
an individual under false pretenses is a
criminal offense subject to a fine of up
to $5,000.
If an access request by a patient seeks
disclosure of any information about the
patient’s provider which is or could be
proprietary information of that provider,
the request must be accompanied by a
disclosure authorization form signed by
the provider.
jspears on DSK121TN23PROD with NOTICES1
CONTESTING RECORD PROCEDURES:
An individual seeking to amend a
record about that individual in this
system of records must submit an
amendment request to the applicable
System Manager identified in the
‘‘System Manager’’ section of this
SORN, containing the same information
required for an access request. The
request must include verification of the
requester’s identity in the same manner
required for an access request; must
reasonably identify the record and
specify the information contested, the
corrective action sought, and the
reasons for requesting the correction;
and should include supporting
information to show how the record is
inaccurate, incomplete, untimely, or
irrelevant.
VerDate Sep<11>2014
20:16 Nov 24, 2021
Jkt 256001
NOTIFICATION PROCEDURES:
An individual who wishes to know if
this system of records contains records
about that individual should submit a
notification request to the applicable
System Manager identified in in the
‘‘System Manager’’ section of this
SORN. The request must contain the
same information required for an access
request and must include verification of
the requester’s identity in the same
manner required for an access request.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
None.
HISTORY:
None.
[FR Doc. 2021–25760 Filed 11–24–21; 8:45 am]
BILLING CODE 4160–15–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—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for 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). Prior to 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 January 25, 2022.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or by mail to 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
SUMMARY:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
information collection request title for
reference.
Information Collection Request Title:
The Stem Cell Therapeutic Outcomes
Database OMB No. 0915–0310—
Extension
Abstract: Given the rapid evolution of
COVID–19 and its impact on those with
compromised immune systems, it is
imperative for the transplant
community to continue collecting
COVID–19 related data. Having access
to COVID–19 vaccination status on
blood stem cell recipients and
understanding immune responses will
assist with making informed decisions
regarding direct clinical care. This will
also inform critical policy decisions.
The Stem Cell Therapeutic and
Research Act of 2005, Public Law (P.L.)
109–129, as amended, provides for the
collection and maintenance of human
blood stem cells for the treatment of
patients and research. It also maintains
a scientific database of information
relating to patients who have been
recipients of a stem cell therapeutics
product (e.g., bone marrow, cord blood,
or other such product) from a donor.
Given the rapid evolution of the
COVID–19 public health emergency and
its impact on immunocompromised
patients, availability of new vaccines,
and continual changes in vaccination
recommendations, HRSA wants to
leverage the required data collection
platform of the Stem Cell Therapeutic
Outcomes Database to obtain vaccine
information for all U.S. allogeneic
hematopoietic stem cell transplant
recipients.
Need and Proposed Use of the
Information: To collect COVID–19
vaccine data, HRSA is requesting an
extension of OMB’s approval of both the
Pre-Transplant Essential Data Form
2400 and Post-Transplant Essential Data
(Post-TED) Form 2450. Collecting these
data will help clinicians and
policymakers to understand the
landscape of vaccination among
immunocompromised patients before
and after a blood stem cell transplant.
HRSA will use this information to
analyze outcomes based on vaccine
manufacturer/type, doses received
(including potential boosters), timing,
and inform future vaccination strategies.
Information currently collected
regarding COVID–19 infections has
already been used in research studies.
HRSA will use data collected prior to
a patient receiving a blood stem cell
transplant to characterize frequencies of
vaccination and level of protection
afforded during and after transplant
based on incidence of COVID infection.
Post-transplant, this information can be
used to assess vaccination rates and
E:\FR\FM\26NON1.SGM
26NON1
67479
Federal Register / Vol. 86, No. 225 / Friday, November 26, 2021 / Notices
timing in blood stem cell recipients,
characterize emerging vaccination
strategies (which may include boosters),
describe possible short and long-term
side effects of vaccines, and analyze the
incidence of COVID–19 infection based
on different vaccination approaches.
This information may guide future
vaccination strategies or COVID
treatments. Vaccination status of
recipients may also be useful for risk
adjustment in the annual transplant
center specific analysis. For example,
Centers for Disease Control and
Prevention advisors could potentially
use COVID–19 vaccination data on
blood stem cell transplant recipients to
make informed decisions regarding
whether to issue any recommendations
for this medically vulnerable
population. The data collected under
this extension request could help
answer these and other questions.
The additional COVID–19 vaccine
questions capture basic information on
vaccination status, vaccine
manufacturer/type, dose(s) given, and
date(s) received. Patients who need a
blood stem cell transplant are typically
aware of their COVID–19 risk and
vaccination status, and the information
is also found on the vaccine cards
carried by most recipients. Questions
about vaccination status will likely
become universal during the intake
process at transplant centers for the next
12 months or more. For these reasons,
HRSA believes the data will be readily
available to data professionals working
at transplant centers via the medical
record. To reduce burden, an
‘‘unknown’’ option has been included
for scenarios where the data cannot be
located, and a ‘‘date estimated’’
checkbox has been included when the
exact date of vaccination is not known.
Although these questions are
anticipated to be asked over the next 12
months and then removed, it is possible
that other COVID–19 related questions
may be requested for inclusion on these
forms in the future given the rapid
evolution of COVID–19 and its impact
on immunocompromised patients,
availability of new vaccines, and
continual changes in vaccination
recommendations.
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
Number of
respondents 1
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
Baseline Pre-Transplant Essential Data (TED) ...................
Disease Classification ..........................................................
Product Form (includes Infusion, HLA, and Infectious Disease Marker inserts) ........................................................
100-day Post-TED ...............................................................
6 month Post-TED ...............................................................
1 year Post-TED ..................................................................
2 year Post-TED ..................................................................
3+ years Post-TED ..............................................................
200
200
48
48
9,600
9,600
2 0.70
3 0.43
6,720
4,160
200
200
200
200
200
200
45
48
43
40
34
172
9,000
9,600
8,600
8,000
6,800
34,400
1.00
0.88
0.85
0.65
0.65
4 0.52
9,000
8,448
7,310
5,200
4,420
17,773
Total ..............................................................................
200
........................
95,600
........................
63,031
1, The
jspears on DSK121TN23PROD with NOTICES1
total of 200 is the number of centers completing the form; the same group will complete all of the forms.
2 The decimal is rounded down, and the actual number is .683333333.
3 The decimal is rounded down, and the actual number is .433333333.
4 The decimal is rounded up, and the actual number is .516667.
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
Maria G. Button,
Director, Executive Secretariat.
The Federal Medical Assistance
Percentages (FMAP), Enhanced Federal
Medical Assistance Percentages
(eFMAP), and disaster-recovery FMAP
adjustments for Fiscal Year 2023 have
been calculated pursuant to the Social
[FR Doc. 2021–25786 Filed 11–24–21; 8:45 am]
BILLING CODE 4165–15–P
VerDate Sep<11>2014
20:16 Nov 24, 2021
Jkt 256001
Federal Financial Participation in State
Assistance Expenditures; Federal
Matching Shares for Medicaid, the
Children’s Health Insurance Program,
and Aid to Needy Aged, Blind, or
Disabled Persons for October 1, 2022
Through September 30, 2023
Office of the Secretary, DHHS.
Notice.
AGENCY:
ACTION:
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Security Act (the Act). These
percentages will be effective from
October 1, 2022 through September 30,
2023. This notice announces the
calculated FMAP rates, in accordance
with sections 1101(a)(8) and 1905(b) of
the Act, that the U.S. Department of
Health and Human Services (HHS) will
use in determining the amount of
federal matching for state medical
assistance (Medicaid), Temporary
Assistance for Needy Families (TANF)
Contingency Funds, Child Support
Enforcement collections, Child Care
Mandatory and Matching Funds of the
Child Care and Development Fund,
Title IV–E Foster Care Maintenance
payments, Adoption Assistance
payments and Kinship Guardianship
E:\FR\FM\26NON1.SGM
26NON1
]]>Agencies
[Federal Register Volume 86, Number 225 (Friday, November 26, 2021)]
[Notices]
[Pages 67478-67479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25786]
-----------------------------------------------------------------------
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--Extension
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for 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). Prior to 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 January
25, 2022.
ADDRESSES: Submit your comments to [email protected] or by mail to 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 collection request title
for reference.
Information Collection Request Title: The Stem Cell Therapeutic
Outcomes Database OMB No. 0915-0310--Extension
Abstract: Given the rapid evolution of COVID-19 and its impact on
those with compromised immune systems, it is imperative for the
transplant community to continue collecting COVID-19 related data.
Having access to COVID-19 vaccination status on blood stem cell
recipients and understanding immune responses will assist with making
informed decisions regarding direct clinical care. This will also
inform critical policy decisions.
The Stem Cell Therapeutic and Research Act of 2005, Public Law
(P.L.) 109-129, as amended, provides for the collection and maintenance
of human blood stem cells for the treatment of patients and research.
It also maintains a scientific database of information relating to
patients who have been recipients of a stem cell therapeutics product
(e.g., bone marrow, cord blood, or other such product) from a donor.
Given the rapid evolution of the COVID-19 public health emergency
and its impact on immunocompromised patients, availability of new
vaccines, and continual changes in vaccination recommendations, HRSA
wants to leverage the required data collection platform of the Stem
Cell Therapeutic Outcomes Database to obtain vaccine information for
all U.S. allogeneic hematopoietic stem cell transplant recipients.
Need and Proposed Use of the Information: To collect COVID-19
vaccine data, HRSA is requesting an extension of OMB's approval of both
the Pre-Transplant Essential Data Form 2400 and Post-Transplant
Essential Data (Post-TED) Form 2450. Collecting these data will help
clinicians and policymakers to understand the landscape of vaccination
among immunocompromised patients before and after a blood stem cell
transplant.
HRSA will use this information to analyze outcomes based on vaccine
manufacturer/type, doses received (including potential boosters),
timing, and inform future vaccination strategies. Information currently
collected regarding COVID-19 infections has already been used in
research studies.
HRSA will use data collected prior to a patient receiving a blood
stem cell transplant to characterize frequencies of vaccination and
level of protection afforded during and after transplant based on
incidence of COVID infection. Post-transplant, this information can be
used to assess vaccination rates and
[[Page 67479]]
timing in blood stem cell recipients, characterize emerging vaccination
strategies (which may include boosters), describe possible short and
long-term side effects of vaccines, and analyze the incidence of COVID-
19 infection based on different vaccination approaches. This
information may guide future vaccination strategies or COVID
treatments. Vaccination status of recipients may also be useful for
risk adjustment in the annual transplant center specific analysis. For
example, Centers for Disease Control and Prevention advisors could
potentially use COVID-19 vaccination data on blood stem cell transplant
recipients to make informed decisions regarding whether to issue any
recommendations for this medically vulnerable population. The data
collected under this extension request could help answer these and
other questions.
The additional COVID-19 vaccine questions capture basic information
on vaccination status, vaccine manufacturer/type, dose(s) given, and
date(s) received. Patients who need a blood stem cell transplant are
typically aware of their COVID-19 risk and vaccination status, and the
information is also found on the vaccine cards carried by most
recipients. Questions about vaccination status will likely become
universal during the intake process at transplant centers for the next
12 months or more. For these reasons, HRSA believes the data will be
readily available to data professionals working at transplant centers
via the medical record. To reduce burden, an ``unknown'' option has
been included for scenarios where the data cannot be located, and a
``date estimated'' checkbox has been included when the exact date of
vaccination is not known. Although these questions are anticipated to
be asked over the next 12 months and then removed, it is possible that
other COVID-19 related questions may be requested for inclusion on
these forms in the future given the rapid evolution of COVID-19 and its
impact on immunocompromised patients, availability of new vaccines, and
continual changes in vaccination recommendations.
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
----------------------------------------------------------------------------------------------------------------
Number of Number of Average burden
Form name respondents responses per Total per response Total burden
\1\ respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Baseline Pre-Transplant 200 48 9,600 \2\ 0.70 6,720
Essential Data (TED)...........
Disease Classification.......... 200 48 9,600 \3\ 0.43 4,160
Product Form (includes Infusion, 200 45 9,000 1.00 9,000
HLA, and Infectious Disease
Marker inserts)................
100-day Post-TED................ 200 48 9,600 0.88 8,448
6 month Post-TED................ 200 43 8,600 0.85 7,310
1 year Post-TED................. 200 40 8,000 0.65 5,200
2 year Post-TED................. 200 34 6,800 0.65 4,420
3+ years Post-TED............... 200 172 34,400 \4\ 0.52 17,773
-------------------------------------------------------------------------------
Total....................... 200 .............. 95,600 .............. 63,031
----------------------------------------------------------------------------------------------------------------
\1>\ The total of 200 is the number of centers completing the form; the same group will complete all of the
forms.
\2\ The decimal is rounded down, and the actual number is .683333333.
\3\ The decimal is rounded down, and the actual number is .433333333.
\4\ The decimal is rounded up, and the actual number is .516667.
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. 2021-25786 Filed 11-24-21; 8:45 am]
BILLING CODE 4165-15-P
