[Federal Register Volume 87, Number 152 (Tuesday, August 9, 2022)]
[Notices]
[Pages 48488-48490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17058]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/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.

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: 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'' (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#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. 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'' (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

[[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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                   Activity                       Number of     responses per   Total annual       Average  burden per  response          Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
                             ``Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program''
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q-Submissions:
    CDRH.....................................           2,160               1           2,160  137..................................             295,920
    CBER.....................................              60               1              60  137..................................               8,220
--------------------------------------------------------------------------------------------------------------------------------------------------------
                           Q-Submissions Using eSTAR (21 CFR Part 814, Subparts A Through E; Section 745A(b) of the FD&C Act)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                              ----------------------------------------------------------------------------------------------------------
        Total................................  ..............  ..............  ..............  .....................................             406,438
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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


