[Federal Register Volume 87, Number 147 (Tuesday, August 2, 2022)]
[Rules and Regulations]
[Pages 47099-47100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16465]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AQ97


Informed Consent and Advance Directives

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: The Department of Veterans Affairs (VA) adopts as final, 
without changes, an interim final rule, as amended by a second interim 
final rule, that amended VA's regulation regarding informed consent and 
advance directives. VA amended the regulation by reorganizing it and 
amending language where necessary to enhance clarity; and 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. VA has also clarified the roles and responsibilities 
of the practitioner and other members of the health care team 
pertaining to the informed consent process.

DATES: This rule is effective August 2, 2022.

FOR FURTHER INFORMATION CONTACT: Lucinda Potter, MSW, LSW, 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: 

Interim Final Rule Published at 85 Federal Register (FR) 31690 (May 20, 
2020)

    In a document published in the FR on May 27, 2020, 85 FR 31690, VA 
amended its regulation (Sec.  17.32 of title 38, Code of Federal 
Regulations (CFR)) concerning informed consent and advance directives 
by reorganizing Sec.  17.32 and revising language where necessary to 
enhance clarity; and making 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. VA provided a 60-day comment 
period, which ended on July 27, 2020. One comment was received; 
however, it did not raise any issues within the scope of the 
rulemaking. We make no changes based on that comment.
    We note that as part of that rule, we invited public comment on 
whether VA should consider inclusion of emancipated minors among those 
listed as next-of-kin or with respect to any situations that might 
arise with respect to an emancipated minor (e.g., a spouse who is an 
emancipated minor under the age of 18). Currently, next-of-kin must be 
18 years of age or older. We received no public comment on this issue 
and make no changes to 38 CFR 17.32 regarding emancipated minors.

Interim Final Rule Published at 87 FR 6425 (February 4, 2022)

    In a document published in the FR on February 4, 2022, 87 FR 6425, 
VA amended Sec.  17.32(c)(6) to clarify that the practitioner is 
ultimately responsible for the informed consent process but may

[[Page 47100]]

delegate elements of the informed consent process to trained personnel. 
VA provided a 60-day comment period, which ended on April 5, 2022. One 
comment was received, which was supportive of the rule. We thank the 
commenter for their support. We make no changes based on that comment.
    Based on the rationale set forth in both interim final rules and in 
this final rule, VA is adopting, as final without changes, the rule 
published at 85 FR 31690, as amended by 87 FR 6425.

Administrative Procedure Act

    VA has considered all relevant input and information contained in 
the comments submitted in response to the interim final rules (85 FR 
31690 and 87 FR 6425) and, for the reasons set forth in the discussion 
further above, has concluded that no changes to the interim final rule 
at 85 FR 31690, as amended by 87 FR 6425, are warranted. Accordingly, 
based upon the authorities and reasons set forth in the interim final 
rules (85 FR 31690 and 87 FR 6425), as supplemented by the additional 
reasons provided in this document in response to comments received, VA 
is adopting the provisions of the interim final rule at 85 FR 31690, as 
amended by 87 FR 6425, as a final rule without changes.

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.

Regulatory Flexibility Act

    The Secretary hereby certifies that this 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.

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. This final rule will have no such effect on 
State, local, and tribal governments, or on the private sector.

Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507) requires that 
VA consider the impact of paperwork and other information collection 
burdens imposed on the public. Except for emergency approvals under 44 
U.S.C. 3507(j), VA may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number. The interim final rule (85 FR 
31690) included a provision constituting revisions to an existing 
collection of information under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3521) that require approval by the Office of Management and 
Budget (OMB) (the provision in the interim final rule is 38 CFR 17.32). 
Accordingly, under 44 U.S.C. 3507(d), VA submitted a copy of the 
interim final rule (85 FR 31690) to OMB for review, and VA requested 
that OMB approve the revised collection of information on an emergency 
basis. VA did not receive any comments on the collection of information 
contained in the interim final rule (85 FR 31690). OMB approved the 
collections of information under control number 2900-0556.

Assistance Listing

    The Assistance 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 Services; 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.

Congressional Review Act

    Pursuant to Subtitle E of the Small Business Regulatory Enforcement 
Fairness Act of 1996 (known as 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).

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 July 25, 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.

PART 17--MEDICAL

    For the reasons set forth in the preamble, VA adopts as final the 
interim final rule published at 85 FR 31690 (May 27, 2020), as amended 
by 87 FR 6425 (February 4, 2022).

Consuela Benjamin,
Regulations Development Coordinator, Office of Regulation Policy & 
Management, Office of General Counsel, Department of Veterans Affairs.
[FR Doc. 2022-16465 Filed 8-1-22; 8:45 am]
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