Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices 67311 

4https://www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/providingregulatory-submissions-medical-devices-electronicformat-submissions-under-section-745ab. 

FDA’s guidance document ‘‘Providing 

Regulatory Submissions for Medical 

Devices in Electronic Format— 

Submissions Under Section 745A(b) of 

the Federal Food, Drug, and Cosmetic 

Act’’ 4 (hereafter referred to as the 

‘‘745A(b) device parent guidance’’) 

provides a process for the development 

of templates to facilitate the preparation, 

submission, and review of regulatory 

submissions for medical devices solely 

in electronic format. As described in the 

745A(b) device parent guidance, FDA 

plans to implement the requirements of 

section 745A(b)(3) of the FD&C Act with 

individual guidances specifying the 

formats for specific submissions and 

corresponding timetables for 

implementation. When finalized, this 

guidance will provide such information 

for De Novo electronic submissions 

solely in electronic format. 

In section 745A(b) of the FD&C Act, 

Congress granted explicit statutory 

authorization to FDA to specify in 

guidance the statutory requirement for 

electronic submissions solely in 

electronic format by providing 

standards, a timetable, and criteria for 

waivers and exemptions. To the extent 

that this draft guidance provides such 

requirements under section 745A(b)(3) 

of the FD&C Act (i.e., standards, 

timetable, criteria for waivers of and 

exemptions), indicated by the use of the 

mandatory words, such as must or 

required, this document is not subject to 

the usual restrictions in FDA’s good 

guidance practice regulations, such as 

the requirement that guidances not 

establish legally enforceable 

responsibilities (see § 10.115(d) (21 CFR 

10.115(d)).) To the extent that this draft 

guidance describes recommendations 

that are not standards, timetable, criteria 

for waivers of, or exemptions under 

section 745A(b)(3) of the FD&C Act, it 

is being issued consistent with FDA’s 

good guidance practices regulation 

(§ 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The draft guidance, when finalized, 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 alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. This draft 

guidance, when finalized, will contain 

both binding and nonbinding 

provisions. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the draft 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 ‘‘Electronic 

Submission Template for Medical 

Device De Novo Requests’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number GUI00021027 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 (OMB) under the Paperwork 

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

3501–3521). The collections of 

information in the following table have 

been approved by OMB: 

21 CFR part Topic OMB control No. 

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

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

800, 801, and 809 ................................................................... Medical Device Labeling Regulations ..................................... 0910–0485 

Dated: September 25, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21405 Filed 9–28–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2781] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Data To Support 

Drug Product Communications as 

Used by the Food and Drug 

Administration 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on a generic 

clearance to collect information to 

support communications used by FDA 

about drug products. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

November 28, 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 28, 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, 

including attachments, to https:// 

www.regulations.gov will be posted to 

the docket unchanged. Because your 


lotter on DSK11XQN23PROD with NOTICES1
67312 Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices 

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–2781 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Data To 

Support Drug Product Communications 

as Used by the Food and Drug 

Administration.’’ 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: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Data To Support Drug Product 

Communications as Used by the Food 

and Drug Administration 

OMB Control Number 0910–0695— 

Extension 

This information collection supports 

Agency outreach and other proactive 

communication efforts. Evaluating 

communication messages and 

supporting materials in advance of a 

communication campaign provides an 

important role in improving FDA 

communications as they allow for an indepth understanding of individuals’ 

knowledge, attitudes, beliefs, 

motivations, feelings, and behaviors. 

Such evaluations are critical in helping 

FDA develop public health 

communications that meet the needs 

and desires of its many diverse target 

audiences. 

We intend to use the following 

methods with general public health 

consumers and healthcare professionals 

in our efforts: individual in-depth 

interviews, focus group discussions, 

intercept interviews, self-administered 

surveys, gatekeeper surveys, all on a 

voluntary basis. The methods to be used 

serve the narrowly defined need for 

direct and informal opinion on a 

specific topic and, as a qualitative and/ 

or quantitative research tools, have two 

major purposes: (1) to obtain 

information that is useful for developing 

variables and measures for formulating 

the basic objectives of risk 

communication campaigns and (2) to 

assess the potential effectiveness of 

messages and materials in reaching and 

successfully communicating with their 

intended audiences. We will use these 

methods to test and refine our ideas and 

to help develop messages and other 

communications but will generally 

conduct further research before making 

important decisions, such as adopting 

new policies and allocating or 

redirecting significant resources to 

support these policies. 

We will use this qualitative and/or 

quantitative research to test messages 

about regulated drug products on a 


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Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices 67313 

variety of subjects related to consumer, 

patient, or healthcare professional 

perceptions and about use of drug 

products and related materials, 

including but not limited to: (1) directto-consumer prescription drug 

promotion; (2) labeling and information 

about prescription and over-the-counter 

drugs; (3) patient medication guides; (4) 

safety and risk communications; (5) 

online sale of medical products; and (6) 

consumer and professional education. 

Annually, we project about 75 

communication studies using the 

variety of research methods listed in 

this document. FDA is requesting an 

extension of these burden hours so as 

not to restrict its ability to gather 

information on public opinion for its 

regulatory and communications 

programs. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Interviews/Surveys ..................................................... 45,000 1 45,000 0.75 (45 minutes) .... 33,750 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Our estimated burden for the 

information collection has changed 

since the last OMB approval. We 

attribute this change to screening more 

potential participants to obtain the very 

specialized and hard-to-recruit 

populations often needed for these 

studies, e.g., vulnerable populations, 

and patients taking or users of a specific 

drug or type of drug, such as opioids 

and other controlled substances, 

biosimilars, etc. 

Dated: September 26, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21419 Filed 9–28–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0996] 

Technical Considerations for Medical 

Devices With Physiologic Closed-Loop 

Control Technology; 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 ‘‘Technical 

Considerations for Medical Devices with 

Physiologic Closed-Loop Control 

Technology.’’ Physiologic closed-loop 

control (PCLC) devices are intended for 

automatic control of a physiologic 

variable(s) through delivery of energy or 

substance using feedback from 

physiologic sensors. PCLC devices may 

play an important role in reducing 

cognitive overload, minimizing human 

error, and enhancing medical care 

during emergency response and medical 

surge situations. This guidance provides 

technical considerations for PCLC 

technology in order to promote 

development and availability of safe and 

effective PCLC medical devices. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 29, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2021–D–0996 for ‘‘Technical 

Considerations for Medical Devices with 

Physiologic Closed-Loop Control 

Technology.’’ 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 


lotter on DSK11XQN23PROD with NOTICES1