Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Be The Match® Patient Support Center Survey-Revision, 38872-38873 [2023-12666]
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Federal Register / Vol. 88, No. 114 / Wednesday, June 14, 2023 / Notices
thinking of FDA on ‘‘Content of
Premarket Submissions for Device
Software Functions.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidance-
III. Paperwork Reduction Act of 1995
While this guidance contains no new
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
regulations, guidance, and forms have
been approved by OMB as listed in the
following table:
OMB
control No.
21 CFR part; guidance; or FDA form
Topic
807, subpart E ..........................................
814, subparts A through E .......................
814, subpart H ..........................................
812 ............................................................
860, subpart D ..........................................
601; Form FDA 356h ................................
Premarket notification ..................................................................................................
Premarket approval ......................................................................................................
Humanitarian Device Exemption ..................................................................................
Investigational Device Exemption ................................................................................
De Novo classification process ....................................................................................
Biologics License; Application to Market a New or Abbreviated New Drug or Biologic for Human Use—Form FDA 356h.
Q-submissions ..............................................................................................................
0910–0120
0910–0231
0910–0332
0910–0078
0910–0844
0910–0338
Medical Device Labeling Regulations ..........................................................................
Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation .....
0910–0485
0910–0073
‘‘Requests for Feedback and Meetings for
Medical Device Submissions: The QSubmission Program’’.
800, 801, and 809 ....................................
820 ............................................................
Dated: June 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
[FR Doc. 2023–12723 Filed 6–13–23; 8:45 am]
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; Be The Match® Patient
Support Center Survey—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA 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
SUMMARY:
VerDate Sep<11>2014
19:24 Jun 13, 2023
Comments on this ICR should be
received no later than July 14, 2023.
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 HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Be The Match® Patient Support Center
Survey
OMB No. 0906–0004—Revision
Abstract: The C.W. Bill Young Cell
Transplantation Program was
established by the Stem Cell
Therapeutic and Research Act of 2005
DATES:
BILLING CODE 4164–01–P
ddrumheller on DSK120RN23PROD with NOTICES1
documents-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics.
Persons unable to download an
electronic copy of ‘‘Content of
Premarket Submissions for Device
Software Functions’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number GUI00000337 and complete
title to identify the guidance you are
requesting.
Jkt 259001
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Frm 00064
Fmt 4703
Sfmt 4703
0910–0756
(Pub. L. 109–129) and was reauthorized
in 2010 (Pub. L. 111–264), 2015 (Pub. L.
114–104) and again in 2021 (Pub. L.
117–15). The C.W. Bill Young Cell
Transplantation Program Office of
Patient Advocacy (OPA) is operated by
the National Marrow Donor Program®
(NMDP). Through OPA, NMDP provides
navigation services, education
resources, and support to people in
need of or who have received an
allogeneic hematopoietic cell transplant
(allo-HCT). As the contractor for OPA,
NMDP is required to conduct surveys to
evaluate patient satisfaction with the
services provided. As such, NMDP will
elicit feedback from HCT patients,
caregivers, and family members who
had contact with the NMDP/Be The
Match® Patient Support Center (PSC) for
service and support. The survey is
administered through a web-based
system. In addition to questions that
measure satisfaction, the survey also
includes demographic questions to
determine the representativeness of
findings.
A 60-day notice was published in the
Federal Register on March 2, 2023, vol.
88, No. 41; pp. 13130–31. There were no
public comments.
Need and Proposed Use of the
Information: HCT is a complex medical
E:\FR\FM\14JNN1.SGM
14JNN1
38873
Federal Register / Vol. 88, No. 114 / Wednesday, June 14, 2023 / Notices
procedure that requires significant
support before, during, and after the
procedure. Many patients experience
barriers that impede access to HCT.
Barriers to HCT-related care and
educational information are multifactorial. The NMDP/Be The Match PSC
offers many programs and services to
support patients, caregivers, and family
members throughout their HCT journey.
Feedback from recipients of NMDP
services is essential to understand the
changing needs for services and
information as well as to demonstrate
the effectiveness of existing services.
The primary use for information
gathered through the survey is to
determine the helpfulness of
participants’ initial contact with the
PSC patient navigators and to identify
areas for improvement in the delivery of
services. Patient navigators are trained
lay or licensed clinical patient
navigators, who respond to requests for
information and support. Program
managers and NMDP leadership use this
evaluation data to share patients’
experiences as well as make program
and resource allocation decisions.
Web-based surveys will be
administered to all participants
(patients, caregivers, and family
members) who have contact with the
PSC. All participants for whom an email
address is known will be invited to
complete the survey online. Survey
respondents will be notified via email
invitation and in the survey instructions
that participation is voluntary, and
responses will be kept confidential. A
follow-up invitation will be sent within
2 weeks to non-respondents.
The survey will include these items to
measure: (1) their experience, (2) if the
contact helped the participant feel more
confident in coping with treatment, (3)
if the contact helped the participant feel
more hopeful, (4) if the contact helped
the participant feel less alone, (5)
increased awareness of available
resources, (6) if the contact helped the
participant feel more informed about
treatment options, (7) if their questions
were answered, and (8) types of
challenges faced by the participant. The
survey data will be analyzed quarterly
and annually, and results will be shared
with program managers. Feedback
indicating a need for improvement will
be reviewed by program managers
biannually and implementation of
resulting program changes or additions
will be documented.
Likely Respondents: Respondents will
include all patients, caregivers, and
family members who have contact with
the Patient Support Center via phone or
email for HCT navigation services and
support (advocacy). The decision to
survey all participants was made based
on the historically low response rate
(∼20 percent) to this survey due to
patients’ frequent transitions in health
status as well as transfer between home
and the hospital for initial treatment
and care for complications. Participants
will receive the survey once in a 1-year
cycle. If a participant contacts the
Patient Support Center one or more
years after the initial contact, they will
receive a second survey. This is because
it is anticipated that the participants’
needs will likely change during the time
lapse.
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
Form name
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Be The Match® Patient Support Center Survey ..................
900
1
900
0.17
153
Total ..............................................................................
900
1
900
0.17
153
The total respondent burden for the
customer satisfaction surveys is
estimated to be 153 hours. HRSA
expects a total of 900 respondents to
complete the Be The Match® Patient
Support Center Survey.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023–12666 Filed 6–13–23; 8:45 am]
BILLING CODE 4165–15–P
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses per
respondent
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; Data System for Organ
Procurement and Transplantation
Network, OMB No. 0915–0157—
Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
SUMMARY:
VerDate Sep<11>2014
19:24 Jun 13, 2023
Jkt 259001
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
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.
Comments on this ICR should be
received no later than July 14, 2023.
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
DATES:
E:\FR\FM\14JNN1.SGM
14JNN1
]]>Agencies
[Federal Register Volume 88, Number 114 (Wednesday, June 14, 2023)]
[Notices]
[Pages 38872-38873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12666]
-----------------------------------------------------------------------
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; Be The Match[supreg]
Patient Support Center Survey--Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA
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 14,
2023.
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 HRSA
Information Collection Clearance Officer, at [email protected] or call
(301) 443-3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Be The Match[supreg] Patient
Support Center Survey
OMB No. 0906-0004--Revision
Abstract: The C.W. Bill Young Cell Transplantation Program was
established by the Stem Cell Therapeutic and Research Act of 2005 (Pub.
L. 109-129) and was reauthorized in 2010 (Pub. L. 111-264), 2015 (Pub.
L. 114-104) and again in 2021 (Pub. L. 117-15). The C.W. Bill Young
Cell Transplantation Program Office of Patient Advocacy (OPA) is
operated by the National Marrow Donor Program[supreg] (NMDP). Through
OPA, NMDP provides navigation services, education resources, and
support to people in need of or who have received an allogeneic
hematopoietic cell transplant (allo-HCT). As the contractor for OPA,
NMDP is required to conduct surveys to evaluate patient satisfaction
with the services provided. As such, NMDP will elicit feedback from HCT
patients, caregivers, and family members who had contact with the NMDP/
Be The Match[supreg] Patient Support Center (PSC) for service and
support. The survey is administered through a web-based system. In
addition to questions that measure satisfaction, the survey also
includes demographic questions to determine the representativeness of
findings.
A 60-day notice was published in the Federal Register on March 2,
2023, vol. 88, No. 41; pp. 13130-31. There were no public comments.
Need and Proposed Use of the Information: HCT is a complex medical
[[Page 38873]]
procedure that requires significant support before, during, and after
the procedure. Many patients experience barriers that impede access to
HCT. Barriers to HCT-related care and educational information are
multi-factorial. The NMDP/Be The Match PSC offers many programs and
services to support patients, caregivers, and family members throughout
their HCT journey. Feedback from recipients of NMDP services is
essential to understand the changing needs for services and information
as well as to demonstrate the effectiveness of existing services. The
primary use for information gathered through the survey is to determine
the helpfulness of participants' initial contact with the PSC patient
navigators and to identify areas for improvement in the delivery of
services. Patient navigators are trained lay or licensed clinical
patient navigators, who respond to requests for information and
support. Program managers and NMDP leadership use this evaluation data
to share patients' experiences as well as make program and resource
allocation decisions.
Web-based surveys will be administered to all participants
(patients, caregivers, and family members) who have contact with the
PSC. All participants for whom an email address is known will be
invited to complete the survey online. Survey respondents will be
notified via email invitation and in the survey instructions that
participation is voluntary, and responses will be kept confidential. A
follow-up invitation will be sent within 2 weeks to non-respondents.
The survey will include these items to measure: (1) their
experience, (2) if the contact helped the participant feel more
confident in coping with treatment, (3) if the contact helped the
participant feel more hopeful, (4) if the contact helped the
participant feel less alone, (5) increased awareness of available
resources, (6) if the contact helped the participant feel more informed
about treatment options, (7) if their questions were answered, and (8)
types of challenges faced by the participant. The survey data will be
analyzed quarterly and annually, and results will be shared with
program managers. Feedback indicating a need for improvement will be
reviewed by program managers biannually and implementation of resulting
program changes or additions will be documented.
Likely Respondents: Respondents will include all patients,
caregivers, and family members who have contact with the Patient
Support Center via phone or email for HCT navigation services and
support (advocacy). The decision to survey all participants was made
based on the historically low response rate (~20 percent) to this
survey due to patients' frequent transitions in health status as well
as transfer between home and the hospital for initial treatment and
care for complications. Participants will receive the survey once in a
1-year cycle. If a participant contacts the Patient Support Center one
or more years after the initial contact, they will receive a second
survey. This is because it is anticipated that the participants' needs
will likely change during the time lapse.
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 Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Be The Match[supreg] Patient 900 1 900 0.17 153
Support Center Survey..........
-------------------------------------------------------------------------------
Total....................... 900 1 900 0.17 153
----------------------------------------------------------------------------------------------------------------
The total respondent burden for the customer satisfaction surveys
is estimated to be 153 hours. HRSA expects a total of 900 respondents
to complete the Be The Match[supreg] Patient Support Center Survey.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-12666 Filed 6-13-23; 8:45 am]
BILLING CODE 4165-15-P
