Medical: Informed Consent-Extension of Time Period and Modification of Witness Requirement for Signature Consent, 68739-68740 [E6-20111]

Download as PDF Federal Register / Vol. 71, No. 228 / Tuesday, November 28, 2006 / Rules and Regulations DEPARTMENT OF DEFENSE Office of the Secretary 32 CFR Part 235 [DOD–2005–OS–0149] RIN 0790–AH86 Sale or Rental of Sexually Explicit Material on DoD Property (DoD Instruction 4105.70) Department of Defense. Final rule; correction. AGENCY: ACTION: SUMMARY: On Wednesday, November 15, 2006 (71 FR 66457), the Department of Defense published a final rule, ‘‘Sale or Rental of Sexually Explicit Material on DoD Property (DoD Instruction 4105.70)’’. This document corrects an error in the summary. DATES: Effective Date: December 15, 2006. FOR FURTHER INFORMATION CONTACT: Commander F. Stich, 703–602–4590. Correction In Federal Register at 71 FR 66457, the SUMMARY of the notice, ‘‘10 U.S.C. 2489a’’ is corrected to read ‘‘10 U.S.C. 2495b’’. All other information remains unchanged. Dated: November 21, 2006. L.M. Bynum, Alternate OSD Federal Register Liaison Officer, DoD. [FR Doc. 06–9417 Filed 11–27–06; 8:45 am] BILLING CODE 5001–06–M DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 17 RIN 2900–AM19 Medical: Informed Consent—Extension of Time Period and Modification of Witness Requirement for Signature Consent Department of Veterans Affairs. ACTION: Final rule. mstockstill on PROD1PC61 with RULES AGENCY: SUMMARY: This document adopts as a final rule the proposed rule amending the Department of Veterans Affairs (VA) medical regulations on informed consent. This final rule extends the period of time during which a signed consent form remains valid from 30 to 60 days and eliminates the requirement that a third-party witness the patient or surrogate and practitioner signing the consent form, except in those VerDate Aug<31>2005 13:50 Nov 27, 2006 Jkt 211001 circumstances where the patient or surrogate signs with an ‘‘X’’ due to a debilitating illness or disability, i.e., significant physical impairment and/or difficulty in executing a signature due to an underlying health condition(s), or is unable to read and write. DATES: Effective Date: December 28, 2006. FOR FURTHER INFORMATION CONTACT: Ruth Cecire, PhD., Policy Analyst, Ethics Policy Service, National Center for Ethics in Health Care (10E), Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420; 202–501– 2012 (this is not a toll-free number). SUPPLEMENTARY INFORMATION: In a document published in the Federal Register on March 9, 2006 (71 FR 5204), VA proposed to amend its medical regulations at 38 CFR 17.32 on informed consent. Specifically, it proposed to extend the time during which a signed consent form is valid from 30 to 60 days. Also, it proposed to eliminate the requirement that a consent form be witnessed, except in those situations where the patient or surrogate signs with an ‘‘X’’ due to a debilitating illness or disability. VA provided a 60-day comment period that ended on May 6, 2006. No comments were received. Based on the rationale set forth in the proposed rule and those contained in this document, we are adopting the provisions of the proposed rule as a final rule without change. 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 an 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 given year. This rule has no such effect on State, local, and tribal governments, or on the private sector. Paperwork Reduction Act of 1995 This rule contains no new collections of information under the Paperwork Reduction Act (44 U.S.C. 3501–3521). The existing information collections associated with the informed consent procedures under § 17.32 have been approved by the Office of Management and Budget (OMB) under 2900–0583. Executive Order 12866 Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 68739 regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Order classifies a rule as a significant regulatory action requiring review by the Office of Management and Budget if it meets any one of a number of specified conditions, including: having an annual affect on the economy of $100 million or more, creating a serious inconsistency or interfering with an action of another agency, materially altering the budgetary impact of entitlements or the rights of entitlement recipients, or raising novel legal or policy issues. VA has examined the economic, legal, and policy implications of this final rule and concluded that it is a significant regulatory action because it raises novel policy issues. Regulatory Flexibility Act The Secretary hereby certifies that this 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. The rule will affect only individuals and will not directly affect any small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604. Catalog of Federal Domestic Assistance The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; and 64.011, Veterans Dental Care. List of Subjects in 38 CFR Part 17 Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Foreign relations, 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, Philippines, Reporting and recordkeeping requirements, Scholarships and fellowships, Travel and transportation expenses, Veterans. Approved: October 23, 2006. Gordon H. Mansfield, Deputy Secretary of Veterans Affairs. For the reasons set out in the preamble, VA amends 38 CFR part 17 to read as follows: I E:\FR\FM\28NOR1.SGM 28NOR1 68740 Federal Register / Vol. 71, No. 228 / Tuesday, November 28, 2006 / Rules and Regulations PART 17—MEDICAL ENVIRONMENTAL PROTECTION AGENCY 1. The authority citation for part 17 continues to read as follows: 40 CFR Part 52 Authority: 38 U.S.C. 501, 1721, and as stated in specific sections. [EPA–R04–OAR–2006–0577–200624(a); FRL–8248–9] 2. Section 17.32 is amended by: I a. Revising the section heading. I b. In paragraph (a), in the definition of signature consent, removing ‘‘, e.g., a published numbered VA form (OF 522) or comparable form approved by the local VA facility’’. I c. Revising paragraph (d)(2). I d. Revising the authority citation at the end of the section. The revisions read as follows: Approval and Promulgation of Implementation Plans; Georgia: Removal of Douglas County Transportation Control Measure I I § 17.32 Informed consent and advance care planning. * * * * * (d) * * * (2) A patient or surrogate will sign with an ‘‘X’’ when the patient or surrogate has a debilitating illness or disability, i.e., significant physical impairment and/or difficulty in executing a signature due to an underlying health condition(s), or is unable to read and write. When the patient’s or surrogate’s signature is indicated by an ‘‘X,’’ two adults must witness the act of signing. By signing, the witnesses are attesting only to the fact that they saw the patient or surrogate and the practitioner sign the form. The signed form must be filed in the patient’s medical record. A properly executed VA-authorized consent form is valid for a period of 60 calendar days. If, however, the treatment plan involves multiple treatments or procedures, it will not be necessary to repeat the informed consent discussion and documentation so long as the course of treatment proceeds as planned, even if treatment extends beyond the 60-day period. If there is a change in the patient’s condition that might alter the diagnostic or therapeutic decision, the consent is automatically rescinded. * * * * * (Authority: 38 U.S.C. 7331–7334) mstockstill on PROD1PC61 with RULES VerDate Aug<31>2005 13:50 Nov 27, 2006 Jkt 211001 SUMMARY: On September 19, 2006, the State of Georgia’s Department of Natural Resources (DNR), through the Georgia Environmental Protection Division (GA EPD), submitted a final State Implementation Plan (SIP) revision to remove the transportation control measure (TCM) related to a compressed natural gas (CNG) refueling station/park and ride transportation center project in Douglas County, Georgia. This TCM was originally submitted by GA EPD for inclusion into the Atlanta portion of the Georgia SIP on August 29, 1997. EPA approved this TCM into the Georgia SIP through direct final rulemaking published in the Federal Register on June 24, 1998 (effective on August 10, 1998). Subsequently, the project sponsor determined that the equipment necessary to implement this project is no longer available, and thus this TCM cannot be implemented as originally anticipated. No SIP credit was claimed for this program, nor were emissions benefits ever realized for this TCM because it was never implemented. Through this rulemaking, EPA is approving the removal of this TCM from the Atlanta portion of the Georgia SIP because this SIP revision meets Clean Air Act (CAA) requirements. DATES: This direct final rule is effective January 29, 2007 without further notice, unless EPA receives adverse comment by December 28, 2006. If adverse comment is received, EPA will publish a timely withdrawal of the direct final rule in the Federal Register and inform the public that the rule will not take effect. Submit your comments, identified by Docket ID No. EPA–R04– 2006–0577, by one of the following methods: 1. www.regulations.gov.: Follow the on-line instructions for submitting comments. 2. E-mail: Benjamin.lynorae@epa.gov. 3. Fax: (404) 562–9019. 4. Mail: ‘‘EPA–R04–OAR–2006– 0577,’’ Air Quality Modeling and ADDRESSES: [FR Doc. E6–20111 Filed 11–27–06; 8:45 am] BILLING CODE 8320–01–P Environmental Protection Agency (EPA). ACTION: Direct final rule. AGENCY: PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 Transportation Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303–8960. 5. Hand Delivery or Courier: Lynorae Benjamin, Air Quality Modeling and Transportation Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303–8960. Such deliveries are only accepted during the Regional Office’s normal hours of operation. The Regional Office’s official hours of business are Monday through Friday, 8:30 to 4:30, excluding Federal holidays. Instructions: Direct your comments to Docket ID No. ‘‘EPA–R04–OAR–2006– 0577.’’ EPA’s policy is that all comments received will be included in the public docket without change and may be made available online at www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit through www.regulations.gov or e-mail, information that you consider to be CBI or otherwise protected. The www.regulations.gov Web site is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through www.regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD–ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA’s public docket visit the EPA Docket Center homepage at https:// www.epa.gov/epahome/dockets.htm. Docket: All documents in the electronic docket are listed in the www.regulations.gov index. Although listed in the index, some information is not publicly available, i.e., CBI or other E:\FR\FM\28NOR1.SGM 28NOR1

Agencies

[Federal Register Volume 71, Number 228 (Tuesday, November 28, 2006)]
[Rules and Regulations]
[Pages 68739-68740]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-20111]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AM19


Medical: Informed Consent--Extension of Time Period and 
Modification of Witness Requirement for Signature Consent

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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

SUMMARY: This document adopts as a final rule the proposed rule 
amending the Department of Veterans Affairs (VA) medical regulations on 
informed consent. This final rule extends the period of time during 
which a signed consent form remains valid from 30 to 60 days and 
eliminates the requirement that a third-party witness the patient or 
surrogate and practitioner signing the consent form, except in those 
circumstances where the patient or surrogate signs with an ``X'' due to 
a debilitating illness or disability, i.e., significant physical 
impairment and/or difficulty in executing a signature due to an 
underlying health condition(s), or is unable to read and write.

DATES: Effective Date: December 28, 2006.

FOR FURTHER INFORMATION CONTACT: Ruth Cecire, PhD., Policy Analyst, 
Ethics Policy Service, National Center for Ethics in Health Care (10E), 
Veterans Health Administration, Department of Veterans Affairs, 810 
Vermont Avenue, NW., Washington, DC 20420; 202-501-2012 (this is not a 
toll-free number).

SUPPLEMENTARY INFORMATION: In a document published in the Federal 
Register on March 9, 2006 (71 FR 5204), VA proposed to amend its 
medical regulations at 38 CFR 17.32 on informed consent. Specifically, 
it proposed to extend the time during which a signed consent form is 
valid from 30 to 60 days. Also, it proposed to eliminate the 
requirement that a consent form be witnessed, except in those 
situations where the patient or surrogate signs with an ``X'' due to a 
debilitating illness or disability. VA provided a 60-day comment period 
that ended on May 6, 2006. No comments were received. Based on the 
rationale set forth in the proposed rule and those contained in this 
document, we are adopting the provisions of the proposed rule as a 
final rule without change.

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 an 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 given year. This rule has no such effect on State, 
local, and tribal governments, or on the private sector.

Paperwork Reduction Act of 1995

    This rule contains no new collections of information under the 
Paperwork Reduction Act (44 U.S.C. 3501-3521). The existing information 
collections associated with the informed consent procedures under Sec.  
17.32 have been approved by the Office of Management and Budget (OMB) 
under 2900-0583.

Executive Order 12866

    Executive Order 12866 directs agencies to assess all 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, 
and other advantages; distributive impacts; and equity). The Order 
classifies a rule as a significant regulatory action requiring review 
by the Office of Management and Budget if it meets any one of a number 
of specified conditions, including: having an annual affect on the 
economy of $100 million or more, creating a serious inconsistency or 
interfering with an action of another agency, materially altering the 
budgetary impact of entitlements or the rights of entitlement 
recipients, or raising novel legal or policy issues. VA has examined 
the economic, legal, and policy implications of this final rule and 
concluded that it is a significant regulatory action because it raises 
novel policy issues.

Regulatory Flexibility Act

    The Secretary hereby certifies that this 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. The rule will affect only individuals and will not directly affect 
any small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rule 
is exempt from the initial and final regulatory flexibility analysis 
requirements of sections 603 and 604.

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for 
the programs affected by this document are 64.009, Veterans Medical 
Care Benefits; 64.010, Veterans Nursing Home Care; and 64.011, Veterans 
Dental Care.

List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, 
Claims, Day care, Dental health, Drug abuse, Foreign relations, 
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, Philippines, Reporting 
and recordkeeping requirements, Scholarships and fellowships, Travel 
and transportation expenses, Veterans.

    Approved: October 23, 2006.
Gordon H. Mansfield,
Deputy Secretary of Veterans Affairs.

0
For the reasons set out in the preamble, VA amends 38 CFR part 17 to 
read as follows:

[[Page 68740]]

PART 17--MEDICAL

0
1. The authority citation for part 17 continues to read as follows:

    Authority: 38 U.S.C. 501, 1721, and as stated in specific 
sections.


0
2. Section 17.32 is amended by:
0
a. Revising the section heading.
0
b. In paragraph (a), in the definition of signature consent, removing 
``, e.g., a published numbered VA form (OF 522) or comparable form 
approved by the local VA facility''.
0
c. Revising paragraph (d)(2).
0
d. Revising the authority citation at the end of the section.
    The revisions read as follows:


Sec.  17.32  Informed consent and advance care planning.

* * * * *
    (d) * * *
    (2) A patient or surrogate will sign with an ``X'' when the patient 
or surrogate has a debilitating illness or disability, i.e., 
significant physical impairment and/or difficulty in executing a 
signature due to an underlying health condition(s), or is unable to 
read and write. When the patient's or surrogate's signature is 
indicated by an ``X,'' two adults must witness the act of signing. By 
signing, the witnesses are attesting only to the fact that they saw the 
patient or surrogate and the practitioner sign the form. The signed 
form must be filed in the patient's medical record. A properly executed 
VA-authorized consent form is valid for a period of 60 calendar days. 
If, however, the treatment plan involves multiple treatments or 
procedures, it will not be necessary to repeat the informed consent 
discussion and documentation so long as the course of treatment 
proceeds as planned, even if treatment extends beyond the 60-day 
period. If there is a change in the patient's condition that might 
alter the diagnostic or therapeutic decision, the consent is 
automatically rescinded.
* * * * *
(Authority: 38 U.S.C. 7331-7334)

 [FR Doc. E6-20111 Filed 11-27-06; 8:45 am]
BILLING CODE 8320-01-P
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