Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The Stem Cell Therapeutic Outcomes Database, OMB No. 0915-0310-Extension, 6610-6611 [2022-02318]
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6610
Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices
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Dated: January 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–02359 Filed 2–3–22; 8:45 am]
BILLING CODE 4164–01–C
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; 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 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 March 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/
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:50 Feb 03, 2022
Jkt 256001
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 paperwork@hrsa.gov or call (301)
443–9094.
SUPPLEMENTARY INFORMATION:
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 (Pub.
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,
PO 00000
Frm 00128
Fmt 4703
Sfmt 4703
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 US allogeneic
hematopoietic stem cell transplant
recipients.
A 60-day notice published in the
Federal Register, 86 FR 67478
(November 26, 2021). There were no
public comments.
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 (Pre-TED)
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.
This information will be used 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.
Data collected prior to a patient
receiving a blood stem cell transplant
will be used to characterize frequencies
of vaccination, and the level of
protection afforded during and after
transplant based on the incidence of
COVID infection. Post-transplant, this
information can be used to assess
vaccination rates and timing in blood
stem cell recipients, characterize
emerging vaccination strategies (which
may include ‘‘boosters’’), describe
possible short and long-term side effects
E:\FR\FM\04FEN1.SGM
04FEN1
EN04FE22.042</GPH>
Food.and Drug.Administration
6611
Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices
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. The vaccination status of
recipients may also be useful for risk
adjustment in the annual transplant
center-specific analysis. For example,
CDC 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 at transplant center
intake 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, 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
Number of
respondents 1
Form name
Number of
responses per
respondent
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
responses
Average
burden per
response
(in hours)
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
total of 200 is the number of centers completing the form; the same group will complete all of the forms.
decimal is rounded up, and the actual number is .683333333.
decimal is rounded down, and the actual number is .433333333.
4 The decimal is rounded up, and the actual number is .516667.
2 The
3 The
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.
lotter on DSK11XQN23PROD with NOTICES1
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022–02318 Filed 2–3–22; 8:45 am]
BILLING CODE 4165–15–P
VerDate Sep<11>2014
18:50 Feb 03, 2022
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Information: Regarding a
Revision to U.S. Public Health Service
Guideline: Assessing Solid Organ
Donors and Monitoring Transplant
Recipients for Human
Immunodeficiency Virus, Hepatitis B
Virus, and Hepatitis C Virus Infection
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Request for information.
AGENCY:
The Office of the Assistant
Secretary for Health in the Department
of Health and Human Services (HHS)
seeks public comment regarding a
proposed revision to the 2020 PHS
Guideline Assessing Solid Organ Donors
SUMMARY:
Jkt 256001
PO 00000
Frm 00129
Fmt 4703
Sfmt 4703
and Monitoring Transplant Recipients
for Human Immunodeficiency Virus,
Hepatitis B Virus, and Hepatitis C Virus
Infection (1). The Organ Procurement
and Transplantation Network (OPTN)
implemented a policy change related to
organ transplant candidate assessment
and testing on March 1, 2021, to align
OPTN policy with the new Guideline
recommendations (2). Previous PHS
Guideline recommendations did not
include a specific timeframe during
which pre-transplant testing for HIV,
HBV, and HCV infections among organ
transplant candidates should occur. In
order to more accurately assess pretransplant infection status and to enable
the investigation of possible solid organ
donor transmission of infection, the
2020 Guideline specified that pretransplant HIV, HBV, and HCV testing
of transplant candidates should occur
during hospital admission for transplant
E:\FR\FM\04FEN1.SGM
04FEN1
]]>Agencies
[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Notices]
[Pages 6610-6611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02318]
-----------------------------------------------------------------------
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; 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 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 March 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--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
(Pub. 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 US allogeneic hematopoietic stem cell transplant recipients.
A 60-day notice published in the Federal Register, 86 FR 67478
(November 26, 2021). There were no public comments.
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 (Pre-TED) 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.
This information will be used 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.
Data collected prior to a patient receiving a blood stem cell
transplant will be used to characterize frequencies of vaccination, and
the level of protection afforded during and after transplant based on
the incidence of COVID infection. Post-transplant, this information can
be used to assess vaccination rates and timing in blood stem cell
recipients, characterize emerging vaccination strategies (which may
include ``boosters''), describe possible short and long-term side
effects
[[Page 6611]]
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. The vaccination status of
recipients may also be useful for risk adjustment in the annual
transplant center-specific analysis. For example, CDC 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 at transplant center intake 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, 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.
----------------------------------------------------------------------------------------------------------------
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 up, 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. 2022-02318 Filed 2-3-22; 8:45 am]
BILLING CODE 4165-15-P
