Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Proposed Rules 7315 

individual. Providing a subject with 

access to these records could impair the 

effectiveness of the Commission’s 

investigations and could significantly 

impede the investigation by providing 

the opportunity for the subject to 

destroy documentary evidence, 

improperly influence witnesses and 

confidential sources, fabricate 

testimony, and engage in other activities 

that could compromise the 

investigation. In addition, providing an 

individual with access to these records 

may reveal the identity of a source who 

furnished information under an express 

promise that their identity would 

remain confidential. Amendment of the 

records in this system of records would 

interfere with ongoing law enforcement 

proceedings and impose an impossible 

administrative burden by requiring law 

enforcement investigations to be 

continuously reinvestigated. 

(3) From subsection (e)(1) (Relevancy 

and Necessity of Information), because 

in the course of conducting and 

adjudicating background investigations, 

the significance of certain information 

may not be clear or the information may 

not be strictly relevant or necessary to 

a specific investigation; but, effective 

investigations require the retention of 

all information that may aid in the 

investigation and provide investigative 

leads. 

(4) From subsection (e)(4)(G), (H), and 

(I) (Agency Requirements) and (f) 

(Agency Rules), because the 

Commission is not required to establish 

requirements, rules, or procedures 

related to access and amendment of 

records in a system of records that is 

exempt from the individual access and 

amendment provisions in subsection (d) 

of the Privacy Act. 

(g) CFTC–49 Whistleblower Records. 

The system of records identified as 

CFTC–49 Whistleblower Records 

contains records related to 

whistleblower tips, complaints and 

referrals, records related to 

investigations and inquiries into 

whistleblower complaints, and records 

related to the whistleblower award 

claim and determination process. 

Pursuant to 5 U.S.C. 552a(k)(2) and 

subject to the requirements and 

limitations set forth therein, the 

Commission is exempting this system of 

records from the following provisions of 

the Privacy Act: 5 U.S.C. 552a(c)(3); 

(d)(1), (2), (3), and (4); (e)(1); (e)(4)(G), 

(H), and (I); and (f), and from the 

following corresponding sections of this 

part: 146.3; 146.5; 146.6(d); 146.11(a)(7), 

(8), and (9); and 146.7(a). Exemptions 

from these particular subsections of the 

Privacy Act are justified for the 

following reasons: 

(1) From subsection (c)(3) 

(Accounting of Certain Disclosures), 

because release of the accounting of 

certain disclosures could alert the 

subject of an investigation to the 

existence and extent of that 

investigation and reveal the 

investigative interests of the 

Commission and the recipient entity. 

Release of such information to the 

subject of an investigation could 

reasonably be anticipated to impede and 

interfere with the Commission’s efforts 

to identify and investigate unlawful 

activities. 

(2) From subsection (d)(1), (2), (3), 

and (4) (Access and Amendment), 

because individual access to these 

records could alert the subject of an 

investigation to the existence and extent 

of that investigation and reveal the 

investigative interests of the 

Commission and others. Providing a 

subject with access to these records 

could impair the effectiveness of the 

Commission’s investigations and could 

significantly impede the investigation 

by providing the opportunity for the 

subject to destroy documentary 

evidence, improperly influence 

witnesses and confidential sources, 

fabricate testimony, and engage in other 

activities that could compromise the 

investigation. Allowing the subject of 

the investigation to amend records in 

this system of records could likewise 

interfere with ongoing law enforcement 

proceedings and impose an impossible 

administrative burden by requiring law 

enforcement investigations to be 

continuously reinvestigated. 

(3) From subsection (e)(1) (Relevancy 

and Necessity of Information), because 

in the course of investigations, the 

significance of certain information may 

not be clear or the information may not 

be strictly relevant or necessary to a 

specific investigation; but, effective 

investigations require the retention of 

all information that may aid in the 

investigation or aid in establishing 

patterns of activity and provide 

investigative leads. 

(4) From subsection (e)(4)(G), (H), and 

(I) (Agency Requirements) and (f) 

(Agency Rules), because the 

Commission is not required to establish 

requirements, rules, or procedures 

related to access and amendment of 

records in a system of records that is 

exempt from the individual access and 

amendment provisions in subsection (d) 

of the Privacy Act. 

§ 146.13 [Removed] 

■ 3. Remove § 146.13. 

Issued in Washington, DC, on January 24, 

2024, by the Commission. 

Christopher Kirkpatrick, 

Secretary of the Commission. 

Note: The following appendix will not 

appear in the Code of Federal Regulations. 

Appendix to Privacy Act Regulations— 

Commission Voting Summary 

On this matter, Chairman Behnam and 

Commissioners Johnson, Goldsmith Romero, 

Mersinger, and Pham voted in the 

affirmative. No Commissioner voted in the 

negative. 

[FR Doc. 2024–01684 Filed 2–1–24; 8:45 am] 

BILLING CODE 6351–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 117 

[Docket No. FDA–2016–D–2343] 

Hazard Analysis and Risk-Based 

Preventive Controls for Human Food; 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or the 

Agency) is announcing the availability 

of a revised draft Introduction, and a 

revised draft Appendix 1, within a 

multichapter guidance for industry 

entitled ‘‘Hazard Analysis and RiskBased Preventive Controls for Human 

Food.’’ This multichapter draft 

guidance, when finalized, will explain 

our current thinking on how to comply 

with the requirements for hazard 

analysis and risk-based preventive 

controls under our rule entitled 

‘‘Current Good Manufacturing Practice, 

Hazard Analysis, and Risk-Based 

Preventive Controls for Human Food.’’ 

We revised the draft Introduction and 

draft Appendix 1: Known or Reasonably 

Foreseeable Hazards (‘‘Potential 

Hazards’’) to address comments 

submitted on drafts that we made 

available in 2016. This draft guidance is 

not final nor is it in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by June 3, 2024 to ensure that the 

Agency considers your comment on this 

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: 


khammond on DSKJM1Z7X2PROD with PROPOSALS
7316 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Proposed Rules 

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– 

2016–D–2343 for ‘‘Hazard Analysis and 

Risk-Based Preventive Controls for 

Human Food.’’ 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 guidance to the Office of 

Food Safety (HFS–300), 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 requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Linda Kahl, Center for Food Safety and 

Applied Nutrition (HFS–024), Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2784. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a revised draft Introduction and a 

revised draft Appendix 1 of a 

multichapter draft guidance for industry 

entitled ‘‘Hazard Analysis and RiskBased Preventive Controls for Human 

Food.’’ We previously announced the 

availability of several chapters of that 

draft guidance as shown in table 1. 

TABLE 1—AVAILABLE DRAFT CHAPTERS IN HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN

FOOD

Chapter No. Chapter title Publication 

N/A ....................................... Introduction ...................................................................... 81 FR 57816, August 24, 2016. 

1 ........................................... The Food Safety Plan ..................................................... 81 FR 57816, August 24, 2016. 

2 ........................................... Conducting a Hazard Analysis ........................................ 81 FR 57816, August 24, 2016. 

3 ........................................... Potential Hazards Associated with the Manufacturing, 

Processing, Packing, and Holding of Human Food.

81 FR 57816, August 24, 2016. 

4 ........................................... Preventive Controls ......................................................... 81 FR 57816, August 24, 2016. 

5 ........................................... Application of Preventive Controls and Preventive Control Management Components.81 FR 57816, August 24, 2016. 

6 ........................................... Use of Heat Treatments as a Process Control .............. 82 FR 41364, August 31, 2017. 

11 ......................................... Food Allergen Program ................................................... 88 FR 66457, September 27, 2023. 

14 ......................................... Recall plan ...................................................................... 84 FR 53347, October 7, 2019. 

15 ......................................... Supply-Chain Program for Human Food Products ......... 83 FR 3449, January 25, 2018. 

16 ......................................... Acidified Foods ................................................................ 88 FR 66457, September 27, 2023. 

Appendix 1 ........................... Potential Hazards for Foods and Processes .................. 81 FR 57816, August 24, 2016. 

Appendix 2 ........................... Food Safety Plan Forms ................................................. 81 FR 57816, August 24, 2016. 

Appendix 3 ........................... Bacterial Pathogen Growth and Inactivation .................. 81 FR 57816, August 24, 2016. 


khammond on DSKJM1Z7X2PROD with PROPOSALS
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