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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.

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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.

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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
[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
SUMMARY:

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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

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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

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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

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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:

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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

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