Document ID: FDA-2011-D-0689-0027
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; De Novo
Classification Process (Evaluation of Automatic Class III Designation)
Posted Date: 2017-08-02T04:00Z

[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)]
[Notices]
[Pages 35971-35973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16230]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0689]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; De Novo 
Classification Process (Evaluation of Automatic Class III Designation)

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 
September 1, 2017.

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

[[Page 35972]]

comments should be identified with the OMB control number 0910-NEW and 
title ``De Novo Classification Process (Evaluation of Automatic Class 
III Designation).'' Also include the FDA docket number found 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, 10A63, 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.

De Novo Classification Process (Evaluation of Automatic Class III 
Designation)

OMB Control Number 0910--NEW

    The draft guidance entitled ``De Novo Classification Process 
(Evaluation of Automatic Class III Designation)'' provides guidance on 
the process for the submission and review of a De Novo classification 
request (hereafter a ``De Novo request'') under section 513(f)(2) of 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
360c(f)(2)), also known as the De Novo classification process. This 
process provides a pathway to class I or class II classification for 
medical devices for which general controls or general and special 
controls provide a reasonable assurance of safety and effectiveness, 
but for which there is no legally marketed predicate device.
    The proposed collection of information is necessary to satisfy the 
previously mentioned statutory requirements for implementing this 
voluntary submission program.
    In the Federal Register of August 14, 2014 (79 FR 47651), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Seven organizations commented on the draft 
guidance document. None of the comments were related to the information 
collection.
    Upon further review of the information collection, it has come to 
our attention that the 60-day notice did not include an estimated hour 
burden for requests for withdrawal or estimated operating and 
maintenance costs for eCopy,\1\ printing, and shipping of De Novo 
submissions. To correct this oversight, we have included these 
estimates here.
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    \1\ See the eCopy guidance, ``eCopy Program for Medical Device 
Submissions; Guidance for Industry and Food and Drug Administration 
Staff,'' at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm313794.pdf.
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    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                                                                               Total
                                                             Number of       Number of     Total annual   Average burden                   operating and
                        Activity                            respondents    responses per     responses     per response     Total hours     maintenance
                                                                            respondent                                                         costs
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                                               De Novo request under section 513(f)(2)(i) of the FD&C Act
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CDRH....................................................              25               1              25             100           2,500  ..............
CBER....................................................               1               1               1             100             100  ..............
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                                               De Novo request under section 513(f)(2)(ii) of the FD&C Act
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CDRH....................................................              25               1              25             180           4,500  ..............
CBER....................................................               1               1               1             180             180  ..............
                                                         -----------------------------------------------------------------------------------------------
    Total De Novo requests..............................  ..............  ..............              52  ..............           7,280          $6,308
Request for withdrawal..................................               5               1               5              10              50               5
                                                         -----------------------------------------------------------------------------------------------
        Total...........................................  ..............  ..............  ..............  ..............           7,330           6,313
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\1\ There are no capital costs associated with this collection of information.

    FDA estimates from past experience with the De Novo classification 
program that the complete process involved with the program under 
section 513(f)(2)(i) of the FD&C Act takes approximately 100 hours, and 
the complete process under section 513(f)(2)(ii) of the FD&C Act takes 
approximately 180 hours. This includes the time for any supplements or 
amendments to the original submission. We estimate that requests for 
withdrawal take approximately 10 minutes. The average burdens per 
response are based upon estimates by FDA administrative and technical 
staff who are familiar with the requirements for submission of a De 
Novo request (and related materials), have consulted and advised 
manufacturers on the submissions, and have reviewed the documentation 
submitted.
    Respondents to the information collection are medical device 
manufacturers seeking to market medical device products that have been 
classified into class III under section 513(f)(2) of the FD&C Act. It 
is expected that the number of De Novo requests will reach a steady 
rate of approximately 52 submissions per year. We expect that we will 
receive approximately five requests for withdrawal per year.
    The operating and maintenance cost for a De Novo submission 
includes the cost of printing, shipping, and the eCopy. We estimate the 
cost burden for a De Novo submission to be $121.30 ($90 printing + $30 
shipping + $1.30 eCopy). The annual cost estimate for De Novo 
submissions is $6,308 (rounded) (52 submissions x $121.30). We estimate 
the cost for a request for withdrawal to be $1 (rounded) ($0.09 
printing 1 page + $0.03 shipping + $1.30 eCopy). The annual cost 
estimate for requests for withdrawal is $5.
    The draft guidance also refers to currently approved information 
collections found in FDA regulations. The collections of information in 
21 CFR part 807, subpart E, are approved under OMB control number 0910-
0120.

[[Page 35973]]

    Dated July 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16230 Filed 8-1-17; 8:45 am]
BILLING CODE 4164-01-P