Agency Information Collection Activities; Proposed Collection; Comment Request; Q-Submission Program for Medical Devices

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Published

August 9, 2022

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or Agency) 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collections associated with the Q-Submission Program for medical devices.

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<title>Federal Register, Volume 87 Issue 152 (Tuesday, August 9, 2022)</title>
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[Federal Register Volume 87, Number 152 (Tuesday, August 9, 2022)]
[Notices]
[Pages 48488-48490]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-17058]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0530]

Agency Information Collection Activities; Proposed Collection;
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 or Agency) 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, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collections associated with the
Q-Submission Program for medical devices.

DATES: Either electronic or written comments on the collection of
information must be submitted by October 11, 2022.

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 October 11, 2022. 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-2012-D-0530 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Q-Submission Program for Medical
Devices.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket

[[Page 48489]]

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#5e0e0c1f0d2a3f38381e383a3f7036362d70393128"><span class="__cf_email__" data-cfemail="c292908391b6a3a4a482a4a6a3ecaaaab1eca5adb4">[email&#160;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, including
each proposed extension of an existing 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 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.

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#2">https://www.fda.gov/about-fda/cdrh-innovation/payor-communication-task-force#2</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 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

[[Page 48490]]

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.
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: August 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17058 Filed 8-8-22; 8:45 am]
BILLING CODE 4164-01-P

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