Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Rules and Regulations 6425 

human factors study that demonstrates 

that an intended user can safely use the 

device for its intended use. 

(7) Device labeling must include the 

following: 

(i) A prominent statement identifying 

the drugs that are compatible with the 

device, including the identity and 

concentration of those drugs as 

appropriate. 

(ii) A description of the minimum and 

maximum basal rates, minimum and 

maximum bolus volumes, and the 

increment size for basal and bolus 

delivery, or other similarly applicable 

information about drug delivery 

parameters. 

(iii) A description of the pump 

accuracy at minimum, intermediate, and 

maximum bolus delivery volumes and 

the method(s) used to establish bolus 

delivery accuracy. For each bolus 

volume, pump accuracy shall be 

described in terms of the number of 

bolus doses measured to be within a 

given range as compared to the 

commanded volume. An acceptable 

accuracy description (depending on the 

drug delivered and bolus volume) may 

be provided as follows for each bolus 

volume tested, as applicable: Number of 

bolus doses with volume that is <25 

percent, 25 percent to <75 percent, 75 

percent to <95 percent, 95 percent to 

<105 percent, 105 percent to <125 

percent, 125 percent to <175 percent, 

175 to 250 percent, and >250 percent of 

the commanded amount. 

(iv) A description of the pump 

accuracy at minimum, intermediate, and 

maximum basal delivery rates and the 

method(s) used to establish basal 

delivery accuracy. For each basal rate, 

pump accuracy shall be described in 

terms of the amount of drug delivered 

after the basal delivery was first 

commanded, without a warmup period, 

up to various time points. The 

information provided must include 

typical pump performance, as well as 

worst-case pump performance observed 

during testing in terms of both overdelivery and under-delivery. An 

acceptable accuracy description 

(depending on the drug delivered) may 

be provided as follows, as applicable: 

The total volume delivered 1 hour, 6 

hours, and 12 hours after starting 

delivery for a typical pump tested, as 

well as for the pump that delivered the 

least and the pump that delivered the 

most at each time point. 

(v) A description of delivery hazard 

alarm performance, as applicable. For 

occlusion alarms, performance shall be 

reported at minimum, intermediate, and 

maximum delivery rates and volumes. 

This description must include the 

specification for the longest time period 

that may elapse before an occlusion 

alarm is triggered under each delivery 

condition, as well as the typical results 

observed during performance testing of 

the pumps. 

(vi) For wireless connection enabled 

devices, a description of the wireless 

quality of service required for proper 

use of the device. 

(vii) For any infusion pumps intended 

for multiple patient reuse, instructions 

for safely reprocessing the device 

between uses. 

Dated: January 26, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02369 Filed 2–3–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 17 

RIN 2900–AQ97 

Informed Consent and Advance 

Directives 

AGENCY: Department of Veterans Affairs. 

ACTION: Interim final rule. 

SUMMARY: The Department of Veterans 

Affairs (VA) published an interim final 

rule amending its regulation regarding 

informed consent and advance 

directives. In that rulemaking, we 

amended the regulation by reorganizing 

it and amending language where 

necessary to enhance clarity. We also 

made changes to facilitate the informed 

consent process, the ability to 

communicate with patients or 

surrogates through available modalities 

of communication, and the execution 

and witness requirements for a VA 

Advance Directive. Before adopting that 

interim final rule as final, VA revises 

the provision related to which 

personnel may be delegated the 

responsibility for providing a patient 

with information needed for the patient 

to make a fully informed consent 

decision. Upon further review, VA has 

determined that this provision requires 

a further change to better clarify roles in 

the team-based delivery of care model. 

We are providing the public an 

opportunity to submit comments solely 

on this amendment. 

DATES:

Effective date: This interim final rule 

is effective February 4, 2022. 

Comments due date: Comments must 

be received on or before April 5, 2022. 

ADDRESSES: Comments may be 

submitted through 

www.Regulations.gov. Comments 

received will be available at 

regulations.gov for public viewing, 

inspection, or copies. 

FOR FURTHER INFORMATION CONTACT: 

Lucinda Potter, LSW, Acting Director of 

Ethics Policy, National Center for Ethics 

in Health Care (10ETH), Veterans Health 

Administration, 810 Vermont Ave. NW, 

Washington, DC 20420; 484–678–5150. 

(This is not a toll-free number). 

SUPPLEMENTARY INFORMATION: In an 

interim final rule published May 27, 

2020 (85 FR 31690), we amended 38 

CFR 17.32, our regulation addressing 

informed consent for treatments and 

procedures, by reorganizing it and 

amending language where necessary to 

enhance clarity. We also made changes 

to facilitate the informed consent 

process, the ability to communicate 

with patients or surrogates through 

available modalities of communication, 

and the execution and witnessing for a 

VA Advance Directive. We amended the 

definition of ‘‘practitioner’’ to include 

other health care professionals whose 

scope of practice agreement or other 

formal delineation of job responsibility 

specifically permits them to obtain 

informed consent, and who are 

appropriately trained and authorized to 

perform the procedure or to provide the 

treatment for which consent is being 

obtained. 

Under the previous informed consent 

rule, the practitioner, who had primary 

responsibility for the patient or who 

would perform the particular procedure 

or provide the treatment, was 

responsible for explaining in language 

understandable to the patient or 

surrogate the nature of a proposed 

procedure or treatment; the expected 

benefits; reasonably foreseeable 

associated risks, complications or side 

effects; reasonable and available 

alternatives; and anticipated results if 

nothing is done. There was no provision 

in the rule addressing the question of 

whether, consistent with a team-based 

delivery of care model, appropriately 

trained health care team members had a 

role in the informed consent process. In 

the May 2020 interim final rule, we 

dealt with that issue in paragraph (c)(6), 

stating that the practitioner may 

delegate to other trained personnel 

responsibility for providing the patient 

with clinical information needed for the 

patient to make a fully informed consent 

decision but must personally verify with 

the patient that the patient has been 

appropriately informed and voluntarily 

consents to the treatment or procedure. 

VA intended that paragraph (c)(6) give 

the practitioner discretion to more fully 

utilize the training and expertise of nonpractitioners within the bounds of the 


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6426 Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Rules and Regulations 

team-based care model. Upon further 

review, VA has determined that this 

paragraph should be amended to more 

clearly reflect VA’s intent to utilize a 

team-based approach for other elements 

of informed consent discussions in 

addition to provision of information to 

the patient. Consistent with 

longstanding VA policy and practice, 

we amend paragraph (c)(6) to more 

broadly state that trained personnel may 

conduct elements of the informed 

consent process when delegated by the 

practitioner. 

We are also removing the term 

‘‘clinical information’’ in this paragraph. 

We believe the term ‘‘clinical 

information’’ in the current paragraph 

(c)(6) could be problematic. It is not 

defined in VA regulations and is used 

only in VA policy documents either 

generically (to describe any health 

information reflected in medical 

records) or to describe specific types of 

stored information such as medicalrelated data, images, sound, and video 

related to certain types of medical 

examinations. ‘‘Clinical information’’ 

could also be narrowly used to describe 

only technical information related to a 

treatment or procedure. A narrow 

construction and application of that 

term is counter to the team model which 

is intended to benefit the patient by 

allowing members of the health care 

team to provide necessary information 

through different perspectives. This 

model also provides the patient an 

opportunity to freely communicate with 

not only the practitioner but also with 

other team members regarding the 

proposed treatment or procedure. 

Based on that rationale, we amend 

paragraph (c)(6) to clarify that the 

practitioner may delegate to trained 

personnel the responsibility of 

conducting elements of the informed 

consent process beyond simply 

providing information. To ensure that 

clinical oversight is retained, the 

practitioner remains responsible for the 

informed consent process and must 

personally verify with the patient that 

the patient has been fully informed and 

voluntarily consents to the treatment or 

procedure. Elements of the informed 

consent process that may be delegated 

to trained personnel include providing 

patient education regarding the 

proposed treatment or procedure, 

identifying the authorized surrogate for 

patients who lack decision-making 

capacity, and assisting with obtaining 

the patient’s (or surrogate’s) signature 

for treatments and procedures that 

require signature informed consent. 

VA believes that this will ensure that 

elements of informed consent 

discussions that may be appropriately 

delegated by providers are not unduly 

limited by regulation, while still making 

clear that the practitioner remains 

responsible for the informed consent 

process and for personally verifying 

with the patient that the patient has 

been fully informed and voluntarily 

consents to the treatment or procedure. 

We are providing a 60-day period for 

submission of comments from the 

public on this amendment of 

§ 17.32(c)(6). We are not accepting any 

public comment on any other content in 

§ 17.32. Following the 60-day public 

comment period, we will review and 

consider comments received and then 

publish a final rulemaking capturing not 

only this interim final rule but also the 

May 2020 interim final rule. 

Administrative Procedure Act 

The Secretary of Veterans Affairs 

finds that there is good cause under the 

provisions of 5 U.S.C. 553(b)(B), to 

publish this amendment as an interim 

final rule without prior notice and the 

opportunity for public comment, and 

under 5 U.S.C. 553(d)(3), to dispense 

with the delayed effective date 

ordinarily prescribed by the 

Administrative Procedure Act (APA). 

Pursuant to section 553(b)(B) of the 

APA, general notice and the opportunity 

for public comment are not required 

with respect to a rulemaking when an 

‘‘agency for good cause finds (and 

incorporates the finding and a brief 

statement of reasons therefor in the 

rules issued) that notice and public 

procedure thereon are impracticable, 

unnecessary, or contrary to the public 

interest.’’ The Secretary finds that it is 

impractical to delay issuance of this rule 

for the purpose of soliciting prior public 

comment because there is an immediate 

and pressing need for VA to respond to 

the current public health crisis and 

national emergency by ensuring 

effective use of health care resources as 

part of the announced VA contingent/ 

crisis standards of care, in addition to 

regular standards of care provided to 

eligible beneficiaries. VA believes 

members of a VA health care team 

should be utilized to the fullest extent 

practicable in providing veterans 

information on risks and benefits of 

proposed treatments or procedures. 

Thus, delaying the implementation of 

this clarifying amendment would be 

contrary to the public interest. 

For these reasons, the Secretary has 

concluded that ordinary notice and 

comment procedures would be both 

impracticable and contrary to the public 

interest. Accordingly, VA issues this 

amendment as a separate interim final 

rule. The Secretary will consider and 

address comments that are received 

within 60 days after the date that this 

interim final rule is published in the 

Federal Register and address them in a 

subsequent Federal Register document 

announcing a final rule incorporating 

any changes made in response to the 

public comments on this interim final 

rule and the May 2020 interim final 

rule. 

The APA also requires a 30-day 

delayed effective date, except for ‘‘(1) a 

substantive rule which grants or 

recognizes an exemption or relieves a 

restriction; (2) interpretative rules and 

statements of policy; or (3) as otherwise 

provided by the agency for good cause 

found and published with the rule.’’ 5 

U.S.C. 553(d). For the reasons stated 

above, the Secretary finds that there is 

also good cause for this interim rule to 

be effective immediately upon 

publication. It is in the public interest 

for VA to immediately adopt the process 

changes noted above to provide for 

effective utilization of VA practitioners 

as it relates to the informed consent 

process during this period of increased 

demand for health care, to provide 

flexibility to utilize alternative 

modalities of communications during 

the COVID–19 National Emergency, and 

to facilitate veterans documenting 

treatment preferences in an advance 

directive. By immediately making 

necessary process changes, the Secretary 

finds good cause to exempt this 

amendment from the APA’s delayed 

effective date requirement. 

Paperwork Reduction Act 

Although this action contains 

provisions constituting collections of 

information, at 38 CFR 17.32, under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3521), no new or proposed 

revised collections of information are 

associated with this interim final rule. 

The information collection requirements 

for § 17.32 are currently approved by the 

Office of Management and Budget 

(OMB) and have been assigned OMB 

control number 2900–0556. 

Regulatory Flexibility Act 

The Secretary hereby certifies that 

this interim final rule will not have a 

significant economic impact on a 

substantial number of small entities as 

they are defined in the Regulatory 

Flexibility Act, 5 U.S.C. 601–612, 

because it affects only the informed 

consent process and use of advance 

directives within the VA health care 

system. 

Therefore, pursuant to 5 U.S.C. 

605(b), the initial and final regulatory 

flexibility analysis requirements of 5 

U.S.C. 603 and 604 do not apply. 


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Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Rules and Regulations 6427 

Executive Orders 12866 and 13563 

Executive Orders 12866 and 13563 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, and other advantages; 

distributive impacts; and equity). 

Executive Order 13563 (Improving 

Regulation and Regulatory Review) 

emphasizes the importance of 

quantifying both costs and benefits, 

reducing costs, harmonizing rules, and 

promoting flexibility. The Office of 

Information and Regulatory Affairs has 

determined that this rule is not a 

significant regulatory action under 

Executive Order 12866. 

The Regulatory Impact Analysis 

associated with this rulemaking can be 

found as a supporting document at 

www.regulations.gov. 

Unfunded Mandates 

The Unfunded Mandates Reform Act 

of 1995 requires, at 2 U.S.C. 1532, that 

agencies prepare an assessment of 

anticipated costs and benefits before 

issuing any rule that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

(adjusted annually for inflation) in any 

one year. The amendment issued here as 

an interim final rule will not result in 

the expenditure of $100 million or more 

by State, local, and tribal governments, 

in the aggregate, or by the private sector. 

Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), the Office of 

Information and Regulatory Affairs 

designated this rule as not a major rule, 

as defined by 5 U.S.C. 804(2). 

Assistance Listing 

The Assistance Listing program 

numbers and titles for the programs 

affected by this document are 64.008— 

Veterans Domiciliary Care; 64.011— 

Veterans Dental Care; 64.012—Veterans 

Prescription Service; 64.013—Veterans 

Prosthetic Appliances; 64.014— 

Veterans State Domiciliary Care; 

64.015—Veterans State Nursing Home 

Care; 64.024—VA Homeless Providers 

Grant and Per Diem Program; 64.026— 

Veterans State Adult Day Health Care; 

64.029—Purchase Care Program; 

64.039—CHAMPVA; 64.040—VHA 

Inpatient Medicine; 64.041—VHA 

Outpatient Specialty Care; 64.042— 

VHA Inpatient Surgery; 64.043—VHA 

Mental Health Residential; 64.044— 

VHA Home Care; 64.045—VHA 

Outpatient Ancillary Services; 64.046— 

VHA Inpatient Psychiatry; 64.047— 

VHA Primary Care; 64.048—VHA 

Mental Health clinics; 64.049—VHA 

Community Living Center; 64.050— 

VHA Diagnostic Care; 64.054—Research 

and Development. 

List of Subjects in 38 CFR Part 17 

Administrative practice and 

procedure, Alcohol abuse, Alcoholism, 

Claims, Day care, Dental health, Drug 

abuse, Government contracts, Grant 

programs—health, Grant programs— 

veterans, Health care, Health facilities, 

Health professions, Health records, 

Homeless, Medical and Dental schools, 

Medical devices, Medical research, 

Mental health programs, Nursing 

homes, Reporting and recordkeeping 

requirements, Travel and transportation 

expenses, Veterans. 

Signing Authority 

Denis McDonough, Secretary of 

Veterans Affairs, approved this 

document on January 31, 2022, and 

authorized the undersigned to sign and 

submit the document to the Office of the 

Federal Register for publication 

electronically as an official document of 

the Department of Veterans Affairs. 

Consuela Benjamin, 

Regulation Development Coordinator, Office 

of Regulation Policy & Management, Office 

of General Counsel, Department of Veterans 

Affairs. 

For the reasons set out in the 

preamble, VA amends 38 CFR part 17 as 

follows: 

PART 17—MEDICAL 

■ 1. The authority citation for part 17 

continues to read as follows: 

Authority: 38 U.S.C. 501, and as noted in 

specific sections. 

■ 2. Amend § 17.32 by revising 

paragraph (c)(6) to read as follows: 

§ 17.32 Informed consent and advance 

directives. 

* * * * * 

(c) * * * 

(6) Trained personnel may conduct 

elements of the informed consent 

process when delegated by the 

practitioner. However, the practitioner 

remains responsible for the informed 

consent process and must personally 

verify with the patient that the patient 

has been fully informed and voluntarily 

consents to the treatment or procedure. 

* * * * * 

[FR Doc. 2022–02316 Filed 2–3–22; 8:45 am] 

BILLING CODE 8320–01–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 21 

Clarification Concerning Tuition and 

Fees Payment Plans for Standard 

Terms and 85/15 Calculations 

AGENCY: Department of Veterans Affairs. 

ACTION: Policy interpretation. 

SUMMARY: The Department of Veterans 

Affairs (VA) provides notice of a policy 

advisory issued on August 31, 2021, by 

VA’s Education Service. The policy 

advisory clarifies and amends VA’s 

previous regulatory interpretation of 

tuition and fees (T&F) payment plans to 

differentiate between types of payment 

plans. Some payment plans should no 

longer be categorized as institutional 

support to a student when calculating 

the ratio of ‘‘supported’’ to ‘‘nonsupported’’ students in a program 

pursuant to the 85/15 Rule. While VA 

is retaining the general rule that a 

student who has a payment plan with 

an Educational Training Institute (ETI) 

should be considered supported, a 

student participating in a payment plan 

that meets the criteria set forth in this 

notice should not be considered 

supported and, instead, should be 

counted on the non-supported side of 

the 85/15 ratio. 

DATES: This policy interpretation is 

applicable from February 4, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Cheryl Amitay, Chief of Policy and 

Regulations Team, Education Service 

(225), Veterans Benefits Administration, 

Department of Veterans Affairs, 810 

Vermont Avenue NW, Washington, DC 

20420, Telephone: 202–461–9800 (This 

is not a toll-free number). 

SUPPLEMENTARY INFORMATION: The 85/15 

rule (38 U.S.C. 3680A(d); 38 CFR 

21.4201(a)) prohibits VA from paying 

educational assistance benefits to any 

new students once ‘‘more than 85 

percent of the students enrolled in the 

[program of education] are having all or 

part of their tuition, fees or other 

charges paid to or for them by the 

educational institution or by the 

Department of Veterans Affairs’’ (38 

U.S.C. 3680A(d)(1)). VA refers to 

students who receive such institutional 

or VA aid as ‘‘supported’’ students. 

Conversely, no less than 15 percent of 

the students enrolled in the program 

must be attending without having any of 

their tuition, fees or other charges paid 

to or for them by the educational 

institution or VA (referred to as nonsupported students). 

Currently, in accordance with 38 CFR 

21.4201, educational institutions are 


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