Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Total Product Life Cycle Advisory Program Pilot, 53429-53431 [2024-13961]
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Federal Register / Vol. 89, No. 123 / Wednesday, June 26, 2024 / Notices
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-201509-18/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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
ddrumheller on DSK120RN23PROD with NOTICES1
Steven Fleischer, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0809,
Steven.Fleischer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of November
30, 2022 (87 FR 73560), FDA announced
the availability of draft GFI #276,
entitled ‘‘Effectiveness of
Anthelmintics: Specific
Recommendations for Products
Proposed for the Prevention of
Heartworm Disease in Dogs,’’ giving
interested persons until January 30,
2023, to comment on the draft guidance.
In response to a request for an
extension, the comment period was
extended to May 1, 2023 (88 FR 3744).
FDA received eight comment
submissions on the draft guidance, some
with numerous discrete comments
within the submission; all comments
were considered as the guidance was
finalized. We clarified our discussion
and recommendations related to
geographic locations, laboratory dose
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18:15 Jun 25, 2024
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confirmation studies, and field
effectiveness studies. We also clarified
that the recommendations in this
guidance are based on current
technology and veterinary
epidemiology, including available
diagnostic methodologies. Individuals
are encouraged to discuss deviations
from these recommendations with FDA,
especially as advances in veterinary
medicine related to heartworm disease,
including disease epidemiology, isolate
characterization, or diagnostic testing
are identified.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Effectiveness of
Anthelmintics: Specific
Recommendations for Products
Proposed for the Prevention of
Heartworm Disease in Dogs.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR part 511 have
been approved under OMB control
number 0910–0117; the collections of
information in 21 CFR part 514 have
been approved under OMB control
number 0910–0032.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: June 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13922 Filed 6–25–24; 8:45 am]
BILLING CODE 4164–01–P
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53429
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.
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.
SUMMARY:
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.
ADDRESSES:
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, PRAStaff@fda.hhs.gov.
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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53430
Federal Register / Vol. 89, No. 123 / Wednesday, June 26, 2024 / Notices
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.
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.
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
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
TAP Pilot Manufacturers Requesting to Participate
Satisfaction Survey Participants ..............................
TAP Pilot Participant Interviews ..............................
Passive Observations ..............................................
Pulse Survey Participants ........................................
225
200
60
100
105
1
2
1
1
1
225
400
60
100
105
0.25 (15 minutes) ......
0.33 (20 minutes) ......
1 ................................
0 ................................
0.03 (2 minutes) ........
56
132
60
0
3
Total 2 ................................................................
........................
........................
........................
....................................
251
1 There
ddrumheller on DSK120RN23PROD with NOTICES1
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).
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-yourdevice/total-product-life-cycle-advisory-programtap.
3 See section V.J.3.b of the MDUFA V
commitment letter, MDUFA Performance Goals and
Procedures, Fiscal Years 2023 Through 2027,
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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;
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• 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
available at: https://www.fda.gov/industry/medicaldevice-user-fee-amendments-mdufa/medicaldevice-user-fee-amendments-2023-mdufa-v.
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Federal Register / Vol. 89, No. 123 / Wednesday, June 26, 2024 / Notices
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 interactionrelated 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
technology to minimize the information
collection burden.
Title of the Collection: Protection of
Human Subjects: Assurance
Identification/IRB Certification/
Declaration of Exemption Form.
Type of Collection: Renewal, 3-year
extension with non-substantive changes
for the Protection of Human Subjects:
Assurance Identification/IRB
Certification/Declaration of Exemption
Form OMB No. 0990–0263 Office of the
Assistant Secretary for Health, Office for
Human Research Protections
Abstract: The Office of the Assistant
Secretary for Health, Office for Human
Research Protections is requesting is
requesting a three-year extension with
non-substantive changes of the
Protection of Human Subjects:
Assurance Identification/IRB
Certification/Declaration of Exemption
Form, OMB No. 0990–0263.
The information collected on the form
is to provide a simplified method for
institutions engaged in research
conducted or supported by the
Department of Health and Human
Services (HHS) to satisfy the
requirements of HHS regulations for the
protection of human subjects at 45 CFR
46.103 for assurance identification and
institutional review board (IRB)
certification and declare exemption
status. Non-substantive changes include
adding instructions that, if additional
assurances apply, those details can be
indicated in the ‘‘Comments’’ section
and clarifying that the form element for
IRB expiration date does not apply to all
projects.
Likely Respondents: Institutions
engaged in research involving human
subjects where the research is supported
by HHS. Institutional use of the form is
also relied upon by other federal
departments and agencies that have
codified or follow the Federal Policy for
the Protection of Human Subjects
(Common Rule), which is codified for
HHS at 45 CFR part 46, subpart A.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0263]
Agency Information Collection
Request (ICR). 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
53431
In compliance with the
requirements of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before July 26, 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 0990–0263–30D
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
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
ESTIMATED ANNUALIZED BURDEN TABLE
Form name
Number of
respondents
Number of
responses per
respondent
Hours per
response
Response
burden
hours
Protection of Human Subjects: Assurance Identification/IRB Certification/
Declaration of Exemption .............................................................................
13,000
2
0.5
13,000
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26JNN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
-----------------------------------------------------------------------------------------------------------
Total \2\............................... .............. .............. .............. .......................................... 251
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
