35154 Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Proposed Rules 

been estimated that approximately 200 

entities will be eligible to vote in the 

referendum. It will take an average of 15 

minutes for each voter to read the voting 

instructions and complete the 

referendum ballot. 

Referendum Order 

Hakim Fobia, Marketing Specialist, 

and Heather Pichelman, Director, 

Promotion and Economics Division, 

Specialty Crops Program, AMS, USDA, 

Stop 0244, Room 1406–S, 1400 

Independence Avenue SW, Washington, 

DC 20250–0244, are designated as 

referendum agents for this referendum. 

The referendum procedures at 7 CFR 

1208.100 through 1208.108, issued 

pursuant to the 1996 Act, will be used 

to conduct the referendum. 

The referendum agents will mail the 

ballots to be cast in the referendum and 

voting instructions to all known, eligible 

producers and importers prior to the 

first day of the voting period. Persons 

who produced 20,000 pounds or more 

of raspberries for processing in the 

United States or imported 20,000 

pounds or more of processed raspberries 

into the United States during the 

representative period and were subject 

to assessment during that period are 

eligible to vote. Persons who received 

an exemption from assessments 

pursuant to § 1208.53 during the entire 

representative period are ineligible to 

vote. Any eligible producer of 

raspberries for processing or importer of 

processed raspberries who does not 

receive a ballot should contact a 

referendum agent no later than one 

week before the end of the voting 

period. Mail ballots must be postmarked 

by October 5. Ballots delivered via 

express mail or email must show proof 

of delivery by no later than 11:59 p.m. 

ET on October 5, 2018, to be counted. 

List of Subjects in 7 CFR Part 1208 

Administrative practice and 

procedure, Advertising, Consumer 

information, Marketing agreements, 

Raspberry promotion, Reporting and 

recordkeeping requirements. 

Authority: 7 U.S.C. 7411–7425; 7 U.S.C. 

7401. 

Dated: July 20, 2018. 

Bruce Summers, 

Administrator. 

[FR Doc. 2018–15894 Filed 7–24–18; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 15 

[Docket No. FDA–2018–N–2689] 

Facilitating Competition and 

Innovation in the Biological Products 

Marketplace; 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 the Agency) is 

announcing a public hearing on FDA’s 

approach to enhancing competition and 

innovation in the biological products 

marketplace, including by facilitating 

greater availability of biosimilar and 

interchangeable products. 

DATES: The public hearing will be held 

on Tuesday, September 4, 2018, from 9 

a.m. to 5 p.m. The public hearing may 

be extended or may end early, 

depending on the level of public 

participation. Persons seeking to attend 

or to present at the public hearing must 

register by Tuesday, August 14, 2018. 

Section III provides attendance and 

registration information. Electronic or 

written comments will be accepted after 

the public hearing until Friday, 

September 21, 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/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before Friday, September 21, 2018. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of Friday, September 21, 

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. 

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– 

2018–N–2689 for ‘‘Facilitating 

Competition and Innovation in the 

Biological Products Marketplace; Public 

Hearing; Request for Comments.’’ 

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 

Division of Dockets Management 

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 


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Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Proposed Rules 35155 

1https://www.fda.gov/drugs/development

approvalprocess/howdrugsaredeveloped

andapproved/approvalapplications/ 

therapeuticbiologicapplications/biosimilars/ 

ucm411418.htm. 

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.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: 

Allison Hoffman, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 1314, Silver Spring, 

MD 20993, 301–796–9203, 

OMPTFeedback@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Biologics Price Competition and 

Innovation Act of 2009 (BPCI Act) 

amended the Public Health Service Act 

(PHS Act) and other statutes to create an 

abbreviated licensure pathway for 

biological products shown to be 

biosimilar to, or interchangeable with, 

an FDA-licensed biological reference 

product. The BPCI Act was intended to 

balance innovation and consumer 

interests. The abbreviated licensure 

pathway, in section 351(k) of the PHS 

Act, allows an applicant (a ‘‘351(k) 

applicant’’) to rely, in part, on FDA’s 

previous determination of safety and 

effectiveness for the reference product 

for approval. The BPCI Act provides, 

among other things, exclusivity periods 

for certain biological products licensed 

in ‘‘stand alone’’ applications under 

section 351(a) of the PHS Act. 

As the marketplace of biological 

products continues to expand and 

evolve, FDA expects that increased 

availability of biosimilars and 

interchangeable products will result in 

more competition and create savings for 

patients and the healthcare system. At 

the same time, we recognize that there 

are challenges to the rapid growth of 

this marketplace. For instance, although 

FDA has approved 11 marketing 

applications for biosimilars as of July 1, 

2018, FDA is aware that the majority of 

biosimilars licensed by FDA have not 

yet been marketed and are not available 

to patients. 

Although such delays in the market 

entry of an approved biosimilar are 

outside FDA’s control, we remain 

focused on FDA’s critical role in 

increasing the availability of biosimilars 

and interchangeable products. 

Recognizing that this is a crucial time in 

the emergence of the marketplace of 

biosimilar and interchangeable 

products, FDA recently developed a 

Biosimilars Action Plan. This Plan 

focuses on four key areas: (1) Improving 

the efficiency of the biosimilar and 

interchangeable product development 

and approval process; (2) maximizing 

scientific and regulatory clarity for the 

biosimilar product development 

community; (3) developing effective 

communications to improve 

understanding of biosimilars among 

patients, clinicians, and payors; and (4) 

supporting market competition by 

reducing gaming of FDA requirements 

or other attempts to unfairly delay 

competition. 

FDA’s Biosimilars Action Plan builds 

on the Agency’s substantial progress, to 

date, implementing the approval 

pathway for biosimilar and 

interchangeable products. For example, 

FDA has issued guidance for industry 

on numerous scientific and regulatory 

issues related to the development of 

proposed biosimilar and 

interchangeable products. FDA also 

created the Biosimilar Product 

Development (BPD) Program to facilitate 

the rapid development of biosimilar and 

interchangeable products. Through 

enrollment in this program, FDA 

provides detailed, product-specific 

advice to manufacturers. As of July 1, 

2018, 68 programs were enrolled in the 

BPD Program and FDA had received 

meeting requests to discuss the 

development of biosimilars for 31 

different reference products. 

FDA has also prioritized its efforts to 

provide useful information about 

licensed biological products to the 

public. FDA publishes the Purple Book: 

Lists of Licensed Biological Products 

with Reference Product Exclusivity and 

Biosimilarity or Interchangeability 

Evaluations 1 to provide information on 

licensed biological products, including 

information on exclusivity for reference 

products and on whether a product has 

been demonstrated to be biosimilar to, 

or interchangeable with, a reference 

product. Another FDA priority is the 

development of educational materials 

for patients, healthcare providers, and 

other stakeholders to increase 

knowledge about biological products, 

including biosimilar and 

interchangeable products. For example, 

FDA launched an educational campaign 

in October 2017 to promote 

understanding by healthcare providers 

of biosimilar and interchangeable 

products and how these products can 

help patients (see, https://www.fda.gov/ 

Drugs/DevelopmentApprovalProcess/ 

HowDrugsareDevelopedandApproved/ 

ApprovalApplications/Therapeutic

BiologicApplications/Biosimilars/ 

ucm580435.htm). 

As FDA continues working to 

implement the BPCI Act, FDA welcomes 

input from the public on how the 

Agency can enhance its efforts to 

increase access by patients to state-ofthe-art, lifesaving treatment options by 

encouraging innovation and 

competition in the biological products 

marketplace. FDA will hold a public 

hearing on September 4, 2018, from 9 

a.m. to 5 p.m., to provide an 

opportunity for all interested 

stakeholders to submit comments. 

The format of the hearing involves 

presentations from the public. The 

Agency will not be inviting specific 

presenters; rather, with this document, 

FDA is soliciting presentations from 

interested stakeholders. FDA also 

invites interested persons to submit 

written comments to the docket on the 

topics described in section II. 

II. Purpose and Scope of the Public 

Hearing 

FDA is soliciting input from the 

public on how to facilitate greater 

availability of biosimilar and 

interchangeable products while 

retaining the balance between 

competition and innovation that 

Congress intended to achieve under the 

BPCI Act. FDA is holding a public 

hearing to receive information and 

comments from a broad group of 

stakeholders, including patients, 


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35156 Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Proposed Rules 

researchers, healthcare providers, 

manufacturers, interested industry, 

professional organizations, and the 

public. The Agency has determined that 

a public hearing is the most appropriate 

way to ensure public engagement. 

FDA welcomes any relevant 

information that stakeholders wish to 

share. FDA is particularly interested in 

stakeholder input on how the Agency 

can achieve the following goals: 

• Facilitate the efficient development 

of biosimilar and interchangeable 

products using state-of-the-art science; 

• Develop information resources, as 

well as scientific or regulatory tools, to 

streamline the development of 

biosimilar and interchangeable 

products; 

• Enhance the efficiency of FDA 

review of marketing applications for 

biosimilar and interchangeable 

products; 

• Provide additional scientific or 

regulatory clarity regarding FDA’s 

regulation of biological products, 

including FDA’s review and approval of 

marketing applications for biological 

products; 

• Increase healthcare provider, 

patient, and payor understanding of 

biological products, including 

biosimilar and interchangeable 

products; and 

• Support market competition by 

addressing attempts to game FDA 

requirements or otherwise delay market 

entry of competing biological products. 

FDA is also interested in stakeholder 

input on the following questions about 

additional steps FDA can take, within 

its statutory authority, related to the 

Agency’s regulation of biological 

products: 

1. FDA is aware that many of the 

biosimilar products that have been 

licensed by FDA are not yet marketed 

and available to patients. What can FDA 

do to help biosimilars and 

interchangeable products reach patients 

more quickly after these products are 

licensed? 

2. FDA uses the Purple Book to 

provide information about biological 

products licensed under section 351 of 

the PHS Act. What additional 

information or features could be 

incorporated into the Purple Book to 

make it more useful to stakeholders, 

including patients, healthcare providers, 

pharmacists, and manufacturers? 

3. FDA expects that the number of 

licensed biosimilar and interchangeable 

products will continue to increase in the 

coming years. In many, if not most, 

cases, FDA anticipates that multiple 

products will be licensed as biosimilar 

to, or interchangeable with, a given 

reference product. What additional 

steps can FDA take to facilitate the 

evolution of the biosimilar and 

interchangeable product marketplace? 

What can FDA do to ensure that 

confidence in these products among 

patients, healthcare providers, 

pharmacists, and other stakeholders will 

continue to grow? 

4. Extensive analytical 

characterization of the proposed 

biosimilar product and the reference 

product serves as the foundation for a 

demonstration of biosimilarity. FDA 

recognizes that obtaining and testing 

multiple lots of the reference product 

adds to the costs of developing a 

biosimilar product. What can FDA do to 

help reduce development costs arising 

from analytical studies of the reference 

product without compromising FDA’s 

robust scientific standards for licensure 

of products under section 351(k) of the 

PHS Act? FDA is particularly interested 

in stakeholder comments on (1) the 

number of lots of each product (the 

proposed biosimilar product and the 

reference product) that should be used 

in analytical studies submitted to 

support licensure of a proposed 

biosimilar product; and (2) how a 351(k) 

applicant should account for and 

evaluate any observed variability in 

analytical attributes among lots of the 

reference product or the proposed 

biosimilar product. 

5. A 351(k) applicant may, with 

adequate scientific justification, use a 

non-U.S.-licensed comparator product 

in certain studies submitted to support 

licensure of a proposed biosimilar 

product. What additional steps can FDA 

take to facilitate multinational 

development programs that may include 

non-U.S.-licensed comparators, to help 

support development of biosimilar 

products? 

6. FDA expects continued innovation 

in the biological product marketplace, 

including innovation during the 

lifecycle of reference products licensed 

under section 351(a) of the PHS Act. 

What can FDA do to ensure that product 

changes during the lifecycle of reference 

products (e.g., changes in product 

presentation) are adequately 

incentivized without inappropriately 

deterring competition from biosimilar 

and interchangeable products, with the 

overall goal of balancing of innovation 

and competition? 

7. Patents or exclusivity may protect 

one or more conditions of use (e.g., 

indications) of the reference product. As 

a result, 351(k) applicants may seek 

licensure of the proposed biosimilar 

product for fewer than all of the 

conditions of use for which the 

reference product is licensed. Once a 

condition of use is no longer protected 

by patents or exclusivity, FDA 

anticipates that 351(k) applicants often 

will seek licensure of their product for 

this condition of use. What challenges 

do 351(k) applicants face in this context 

and what should FDA do to achieve the 

appropriate balance between innovation 

and competition when one or more 

conditions of use of the reference 

product are protected by exclusivity or 

patents? 

8. The scope of exclusivity under 

section 351(k)(7) of the PHS Act may 

also affect biological product innovation 

and market entry of biosimilars. 

Accordingly, FDA seeks comment on 

the potential application of ‘‘umbrella 

exclusivity’’ under section 351(k)(7). If 

umbrella exclusivity were to apply in 

this context, a biological product that 

would not be eligible for a new period 

of exclusivity under section 351(k)(7)(C) 

would nevertheless be protected for the 

duration of the exclusivity period for a 

previously approved reference product. 

See, for example, 54 FR 28872 at 28897 

(July 10, 1989) for an explanation of 

how umbrella exclusivity functions 

under the Hatch-Waxman scheme, a 

related and potentially instructive 

context (available at: https://

cdn.loc.gov/service/ll/fedreg/fr054/ 

fr054130/fr054130.pdf). Thus, umbrella 

exclusivity could help shield certain 

biological products that would 

otherwise not be eligible for their own 

period of exclusivity under section 

351(k)(7)(C) from biosimilar 

competition. What considerations 

support recognition of umbrella 

exclusivity under section 351(k)(7), and 

what considerations disfavor 

recognizing umbrella exclusivity? How 

would umbrella exclusivity promote 

biological product innovation, and what 

effect would it have on market entry of 

biosimilars? What is the relevance and 

significance, if any, of the patent 

scheme in considering this issue? 

9. What other challenges have the 

potential to disrupt the balance between 

innovation and competition in the 

biological product marketplace and how 

can FDA or other stakeholders address 

these challenges? 

III. Participating in the Public Hearing 

Registration and Requests for Oral 

Presentations: 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 (see Streaming 

Webcast of the Public Hearing)) and/or 

present at the hearing, please register for 

the hearing and, if appropriate, request 

an oral presentation or participation in 


daltland on DSKBBV9HB2PROD with PROPOSALS
Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Proposed Rules 35157 

the open public hearing by sending an 

email to OMPTfeedback@fda.hhs.gov by 

Tuesday, August 14, 2018. Requests for 

participation in the open public hearing 

are accepted until 9 a.m. on Tuesday 

September 4, 2018, and will be accepted 

as long as time allows. The email should 

contain complete contact information 

for each attendee (name, title, degree(s), 

affiliation, address, email address, and 

telephone number). For those wishing to 

present at the hearing, the email should 

also include a presentation title. Those 

without email access can register by 

contacting Allison Hoffman at 301–796– 

9203 by Tuesday, August 14, 2018 (see 

FOR FURTHER INFORMATION CONTACT). An 

agenda for the hearing and any other 

background materials will be made 

available 5 days before the hearing at 

https://www.fda.gov/NewsEvents/ 

MeetingsConferencesWorkshops/ 

UCM610692.htm. 

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 presenter will 

depend on the number of individuals 

who wish to speak. Presenters are 

encouraged to submit an electronic copy 

of their presentation (PowerPoint or 

PDF) to OMPTfeedback@fda.hhs.gov on 

or before Thursday, August 16, 2018. 

Those who are not giving electronic 

presentations are encouraged to submit 

a single slide (PowerPoint or PDF) with 

their name, affiliation, and topic. 

Persons registered to make either an oral 

presentation or participate as part of the 

open public hearing 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/NewsEvents/ 

MeetingsConferencesWorkshops/ 

ucm580561.htm. 

If you need special accommodations 

because of a disability, please contact 

OMPTFeedback@fda.hhs.gov (see FOR

FURTHER INFORMATION CONTACT) no later 

than Friday, August 17, 2018, at 12 

noon Eastern Time. 

Streaming Webcast of the Public 

Hearing: For those unable to attend in 

person, FDA will provide a live webcast 

of the hearing. To join the hearing via 

the webcast, please go to https://

collaboration.fda.gov/biosimilarspart15. 

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 (see 

ADDRESSES). 

IV. Notification of Hearing Under 21 

CFR Part 15 

The Commissioner of Food and Drugs 

is announcing that the public hearing 

will be held in accordance with part 15 

(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, the Center for Drug 

Evaluation and Research, and the Center 

for Biologics Evaluation and Research. 

Under § 15.30(f) (21 CFR 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 at the conclusion of 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 21 CFR 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 

notification, conflict with any 

provisions set out in part 15, this 

notification acts as a waiver of those 

provisions as specified in § 15.30(h). 

Dated: July 19, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15859 Filed 7–24–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF LABOR 

Mine Safety and Health Administration 

30 CFR 56 and 75 

[Docket No. MSHA–2018–0016] 

RIN 1219–AB91 

Safety Improvement Technologies for 

Mobile Equipment at Surface Mines, 

and for Belt Conveyors at Surface and 

Underground Mines 

AGENCY: Mine Safety and Health 

Administration, Labor. 

ACTION: Announcement of public 

stakeholder meetings. 

SUMMARY: The Mine Safety and Health 

Administration (MSHA) is announcing 

the dates and locations of public 

stakeholder meetings on the Agency’s 

Request for Information on Safety 

Improvement Technologies for Mobile 

Equipment at Surface Mines, and for 

Belt Conveyors at Surface and 

Underground Mines. 

DATES: Comments must be received or 

postmarked by midnight Eastern 

Standard Time on December 24, 2018. 

The meeting dates and locations are 

listed in the SUPPLEMENTARY

INFORMATION section of this document. 

ADDRESSES: Federal Register 

Publications: Access documents 

electronically at http://www.msha.gov/ 

regsinfo.htm or http://

www.regulations.gov [Docket No. 

MSHA–2018–0016]. 

FOR FURTHER INFORMATION CONTACT: 

Sheila A. McConnell, Director, Office of 

Standards, Regulations, and Variances, 

MSHA, at mcconnell.sheila.a@dol.gov 

(email), 202–693–9440 (voice), or 202– 

693–9441 (fax). These are not toll-free 

numbers. 

SUPPLEMENTARY INFORMATION: 

I. Stakeholder Meetings 

MSHA will hold six public 

stakeholder meetings and one webinar 

on the Agency’s Request for Information 

(RFI) addressing Safety Improvement 

Technologies for Mobile Equipment at 

Surface Mines, and for Belt Conveyors 

at Surface and Underground Mines. The 

meetings will be conducted in an 

informal manner. Presenters and 

attendees may provide written 

information to the court reporter for 

inclusion in the record. MSHA will 

make transcripts of the meetings 

available at http://www.regulations.gov 

and on MSHA’s website at: https://

arlweb.msha.gov/currentcomments.asp. 

Interested parties may attend these 

stakeholder meetings either in-person or 


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