Agency Information Collection Request; 30-Day Public Comment Request, 26898-26899 [2024-07934]
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Federal Register / Vol. 89, No. 74 / Tuesday, April 16, 2024 / Notices
clinical trials that are intended to
generate evidence of safety and
effectiveness of therapies that in turn
showcase the value of clinical trial
innovations. CDER leads or co-leads
several ongoing programs to advance
innovation, and CDER recognizes that
additional innovative areas would
benefit from the enhanced interactions
that are the staple of these programs.
CDER also recognizes that
opportunities exist to further enhance
the adoption of clinical trial
innovations, including the amplification
of lessons learned across CDER’s robust
clinical innovation programs. On
October 17, 2023, CDER solicited public
comments on the barriers and
facilitators to incorporating successful
or promising innovative clinical trial
approaches in drug development
programs. These public comments were
discussed as part of a public workshop
led by the Duke-Margolis Institute for
Health Policy, under a cooperative
agreement with FDA, on March 19 and
20, 2024. Topics addressed during the
workshop included, but were not
limited to, those listed below:
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• Evolution of clinical research and the
current state of trial innovation
• Regulatory and compliance
considerations
• Patient-centric and recruitment
considerations
• Infrastructure and organizational
considerations
• Global regulatory collaboration on
clinical trial innovation
• Collaborations across industry,
academia, and FDA to leverage
innovation
• Future directions on clinical trial
innovation
As a result of these discussions and
internal deliberation, FDA is
establishing C3TI to further enhance
clinical trial innovation for drug
development and regulatory decision
making. C3TI will serve as a central hub
to (1) facilitate the sharing of lessons
learned across CDER’s existing clinical
trial innovation programs, (2)
communicate and collaborate with
external parties about innovative
clinical trials, and (3) manage a C3TI
Demonstration Program that will
expand opportunities for sponsors of
innovative clinical trials in the areas
described below that are under a preinvestigational new drug application
(pre-IND) or IND to interact with CDER
staff.
II. Goals of C3TI
Specifically, C3TI aims to:
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• Assist stakeholders involved in
clinical research in staying current
with clinical trial innovations
• Improve the efficiency and
effectiveness of clinical trials
• Help increase the participation of
diverse populations in clinical trials
• Enhance the quality of clinical trial
data
• Accelerate the development of safe
and effective new drugs
• Serve as a central hub for knowledge
management and coordinating lessons
learned across CDER’s clinical trial
innovation programs
• Establish a C3TI Demonstration
Program that will include case
examples from ongoing development
programs in the project areas
described below to spur innovation
across therapeutic areas
III. Activities of C3TI
C3TI provides a single CDER location
to engage stakeholders and assist with
non-product-specific questions on
innovative clinical trial approaches.
C3TI maintains a website at fda.gov/
C3TI to centralize information on
existing and new CDER clinical trial
innovation efforts, including links to
existing websites and resources. C3TI
can be contacted at
CDERClinicalTrialInnovation@
fda.hhs.gov. Additionally, C3TI will
coordinate and act as a liaison to
facilitate information sharing with
external stakeholders, as appropriate
and permitted by law, when they engage
CDER on general clinical trial
innovation matters. It will also support
knowledge sharing internally through
various mechanisms, such as discussion
forums and communications, and a
centralized knowledge repository. This
repository will curate knowledge about
completed CDER clinical trial
innovation activities and maintain a
comprehensive portfolio of ongoing
efforts and knowledge resources.
A critical component of C3TI is
expanding the subject areas that could
benefit from enhanced communication
between CDER and sponsors and serve
as case examples to spur further
innovation. Therefore, C3TI will manage
a demonstration program that includes
three initial subject matter/project areas
described below. The program is for
selected sponsors of innovative clinical
trials in certain initial project areas
under a pre-IND or IND with CDER that
are intended to support new drug
product approvals or changes to
approved drug product labeling and that
will serve as case examples that can be
shared both internally and externally to
foster innovation across therapeutic
areas. If selected, sponsors will have the
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opportunity for enhanced
communication and interaction with
CDER staff. Because the goal of selecting
these case examples from clinical trials
under a pre-IND or IND is to ultimately
share lessons learned more broadly with
the clinical trial community,
participating sponsors and FDA will
agree on aspects of the development
program that FDA can disclose even
before a drug is approved.
The three initial project areas under
the C3TI Demonstration Program are (1)
point-of-care or pragmatic trials, (2)
Bayesian analyses, and (3) trials using
selective safety data collection. More
information about the C3TI
Demonstration Program, including how
to participate and how the program
differs from existing clinical trial
innovation programs, is available on the
C3TI website: fda.gov/C3TI.
IV. Paperwork Reduction Act of 1995
For the C3TI Demonstration Program,
FDA will request information from no
more than nine sponsors. Initial
statements of interest from sponsors
interested in being evaluated for
participation in the C3TI Demonstration
Program are not ‘‘information’’ in
accordance with 5 CFR 1320.3(h)(1).
Thus, this notice contains no new
collection of information.
This notice also refers to previously
approved FDA collections of
information. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3521). The
collections of information in 21 CFR
part 312 have been approved under
OMB control number 0910–0014. The
collections of information relating to
formal meetings between sponsors or
applicants and FDA has been approved
under OMB control number 0910–0001.
Dated: April 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–07829 Filed 4–15–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0330]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
SUMMARY:
E:\FR\FM\16APN1.SGM
16APN1
26899
Federal Register / Vol. 89, No. 74 / Tuesday, April 16, 2024 / Notices
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services (HHS), is
publishing the following summary of a
proposed collection for public
comment.
Comments on the ICR must be
received on or before May 16, 2024.
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 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 264–0041, or PRA@HHS.GOV.
When submitting comments or
requesting information, please include
the document identifier 0990–0330–60D
and project title for reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (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.
Title of the Collection: Appellant
Climate Survey.
Type of Collection: Revision.
OMB No. 0990–0330, HHS, OS, Office
of Medicare Hearings and Appeals.
Abstract:
DATES:
The Department of Health and Human
Services under the Office of Medicare
Hearings and Appeals is doing the
annual OMHA Appellant Climate
Survey. This is a survey of Medicare
beneficiaries, providers, suppliers, or
their representatives who participated
in a hearing before an Administrative
Law Judge (ALJ) from OMHA.
Appellants dissatisfied with the
outcome of their Level 2 Medicare
appeal may request a hearing before an
OMHA ALJ. The Appellant Climate
Survey will be used to measure
appellant satisfaction with their OMHA
appeals experience, as opposed to their
satisfaction with a specific ruling.
OMHA was established by the Medicare
Prescription Drug, Improvement, and
Modernization Act (MMA) of 2003 (Pub.
L. 108–173) and became operational on
July 1, 2005. The MMA legislation also
directed HHS to consider the feasibility
of conducting hearings using telephone
or video-teleconference (VTC)
technologies. In carrying out this
mandate, OMHA makes use of both
telephone and VTC to provide
appellants with a vast nationwide
network of Field Offices for hearings.
The first 3-year administration cycle of
the OMHA survey began in fiscal year
(FY) 2008, a second 3-year cycle began
in FY 2011, a third 3-year cycle began
in FY 2014, a fourth 3-year cycle began
in FY 2018, and a fifth 3-year cycle
began in FY 2021. The survey will
continue to be conducted annually over
a 3-year period with the next data
collection cycle beginning in FY 2024.
The survey instrument includes
several changes from the prior 3-year
cycle: Added a new section, ‘‘Request
for Hearing.’’ The section focuses on
how customers requested a hearing,
how satisfied they were with the
method they used to request a hearing,
and about the clarity of form OMHA–
100 (Request for ALJ Hearing or Review
of Dismissal).
Changed ‘‘Hard Copy, internet and
Phone Information’’ section to
‘‘Communications and Web Tools’’
section.
Added a brief statement about when
customers should have received the
‘‘Notice of Nondiscrimination’’
document.
Added two satisfaction questions for
appellants who used the e-Appeal
Portal—one about updates the portal
provides on their appeal and another
about using the portal for uploading
documents electronically.
Changed ‘‘Telephone Hearing’’
section to ‘‘Hearing.’’ The appellant is
asked what type of hearing they had
(telephone or video) and satisfaction
with using that method. If they attended
a telephone hearing, appellants will be
asked whether they were offered the
option of a video hearing; if not, they
will be asked if they would have
participated in a video hearing if
offered.
Data collection instruments and
recruitment materials will be offered in
English and Spanish. The estimated
total number of respondents across all 3
years is 2,400 (800 respondents each FY
for FY 2024, FY 2025, and FY2026). The
estimated total annual burden hours
expected across all years is 600 hours
(200 hours each FY for FY 2024, FY
2025, and FY 2026).
The survey will be conducted
annually, and survey respondents will
consist of Medicare beneficiaries and
non-beneficiaries (i.e., providers,
suppliers) who participated in a hearing
before an OMHA ALJ. OMHA will draw
a representative, nonredundant sample
of appellants whose cases have been
closed in the first 6 months of the
surveyed fiscal year.
ESTIMATED ANNUALIZED BURDEN HOUR TABLE
Forms
(if necessary)
Respondents
(if necessary)
khammond on DSKJM1Z7X2PROD with NOTICES
Total ...........................................
Number of
respondents
Average
burden per
response
(in hours)
Number responses per
respondent
Beneficiaries .....................................
Non-Beneficiaries .............................
400
400
1
1
15/60
15/60
100
100
...........................................................
800
1
15/60
200
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2024–07934 Filed 4–15–24; 8:45 am]
BILLING CODE 4150–46–P
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19:09 Apr 15, 2024
Total burden
hours
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]]>Agencies
[Federal Register Volume 89, Number 74 (Tuesday, April 16, 2024)]
[Notices]
[Pages 26898-26899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07934]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0330]
Agency Information Collection Request; 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork
[[Page 26899]]
Reduction Act of 1995, the Office of the Secretary (OS), Department of
Health and Human Services (HHS), is publishing the following summary of
a proposed collection for public comment.
DATES: Comments on the ICR must be received on or before May 16, 2024.
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 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 264-0041, or [email protected]. When submitting comments or
requesting information, please include the document identifier 0990-
0330-60D and project title for reference.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (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.
Title of the Collection: Appellant Climate Survey.
Type of Collection: Revision.
OMB No. 0990-0330, HHS, OS, Office of Medicare Hearings and
Appeals.
Abstract:
The Department of Health and Human Services under the Office of
Medicare Hearings and Appeals is doing the annual OMHA Appellant
Climate Survey. This is a survey of Medicare beneficiaries, providers,
suppliers, or their representatives who participated in a hearing
before an Administrative Law Judge (ALJ) from OMHA. Appellants
dissatisfied with the outcome of their Level 2 Medicare appeal may
request a hearing before an OMHA ALJ. The Appellant Climate Survey will
be used to measure appellant satisfaction with their OMHA appeals
experience, as opposed to their satisfaction with a specific ruling.
OMHA was established by the Medicare Prescription Drug, Improvement,
and Modernization Act (MMA) of 2003 (Pub. L. 108-173) and became
operational on July 1, 2005. The MMA legislation also directed HHS to
consider the feasibility of conducting hearings using telephone or
video-teleconference (VTC) technologies. In carrying out this mandate,
OMHA makes use of both telephone and VTC to provide appellants with a
vast nationwide network of Field Offices for hearings. The first 3-year
administration cycle of the OMHA survey began in fiscal year (FY) 2008,
a second 3-year cycle began in FY 2011, a third 3-year cycle began in
FY 2014, a fourth 3-year cycle began in FY 2018, and a fifth 3-year
cycle began in FY 2021. The survey will continue to be conducted
annually over a 3-year period with the next data collection cycle
beginning in FY 2024.
The survey instrument includes several changes from the prior 3-
year cycle: Added a new section, ``Request for Hearing.'' The section
focuses on how customers requested a hearing, how satisfied they were
with the method they used to request a hearing, and about the clarity
of form OMHA-100 (Request for ALJ Hearing or Review of Dismissal).
Changed ``Hard Copy, internet and Phone Information'' section to
``Communications and Web Tools'' section.
Added a brief statement about when customers should have received
the ``Notice of Nondiscrimination'' document.
Added two satisfaction questions for appellants who used the e-
Appeal Portal--one about updates the portal provides on their appeal
and another about using the portal for uploading documents
electronically.
Changed ``Telephone Hearing'' section to ``Hearing.'' The appellant
is asked what type of hearing they had (telephone or video) and
satisfaction with using that method. If they attended a telephone
hearing, appellants will be asked whether they were offered the option
of a video hearing; if not, they will be asked if they would have
participated in a video hearing if offered.
Data collection instruments and recruitment materials will be
offered in English and Spanish. The estimated total number of
respondents across all 3 years is 2,400 (800 respondents each FY for FY
2024, FY 2025, and FY2026). The estimated total annual burden hours
expected across all years is 600 hours (200 hours each FY for FY 2024,
FY 2025, and FY 2026).
The survey will be conducted annually, and survey respondents will
consist of Medicare beneficiaries and non-beneficiaries (i.e.,
providers, suppliers) who participated in a hearing before an OMHA ALJ.
OMHA will draw a representative, nonredundant sample of appellants
whose cases have been closed in the first 6 months of the surveyed
fiscal year.
Estimated Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Number Average burden
Forms (if necessary) Respondents (if Number of responses per per response Total burden
necessary) respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Beneficiaries... 400 1 15/60 100
Non- 400 1 15/60 100
Beneficiaries.
---------------------------------------------------------------------------------
Total..................... ................ 800 1 15/60 200
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2024-07934 Filed 4-15-24; 8:45 am]
BILLING CODE 4150-46-P
