[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Notices]
[Pages 78693-78694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 Sanford, 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-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'' (https://www.fda.gov/media/114034/download) 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 
(https://www.fda.gov/about-fda/cdrh-innovation/payor-communication-task-force). 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'' (https://www.fda.gov/media/131064/download), FDA has 
developed an ``electronic Submission Template and Resource'' (eSTAR) 
for Q-submissions to facilitate the preparation of submissions in 
electronic format (https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program). 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