66460 Federal Register / Vol. 88, No. 186 / Wednesday, September 27, 2023 / Notices 

Submissions for Management of 

Cybersecurity in Medical Devices,’’ 

issued October 2, 2014. The changes 

since the 2014 guidance are intended to 

further emphasize the importance of 

ensuring that devices are designed 

securely and are designed to be capable 

of mitigating emerging cybersecurity 

risks throughout the total product 

lifecycle (TPLC), and to clearly outline 

FDA’s recommendations for premarket 

submission information to address 

cybersecurity concerns. As discussed in 

the guidance, one way these TPLC 

considerations for devices can be 

achieved is through the implementation 

and adoption of the Secure Product 

Development Framework. The 

recommendations in this guidance are 

intended to promote consistency, 

facilitate efficient premarket review, and 

help ensure that marketed medical 

devices are sufficiently resilient to 

cybersecurity threats. 

A notice of availability of the draft 

guidance appeared in the Federal 

Register of April 8, 2022 (87 FR 20873). 

FDA considered comments received and 

revised the guidance as appropriate in 

response to the comments, including 

aligning with industry best practices, as 

well as further clarifying the level of 

documentation recommended. 

Additionally, we have clarified 

interoperability considerations and that 

cybersecurity controls should not be 

intended to prohibit a user from 

accessing their device data. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Cybersecurity in 

Medical Devices: Quality System 

Considerations and Content of 

Premarket Submissions.’’ 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. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.regulations.gov, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents or 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics. 

Persons unable to download an 

electronic copy of ‘‘Cybersecurity in 

Medical Devices: Quality System 

Considerations and Content of 

Premarket Submissions’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number GUI00001825 and 

complete title to identify the guidance 

you are requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no new 

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 under the Paperwork Reduction 

Act of 1995. The collections of 

information in the following FDA 

regulations, guidance, and forms have 

been approved by OMB as listed in the 

following table: 

21 CFR part or guidance Topic OMB Control 

No. 

807, subpart E ............................................................................ Premarket notification ................................................................. 0910–0120 

814, subparts A through E ......................................................... Premarket approval .................................................................... 0910–0231 

814, subpart H ............................................................................ Humanitarian Use Devices; Humanitarian Device Exemption ... 0910–0332 

812 .............................................................................................. Investigational Device Exemption .............................................. 0910–0078 

860, subpart D ............................................................................ De Novo classification process .................................................. 0910–0844 

‘‘Requests for Feedback and Meetings for Medical Device 

Submissions: The Q-Submission Program’’.

Q-Submissions and early payor feedback request programs 

for medical devices.

0910–0756 

800, 801, 809, and 830 .............................................................. Medical device labeling regulations; Unique device identification.0910–0485 

820 .............................................................................................. Current good manufacturing practice (CGMP); Quality system 

(QS) regulation.

0910–0073 

Dated: September 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20955 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–2023–N–0487] 

Discussion Paper: Artificial 

Intelligence in Drug Manufacturing, 

Notice; Request for Information and 

Comments; Reopening of the 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for information 

and comments; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

reopening the comment period for the 

notice, published in the Federal 

Register of March 1, 2023, establishing 

a public docket and requesting 

information and comments. FDA is 

reopening the comment period to 

update comments and to receive any 

new information. 

DATES: FDA is reopening the comment 

period on the notice published March 1, 

2023 (88 FR 12943). Either electronic or 

written comments must be submitted by 

November 27, 2023. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

November 27, 2023. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

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, 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 186 / Wednesday, September 27, 2023 / Notices 66461 

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– 

2023–N–0487 for ‘‘Discussion Paper: 

Artificial Intelligence in Drug 

Manufacturing, Notice; Request for 

Information and Comments.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Giaquinto Friedman, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 4162, 

Silver Spring, MD 20993, 240–402– 

7930, Elizabeth.Giaquinto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of March 1, 2023 (88 

FR 12943), FDA established a public 

docket to solicit comments on the 

‘‘Discussion Paper: Artificial 

Intelligence in Drug Manufacturing.’’ 

The discussion paper presents areas for 

consideration and policy development 

identified by the Center for Drug 

Evaluation and Research (CDER) 

scientific and policy experts associated 

with application of artificial intelligence 

to pharmaceutical manufacturing. The 

discussion paper includes a series of 

questions to stimulate feedback from the 

public, including CDER and the Center 

for Biologics Evaluation and Research 

stakeholders. 

Interested persons were originally 

given until May 1, 2023, to comment on 

the content of the discussion paper. 

Following publication of the March 1, 

2023, notice, FDA has decided to reopen 

the public docket to allow interested 

persons additional time to comment on 

the discussion paper. We note that there 

is also a public workshop organized by 

FDA and the Product Quality Research 

Institute entitled ‘‘Regulatory 

Framework for the Utilization of 

Artificial Intelligence in Pharmaceutical 

Manufacturing: An Opportunity for 

Stakeholder Engagement,’’ which is 

scheduled for September 26 and 27, 

2023 (https://pqri.org/fda-pqriaiworkshop/). 

Dated: September 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20902 Filed 9–26–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0324] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before November 27, 

2023. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 264–0041 and PRA@HHS.GOV. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990–0324–60D 

and project title for reference, to 

Sherrette A. Funn, email: 

Sherrette.Funn@hhs.gov, PRA@

HHS.GOV or call (202) 264–0041 the 

Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Report of 

Dental Examination of Applicants to the 

Public Health Service Commissioned 

Corps. 


ddrumheller on DSK120RN23PROD with NOTICES1