[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]


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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.

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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\
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    \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).
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    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\
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    \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).
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    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
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                                                                                 Units
                                                                 ------------------------------------
          Category              Primary       Low        High                  Discount     Period       Notes
                               estimate    estimate    estimate      Year        rate       covered
                                                                    dollars    (percent)    (years)
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Benefits:
    Annualized..............  ..........  ..........  ..........  ..........           7          10
    Monetized $millions/year  ..........  ..........  ..........  ..........           3          10
    Annualized..............  ..........  ..........  ..........  ..........           7  ..........
    Quantified..............  ..........  ..........  ..........  ..........           3  ..........
                             ------------------------------------------------------------------------
    Qualitative.............      Avoid potential unintended      ..........  ..........  ..........
                                         consequences
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Costs:
    Annualized..............  ..........  ..........  ..........  ..........           7          10
    Monetized $millions/year  ..........  ..........  ..........  ..........           3          10
    Annualized..............  ..........  ..........  ..........  ..........           7  ..........
    Quantified..............  ..........  ..........  ..........  ..........           3  ..........
                             ------------------------------------------------------------------------
    Qualitative.............       Negligible costs, if any       ..........  ..........  ..........
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Transfers:
    Federal.................  ..........  ..........  ..........  ..........           7  ..........
    Annualized..............  ..........  ..........  ..........  ..........           3  ..........
    Monetized $millions/year  ..........  ..........  ..........  ..........  ..........  ..........
                             ------------------------------------------------------------------------
    From/To.................  From:
                              To:
                             ------------------------------------------------------------------------
    Other...................  ..........  ..........  ..........  ..........           7  ..........
    Annualized..............  ..........  ..........  ..........  ..........           3  ..........
    Monetized $millions/year  ..........  ..........  ..........  ..........  ..........  ..........
                             ------------------------------------------------------------------------
    From/To.................  From:
                              To:
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Effects:
    State, Local or Tribal Government: None.....................................................................
    Small Business: None........................................................................................
    Wages: None.................................................................................................
    Growth: None................................................................................................
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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


