[Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)]
[Proposed Rules]
[Pages 2388-2393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00646]



[[Page 2388]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 10 and 800

[Docket No. FDA-2016-N-2378]
RIN 0910-AH37


Internal Agency Review of Decisions; Requests for Supervisory 
Review of Certain Decisions Made by the Center for Devices and 
Radiological Health

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
implement regulations regarding internal agency supervisory review of 
certain decisions related to devices regulated by the Center for 
Devices and Radiological Health (CDRH) under the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) to conform to the applicable provisions in 
the Food and Drug Administration Safety and Innovation Act (FDASIA) and 
the 21st Century Cures Act (Cures Act). FDA is taking this action to 
codify the procedures and timeframes for supervisory review of 
significant decisions pertaining to devices within CDRH. FDA is also 
proposing regulations to provide new procedural requirements for 
requesting internal agency supervisory review within CDRH of other 
types of decisions made by CDRH not addressed in FDASIA and the Cures 
Act. This action is also part of FDA's implementation of Executive 
Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively 
reviewing existing regulations to identify opportunities for repeal, 
replacement, or modification that will result in meaningful burden 
reduction, while allowing the Agency to achieve its public health 
mission and fulfill statutory obligations.

DATES: Submit either electronic or written comments by April 17, 2018. 
See section V of this document for the proposed effective date of a 
final rule that may issue based on this proposal.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 17, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal Rulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions.'')

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include Docket No. FDA-
2016-N-2378 for ``Internal Agency Review of Decisions; Requests for 
Supervisory Review of Certain Decisions Made by the Center for Devices 
and Radiological Health.'' Received comments, those filed in a timely 
manner (see ADDRESSES) will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Adaeze Teme, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5574, Silver Spring, MD 20993-0002, 240-402-0768; 
or the Ombudsman for the Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 
4282, Silver Springs, MD 20993-0002, 301-796-5669, or 
<a href="/cdn-cgi/l/email-protection#175453455f587a756273647a767957717376397f7f6439707861"><span class="__cf_email__" data-cfemail="1e5d5a4c5651737c6b7a6d737f705e787a7f3076766d30797168">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Purpose of the Proposed Rule

    The purpose of this proposed rule is to implement regulations on 
the procedures regarding internal agency supervisory review of certain 
decisions made by CDRH under the FD&C Act. Section 603 of FDASIA added 
new section 517A to the FD&C Act (21 U.S.C. 360g-1), which was amended 
by

[[Page 2389]]

sections 3051 and 3058 of the Cures Act. These provisions established 
procedures and timeframes for supervisory review under Sec.  10.75 (21 
CFR 10.75) of significant decisions by CDRH pertaining to devices. 
After the enactment of FDASIA, FDA issued a guidance document entitled 
``Center for Devices and Radiological Health Appeals Processes: 
Questions and Answers About 517A--Guidance for Industry and Food and 
Drug Administration Staff'' (Q&A Guidance) to provide interpretation of 
key provisions of section 517A, including those that pertain to 
requests for supervisory review of significant decisions by CDRH (Ref. 
1). FDA is proposing this regulation to codify (1) the procedures and 
timeframes for Sec.  10.75 appeals of ``significant decisions'' by CDRH 
established under section 517A and (2) the interpretation of key 
provisions of section 517A of the FD&C Act regarding supervisory 
review. In addition, the proposed regulations would introduce new 
procedural requirements for supervisory review within CDRH of other 
CDRH decisions that were not addressed in FDASIA and the Cures Act.
    The proposed regulations will provide transparency and clarity for 
internal and external stakeholders on CDRH's process for supervisory 
review of decisions and will give requesters new predictability through 
binding deadlines for FDA action on a request for supervisory review 
within CDRH and the Center's internal agency review of ``significant 
decisions.'' Furthermore, this proposal, when finalized, will codify 
the types of decisions that are considered ``significant decisions,'' 
for which the timeframes apply. The proposed regulations will also 
codify the timeframe for submission of requests for the review of other 
decisions within CDRH.

B. Summary of the Major Provisions of the Proposed Rule

    FDA proposes to amend part 10 (21 CFR part 10) by adding Sec.  
10.75(e). Section 10.75 currently provides that an interested person 
outside the Agency may request internal agency review of a decision of 
an FDA employee. FDA proposes to amend Sec.  10.75 to add paragraph 
(e), which would require that requests for internal agency supervisory 
review within CDRH of a decision also comply with proposed Sec.  800.75 
(21 CFR 800.75). This proposed change to the regulations would 
encompass both significant decisions under section 517A of the FD&C Act 
and other decisions by CDRH employees.
    The proposed rule would also add new Sec.  800.75 to part 800 (21 
CFR part 800). Proposed Sec.  800.75 would incorporate in the 
regulations the provisions of section 517A of the FD&C Act for review 
of ``significant decisions'' related to devices regulated under the 
FD&C Act by CDRH. Proposed Sec.  800.75 would define ``significant 
decisions.'' Section 800.75 would also include the timeframes for 
submission of requests for internal agency review of significant 
decisions within CDRH and for responses to such requests.
    Proposed Sec.  800.75 would further address requests for 
supervisory review within CDRH of decisions other than section 517A 
decisions and would indicate the timeframe for submission of these 
requests for internal agency review.

C. Legal Authority

    FDA's legal authority to implement requirements pertaining to the 
process and timelines for Sec.  10.75 appeals of decisions within CDRH 
derives from sections 510(k), 515, 515C, 517A, and 520(g) of the FD&C 
Act (21 U.S.C. 360(k), 360e, 360e-3, 360g-1, and 360j) and other 
provisions under which a decision might be appealed, and 701(a) of the 
FD&C Act (21 U.S.C. 371(a)). Section 701(a) of the FD&C Act gives FDA 
general rulemaking authority to issue regulations for the efficient 
enforcement of the FD&C Act.

D. Costs and Benefits

    We expect the costs and benefits of the proposed rule to be 
negligible.

II. Background

A. Regulations on Internal Agency Review

    FDA has long provided a path for outside parties to request 
internal agency review of decisions. A procedure for this type of 
review was first published as a proposed regulation in 1975 (40 FR 
40682, September 3, 1975) (Ref. 2). In the preamble for the proposed 
rule, the Agency recognized that a process for administrative review of 
Agency decisions would advise outside parties how they should pursue 
matters that interest and concern them (40 FR 40682 at 40693). A final 
rule published in 1977 incorporated these provisions into the Code of 
Federal Regulations at 21 CFR 2.17 (42 FR 4680, January 25, 1977) (Ref. 
3).
    These regulations provided that any decision of an FDA employee, 
other than the Commissioner, on any matter was subject to review by the 
employee's supervisor under any of the following circumstances: (1) At 
the request of the employee, (2) on the initiative of the supervisor, 
(3) at the request of any interested person outside of the Agency, or 
(4) as required by duly promulgated delegations of authority. The 
review shall be accomplished by consultation between the employee and 
the supervisor, by review of the administrative file, or both. The 
review shall ordinarily follow established Agency channels of 
supervision. Internal agency review shall be based on the data and 
information available in the administrative file. If an interested 
person presents new data or information not contained in the 
administrative file, then the matter shall be returned to the 
appropriate lower level within the Agency for a reevaluation based upon 
the new information (Sec.  2.17 (1977)).
    The following year, in 1978, a proposed rule was published to 
reorganize and revise the Agency's administrative practices and 
procedures regulations (43 FR 51966, November 7, 1978) (Ref. 4). When 
the final rule for this action was published, the regulations for 
internal agency review were moved from Sec.  2.17 and redesignated as 
Sec.  10.75 (44 FR 22318, April 13, 1979) (Ref. 5), where these 
regulations remain today.
    In 1998, Sec.  10.75 was amended to add provisions allowing a 
sponsor, applicant, or manufacturer of a drug or device to request 
review of a scientific controversy by an appropriate scientific 
advisory panel or advisory committee (63 FR 63978, November 18, 1998). 
Aside from the specific situation addressed by the amendment, the 
elements of internal agency review under Sec.  10.75 relating to who 
may request the review and the information on which the review must be 
based remained unchanged.
    Section 10.75 contains regulations that establish an orderly 
process for internal agency review of decisions, based on information 
in the FDA administrative file. Section 10.75 applies to requests for 
review of decisions made by any FDA employee, other than decisions by 
the Commissioner of Food and Drugs. Section 10.75 does not establish 
timelines for requests for Agency review or for the Agency to act upon 
these requests. The FDA guidance document entitled ``Center for Devices 
and Radiological Health Appeals Processes--Guidance for Industry and 
Food and Drug Administration Staff'' describes the Sec.  10.75 appeal 
processes available to outside stakeholders to request review of 
decisions or actions by CDRH employees (Ref. 6).

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B. Agency Documentation and Review of Significant Decisions Regarding 
Devices Under Section 517A of the Federal Food, Drug, and Cosmetic Act

    On July 9, 2012, the FD&C Act (21 U.S.C. 301 et seq.) was amended 
by FDASIA. Section 603 of FDASIA added new section 517A to the FD&C 
Act, which specifies procedures and timeframes for the supervisory 
review of significant decisions pertaining to devices regulated by 
CDRH.
    On December 13, 2016, the FD&C Act (21. U.S.C. 301 et seq.) was 
further amended by the Cures Act. Section 3051 of the Cures Act, 
``Breakthrough Devices,'' added section 515C to the FD&C Act and 
amended section 517A(a)(1) to include any significant decision by CDRH 
regarding a request for designation as a breakthrough device under 
section 515C.
    In addition, section 3058, ``Least Burdensome Device Review,'' of 
the Cures Act amended section 517A(a) by adding subsection (3), which 
requires that the substantive summary include a brief statement of how 
the least burdensome requirements were considered and applied 
consistent with sections 513(i)(1)(D), 513(a)(3)(D), and 515(c)(5) of 
the FD&C Act, as applicable.
    Section 517A of the FD&C Act provides that any person may request a 
supervisory review of any significant decision of CDRH regarding the 
submission or review of a report under section 510(k), an application 
under section 515, a request for designation under section 515C, or an 
application for an exemption under section 520(g) of the FD&C Act. Any 
person may request such review, which may be conducted at the next 
supervisory level or higher above the individual who made the 
significant decision. Where the request for supervisory review was made 
at the organizational level, any person may request a supervisory 
review to the next organizational level or higher above the level at 
which the decision was made. In addition, the Office or Center Director 
may designate a Deputy Director to be their representative as the 
authority for a request made to that level. In this situation, a 
request for review heard by a Deputy is rendered on behalf of the 
Director and constitutes a review by that level of the organization 
(Ref. 6).
    Section 517A of the FD&C Act includes specific timeframes both for 
the person requesting review and for FDA to respond to such a request. 
A request for review of a significant decision is required to be 
submitted to FDA not later than 30 days after such decision. In 
responding to this request, if the requester seeks an in-person meeting 
or a teleconference review, FDA is required to schedule the requested 
interaction not later than 30 days after the request is made. FDA is 
required to issue a decision not later than 30 days after the 
interaction, or, in the case of a person who does not seek an in-person 
meeting or teleconference review, FDA is required to issue a decision 
no later than 45 days after the request for supervisory review is 
received by FDA. An exception to the timeframes related to scheduling 
an in-person meeting or teleconference review, and to FDA's decision on 
a request for supervisory review of the significant decision, is 
provided in cases that are referred to experts outside of FDA. Although 
the procedures and timeframes in section 517A of the FD&C Act apply to 
an initial request for supervisory review of a significant decision by 
CDRH, CDRH has chosen to enhance transparency and predictability and 
apply those procedures and timeframes as well to sequential requests 
for supervisory review of significant decisions that are submitted to 
CDRH.

III. Legal Authority

    We are proposing to codify the procedures and timeframes in section 
517A of the FD&C Act, added by section 603 of FDASIA and amended by the 
Cures Act, for Sec.  10.75 appeals of ``significant decisions'' 
regarding the submission or review of a report under section 510(k), an 
application under section 515, a request for designation under section 
515C, or an application for an exemption under section 520(g) of the 
FD&C Act.
    We are also proposing additional procedural requirements for Sec.  
10.75 appeals submitted to CDRH of other types of CDRH decisions not 
addressed in the FDASIA and the Cures Act.
    FDA's legal authority to implement requirements pertaining to the 
process and timelines for Sec.  10.75 appeals submitted to CDRH derives 
from sections 510(k), 515, 515C, 517A, and 520(g) of the FD&C Act and 
other provisions under which a decision might be appealed, and 701(a) 
of the FD&C Act. Section 701(a) of the FD&C Act gives FDA general 
rulemaking authority to issue regulations for the efficient enforcement 
of the FD&C Act.

IV. Description of the Proposed Rule

    The proposed rule would, if finalized, incorporate the procedures 
and timeframes in section 517A to an initial or sequential request for 
supervisory review within CDRH of ``significant decisions'' by CDRH 
into FDA's regulations. The proposed regulations would also introduce 
new procedural requirements for requests for supervisory review within 
CDRH under Sec.  10.75 of decisions that do not fall under 
``significant decisions'' under section 517A of the FD&C Act.
    FDA proposes to amend part 10 by adding Sec.  10.75(e). Section 
10.75 currently provides that an interested person outside the Agency 
may request internal agency review of a decision of an FDA employee. 
FDA proposes to amend Sec.  10.75 to add paragraph (e), which would 
require that requests for internal agency supervisory review within 
CDRH also comply with proposed Sec.  800.75. This proposed change to 
the regulations would encompass both significant decisions under 
section 517A of the FD&C Act and other types of decisions.
    The proposed rule would add new Sec.  800.75 to part 800. Proposed 
Sec.  800.75 would incorporate, into the regulations, the provisions of 
section 517A of the FD&C Act for review of significant decisions 
related to devices regulated under the FD&C Act by CDRH. Proposed Sec.  
800.75 would define ``significant decisions.'' Section 800.75 would 
also include the timeframes for submission of requests for internal 
agency review of significant decisions within CDRH and for responses to 
such requests.
    Proposed Sec.  800.75 would further address the review of decisions 
other than 517A decisions and would indicate the timeframe for 
submission of these requests for internal agency review within CDRH.

A. Proposed Revisions to Sec.  10.75

    Part 10 would be amended to add Sec.  10.75(e). FDA proposes to add 
language to clarify that requests by interested persons outside the 
Agency for internal agency review of a decision within CDRH must also 
comply with proposed Sec.  800.75. Proposed Sec.  10.75(e) would not be 
limited to significant decisions under section 517A of the FD&C Act. 
Rather, proposed Sec.  10.75(e) would also encompass review of 
decisions other than 517A decisions made by CDRH.

B. Proposed Sec.  800.75

    Section 517A of the FD&C Act establishes procedural requirements, 
including timeframes for a request for internal agency review of a 
``significant decision'' by CDRH. ``Significant decision'' is not 
defined in the statutory provision. FDA is proposing to define 
``significant decision,'' to provide greater clarity regarding which 
decisions fall within this statutory term.
    A ``517A decision'' would be defined as a significant decision 
regarding a device as set forth in section 517A of the

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FD&C Act. We are proposing to use the term ``517A decision'' rather 
than the term ``significant decision'' because we do not want to imply 
that all other decisions of the Agency that do not fall within section 
517A of the FD&C Act are not significant. Similarly, we did not want to 
use the term ``non-significant decision'' when speaking of decisions 
outside of the scope of section 517A, as that might imply some 
unintended assessment on our part concerning the importance of these 
types of decisions. In addition, because we are proposing these 
regulations to include regulatory decisions by CDRH besides those set 
forth in section 517A, we wanted to avoid any confusion that might 
occur in distinguishing between these two categories of decisions. For 
these reasons, we instead are proposing to use the term ``517A 
decision'' for those decisions that are identified under section 517A 
as significant decisions, and to refer to other decisions by CDRH as 
``non-517A decisions.''
    The review procedures under section 517A of the FD&C Act apply only 
to a request for review of a significant decision by CDRH regarding 
submission or review of a report under section 510(k) (Premarket 
Notification), an application under section 515 (Premarket Approval or 
``PMA''/Humanitarian Device Exemption or ``HDE''), a request for 
designation under section 515C (Breakthrough Devices), or an 
application for an exemption under section 520(g) of the FD&C Act 
(Investigational Device Exemption or ``IDE''). CDRH is proposing that 
only the following decisions be considered significant decisions under 
section 517A of the FD&C Act and, thus, defined for purposes of this 
proposed rule as ``517A decisions'':
    <bullet> 510(k): Not substantially equivalent; Substantially 
equivalent.
    <bullet> PMA/HDE: Not approvable; Approvable; Approval; Denial.
    <bullet> Breakthrough Devices: Expedited access pathway (Ref. 7) 
program request for breakthrough designation for devices subject to 
premarket notification, premarket approval, or de novo requests. Grant; 
Denial of request for breakthrough designation.
    <bullet> IDE: Disapproval; Approval.
    <bullet> Failure to reach agreement on protocol under section 
520(g)(7) of the FD&C Act.
    <bullet> ``Clinical Hold'' determinations under section 520(g)(8) 
of the FD&C Act.
    In proposing Sec.  800.75, we are mindful that outside parties may 
use Sec.  10.75 to request review of decisions other than 517A 
decisions. For this reason, we are also proposing new procedural 
requirements for internal agency supervisory review within CDRH under 
Sec.  10.75 of non-517A decisions made by CDRH employees. A request for 
supervisory review of a CDRH decision other than a 517A decision is to 
be received no later than 60 days after the date of the decision that 
is subject to review. Any request received after 60 days in these cases 
will be denied as untimely, unless CDRH, for good cause related to 
circumstances beyond the control of the submitter, such as snow 
emergency, Federal Government shutdown, or other unforeseen emergency 
event, permits the request to be filed after 60 days.
    Section 800.75 proposes that requests for CDRH review of 517A 
decisions and non-517A decisions must be addressed to the next 
organizational level or higher above the individual who made the 
decision. Requests to elevate the review of such decisions should 
include a rationale. The decision to collapse two or more levels of 
review or to elevate a review would solely be at CDRH's discretion. In 
addition, requesters should have exhausted review through the 
supervisory chain below the Center Director level prior to request for 
review at the Center Director level.
    As provided in the FDA guidance, entitled ``eCopy Program for 
Medical Device Submissions--Guidance for Industry and Food and Drug 
Administration Staff'' (eCopy guidance), appeals to submission types 
identified under section 745A(b) of the FD&C Act are subject to the 
electronic format requirements. (Ref. 8). Therefore, 10.75 requests for 
supervisory review of 517A decisions within CDRH, and certain decisions 
other than 517A decisions, must be submitted in accordance with section 
745A(b) and the standards established by the eCopy guidance, when 
applicable. In addition, requests for breakthrough designation under 
section 515C of the FD&C Act for devices under sections 510(k), 
513(f)(2), and 515(c) of the FD&C Act would be considered 
``presubmissions'' to those submission types as identified under 
section 745A, and, therefore, requests for breakthrough designation 
would be subject to section 745A(b), and likewise, Sec.  10.75 requests 
for review within CDRH.
    Further, Sec.  800.75 proposes that requests for supervisory review 
of CDRH decisions other than 517A decisions must be sent to the CDRH 
Ombudsman, and those decisions, other than 517A decisions not subject 
to section 745A, are to be submitted in electronic format. Further 
instructions will be provided regarding submission of such requests in 
electronic format.

V. Proposed Effective Date

    FDA is proposing that any final rule based on this proposal become 
effective 90 days after the date of publication of a final rule in the 
Federal Register or at a later date if stated in the final rule.

VI. Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under E.O. 12866, 
E.O. 13563, E.O. 13771, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). 
E.O. 12866 and 13563 direct us to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). E.O. 13771 requires that 
the costs associated with significant new regulations ``shall, to the 
extent permitted by law, be offset by the elimination of existing costs 
associated with at least two prior regulations.'' We believe that this 
proposed rule is not a significant regulatory action as defined by E.O. 
12866. It has been determined that this proposed rule is an action that 
does not impost more than de minimis costs.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because we anticipate that the costs of the rule would be de 
minimis, we propose to certify that the proposed rule will not have a 
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $148 million, using the most current (2016) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount. We have developed a comprehensive Economic Analysis of Impacts 
that assesses the impacts of the proposed rule.
    The proposed rule would (1) define ``517A decision,'' (2) apply to 
requests submitted to CDRH for review of 517A

[[Page 2392]]

decisions and decisions other than 517A decisions made by CDRH, and (3) 
establish timelines and procedures for an interested person to request 
supervisory review of these decisions by CDRH. By setting specific 
timelines for persons to submit requests for supervisory review, the 
proposed rule would help clarify the supervisory review process and 
provide firms with an incentive to promptly submit review requests. The 
proposed rule would also establish timelines for CDRH review of 517A 
decisions, reducing uncertainty about when interested persons would 
know the outcome of their requests for supervisory review. Because the 
proposed rule would not change the effort needed to prepare and submit 
a request for supervisory review, we anticipate that affected 
interested persons would incur only negligible costs to read and learn 
about the provisions of the proposed rule. We do not expect additional 
costs for FDA.
    We received 42 requests for review in 2013, 28 requests for review 
in 2014, 20 requests for review in 2015, and 20 requests for review in 
2016. We estimate that each request for review required 70 hours of 
CDRH staff time. One possible benefit of the proposed rule, if 
finalized, is that it may reduce the number of hours required per 
request for review. If firms have more clarity about the request for 
review process, they may not have to spend as much time navigating the 
process, and we may not need to spend as much time guiding them through 
the process.

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VIII. Paperwork Reduction Act of 1995

    This proposed rule refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information regarding the appeals process for devices in 
the guidance document entitled ``Center for Devices and Radiological 
Health Appeals Processes'' have been approved under OMB control number 
0910-0738; the collections of information in 21 CFR part 807, subpart E 
(premarket notification) have been approved under OMB control number 
0910-0120; the collections of information for De Novo classification 
requests have been approved under the OMB control number 0910-0844; the 
collections of information in 21 CFR part 812 (investigational device 
exemption) have been approved under OMB control number 0910-0078; the 
collections of information in 21 CFR part 814 (premarket approval) have 
been approved under OMB control number 0910-0231; and the collections 
of information in 21 CFR part 814, subpart H (humanitarian use devices) 
have been approved under OMB control number 0910-0332.

IX. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
the proposed rule does not contain policies that would have substantial 
direct effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
we conclude that the proposed rule does not contain policies that have 
federalism implications as defined in the Executive Order and, 
consequently, a federalism summary impact statement is not required.

X. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at http://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. ``Center for Devices and Radiological Health Appeals Processes: 
Questions and Answers About 517A--Guidance for Industry and Food and 
Drug Administration Staff,'' July 30, 2014, available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM352254.pdf.
2. 40 FR 40682, September 3, 1975 http://heinonline.org/HOL/PDFsearchable?handle=hein.fedreg/040171&collection=fedreg§ion=0&id=179&print=1§ioncount=1&ext=.pdf&nocover=.
3. 42 FR 4680, January 25, 1977 http://heinonline.org/HOL/PDFsearchable?handle=hein.fedreg/042016&collection=fedreg§ion=0&id=250&print=1§ioncount=1&ext=.pdf&nocover=.
4. 43 FR 51966, November 7, 1978 http://heinonline.org/HOL/PrintRequest?collection=fedreg&nocover=&handle=hein.fedreg%2F043216&id=186§ion=&skipstep=1&fromid=186&toid=238&format=PDFsearchable&submitx=Print%2FDownload&submit1=Print%2FDownload+Custom+Range.
5. 44 FR 22318, April 13, 1979 http://heinonline.org/HOL/PrintRequest?collection=fedreg&nocover=&handle=hein.fedreg%2F044073&id=258§ion=&skipstep=1&fromid=258&toid=376&format=PDFsearchable&submitx=Print%2FDownload&submit1=Print%2FDownload+Custom+Range.
6. ``Center for Devices and Radiological Health Appeals Processes--
Guidance for Industry and Food and Drug Administration Staff,'' May 
17, 2013, available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284670.pdf.
7. ``Expedited Access for Premarket Approval and De Novo Medical 
Devices Intended for Unmet Medical Need for Life Threatening or 
Irreversibly Debilitating Diseases or Conditions--Guidance for 
Industry and Food and Drug Administration Staff,'' April 13, 2015, 
available at: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm393978.pdf.
8. ``eCopy Program for Medical Device Submissions--Guidance for 
Industry and Food and Drug Administration Staff,'' December 3, 2015, 
available at: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm313794.pdf.

List of Subjects

21 CFR Part 10

    Administrative practice and procedure, News media.

21 CFR Part 800

    Administrative practice and procedure, Medical devices, Ophthalmic 
goods and services, Packaging and containers, Reporting and 
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR parts 10 and 800 be amended as follows:

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

0
1. The authority citation for part 10 continues to read as follows:

    Authority:  5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b, 264.

0
2. In Sec.  10.75, add paragraph (e) to read as follows:

[[Page 2393]]

Sec.  10.75   Internal agency review of decisions.

* * * * *
    (e) Each request by an interested person for review of a decision 
within the Center for Devices and Radiological Health shall also comply 
with Sec.  800.75 of this chapter.

PART 800--GENERAL

0
3. The authority citation for part 800 is revised to read as follows:

    Authority:  5 U.S.C. 551-559; 21 U.S.C. 301-399f.

0
4. In part 800, add Sec.  800.75 to subpart C to read as follows:


Sec.  800.75   Requests for supervisory review of certain decisions 
made by the Center for Devices and Radiological Health.

    (a) The following definitions shall apply to this section:
    (1) FDA means the Food and Drug Administration.
    (2) 517A decision means a significant decision made by the Center 
for Devices and Radiological Health, as set forth in section 517A of 
the Federal Food, Drug, and Cosmetic Act, and includes one of the 
following decisions:
    (i) A substantially equivalent order under Sec.  807.100(a)(1) of 
this chapter, or a not substantially equivalent order under Sec.  
807.100(a)(2) of this chapter;
    (ii) An approval order under Sec.  814.44(d) of this chapter, an 
approvable letter under Sec.  814.44(e) of this chapter, a not 
approvable letter under Sec.  814.44(f) of this chapter, or an order 
denying approval under Sec.  814.45 of this chapter;
    (iii) An approval order under Sec.  814.116(b) of this chapter, an 
approvable letter under Sec.  814.116(c) of this chapter, a not 
approvable letter under Sec.  814.116(d) of this chapter, or an order 
denying approval under Sec.  814.118 of this chapter;
    (iv) A grant or denial of a request for breakthrough device 
designation under section 515C of the Federal Food, Drug, and Cosmetic 
Act;
    (v) An approval order under Sec.  812.30(a) of this chapter or a 
disapproval order under Sec.  812.30(c) of this chapter;
    (vi) A failure to reach agreement letter under section 520(g)(7) of 
the Federal Food, Drug, and Cosmetic Act; or
    (vii) A clinical hold determination under section 520(g)(8) of the 
Federal Food, Drug, and Cosmetic Act.
    (3) CDRH means the Center for Devices and Radiological Health.
    (b) Submission of request.
    (1) Review of 517A decisions.
    (i) An initial or sequential request for supervisory review within 
CDRH of a 517A decision under Sec.  10.75 of this chapter must be 
addressed to the next organizational level or higher above the 
individual who made the decision; submitted in electronic format in 
accordance with section 745A(b) of the Federal Food, Drug, and Cosmetic 
Act; marked ``Appeal: Request for Supervisory Review;'' and received by 
CDRH no later than 30 days after the date of the decision involved. Any 
such request for supervisory review not received by CDRH within 30 days 
after the date of the decision involved is not eligible for review. 
Except as provided in paragraph (b)(1)(ii) or (iii) of this section, 
FDA will render a decision within 45 days of the request for 
supervisory review.
    (ii) A person requesting supervisory review under paragraph 
(b)(1)(i) may request an in-person meeting or teleconference with the 
supervisor reviewing the request for supervisory review. Except as 
provided in paragraph (b)(1)(iii) of this section, if a request for in-
person meeting or teleconference is included in the request for 
supervisory review to CDRH, CDRH will schedule the meeting or 
teleconference to occur within 30 days of receipt of the request. 
Except as provided in paragraph (b)(1)(iii) of this section, a decision 
will be rendered within 30 days of such meeting or teleconference.
    (iii) The timeframes for CDRH to render a decision provided in 
(b)(1)(i) and (ii), and the timeframe to schedule an in-person meeting 
or teleconference review in (b)(1)(ii) of this section do not apply, if 
a matter related to the 517A decision under review is referred by CDRH 
to external experts, such as an advisory committee, as provided in 
Sec.  10.75(b) of this chapter.
    (2) An initial or sequential request for supervisory review within 
CDRH under Sec.  10.75 of this chapter of a decision other than a 517A 
decision that is not received by CDRH within 60 days after the date of 
the decision involved will be denied as untimely, unless CDRH, for good 
cause, permits the request to be filed after 60 days. An initial or 
sequential request for supervisory review within CDRH of a decision 
other than a 517A decision must be addressed to the next organizational 
level or higher above the individual who made the decision; submitted 
in electronic format in accordance with section 745A(b) of the Federal 
Food, Drug, and Cosmetic Act, when applicable; marked, ``Appeal: 
Request for Supervisory Review'' in the subject line of the electronic 
request; and sent to the CDRH Ombudsman at <a href="/cdn-cgi/l/email-protection#460502140e092b243322352b272806202227682e2e3568212930"><span class="__cf_email__" data-cfemail="8ac9ced8c2c5e7e8ffeef9e7ebe4caeceeeba4e2e2f9a4ede5fc">[email protected]</span></a>.

    Dated: January 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00646 Filed 1-16-18; 8:45 am]
 BILLING CODE 4164-01-P


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