83_FR_11691 83 FR 11639 - 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

83 FR 11639 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 52 (March 16, 2018)

Page Range11639-11642
FR Document2018-05347

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.

Federal Register, Volume 83 Issue 52 (Friday, March 16, 2018) 
[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Rules and Regulations]
[Pages 11639-11642]
From the Federal Register Online  [www.thefederalregister.org]
[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\
---------------------------------------------------------------------------

    \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

Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Rules and Regulations 11639 of Federal Regulations, which action DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: was approved by the Director of the HUMAN SERVICES Kelley Nduom, Center for Drug Federal Register in accordance with 5 Evaluation and Research, Office of U.S.C. 552(a) and 1 CFR part 51. You Food and Drug Administration Regulatory Policy, Food and Drug must comply with these requirements in Administration, 10903 New Hampshire order for documents to be timely 21 CFR Parts 201, 801, and 1100 Ave., Bldg. 51, Rm. 6221, Silver Spring, received and accepted. The EDGAR [Docket No. FDA–2015–N–2002] MD 20993, 301–796–8597, Filer Manual is available for website kelley.nduom@fda.hhs.gov. RIN 0910–AH94 viewing and printing; the address for SUPPLEMENTARY INFORMATION: the Filer Manual is https://www.sec.gov/ Clarification of When Products Made info/edgar/edmanuals.htm. You can or Derived From Tobacco Are I. Background obtain paper copies of the EDGAR Filer Regulated as Drugs, Devices, or Manual from the following address: In the Federal Register of January 9, Combination Products; Amendments Public Reference Room, U.S. Securities to Regulations Regarding ‘‘Intended 2017 (82 FR 2193), FDA published a and Exchange Commission, 100 F Street Uses’’; Partial Delay of Effective Date final rule entitled ‘‘Clarification of NE, Washington, DC 20549, on official When Products Made or Derived From AGENCY: Food and Drug Administration, Tobacco Are Regulated as Drugs, business days between the hours of HHS. Devices, or Combination Products; 10:00 a.m. and 3:00 p.m. You can also ACTION: Final rule; partial delay of Amendments to Regulations Regarding inspect the document at the National effective date. ‘Intended Uses’’’ (January 2017 final Archives and Records Administration (NARA). For information on the rule). The final rule added a new SUMMARY: The Food and Drug availability of this material at NARA, regulation (§ 1100.5 (21 CFR 1100.5)) to Administration (FDA, the Agency, or call 202–741–6030, or go to: https:// we) is issuing this final rule to delay the title 21 of the Code of Federal www.archives.gov/federal-register/cfr/ effective date of amendments to the Regulations (CFR) to describe the ibr-locations.html. existing medical product ‘‘intended circumstances in which a product made use’’ regulations, contained in the final or derived from tobacco that is intended PART 274—FORMS PRESCRIBED rule published January 9, 2017, until for human consumption will be subject UNDER THE INVESTMENT COMPANY further notice. This final rule delays the to regulation as a drug, device, or a ACT OF 1940 effective date of the amendments to combination product under the FD&C allow further consideration of the Act. The rule also amended FDA’s ■ 3. The authority citation for part 274 substantive issues raised in the existing regulations describing the types continues to read in part as follows: comments received regarding the of evidence that may be considered in amendments. This action does not delay determining a medical product’s Authority: 15 U.S.C. 77f, 77g, 77h, 77j, 77s, the effective date of the portions of the intended uses (§§ 201.128 and 801.4 (21 78c(b), 78l, 78m, 78n, 78o(d), 80a–8, 80a–24, January 9, 2017, final rule that describe CFR 201.128 (drugs) and 21 CFR 801.4 80a–26, 80a–29, and Pub. L. 111–203, sec. the circumstances in which a product (devices))). 939A, 124 Stat. 1376 (2010), unless otherwise made or derived from tobacco that is In the Federal Register of February 7, noted. intended for human consumption will * * * * * 2017 (82 FR 9501), in accordance with be subject to regulation as a drug, the memorandum of January 20, 2017, ■ 4. Form ID (referenced in §§ 239.63, device, or a combination product under the Federal Food, Drug, and Cosmetic from the Assistant to the President and 249.446, 269.7 and 274.402 of this Chief of Staff, entitled ‘‘Regulatory chapter) is amended to add in ‘‘PART Act (FD&C Act), which remains March 19, 2018. Freeze Pending Review,’’ we delayed, I—APPLICATION FOR ACCESS CODES until March 21, 2017, the effective date TO FILE ON EDGAR’’ the following text DATES: Effective March 16, 2018, the amendments made to §§ 201.128 and of the final rule. and checkbox ‘‘Access codes will be 801.4, revised at 82 FR 2193 (January 9, On February 8, 2017, various industry used to submit draft registration or draft 2017), delayed at 82 FR 9501 (February organizations filed a petition raising offering statement. b’’ 7, 2017) until March 21, 2017, and concerns with the January 2017 final Note: The text of Form ID does not, and the further delayed at 82 FR 14319 (March rule, requesting reconsideration and a amendment will not, appear in the Code of 20, 2017) until March 19, 2018, are stay pursuant to 21 CFR 10.33(b) and Federal Regulations. delayed indefinitely. Section 1100.5, 10.35(b) (see FDA–2015–N–2002–1977). added at 82 FR 2193 (January 9, 2017), The petition requests that FDA By the Commission. delayed at 82 FR 9501 (February 7, reconsider the amendments to the Dated: March 8, 2018. 2017) until March 21, 2017, and further ‘‘intended use’’ regulations and issue a Brent J. Fields, delayed at 82 FR 14319 (March 20, new final rule that, with respect to the Secretary. 2017) until March 19, 2018, is effective intended use regulations at §§ 201.128 [FR Doc. 2018–05238 Filed 3–15–18; 8:45 am] March 19, 2018. and 801.4, reverts to the language of the BILLING CODE 8011–01–P ADDRESSES: For access to the docket to September 25, 2015, proposed rule. The read background documents or petition also requests that FDA comments received, go to https:// indefinitely stay the rule because jstallworth on DSKBBY8HB2PROD with RULES www.regulations.gov and insert the petitioners argue that (1) the final rule docket number found in brackets in the was issued in violation of the fair notice heading of this final rule into the requirement under the Administrative ‘‘Search’’ box and follow the prompts, Procedure Act (APA) (petition at pp. and/or go to the Dockets Management 10–13) and (2) the ‘‘totality of the Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. evidence’’ language in the final rule is VerDate Sep<11>2014 14:39 Mar 15, 2018 Jkt 244001 PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 E:\FR\FM\16MRR1.SGM 16MRR1

11640 Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Rules and Regulations a new and unsupported legal standard II. Comments on the Proposed Rule and (Response) We agree that it is (petition at pp. 10, 13–21).1 FDA Responses appropriate to delay the effective date of In the Federal Register of March 20, the final rule and we will consider the A. Introduction 2017 (82 FR 14319), we further delayed legal concerns raised regarding the We received 19 comments on the January 2017 final rule as we continue the effective date of the final rule until proposed delay from drug and device to work diligently on the issues relating March 19, 2018, and reopened the industries, various associations and to intended use raised in the underlying docket to invite additional public organizations, academia, and individual rulemaking. comment on the rule. Fifteen comments submitters, including a health (Comment 2) Several of the comments were submitted to the docket in professional and consumers. We supporting the delay also included response. Two of the comments describe and respond to the comments specific proposals and submitted to the docket related to the in sections II.B through II.D of this recommendations for how FDA should new regulation included in the final document. We have numbered each address issues related to intended use, rule that describes circumstances in comment to help distinguish between and specifically amendments to which a product made or derived from different comments. We have grouped §§ 201.128 and 801.4, going forward. tobacco that is intended for human similar comments together under the For example, these comments stated consumption will be subject to same number and, in some cases, we that FDA should: regulation as a drug, device, or a have separated different issues a. Adopt the approach set forth in the combination product under the FD&C discussed in the same comment and September 2015 proposed rule preamble Act (§ 1100.5). Neither comment designated them as distinct comments and codified—including deletion of the requested a delay in the effective date of for purposes of our responses. The ‘‘knowledge’’ sentences in §§ 201.128 that new regulation. The remainder of number assigned to each comment or and 801.4—and ensure that all guidance the comments related to the comment topic is purely for and policy documents are aligned with amendments to FDA’s existing organizational purposes and does not that approach; regulations describing the types of signify the comment’s value or b. Withdraw the January 2017 final evidence that may be considered in importance or the order in which rule and the ‘‘totality of the determining a medical product’s comments were received. circumstances’’ test included in that intended use (§§ 201.128 and 801.4). rule; B. Description of Comments in Support c. Revise §§ 201.128 and 801.4 to Many of these comments opposed what of the Delay and FDA Response they described as a broadening from the make them ‘‘more consistent with The majority of comments supported applicable law’’; and/or September 25, 2015, proposed rule (see the proposed delay and included d. Clarify that certain types of 80 FR 57756 at 57764 to 57765) of the specific proposals and evidence, such as the following, do not types of evidence that could be recommendations for how FDA should constitute evidence of intended use: (i) considered in determining intended use, address issues related to intended use, Scientific exchange, (ii) truthful, non- and specifically raised concerns with and amendments to §§ 201.128 and misleading communications, and/or (iii) the ‘‘totality of the evidence’’ language 801.4, going forward. In the following mere knowledge of unapproved use by included in the final rule.2 paragraphs, we discuss and respond to third parties, including when in To allow for further consideration of such comments. combination with non-promotional the substantive issues raised in these (Comment 1) Many of the comments communication. comments, in the Federal Register of expressed support for the delay based (Response) The wide-ranging January 16, 2018 (83 FR 2092) (January on legal concerns with the January 2017 proposals and recommendations for 2018 proposed rule), we proposed to final rule. Among these legal concerns how FDA should address issues related delay the effective date of the were arguments that the final rule: (1) to intended use and §§ 201.128 and amendments to the existing medical Violates the First Amendment by 801.4 in these and other comments product ‘‘intended use’’ regulations regulating truthful speech regarding underscore the complexities of the contained in the January 2017 final rule, lawful activity; (2) violates the due issues involved. We believe these until further notice (§§ 201.128 and process clause of the Fifth Amendment comments provide additional support 801.4). We did not propose to delay the to the extent that the types of evidence for the delay of the effective date of effective date of the portions of the final to be considered are not clearly defined; amendments to the existing medical rule that issued a new regulation (3) unlawfully interferes with the product ‘‘intended use’’ regulations. The regarding products made or derived practice of medicine; (4) departs from Agency needs more time to consider the from tobacco that are intended for relevant statutory text, legislative feedback we received, make sure that human consumption (§ 1100.5). The history, case law, and FDA past our approach is guided by our public Agency received 19 comments to the practices, and/or (5) was issued in health mandate, and ensure the clarity docket on the proposed delay, which are violation of the notice requirement of our rules on the subject. We will summarized below. under the APA based on the inclusion consider these proposals and of the ‘‘totality of the evidence’’ recommendations as we continue to 1 For a more comprehensive discussion of the language in that final rule. Many of work diligently on the issues relating to arguments raised in the petition, please see the these arguments were based, at least in intended use raised in the underlying March 2017 final rule (82 FR 14319 at 14320 to part, on what commenters described as rulemaking. 14321) and the January 2018 proposed rule (83 FR a broadening from the September 25, (Comment 3) One comment stated jstallworth on DSKBBY8HB2PROD with RULES 2092 at 2095). Consistent with this rule, FDA is granting in part the petition. Specifically, we are 2015, proposed rule (see 80 FR 57756 at that the proposed rule should be granting petitioners’ request for an indefinite stay 57764 to 57765) of the types of evidence delayed due to several Federal lawsuits of the effective date of the amendments to the that could be considered in determining involving FDA and vaping firms. That intended use regulations (see FDA–2015–N–2002). intended use, and specifically raised comment further asserted that FDA 2 For a more comprehensive discussion of the comments submitted to the reopened docket, please concerns with the ‘‘totality of the acted deceptively and violated the see the January 2018 proposed rule (83 FR 2092 at evidence’’ language included in the Constitution, that FDA should provide 2095). January 2017 final rule. clear rulemaking procedures, that the VerDate Sep<11>2014 14:39 Mar 15, 2018 Jkt 244001 PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 E:\FR\FM\16MRR1.SGM 16MRR1

Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Rules and Regulations 11641 tobacco and medical products parts of to these comments, the Agency received Federal Register. Thus, the the rule both should not be addressed a petition specifically requesting that Commissioner finds good cause under piecemeal and should be cleanly split, the Commissioner ‘‘indefinitely stay the 21 CFR 10.40(c)(4)(ii) to make this rule and that the docket should be closed. Final Rule’’ (petition at p. 1). The effective on the day of publication. (Response) To the extent the comment petition raised a number of concerns intended to support the delay of the IV. Economic Analysis of Impacts with the January 2017 final rule, effective date of the medical product including constitutional concerns and We have examined the impacts of the portions of the January 2017 final rule, public health concerns related to what final rule under Executive Order 12866, we agree. However, to the extent the the petition stated could be a chilling of Executive Order 13563, Executive Order comment intended to assert that the valuable scientific speech. While the 13771, the Regulatory Flexibility Act (5 effective date of new § 1100.5 should Agency remains committed to providing U.S.C. 601–612), and the Unfunded likewise be delayed, the comment is clarity on issues relating to intended Mandates Reform Act of 1995 (Pub. L. outside the scope of this rulemaking. In use, we have determined that it best 104–4). Executive Orders 12866 and any event, we disagree that there is any serves the public health for the Agency 13563 direct us to assess all costs and reason to delay the effective date of to take additional time to carefully benefits of available regulatory § 1100.5. As noted in the January 2018 consider all of these concerns and delay alternatives and, when regulation is proposed rule, when FDA reopened the the effective date of the January 2017 necessary, to select regulatory docket for the January 2017 final rule, final rule. The petitioners raised approaches that maximize net benefits the Agency did not receive any significant concerns with the text of the (including potential economic, comments requesting that we further ‘‘intended use’’ amendments, which environmental, public health and safety, delay the effective date of § 1100.5 or were echoed by several additional and other advantages; distributive that we make any changes to that commenters. The Agency does not impacts; and equity). Executive Order regulation. This comment likewise did believe that indefinitely delaying the 13771 requires that the costs associated not suggest any changes to the substance effective date of the January 2017 final with significant new regulations ‘‘shall, of that regulation. To the extent the rule to consider these issues will create to the extent permitted by law, be offset comment can be understood to relate to a public health risk. To the contrary, the by the elimination of existing costs the substance of the amendments to the potential for confusion and uncertainty associated with at least two prior intended use regulations, we will regarding the text of the January 2017 regulations.’’ We believe that this final consider them as we continue to work final rule might affect FDA’s medical rule is not a significant regulatory action diligently on the issues relating to product jurisdiction in ways that FDA as defined by Executive Order 12866. intended use raised in the underlying did not intend when it set out to clarify The final rule is not a regulatory or rulemaking. the ‘‘intended use’’ regulations. deregulatory action for the purposes of Accordingly, the Commissioner has Executive Order 13771. C. Description of Comment in The Regulatory Flexibility Act Opposition to the Delay and FDA concluded that the delay is warranted because it is in the public interest and requires us to analyze regulatory options Response that would minimize any significant the interest of justice (see § 10.35(e)). As (Comment 4) One comment opposed noted above, we will consider the impact of a rule on small entities. the proposed delay and asked that FDA concerns, recommendations, and Because this final rule will impose not further delay implementation of the proposals set forth in these comments as negligible costs, if any, we certify that January 2017 final rule. The comment we continue to work diligently on the the final rule will not have a significant expressed support for the January 2017 issues relating to intended use raised in economic impact on a substantial final rule, stating that (1) the ‘‘totality of the underlying rulemaking. number of small entities. evidence’’ language does not lower the The Unfunded Mandates Reform Act relevant evidentiary standard and (2) D. Description of Comments Outside the of 1995 (section 202(a)) requires us to there has been adequate notice and Scope of This Rulemaking and FDA prepare a written statement, which opportunity to be heard regarding the Response includes an assessment of anticipated final rule. The comment recommended (Comment 5) Several comments costs and benefits, before issuing ‘‘any that FDA build on the approach it has supported FDA suspending rulemaking rule that includes any Federal mandate adopted in the past several years to and closing the docket to address issues that may result in the expenditure by address intended use issues and argued related to a specific drug product. State, local, and tribal governments, in against the removal of the ‘‘knowledge’’ (Response) These comments appear to the aggregate, or by the private sector, of sentences in §§ 201.128 and 801.4. concern product-specific issues that are $100,000,000 or more (adjusted (Response) With respect to the request outside the scope of this rulemaking. annually for inflation) in any one year.’’ not to delay implementation of the The current threshold after adjustment January 2017 final rule, under FDA III. Effective/Compliance Date(s) for inflation is $148 million, using the regulations, the Commissioner of Food This rule is effective March 16, 2018. most current (2016) Implicit Price and Drugs (Commissioner) is authorized As provided at 82 FR 14319, March 20, Deflator for the Gross Domestic Product. to stay, including for an indefinite time 2017, the amendments to FDA’s existing This final rule would not result in an period, the effective date of any action regulations describing the types of expenditure in any year that meets or if the stay is in the public interest and evidence that may be considered in exceeds this amount. the interest of justice (see § 10.35(a) to determining a medical product’s We received no comments on the (b), (e) to (f) (21 CFR 10.35(a) to (b), (e) intended uses (§§ 201.128 (drugs) and proposed rule that specifically jstallworth on DSKBBY8HB2PROD with RULES to (f))). We believe that the delay is 801.4 (devices)) will take effect on addressed our preliminary regulatory reasonable and appropriate in light of March 19, 2018. In order to delay that impact analysis. Therefore, we retain the complex issues under consideration effective date, this final rule needs to be our preliminary estimate that the final and the wide range of concerns, effective on or before March 19, 2018, rule will maintain the status quo for the proposals, and recommendations we and therefore it is not possible for this medical product industries and impose have received in comments from rule delaying that effective date to take no additional burden on affected stakeholders on these issues. In addition effect 30 days from publication in the entities. In table 1, we provide the costs VerDate Sep<11>2014 14:39 Mar 15, 2018 Jkt 244001 PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 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 and Office of Information and Information Center Accounting Regulatory Information Service Center Regulatory Affairs Consolidated information. TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF FINAL RULE Units Primary Low High Category 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 Government and the States, or on the does not contain policies that have We have determined under 21 CFR distribution of power and tribal implications as defined in the 25.20(h) that this action is of a type that responsibilities among the various Executive Order and, consequently, a does not individually or cumulatively levels of government. Accordingly, we tribal summary impact statement is not have a significant effect on the human conclude that the rule does not contain required. environment. Therefore, neither an policies that have federalism Dated: March 12, 2018. environmental assessment nor an implications as defined in the Executive Leslie Kux, environmental impact statement is Order and, consequently, a federalism Associate Commissioner for Policy. required. summary impact statement is not [FR Doc. 2018–05347 Filed 3–15–18; 8:45 am] required. VI. Paperwork Reduction Act of 1995 BILLING CODE 4164–01–P VIII. Consultation and Coordination This final rule contains no collection With Indian Tribal Governments of information. Therefore, clearance by the Office of Management and Budget We have analyzed this rule in DEPARTMENT OF HOMELAND under the Paperwork Reduction Act of accordance with the principles set forth SECURITY 1995 is not required. in Executive Order 13175. We have determined that the rule does not Coast Guard VII. Federalism contain policies that would have a jstallworth on DSKBBY8HB2PROD with RULES We have analyzed this final rule in substantial direct effect on one or more 33 CFR Part 117 accordance with the principles set forth Indian Tribes, on the relationship in Executive Order 13132. We have between the Federal Government and [Docket No. USCG–2018–0070] determined that the rule does not Indian Tribes, or on the distribution of Drawbridge Operation Regulation; St. contain policies that have substantial power and responsibilities between the Johns River, Jacksonville, FL direct effects on the States, on the Federal Government and Indian Tribes. relationship between the National Accordingly, we conclude that the rule AGENCY: Coast Guard, DHS. VerDate Sep<11>2014 14:39 Mar 15, 2018 Jkt 244001 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\16MRR1.SGM 16MRR1


Document Created: 2018-03-16 01:12:20
Document Modified: 2018-03-16 01:12:20
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; partial delay of effective date.
DatesEffective 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.
ContactKelley 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]
FR Citation83 FR 11639 
RIN Number0910-AH94
CFR Citation21 CFR 1100
21 CFR 201
21 CFR 801
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