[Federal Register Volume 84, Number 127 (Tuesday, July 2, 2019)]
[Notices]
[Pages 31600-31602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14066]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6069]


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 or Agency) 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 August 
1, 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 0910-0844. 
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, 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.

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

OMB Control Number 0910-0844--Revision

    The draft guidance entitled ``Acceptance Review for De Novo 
Classification Requests'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-classification-requests) explains the procedures and criteria FDA intends to use in 
assessing whether a request for an evaluation of automatic class III 
designation (De Novo classification request or De Novo request) meets a 
minimum threshold of acceptability and should be accepted for 
substantive review. The draft guidance discusses De Novo acceptance 
review policies and procedures, ``Refuse to Accept'' principles, and 
the elements of the De Novo Acceptance Checklist and the Recommended 
Content Checklist and was issued to be responsive to an explicit 
deliverable identified in the Medical Device User Fee Amendments of 
2017.
    To aid in the acceptance review, the guidance recommends that 
requesters complete and submit with their De Novo request an Acceptance 
Checklist that identifies the location of supporting information for 
each acceptance element and a Recommended Content Checklist that 
identifies the location of supporting information for each recommended 
content element. Therefore, we request revision of OMB control number 
0910-0844, ``De Novo Classification Process (Evaluation of Automatic 
Class III Designation)'' to include the Acceptance Checklist and the 
Recommended Content Checklist in the hourly burden estimate for De Novo 
requests.
    Respondents to the information collection are medical device 
manufacturers seeking to market medical device products through 
submission of a De Novo classification request under section 513(f)(2) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(2)).
    In the Federal Register of October 30, 2017 (82 FR 50135), FDA 
published a 60-day notice requesting public comment on the draft 
guidance and the proposed collection of information. We received 
various comments on the draft guidance. We describe and respond to the 
comments related to the proposed information collection in the 
following paragraphs. We have numbered each comment to help distinguish 
between different comments. We have grouped similar comments together 
under the same number, and, in some cases, we have separated different 
issues discussed in the same set of comments and designated them as 
distinct comments for purposes of our responses. The number assigned to 
each comment or comment topic is purely for organizational purposes and 
does not signify the comment's value or importance or the order in 
which comments were received.
    (Comment 1) One comment proposed that, in section VII.B of the 
draft guidance (``Prior Submission(s) Relevant to the De Novo Request 
Under Review''), FDA revise the phrase ``For certain De Novo requests, 
the requester may have previously provided other submissions for the 
same device for which FDA provided feedback related to the data or 
information needed to support De Novo classification (e.g., a pre-
submission request, investigational device exemption, prior Not 
Substantially Equivalent (NSE) determination, or prior 510(k) or De 
Novo that was deleted or withdrawn)'' to read, ``For certain De Novo 
requests, the requester may have previously provided other submissions, 
or there may be related FDA correspondence or other relevant 
information for the same device, for which FDA provided feedback 
related to the data or information needed to support De Novo 
classification . . .'' The commenter noted that there may be informal 
correspondence that is pertinent to the De Novo and this should be 
explicitly requested in the ``Recommended Content Checklist'' in 
Appendix B.
    (Response 1) FDA does not agree with the proposed revision. This 
element was intended to specifically focus on pertinent premarket 
submissions and formal communications that have undergone supervisory 
review.
    (Comment 2) One comment suggested that elements identified as ``N/
A'' should require an accompanying rationale because an inadvertent 
selection of a N/A answer may result in a ``Refuse to Accept'' (RTA) 
decision.
    (Response 2) We do not agree with this comment. Selection of ``N/
A'' for any element would not lead to an RTA decision. As explained in 
section VI.C of the guidance, ``. . . the item should receive an answer 
of ``yes'' or ``N/A'' for the De Novo request to be accepted for 
substantive review.''
    (Comment 3) Two commenters suggested that the preliminary questions 
in Appendix A (``Acceptance Checklist

[[Page 31601]]

for De Novo Classification Requests'') of the guidance should be 
removed and included in a document to be used by FDA reviewers or 
should clarify that these are to be completed by FDA personnel only. 
FDA recommends that requesters complete the checklists in Appendices A 
and B (``Recommended Content Checklist for De Novo Classification 
Requests''); however, the preliminary questions are intended for FDA 
reviewers.
    (Response 3) We do not agree with these commenters. The 
instructions for the Preliminary Questions within the checklist in 
Appendix A clearly state that ``Boxes checked in this section represent 
FDAs preliminary assessment of these questions at the time of 
administrative review.''
    (Comment 4) Two commenters proposed that the Organizational 
Elements in Appendix A be removed or included in Appendix B instead. 
The commenters noted that these organizational elements should not 
result in an RTA designation and, as such, should not be present in 
Appendix A.
    (Response 4) We decline to make this change. These are important 
administrative elements that will allow the FDA reviewer to determine 
if the submission is sufficiently organized in order to perform the 
subsequent RTA review.
    (Comment 5) Two commenters proposed that, in Appendix A of the 
draft guidance, under the section ``Elements of a Complete De Novo 
Request,'' we remove the second and third paragraphs from Question 1a, 
or move them to Appendix B. Question 1a requests ``[a] description of 
the technology (features, materials, and principles of operation) for 
achieving the intended effect.'' The commenters assert that the second 
and third paragraphs begin to assess ``the sufficiency'' of the device 
description by necessitating detailed device information for acceptance 
of the De Novo request. In addition, the commenter believes the 
language in the second paragraph (``Where necessary to describe the 
device, . . .'') is subjective and would necessitate a substantive 
review of the device description to determine adequacy.
    (Response 5) We do not agree with the commenters' description. 
Because of the wide variety of device types reviewed through the De 
Novo Program, the reviewer needs flexibility to determine if 
engineering or representative drawings are necessary for a complete 
device description. This element is only requesting the inclusion of 
such information; it is not asking the reviewer to determine the 
adequacy of the information.
    (Comment 6) One comment proposed that, in Appendix A of the draft 
guidance, under section C of ``Elements of a Complete De Novo 
Request,'' FDA remove the phrase ``detailed information and'' in the 
prefaces to questions 3 through 7. The commenter believes that this 
request for ``detailed information'' exceeds the intention of the RTA 
review which would simply assess the presence of information or a 
rationale, if not present.
    (Response 6) We do not agree with this suggestion. The language in 
question states ``To the extent that the submission relies upon the 
following information to provide detailed information and reasons for 
the recommended classification, the De Novo request provides the 
following . . .''--therefore the request for the purposes of the 
Checklist is not for the ``detailed information,'' per se, but rather 
identifying aspects of the submission for which detailed information 
will be evaluated during substantive review. Consistent with the policy 
outlined in the guidance, reviewers will not conduct a detailed review 
of such information during the RTA phase.
    (Comment 7) A comment requested clarity on the extent of 
information, and location of such information, to be included regarding 
clinical studies conducted outside the United States.
    (Response 7) The element requesting a summary and full study report 
for clinical studies (Appendix B, Section E, Question 6) does not 
require or specify the source of clinical study information. Therefore, 
we disagree that additional revision to this element is necessary--this 
pertains to clinical data from studies conducted either within or 
outside the United States.
    (Comment 8) A comment proposed we remove questions 2b and 2c from 
section D of the Acceptance Checklist, requesting information to be 
included as part of the Financial Certification (Form FDA 3454) and 
Financial Disclosure (Form FDA 3455) forms. The commenter believes that 
the requested information in these questions should be reviewed during 
substantive review of the De Novo request.
    (Response 8) We do not agree. These questions are ensuring that 
required content in the Financial Certification Forms are included for 
review. We are not assessing the adequacy of the content.
    (Comment 9) A comment proposed that we move element 1 in Appendix 
B, Section A, requesting ``all content used to support the De Novo 
request is written in English,'' to the Acceptance Checklist in 
Appendix A. One would expect that content be provided in English in 
order to conduct a substantive review of the De Novo request.
    (Response 9) We decline to make this change. There is no statutory 
requirement for providing documentation in English.
    (Comment 10) A comment recommends that further guidance 
``explicitly and specifically incorporate least burdensome concepts.'' 
The commenter believes that the draft guidance outlines processes that 
may not embody least burdensome principles.
    (Response 10) We have not made changes based on this comment. FDA 
defines least burdensome to be the minimum amount of information 
necessary to adequately address a regulatory question or issue through 
the most efficient manner at the right time. The least burdensome 
provisions and guiding principles do not change the applicable 
regulatory or statutory requirements. We believe the recommendations in 
the guidance are consistent with the least burdensome provisions and 
guiding principles, and we apply them in identifying what FDA believes 
to be the minimum information that the Agency relies on to complete 
premarket submission review in the most efficient manner. For 
information on the least burdensome provisions, refer to FDA's guidance 
for industry, ``The Least Burdensome Provisions: Concept and 
Principles'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles).
    (Comment 11) A comment requested that FDA provide clarification on 
the RTA process, as the draft guidance suggests a De Novo request could 
be refused based upon ``immaterial issues.'' The commenter recommends 
addition of a ``materiality standard'' that would limit refusal to 
accept a De Novo request ``to instances where the missing information 
is both material and relevant to the assessment of the safety or 
efficiency [sic]of the device.''
    (Response 11) We consider the ``materiality standard'' that the 
commenter proposes, i.e., that the scope for denial of a review is 
limited to instances where the missing information is both material and 
relevant to the assessment of the safety or effectiveness of the 
device, to be the fundamental basis for the Acceptance Checklist in 
Appendix A. Elements requested in Appendix A are required by statute 
and applicable regulations and, as such, we

[[Page 31602]]

consider these to be material and relevant to the substantive review of 
the De Novo request.
    (Comment 12) One comment proposed that FDA staff should be able to 
use discretion in order to request missing checklist items 
interactively, rather than to RTA when there are one or more items 
missing from the Acceptance Checklist as described in section III.A of 
the guidance. This would aid in ensuring a least burdensome approach 
was applied to this process.
    (Response 12) We do not believe that revisions are necessary in 
response to this comment. Within section III.A, the guidance states 
that ``FDA staff also has discretion to request missing checklist items 
interactively from requesters during the RTA review. Interaction during 
the RTA reviews is dependent on FDA staff's determination that 
outstanding issues are appropriate for interactive review and that 
adequate time is available for the requester to provide supporting 
information and for FDA staff to assess responses.''
    We believe the recommendations in the guidance are consistent with 
the least burdensome provisions and guiding principles, and we apply 
them in identifying what FDA believes to be the minimum information 
that the Agency relies on to complete premarket submission review in 
the most efficient manner. For information on the least burdensome 
provisions, refer to FDA's guidance, ``The Least Burdensome Provisions: 
Concept and Principles.''
    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 requests
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De Novo request under 21 U.S.C. 513(f)(2)(A)(i):
    CDRH................................................               2               1               2             100             200
    CBER................................................               1               1               1             100             100
De Novo request under 21 U.S.C. 513(f)(2)(A)(ii):
    CDRH................................................              56               1              56             180          10,080
    CBER................................................               1               1               1             180             180
    Acceptance Checklist................................              60               1              60               1              60
    Recommended Content Checklist.......................              60               1              60               1              60
Total De Novo requests..................................  ..............  ..............              60  ..............          10,680          $7,278
Request for withdrawal \2\..............................               5               1               5              10              50               5
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............          10,730           7,283
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\1\ There are no capital costs associated with this collection of information.
\2\ No change from approved information collection. This information is retained for the convenience of the reader.

    Based on updated program data and trends, we expect to receive 
approximately 60 De Novo requests per year. We have not changed our 
estimates of the Average Burden per Response for De Novo requests.
    We estimate that it will take approximately 1 hour to prepare an 
Acceptance Checklist and 1 hour to prepare a Recommended Content 
Checklist. Our estimate assumes that each De Novo request will include 
both checklists.
    Approved operating and maintenance costs for a De Novo request 
include printing, shipping, and eCopy costs. We have updated the 
operating and maintenance costs to account for the updated burden 
estimate for De Novo requests (resulting in an increase of $970 to the 
total estimated operating and maintenance costs). However, we believe 
any increase of the operating and maintenance cost resulting from the 
addition of the Acceptance Checklist and Recommended Content Checklist 
to be de minimis.
    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, including the Acceptance 
Checklist and Recommended Content Checklist, to be $121.30 ($90 
printing + $30 shipping + $1.30 eCopy). The annual cost estimate for De 
Novo submissions is $7,278 (60 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.
    Our estimated burden for the information collection reflects an 
overall increase of 3,400 hours. We attribute this adjustment to the 
addition of the Acceptance Checklist and the Recommended Content 
Checklist and to an increase in the number of submissions we received 
during the approval period. For clarity, we have separated the 
Acceptance Checklist and Recommended Content Checklist into distinct 
line-items in table 1.

    Dated: June 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14066 Filed 7-1-19; 8:45 am]
BILLING CODE 4164-01-P


