[Federal Register Volume 89, Number 123 (Wednesday, June 26, 2024)]
[Notices]
[Pages 53429-53431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://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. 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, 
[email protected].

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

[[Page 53430]]

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: https://www.fda.gov/medical-devices/how-study-and-market-your-device/total-product-life-cycle-advisory-program-tap.
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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: https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v.
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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:
     participant satisfaction with the timeliness, frequency, 
quality, and efficiency of interactions with and written feedback from 
FDA;
     participant satisfaction with the timeliness, frequency, 
quality, and efficiency of voluntary interactions with non-FDA 
stakeholders facilitated by FDA (if utilized); and
     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

[[Page 53431]]

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