Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health, 2388-2393 [2018-00646]
Download as PDF
<![CDATA[
2388
Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Proposed Rules
postmarked or the delivery service
acceptance receipt is on or before that
date.
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.
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
ethrower on DSK3G9T082PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
16:35 Jan 16, 2018
Jkt 244001
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
PO 00000
Frm 00016
Fmt 4702
Sfmt 4702
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/201523389.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
CDRHOmbudsman@fda.hhs.gov.
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
E:\FR\FM\17JAP1.SGM
17JAP1
Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Proposed Rules
sections 3051 and 3058 of the Cures Act.
These provisions established procedures
and timeframes for supervisory review
under § 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
§ 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.
ethrower on DSK3G9T082PROD with PROPOSALS
B. Summary of the Major Provisions of
the Proposed Rule
FDA proposes to amend part 10 (21
CFR part 10) by adding § 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 § 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 § 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.
VerDate Sep<11>2014
16:35 Jan 16, 2018
Jkt 244001
The proposed rule would also add
new § 800.75 to part 800 (21 CFR part
800). Proposed § 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 § 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 § 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 § 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
PO 00000
Frm 00017
Fmt 4702
Sfmt 4702
2389
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 (§ 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 § 2.17 and
redesignated as § 10.75 (44 FR 22318,
April 13, 1979) (Ref. 5), where these
regulations remain today.
In 1998, § 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 § 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 § 10.75 appeal processes
available to outside stakeholders to
request review of decisions or actions by
CDRH employees (Ref. 6).
E:\FR\FM\17JAP1.SGM
17JAP1
2390
Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Proposed Rules
ethrower on DSK3G9T082PROD with PROPOSALS
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
VerDate Sep<11>2014
16:35 Jan 16, 2018
Jkt 244001
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 § 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 § 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 § 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
PO 00000
Frm 00018
Fmt 4702
Sfmt 4702
requirements for requests for
supervisory review within CDRH under
§ 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 § 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 § 10.75 to add paragraph (e),
which would require that requests for
internal agency supervisory review
within CDRH also comply with
proposed § 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
§ 800.75 to part 800. Proposed § 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
§ 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 § 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 § 10.75
Part 10 would be amended to add
§ 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 § 800.75. Proposed § 10.75(e)
would not be limited to significant
decisions under section 517A of the
FD&C Act. Rather, proposed § 10.75(e)
would also encompass review of
decisions other than 517A decisions
made by CDRH.
B. Proposed § 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
E:\FR\FM\17JAP1.SGM
17JAP1
ethrower on DSK3G9T082PROD with PROPOSALS
Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Proposed Rules
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 § 800.75, we are mindful
that outside parties may use § 10.75 to
request review of decisions other than
517A decisions. For this reason, we are
also proposing new procedural
requirements for internal agency
VerDate Sep<11>2014
16:35 Jan 16, 2018
Jkt 244001
supervisory review within CDRH under
§ 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,
§ 10.75 requests for review within
CDRH.
Further, § 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.
PO 00000
Frm 00019
Fmt 4702
Sfmt 4702
2391
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
E:\FR\FM\17JAP1.SGM
17JAP1
2392
Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Proposed Rules
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.
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.
ethrower on DSK3G9T082PROD with PROPOSALS
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.
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 https://
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.
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
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: https://www.fda.gov/
downloads/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM352254.pdf.
2. 40 FR 40682, September 3, 1975 https://
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 https://
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 https://
heinonline.org/HOL/PrintRequest?
VerDate Sep<11>2014
17:05 Jan 16, 2018
Jkt 244001
PO 00000
Frm 00020
Fmt 4702
Sfmt 4702
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 https://
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: https://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: https://www.fda.gov/
downloads/medicaldevices/
deviceregulationandguidance/guidance
documents/ucm393978.pdf.
8. ‘‘eCopy Program for Medical Device
Submissions—Guidance for Industry and
Food and Drug Administration Staff,’’
December 3, 2015, available at: https://
www.fda.gov/downloads/
medicaldevices/deviceregulation
andguidance/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
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.
2. In § 10.75, add paragraph (e) to read
as follows:
■
E:\FR\FM\17JAP1.SGM
17JAP1
Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Proposed Rules
§ 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 § 800.75
of this chapter.
PART 800—GENERAL
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.
4. In part 800, add § 800.75 to subpart
C to read as follows:
■
ethrower on DSK3G9T082PROD with PROPOSALS
§ 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 § 807.100(a)(1) of this chapter, or
a not substantially equivalent order
under § 807.100(a)(2) of this chapter;
(ii) An approval order under
§ 814.44(d) of this chapter, an
approvable letter under § 814.44(e) of
this chapter, a not approvable letter
under § 814.44(f) of this chapter, or an
order denying approval under § 814.45
of this chapter;
(iii) An approval order under
§ 814.116(b) of this chapter, an
approvable letter under § 814.116(c) of
this chapter, a not approvable letter
under § 814.116(d) of this chapter, or an
order denying approval under § 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
§ 812.30(a) of this chapter or a
disapproval order under § 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
VerDate Sep<11>2014
16:35 Jan 16, 2018
Jkt 244001
517A decision under § 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
§ 10.75(b) of this chapter.
(2) An initial or sequential request for
supervisory review within CDRH under
§ 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
CDRHOmbudsman@fda.hhs.gov.
PO 00000
Frm 00021
Fmt 4702
Sfmt 4702
2393
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. FDA–2017–N–0763]
RIN 0910–AH43
Food Labeling: Health Claims; Soy
Protein and Coronary Heart Disease;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Proposed rule; extension of
comment period.
ACTION:
The Food and Drug
Administration (FDA or we) is
extending the comment period for the
proposed rule that appeared in the
Federal Register of October 31, 2017.
We are taking this action in response to
requests for an extension to allow
interested persons additional time to
submit comments.
DATES: FDA is extending the comment
period on the proposed rule published
on October 31, 2017 (82 FR 50324).
Submit either electronic or written
comments by March 19, 2018.
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 March 19,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of March 19, 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.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking 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
E:\FR\FM\17JAP1.SGM
17JAP1
]]>Agencies
[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 https://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: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM352254.pdf.
2. 40 FR 40682, September 3, 1975 https://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 https://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 https://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 https://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: https://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: https://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: https://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
