[Federal Register Volume 77, Number 238 (Tuesday, December 11, 2012)]
[Notices]
[Pages 73662-73663]
[FR Doc No: 2012-29788]

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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; Guidance on Medical
Devices: The Pre-Submission Program and Meetings With FDA Staff

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 January
10, 2013.

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:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-NEW and
Title: ``Medical Devices: The Pre-Submission Program and Meetings with
FDA Staff.'' Also, include the FDA docket number found in brackets in
the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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.

Guidance on Medical Devices: Pre-Submission Program and Meetings with
FDA Staff--(OMB Control Number 0910-NEW)

    This guidance 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. When approved by OMB, this
guidance document will supersede ``Pre-IDE Program: Issues and
Answers--Blue Book Memo D99-1'' dated March 25, 1999.
    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.
    Over time, the FDA pre-investigational device exemption (pre-IDE)
program evolved to include feedback on premarket approval (PMA)
applications, humanitarian device exemption applications, and 510(k)
submissions, as well as to address questions related to whether a
clinical study requires submission of an IDE. During discussions with
representatives of the medical device industry in the development of
the Agency's recommendations for Medical Device User Fee Amendments
2012 (MDUFA III), both the industry and the Agency agreed that the Pre-
Submission (formerly pre-IDE) process provided important additional
transparency to the IDE and premarket review processes. In response,
the Secretary's 2012 Commitment Letter to Congress (MDUFA III
Commitment Letter) included FDA's commitment to institute a structured
process for managing Pre-Submissions.
    To fulfill the Secretary's commitment to the to industry, this
final guidance: (1) Describes the Pre-Submission program (formerly the
IDE program) for medical devices reviewed in CDRH and CBER; (2) assists
device manufacturers and their representatives who seek meetings with
the FDA by providing guidance and recommendations regarding information
that should be included in a Pre-Submission Package; and (3) provides
guidance as to the

procedures that CDRH and CBER intend to follow when industry
representatives or application sponsors request a meeting with review
staff.
    In the Federal Register of July 13, 2012 (77 FR 41413), FDA
published a notice of availability combined with a 60-day notice
requesting public comment on the proposed collection of information.
FDA received no PRA-related comments.
    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............................           2,465               1           2,465             137         337,705
CBER............................              79               1              79             137          10,823
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         348,528
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\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 estimates that it will receive approximately 2,544
pre-submission packages annually. The Agency reached this estimate by
reviewing the number of submissions received by the Agency under the
Pre-IDE program over the past 10 years. Based on FDA's experience with
the Pre-IDE program, FDA expects the Pre-Submission program to continue
to be utilized as a viable program in the future and expects that the
number of pre-submission packages will increase over its current rate
and reach a steady state of approximately 2,544 submissions per year.
    FDA estimates from past experience with the Pre-IDE program that
the complete process involved with the program takes approximately 137
hours. This average is based upon estimates by FDA administrative and
technical staff that is familiar with the requirements for submission
of a Pre-Submission and related materials, have consulted and advised
manufacturers on these requirements, and have reviewed the
documentation submitted.
    Therefore, the total reporting burden hours is estimated to be
348,528 hours.

             Table 2--Estimated Annual Reporting Burden \1\
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    Number of         Total burden                         Total cost
   respondents      hours annualized  Hourly wage rate     annualized
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          2,544                137               $150       $52,279,200
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\1\ There are no capital costs or operating and maintenance costs
  associated with this collection of information.

    The average to industry per hour for this type of work is $150,
resulting in a cost of $20,550 per respondent. The estimated submission
cost of $20,550 multiplied by 2,544 submissions per year equals
$52,279,200, which is the aggregated industry reporting cost
annualized.
    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. However, we recognize there is a variance in
the preparation submission because of the vast and varying complexities
of medical devices.

    Dated: December 3, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29788 Filed 12-10-12; 8:45 am]
BILLING CODE 4160-01-P