Notice2024-05970
Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Total Product Life Cycle Advisory Program Pilot
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Published
March 21, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 56 (Thursday, March 21, 2024)</title>
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[Federal Register Volume 89, Number 56 (Thursday, March 21, 2024)]
[Notices]
[Pages 20209-20211]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#beeeecffedcadfd8d8fed8dadf90d6d6cd90d9d1c8"><span class="__cf_email__" data-cfemail="9ececcdfcdeafff8f8def8faffb0f6f6edb0f9f1e8">[email protected]</span></a>.
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
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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: <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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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:
<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. 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
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