25432 Federal Register / Vol. 87, No. 83 / Friday, April 29, 2022 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1 

[Docket No. FDA–2022–D–0370] 

The Accredited Third-Party 

Certification Program: Questions and 

Answers; Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the availability of a 

draft guidance for industry entitled 

‘‘The Accredited Third-Party 

Certification Program: Questions and 

Answers.’’ The draft guidance, when 

finalized, will answer frequently asked 

questions relating to the requirements of 

the Accredited Third-Party Certification 

Program, and is intended to assist 

accreditation bodies’, third-party 

certification bodies’, and eligible 

entities’ understanding of the regulation 

and program requirements. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by July 28, 2022 to ensure that the 

Agency considers your comment on the 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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– 

2022–D–0370 for ‘‘The Accredited 

Third-Party Certification Program: 

Questions and Answers.’’ 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, 240–402–7500. 

• 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.govinfo.gov/content/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, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Center for Food Safety and Applied 

Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740. Send two selfaddressed adhesive labels to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance. 

FOR FURTHER INFORMATION CONTACT: 

Doriliz De Leon, Center for Food Safety 

and Applied Nutrition (HFS–607), Food 

and Drug Administration, 5001 Campus 

Dr., College Park, MD 20740, 240–402– 

2772. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a draft guidance for industry entitled 

‘‘The Accredited Third-Party 

Certification Program: Questions and 

Answers.’’ We are issuing the draft 

guidance consistent with our good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the current 

thinking of FDA on this topic. It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternate approach if it 

satisfies the requirements of the 

applicable statutes and regulations. 

The FDA Food Safety Modernization 

Act (Pub. L. 111–353) added section 808 

to the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 384d), which 

directs FDA to establish a program for 

accreditation of third-party certification 

bodies to conduct food safety audits and 

to certify that eligible foreign food 

entities (including registered foreign 

food facilities) and food produced by 

such entities meet applicable FDA 

requirements for purposes of sections 

801(q) (21 U.S.C. 381(q)) and 806 (21 

U.S.C. 384b) of the FD&C Act. On 

November 27, 2015, FDA issued the 

final rule, ‘‘Accreditation of Third-Party 

Certification Bodies to Conduct Food 

Safety Audits and to Issue 

Certifications’’ (also referred to as the 

TPP regulation) (80 FR 74569; 21 CFR 

part 1, subpart M). This draft guidance, 


lotter on DSK11XQN23PROD with PROPOSALS1
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 


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