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 


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67314 Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices 

1The term drug as used in this guidance refers 

to both human drugs and biological products unless 

otherwise 

specified. 

2See http://wayback.archive-it.org/7993/

20170112084803/http:/www.fda.gov/ 

MedicalDevices/NewsEvents/

WorkshopsConferences/ucm457581.htm. 

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)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Technical 

Considerations for Medical Devices with 

Physiologic Closed-Loop Control 

Technology’’ to the Office of Policy, 

Center for Devices and Radiological 

Health (CDRH), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Christopher Scully, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 62, Rm. 1130, Silver Spring, 

MD 20993–0002, 301–796–2928. 

SUPPLEMENTARY INFORMATION: 

I. Background 

PCLC technology can enable 

automation in a variety of medical 

device types including infusion 

systems, ventilators, extracorporeal 

systems, and stimulation systems. 

Automated adjustments of a physiologic 

variable(s) through the delivery or 

removal of energy or article (e.g., drugs,1

or liquid or gas regulated as a medical 

device), such as automated fluid 

resuscitation, ventilation/oxygenation 

and anesthesia delivery, are emerging 

applications for the critical and 

emergency care environments. PCLC 

devices may benefit the patient by 

facilitating safe and effective, consistent, 

and timely delivery or removal of 

energy or article. However, introducing 

automation and reducing clinician 

involvement can incur new types of 

hazards which may render the medical 

device unsafe if not properly designed 

or evaluated. This guidance provides 

technical considerations for PCLC 

technology during device development 

to support the safe and effective design 

and evaluation of PCLC medical 

devices. 

CDRH held a public workshop 

entitled ‘‘Physiological Closed-Loop 

Controlled Devices’’ on October 13 and 

14, 2015 2 with the aim of fostering an 

open discussion on design and 

evaluation considerations associated 

with PCLC devices used in critical care 

environments. This workshop provided 

a forum for medical device 

manufacturers, clinical users and 

academia to discuss technical 

considerations for automated medical 

devices with PCLC technology. The 

feedback and recommendations 

provided at the meeting were 

incorporated in this guidance. 

A notice of availability of the draft 

guidance appeared in the Federal 

Register of December 23, 2021 (86 FR 

72971). FDA considered comments 

received and revised the guidance as 

appropriate in response to the 

comments, including clarification that 

the scope of the guidance is limited to 

recommendations regarding PCLC 

aspects of a device, adding potential 

benefits of PCLC devices, adding 

references to applicable guidance 

documents and standards, adding more 

examples of PCLC device functions, 

revising technical considerations in 

PCLC device design, and addressing 

device interoperability. 

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 Technical 

Considerations for Medical Devices with 

Physiologic Closed-Loop Control 

Technology. 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 or https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Persons unable to download an 

electronic copy of ‘‘Technical 

Considerations for Medical Devices with 

Physiologic Closed-Loop Control 

Technology’’ may send an email request 

to CDRH-Guidance@fda.hhs.gov to 

receive an electronic copy of the 

document. Please use the document 

number GUI01500085 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 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 


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Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices 67315 

21 CFR part or guidance Topic OMB control 

No. 

‘‘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 

803 .............................................................................................. Medical Device Reporting .......................................................... 0910–0437 

820 .............................................................................................. Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.0910–0073 

58 ................................................................................................ Good Laboratory Practice (GLP) Regulations for Nonclinical 

Laboratory Studies.

0910–0119 

Dated: September 26, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21412 Filed 9–28–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Supplemental Award; Infant, 

Child, and Adolescent Preventive 

Services 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice of supplemental award. 

SUMMARY: In fiscal year (FY) 2023, 

HRSA will provide supplemental funds 

to continue to provide technical 

assistance to pediatric primary care 

providers nationwide to connect them 

with Pediatric Mental Health Care 

Access (PMHCA) programs in their 

areas and to increase their capacity to 

provide pediatric mental and behavioral 

health care services. 

FOR FURTHER INFORMATION CONTACT: 

Lauren Ramos, Director, Division of 

Maternal and Child Health Workforce 

Development, Maternal and Child 

Health Bureau, Health Resources and 

Services Administration, at LRamos@

hrsa.gov and 301–443–6091. 

SUPPLEMENTARY INFORMATION: 

Intended Recipient of the Award: The 

American Academy of Pediatrics (AAP), 

as the sole recipient under HRSA–23– 

074. 

Amount of Non-Competitive Award: 

One award for $2,000,000. 

Supplemental funding for similar 

activities may be considered in FYs 

2024 and 2025, subject to availability of 

funding for the activity and satisfactory 

performance of the recipient. 

Project Period: September 30, 2023, to 

September 29, 2024. 

CFDA Number: 93.110. 

Award Instrument: Supplement for 

Services. 

Authority: 42 U.S.C. 254c-19 (§ 330M 

of the Public Health Service Act), as 

amended by Section 11005 of the 

Bipartisan Safer Communities Act (Pub. 

L. 117–159)). 

TABLE 1—RECIPIENTS AND AWARD AMOUNTS

Grant No. Award recipient name City, state Award 

amount 

U04MC31627 American Academy of Pediatrics ............................................................................................................ Itasca, IL .. $2,000,000 

Justification: Congress provided 

additional appropriations for the 

PMHCA program in FY 2022 that have 

allowed existing PMHCA projects to 

enhance workforce capacity to address 

the growing behavioral health needs 

among children and adolescents. This 

supplemental funding will support 

continued expansion of the reach and 

capacity of PMHCA programs in 

providing training and tele-consult 

support to pediatric primary care 

providers. 

Carole Johnson, 

Administrator. 

[FR Doc. 2023–21485 Filed 9–28–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Supplemental Award; 

Emergency Medical Services for 

Children Innovation and Improvement 

Center 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice of supplemental award. 

SUMMARY: For fiscal year 2023, HRSA 

will provide additional supplemental 

funds for the Emergency Medical 

Services for Children Innovation and 

Improvement Center to continue to 

provide assistance to a Pediatric Mental 

Health Care Access (PMHCA) award 

recipient so that they can improve 

access to PMHCA program activities in 

emergency departments. 

FOR FURTHER INFORMATION CONTACT: 

Lauren Ramos, Director, Division of 

Maternal and Child Health Workforce 

Development, Maternal and Child 

Health Bureau, Health Resources and 

Services Administration, at LRamos@

hrsa.gov and (301)443–6091. 

SUPPLEMENTARY INFORMATION: 

Intended Recipient of the Award: The 

University of Texas at Austin, the sole 

recipient of HRSA–20–037 

Amount of Non-Competitive Award: 

One award for $1,000,000. 

Project Period: September 30, 2023, to 

September 29, 2024. 

CFDA Number: 93.110. 

Award Instrument: Supplement. 

Authority: 42 U.S.C. 254c–19 section 

330M of the Public Health Service Act 

as amended by section 11005 of the 

Bipartisan Safer Communities Act (Pub. 

L. 117–159)) 


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