Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Be The Match® Patient Support Center Survey, 13130-13131 [2023-04235]
Download as PDF
13130
Federal Register / Vol. 88, No. 41 / Thursday, March 2, 2023 / Notices
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 12, 2023.
Closed Committee Deliberations: On
April 26, 2023, from 12:05 p.m. to 1
p.m. Eastern Time, the meeting will be
closed to permit discussion where
disclosure would constitute a clearly
unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The
recommendations of the advisory
committee regarding the progress of the
individual investigators’ research
programs, along with other information,
will be discussed during this session.
We believe that public discussion of
these recommendations on individual
scientists would constitute an
unwarranted invasion of personal
privacy.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Christina Vert
or Marie DeGregorio at CBERBPAC@
fda.hhs.gov (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for
procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2023–N–0094]
Joint Meeting of the Nonprescription
Drugs Advisory Committee and the
Anesthetic and Analgesic Drug
Products Advisory Committee;
Cancellation
Food and Drug Administration,
HHS.
ACTION:
Notice.
The meeting of the
Nonprescription Drugs Advisory
SUMMARY:
VerDate Sep<11>2014
18:21 Mar 01, 2023
Jkt 259001
Dated: February 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–04271 Filed 3–1–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Be The
Match® Patient Support Center Survey
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 May 1, 2023.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or by mail at:
HRSA Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
SUMMARY:
[FR Doc. 2023–04270 Filed 3–1–23; 8:45 am]
AGENCY:
Committee and the Anesthetic and
Analgesic Drug Products Advisory
Committee scheduled for March 20,
2023, is cancelled. This meeting was
announced in the Federal Register of
January 30, 2023. The meeting is no
longer needed.
FOR FURTHER INFORMATION CONTACT:
Moon Choi, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–2894, email:
NDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting,
which was announced in the Federal
Register of January 30, 2023 (88 FR
5893).
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Samantha Miller, the HRSA
Information Collection Clearance
Officer, at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
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
(Public Law [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’s
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 (HCT). As the contractor for
the 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
representativeness of findings.
Need and Proposed Use of the
Information: HCT is a complex medical
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
E:\FR\FM\02MRN1.SGM
02MRN1
13131
Federal Register / Vol. 88, No. 41 / Thursday, March 2, 2023 / Notices
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 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 patients, caregivers, and family
members who have contact with the
PSC 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 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 PSC one or
more years after the initial contact, they
will receive a second survey. This is
because we anticipate 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.
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.
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
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. 2023–04235 Filed 3–1–23; 8:45 am]
BILLING CODE 4165–15–P
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses per
respondent
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Office of the Assistant
Secretary for Health, Office of the
AGENCY:
VerDate Sep<11>2014
18:21 Mar 01, 2023
Jkt 259001
Secretary, Department of Health and
Human Services.
ACTION:
Notice.
Pursuant to section 10(a) of
the Federal Advisory Committee Act,
U.S.C. Appendix 2, notice is hereby
given that the Secretary’s Advisory
Committee on Human Research
Protections (SACHRP) will hold a
meeting that will be open to the public.
Information about SACHRP, the full
meeting agenda, and instructions for
linking to public access will be posted
on the SACHRP website at https://
www.dhhs.gov/ohrp/sachrp-committee/
meetings/.
SUMMARY:
The meeting will be held on
Wednesday, March 22, 2023 from 11:00
a.m. until 5:00 p.m., and Thursday,
March 23, 2023, from 11:00 a.m. until
5:00 p.m. (times are tentative and
subject to change). The confirmed times
and agenda will be posted on the
SACHRP website as this information
becomes available.
DATES:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
This meeting will be held
via webcast. Members of the public may
also attend the meeting via webcast.
Instructions for attending via webcast
will be posted at least one week prior
to the meeting at https://www.hhs.gov/
ohrp/sachrp-committee/meetings/
index.html.
FOR FURTHER INFORMATION CONTACT: Julia
Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; telephone: 240–453–
8141; fax: 240–453–6909; email address:
SACHRP@hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. 217a, section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services, through
the Assistant Secretary for Health, on
issues and topics pertaining to or
associated with the protection of human
research subjects.
ADDRESSES:
E:\FR\FM\02MRN1.SGM
02MRN1
Agencies
[Federal Register Volume 88, Number 41 (Thursday, March 2, 2023)]
[Notices]
[Pages 13130-13131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04235]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: Be The
Match[supreg] Patient Support Center Survey
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 May 1,
2023.
ADDRESSES: Submit your comments to [email protected] or by mail at:
HRSA Information Collection Clearance Officer, Room 14N39, 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 HRSA Information Collection Clearance Officer, at (301) 443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the ICR title for reference.
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
(Public Law [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's 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 (HCT). As the contractor for
the 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 representativeness of
findings.
Need and Proposed Use of the Information: HCT is a complex medical
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
[[Page 13131]]
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 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 patients, caregivers,
and family members who have contact with the PSC 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
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 PSC one or more years
after the initial contact, they will receive a second survey. This is
because we anticipate 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.
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.
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
----------------------------------------------------------------------------------------------------------------
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. 2023-04235 Filed 3-1-23; 8:45 am]
BILLING CODE 4165-15-P