Federal Register / Vol. 87, No. 83 / Friday, April 29, 2022 / Proposed Rules 25433 

when finalized, will answer frequently 

asked questions relating to the 

requirements of the Accredited ThirdParty Certification Program established 

in 21 CFR part 1, subpart M (21 CFR 

1.600 through 1.695, 21 CFR 1.700 

through 1.725), and is intended to assist 

the accreditation bodies’, third-party 

certification bodies’, and eligible 

entities’ understanding of the TPP 

regulation and program requirements. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required. The previously 

approved collections of information are 

subject to review by OMB under the 

PRA. The collections of information 

under the TPP regulation in 21 CFR part 

1, subpart M have been approved under 

OMB control number 0910–0750. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments or https://

www.regulations.gov. Use the FDA 

website listed in the previous sentence 

to find the most current version of the 

guidance. 

Dated: April 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09232 Filed 4–28–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE INTERIOR 

Office of Surface Mining Reclamation 

and Enforcement 

30 CFR Part 913 

[SATS No. IL–111–FOR; Docket ID: OSM– 

2022–0002; S1D1S SS08011000 SX064A000 

222S180110; S2D2S SS08011000 

SX064A000 22XS501520] 

Illinois 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 Illinois 

regulatory program (hereinafter, the 

Illinois program) under the Surface 

Mining Control and Reclamation Act of 

1977 (SMCRA or the Act). The 

amendment proposes the removal of 

revegetation success standards and 

statistically valid sampling techniques 

from inclusion in the approved 

regulatory program as allowed by the 

2006 Topsoil Redistribution and 

Revegetation Success Standards Final 

Rule. This amendment also updates 

references and makes minor editorial 

changes. This document gives the times 

and locations that the Illinois program 

and this proposed amendment to that 

program are available for your 

inspection, the comment period during 

which you may submit written 

comments on the amendment, and the 

procedures that 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., Central Standard Time (c.s.t.), May 

31, 2022. If requested, we may hold a 

public hearing or meeting on the 

amendment on May 24, 2022. We will 

accept requests to speak at a hearing 

until 4:00 p.m., c.s.t. on May 16, 2022. 

ADDRESSES: You may submit comments, 

identified by SATS No. IL–111–FOR, by 

any of the following methods: 

• Mail/Hand Delivery: William L. 

Joseph, Chief, Alton Field Division, 

Office of Surface Mining Reclamation 

and Enforcement, 501 Belle Street, Suite 

216, Alton, Illinois 62002–6169. 

• Fax: (618) 463–6470. 

• Federal eRulemaking Portal: The 

amendment has been assigned Docket 

ID: OSM–2022–0002. If you would like 

to submit comments, go to https://

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 Illinois program, 

this amendment, a listing of any 

scheduled public hearings or meetings, 

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 Alton Field 

Division or the full text of the program 

amendment is available for you to read 

at www.regulations.gov. 

William L. Joseph, Chief, Alton Field 

Division, Office of Surface Mining 

Reclamation and Enforcement, 501 Belle 

Street, Suite 216, Alton, Illinois 62002– 

6169, Telephone: (618) 463–6463, 

Email: bjoseph@osmre.gov. 

In addition, you may review a copy of 

the amendment during regular business 

hours at the following location: Office of 

Mines and Minerals, Illinois Department 

of Natural Resources, One Natural 

Resources Way, Springfield, IL 62702– 

1271, Telephone: (618) 439–9111. 

FOR FURTHER INFORMATION CONTACT: 

William L. Joseph, Chief, Alton Field 

Division. Telephone (618) 463–6463, 

Email: bjoseph@osmre.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background on the Illinois Program 

II. Description of the Proposed Amendment 

III. Public Comment Procedures 

IV. Statutory and Executive Order Reviews 

I. Background on the Illinois Program 

Subject to OSMRE’s oversight, 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 nonIndian lands within its borders by 

demonstrating that its approved, State 

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 Illinois program on June 1, 

1982. You can find background 

information on the Illinois program, 

including the Secretary’s findings, the 

disposition of comments, and 

conditions of approval of the Illinois 

program in the June 1, 1982, Federal 

Register (47 FR 23858). You can also 

find later actions concerning the Illinois 

program and program amendments at 30 

CFR 913.10, 913.15, and 913.17. 

II. Description of the Proposed 

Amendment 

By letter dated February 4, 2022 

(Administrative Record No. IL–5119), 

Illinois sent us an amendment to its 

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

et seq.). The amendment proposes the 

removal of revegetation success 

standards and sampling techniques from 

inclusion in the approved regulatory 

program as allowed by the 2006 Topsoil 

Redistribution and Revegetation Success 

Standards Final Rule (71 FR 51684). 

This change was driven by recent 

fluctuations in available datasets for 

their Agricultural Lands Productivity 

Formula. No longer including these 

standards and techniques in their 

regulations and providing them as a 


lotter on DSK11XQN23PROD with PROPOSALS1
25434 Federal Register / Vol. 87, No. 83 / Friday, April 29, 2022 / Proposed Rules 

separate publicly available document as 

approved in the 2006 OSMRE rule will 

provide the ability to be more 

responsive to changes in dataset 

availability. Illinois would not be 

required to process a formal regulation 

amendment in order to remain 

compliant if data for a particular crop 

and/or area is not available. Illinois 

could process changes to their locally 

available document instead. This 

amendment also updates references and 

makes minor editorial changes. The full 

text of the program and/or plan 

amendment is available for you to read 

at the locations listed above under 

ADDRESSES or at www.regulations.gov. 

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 program. 

Electronic or Written Comments 

If you submit written or electronic 

comments on the proposed rule during 

the 30-day comment period, 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 

regulations 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., c.s.t. on May 16, 2022. 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. Statutory and Executive Order 

Reviews 

Executive Order 12866—Regulatory 

Planning and Review and Executive 

Order 13563—Improving Regulation 

and Regulatory Review 

Executive Order 12866 provides that 

the Office of Information and Regulatory 

Affairs in the Office of Management and 

Budget (OMB) will review all significant 

rules. Pursuant to OMB guidance, dated 

October 12, 1993, the approval of State 

program amendments is exempted from 

OMB review under Executive Order 

12866. Executive Order 13563, which 

reaffirms and supplements Executive 

Order 12866, retains this exemption. 

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 publish a notice in the Federal 

Register indicating receipt of the 

proposed amendment, its text or a 

summary of its terms, and an 

opportunity for public comment. We 

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 913 

Intergovernmental relations, Surface 

mining, Underground mining. 

Alfred L. Clayborne, 

Regional Director, Interior Regions 3, 4, 

and 6. 

[FR Doc. 2022–09190 Filed 4–28–22; 8:45 am] 

BILLING CODE 4310–05–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket Number USCG–2022–0161] 

RIN 1625–AA08 

Special Local Regulation; Back River, 

Baltimore County, MD 

AGENCY: Coast Guard, Homeland 

Security (DHS). 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard is proposing 

to establish temporary special local 

regulations for certain waters of Back 

River. This action is necessary to 

provide for the safety of life on these 

navigable waters located in Baltimore 

County, MD, during a high-speed power 

boat event on July 16, 2022 (alternate 

date on July 17, 2022). This proposed 

rulemaking would prohibit persons and 

vessels from being in the regulated area 

unless authorized by the Captain of the 

Port Maryland-National Capital Region 

or the Coast Guard Event Patrol 

Commander. We invite your comments 

on this proposed rulemaking. 

DATES: Comments and related material 

must be received by the Coast Guard on 

or before May 31, 2022. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2022–0161 using the Federal 

eRulemaking Portal at https://

www.regulations.gov. See the ‘‘Public 

Participation and Request for 

Comments’’ portion of the 


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