2092 Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Proposed Rules 

under the criteria of the Regulatory 

Flexibility Act. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 14 CFR part 

39 as follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

■ 1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by 

removing Airworthiness Directive (AD) 

2014–02–01, Amendment 39–17729 (79 

FR 7382, February 7, 2014), and adding 

the following new AD: 

Bombardier, Inc.: Docket No. FAA–2017– 

1246; Product Identifier 2017–NM–086– 

AD. 

(a) Comments Due Date 

We must receive comments by March 2, 

2018. 

(b) Affected ADs 

This AD replaces AD 2014–02–01, 

Amendment 39–17729 (79 FR 7382, February 

7, 2014) (‘‘AD 2014–02–01’’). 

(c) Applicability 

This AD applies to the airplanes identified 

in paragraphs (c)(1) and (c)(2) of this AD, 

certificated in any category. 

(1) Bombardier, Inc., Model CL–600–2C10 

(Regional Jet Series 700, 701, & 702) 

airplanes, serial number 10002 through 

10344 inclusive. 

(2) Bombardier, Inc., Model CL–600–2D15 

(Regional Jet Series 705) airplanes and Model 

CL–600–2D24 (Regional Jet Series 900) 

airplanes, serial numbers 15001 through 

15397 inclusive. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 27, Flight controls. 

(e) Reason 

This AD was prompted by reports that 

when installing the rudder travel limiter 

(RTL) return springs, the RTL limiter arm 

assembly lug can become deformed. We are 

issuing this AD to prevent deformed RTL 

limiter arm assembly lugs, which can lead to 

failure of the limiter arm assembly lug. In 

combination with failure of the RTL, failure 

of the limiter arm assembly lug could result 

in reduced controllability of the airplane. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Inspections, Modification, and 

Replacement 

(1) For airplanes equipped with RTL return 

spring part number BA–670–93465–1 or 

E0650–069–02750S: Within 800 flight hours 

or 4 months after the effective date of this 

AD, whichever occurs first, do a detailed 

visual inspection of the casing of the primary 

actuator for signs of chafing or missing paint, 

and all applicable corrective actions; replace 

the RTL return springs; and do an eddy 

current inspection of the lugs of the RTL 

limiter arm assembly for cracks, and modify 

or replace the RTL limiter arm assembly, as 

applicable; in accordance with Part A of the 

Accomplishment Instructions of Bombardier 

Service Bulletin 670BA–27–070, Revision B, 

dated March 31, 2017. Accomplishment of 

the actions specified in Bombardier Service 

Bulletin 670BA–27–059 does not meet the 

requirements of this paragraph. 

(2) For airplanes equipped with RTL return 

spring part number BA–670–93468–1: Within 

8,000 flight hours after the effective date of 

this AD, do a detailed visual inspection of 

the RTL return springs for signs of chafing, 

and applicable corrective actions; a detailed 

visual inspection of the casing of the primary 

actuator for signs of chafing or missing paint, 

and all applicable corrective actions; and do 

an eddy current inspection of the lugs of the 

RTL limiter arm assembly for cracks, and 

modify or replace the RTL limiter arm 

assembly, as applicable; in accordance with 

Part B of the Accomplishment Instructions of 

Bombardier Service Bulletin 670BA–27–070, 

Revision B, dated March 31, 2017. 

Accomplishment of the actions specified in 

Bombardier Service Bulletin 670BA–27–059 

does not meet the requirements of this 

paragraph. 

(h) Credit for Previous Actions 

This paragraph provides credit for actions 

required by paragraph (g) of this AD, if those 

actions were performed before the effective 

date of this AD using the service information 

specified in paragraph (h)(1) or (h)(2) of this 

AD. 

(1) Bombardier Service Bulletin 670BA– 

27–070, dated December 17, 2015. 

(2) Bombardier Service Bulletin 670BA– 

27–070, Revision A, dated September 01, 

2016. 

(i) Other FAA AD Provisions 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, New York ACO 

Branch, FAA, has the authority to approve 

AMOCs for this AD, if requested using the 

procedures found in 14 CFR 39.19. In 

accordance with 14 CFR 39.19, send your 

request to your principal inspector or local 

Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the ACO, send it to ATTN: 

Program Manager, Continuing Operational 

Safety, FAA, New York ACO Branch, 1600 

Stewart Avenue, Suite 410, Westbury, NY 

11590; telephone: 516–228–7300; fax: 516– 

794–5531. Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. Before 

using any approved AMOC, notify your 

appropriate principal inspector, or lacking a 

principal inspector, the manager of the local 

flight standards district office/certificate 

holding district office. 

(2) Contacting the Manufacturer: For any 

requirement in this AD to obtain corrective 

actions from a manufacturer, the action must 

be accomplished using a method approved 

by the Manager, New York ACO Branch, 

FAA; or Transport Canada Civil Aviation 

(TCCA); or Bombardier Inc.’s TCCA Design 

Approval Organization (DAO). If approved by 

the DAO, the approval must include the 

DAO-authorized signature. 

(j) Related Information 

(1) Refer to Mandatory Continuing 

Airworthiness Information (MCAI) Canadian 

AD CF–2017–19, dated June 6, 2017, for 

related information. This MCAI may be 

found in the AD docket on the internet at 

http://www.regulations.gov by searching for 

and locating Docket No. FAA–2017–1246. 

(2) For more information about this AD, 

contact Cesar Gomez, Aerospace Engineer, 

Airframe and Mechanical Systems Section, 

FAA, New York ACO Branch, 1600 Stewart 

Avenue, Suite 410, Westbury, NY 11590; 

telephone: 516–228–7318; fax: 516–794– 

5531. 

(3) For service information identified in 

this AD, contact Bombardier, Inc., 400 CoˆteVertu Road West, Dorval, Que ́bec H4S 1Y9, 

Canada; Widebody Customer Response 

Center North America toll-free telephone: 1– 

866–538–1247 or direct-dial telephone: 1– 

514–855–2999; fax: 514–855–7401; email: 

ac.yul@aero.bombardier.com; internet: 

http://www.bombardier.com. You may view 

this service information at the FAA, 

Transport Standards Branch, 1601 Lind 

Avenue SW, Renton, WA. For information on 

the availability of this material at the FAA, 

call 425–227–1221. 

Issued in Renton, Washington, on 

December 28, 2017. 

John P. Piccola, Jr., 

Acting Director, System Oversight Division, 

Aircraft Certification Service. 

[FR Doc. 2018–00340 Filed 1–12–18; 8:45 am] 

BILLING CODE 4910–13–P 

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. 


daltland on DSKBBV9HB2PROD with PROPOSALS
Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Proposed Rules 2093 

ACTION: Proposed rule; partial delay of 

effective date. 

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, 

kelley.nduom@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 9, 

2017 (82 FR 2193), FDA published a 

final rule entitled ‘‘Clarification of 

When Products Made or Derived From 

Tobacco Are Regulated as Drugs, 

Devices, or Combination Products; 

Amendments to Regulations Regarding 

‘Intended Uses.’ ’’ The final rule added 

a new regulation (§ 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)). 


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2094 Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Proposed Rules 

1This 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. 

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 

(§§ 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

Two of the comments submitted to 

the docket related to the new regulation 

included in the final rule that describes 

circumstances in which a product made 

or derived from tobacco that is intended 

for human consumption will be subject 

to regulation as a drug, device, or a 

combination product under the FD&C 

Act (§ 1100.5). 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 (§§ 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 

(§§ 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 § 1100.5 to title 21 of the 

CFR and amending the intended use 

regulations found at §§ 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 


daltland on DSKBBV9HB2PROD with PROPOSALS
Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Proposed Rules 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 

§§ 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 (§ 1100.5). As 

noted, the Agency did not receive any 

comments requesting that we further 

delay the effective date of § 1100.5 or 

that we make any changes to that 

regulation. The effective date of § 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

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

(years) 

Benefits: 

Annualized ................................... ........................ ........................ ........................ 2016 7 10 

Monetized $millions/year ............. ........................ ........................ ........................ 2016 3 10 

Annualized ................................... ........................ ........................ ........................ 2016 7 10 


daltland on DSKBBV9HB2PROD with PROPOSALS
2096 Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Proposed Rules 

TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF THE PROPOSED RULE—Continued 

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

(years) 

Quantified .................................... ........................ ........................ ........................ 2016 3 10

Qualitative .................................... None 

Costs: 

Annualized ................................... ........................ ........................ ........................ 2016 7 10 

Monetized $millions/year ............. ........................ ........................ ........................ 2016 3 10 

Annualized ................................... ........................ ........................ ........................ 2016 7 10 

Quantified .................................... ........................ ........................ ........................ 2016 3 10

Qualitative .................................... Negligible costs, if any. 

Transfers: 

Federal ......................................... ........................ ........................ ........................ 2016 7 10 

Annualized ................................... ........................ ........................ ........................ 2016 3 10 

Monetized $/year ......................... From: To: 

Other ............................................ ........................ ........................ ........................ 2016 3 10 

Annualized ................................... ........................ ........................ ........................ 2016 3 10 

Monetized $/year ......................... From: To: 

Effects: 

State, Local or Tribal Government: None 

Small Business: None 

Wages: None 

Growth: None 

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 


daltland on DSKBBV9HB2PROD with PROPOSALS
Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Proposed Rules 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 

(§§ 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 §§ 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 §§ 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] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R01–OAR–2017–0697; FRL–9972–98– 

Region 1] 

Air Plan Approval; Connecticut; 

Revision of the Low Emission Vehicles 

Program 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve a 

State Implementation Plan (SIP) 

revision submitted by the State of 

Connecticut on December 14, 2015. This 

SIP revision includes Connecticut’s 

revised regulation for new motor vehicle 

emission standards. Connecticut has 

updated its rule to be consistent with 

various updates made to California’s 

low emission vehicle (LEV) program. 

The Connecticut LEV regulations also 

include updates to the zero emission 

vehicle (ZEV) provision. Connecticut 

has adopted these revisions to reduce 

emissions of volatile organic 

compounds (VOC), particulate matter 

(PM), and nitrogen oxides (NOX) in 

accordance with the requirements of the 

Clean Air Act (CAA), as well as to 

reduce greenhouse gases. The intended 

effect of this action is to propose 

approval of Connecticut’s December 14, 

2015 SIP revision. This action is being 

taken under the CAA. 

DATES: Written comments must be 

received on or before February 15, 2018. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R01– 

OAR–2017–0697 at 

www.regulations.gov, or via email to 

rackauskas.eric@epa.gov. For comments 

submitted at Regulations.gov, follow the 

online instructions for submitting 

comments. Once submitted, comments 

cannot be edited or removed from 

Regulations.gov. For either manner of 

submission, the EPA may publish any 

comment received to its public docket. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. Multimedia 

submissions (audio, video, etc.) must be 

accompanied by a written comment. 

The written comment is considered the 

official comment and should include 

discussion of all points you wish to 

make. The EPA will generally not 

consider comments or comment 

contents located outside of the primary 

submission (i.e. on the web, cloud, or 

other file sharing system). For 

additional submission methods, please 

contact the person identified in the FOR

FURTHER INFORMATION CONTACT section. 

For the full EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effective comments, please visit 

www.epa.gov/dockets/commenting-epadockets. Publicly available docket 

materials are available at 

www.regulations.gov or at the U.S. 

Environmental Protection Agency, EPA 

New England Regional Office, Office of 

Ecosystem Protection, Air Quality 

Planning Unit, 5 Post Office Square— 

Suite 100, Boston, MA. EPA requests 

that if at all possible, you contact the 

contact listed in the FOR FURTHER

INFORMATION CONTACT section to 

schedule your inspection. The Regional 

Office’s official hours of business are 

Monday through Friday, 8:30 a.m. to 

4:30 p.m., excluding legal holidays. 

FOR FURTHER INFORMATION CONTACT: Eric 

Rackauskas, Air Quality Planning Unit, 

U.S. Environmental Protection Agency, 

EPA New England Regional Office, 5 

Post Office Square, Suite 100 (mail 

code: OEP05–2), Boston, MA 02109– 

3912, telephone number (617) 918– 

1628, fax number (617) 918–0628, email 

rackauskas.eric@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document whenever 

‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean 

EPA. 

Table of Contents 

I. Background and Purpose 

II. The California LEV Program 

III. Relevant EPA and CAA Requirements 

IV. Proposed Action 

V. Incorporation by Reference 

VI. Statutory and Executive Order Reviews 

I. Background and Purpose 

On December 14, 2015, the 

Connecticut Department of Energy and 

Environmental Protection (DEEP) 

submitted a revision to its SIP 

consisting of the amended Section 22a– 

174–36b ‘‘Low Emission Vehicle II 

Program’’ (LEV II) and the newly 

adopted Section 22a–174–36c ‘‘Low 

Emission Vehicle III Program’’ (LEV III) 

of the Regulations of Connecticut State 

Agencies (RCSA). This SIP revision 

proposes to adopt regulations to mirror 

the California Air Resources Board 

(CARB) emission limits for new 

passenger cars, light-duty trucks, and 

medium-duty passenger vehicles sold, 

leased, imported, delivered, purchased, 

rented, acquired, or received in the State 

of Connecticut. Connecticut’s amended 

LEV II and adopted LEV III programs 

were submitted as part of an overall 

revision to their ‘‘infrastructure SIP’’ for 

the 2012 Fine Particle (PM2.5) National 


daltland on DSKBBV9HB2PROD with PROPOSALS