Federal Register / Vol. 89, No. 179 / Monday, September 16, 2024 / Rules and Regulations 75493 

thus avoid automatic classification in 

class III, it would have to comply with 

the special controls named in this final 

order. The necessary special controls 

appear in the regulation codified by this 

order. This device is subject to 

premarket notification requirements 

under section 510(k) of the FD&C Act. 

III. Analysis of Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

IV. Paperwork Reduction Act of 1995 

This final order establishes special 

controls that refer to previously 

approved collections of information 

found in other FDA regulations and 

guidance. These collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3521). The 

collections of information in part 860, 

subpart D, regarding De Novo 

classification have been approved under 

OMB control number 0910–0844; the 

collections of information in 21 CFR 

part 814, subparts A through E, 

regarding premarket approval, have 

been approved under OMB control 

number 0910–0231; the collections of 

information in part 807, subpart E, 

regarding premarket notification 

submissions, have been approved under 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 820, regarding quality system 

regulation, have been approved under 

OMB control number 0910–0073; and 

the collections of information in 21 CFR 

parts 801 and 809, regarding labeling, 

have been approved under OMB control 

number 0910–0485. 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratories, Medical 

devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 866 is 

amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

■ 1. The authority citation for part 866 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. Add § 866.3236 to subpart D to read 

as follows: 

§ 866.3236 Device to detect or measure 

nucleic acid from viruses associated with 

head and neck cancers. 

(a) Identification. A device to detect 

or measure nucleic acid from viruses 

associated with head and neck cancers 

is an in vitro diagnostic test for 

prescription use in the detection of viral 

nucleic acid in nasopharyngeal or 

oropharyngeal cellular specimens from 

patients with signs and symptoms of 

head and neck cancer. The test result is 

intended to be used in conjunction with 

other clinical information to aid in 

assessing the clinical status of virusassociated head and neck cancers and/ 

or the likelihood that head and neck 

cancer is present. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Any device used for specimen 

collection and transport must be FDAcleared, -approved, or -classified as 

510(k) exempt (standalone or as part of 

a test system) for the collection of 

human specimens; alternatively, the 

sample collection device must be 

cleared in a premarket submission as a 

part of this device. 

(2) The labeling required under 

§ 809.10(b) of this chapter must include, 

as determined to be appropriate by FDA: 

(i) An intended use statement that 

includes the following: 

(A) The analyte(s) detected by the 

device; 

(B) Data output of the device 

(qualitative, semiquantitative, or 

quantitative); 

(C) The specimen types with which 

the device is intended for use; 

(D) The clinical indications 

appropriate for test use (e.g., in 

conjunction with endoscopy); 

(E) The intended use populations 

(e.g., signs and symptoms, ethnicity); 

and 

(F) The intended use location(s) (e.g., 

specific name and location of testing 

facility or facilities). 

(ii) A detailed device description, 

including reagents, instruments, 

ancillary materials, specimen collection 

and transport devices, controls, and a 

detailed explanation of the 

methodology, including all preanalytical methods for processing of 

specimens. 

(iii) A detailed explanation of the 

interpretation of results. 

(iv) Limiting statements indicating: 

(A) The device is not intended for use 

in screening for head and neck cancer 

in asymptomatic populations. 

(B) Results of the device are not 

predictive of a patient’s future risk of 

head and neck cancer. 

(C) Patients who test negative for the 

virus should be managed in accordance 

with the standard of care, based on the 

assessment of endoscopy and/or other 

clinical information by a licensed 

healthcare professional. 

(D) Results of the device are not 

intended to be used as the sole basis for 

determining the need for biopsy or for 

any other patient management decision. 

(3) Design verification and validation 

must include the following: 

(i) A detailed device description 

including pre-analytical specimen 

processing, assay technology, target 

region, primer/probe sequences, 

reagents, controls, instrument 

requirements, and the computational 

path from collected raw data to reported 

result. 

(ii) Detailed documentation and 

results from analytical performance 

studies, including characterization of 

the cutoff(s), limit of detection, limit of 

quantitation, precision (including 

multisite reproducibility, if applicable), 

inclusivity, cross-reactivity, 

interference, carryover/crosscontamination, reagent stability, and 

specimen/sample stability, as 

determined to be appropriate by FDA. 

(iii) Detailed documentation of a 

clinical performance study that includes 

patients from the intended use 

population, including the clinical study 

protocol, with a predefined statistical 

analysis plan, and a clinical study 

report with testing results and results of 

all statistical analyses. 

(iv) A detailed description of the 

impact of any software, including 

software applications and software 

incorporated in hardware-based devices, 

on the device’s functions. 

Dated: September 10, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–20896 Filed 9–13–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 876 

[Docket No. FDA–2024–N–4082] 

Medical Devices; Therapeutic Devices; 

Classification of the Pediatric 

Continuous Renal Replacement 

Therapy System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 


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1FDA notes that the ACTION caption for this final 

order is styled as ‘‘Final amendment; final order,’’ 

rather than ‘‘Final order.’’ Beginning in December 

2019, this editorial change was made to indicate 

that the document ‘‘amends’’ the Code of Federal 

Regulations. The change was made in accordance 

with the Office of Federal Register’s (OFR) 

interpretations of the Federal Register Act (44 

U.S.C. chapter 15), its implementing regulations (1 

CFR 5.9 and parts 21 and 22), and the Document 

Drafting Handbook. 

classifying the pediatric continuous 

renal replacement therapy system into 

class II (special controls). The special 

controls that apply to the device type 

are identified in this order and will be 

part of the codified language for the 

pediatric continuous renal replacement 

therapy system’s classification. We are 

taking this action because we have 

determined that classifying the device 

into class II (special controls) will 

provide a reasonable assurance of safety 

and effectiveness of the device. We 

believe this action will also enhance 

patients’ access to beneficial innovative 

devices. 

DATES: This order is effective September 

16, 2024. The classification was 

applicable on April 29, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Gema Gonzalez, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2530, Silver Spring, 

MD 20993–0002, 301–796–6519, 

Gema.Gonzalez@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

pediatric continuous renal replacement 

therapy system as class II (special 

controls), which we have determined 

will provide a reasonable assurance of 

safety and effectiveness. 

The automatic assignment of class III 

occurs by operation of law and without 

any action by FDA, regardless of the 

level of risk posed by the new device. 

Any device that was not in commercial 

distribution before May 28, 1976, is 

automatically classified as, and remains 

within, class III and requires premarket 

approval unless and until FDA takes an 

action to classify or reclassify the device 

(see 21 U.S.C. 360c(f)(1)). We refer to 

these devices as ‘‘postamendments 

devices’’ because they were not in 

commercial distribution prior to the 

date of enactment of the Medical Device 

Amendments of 1976, which amended 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). 

FDA may take a variety of actions in 

appropriate circumstances to classify or 

reclassify a device into class I or II. We 

may issue an order finding a new device 

to be substantially equivalent under 

section 513(i) of the FD&C Act (see 21 

U.S.C. 360c(i)) to a predicate device that 

does not require premarket approval. 

We determine whether a new device is 

substantially equivalent to a predicate 

device by means of the procedures for 

premarket notification under section 

510(k) of the FD&C Act (21 U.S.C. 

360(k)) and part 807 (21 CFR part 807). 

FDA may also classify a device 

through ‘‘De Novo’’ classification, a 

common name for the process 

authorized under section 513(f)(2) of the 

FD&C Act (see also part 860, subpart D 

(21 CFR part 860, subpart D)). Section 

207 of the Food and Drug 

Administration Modernization Act of 

1997 (Pub. L. 105–115) established the 

first procedure for De Novo 

classification. Section 607 of the Food 

and Drug Administration Safety and 

Innovation Act (Pub. L. 112–144) 

modified the De Novo application 

process by adding a second procedure. 

A device sponsor may utilize either 

procedure for De Novo classification. 

Under the first procedure, the person 

submits a 510(k) for a device that has 

not previously been classified. After 

receiving an order from FDA classifying 

the device into class III under section 

513(f)(1) of the FD&C Act, the person 

then requests a classification under 

section 513(f)(2). 

Under the second procedure, rather 

than first submitting a 510(k) and then 

a request for classification, if the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence, that person requests a 

classification under section 513(f)(2) of 

the FD&C Act. 

Under either procedure for De Novo 

classification, FDA is required to 

classify the device by written order 

within 120 days. The classification will 

be according to the criteria under 

section 513(a)(1) of the FD&C Act. 

Although the device was automatically 

placed within class III, the De Novo 

classification is considered to be the 

initial classification of the device. 

When FDA classifies a device into 

class I or II via the De Novo process, the 

device can serve as a predicate for 

future devices of that type, including for 

510(k)s (see section 513(f)(2)(B)(i) of the 

FD&C Act). As a result, other device 

sponsors do not have to submit a De 

Novo request or premarket approval 

application to market a substantially 

equivalent device (see section 513(i) of 

the FD&C Act, defining ‘‘substantial 

equivalence’’). Instead, sponsors can use 

the 510(k) process, when necessary, to 

market their device. 

II. De Novo Classification 

On October 9, 2018, FDA received 

Medtronic, Inc.’s request for De Novo 

classification of the CARPEDIEM 

System. FDA reviewed the request in 

order to classify the device under the 

criteria for classification set forth in 

section 513(a)(1) of the FD&C Act. 

We classify devices into class II if 

general controls by themselves are 

insufficient to provide reasonable 

assurance of safety and effectiveness, 

but there is sufficient information to 

establish special controls that, in 

combination with the general controls, 

provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use (see 21 U.S.C. 

360c(a)(1)(B)). After review of the 

information submitted in the request, 

we determined that the device can be 

classified into class II with the 

establishment of special controls. FDA 

has determined that these special 

controls, in addition to the general 

controls, will provide reasonable 

assurance of the safety and effectiveness 

of the device. 

Therefore, on April 29, 2020, FDA 

issued an order to the requester 

classifying the device into class II. In 

this final order, FDA is codifying the 

classification of the device by adding 21 

CFR 876.5861.1 We have named the 

generic type of device pediatric 

continuous renal replacement therapy 

system, and it is identified as a device 

intended for use as an artificial kidney 

system for the management of pediatric 

patients with acute kidney injury and/ 

or fluid overload by performing such 

therapies as hemodialysis, 

hemofiltration, hemodiafiltration, and 

isolated ultrafiltration. Using a 

hemodialyzer with a semipermeable 

membrane, the hemodialysis system 

removes toxins or excess fluid from the 

patient’s blood using the principles of 

convection (via ultrafiltration) and/or 

diffusion (via a concentration gradient 

in dialysate). The hemodialysis delivery 

machine, with an automated 

ultrafiltration controller, controls and 

monitors the parameters related to this 

processing, including the rate at which 

blood and dialysate are pumped through 

the system, and the rate at which fluid 

is removed from the patient. During 

treatment, a patient’s blood is circulated 

through the blood tubing set connected 

to the hemodialyzer’s blood 

compartment. Blood access devices and 

accessories for hemodialysis required 

for the prescribed treatment are 

regulated under 21 CFR 876.5540. 

FDA has identified the following risks 

to health associated specifically with 

this type of device and the measures 


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required to mitigate these risks in table 

1. 

TABLE 1—PEDIATRIC CONTINUOUS RENAL REPLACEMENT THERAPY SYSTEM RISKS AND MITIGATION MEASURES

Identified risks to health Mitigation measures 

Adverse tissue reaction .......................................................................................... Biocompatibility evaluation, 

Pyrogenicity testing, and 

Non-clinical performance testing. 

Death ...................................................................................................................... Labeling, 

Clinical performance testing, and 

Usability testing. 

Infection .................................................................................................................. Labeling, 

Reprocessing validation, 

Pyrogenicity testing, 

Shelf life testing, and 

Usability testing. 

Inadequate or incomplete treatment ...................................................................... Non-clinical performance testing; 

Clinical performance testing; 

Labeling; 

Shelf-life testing; 

Usability testing; and 

Software verification, validation, and hazard analysis. 

Clearance of essential blood substances or medications ..................................... Non-clinical performance testing; 

Clinical performance testing; 

Labeling; 

Shelf-life testing; 

Usability testing; and 

Software verification, validation, and hazard analysis. 

Blood loss or blood cell destruction ....................................................................... Non-clinical performance testing; 

Clinical performance testing; 

Labeling; 

Shelf-life testing; and 

Software verification, validation, and hazard analysis. 

Thermal injury ........................................................................................................ Non-clinical performance testing; 

Clinical performance testing; 

Labeling; 

Shelf-life testing; 

Usability testing; and 

Software verification, validation, and hazard analysis. 

Blood leak into the dialysis fluid ............................................................................ Non-clinical performance testing; 

Clinical performance testing; 

Labeling; 

Shelf-life testing; and 

Software verification, validation, and hazard analysis. 

Fluid imbalance ...................................................................................................... Non-clinical performance testing; 

Clinical performance testing; 

Labeling; 

Shelf-life testing; and 

Software verification, validation, and hazard analysis. 

Air embolism .......................................................................................................... Non-clinical performance testing; 

Clinical performance testing; 

Labeling; 

Shelf-life testing; 

Usability testing; and 

Software verification, validation, and hazard analysis. 

Fluid pump(s) reversal resulting in air infusion via the arterial bloodline .............. Non-clinical performance testing; 

Clinical performance testing; 

Labeling; 

Shelf-life testing; 

Usability testing; and 

Software, verification, validation, and hazard analysis. 

Electrical shock ...................................................................................................... Electrical safety testing. 

Electromagnetic interference with other devices/equipment ................................. Electromagnetic compatibility (EMC) testing. 

FDA has determined that special 

controls, in combination with the 

general controls, address these risks to 

health and provide reasonable assurance 

of safety and effectiveness. For a device 

to fall within this classification, and 

thus avoid automatic classification in 

class III, it would have to comply with 

the special controls named in this final 

order. The necessary special controls 

appear in the regulation codified by this 

order. This device is subject to 

premarket notification requirements 

under section 510(k) of the FD&C Act. 

III. Analysis of Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 


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neither an environmental assessment 

nor an environmental impact statement 

is required. 

IV. Paperwork Reduction Act of 1995 

This final order establishes special 

controls that refer to previously 

approved collections of information 

found in other FDA regulations and 

guidance. These collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3521). The 

collections of information in part 860, 

subpart D, regarding De Novo 

classification have been approved under 

OMB control number 0910–0844; the 

collections of information in 21 part 

814, subparts A through E, regarding 

premarket approval, have been 

approved under OMB control number 

0910–0231; the collections of 

information in part 807, subpart E, 

regarding premarket notification 

submissions, have been approved under 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 820, regarding quality system 

regulation, have been approved under 

OMB control number 0910–0073; and 

the collections of information in part 

801, regarding labeling, have been 

approved under OMB control number 

0910–0485. 

List of Subjects in 21 CFR Part 876 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 876 is 

amended as follows: 

PART 876—GASTROENTEROLOGYUROLOGY DEVICES 

■ 1. The authority citation for part 876 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. Add § 876.5861 to subpart F to read 

as follows: 

§ 876.5861 Pediatric continuous renal 

replacement therapy system. 

(a) Identification. A pediatric 

continuous renal replacement therapy 

hemodialysis system is a device 

intended for use as an artificial kidney 

system for the management of pediatric 

patients with acute kidney injury and/ 

or fluid overload by performing such 

therapies as hemodialysis, 

hemofiltration, hemodiafiltration, and 

isolated ultrafiltration. Using a 

hemodialyzer with a semipermeable 

membrane, the hemodialysis system 

removes toxins or excess fluid from the 

patient’s blood using the principles of 

convection (via ultrafiltration) and/or 

diffusion (via a concentration gradient 

in dialysate). The hemodialysis delivery 

machine, with an automated 

ultrafiltration controller, controls and 

monitors the parameters related to this 

processing, including the rate at which 

blood and dialysate are pumped through 

the system, and the rate at which fluid 

is removed from the patient. During 

treatment, a patient’s blood is circulated 

through the blood tubing set connected 

to the hemodialyzer’s blood 

compartment. Blood access devices and 

accessories for hemodialysis required 

for the prescribed treatment are 

regulated under § 876.5540. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Clinical performance testing must 

confirm the safety and the accuracy, 

precision, and reproducibility of the 

non-clinical performance data under 

anticipated conditions of use. 

(2) Usability testing must demonstrate 

that a user can correctly use the 

hemodialysis delivery device based 

solely on reading the instructions for 

use. 

(3) Non-clinical performance testing 

data must demonstrate that the device 

performs as intended under anticipated 

conditions of use. The following 

performance characteristics must be 

tested: 

(i) Hemodialysis delivery system 

performance testing must include: 

(A) Fluid flow accuracy testing; and 

(B) Functional testing of system 

components including sensors, pumps, 

and scales to acceptance criteria. 

(ii) Hemodialyzer performance testing 

must include: 

(A) Ultrafiltration; 

(B) Blood and dialysate pressure drop; 

(C) Clearance rates; 

(D) Sieving coefficients; 

(E) Mechanical hemolysis; 

(F) Structural integrity; 

(G) Blood compartment integrity; 

(H) Volume of the blood 

compartment; and 

(I) Chemical analysis of the dialyzer 

membrane. 

(iii) Blood tubing set performance 

testing must include: 

(A) Pressure leak testing; 

(B) Worst-case endurance testing; 

(C) Priming volume assessment; 

(D) Tensile testing of joints and 

materials of all tubing segments; 

(E) Pressure transducer leak testing; 

(F) Clamp occlusion; 

(G) Mechanical hemolysis; and 

(H) Kink testing. 

(4) Software verification, validation, 

and hazard analysis must be performed. 

(5) Performance data must 

demonstrate the electromagnetic 

compatibility (EMC), electrical safety, 

and wireless compatibility of the device. 

(6) The tissue-contacting components 

of the device must be demonstrated to 

be biocompatible. 

(7) Performance data must 

demonstrate the sterility of the patientcontacting components of the device. 

(8) Performance data must validate 

the reprocessing instructions for the 

reusable components of the device. 

(9) The patient-contacting 

components of the device must be 

demonstrated to be non-pyrogenic. 

(10) Performance data must support 

the shelf life of the device by 

demonstrating continued sterility, 

package integrity, and device 

functionality over the identified shelf 

life. 

(11) Device labeling must include: 

(i) Hemodialysis delivery system 

labeling must provide detailed 

information regarding the safe use of the 

dialysis machine, including: 

(A) Overall description of the device 

and individual components or 

accessories labeled for use with the 

delivery system; 

(B) Description of the safety-related 

components included in the system; 

(C) Identification of operational 

parameters; 

(D) Alarms and troubleshooting 

information; 

(E) Cleaning, disinfection, and 

preventative maintenance procedures; 

and 

(F) A statement that the device is 

intended for use by operators trained in 

the administration of continuous renal 

replacement therapy and in the 

management of its complications. 

(ii) Hemodialyzer labeling must 

include: 

(A) Description of compatibility; 

(B) Shelf life; 

(C) Storage conditions; 

(D) Instructions for the preparation of 

the hemodialyzer, initiation of dialysis, 

troubleshooting, and discontinuance of 

dialysis; 

(E) Membrane surface area, priming 

(blood) volume, maximum 

transmembrane pressure, maximum 

blood flow and maximum dialysate rate 

for each model; 

(F) Summary of the in vitro 

performance data; and 

(G) A non-pyrogenic statement. 

(iii) Blood tubing set labeling must 

provide detailed information regarding 

the safe use of the device, including: 

(A) Description of compatibility; 

(B) Shelf life; 

(C) Storage conditions; 

(D) Identification of the components 

in the package; 


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(E) Total length of the arterial and 

venous tubing sets; 

(F) Outer diameter (OD) of the pump 

segment; 

(G) Priming volume; 

(H) Identification of the hemodialysis 

delivery systems which are compatible 

with the blood tubing set; 

(I) Identification of the largest gauge 

needle that can be used with the 

injection port, if applicable; and 

(J) Identification of the maximum 

operating pressures for the transducer 

protectors. 

Dated: September 11, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–20999 Filed 9–13–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

24 CFR Part 214 

[Docket No. FR–6388–F–02] 

RIN 2502–AJ70 

Modernizing the Delivery of Housing 

Counseling Services 

AGENCY: Office of the Assistant 

Secretary for Housing—Federal Housing 

Commissioner, HUD. 

ACTION: Final rule. 

SUMMARY: The Department of Housing 

and Urban Development (HUD) is 

issuing this final rule to update HUD’s 

regulations that require participating 

agencies to provide in-person 

counseling to clients that prefer this 

format to reflect advances in technology, 

align with client engagement 

preferences, and preserve consumer 

protections. The final rule amends 

HUD’s regulations to allow housing 

counseling agencies to use alternative 

communication methods, including 

virtual meeting tools, in lieu of 

providing in-person services. 

Participating agencies that choose not to 

provide in-person services are required 

to refer clients to local providers that 

provide such services, when requested. 

After considering public comments 

received in response to the proposed 

rule HUD published on October 25, 

2023, this final rule adopts the proposed 

rule without change. 

DATES: Effective October 16, 2024. 

FOR FURTHER INFORMATION CONTACT: 

David Valdez, Senior Housing Program 

Specialist, Department of Housing and 

Urban Development, 1331 Lamar St. 

Suite 550, Houston, TX 77002, 

telephone 713–718–3178 (this is not a 

toll-free number). HUD welcomes and is 

prepared to receive calls from 

individuals who are deaf or hard of 

hearing, as well as individuals with 

speech or communication disabilities. 

To learn more about how to make an 

accessible telephone call, please visit 

https://www.fcc.gov/consumers/guides/

telecommunications-relay-service-trs. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 106 of the Housing and Urban 

Development Act of 1968 (12 U.S.C. 

1701x) (Section 106) authorizes HUD’s 

Housing Counseling program (see 

Sections 106(a)(1)(iii) and 106(a)(2)). On 

October 25, 2023, HUD published the 

‘‘Modernizing the Delivery of Housing 

Counseling Services’’ proposed rule 

(‘‘the proposed rule’’) in the Federal 

Register, at 88 FR 73298, to revise the 

current regulations governing HUD’s 

Housing Counseling program to align 

with client engagement preferences, and 

to preserve consumer protections, while 

leaving in place existing guardrails that 

ensure participating agencies 

demonstrate knowledge and a 

connection to the community they 

serve, whether they choose to do so by 

providing virtual, in-person, or hybrid 

services. 

As described in the proposed rule, on 

September 28, 2007, HUD published a 

final rule titled, ‘‘Housing Counseling 

Program,’’ at 72 FR 55637, which 

established regulations for HUD’s 

Housing Counseling program (see 24 

CFR 214.103(l) and 24 CFR 214.300, in 

particular). These regulations had not 

been amended since they were 

established. Section 214.300(a)(3) 

required agencies that provide housing 

counseling services to provide in-person 

counseling services at one of the 

agency’s facilities or an alternate 

location to clients that preferred that 

format. When this requirement was 

adopted, housing counseling and 

education were primarily conducted inperson and the conventional wisdom 

was that in-person service was the most 

effective service delivery method. 

However, alternatives to in-person 

service have also proven to be effective. 

In 2020, due to ongoing public health 

concerns around the spread of 

Coronavirus Disease 2019 (COVID–19), 

HUD issued a Temporary Partial Waiver 

of 24 CFR 214.300(a)(3), In-Person 

Housing Counseling Requirement, that 

allowed housing counseling agencies to 

utilize alternative methods to conduct 

housing counseling and education with 

clients in lieu of meeting in-person. 

Feedback received regarding this waiver 

indicated that these alternative methods 

were more practical, cost-effective, and 

accessible, and did not lead to adverse 

compliance issues or negative financial 

impacts. This feedback, increased 

consumer preference for virtual service 

delivery, and reduced burdens and costs 

for participating agencies, all weigh in 

favor of modernizing the current 

regulations. 

HUD’s proposed rule, then, proposed 

amending the regulations such that 

participating agencies must maintain at 

least one facility and may provide 

remote housing counseling. Additional 

details about the proposed rule may be 

found at 88 FR 73298 (October 25, 

2023). 

II. Final Rule 

This final rule adopts the proposed 

rule without change. This rule will help 

reduce the costs of providing housing 

counseling by allowing participating 

agencies to provide housing counseling 

services at a facility or at an alternate 

location, via telephone, or via 

collaborative online software. All 

facilities must have an identified, 

private space available for the provision 

of counseling services, whether those 

services are in-person or virtual, and 

housing counseling agencies that do not 

provide in-person counseling services 

must refer clients to agencies that 

provide in-person counseling services 

upon a client’s request. This rule does 

not change the requirements that every 

housing counseling agency must 

continue to meet for HUD approval as 

a counseling agency, regardless of the 

setting or format of housing counseling 

services, including having functioned 

for at least one year in the geographical 

area(s) the agency identified in its 

housing counseling work plan, having 

sufficient resources to implement that 

proposed work plan, and being able to 

demonstrate knowledge of local housing 

markets and community resources. 

III. The Public Comments 

HUD received 33 public comments on 

the proposed rule from various 

interested parties, including housing 

finance companies, housing counseling 

service agencies (including HUDapproved agencies), housing counselors, 

state housing agency associations, 

community development and other 

nonprofit organizations, and other 

individuals and entities. 

Support for the Rule 

Most commenters supported HUD’s 

proposal and supported providing 

individuals with options for different 

formats and types of housing counseling 

services, including telephonic and 

online services. Some commenters cited 

general benefits such as increased 


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