[Federal Register Volume 91, Number 32 (Wednesday, February 18, 2026)]
[Notices]
[Pages 7495-7496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-03096]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1812]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Q-Submission and Early Payor Feedback Request Programs
and Medical Device Development Tools
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) 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 March 20, 2026.
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 OMB control number for
this information collection is 0910-0756. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Barrett, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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.
Q-Submission and Early Payor Feedback Request Programs and Medical
Device Development Tools
OMB Control Number 0910-0756--Revision
The guidance entitled ``Requests for Feedback and Meetings for
Medical Device Submissions: The Q-Submission Program'' (May 2025)
(available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program) provides an overview of the
mechanisms available to submitters through which they can request
feedback from or a meeting with FDA regarding certain potential or
planned medical device submissions reviewed by the Center for Devices
and Radiological Health (CDRH) and the Center for Biologics Evaluation
and Research (CBER). The guidance provides recommendations regarding
certain types of Q-Submissions, such as Pre-Submissions, Submission
Issue Requests, Study Risk Determinations, Informational Meetings, and
other Q-Submission Types and other uses of the Q-Submission Program.
Recent updates in May 2025 to the Q-Submission guidance moved the
instructions for information collection related to requests for
feedback regarding development of a Medical Device Development Tool
(MDDT), which were previously tracked as Informational Meeting Q-
Submissions. We are revising this information collection to add the FDA
guidance entitled ``Qualification of Medical Device Development Tools:
Guidance for Industry, Tool Developers, and Food and Drug
Administration Staff'' (July 2023) (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/qualification-medical-device-development-tools), which includes instructions for
submitting requests for feedback regarding MDDTs. The submission
instructions are otherwise unchanged, but the MDDT guidance is now the
collection instrument associated with the existing MDDT burden.
Early Payor Feedback Program
Prior to submitting a Pre-Submission, medical device sponsors may
request that one or more payor organizations join a Pre-Submission
meeting. Payors include public payors such as Centers for Medicare &
Medicaid Services, private health plans, health technology assessment
groups, and others who provide input into coverage, procurement, and
reimbursement decisions. To facilitate such opportunities to obtain
payor input, FDA provides information about our Early Payor Feedback
Program (EPFP) and a list of current payor participants on our website
(available at https://www.fda.gov/about-fda/cdrh-innovation/payor-communication-task-force#2). For payors to decide which devices to
provide feedback on, we have developed a voluntary form for
manufacturers to provide basic information regarding their device. This
form is shared with the payors from whom the manufacturer is requesting
feedback.
eSTAR for Q-Submissions
Under section 745A(b) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 379k-1(b)), amended by section 207 of the FDA
Reauthorization Act of 2017 (Pub. L. 115-52), and consistent with the
Medical Device User Fee Amendments 2017 (MDUFA IV) Commitment Letter
and the FDA guidance document entitled ``Providing Regulatory
Submissions for Medical Devices in Electronic Format--Submissions Under
Section 745A(b) of the Federal Food, Drug, and Cosmetic Act'' (July
2020) (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-medical-devices-electronic-format-submissions-under-section-745ab), FDA has
developed an ``electronic Submission Template and Resource'' (eSTAR)
for Q-submissions to facilitate the preparation of submissions in
electronic format (available at https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program). The use of eSTAR for
Q-Submissions is currently voluntary.
In the Federal Register of July 14, 2025 (90 FR 31225), 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:
[[Page 7496]]
Table 1--Estimated Annual Reporting Burden 1 2
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Number of Total
Activity Number of responses per annual Average burden per response Total
respondents respondent responses hours
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``Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program''
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Q-Submissions:
CDRH........................ 5,750 1 5,750 137........................ 787,750
CBER........................ 60 1 60 137........................ 8,220
Q-Submissions using eSTAR:
CDRH........................ 850 1 850 69......................... 58,650
CBER........................ 40 1 40 69......................... 2,760
eSTAR setup................. 1,480 1 1,480 0.08 (5 minutes)........... 118
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Early Payor Feedback Program (EPFP)
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Manufacturer request to 35 1 35 2.......................... 70
participate in EPFP.
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Medical Device Development Tools (MDDT)
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MDDT Submissions................ 50 1 50 137........................ 6,850
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Total........................... ............ .............. ......... ........................... 864,418
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\1\ Numbers are rounded.
\2\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on our experience with the Q-Submission and Early Payor
Feedback Request Programs and Medical Device Development Tools, our
estimated burden for the information collection reflects an overall
increase of 451,180 hours and 4,535 responses annually. We attribute
this adjustment to an increase in the number of respondents according
to FDA data. As discussed above, recent updates to the Q-Submission
guidance moved the instructions for information collection related to
requests for feedback regarding development of MDDTs to the MDDT
guidance. MDDT proposal and qualification packages were previously
tracked as Informational Meeting Q-Submissions. The MDDT submission
instructions and previously approved burden estimate are otherwise
unchanged, but the MDDT guidance is now the collection instrument
associated with the existing MDDT burden. Accordingly, we have moved
the burden for MDDT submissions to a distinct line item in the burden
table to reflect the updated collection instrument. There is no new
collection of information occurring in this revision. However,
submissions related to MDDTs (Medical Device Development Tools), which
were previously tracked as ``Informational Meetings'' Q-Submissions,
are now tracked separately.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03096 Filed 2-17-26; 8:45 am]
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