Notice2022-27815
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Q-Submission Program for Medical Devices
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 22, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 245 (Thursday, December 22, 2022)</title>
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[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Notices]
[Pages 78693-78694]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27815]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0530]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Q-Submission Program
for Medical Devices
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 January 23, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#1a4a485b496e7b7c7c5a7c7e7b34727269347d756c"><span class="__cf_email__" data-cfemail="91c1c3d0c2e5f0f7f7d1f7f5f0bff9f9e2bff6fee7">[email protected]</span></a>.
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-Submissions Program for Medical Devices
OMB Control Number 0910-0756--Revision
The guidance entitled ``Requests for Feedback and Meetings for
Medical Device Submissions: The Q-Submission Program'' (<a href="https://www.fda.gov/media/114034/download">https://www.fda.gov/media/114034/download</a>) 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.
Respondents are medical device manufacturers subject to FDA's laws
and regulations. FDA's annual estimate of 3,700 submissions is based on
recent trends. FDA's administrative and technical staffs, who are
familiar with Q-Submissions, estimate that an average of 137 hours is
needed to prepare a Q-Submission.
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
(<a href="https://www.fda.gov/about-fda/cdrh-innovation/payor-communication-task-force">https://www.fda.gov/about-fda/cdrh-innovation/payor-communication-task-force</a>). 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. We expect
preparation and submission of the form to take no more than 2 hours.
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
[[Page 78694]]
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'' (<a href="https://www.fda.gov/media/131064/download">https://www.fda.gov/media/131064/download</a>), FDA has
developed an ``electronic Submission Template and Resource'' (eSTAR)
for Q-submissions to facilitate the preparation of submissions in
electronic format (<a href="https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program">https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program</a>). The use of eSTAR for Q-
Submissions is currently voluntary. We assume approximately 40 percent
of Q-Submissions will use eSTAR and that preparation using eSTAR will
take approximately half the time of preparing a submission without
using eSTAR.
We estimate a setup burden of 5 minutes for new eSTAR users.
Respondents will only need to set up eSTAR the first time they use it.
We note that because some respondents may have already undergone eSTAR
set up for other types of submission, e.g., premarket notification,
fewer respondents may need to undergo eSTAR setup than estimated.
In the Federal Register of August 9, 2022 (87 FR 48488), 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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``Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program''
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Q-Submissions:
CDRH......................................... 2,160 1 2,160 137.................................. 295,920
CBER......................................... 60 1 60 137.................................. 8,220
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Q-Submissions using eSTAR (21 CFR part 814, subparts A through E; section 745A(b) of the FD&C Act)
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CDRH......................................... 1,440 1 1,440 69................................... 99,360
CBER......................................... 40 1 40 69................................... 2,760
eSTAR setup.................................. 1,480 1 1,480 0.08 (5 minutes)..................... 118
Manufacturer request to participate in EPFP.. 30 1 30 2.................................... 60
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Total.................................... .............. .............. .............. ..................................... 406,438
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Including the EPFP form represents a revision to this information
collection request. Our estimated burden for the information collection
reflects the availability of eSTAR to assist electronic preparation of
Q-submissions and addition of the EPFP form, resulting in an overall
decrease of 85,803 hours.
Dated: December 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27815 Filed 12-21-22; 8:45 am]
BILLING CODE 4164-01-P
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