
[Federal Register Volume 78, Number 211 (Thursday, October 31, 2013)]
[Notices]
[Pages 65332-65334]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25964]


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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 
December 2, 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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed

[[Page 65333]]

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. 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. 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, Evaluation of 
Automatic Class III Designations (de novo petitions), 510(k) 
submissions, Clinical Laboratory Improvement Amendments categorization 
requests, 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 the Medical Device User Fee Amendments 
of 2012 (MDUFA III) (Pub. L. 112-144), 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 industry, this final 
guidance: (1) Describes the Pre-Submission program (formerly the IDE 
program) for medical devices reviewed in CDRH and CBER; (2) describes 
other feedback mechanisms including Informational Meetings, Study Risk 
Determinations, Formal Early Collaboration Meetings, and Submission 
Issue Meetings; (3) 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 or other request for feedback; and (4) 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.

[[Page 65334]]



                                 Table 2--Estimated Annual Reporting Burden \1\
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                                                                 Total burden
                    Number of respondents                           hours         Hourly wage       Total cost
                                                                  annualized          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: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25964 Filed 10-30-13; 8:45 am]
BILLING CODE 4160-01-P


