[Federal Register Volume 84, Number 221 (Friday, November 15, 2019)]
[Notices]
[Pages 62540-62541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24803]


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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: Fax written comments on the collection of information by 
December 16, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0756. 
Also include the FDA docket number found

[[Page 62541]]

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, 
PRAStaff@fda.hhs.gov.

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 Program for Medical Devices

OMB Control Number 0910-0756--Extension

    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-Submissions Types and other uses of the Q-Submission Program.
    For clarity and consistency with the guidance that describes the 
program, we are requesting that the title of the information collection 
request, OMB control number 0910-0756, be changed to ``Q-Submission 
Program for Medical Devices.''
    In the Federal Register of August 13, 2019 (84 FR 40069), 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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                                                      Annual
           FDA Center                Number of    frequency  per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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CDRH............................           3,502               1           3,502             137         479,774
CBER............................              91               1              91             137          12,467
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................  ..............  ..............  ..............  ..............         492,241
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\1\ There are no capital costs or operating and maintenance cost associated with this of information.

    Respondents are medical device manufacturers subject to FDA's laws 
and regulations. FDA's annual estimate of 3,593 submissions is based on 
experienced recent trends. FDA's administrative and technical staffs, 
who are familiar with Q-Submissions, estimate that an average of 137 
hours is required to prepare a Q-Submission.
    Our estimated burden for the information collection reflects an 
overall increase of 143,713 hours. We attribute this adjustment to an 
increase in the number of submissions we received based on FY18 data.

    Dated: November 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24803 Filed 11-14-19; 8:45 am]
 BILLING CODE 4164-01-P


