Federal Register / Vol. 88, No. 186 / Wednesday, September 27, 2023 / Notices 66457 

currently funded to carry out The Link 

Center Project for the period of 

September 1, 2022, through August 31, 

2027. Much work has already been 

completed and further tasks are 

currently being accomplished. It would 

be unnecessarily time consuming and 

disruptive to the Link Center project 

and the beneficiaries being served for 

ACL to establish a new grantee at this 

time when critical services are presently 

being provided in an efficient manner. 

SAMHSA also has determined that the 

award of another contract or grant to 

provide these services would duplicate 

the activities carried out under this 

cooperative agreement. SAMHSA has 

further determined that a grant 

supplement to support the 988 State 

Policy Academy through this 

cooperative agreement is likely to be 

less expensive than a separate 

arrangement. This agreement promotes 

government efficiency and reduces the 

possibility of costly duplication of 

effort. 

Dated: September 21, 2023. 

Alison Barkoff, 

Senior Official Performing the Duties of the 

Administrator and the Assistant Secretary for 

Aging. 

[FR Doc. 2023–21046 Filed 9–26–23; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[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Draft Guidance for Industry; 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, the Agency, or 

we) is announcing the availability of 

two additional draft chapters of a 

multichapter draft guidance for industry 

entitled ‘‘Hazard Analysis and RiskBased Preventive Controls for Human 

Food.’’ This multichapter draft 

guidance, when finalized, will explain 

FDA’s current thinking on how to 

comply with the requirements for 

hazard analysis and risk-based 

preventive controls under FDA’s 

regulation entitled ‘‘Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Human Food.’’ The newly 

available draft chapters are entitled 

‘‘Chapter 11—Food Allergen Program’’ 

and ‘‘Chapter 16—Acidified Foods.’’ 

This draft guidance is not final nor is it 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written comments on the draft guidance 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 March 25, 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: 

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 draft 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 self-addressed 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–300), Food and 

Drug Administration, 5001 Campus Dr., 

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


ddrumheller on DSK120RN23PROD with NOTICES1
66458 Federal Register / Vol. 88, No. 186 / Wednesday, September 27, 2023 / Notices 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

two draft chapters entitled ‘‘Chapter 

11—Food Allergen Program’’ and 

‘‘Chapter 16—Acidified Foods’’ 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. 

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

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

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. 

We also are announcing changes to 

the expected table of contents for the 

complete multichapter guidance. 

We are issuing these chapters 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 how to comply with 

the requirements for hazard analysis 

and risk-based preventive controls 

under part 117 (21 CFR part 117), 

principally in subparts C and G. It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative 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. 

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. 

III. 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. 

IV. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

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

www.fda.govregulatory-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: September 20, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20738 Filed 9–26–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–1158] 

Cybersecurity in Medical Devices: 

Quality System Considerations and 

Content of Premarket Submissions; 

Guidance for Industry and Food and 

Drug Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance entitled ‘‘Cybersecurity in 

Medical Devices: Quality System 

Considerations and Content of 

Premarket Submissions.’’ As more 

medical devices are becoming 

interconnected, cybersecurity threats 

have become more numerous, more 

frequent, more severe, and more 

clinically impactful. As a result, 

ensuring medical device safety and 

effectiveness includes adequate medical 

device cybersecurity, as well as its 

security as part of the larger system. 

This final guidance supersedes the final 

guidance ‘‘Content of Premarket 

Submissions for Management of 

Cybersecurity in Medical Devices,’’ 

issued October 2, 2014. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 27, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 


ddrumheller on DSK120RN23PROD with NOTICES1