Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Proposed Rules 7317 

We are issuing these revised sections 

of the draft guidance consistent with our 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 The draft guidance, when 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 ‘‘Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Human Food.’’ 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 (FSMA) (Pub. L. 111–353) enables 

FDA to better protect public health by 

helping to ensure the safety and security 

of the food supply. FSMA enables FDA 

to focus more on preventing food safety 

problems rather than relying primarily 

on reacting to problems after they occur. 

FSMA recognizes the important role 

industry plays in ensuring the safety of 

the food supply, including the adoption 

of modern systems of preventive 

controls in food production. 

Section 103 of FSMA amended the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act), by adding section 418 (21 

U.S.C. 350g) with requirements for 

hazard analysis and risk-based 

preventive controls for establishments 

that are required to register as food 

facilities under our regulations in 21 

CFR part 1, subpart H, in accordance 

with section 415 of the FD&C Act (21 

U.S.C. 350d). We have established 

regulations to implement these 

requirements within part 117 (21 CFR 

part 117). 

The multichapter draft guidance for 

industry is intended to explain our 

current thinking on how to comply with 

the requirements for hazard analysis 

and risk-based preventive controls 

under part 117, principally in subparts 

C and G. One revised draft that we are 

announcing in this document is 

‘‘Introduction and General Information 

Applicable to This Guidance.’’ We 

revised the draft Introduction that we 

made available in 2016 to address 

comments submitted regarding the draft 

Introduction, include all draft 

definitions that we subsequently 

included in chapters we have made 

available, and add draft 

recommendations for training 

applicable to most topics covered in the 

multichapter guidance. We also added 

two administrative features. One feature 

is a comprehensive bibliography of 

references that we cited within the 

chapters previously made available, as 

well as references that we expect to cite 

in the additional chapters that we have 

included in the table of contents. 

Another feature is a compilation of 

resources that could be useful to 

persons who use the multichapter 

guidance. 

The second revised draft that we are 

announcing in this document is 

‘‘Appendix 1: Known or Reasonably 

Foreseeable Hazards (‘‘Potential 

Hazards’’).’’ We revised the draft 

Appendix 1 that we made available in 

2016 to add text providing context for 

what the Appendix is, how it was 

developed, and how it should be used. 

To address comments submitted 

regarding the draft Appendix, we made 

several changes, including: (1) 

significantly revised product categories 

(which emphasize ingredients that go 

into foods rather than finished foods 

that can be formulated with many 

variations of such ingredients); (2) 

replaced a series of tables listing known 

or reasonably foreseeable (‘‘potential’’) 

process-related hazards with a 

discussion of such hazards; (3) provided 

a general discussion of food allergen 

hazards rather than identify known or 

reasonably foreseeable (‘‘potential’’) 

food allergen hazards that could apply 

to multiple product categories; and (4) 

identified scientific, technical, or 

regulatory information that we 

considered when identifying some 

hazards that are known or reasonably 

foreseeable (‘‘potential’’), but less 

common, hazards in some food 

categories. 

We intend to announce the 

availability for public comment of 

additional chapters of the draft guidance 

as we complete them. The titles of the 

additional chapters that we expect to 

make available for public comment are 

included in the table of contents for the 

complete multichapter guidance. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in part 117 have been 

approved under OMB control number 

0910–0751. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/FoodGuidances, https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. Use the 

FDA website listed in the previous 

sentence to find the most current 

version of the guidance. 

Dated: January 26, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01911 Filed 1–30–24; 4:15 pm] 

BILLING CODE 4164–01–P 

DEPARTMENT OF EDUCATION 

34 CFR Chapter VI 

[Docket ID ED–2023–OPE–0123] 

Negotiated Rulemaking Committee; 

Announcement of Fourth Session of 

Committee Meetings—Title IV Federal 

Student Aid Programs, Student Debt 

Relief 

AGENCY: Office of Postsecondary 

Education, Department of Education. 

ACTION: Notice of intent to establish 

negotiated rulemaking committee; 

amendment. 

SUMMARY: On August 31, 2023, we 

announced our intention to establish the 

Student Debt Relief Negotiated 

Rulemaking Committee (Committee) to 

develop proposed regulations related to 

the modification, waiver, release, or 

compromise of Federal student loans 

under the Higher Education Act of 1965, 

as amended (HEA). We now announce 

a fourth session of Committee 

negotiations on February 22 and 23, 

2024. 

DATES: The dates, times, and location of 

the fourth Committee meeting are set 

out in the Amended Schedule for 

Negotiation Sessions section under 

SUPPLEMENTARY INFORMATION. 

FOR FURTHER INFORMATION CONTACT: For 

information about the content of this 

document, including information about 

the negotiated rulemaking process or the 

schedule for negotiations, please contact 

Rene Tiongquico. Telephone: (202) 453– 

7513. Email: rene.tiongquico@ed.gov. 

For information about negotiated 

rulemaking, see ‘‘The Negotiated 

Rulemaking Process for Title IV 

Regulations—Frequently Asked 

Questions’’ at https://www2.ed.gov/ 

policy/highered/reg/hearulemaking/ 

hea08/neg-reg-faq.html. 

If you are deaf, hard of hearing, or 

have a speech disability and wish to 

access telecommunications relay 

services, please dial 7–1–1. 

SUPPLEMENTARY INFORMATION: On August 

31, 2023, we published in the Federal 

Register (88 FR 60163) an 

announcement of our intent to establish 

the Committee under section 492 of the 

HEA to develop proposed regulations 

related to section 432(a) of the HEA, 

which relate to the modification, 

waiver, or compromise of Federal 


khammond on DSKJM1Z7X2PROD with PROPOSALS
7318 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Proposed Rules 

1 80 FR 65292 (October 26, 2015). 

student loans by the Department. In that 

announcement, we set a schedule for 

Committee meetings and requested 

nominations for individual negotiators 

who represent key stakeholder 

constituencies for the issue to be 

negotiated to serve on the Committee. 

The Committee met on October 10–11, 

November 6–7, and December 11–12, 

2023. During the negotiation sessions, 

the Committee discussed proposed 

regulations presented by the 

Department. At the end of the third 

negotiation session, the Committee took 

final consensus checks on each of the 

proposed regulations presented by the 

Department. In addition to the proposed 

regulations presented by the 

Department, the Committee discussed 

whether and how the Department could 

identify borrowers who are facing 

hardship but whose situations may not 

be reflected in either existing 

regulations or in the proposed 

regulations considered by the 

Committee. 

Based upon a continued review of 

information related to hardship, the 

Department will convene the Committee 

for a fourth session to discuss only 

proposed regulations relating to that 

issue. The Committee will not discuss 

the proposed regulations for which it 

already conducted final consensus 

checks. 

Amended Schedule for Negotiation 

Sessions: The Committee will meet for 

a fourth session on February 22–23, 

2024. 

Session times will be from 10 a.m. to 

12 p.m. and 1 p.m. to 4 p.m., with a 

public comment period from 

approximately 3 p.m. to 4 p.m., Eastern 

time on February 22, 2024. The 

Department will hold public comment 

only on February 22, 2024. 

This session will be conducted 

virtually and available for the public to 

view. Individuals who wish to observe 

the Committee meetings must register. 

We will post a registration link closer to 

the start of negotiations on our website 

at www2.ed.gov/policy/highered/reg/ 

hearulemaking/2023/index.html. The 

Department will also post recordings 

and transcripts of the meetings on that 

site. 

We will provide information on how 

to request time to speak on our website 

at www2.ed.gov/policy/highered/reg/ 

hearulemaking/2023/index.html. 

Accessible Format: On request to the 

program contact person listed under FOR

FURTHER INFORMATION CONTACT, 

individuals with disabilities can obtain 

this document in an accessible format. 

The Department will provide the 

requestor with an accessible format that 

may include Rich Text Format (RTF) or 

text format (txt), a thumb drive, an MP3 

file, braille, large print, audiotape, or 

compact disc, or other accessible format. 

Electronic Access to this Document: 

The official version of this document is 

the document published in the Federal 

Register. You may access the official 

edition of the Federal Register and the 

Code of Federal Regulations at 

www.govinfo.gov. At this site you can 

view this document, as well as all other 

documents of this Department 

published in the Federal Register, in 

text or Portable Document Format 

(PDF). To use PDF, you must have 

Adobe Acrobat Reader, which is 

available free at the site. You may also 

access the documents of the Department 

published in the Federal Register by 

using the article search feature at 

www.federalregister.gov. Specifically, 

through the advanced search feature at 

this site, you can limit your search to 

documents published by the 

Department. 

Program Authority: 20 U.S.C. 1098a. 

Nasser H. Paydar, 

Assistant Secretary, Office of Postsecondary 

Education. 

[FR Doc. 2024–02107 Filed 2–1–24; 8:45 am] 

BILLING CODE 4000–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2022–0494; FRL–9931–01– 

R9] 

Air Plan Approval; Nevada; Clark 

County Department of Environment 

and Sustainability; Nonattainment New 

Source Review; 2015 Ozone Standard 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve a 

state implementation plan (SIP) revision 

submitted by the State of Nevada 

addressing the nonattainment new 

source review (NNSR) requirements for 

the 2015 ozone National Ambient Air 

Quality Standards (NAAQS). This SIP 

revision addresses the Clark County 

Department of Environment and 

Sustainability (DES or ‘‘Department’’) 

portion of the Nevada SIP. This action 

is being taken pursuant to the Clean Air 

Act (CAA or ‘‘Act’’) and its 

implementing regulations. 

DATES: Comments must be received on 

or before March 4, 2024. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R09– 

OAR–2022–0494, at https://

www.regulations.gov. For comments 

submitted at Regulations.gov, follow the 

online instructions for submitting 

comments. Once submitted, comments 

cannot be edited or removed from 

Regulations.gov. 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 

https://www2.epa.gov/dockets/ 

commenting-epa-dockets. If you need 

assistance in a language other than 

English or if you are a person with 

disabilities who needs a reasonable 

accommodation at no cost to you, please 

contact the person identified in the FOR

FURTHER INFORMATION CONTACT section. 

FOR FURTHER INFORMATION CONTACT: 

Amita Muralidharan, EPA Region IX, 75 

Hawthorne St., San Francisco, CA 

94105. By phone: (415) 947–4140 or by 

email at muralidharan.amita@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document, ‘‘we,’’ ‘‘us,’’ 

and ‘‘our’’ refer to the EPA. 

Table of Contents 

I. Background and Purpose 

II. The State’s Submittal 

A. What did the State submit? 

B. What is the purpose of the submitted 

certification letter? 

III. Analysis of Nonattainment New Source 

Review Requirements 

IV. Proposed Action and Public Comment 

V. Statutory and Executive Order Reviews 

I. Background and Purpose 

On October 26, 2015, the EPA 

promulgated a revised ozone NAAQS of 

0.070 parts per million (ppm).1 Upon 

promulgation of a new or revised 

NAAQS, the CAA requires the EPA to 

designate as nonattainment any area 

that is violating the NAAQS based on 

the three most recent years of ambient 


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