Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Proposed Rules 30595 

g. How should Commerce adjust 

conditions in response to the increasing 

capabilities of non-U.S. entities? How 

frequently should NOAA evaluate those 

increasing capabilities? 

h. How can Commerce best provide 

transparency to licensees regarding 

classified national security risks? 

Topic 4: Compliance and Enforcement 

The Secretary is required to ensure 

compliance with the regulations and 

with licenses (51 U.S.C. 60123, 15 CFR 

960.13–960.15). To meet this obligation, 

NOAA must collect information, but it 

seeks to minimize the burden on 

licensees. 

With this background in mind, the 

Department seeks general comments on 

this topic. In addition, the Department 

seeks input in response to the following 

specific questions: 

a. What are appropriate mechanisms 

for ensuring compliance? Currently, 

Commerce uses site visits, virtual 

inspections, quarterly and annual 

audits, and no-notice inspections as 

needed. 

b. How should Commerce ensure 

compliance when multiple parties 

(including investors) play a role in a 

single licensed system? Options could 

include licensing all involved parties, or 

holding a single licensee responsible for 

the entire system. 

c. Are there any improvements the 

Department could make to its formal 

adjudication procedures in the 

regulations? 

d. Should Commerce mandate 

licensees to use certain technical 

standards, or particular software, for 

compliance purposes? If so, what 

standards or software should Commerce 

require? 

e. Should Commerce adopt different 

compliance policies and procedures for 

the different categories described in 

Topic 2? If so, what policies and 

procedures would be appropriate for the 

different categories? 

Topic 5: Integration With Other 

Licensing and Regulatory Regimes 

The Department recognizes that many 

NOAA-licensed systems also require 

licenses from other U.S. Government 

agencies, and occasionally from 

agencies in other countries. The 

Department seeks to reduce the overall 

regulatory burden to licensees, when 

possible. 

With this background in mind, 

Commerce seeks general comments on 

this topic. In addition, the Department 

seeks input in response to the following 

specific questions: 

a. Within statutory constraints, how 

can Commerce avoid redundancies and 

inconsistencies between domestic 

regulatory regimes? 

b. Within statutory constraints, how 

can Commerce minimize burdens to 

licensees who operate in multiple 

countries and are subject to multiple 

countries’ regulatory regimes? 

Classification 

This advance notice of proposed 

rulemaking was determined to be 

significant for purposes of E.O. 12866. 

Dated: June 25, 2018. 

Stephen Volz, 

Assistant Administrator for Satellite and 

Information Services, National Oceanic and 

Atmospheric Administration, Department of 

Commerce. 

[FR Doc. 2018–14038 Filed 6–28–18; 8:45 am] 

BILLING CODE 3510–HR–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 15 

[Docket No. FDA–2018–N–2309] 

The Food and Drug Administration 

Predictive Toxicology Roadmap and Its 

Implementation; Public Hearing; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of public hearing; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing a public hearing to solicit 

comments on FDA’s Predictive 

Toxicology Roadmap, which was issued 

by FDA on December 6, 2017. FDA is 

seeking comments on how to foster the 

development and evaluation of 

emerging toxicological methods and 

new technologies and incorporate these 

methods and technologies into 

regulatory review, as applicable. 

DATES: The public hearing will be held 

on Wednesday, September 12, 2018, 

from 9 a.m. to 4 p.m. Persons seeking to 

attend or to present at the public 

hearing must register by Wednesday, 

August 29, 2018. Section III provides 

attendance and registration information. 

Electronic or written comments will be 

accepted after the public hearing until 

Friday, October 12, 2018. 

ADDRESSES: The public hearing will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503A), Silver Spring, MD 20993–0002. 

Entrance for public hearing participants 

(non-FDA employees) is through 

Building 1, where routine security 

check procedures will be performed. For 

parking and security information, please 

refer to: https://www.fda.gov/ 

AboutFDA/WorkingatFDA/Buildingsand

Facilities/WhiteOakCampus

Information/ucm241740.htm. 

Electronic Submissions 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

via the https://www.regulations.gov 

electronic filing system by midnight 

Eastern Time on October 12, 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. 

• 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– 


sradovich on DSK3GMQ082PROD with PROPOSALS
30596 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Proposed Rules 

2018–N–2309 for ‘‘The FDA Predictive 

Toxicology Roadmap and its 

Implementation; Public Hearing; 

Request for Comments.’’ Received 

comments 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: https://www.fda.gov/ 

regulatoryinformation/dockets/ 

default.htm. 

Docket: For access to the docket to 

read background documents or the 

received electronic and written/paper 

comments, 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: 

Tracy Chen, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4309A, Silver Spring, 

MD 20993, Tracy.Chen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The scientific discipline of toxicology 

is particularly essential to FDA’s 

mission because it is applied across the 

breadth of FDA-regulated product areas. 

Toxicological testing is performed 

during the development and evaluation 

of FDA-regulated products, ranging from 

human and animal drugs and medical 

devices to food and food ingredients, 

human biologics, and tobacco products. 

Advances in systems biology, stem cells, 

engineered tissues, and mathematical 

modeling are creating unique 

opportunities to improve toxicology’s 

predictive ability, potentially enhancing 

FDA’s ability to predict risk. Also 

critical is the potential of these 

advances for replacing, reducing, and/or 

refining animal testing. Today, novel 

methods such as organs on a chip and 

mathematical modeling are generating 

unique opportunities that may improve 

our ability to quickly and more 

accurately predict potential toxicities 

and reduce associated risks to the 

public. 

FDA centers have each taken 

significant steps to enhance the use and 

evaluation of cutting-edge toxicological 

assays. However, more work needs to be 

done to achieve broad acceptance of 

new toxicology methodologies and 

technologies. FDA’s six product centers 

have different legal authorities for 

evaluating product safety or toxicity. 

Nevertheless, more robust 

methodological evaluation and datasets 

can help speed the acceptance of 

emerging predictive toxicology methods 

across the regulatory product areas. 

FDA recognized that a comprehensive 

strategy was needed to evaluate new 

methodologies and technologies for 

their potential to offer greater predictive 

ability and to protect public health. 

Acceptance of any new toxicology 

testing method will require convincing 

data as well as continuous dialogue and 

feedback among all relevant 

stakeholders, from development to 

implementation, including qualification 

and acceptance by regulatory 

authorities. 

To ensure that FDA continues to 

employ cutting-edge science to assess 

the toxicity of its regulated products and 

to leverage advances being made in 

toxicology, the Commissioner of Food 

and Drugs (the Commissioner) tasked 

the Agency’s Toxicology Working Group 

with developing a more efficient process 

for identifying and qualifying emerging 

predictive toxicology technologies. 

Established in 2015 and comprised of 

senior FDA toxicologists from across the 

Agency, the Working Group has deep 

expertise in the various FDA product 

areas and knowledge of the differing 

legal authorities for evaluating toxicity 

in those product areas. 

For a new testing method to be 

accepted for use in determining the 

toxicity of an FDA-regulated product 

there must be convincing data to ensure 

that the method can be relied upon for 

both product development and 

regulatory decision-making. FDA 

evaluates the test or series of tests for 

their applicability, limitations, 

relevance, reliability, accuracy, 

reproducibility, and sensitivity in the 

evaluation of human response and 

toxicity. Undergoing this process 

requires continuous dialogue and 

feedback among all relevant 

stakeholders, beginning with developers 

and ending with qualification and 

acceptance by regulatory authorities. 

FDA’s Predictive Toxicology 

Roadmap (https://www.fda.gov/ 

PredictiveToxRoadmap) is a six-part 

framework for integrating predictive 

toxicology methods into safety and risk 

assessments. Among other 

recommendations, it calls for FDA 

research to identify data gaps and to 

support research to ensure that the most 

promising technologies are developed, 

validated, and integrated into regulatory 

use. The roadmap also identifies 

toxicology issues that need addressing 

for FDA-regulated products and 

toxicology areas that could benefit from 

improved predictivity. Because this is a 

high priority for the Agency, FDA’s 

Toxicology Working Group will be 

reporting yearly to FDA’s Chief Scientist 

on progress made in this important 

effort. 

II. Topics for Discussion at the Public 

Hearing 

The purpose of this public meeting is 

to invite public comment on how FDA 

can better work with its stakeholders to 

implement the goals of its Predictive 

Toxicology Roadmap. We invite 

interested parties to submit comments, 

especially on the questions listed below 

on each of the six parts in the roadmap. 

Comments on additional areas are also 

welcome. 

A. FDA Toxicology Working Group 

FDA has formed a senior-level 

Toxicology Working Group under the 

direction of the Commissioner to foster 

enhanced communication among FDA 

product centers and researchers and 

leverage FDA resources to advance the 

evaluation and integration of emerging 

predictive toxicology methods and new 

technologies into regulatory safety and 

risk assessments. 

1. Which goals of the FDA Roadmap 

are most important to FDA 

stakeholders? 

2. What role could FDA stakeholders 

play in achieving these goals? 


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Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Proposed Rules 30597 

B. Training 

Continuing current education in new 

predictive toxicology methods is 

essential for FDA regulators. 

1. What training topics and 

approaches do you think would help 

FDA staff to appropriately implement 

new alternative methods? 

2. Are there relevant courses that you 

can recommend? 

3. Should FDA partner with its 

stakeholders for these training courses 

and how might this be achieved? 

C. Continued Communication 

FDA will continue to reaffirm its 

commitment to and support for 

incorporating data from newly qualified 

toxicology methods into regulatory 

submissions and encourage discussions 

with stakeholders as part of the 

regulatory submission process. 

1. How can FDA better communicate 

with stakeholders to encourage 

discussion on the use of qualified new 

toxicology methods early in the 

regulatory process? 

2. How can new toxicology methods 

and approaches be integrated into FDA’s 

review of regulated products? 

3. What information do stakeholders 

need from FDA to qualify alternative 

methods for a specific context of use? 

D. Collaborations 

FDA will continue its long practice of 

fostering collaborations across 

disciplines nationally and 

internationally. 

1. What partnerships could be useful 

to FDA to advance the roadmap? 

2. Are there existing partnerships that 

FDA should be involved in to achieve 

the roadmap’s goals? 

E. Research 

FDA’s research programs will identify 

data gaps and support research to 

ensure that the most promising 

technologies are identified, evaluated, 

and integrated into product 

development and assessment. 

1. What data gaps should be 

addressed by FDA research and research 

conducted by external groups? 

2. How can FDA encourage and 

support research in areas of importance 

to its mission? 

3. How could FDA and stakeholders 

evaluate whether alternative methods 

are appropriately qualified for a specific 

context of use? 

F. Oversight 

The Toxicology Working Group, with 

representation from each FDA center, 

will track the progress of these 

recommendations and report to FDA’s 

Chief Scientist annually. 

1. How can FDA ensure transparency 

in its progress? 

2. How can FDA better foster 

opportunities to share ideas and 

knowledge with its stakeholders? 

3. How can FDA highlight 

collaborations on the development and 

testing of new methods? 

III. Participating in the Public Hearing 

Registration and Requests To Make an 

Oral Presentation: The FDA Conference 

Center at the White Oak location is a 

Federal facility with security procedures 

and limited seating. Attendance will be 

free and on a first-come, first-served 

basis. If you wish to attend either in 

person or by webcast and/or present at 

the hearing, please register by Friday, 

August 17, 2018, at the following 

website at: https://www.fda.gov/ 

PredictiveToxRoadmap. 

FDA will try to accommodate all 

persons who wish to make a 

presentation. Individuals wishing to 

present should identify the number of 

the specific question, or questions, they 

wish to address. This will help FDA 

organize the presentations. Individuals 

and organizations with common 

interests should consolidate or 

coordinate their presentations and 

request time for a joint presentation. 

FDA will notify registered presenters of 

their scheduled presentation times. The 

time allotted for each presentation will 

depend on the number of individuals 

who wish to speak but should last a 

maximum of 10 minutes. Presenters are 

encouraged to submit an electronic copy 

of their presentation to Tracy.Chen@

fda.hhs.gov (See FOR FURTHER

INFORMATION CONTACT) on or before 

Friday, August 24, 2018. Persons 

registered to make an oral presentation 

are encouraged to arrive at the hearing 

room early and check in at the onsite 

registration table to confirm their 

designated presentation time. An 

agenda for the hearing and any other 

background materials will be made 

available 5 days before the hearing at 

https://www.fda.gov/Predictive

ToxRoadmap. 

If you need special accommodations 

because of a disability, please contact 

Shari Solomon (shari.solomon@

fda.hhs.gov) no later than Friday, 

August 17, 2018, at 12 noon Eastern 

Time. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at https://

www.regulations.gov. It may be viewed 

at the Dockets Management Staff, 5630 

Fishers Lane, Room 1061, Rockville, MD 

20852. 

TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS TO THE RULEMAKING

DOCKETS

Activity Date Electronic address Address 

Public hearing .............................. September 12, 2018 .................. ............................................................... FDA White Oak Campus, 10903 

New Hampshire Ave., Bldg. 

31, Rm. 1503A, Silver Spring, 

MD 20993. 

Advance registration .................... By Wednesday, August 29, 

2018.

https://www.fda.gov/ 

predictivetoxroadmap.

Technical assistance ................... .................................................... Jeffery.Rexrode@fda.hhs.gov ..............

Request to make an oral presentation.By Friday, August 17, 2018 ....... Tracy.Chen@fda.hhs.gov .....................

Send PowerPoint slides (10 minutes maximum).By Friday August 24, 2018 ........ Tracy.Chen@fda.hhs.gov .....................

Request special accommodations 

due to a disability.

By Friday, August 17, 2018 ....... shari.solomon@fda.hhs.gov .................

Submit electronic or written comments.By October 12, 2018 .................. https://www.regulations.gov .................. Dockets Management Staff 

(HFA–305), Food and Drug 

Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, 

MD 20852. 


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30598 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Proposed Rules 

1PM2.5 refers to particulate matter of 2.5 microns 

or less in diameter, often referred to as ‘‘fine’’ 

particles. 

IV. Notice of Hearing Under 21 CFR 

Part 15 

The Commissioner is announcing that 

the public hearing will be held in 

accordance with 21 CFR part 15. The 

hearing will be conducted by a 

presiding officer, who will be 

accompanied by FDA senior 

management from the Office of the 

Commissioner and the relevant Centers/ 

Offices. Under § 15.30(f), the hearing is 

informal and the rules of evidence do 

not apply. No participant may interrupt 

the presentation of another participant. 

Only the presiding officer and panel 

members can pose questions; they can 

question any person during or after each 

presentation. Public hearings under part 

15 are subject to FDA’s policy and 

procedures for electronic media 

coverage of FDA’s public administrative 

proceedings (21 CFR part 10, subpart C). 

Under § 10.205, representatives of the 

media may be permitted, subject to 

certain limitations, to videotape, film, or 

otherwise record FDA’s public 

administrative proceedings, including 

presentations by participants. The 

hearing will be transcribed as stipulated 

in § 15.30(b) (see Transcripts). To the 

extent that the conditions for the 

hearing, as described in this notice, 

conflict with any provisions set out in 

part 15, this notice acts as a waiver of 

those provisions as specified in 

§ 15.30(h). 

Dated: June 26, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14052 Filed 6–28–18; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R01–OAR–2017–0696; FRL–9979– 

82—Region 1] 

Air Plan Approval; Vermont; 

Infrastructure State Implementation 

Plan Requirements for the 2012 PM2.5

NAAQS 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve 

elements of a State Implementation Plan 

(SIP) submission from Vermont that 

addresses the infrastructure 

requirements of the Clean Air Act (CAA 

or Act)—including the interstate 

transport provisions—for the 2012 fine 

particle (PM2.5) National Ambient Air 

Quality Standards (NAAQS). The 

infrastructure requirements are designed 

to ensure that the structural components 

of each state’s air quality management 

program are adequate to meet the state’s 

responsibilities under the CAA. This 

action is being taken under the Clean 

Air Act. 

DATES: Written comments must be 

received on or before July 30, 2018. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R01– 

OAR–2017–0696, to the 

www.regulations.gov website or via 

email to simcox.alison@epa.gov. For 

comments submitted to the 

www.regulations.gov website, follow the 

online instructions for submitting 

comments. Once submitted, comments 

cannot be edited or removed from 

www.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: 

Alison C. Simcox, Air Quality 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, tel. 

(617) 918–1684; simcox.alison@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document whenever 

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

EPA. 

Table of Contents 

I. Background and Purpose 

A. What Vermont SIP submissions does 

this rulemaking address? 

B. What is the scope of this rulemaking? 

II. What guidance is EPA using to evaluate 

these SIP submissions? 

III. EPA’s Review 

A. Section 110(a)(2)(A)—Emission Limits 

and Other Control Measures 

B. Section 110(a)(2)(B)—Ambient Air 

Quality Monitoring/Data System 

C. Section 110(a)(2)(C)—Program for 

Enforcement of Control Measures and for 

Construction or Modification of 

Stationary Sources 

D. Section 110(a)(2)(D)—Interstate 

Transport 

E. Section 110(a)(2)(E)—Adequate 

Resources 

F. Section 110(a)(2)(F)—Stationary Source 

Monitoring System 

G. Section 110(a)(2)(G)—Emergency 

Powers 

H. Section 110(a)(2)(H)—Future SIP 

Revisions 

I. Section 110(a)(2)(I)—Nonattainment Area 

Plan or Plan Revisions Under Part D 

J. Section 110(a)(2)(J)—Consultation With 

Government Officials; Public 

Notifications; Prevention of Significant 

Deterioration; Visibility Protection 

K. Section 110(a)(2)(K)—Air Quality 

Modeling/Data 

L. Section 110(a)(2)(L)—Permitting Fees 

M. Section 110(a)(2)(M)—Consultation/ 

Participation by Affected Local Entities 

IV. Proposed Action 

V. Statutory and Executive Order Reviews 

I. Background and Purpose 

A. What Vermont SIP submissions does 

this rulemaking address? 

This rulemaking addresses a SIP 

submission from the Vermont 

Department of Environmental 

Conservation (VT DEC). The state 

submitted its infrastructure SIP for the 

2012 fine particle (PM2.5 1) National 

Ambient Air Quality Standard (NAAQS) 

on October 31, 2017. This included an 

enclosure addressing the ‘‘Good 

Neighbor’’ (or ‘‘transport’’) provisions 

for the 2012 PM2.5 NAAQS (Section 

110(a)(2)(D)(i)(I) of the CAA). Under 

sections 110(a)(1) and (2) of the CAA, 

states are required to submit 

infrastructure SIPs to ensure that SIPs 

provide for implementation, 

maintenance, and enforcement of the 

NAAQS, including the 2012 PM2.5

NAAQS. 


sradovich on DSK3GMQ082PROD with PROPOSALS