Technical Considerations for Medical Devices With Physiologic Closed-Loop Control Technology; Guidance for Industry and Food and Drug Administration Staff; Availability, 67313-67315 [2023-21412]

Download as PDF Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices 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 67313 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 Number of respondents Activity Interviews/Surveys ..................................................... 1 There Dated: September 26, 2023. Lauren K. Roth, Associate Commissioner for Policy. 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 Food and Drug Administration, HHS. Notice of availability. 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 SUMMARY: lotter on DSK11XQN23PROD with NOTICES1 1 VerDate Sep<11>2014 21:46 Sep 28, 2023 Jkt 259001 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 [FR Doc. 2023–21419 Filed 9–28–23; 8:45 am] ACTION: 45,000 Total annual responses 45,000 Average burden per response 0.75 (45 minutes) .... Total hours 33,750 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. AGENCY: Number of responses per respondent 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: PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 • 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 E:\FR\FM\29SEN1.SGM 29SEN1 67314 Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices 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-201509-18/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: lotter on DSK11XQN23PROD with NOTICES1 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: OMB control No. 21 CFR part or guidance Topic 807, subpart E ............................................................................ 814, subparts A through E .......................................................... 814, subpart H ............................................................................ 812 .............................................................................................. 860, subpart D ............................................................................ Premarket notification ................................................................ Premarket approval .................................................................... Humanitarian Use Devices; Humanitarian Device Exemption .. Investigational Device Exemption .............................................. De Novo classification process .................................................. 1 The term drug as used in this guidance refers to both human drugs and biological products unless otherwise VerDate Sep<11>2014 21:46 Sep 28, 2023 Jkt 259001 specified. 2 See https://wayback.archive-it.org/7993/ 20170112084803/http:/www.fda.gov/ PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 0910–0120 0910–0231 0910–0332 0910–0078 0910–0844 MedicalDevices/NewsEvents/ WorkshopsConferences/ucm457581.htm. E:\FR\FM\29SEN1.SGM 29SEN1 Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices OMB control No. 21 CFR part or guidance Topic ‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’. 800, 801, 809, and 830 .............................................................. Q-submissions and Early Payor Feedback Request Programs for Medical Devices. Medical Device Labeling Regulations; Unique Device Identification. Medical Device Reporting .......................................................... Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation. Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies. 803 .............................................................................................. 820 .............................................................................................. 58 ................................................................................................ Dated: September 26, 2023. Lauren K. Roth, Associate Commissioner for Policy. 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), SUMMARY: [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 Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice of supplemental award. AGENCY: 67315 0910–0756 0910–0485 0910–0437 0910–0073 0910–0119 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 U04MC31627 American Academy of Pediatrics ............................................................................................................ Itasca, IL .. 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES Carole Johnson, Administrator. ACTION: [FR Doc. 2023–21485 Filed 9–28–23; 8:45 am] SUMMARY: lotter on DSK11XQN23PROD with NOTICES1 BILLING CODE 4165–15–P VerDate Sep<11>2014 21:46 Sep 28, 2023 Jkt 259001 Health Resources and Services Administration Notice of Supplemental Award; Emergency Medical Services for Children Innovation and Improvement Center Health Resources and Services Administration (HRSA), Department of Health and Human Services. AGENCY: Notice of supplemental award. 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 PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 Award amount $2,000,000 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)) E:\FR\FM\29SEN1.SGM 29SEN1

Agencies

[Federal Register Volume 88, Number 188 (Friday, September 29, 2023)]
[Notices]
[Pages 67313-67315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21412]


-----------------------------------------------------------------------

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

[[Page 67314]]

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 self-addressed 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.
---------------------------------------------------------------------------

    \1\ The term drug as used in this guidance refers to both human 
drugs and biological products unless otherwise
    specified.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \2\ See https://wayback.archive-it.org/7993/20170112084803/http:/www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm457581.htm.
---------------------------------------------------------------------------

    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-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-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 [email protected] 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:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
814, subpart H.................  Humanitarian Use              0910-0332
                                  Devices; Humanitarian
                                  Device Exemption.
812............................  Investigational Device        0910-0078
                                  Exemption.
860, subpart D.................  De Novo classification        0910-0844
                                  process.

[[Page 67315]]

 
``Requests for Feedback and      Q-submissions and Early       0910-0756
 Meetings for Medical Device      Payor Feedback Request
 Submissions: The Q-Submission    Programs for Medical
 Program''.                       Devices.
800, 801, 809, and 830.........  Medical Device Labeling       0910-0485
                                  Regulations; Unique
                                  Device Identification.
803............................  Medical Device                0910-0437
                                  Reporting.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
58.............................  Good Laboratory               0910-0119
                                  Practice (GLP)
                                  Regulations for
                                  Nonclinical Laboratory
                                  Studies.
------------------------------------------------------------------------


    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
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