Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Proposed Rules 2953 

MD 20993, 301–796–8930, 

combination@fda.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register on September 26, 2017 

(82 FR 44803), FDA published a 

document announcing a public hearing 

on November 16, 2017, regarding a 

potential approach for device sponsors 

who seek to obtain marketing 

authorization for their products that are 

intended for a new use with an 

approved, marketed drug when the 

sponsor for the approved, marketed 

drug does not wish to pursue or 

collaborate on the new use. The purpose 

of the public hearing was to obtain 

comments from stakeholders on the 

potential approach presented in the 

Federal Register document as well as 

comments on public health, scientific, 

regulatory, or legal considerations 

relating to other medical products 

intended for new uses with approved, 

marketed medical products of a 

different type where the sponsor for the 

approved, marketed product does not 

wish to pursue or collaborate on the 

new use. We sought this type of public 

engagement because of the potential 

importance of the issue for public health 

and the need for input across the 

medical product industry and among 

public health stakeholders regarding 

how FDA should proceed. The 

comments that FDA receives in relation 

to this public hearing may help inform 

the further development of this 

approach. 

The document stated that comments 

would be accepted until January 15, 

2018, and that untimely comments 

would not be considered. Near the end 

of the comment period, we received a 

request, submitted on behalf of several 

potential commenters, for more time to 

develop comments. We have considered 

this request and are reopening the 

comment period for an additional 30 

days. We believe that this reopening 

allows adequate time for interested 

persons to submit comments without 

delaying further Agency efforts on this 

topic. 

Dated: January 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00991 Filed 1–19–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE INTERIOR 

Office of Surface Mining Reclamation 

and Enforcement 

30 CFR Part 901 

[SATS No. AL–082–FOR; Docket ID: OSM– 

2017–0011; S1D1S SS08011000 SX064A000 

189S180110; S2D2S SS08011000 

SX064A000 18XS501520] 

Alabama Regulatory Program 

AGENCY: Office of Surface Mining 

Reclamation and Enforcement, Interior. 

ACTION: Proposed rule; public comment 

period and opportunity for public 

hearing on proposed amendment. 

SUMMARY: We, the Office of Surface 

Mining Reclamation and Enforcement 

(OSMRE), are announcing receipt of a 

proposed amendment to the Alabama 

regulatory program (Alabama program) 

under the Surface Mining Control and 

Reclamation Act of 1977 (SMCRA or the 

Act). Alabama proposes revisions to its 

program regarding annual permit fees. 

Alabama revised its program at its own 

initiative to raise revenues sufficient to 

fund the Alabama Surface Mining 

Commission’s (ASMC) share of costs to 

administer their coal regulatory 

program, including the cost of 

reviewing, administering, inspecting, 

and enforcing surface coal mining 

permits in Alabama. 

This document gives the locations 

and times where the Alabama program 

documents and proposed amendment to 

that program are available for your 

inspection, establishes the comment 

period during which you may submit 

written comments on the amendment, 

and describes the procedures we will 

follow for the public hearing, if one is 

requested. 

DATES: We will accept written 

comments on this amendment until 4:00 

p.m., CST, February 21, 2018. If 

requested, we will hold a public hearing 

about the amendment on February 16, 

2018. We will accept requests to speak 

at a hearing until 4:00 p.m., CST on 

February 6, 2018. 

ADDRESSES: You may submit comments, 

identified by SATS No. AL–082–FOR, 

by any of the following methods: 

• Mail/Hand Delivery: William 

Joseph, Acting Director, Birmingham 

Field Office, Office of Surface Mining 

Reclamation and Enforcement, 135 

Gemini Circle, Suite 215, Homewood, 

Alabama 35209. 

• Fax: (205) 290–7280. 

• Federal eRulemaking Portal: The 

amendment has been assigned Docket 

ID OSM–2017–0011. If you would like 

to submit comments go to http://

www.regulations.gov. Follow the 

instructions for submitting comments. 

Instructions: All submissions received 

must include the agency name and 

docket number for this rulemaking. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see the 

‘‘Public Comment Procedures’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

review copies of the Alabama program, 

this amendment, a listing of any 

scheduled public hearings, and all 

written comments received in response 

to this document, you must go to the 

address listed below during normal 

business hours, Monday through Friday, 

excluding holidays. You may receive 

one free copy of the amendment by 

contacting OSMRE’s Birmingham Field 

Office or the full text of the program 

amendment is available for you to 

review at www.regulations.gov. 

William Joseph, Acting Director, 

Birmingham Field Office, Office of 

Surface Mining Reclamation and 

Enforcement, 135 Gemini Circle, Suite 

215, Homewood, Alabama 35209, 

Telephone: (205) 290–7282, email: 

bjoseph@osmre.gov. 

In addition, you may review a copy of 

the amendment during regular business 

hours at the following location: 

Alabama Surface Mining Commission, 

1811 Second Ave., P.O. Box 2390, 

Jasper, Alabama 35502–2390, 

Telephone: (205) 221–4130. 

FOR FURTHER INFORMATION CONTACT: 

William Joseph, Acting Director, 

Birmingham Field Office. Telephone: 

(205) 290–7282, email: bjoseph@

osmre.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background on the Alabama Program 

II. Description of the Proposed Amendment 

III. Public Comment Procedures 

IV. Procedural Determinations 

I. Background on the Alabama Program 

Section 503(a) of the Act permits a 

State to assume primacy for the 

regulation of surface coal mining and 

reclamation operations on non-Federal 

and non-Indian lands within its borders 

by demonstrating that its program 

includes, among other things, state laws 

and regulations that govern surface coal 

mining and reclamation operations in 

accordance with the Act and consistent 

with the Federal regulations. See 30 

U.S.C. 1253(a)(1) and (7). On the basis 

of these criteria, the Secretary of the 

Interior conditionally approved the 

Alabama program effective May 20, 

1982. You can find background 

information on the Alabama program, 


ethrower on DSK3G9T082PROD with PROPOSALS
2954 Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Proposed Rules 

including the Secretary’s findings, the 

disposition of comments, and the 

conditions of approval of the Alabama 

program in the May 20, 1982, Federal 

Register (47 FR 22030). You can also 

find later actions concerning the 

Alabama program and program 

amendments at 30 CFR 901.10, 901.15 

and 901.16. 

II. Description of the Proposed 

Amendment 

By email dated August 14, 2017 

(Administrative Record No. AL–0672), 

Alabama sent us an amendment to its 

program under SMCRA (30 U.S.C. 1201 

et seq.) at its own initiative. Below is a 

summary of the changes proposed by 

Alabama. The full text of the program 

amendment is available for you to read 

at the locations listed above under 

ADDRESSES. 

Alabama Administrative Code 880–X– 

8B–.07 

Alabama proposes revisions to its 

program regarding annual permit fees 

by: 

(1) Increasing the initial acreage fee 

from $35.00 per acre to $75.00, to be 

paid on each acre in a permit covered 

by a performance bond prior to the 

initiation of operations on the permit (or 

on an increment of an acre if increments 

are used), and to be paid on all bonded 

acreage covered by a permit renewal; 

(2) Increasing the basic fee for a coal 

exploration permit application from 

$2,000.00 to $2,500.00; 

(3) Increasing the basic fee for a 

permit renewal application from 

$1,000.00 to $2,500.00; 

(4) Increasing the basic fee for a 

permit transfer application from $200.00 

to $500.00; 

(5) Adding an annual acreage fee for 

expired permits of $15.00, per acre, to 

be paid by December 31st of each year 

on each acre covered by a performance 

bond as of October 1st of the year; and 

(6) Adding the inspection of permits 

to the ASMC’s uses for the deposited 

permit fees. 

Alabama fully funds its share of costs 

to regulate the coal mining industry 

with fees paid by the coal industry. The 

proposed fee revisions are intended to 

provide adequate funding to pay the 

State’s cost of operating its regulatory 

program. The ASMC does not expect the 

increase in permit fees to exceed the 

actual or anticipated cost of reviewing, 

administering, inspecting, and enforcing 

surface coal mining permits in Alabama. 

III. Public Comment Procedures 

Under the provisions of 30 CFR 

732.17(h), we are seeking your 

comments on whether the amendment 

satisfies the applicable program 

approval criteria of 30 CFR 732.15. If we 

approve the amendment, it will become 

part of the State plan. 

Electronic or Written Comments 

If you submit written comments, they 

should be specific, confined to issues 

pertinent to the proposed regulations, 

and explain the reason for any 

recommended change(s). We appreciate 

any and all comments, but those most 

useful and likely to influence decisions 

on the final program will be those that 

either involve personal experience or 

include citations to and analyses of 

SMCRA, its legislative history, its 

implementing regulations, case law, 

other pertinent State or Federal laws or 

regulations, technical literature, or other 

relevant publications. 

We cannot ensure that comments 

received after the close of the comment 

period (see DATES) or sent to an address 

other than those listed (see ADDRESSES) 

will be included in the docket for this 

rulemaking and considered. 

Public Availability of Comments 

Before including your address, phone 

number, email address, or other 

personal identifying information in your 

comment, you should be aware that 

your entire comment—including your 

personal identifying information—may 

be made publicly available at any time. 

While you can ask us in your comment 

to withhold your personal identifying 

information from public review, we 

cannot guarantee that we will be able to 

do so. 

Public Hearing 

If you wish to speak at the public 

hearing, contact the person listed under 

FOR FURTHER INFORMATION CONTACT by 

4:00 p.m., CST on February 15, 2018. If 

you are disabled and need reasonable 

accommodations to attend a public 

hearing, contact the person listed under 

FOR FURTHER INFORMATION CONTACT. We 

will arrange the location and time of the 

hearing with those persons requesting 

the hearing. If no one requests an 

opportunity to speak, we will not hold 

a hearing. 

To assist the transcriber and ensure an 

accurate record, we request, if possible, 

that each person who speaks at the 

public hearing provide us with a written 

copy of his or her comments. The public 

hearing will continue on the specified 

date until everyone scheduled to speak 

has been given an opportunity to be 

heard. If you are in the audience and 

have not been scheduled to speak and 

wish to do so, you will be allowed to 

speak after those who have been 

scheduled. We will end the hearing after 

everyone scheduled to speak and others 

present in the audience who wish to 

speak, have been heard. 

Public Meeting 

If only one person requests an 

opportunity to speak, we may hold a 

public meeting rather than a public 

hearing. If you wish to meet with us to 

discuss the amendment, please request 

a meeting by contacting the person 

listed under FOR FURTHER INFORMATION

CONTACT. All such meetings are open to 

the public and, if possible, we will post 

notices of meetings at the locations 

listed under ADDRESSES. We will make 

a written summary of each meeting a 

part of the administrative record. 

IV. Procedural Determinations 

Executive Order 12866—Regulatory 

Planning and Review 

Pursuant to Office of Management and 

Budget (OMB) Guidance and dated 

October 12, 1993, the approval of state 

program amendments is exempted from 

OMB review under Executive Order 

12866. 

Other Laws and Executive Orders 

Affecting Rulemaking 

When a State submits a program 

amendment to OSMRE for review, our 

regulations at 30 CFR 732.17(h) require 

us to hold a public hearing on a program 

amendment if it changes the objectives, 

scope or major policies followed, or 

make a finding that the State provided 

adequate notice and opportunity for 

public comment. Alabama has elected to 

have OSMRE publish a notice in the 

Federal Register indicating receipt of 

the proposed amendment and soliciting 

comments. We will conclude our review 

of the proposed amendment after the 

close of the public comment period and 

determine whether the amendment 

should be approved, approved in part, 

or not approved. At that time, we will 

also make the determinations and 

certifications required by the various 

laws and executive orders governing the 

rulemaking process and include them in 

the final rule. 

List of Subjects in 30 CFR Part 901 

Intergovernmental relations, Surface 

mining, Underground mining. 

Dated: August 28, 2017. 

Alfred L. Clayborne, 

Regional Director, Mid-Continent Region. 

Editorial Note: This document was 

received for publication by the Office of the 

Federal Register on January 17, 2018. 

[FR Doc. 2018–01053 Filed 1–19–18; 8:45 am] 

BILLING CODE 4310–05–P 


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