Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Partial Delay of Effective Date, 11639-11642 [2018-05347]
Download as PDF
<![CDATA[
Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Rules and Regulations
of Federal Regulations, which action
was approved by the Director of the
Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You
must comply with these requirements in
order for documents to be timely
received and accepted. The EDGAR
Filer Manual is available for website
viewing and printing; the address for
the Filer Manual is https://www.sec.gov/
info/edgar/edmanuals.htm. You can
obtain paper copies of the EDGAR Filer
Manual from the following address:
Public Reference Room, U.S. Securities
and Exchange Commission, 100 F Street
NE, Washington, DC 20549, on official
business days between the hours of
10:00 a.m. and 3:00 p.m. You can also
inspect the document at the National
Archives and Records Administration
(NARA). For information on the
availability of this material at NARA,
call 202–741–6030, or go to: https://
www.archives.gov/federal-register/cfr/
ibr-locations.html.
PART 274—FORMS PRESCRIBED
UNDER THE INVESTMENT COMPANY
ACT OF 1940
3. The authority citation for part 274
continues to read in part as follows:
■
Authority: 15 U.S.C. 77f, 77g, 77h, 77j, 77s,
78c(b), 78l, 78m, 78n, 78o(d), 80a–8, 80a–24,
80a–26, 80a–29, and Pub. L. 111–203, sec.
939A, 124 Stat. 1376 (2010), unless otherwise
noted.
*
*
*
*
*
4. Form ID (referenced in §§ 239.63,
249.446, 269.7 and 274.402 of this
chapter) is amended to add in ‘‘PART
I—APPLICATION FOR ACCESS CODES
TO FILE ON EDGAR’’ the following text
and checkbox ‘‘Access codes will be
used to submit draft registration or draft
offering statement. b’’
■
Note: The text of Form ID does not, and the
amendment will not, appear in the Code of
Federal Regulations.
By the Commission.
Dated: March 8, 2018.
Brent J. Fields,
Secretary.
[FR Doc. 2018–05238 Filed 3–15–18; 8:45 am]
jstallworth on DSKBBY8HB2PROD with RULES
BILLING CODE 8011–01–P
VerDate Sep<11>2014
14:39 Mar 15, 2018
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201, 801, and 1100
[Docket No. FDA–2015–N–2002]
RIN 0910–AH94
Clarification of When Products Made
or Derived From Tobacco Are
Regulated as Drugs, Devices, or
Combination Products; Amendments
to Regulations Regarding ‘‘Intended
Uses’’; Partial Delay of Effective Date
AGENCY:
Food and Drug Administration,
HHS.
Final rule; partial delay of
effective date.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is issuing this final rule to delay the
effective date of amendments to the
existing medical product ‘‘intended
use’’ regulations, contained in the final
rule published January 9, 2017, until
further notice. This final rule delays the
effective date of the amendments to
allow further consideration of the
substantive issues raised in the
comments received regarding the
amendments. This action does not delay
the effective date of the portions of the
January 9, 2017, final rule that describe
the circumstances in which a product
made or derived from tobacco that is
intended for human consumption will
be subject to regulation as a drug,
device, or a combination product under
the Federal Food, Drug, and Cosmetic
Act (FD&C Act), which remains March
19, 2018.
DATES: Effective March 16, 2018, the
amendments made to §§ 201.128 and
801.4, revised at 82 FR 2193 (January 9,
2017), delayed at 82 FR 9501 (February
7, 2017) until March 21, 2017, and
further delayed at 82 FR 14319 (March
20, 2017) until March 19, 2018, are
delayed indefinitely. Section 1100.5,
added at 82 FR 2193 (January 9, 2017),
delayed at 82 FR 9501 (February 7,
2017) until March 21, 2017, and further
delayed at 82 FR 14319 (March 20,
2017) until March 19, 2018, is effective
March 19, 2018.
ADDRESSES: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number found in brackets in the
heading of this final rule into the
‘‘Search’’ box and follow the prompts,
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
SUMMARY:
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
11639
FOR FURTHER INFORMATION CONTACT:
Kelley Nduom, Center for Drug
Evaluation and Research, Office of
Regulatory Policy, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6221, Silver Spring,
MD 20993, 301–796–8597,
kelley.nduom@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 9,
2017 (82 FR 2193), FDA published a
final rule entitled ‘‘Clarification of
When Products Made or Derived From
Tobacco Are Regulated as Drugs,
Devices, or Combination Products;
Amendments to Regulations Regarding
‘Intended Uses’’’ (January 2017 final
rule). The final rule added a new
regulation (§ 1100.5 (21 CFR 1100.5)) to
title 21 of the Code of Federal
Regulations (CFR) to describe the
circumstances in which a product made
or derived from tobacco that is intended
for human consumption will be subject
to regulation as a drug, device, or a
combination product under the FD&C
Act. The rule also amended FDA’s
existing regulations describing the types
of evidence that may be considered in
determining a medical product’s
intended uses (§§ 201.128 and 801.4 (21
CFR 201.128 (drugs) and 21 CFR 801.4
(devices))).
In the Federal Register of February 7,
2017 (82 FR 9501), in accordance with
the memorandum of January 20, 2017,
from the Assistant to the President and
Chief of Staff, entitled ‘‘Regulatory
Freeze Pending Review,’’ we delayed,
until March 21, 2017, the effective date
of the final rule.
On February 8, 2017, various industry
organizations filed a petition raising
concerns with the January 2017 final
rule, requesting reconsideration and a
stay pursuant to 21 CFR 10.33(b) and
10.35(b) (see FDA–2015–N–2002–1977).
The petition requests that FDA
reconsider the amendments to the
‘‘intended use’’ regulations and issue a
new final rule that, with respect to the
intended use regulations at §§ 201.128
and 801.4, reverts to the language of the
September 25, 2015, proposed rule. The
petition also requests that FDA
indefinitely stay the rule because
petitioners argue that (1) the final rule
was issued in violation of the fair notice
requirement under the Administrative
Procedure Act (APA) (petition at pp.
10–13) and (2) the ‘‘totality of the
evidence’’ language in the final rule is
E:\FR\FM\16MRR1.SGM
16MRR1
11640
Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Rules and Regulations
jstallworth on DSKBBY8HB2PROD with RULES
a new and unsupported legal standard
(petition at pp. 10, 13–21).1
In the Federal Register of March 20,
2017 (82 FR 14319), we further delayed
the effective date of the final rule until
March 19, 2018, and reopened the
docket to invite additional public
comment on the rule. Fifteen comments
were submitted to the docket in
response. Two of the comments
submitted to the docket related to the
new regulation included in the final
rule that describes circumstances in
which a product made or derived from
tobacco that is intended for human
consumption will be subject to
regulation as a drug, device, or a
combination product under the FD&C
Act (§ 1100.5). Neither comment
requested a delay in the effective date of
that new regulation. The remainder of
the comments related to the
amendments to FDA’s existing
regulations describing the types of
evidence that may be considered in
determining a medical product’s
intended use (§§ 201.128 and 801.4).
Many of these comments opposed what
they described as a broadening from the
September 25, 2015, proposed rule (see
80 FR 57756 at 57764 to 57765) of the
types of evidence that could be
considered in determining intended use,
and specifically raised concerns with
the ‘‘totality of the evidence’’ language
included in the final rule.2
To allow for further consideration of
the substantive issues raised in these
comments, in the Federal Register of
January 16, 2018 (83 FR 2092) (January
2018 proposed rule), we proposed to
delay the effective date of the
amendments to the existing medical
product ‘‘intended use’’ regulations
contained in the January 2017 final rule,
until further notice (§§ 201.128 and
801.4). We did not propose to delay the
effective date of the portions of the final
rule that issued a new regulation
regarding products made or derived
from tobacco that are intended for
human consumption (§ 1100.5). The
Agency received 19 comments to the
docket on the proposed delay, which are
summarized below.
1 For a more comprehensive discussion of the
arguments raised in the petition, please see the
March 2017 final rule (82 FR 14319 at 14320 to
14321) and the January 2018 proposed rule (83 FR
2092 at 2095). Consistent with this rule, FDA is
granting in part the petition. Specifically, we are
granting petitioners’ request for an indefinite stay
of the effective date of the amendments to the
intended use regulations (see FDA–2015–N–2002).
2 For a more comprehensive discussion of the
comments submitted to the reopened docket, please
see the January 2018 proposed rule (83 FR 2092 at
2095).
VerDate Sep<11>2014
14:39 Mar 15, 2018
Jkt 244001
II. Comments on the Proposed Rule and
FDA Responses
A. Introduction
We received 19 comments on the
proposed delay from drug and device
industries, various associations and
organizations, academia, and individual
submitters, including a health
professional and consumers. We
describe and respond to the comments
in sections II.B through II.D of this
document. We have numbered each
comment to help distinguish between
different comments. We have grouped
similar comments together under the
same number and, in some cases, we
have separated different issues
discussed in the same comment and
designated them as distinct comments
for purposes of our responses. The
number assigned to each comment or
comment topic is purely for
organizational purposes and does not
signify the comment’s value or
importance or the order in which
comments were received.
B. Description of Comments in Support
of the Delay and FDA Response
The majority of comments supported
the proposed delay and included
specific proposals and
recommendations for how FDA should
address issues related to intended use,
and amendments to §§ 201.128 and
801.4, going forward. In the following
paragraphs, we discuss and respond to
such comments.
(Comment 1) Many of the comments
expressed support for the delay based
on legal concerns with the January 2017
final rule. Among these legal concerns
were arguments that the final rule: (1)
Violates the First Amendment by
regulating truthful speech regarding
lawful activity; (2) violates the due
process clause of the Fifth Amendment
to the extent that the types of evidence
to be considered are not clearly defined;
(3) unlawfully interferes with the
practice of medicine; (4) departs from
relevant statutory text, legislative
history, case law, and FDA past
practices, and/or (5) was issued in
violation of the notice requirement
under the APA based on the inclusion
of the ‘‘totality of the evidence’’
language in that final rule. Many of
these arguments were based, at least in
part, on what commenters described as
a broadening from the September 25,
2015, proposed rule (see 80 FR 57756 at
57764 to 57765) of the types of evidence
that could be considered in determining
intended use, and specifically raised
concerns with the ‘‘totality of the
evidence’’ language included in the
January 2017 final rule.
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
(Response) We agree that it is
appropriate to delay the effective date of
the final rule and we will consider the
legal concerns raised regarding the
January 2017 final rule as we continue
to work diligently on the issues relating
to intended use raised in the underlying
rulemaking.
(Comment 2) Several of the comments
supporting the delay also included
specific proposals and
recommendations for how FDA should
address issues related to intended use,
and specifically amendments to
§§ 201.128 and 801.4, going forward.
For example, these comments stated
that FDA should:
a. Adopt the approach set forth in the
September 2015 proposed rule preamble
and codified—including deletion of the
‘‘knowledge’’ sentences in §§ 201.128
and 801.4—and ensure that all guidance
and policy documents are aligned with
that approach;
b. Withdraw the January 2017 final
rule and the ‘‘totality of the
circumstances’’ test included in that
rule;
c. Revise §§ 201.128 and 801.4 to
make them ‘‘more consistent with
applicable law’’; and/or
d. Clarify that certain types of
evidence, such as the following, do not
constitute evidence of intended use: (i)
Scientific exchange, (ii) truthful, nonmisleading communications, and/or (iii)
mere knowledge of unapproved use by
third parties, including when in
combination with non-promotional
communication.
(Response) The wide-ranging
proposals and recommendations for
how FDA should address issues related
to intended use and §§ 201.128 and
801.4 in these and other comments
underscore the complexities of the
issues involved. We believe these
comments provide additional support
for the delay of the effective date of
amendments to the existing medical
product ‘‘intended use’’ regulations. The
Agency needs more time to consider the
feedback we received, make sure that
our approach is guided by our public
health mandate, and ensure the clarity
of our rules on the subject. We will
consider these proposals and
recommendations as we continue to
work diligently on the issues relating to
intended use raised in the underlying
rulemaking.
(Comment 3) One comment stated
that the proposed rule should be
delayed due to several Federal lawsuits
involving FDA and vaping firms. That
comment further asserted that FDA
acted deceptively and violated the
Constitution, that FDA should provide
clear rulemaking procedures, that the
E:\FR\FM\16MRR1.SGM
16MRR1
Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Rules and Regulations
jstallworth on DSKBBY8HB2PROD with RULES
tobacco and medical products parts of
the rule both should not be addressed
piecemeal and should be cleanly split,
and that the docket should be closed.
(Response) To the extent the comment
intended to support the delay of the
effective date of the medical product
portions of the January 2017 final rule,
we agree. However, to the extent the
comment intended to assert that the
effective date of new § 1100.5 should
likewise be delayed, the comment is
outside the scope of this rulemaking. In
any event, we disagree that there is any
reason to delay the effective date of
§ 1100.5. As noted in the January 2018
proposed rule, when FDA reopened the
docket for the January 2017 final rule,
the Agency did not receive any
comments requesting that we further
delay the effective date of § 1100.5 or
that we make any changes to that
regulation. This comment likewise did
not suggest any changes to the substance
of that regulation. To the extent the
comment can be understood to relate to
the substance of the amendments to the
intended use regulations, we will
consider them as we continue to work
diligently on the issues relating to
intended use raised in the underlying
rulemaking.
C. Description of Comment in
Opposition to the Delay and FDA
Response
(Comment 4) One comment opposed
the proposed delay and asked that FDA
not further delay implementation of the
January 2017 final rule. The comment
expressed support for the January 2017
final rule, stating that (1) the ‘‘totality of
evidence’’ language does not lower the
relevant evidentiary standard and (2)
there has been adequate notice and
opportunity to be heard regarding the
final rule. The comment recommended
that FDA build on the approach it has
adopted in the past several years to
address intended use issues and argued
against the removal of the ‘‘knowledge’’
sentences in §§ 201.128 and 801.4.
(Response) With respect to the request
not to delay implementation of the
January 2017 final rule, under FDA
regulations, the Commissioner of Food
and Drugs (Commissioner) is authorized
to stay, including for an indefinite time
period, the effective date of any action
if the stay is in the public interest and
the interest of justice (see § 10.35(a) to
(b), (e) to (f) (21 CFR 10.35(a) to (b), (e)
to (f))). We believe that the delay is
reasonable and appropriate in light of
the complex issues under consideration
and the wide range of concerns,
proposals, and recommendations we
have received in comments from
stakeholders on these issues. In addition
VerDate Sep<11>2014
14:39 Mar 15, 2018
Jkt 244001
to these comments, the Agency received
a petition specifically requesting that
the Commissioner ‘‘indefinitely stay the
Final Rule’’ (petition at p. 1). The
petition raised a number of concerns
with the January 2017 final rule,
including constitutional concerns and
public health concerns related to what
the petition stated could be a chilling of
valuable scientific speech. While the
Agency remains committed to providing
clarity on issues relating to intended
use, we have determined that it best
serves the public health for the Agency
to take additional time to carefully
consider all of these concerns and delay
the effective date of the January 2017
final rule. The petitioners raised
significant concerns with the text of the
‘‘intended use’’ amendments, which
were echoed by several additional
commenters. The Agency does not
believe that indefinitely delaying the
effective date of the January 2017 final
rule to consider these issues will create
a public health risk. To the contrary, the
potential for confusion and uncertainty
regarding the text of the January 2017
final rule might affect FDA’s medical
product jurisdiction in ways that FDA
did not intend when it set out to clarify
the ‘‘intended use’’ regulations.
Accordingly, the Commissioner has
concluded that the delay is warranted
because it is in the public interest and
the interest of justice (see § 10.35(e)). As
noted above, we will consider the
concerns, recommendations, and
proposals set forth in these comments as
we continue to work diligently on the
issues relating to intended use raised in
the underlying rulemaking.
D. Description of Comments Outside the
Scope of This Rulemaking and FDA
Response
(Comment 5) Several comments
supported FDA suspending rulemaking
and closing the docket to address issues
related to a specific drug product.
(Response) These comments appear to
concern product-specific issues that are
outside the scope of this rulemaking.
III. Effective/Compliance Date(s)
This rule is effective March 16, 2018.
As provided at 82 FR 14319, March 20,
2017, the amendments to FDA’s existing
regulations describing the types of
evidence that may be considered in
determining a medical product’s
intended uses (§§ 201.128 (drugs) and
801.4 (devices)) will take effect on
March 19, 2018. In order to delay that
effective date, this final rule needs to be
effective on or before March 19, 2018,
and therefore it is not possible for this
rule delaying that effective date to take
effect 30 days from publication in the
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
11641
Federal Register. Thus, the
Commissioner finds good cause under
21 CFR 10.40(c)(4)(ii) to make this rule
effective on the day of publication.
IV. Economic Analysis of Impacts
We have examined the impacts of the
final rule under Executive Order 12866,
Executive Order 13563, Executive Order
13771, the Regulatory Flexibility Act (5
U.S.C. 601–612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L.
104–4). Executive Orders 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). Executive Order
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 final
rule is not a significant regulatory action
as defined by Executive Order 12866.
The final rule is not a regulatory or
deregulatory action for the purposes of
Executive Order 13771.
The Regulatory Flexibility Act
requires us to analyze regulatory options
that would minimize any significant
impact of a rule on small entities.
Because this final rule will impose
negligible costs, if any, we certify that
the final 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 issuing ‘‘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 final rule would not result in an
expenditure in any year that meets or
exceeds this amount.
We received no comments on the
proposed rule that specifically
addressed our preliminary regulatory
impact analysis. Therefore, we retain
our preliminary estimate that the final
rule will maintain the status quo for the
medical product industries and impose
no additional burden on affected
entities. In table 1, we provide the costs
E:\FR\FM\16MRR1.SGM
16MRR1
11642
Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Rules and Regulations
and benefits of the final rule in the
Regulatory Information Service Center
and Office of Information and
Regulatory Affairs Consolidated
Information Center Accounting
information.
TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF FINAL RULE
Units
Category
Primary
estimate
Low
estimate
High
estimate
Benefits:
Annualized ......................................................
Monetized $millions/year ................................
Annualized ......................................................
Quantified ........................................................
..................
..................
..................
..................
..................
..................
..................
..................
..................
..................
..................
..................
Qualitative .......................................................
Costs:
Annualized ......................................................
Monetized $millions/year ................................
Annualized ......................................................
Quantified ........................................................
Qualitative .......................................................
Transfers:
Federal ............................................................
Annualized ......................................................
Monetized $millions/year ................................
..................
..................
..................
..................
..................
..................
..................
..................
Negligible costs, if any
..................
..................
..................
From/To ..........................................................
..................
..................
..................
From/To ..........................................................
..................
..................
..................
From:
Other ...............................................................
Annualized ......................................................
Monetized $millions/year ................................
..................
..................
..................
Period
covered
(years)
From:
..................
..................
..................
..................
7
3
7
3
..................
..................
..................
..................
..................
..................
..................
7
3
7
3
10
10
..................
..................
..................
..................
..................
..................
..................
7
3
..................
..................
..................
..................
7
3
..................
Notes
10
10
..................
..................
..................
Avoid potential unintended
consequences
..................
..................
..................
..................
Discount
rate
(percent)
Year
dollars
..................
..................
..................
To:
..................
..................
..................
..................
..................
..................
..................
..................
..................
To:
Effects:
State, Local or Tribal Government: None.
Small Business: None.
Wages: None.
Growth: None.
V. Analysis of Environmental Impact
We have determined under 21 CFR
25.20(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.
VI. Paperwork Reduction Act of 1995
jstallworth on DSKBBY8HB2PROD with RULES
VII. Federalism
We have analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. We have
determined that the rule does not
contain policies that have substantial
direct effects on the States, on the
relationship between the National
14:39 Mar 15, 2018
Jkt 244001
does not contain policies that have
tribal implications as defined in the
Executive Order and, consequently, a
tribal summary impact statement is not
required.
Dated: March 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–05347 Filed 3–15–18; 8:45 am]
BILLING CODE 4164–01–P
This final rule contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
VerDate Sep<11>2014
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Accordingly, we
conclude that the 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.
VIII. Consultation and Coordination
With Indian Tribal Governments
We have analyzed this rule in
accordance with the principles set forth
in Executive Order 13175. We have
determined that the rule does not
contain policies that would have a
substantial direct effect on one or more
Indian Tribes, on the relationship
between the Federal Government and
Indian Tribes, or on the distribution of
power and responsibilities between the
Federal Government and Indian Tribes.
Accordingly, we conclude that the rule
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2018–0070]
Drawbridge Operation Regulation; St.
Johns River, Jacksonville, FL
AGENCY:
E:\FR\FM\16MRR1.SGM
Coast Guard, DHS.
16MRR1
]]>Agencies
[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Rules and Regulations]
[Pages 11639-11642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05347]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201, 801, and 1100
[Docket No. FDA-2015-N-2002]
RIN 0910-AH94
Clarification of When Products Made or Derived From Tobacco Are
Regulated as Drugs, Devices, or Combination Products; Amendments to
Regulations Regarding ``Intended Uses''; Partial Delay of Effective
Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; partial delay of effective date.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing this final rule to delay the effective date of amendments to
the existing medical product ``intended use'' regulations, contained in
the final rule published January 9, 2017, until further notice. This
final rule delays the effective date of the amendments to allow further
consideration of the substantive issues raised in the comments received
regarding the amendments. This action does not delay the effective date
of the portions of the January 9, 2017, final rule that describe the
circumstances in which a product made or derived from tobacco that is
intended for human consumption will be subject to regulation as a drug,
device, or a combination product under the Federal Food, Drug, and
Cosmetic Act (FD&C Act), which remains March 19, 2018.
DATES: Effective March 16, 2018, the amendments made to Sec. Sec.
201.128 and 801.4, revised at 82 FR 2193 (January 9, 2017), delayed at
82 FR 9501 (February 7, 2017) until March 21, 2017, and further delayed
at 82 FR 14319 (March 20, 2017) until March 19, 2018, are delayed
indefinitely. Section 1100.5, added at 82 FR 2193 (January 9, 2017),
delayed at 82 FR 9501 (February 7, 2017) until March 21, 2017, and
further delayed at 82 FR 14319 (March 20, 2017) until March 19, 2018,
is effective March 19, 2018.
ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule 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: Kelley Nduom, Center for Drug
Evaluation and Research, Office of Regulatory Policy, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6221, Silver
Spring, MD 20993, 301-796-8597, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 9, 2017 (82 FR 2193), FDA
published a final rule entitled ``Clarification of When Products Made
or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination
Products; Amendments to Regulations Regarding `Intended Uses'''
(January 2017 final rule). The final rule added a new regulation (Sec.
1100.5 (21 CFR 1100.5)) to title 21 of the Code of Federal Regulations
(CFR) to describe the circumstances in which a product made or derived
from tobacco that is intended for human consumption will be subject to
regulation as a drug, device, or a combination product under the FD&C
Act. The rule also amended FDA's existing regulations describing the
types of evidence that may be considered in determining a medical
product's intended uses (Sec. Sec. 201.128 and 801.4 (21 CFR 201.128
(drugs) and 21 CFR 801.4 (devices))).
In the Federal Register of February 7, 2017 (82 FR 9501), in
accordance with the memorandum of January 20, 2017, from the Assistant
to the President and Chief of Staff, entitled ``Regulatory Freeze
Pending Review,'' we delayed, until March 21, 2017, the effective date
of the final rule.
On February 8, 2017, various industry organizations filed a
petition raising concerns with the January 2017 final rule, requesting
reconsideration and a stay pursuant to 21 CFR 10.33(b) and 10.35(b)
(see FDA-2015-N-2002-1977). The petition requests that FDA reconsider
the amendments to the ``intended use'' regulations and issue a new
final rule that, with respect to the intended use regulations at
Sec. Sec. 201.128 and 801.4, reverts to the language of the September
25, 2015, proposed rule. The petition also requests that FDA
indefinitely stay the rule because petitioners argue that (1) the final
rule was issued in violation of the fair notice requirement under the
Administrative Procedure Act (APA) (petition at pp. 10-13) and (2) the
``totality of the evidence'' language in the final rule is
[[Page 11640]]
a new and unsupported legal standard (petition at pp. 10, 13-21).\1\
---------------------------------------------------------------------------
\1\ For a more comprehensive discussion of the arguments raised
in the petition, please see the March 2017 final rule (82 FR 14319
at 14320 to 14321) and the January 2018 proposed rule (83 FR 2092 at
2095). Consistent with this rule, FDA is granting in part the
petition. Specifically, we are granting petitioners' request for an
indefinite stay of the effective date of the amendments to the
intended use regulations (see FDA-2015-N-2002).
---------------------------------------------------------------------------
In the Federal Register of March 20, 2017 (82 FR 14319), we further
delayed the effective date of the final rule until March 19, 2018, and
reopened the docket to invite additional public comment on the rule.
Fifteen comments were submitted to the docket in response. Two of the
comments submitted to the docket related to the new regulation included
in the final rule that describes circumstances in which a product made
or derived from tobacco that is intended for human consumption will be
subject to regulation as a drug, device, or a combination product under
the FD&C Act (Sec. 1100.5). Neither comment requested a delay in the
effective date of that new regulation. The remainder of the comments
related to the amendments to FDA's existing regulations describing the
types of evidence that may be considered in determining a medical
product's intended use (Sec. Sec. 201.128 and 801.4). Many of these
comments opposed what they described as a broadening from the September
25, 2015, proposed rule (see 80 FR 57756 at 57764 to 57765) of the
types of evidence that could be considered in determining intended use,
and specifically raised concerns with the ``totality of the evidence''
language included in the final rule.\2\
---------------------------------------------------------------------------
\2\ For a more comprehensive discussion of the comments
submitted to the reopened docket, please see the January 2018
proposed rule (83 FR 2092 at 2095).
---------------------------------------------------------------------------
To allow for further consideration of the substantive issues raised
in these comments, in the Federal Register of January 16, 2018 (83 FR
2092) (January 2018 proposed rule), we proposed to delay the effective
date of the amendments to the existing medical product ``intended use''
regulations contained in the January 2017 final rule, until further
notice (Sec. Sec. 201.128 and 801.4). We did not propose to delay the
effective date of the portions of the final rule that issued a new
regulation regarding products made or derived from tobacco that are
intended for human consumption (Sec. 1100.5). The Agency received 19
comments to the docket on the proposed delay, which are summarized
below.
II. Comments on the Proposed Rule and FDA Responses
A. Introduction
We received 19 comments on the proposed delay from drug and device
industries, various associations and organizations, academia, and
individual submitters, including a health professional and consumers.
We describe and respond to the comments in sections II.B through II.D
of this document. We have numbered each comment to help distinguish
between different comments. We have grouped similar comments together
under the same number and, in some cases, we have separated different
issues discussed in the same comment and designated them as distinct
comments for purposes of our responses. The number assigned to each
comment or comment topic is purely for organizational purposes and does
not signify the comment's value or importance or the order in which
comments were received.
B. Description of Comments in Support of the Delay and FDA Response
The majority of comments supported the proposed delay and included
specific proposals and recommendations for how FDA should address
issues related to intended use, and amendments to Sec. Sec. 201.128
and 801.4, going forward. In the following paragraphs, we discuss and
respond to such comments.
(Comment 1) Many of the comments expressed support for the delay
based on legal concerns with the January 2017 final rule. Among these
legal concerns were arguments that the final rule: (1) Violates the
First Amendment by regulating truthful speech regarding lawful
activity; (2) violates the due process clause of the Fifth Amendment to
the extent that the types of evidence to be considered are not clearly
defined; (3) unlawfully interferes with the practice of medicine; (4)
departs from relevant statutory text, legislative history, case law,
and FDA past practices, and/or (5) was issued in violation of the
notice requirement under the APA based on the inclusion of the
``totality of the evidence'' language in that final rule. Many of these
arguments were based, at least in part, on what commenters described as
a broadening from the September 25, 2015, proposed rule (see 80 FR
57756 at 57764 to 57765) of the types of evidence that could be
considered in determining intended use, and specifically raised
concerns with the ``totality of the evidence'' language included in the
January 2017 final rule.
(Response) We agree that it is appropriate to delay the effective
date of the final rule and we will consider the legal concerns raised
regarding the January 2017 final rule as we continue to work diligently
on the issues relating to intended use raised in the underlying
rulemaking.
(Comment 2) Several of the comments supporting the delay also
included specific proposals and recommendations for how FDA should
address issues related to intended use, and specifically amendments to
Sec. Sec. 201.128 and 801.4, going forward. For example, these
comments stated that FDA should:
a. Adopt the approach set forth in the September 2015 proposed rule
preamble and codified--including deletion of the ``knowledge''
sentences in Sec. Sec. 201.128 and 801.4--and ensure that all guidance
and policy documents are aligned with that approach;
b. Withdraw the January 2017 final rule and the ``totality of the
circumstances'' test included in that rule;
c. Revise Sec. Sec. 201.128 and 801.4 to make them ``more
consistent with applicable law''; and/or
d. Clarify that certain types of evidence, such as the following,
do not constitute evidence of intended use: (i) Scientific exchange,
(ii) truthful, non-misleading communications, and/or (iii) mere
knowledge of unapproved use by third parties, including when in
combination with non-promotional communication.
(Response) The wide-ranging proposals and recommendations for how
FDA should address issues related to intended use and Sec. Sec.
201.128 and 801.4 in these and other comments underscore the
complexities of the issues involved. We believe these comments provide
additional support for the delay of the effective date of amendments to
the existing medical product ``intended use'' regulations. The Agency
needs more time to consider the feedback we received, make sure that
our approach is guided by our public health mandate, and ensure the
clarity of our rules on the subject. We will consider these proposals
and recommendations as we continue to work diligently on the issues
relating to intended use raised in the underlying rulemaking.
(Comment 3) One comment stated that the proposed rule should be
delayed due to several Federal lawsuits involving FDA and vaping firms.
That comment further asserted that FDA acted deceptively and violated
the Constitution, that FDA should provide clear rulemaking procedures,
that the
[[Page 11641]]
tobacco and medical products parts of the rule both should not be
addressed piecemeal and should be cleanly split, and that the docket
should be closed.
(Response) To the extent the comment intended to support the delay
of the effective date of the medical product portions of the January
2017 final rule, we agree. However, to the extent the comment intended
to assert that the effective date of new Sec. 1100.5 should likewise
be delayed, the comment is outside the scope of this rulemaking. In any
event, we disagree that there is any reason to delay the effective date
of Sec. 1100.5. As noted in the January 2018 proposed rule, when FDA
reopened the docket for the January 2017 final rule, the Agency did not
receive any comments requesting that we further delay the effective
date of Sec. 1100.5 or that we make any changes to that regulation.
This comment likewise did not suggest any changes to the substance of
that regulation. To the extent the comment can be understood to relate
to the substance of the amendments to the intended use regulations, we
will consider them as we continue to work diligently on the issues
relating to intended use raised in the underlying rulemaking.
C. Description of Comment in Opposition to the Delay and FDA Response
(Comment 4) One comment opposed the proposed delay and asked that
FDA not further delay implementation of the January 2017 final rule.
The comment expressed support for the January 2017 final rule, stating
that (1) the ``totality of evidence'' language does not lower the
relevant evidentiary standard and (2) there has been adequate notice
and opportunity to be heard regarding the final rule. The comment
recommended that FDA build on the approach it has adopted in the past
several years to address intended use issues and argued against the
removal of the ``knowledge'' sentences in Sec. Sec. 201.128 and 801.4.
(Response) With respect to the request not to delay implementation
of the January 2017 final rule, under FDA regulations, the Commissioner
of Food and Drugs (Commissioner) is authorized to stay, including for
an indefinite time period, the effective date of any action if the stay
is in the public interest and the interest of justice (see Sec.
10.35(a) to (b), (e) to (f) (21 CFR 10.35(a) to (b), (e) to (f))). We
believe that the delay is reasonable and appropriate in light of the
complex issues under consideration and the wide range of concerns,
proposals, and recommendations we have received in comments from
stakeholders on these issues. In addition to these comments, the Agency
received a petition specifically requesting that the Commissioner
``indefinitely stay the Final Rule'' (petition at p. 1). The petition
raised a number of concerns with the January 2017 final rule, including
constitutional concerns and public health concerns related to what the
petition stated could be a chilling of valuable scientific speech.
While the Agency remains committed to providing clarity on issues
relating to intended use, we have determined that it best serves the
public health for the Agency to take additional time to carefully
consider all of these concerns and delay the effective date of the
January 2017 final rule. The petitioners raised significant concerns
with the text of the ``intended use'' amendments, which were echoed by
several additional commenters. The Agency does not believe that
indefinitely delaying the effective date of the January 2017 final rule
to consider these issues will create a public health risk. To the
contrary, the potential for confusion and uncertainty regarding the
text of the January 2017 final rule might affect FDA's medical product
jurisdiction in ways that FDA did not intend when it set out to clarify
the ``intended use'' regulations.
Accordingly, the Commissioner has concluded that the delay is
warranted because it is in the public interest and the interest of
justice (see Sec. 10.35(e)). As noted above, we will consider the
concerns, recommendations, and proposals set forth in these comments as
we continue to work diligently on the issues relating to intended use
raised in the underlying rulemaking.
D. Description of Comments Outside the Scope of This Rulemaking and FDA
Response
(Comment 5) Several comments supported FDA suspending rulemaking
and closing the docket to address issues related to a specific drug
product.
(Response) These comments appear to concern product-specific issues
that are outside the scope of this rulemaking.
III. Effective/Compliance Date(s)
This rule is effective March 16, 2018. As provided at 82 FR 14319,
March 20, 2017, the amendments to FDA's existing regulations describing
the types of evidence that may be considered in determining a medical
product's intended uses (Sec. Sec. 201.128 (drugs) and 801.4
(devices)) will take effect on March 19, 2018. In order to delay that
effective date, this final rule needs to be effective on or before
March 19, 2018, and therefore it is not possible for this rule delaying
that effective date to take effect 30 days from publication in the
Federal Register. Thus, the Commissioner finds good cause under 21 CFR
10.40(c)(4)(ii) to make this rule effective on the day of publication.
IV. Economic Analysis of Impacts
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 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). Executive Order 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 final rule is not a significant regulatory action as
defined by Executive Order 12866. The final rule is not a regulatory or
deregulatory action for the purposes of Executive Order 13771.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this final rule will impose negligible costs, if any,
we certify that the final 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 issuing ``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 final rule would not result in an
expenditure in any year that meets or exceeds this amount.
We received no comments on the proposed rule that specifically
addressed our preliminary regulatory impact analysis. Therefore, we
retain our preliminary estimate that the final rule will maintain the
status quo for the medical product industries and impose no additional
burden on affected entities. In table 1, we provide the costs
[[Page 11642]]
and benefits of the final rule in the Regulatory Information Service
Center and Office of Information and Regulatory Affairs Consolidated
Information Center Accounting information.
Table 1--Summary of Benefits, Costs and Distributional Effects of Final Rule
----------------------------------------------------------------------------------------------------------------
Units
------------------------------------
Category Primary Low High Discount Period Notes
estimate estimate estimate Year rate covered
dollars (percent) (years)
----------------------------------------------------------------------------------------------------------------
Benefits:
Annualized.............. .......... .......... .......... .......... 7 10
Monetized $millions/year .......... .......... .......... .......... 3 10
Annualized.............. .......... .......... .......... .......... 7 ..........
Quantified.............. .......... .......... .......... .......... 3 ..........
------------------------------------------------------------------------
Qualitative............. Avoid potential unintended .......... .......... ..........
consequences
----------------------------------------------------------------------------------------------------------------
Costs:
Annualized.............. .......... .......... .......... .......... 7 10
Monetized $millions/year .......... .......... .......... .......... 3 10
Annualized.............. .......... .......... .......... .......... 7 ..........
Quantified.............. .......... .......... .......... .......... 3 ..........
------------------------------------------------------------------------
Qualitative............. Negligible costs, if any .......... .......... ..........
----------------------------------------------------------------------------------------------------------------
Transfers:
Federal................. .......... .......... .......... .......... 7 ..........
Annualized.............. .......... .......... .......... .......... 3 ..........
Monetized $millions/year .......... .......... .......... .......... .......... ..........
------------------------------------------------------------------------
From/To................. From:
To:
------------------------------------------------------------------------
Other................... .......... .......... .......... .......... 7 ..........
Annualized.............. .......... .......... .......... .......... 3 ..........
Monetized $millions/year .......... .......... .......... .......... .......... ..........
------------------------------------------------------------------------
From/To................. From:
To:
----------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: None.....................................................................
Small Business: None........................................................................................
Wages: None.................................................................................................
Growth: None................................................................................................
----------------------------------------------------------------------------------------------------------------
V. Analysis of Environmental Impact
We have determined under 21 CFR 25.20(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.
VI. Paperwork Reduction Act of 1995
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
VII. Federalism
We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the rule
does not contain policies that 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 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.
VIII. Consultation and Coordination With Indian Tribal Governments
We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that would have a substantial direct effect on one
or more Indian Tribes, on the relationship between the Federal
Government and Indian Tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian Tribes.
Accordingly, we conclude that the rule does not contain policies that
have tribal implications as defined in the Executive Order and,
consequently, a tribal summary impact statement is not required.
Dated: March 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05347 Filed 3-15-18; 8:45 am]
BILLING CODE 4164-01-P
