[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]]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
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.
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:
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.
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.
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
[email protected].
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).
[[Page 2390]]
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
[[Page 2391]]
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'':
510(k): Not substantially equivalent; Substantially
equivalent.
PMA/HDE: Not approvable; Approvable; Approval; Denial.
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.
IDE: Disapproval; Approval.
Failure to reach agreement on protocol under section
520(g)(7) of the FD&C Act.
``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 [email protected].
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