Notice2024-13961
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Total Product Life Cycle Advisory Program Pilot
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 26, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 89 Issue 123 (Wednesday, June 26, 2024)</title>
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[Federal Register Volume 89, Number 123 (Wednesday, June 26, 2024)]
[Notices]
[Pages 53429-53431]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-13961]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-1201]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Voluntary Total
Product Life Cycle Advisory Program Pilot
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by July 26, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The title of this
information collection is Voluntary Total Product Life Cycle Advisory
Program Pilot. Also include the FDA docket number found in brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
<a href="/cdn-cgi/l/email-protection#a8f8fae9fbdcc9cecee8ceccc986c0c0db86cfc7de"><span class="__cf_email__" data-cfemail="09595b485a7d686f6f496f6d682761617a276e667f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot
OMB Control Number 0910-NEW
This information collection supports the TPLC TAP. FDA's Center for
Devices and Radiological Health launched the voluntary TAP Pilot in
2023 (87 FR 61605; October 12, 2022). The TAP Pilot is one of the
commitments agreed to between FDA and industry as part of the
reauthorization of the Medical Device
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User Fee Amendments for fiscal year (FY) 2023 through FY 2027 \1\
(MDUFA V).\2\ The long-term vision for TAP is to help spur more rapid
development and more rapid and widespread patient access to safe,
effective, high-quality medical devices of public health importance.
Over the course of MDUFA V, the voluntary TAP Pilot is intended to
demonstrate the feasibility and benefits of process improvements to
FDA's early interactions with participants and of FDA's facilitation of
interactions between participants and stakeholders that support the
vision for TAP.
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\1\ MDUFA V spans from FY 2023 through FY 2027. The fiscal year
runs from October 1 through September 30, so FY 2023 runs from
October 1, 2022, through September 30, 2023.
\2\ For more information on FDA's TAP Pilot, see the TAP Pilot
web page at: <a href="https://www.fda.gov/medical-devices/how-study-and-market-your-device/total-product-life-cycle-advisory-program-tap">https://www.fda.gov/medical-devices/how-study-and-market-your-device/total-product-life-cycle-advisory-program-tap</a>.
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A key goal of the TAP Pilot is to improve various aspects of
medical device development and to increase the predictability and
reduce the time from concept to commercialization, in part, by
facilitating robust engagement early in the process with FDA, industry,
and key stakeholders.
The MDUFA V commitment letter states that FDA will conduct an
assessment of the overall outcomes of the TAP Pilot that will include a
participant satisfaction survey and quantitative and qualitative
success metrics that include, but are not limited to: (1) the extent to
which FDA is successful at meeting the quantitative goals described in
V.J.3.b \3\ of the MDUFA V commitment letter; (2) participant
satisfaction with the timeliness, frequency, quality, and efficiency of
interactions with and written feedback from FDA; (3) participant
satisfaction with the timeliness, frequency, quality, and efficiency of
voluntary interactions with non-FDA stakeholders facilitated by FDA (if
utilized); and (4) an overall assessment of the outcomes of the TAP
Pilot and opportunities for improvement.
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\3\ See section V.J.3.b of the MDUFA V commitment letter, MDUFA
Performance Goals and Procedures, Fiscal Years 2023 Through 2027,
available at: <a href="https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v">https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v</a>.
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In the Federal Register of March 21, 2024 (89 FR 20209), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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TAP Pilot Manufacturers Requesting to 225 1 225 0.25 (15 minutes)......................... 56
Participate.
Satisfaction Survey Participants............ 200 2 400 0.33 (20 minutes)......................... 132
TAP Pilot Participant Interviews............ 60 1 60 1......................................... 60
Passive Observations........................ 100 1 100 0......................................... 0
Pulse Survey Participants................... 105 1 105 0.03 (2 minutes).......................... 3
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Total \2\............................... .............. .............. .............. .......................................... 251
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Totals may not sum due to rounding.
Upon further review of the proposed information collection, we
updated the burden table to include a distinct line item for Passive
Observations for the TAP Pilot and to adjust the estimated number of
respondents expected for the Pulse Survey.
FDA estimates that approximately 225 manufacturers will submit a
request to participate in the TAP Pilot. Any sponsors who participate
in the TAP Pilot will be invited to take the survey. As such, there is
no sampling plan; the whole population of TAP Pilot participants will
be invited to participate. TAP Pilot participants consist of both
applicants and external stakeholders, such as professional societies,
payers, and patient advocacy groups.
We estimate that approximately 200 manufacturers will qualify and
therefore will be surveyed 2 times per year. In addition, around 60
manufacturers will be interviewed after completing an application to
participate. Manufacturers will also be surveyed 1 additional time per
year just to gage satisfaction over time with their experience
interacting with FDA. This equates to 251 burden hours per year
(rounded).
Application To Participate in TAP Pilot Program
FDA is developing a software portal mechanism through which
sponsors interested in device enrollment into the TAP Pilot program can
submit an application to join.
TAP Pilot Participant Satisfaction Survey
This assessment includes a participant survey utilizing
quantitative and qualitative success metrics. Data collected under this
survey will help FDA evaluate the TAP Pilot. Specifically, FDA seeks to
evaluate:
<bullet> participant satisfaction with the timeliness, frequency,
quality, and efficiency of interactions with and written feedback from
FDA;
<bullet> participant satisfaction with the timeliness, frequency,
quality, and efficiency of voluntary interactions with non-FDA
stakeholders facilitated by FDA (if utilized); and
<bullet> other outcomes of the TAP Pilot and opportunities for
improvement.
Any sponsors who participate in the TAP Pilot will be invited to
take the survey.
TAP Pilot Participant Interviews
In support of qualitative success metrics and sentiments around the
operation of the TAP Pilot, FDA seeks to conduct interviews with TAP
Pilot participants, including applicants and external stakeholders,
such as professional societies, payers, and patient advocacy groups.
The purpose of these interviews is to better understand individual
participants' experiences in the TAP Pilot. Data collected in these
interviews will help FDA understand the impact of the TAP Pilot and
potential opportunities for improvement in TAP processes and
operations. All
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TAP Pilot participants will make up the potential group of respondents
for the interviews, however, FDA intends to interview only a stratified
sample of all potential participants.
TAP Pilot Passive Observations
FDA would like to obtain interaction-related data by passively
observing meetings between FDA staff, applicants, and external
stakeholders. Passive observations impose no burden on respondents, as
they are solely conducted by FDA staff without requiring any input or
action from the respondents. We plan to use a structured observational
meeting form or checklist to standardize data collection. The purpose
of these observations is to evaluate meeting attendance, level of
collaboration, and the degree to which key processes and activities are
being adhered. Data collected may also support identification of
improvement opportunities to the TAP Pilot. We do not intend to
actively collect information from meeting participants directly (e.g.,
by asking questions or collecting documents).
TAP Pilot Participant Pulse Surveys
FDA seeks to obtain quantitative satisfaction ratings and free-
response data from TAP Pilot participants using a 2-question survey
deployed closely following TAP Pilot interactions (e.g.,
teleconferences, written feedback). The same pulse survey will be
administered after each interaction. The purpose of these surveys is to
measure level of satisfaction with the interaction and allow for an
opportunity for participants to provide feedback regarding the
interaction.
Dated: June 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13961 Filed 6-25-24; 8:45 am]
BILLING CODE 4164-01-P
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