Document ID: FDA-2012-D-0530-0029
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Pre-Submission
Program for Medical Devices
Posted Date: 2016-10-20T04:00Z

[Federal Register Volume 81, Number 203 (Thursday, October 20, 2016)]
[Notices]
[Pages 72593-72594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25359]

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

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; Pre-Submission 
Program for Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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 
November 21, 2016.

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 in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 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.

Pre-Submission Program for Medical Devices--OMB Control Number 0910-
0756--Extension

    The guidance entitled ``Requests for Feedback on Medical Device 
Submissions: The Pre-Submission Program and Meetings with Food and Drug 
Administration Staff'' describes the Pre-Submission program for medical 
devices reviewed in the Center for Devices and Radiological Health 
(CDRH) and the Center for Biologics Evaluation and Research (CBER). The 
guidance provides recommendations regarding the information that should 
be submitted in a Pre-Submission package and procedures that should be 
followed for meetings between CDRH and CBER staff and industry 
representatives or application sponsors. In addition to Pre-
Submissions, the guidance addresses other feedback mechanisms including 
Informational Meetings, Study Risk Determinations, Formal Early 
Collaboration Meetings, and Submission Issue Meetings and the 
procedures to request feedback using these mechanisms.
    A Pre-Submission is defined as a formal written request from an 
applicant for feedback from FDA to be provided in the form of a formal 
written response or, if the manufacturer chooses, a meeting or 
teleconference in which the feedback is documented in meeting minutes. 
A Pre-Submission is appropriate when FDA's feedback on specific 
questions is necessary to guide product development and/or application 
preparation. The proposed collections of information are necessary to 
allow the Agency to receive Pre-Submission packages in order to 
implement this voluntary submission program.
    For clarity, we are requesting that the title of the information 
collection request, OMB control number 0910-0756, be changed to ``Pre-
Submission Program for Medical Devices.''
    In the Federal Register of July 28, 2016 (81 FR 49678), 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:

[[Page 72594]]

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
           FDA center                Number of     frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
----------------------------------------------------------------------------------------------------------------
CDRH............................           2,465               1           2,465             137         337,705
CBER............................              79               1              79             137          10,823
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         348,528
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Respondents are medical device manufacturers subject to FDA's laws 
and regulations. FDA's annual estimate of 2,544 submissions is based on 
experienced trends over the past several years. FDA's administrative 
and technical staffs, who are familiar with the requirements for 
current Pre-Submissions, estimate that an average of 137 hours is 
required to prepare a Pre-Submission.

    Dated: October 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25359 Filed 10-19-16; 8:45 am]
 BILLING CODE 4164-01-P