Document ID: FDA-2015-N-2002-2008
Agency: fda
Document Type: Proposed Rule
Title: Clarification of When Products Made or Derived From Tobacco Are
Regulated as Drugs, Devices, or Combination Products; Amendments
to Regulations Regarding ‘‘Intended Uses’’; Proposed Partial Delay of
Effective Date
Posted Date: 2018-01-16T05:00Z

[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)]
[Proposed Rules]
[Pages 2092-2097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00555]

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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''; Proposed Partial Delay of 
Effective Date

AGENCY: Food and Drug Administration, HHS.

[[Page 2093]]

ACTION: Proposed rule; partial delay of effective date.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
proposing to delay the effective date of certain portions of a final 
rule published in the Federal Register of January 9, 2017. In the 
Federal Register of February 7, 2017, we delayed until March 21, 2017, 
the effective date of the final rule. In the Federal Register of March 
20, 2017, we further delayed the effective date of the final rule until 
March 19, 2018, and invited public comment on the rule. This action, if 
finalized, will delay until further notice the effective date of the 
portions of the final rule amending FDA's existing regulations 
describing the types of evidence that may be considered in determining 
a medical product's intended uses. FDA received a number of comments on 
the final rule that raise questions about the amendments to the 
existing medical product ``intended use'' regulations. FDA is proposing 
to delay the effective date of the amendments to the existing medical 
product ``intended use'' regulations to allow further consideration of 
the substantive issues raised in the comments received. This action, if 
finalized, will not further delay the effective date of the new 
regulation that describes 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).

DATES: Submit either electronic or written comments on this proposed 
rule by February 5, 2018.

ADDRESSES: You may submit comments on the proposed rule for partial 
delay as follows. Electronic comments must be submitted on or before 
February 5, 2018. The https://www.regulations.gov electronic filing 
system will accept comments until midnight Eastern Time at the end of 
February 5, 2018. Comments received by mail/hand delivery/courier (for 
written/paper submissions) will be considered timely if they are 
postmarked or the delivery service acceptance receipt is on or before 
that date. Please note that late, untimely filed comments will not be 
considered.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions.'')

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-2002 for ``Clarification of When Products Made or Derived 
from Tobacco Are Regulated as Drugs, Devices, or Combination Products; 
Amendments to Regulations Regarding `Intended Uses'; Proposed Partial 
Delay of Effective Date.'' Received comments, those filed in a timely 
manner (see ADDRESSES), will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: 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.' '' The 
final rule added a new regulation (Sec.  1100.5) to title 21 of the 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 
Federal Food, Drug, and Cosmetic Act (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 (21 CFR 
201.128 (drugs) and 21 CFR 801.4 (devices)).

[[Page 2094]]

    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. 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.
    The comments we received are summarized below. To allow further 
consideration of the substantive issues raised in these comments, FDA 
is proposing to delay the effective date of the amendments to the 
existing medical product ``intended use'' regulations (Sec. Sec.  
201.128 and 801.4) contained in the final rule of January 9, 2017, 
until further notice. See 21 CFR 10.35(a) and (b) (stating that FDA 
``may at any time stay or extend the effective date of an action 
pending or following a decision on any matter'' and recognizing that 
the stay may be ``for an indefinite time period''). The Agency must 
solicit public comment on this proposed delay, consider the comments 
submitted, and prepare and publish a final notification of the delay 
before March 19, 2018, when the final rule is scheduled to take effect. 
In light of this limited timeframe, it is impracticable to provide 60 
days for comment on this proposed delay. Thus, the Commissioner of Food 
and Drugs finds good cause under 21 CFR 10.40(b)(2) for providing a 
shortened comment period, ending February 5, 2018. In light of the date 
on which the current delay of the effective date will expire unless 
further extended, no extensions on the comment period will be granted.

II. Summary of Comments Received in the Reopened Docket of the Final 
Rule

    Fifteen comments were submitted to the docket for the January 9, 
2017 final rule after the docket was reopened on March 20, 2017. These 
comments were submitted by the drug and device industries, various 
associations, academia, and individual submitters including a health 
professional and a consumer. A brief summary of these comments is 
included below.\1\
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    \1\ This summary is not intended to be a comprehensive 
discussion of the comments nor should it be construed to suggest 
that FDA has made any decisions about the substantive issues raised 
in the comments.
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    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). One comment 
criticized the modified risk tobacco product provisions of the FD&C 
Act. The other comment supported the new regulation and criticized the 
delay in its issuance. Neither comment sought a delay in the effective 
date of that new regulation.
    Thirteen of the 15 comments submitted to the docket 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. Several of these comments urged a 
narrowing of the types of evidence that could be considered in 
determining intended use. Some comments stated that only promotional or 
external claims should be included in the consideration of intended 
use, while other comments asserted that scientific exchange, truthful 
non-misleading communications, and/or mere knowledge of unapproved use 
should be expressly excluded from consideration. In contrast, a few 
comments stated that the types of evidence included in the final rule 
were appropriate at least for certain subsets of medical products, such 
as wholly unapproved medical products and non-prescription devices.
    Several comments raised legal concerns with the final rule, 
including arguments to the effect that the 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; and (4) 
departs from relevant statutory text, legislative history, case law, 
and FDA past practices. Several comments asserted that the January 9, 
2017, final rule was issued in violation of the notice requirement 
under the Administrative Procedure Act (APA) based on the inclusion of 
the ``totality of the evidence'' language in that final rule.
    In addition to these legal concerns, several comments asserted that 
the final rule could have potentially negative public health 
implications, including impeding important communications between 
manufacturers and patients, healthcare professionals, and payors; 
reducing healthcare options for patients; and harming patient outcomes. 
In contrast, another comment asserted that narrowing the scope of 
evidence of intended use could jeopardize the Agency's ability to take 
enforcement actions against illicit substances, counterfeit products, 
and synthetic drugs, among other products.
    Based on some of the above concerns, several comments urged FDA to 
stay indefinitely or revoke the final rule. Other comments recommended 
that FDA adopt the ``intended use'' language proposed in the September 
25, 2015, proposed rule, or engage in a new rulemaking.

III. Scope of and Rationale for the Proposed Partial Delay of the 
Effective Date of the Final Rule

    We are proposing to delay the effective date of the portions of the 
final rule amending the existing medical product ``intended use'' 
regulations (Sec. Sec.  201.128 and 801.4) until further notice, to 
allow for additional consideration of the issues raised in the comments 
described above. This action should not be construed to indicate that 
FDA has made any decisions about either the substantive arguments made 
in these comments or the issues discussed in previous Federal Register 
notifications regarding the amendments to these ``intended use'' 
regulations.
    When the Agency proposed amendments to the existing intended use 
regulations in 2015, the objective was not to reflect a change in FDA's 
approach regarding evidence of intended use for drugs and devices. 
These proposed amendments were intended to better reflect FDA's 
existing interpretation and application of these regulations (see 80 FR 
57756 at 57761). Specifically, the amendments were intended to clarify 
that FDA would not regard a firm as intending an unapproved new use for 
an approved or cleared drug or device based solely on that firm's 
knowledge that its product was being prescribed or used by doctors for 
such use (see 80 FR 57756 at 57761). FDA proposed to delete the last 
sentence of the intended use regulations to provide this clarification, 
in addition to some other changes.
    In the Federal Register of January 9, 2017, we published final 
regulations adding new Sec.  1100.5 to title 21 of the CFR and amending 
the intended use regulations found at Sec. Sec.  201.128 and 801.4. The 
provisions in the final rule amending the intended use regulations were 
modified from the proposed rule because of comments we received that

[[Page 2095]]

suggested to us that the proposed changes might not provide adequate 
clarity to manufacturers (see 82 FR 2193 at 2207). Significant comments 
were submitted on the proposed rule that indicated misunderstanding of 
the very limited scope of what FDA intended by the proposed changes to 
the intended use provisions.
    In response to the new language in the final rule, a petition 
raising concerns with the final language was submitted by various 
industry organizations on February 8, 2017 (``petition'' and 
``petitioners''). 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. Petitioners ask that the final rule be stayed indefinitely 
and reconsidered for two independent reasons (petition at pg. 10). 
First, they argue that the final rule was issued in violation of the 
fair notice requirement under the Administrative Procedure Act (APA) 
(petition at pgs. 10-13). Second, they argue that the ``totality of the 
evidence'' language in the final rule is a new and unsupported legal 
standard (petition at pgs. 10, 13-21). The petitioners contend that the 
final rule unexpectedly expanded the understanding of intended use, and 
that adding the new final sentence referencing the ``totality of the 
evidence'' was a reversal of the proposed rule that violates the APA's 
notice-and-comment provisions (petition at pg. 11). Petitioners express 
the view that the wording used in the proposed rule would have helped 
to address substantial concerns they have regarding FDA's intended use 
definitions, while the final rule exacerbates those concerns (petition 
at pg. 11). These concerns include constitutional concerns (petition at 
pg. 19-21), and public health concerns related to chilling valuable 
scientific speech (petition at pg. 21). Based in part on the questions 
raised by the petition, 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.
    The issues raised by the petition, as well as the comments we have 
received on the 2015 proposed rule, the January 2017 delay of the 
effective date, and the March 2017 delay of the effective date 
(discussed above in section II) underscore for FDA the potential for 
confusion related to the language in the final rule. ``Intended use'' 
is fundamental to medical product jurisdiction under the FD&C Act (21 
U.S.C. 321(g) (definition of ``drug'') and 21 U.S.C. 321(h) (definition 
of ``device'')). Lack of clarity regarding the text of the final rule 
might affect FDA's medical product jurisdiction in ways that FDA did 
not intend when it set out to clarify one point regarding ``intended 
use.'' Although FDA remains committed to the goal of the intended use 
rulemaking because it reflects current agency policy, FDA has 
tentatively concluded, for the reasons set forth above, that the Agency 
needs additional time for further consideration. FDA continues to work 
diligently on the issues relating to intended use raised in the 
underlying rulemaking and remains committed to rulemaking on this 
issue.
    FDA does not propose to further delay the effective date of the 
portions of the final rule that issued a new regulation that describes 
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 (Sec.  1100.5). As noted, 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. The effective date of Sec.  1100.5 remains March 19, 2018.

IV. Economic Analysis of Impacts

    We have examined the impacts of the proposed 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 proposed rule is not a significant regulatory action 
as defined by Executive Order 12866. Moreover, this proposed rule is an 
action that does not impose more than de minimis costs and, 
consequently, 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 we expect the proposed rule to impose negligible 
costs, if any, we propose to certify that the rule will not have a 
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $148 million, using the most current (2016) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in expenditure in any year that meets or exceeds this 
amount.
    In table 1, we provide 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 the Proposed Rule
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                                                                                                                Units
                                                                                                  ---------------------------------
            Category               Primary  estimate       Low  estimate        High  estimate                             Period           Notes
                                                                                                      Year     Discount   covered
                                                                                                    dollars    rate (%)   (years)
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Benefits:
    Annualized.................  ....................  ....................  ....................       2016          7         10  ....................
    Monetized $millions/year...  ....................  ....................  ....................       2016          3         10  ....................
    Annualized.................  ....................  ....................  ....................       2016          7         10  ....................

[[Page 2096]]

 
    Quantified.................  ....................  ....................  ....................       2016          3         10  ....................
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    Qualitative................  None                                                                                               ....................
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Costs:
    Annualized.................  ....................  ....................  ....................       2016          7         10  ....................
    Monetized $millions/year...  ....................  ....................  ....................       2016          3         10  ....................
    Annualized.................  ....................  ....................  ....................       2016          7         10  ....................
    Quantified.................  ....................  ....................  ....................       2016          3         10  ....................
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    Qualitative................  Negligible costs, if any.                                                                          ....................
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Transfers:
    Federal....................  ....................  ....................  ....................       2016          7         10  ....................
     Annualized................  ....................  ....................  ....................       2016          3         10  ....................
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    Monetized $/year...........  From:
                                 To:                                                               .........
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    Other......................  ....................  ....................  ....................       2016          3         10  ....................
    Annualized.................  ....................  ....................  ....................       2016          3         10  ....................
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    Monetized $/year...........  From:
                                 To:                                                               .........
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Effects:
    State, Local or Tribal Government: None
    Small Business: None
    Wages: None
    Growth: None
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    On January 9, 2017, we published the final rule ``Clarification of 
When Products Made or Derived from Tobacco are Regulated as Drugs, 
Devices, or Combination Products; Amendments to Regulations Regarding 
`Intended Uses'.'' We refer to this final rule as the Clarifications 
Final Rule in this section of the preamble. The Clarifications Final 
Rule included changes to the ``intended uses'' provisions for medical 
products. In the Federal Register of March 20, 2017, we further delayed 
the effective date of the final rule--we extended the effective date of 
the Clarifications Final Rule to March 19, 2018 and reopened the docket 
to invite public comments on the medical products ``intended uses'' 
provisions. Comments submitted to the docket revealed a number of 
stakeholders had questions and concerns about possible implications of 
our revised ``intended uses'' provisions for medical products. Thus, 
the proposed rule would delay until further notice the changes to the 
``intended uses'' provisions in the Clarifications Final Rule, and give 
all stakeholders and FDA sufficient time to consider the substantive 
issues raised by the comments to the docket.
    When we conducted our economic analysis of the final rule that 
published on January 9, 2017, we expected that the benefits and costs 
of the rule for drug sponsors and for device manufacturers would be 
negligible, if any, because we anticipated that the final rule would 
leave the existing policies for these industries unchanged. As 
discussed in section II, we revised the intended use provisions for 
medical products in the final rule to clarify our position that the 
intended use of a medical products can be based on any relevant source 
of evidence, including a variety of direct and circumstantial evidence. 
Thus, we expected that the final rule would maintain the status quo and 
not impact current business practices.
    Comments submitted to the reopened docket for the January 9, 2017, 
final rule indicate that at least some of the medical products 
industries believe that the final rule would change current practices 
and impose new burdens not captured in our final regulatory impact 
analysis. By delaying the final rule's intended use provisions for 
medical products, this proposed rule would maintain the status quo for 
medical products.
    We judge that the proposed rule, if finalized, would thus avoid any 
potential unintended burden caused by the final rule. Moreover, drug 
sponsors and medical device manufacturers would likely learn about the 
proposed rule through industry news sources and not incur one-time 
costs to learn about the rule. We request comment on our assumptions.

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

    FDA has determined that this proposed rule contains no collection 
of information as defined by 5 CFR 1320.3(c). 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 proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
this proposed 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

[[Page 2097]]

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 proposed rule in accordance with the 
principles set forth in Executive Order 13175. We have tentatively 
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. The Agency solicits comments from tribal 
officials on any potential impact on Indian Tribes from this proposed 
action.

IX. Other Issues for Consideration

    This proposed rule would only delay the effective date of the 
portions of a final rule amending the ``intended use'' regulations for 
medical products (Sec. Sec.  201.128 and 801.4), published in the 
Federal Register of January 9, 2017. Therefore, comments to this 
proposed rule should pertain to this delay of the effective date only 
with respect to such provisions.

X. Request for Comments

    FDA is proposing to delay, until further notice, the effective date 
of the amendments to Sec. Sec.  201.128 and 801.4 that were published 
at 82 FR 2193 on January 9, 2017. FDA had previously delayed the 
effective date on February 7, 2017 (82 FR 9501), and on March 20, 2017 
(82 FR 14319). FDA requests comment on this proposal to further delay 
the effective date of the amendments to Sec. Sec.  201.128 and 801.4.

    Dated: January 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00555 Filed 1-12-18; 8:45 am]
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