[Federal Register Volume 89, Number 56 (Thursday, March 21, 2024)]
[Notices]
[Pages 20209-20211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05970]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-1201]


Agency Information Collection Activities; Proposed Collection; 
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, the Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collections associated with 
Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot.

DATES: Either electronic or written comments on the collection of 
information must be submitted by May 20, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 20, 2024. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2024-N-1201 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Voluntary Total Product Life 
Cycle Advisory Program Pilot.'' Received comments, those filed in a 
timely manner (see ADDRESSES), will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information

[[Page 20210]]

is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot

OMB Control Number 0910-NEW

    This information collection supports the TPLC Advisory Program 
(TAP) Pilot. FDA's Center for Devices and Radiological Health (CDRH) 
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 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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    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     Total hours
                                  respondents     respondent       responses      per response
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TAP Pilot Manufacturers                    225               1             225  0.25 (15                      56
 Requesting to Participate.                                                      minutes).
Satisfaction Survey                        200               2             400  0.33 (20                     132
 Participants.                                                                   minutes).
TAP Pilot Participant                       60               1              60  1...............              60
 Interviews and Passive
 Observations.
Pulse Survey Participants.....             200               1             200  0.03 (2 minutes)               6
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    Total \2\.................  ..............  ..............  ..............  ................             254
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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.

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 
request enrollment. FDA estimates that approximately 225 manufacturers 
will submit a request to participate in the TAP Pilot.

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. We estimate that approximately 200 manufacturers will 
qualify and therefore will be surveyed 2 times per year.

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

[[Page 20211]]

in TAP processes and operations. All 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. In addition, around 60 manufacturers will be interviewed 
after completing an application to participate.

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. Manufacturers will also be surveyed one additional time 
per year just to gauge satisfaction over time with their experience 
interacting with FDA. This equates to 254 burden hours per year 
(rounded).
    To supplement the data collection methods listed above, FDA would 
like to obtain interaction-related data by passively observing meetings 
among FDA staff, applicants, and external stakeholders. We plan to use 
an internal 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 this information from 
meeting participants directly (e.g., by asking questions or collecting 
documents).

    Dated: March 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05970 Filed 3-20-24; 8:45 am]
BILLING CODE 4164-01-P