Federal Register / Vol. 72, No. 45 / Thursday, March 8, 2007 / Rules and Regulations 10365 

notice that it is a significant regulatory 

action because it exceeds the $100 

million threshold. 

Paperwork Reduction Act 

The collection of information under 

the Paperwork Reduction Act (44 U.S.C. 

3501–3521) referenced in this final rule 

has been approved under OMB control 

number 2900–0671. 

Regulatory Flexibility Act 

The Secretary of Veterans Affairs 

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). Only 

service members and their beneficiaries 

could be directly affected. Therefore, 

pursuant to 5 U.S.C. 605(b), this rule is 

exempt from the final regulatory 

flexibility analysis requirements of 5 

U.S.C. 604. 

Catalog of Federal Domestic Assistance 

Numbers 

The Catalog of Federal Domestic 

Assistance Program number for this 

regulation is 64.103, Life Insurance for 

Veterans. 

List of Subjects in 38 CFR Part 9 

Life insurance, Military personnel, 

Veterans. 

Approved: November 30, 2006. 

Gordon H. Mansfield, 

Deputy Secretary of Veterans Affairs. 

■ For the reasons set out in the 

preamble, the interim final rule 

amending 38 CFR part 9, which was 

published at 70 FR 75940 on December 

22, 2005, is adopted as a final rule with 

the following changes: 

PART 9—SERVICEMEMBERS’ GROUP 

LIFE INSURANCE AND VETERANS’

GROUP LIFE INSURANCE 

■ 1. The authority citation for part 9 is 

revised to read as follows: 

Authority: 38 U.S.C. 501, 1965–1980A. 

■ 2. Section 9.20 is amended by: 

■ a. Revising paragraph (d)(1). 

■ b. Revising paragraph (d)(4). 

■ c. Revising paragraph (f) 

■ d. Adding paragraph (j). 

■ e. Adding an information collection 

approval parenthetical number 

immediately following the authority 

citation. 

The revisions and additions read as 

follows: 

§ 9.20 Traumatic injury protection. 

* * * * * 

(d) * * * 

(1) You must be a member of the 

uniformed services who is insured by 

Servicemembers’ Group Life Insurance 

under section 1967(a)(1)(A)(i), (B) or 

(C)(i) of title 38, United States Code, on 

the date you sustained a traumatic 

injury, except if you are a member who 

experienced a traumatic injury on or 

after October 7, 2001, through and 

including December 1, 2005, and your 

scheduled loss was a direct result of 

injuries incurred in Operation Enduring 

Freedom or Operation Iraqi Freedom. 

(For this purpose, you will be 

considered a member of the uniformed 

services until midnight on the date of 

termination of your duty status in the 

uniformed services that established your 

eligibility for Servicemembers’ Group 

Life Insurance, notwithstanding an 

extension of your Servicemembers’

Group Life Insurance coverage under 

section 1968(a) of title 38, United States 

Code.) 

* * * * * 

(4) You must suffer a scheduled loss 

under paragraph (e)(7) of this section 

within two years of the traumatic injury. 

* * * * * 

(f) Who will determine eligibility for 

traumatic injury protection benefits? 

Each uniformed service will certify its 

own members for traumatic injury 

protection benefits based upon section 

1032 of Public Law 109–13, section 501 

of Public Law 109–233, and this section. 

The uniformed service will certify 

whether you were at the time of the 

traumatic injury insured under 

Servicemembers’ Group Life Insurance 

and whether you have sustained a 

qualifying loss. 

* * * * * 

(j) The Traumatic Servicemembers’

Group Life Insurance program will be 

administered in accordance with this 

rule, except to the extent that any 

regulatory provision is inconsistent with 

subsequently enacted applicable law. 

(The Office of Management and Budget 

has approved the information collection 

requirements in this section under 

control number 2900–0671.) 

[FR Doc. E7–4141 Filed 3–7–07; 8:45 am] 

BILLING CODE 8320–01–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 17 

RIN 2900–AM21 

Medical: Informed Consent—Designate 

Health Care Professionals To Obtain 

Informed Consent 

AGENCY: Department of Veterans Affairs. 

ACTION: Final rule. 

SUMMARY: This document amends U.S. 

Department of Veterans Affairs (VA) 

medical regulations on informed 

consent. The final rule authorizes VA to 

designate additional categories of health 

care professionals to obtain the 

informed consent of patients or their 

surrogates for clinical treatment and 

procedures and to sign the consent 

form. 

DATES: Effective Date: April 9, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Ruth Cecire, PhD, Policy Analyst, 

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 February 1, 2006 (71 FR 

5204), VA proposed to amend 38 CFR 

17.32 to authorize the designation of 

additional categories of health care 

professionals to obtain the informed 

consent of patients or their surrogates 

and to sign the consent form. The 

comment period for this proposed rule 

ended April 3, 2006. We received one 

comment and now issue this final rule. 

This rule amends VA medical 

regulations on informed consent and 

brings VA practice in line with current 

professional standards of care. 

Specifically, it allows VA to designate 

appropriately trained health care 

professionals (e.g., advanced practice 

nurses and physician assistants), who 

have primary responsibility for the 

patient or who will perform a particular 

procedure or provide a treatment, to 

conduct the informed consent 

discussion and sign the consent form. 

These changes and the specific 

requirements that define ‘‘appropriately 

trained health care professionals’’ will 

be documented in a revision to VHA 

Handbook 1004.1, Informed Consent for 

Clinical Treatments and Procedures. 

The current definition of practitioner 

encompasses any health care 

professional who has been granted 

specific clinical privileges to perform 

the treatment or procedure. It also 

includes medical and dental residents 

who may not be clinically privileged but 

who, under the current regulation, may 

obtain the informed consent and sign 

the consent form. This rule extends the 

exception regarding clinical privileging 

to other appropriately trained health 

care professionals, which will be clearly 

defined in national VA policy. 

This change is required because 

clinical privileges are not granted to all 

health care professionals in VA who 

provide treatments and procedures. 


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10366 Federal Register / Vol. 72, No. 45 / Thursday, March 8, 2007 / Rules and Regulations 

Some health care professionals work 

under specific ‘‘scope of practice’’

agreements or other formal delineations 

of job responsibility that specify which 

treatments and procedures the 

individual can provide based on his or 

her training, certification, knowledge, 

skills, and/or licensure. These 

agreements are developed and signed at 

the local facility level based on national 

policy requirements. Under the current 

regulatory definition of practitioner, 

physician assistants, advanced practice 

nurses and other appropriately trained 

health care professionals who are not 

clinically privileged but are performing 

procedures or providing treatments, as 

approved by their facility and supported 

by the standards of their respective 

professions, may not obtain informed 

consent from the patient. This rule 

would allow these treating practitioners 

to obtain informed consent from the 

patient and sign the consent form. This 

scope of practice will be limited to those 

specific individuals who meet detailed 

requirements set by VA national policy 

and who also gain approval from their 

local facility to carry out these duties. 

No change is made to the general 

requirements for informed consent in 

this rule. The practitioner, who has 

primary responsibility for the patient or 

who will perform the particular 

procedure or provide the treatment, 

must obtain consent from the patient as 

described in the regulation. 

VA received one comment asking that 

we omit reference to designated ‘‘health 

care professionals’’ and expand the 

definition of ‘‘practitioner’’ to include 

advanced practice nurses and physician 

assistants only. The commenter 

suggested that other health care 

professionals may lack the 

qualifications necessary to obtain 

patients’ informed consent. VA 

recognizes that many health care 

professionals may lack appropriate 

qualifications to obtain informed 

consent. Indeed, some advanced 

practice nurses and physician assistants 

may not be qualified to do so. However, 

the commenters’ proposed change 

neither ensures quality nor allows VA to 

remedy the problem that non-privileged 

providers are currently prohibited from 

obtaining consent from the patients they 

treat. We believe that promoting direct 

communication between the treating 

practitioner and the patient improves 

informed consent and improves patient 

care. Ensuring that providers are 

appropriately qualified to conduct 

informed consent discussions with 

patients will be addressed through 

establishing national requirements in 

VA policy and holding local VHA 

facilities accountable for making certain 

that each individual provider assigned 

those duties is competent to perform 

them. In our view, the rule’s proviso, 

that designation is authorized only for 

other appropriately trained health care 

professionals, when combined with the 

regulation’s requirement that consent be 

obtained by the health care professional 

who has primary responsibility for the 

patient or who will perform the 

particular procedure or provide the 

treatment, allows VA a necessary level 

of control over quality through the 

specification in policy and certification 

in practice of ‘‘appropriately trained 

health care professionals.’’ Accordingly, 

we made no change based on this 

comment. 

We are also making nonsubstantive 

changes to make the terminology used 

in the regulation consistent with current 

Department practice. These include 

changing ‘‘health-care’’ to ‘‘health care’’

and ‘‘medical record’’ to ‘‘health record’’

throughout the section. 

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 would have no 

such effect on State, local, and tribal 

governments, or the private sector. 

Paperwork Reduction Act of 1995 

This document contains no provisions 

constituting a collection of information 

under the Paperwork Reduction Act (44 

U.S.C. 3501–3521). The existing 

information collections associated with 

the informed consent process have been 

approved by OMB under control 

number 2900–0583. 

Executive Order 12866—Regulatory 

Planning and Review 

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 has concluded that 

it is a significant regulatory action 

because it raises novel policy issues. 

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). 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 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 24, 2006. 

Gordon H. Mansfield, 

Deputy Secretary of Veterans Affairs. 

■ For the reasons set forth in the 

preamble, 38 CFR part 17 is amended as 

set forth below: 

PART 17—MEDICAL 

■ 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. 

■ 2. Section 17.32 is amended by: 

■ a. Removing ‘‘health-care’’ each time 

it appears and adding in its place 

‘‘health care’’. 


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Federal Register / Vol. 72, No. 45 / Thursday, March 8, 2007 / Rules and Regulations 10367 

■ b. Removing ‘‘medical record’’ each 

time it appears and adding in its place 

‘‘health record’’. 

■ c. In the list of definitions in 

paragraph (a), revising the definition of 

‘‘Practitioner’’. 

The revision reads as follows: 

§ 17.32 Informed consent and advance 

care planning. 

(a) * * * 

Practitioner. Any physician, dentist, 

or health care professional who has 

been granted specific clinical privileges 

to perform the treatment or procedure. 

For the purpose of obtaining informed 

consent for medical treatment, the term 

practitioner includes medical and 

dental residents and other appropriately 

trained health care professionals 

designated by VA regardless of whether 

they have been granted clinical 

privileges. 

* * * * * 

[FR Doc. E7–4142 Filed 3–7–07; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 51 

[EPA–HQ–OAR–2001–0004; FRL–8283–9] 

RIN 2060–AM59 

Nonattainment New Source Review 

(NSR) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The EPA is finalizing 

revisions to the regulations governing 

the nonattainment new source review 

(NSR) program mandated by section 

110(a)(2)(C) of the Clean Air Act (CAA 

or Act). These revisions implement 

changes to the preconstruction review 

requirements for major stationary 

sources in nonattainment areas in 

interim periods between designation of 

new nonattainment areas and adoption 

of a revised State Implementation Plan 

(SIP). The revisions conform the 

nonattainment permitting rules that 

apply during the SIP development 

period following nonattainment 

designations before SIP approval to the 

Federal permitting rules applicable to 

SIP-approved programs. The changes 

are intended to provide a consistent 

national program for permitting major 

stationary sources in nonattainment 

areas under section 110(a)(2)(C) and part 

D of title I of the Act. In particular, these 

changes conform the regulations to the 

NSR reform provisions that EPA 

promulgated by notice dated December 

31, 2002, except that these changes do 

not include the NSR reform provisions 

for ‘‘clean units’’ or ‘‘pollution control 

projects,’’ which the U.S. Court of 

Appeals for the D.C. Circuit vacated in 

New York v. EPA, 413 F.3d 3 (DC Cir. 

2005). In addition, these changes 

include an interim interpretation of the 

NSR reform provision for a ‘‘reasonable 

possibility’’ standard for recordkeeping 

and reporting requirements, in 

accordance with that court decision. 

This interim interpretation to the 

‘‘reasonable possibility‘‘ standard 

applies for appendix S purposes, 

pending the completion of rulemaking 

to develop a more complete 

interpretation. 

DATES: This final rule is effective on 

May 7, 2007. 

ADDRESSES: The EPA has established a 

docket for this action under Docket ID 

No. EPA–HQ–OAR–2001–0004. All 

documents in the docket are listed on 

the http://www.regulations.gov Web 

site. Although listed in the index, some 

information may not be publicly 

available, e.g., CBI or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically through 

http://www.regulations.gov or in hard 

copy at the Air Docket, EPA/DC, EPA 

West, Room 3334, 1301 Constitution 

Ave., NW., Washington, DC. The Public 

Reading Room is open from 8:30 a.m. to 

4:30 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Public Reading Room is 

(202) 566–1744, and the telephone 

number for the Air Docket is (202) 566–

1742. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Lisa Sutton, Air Quality Policy Division, 

Office of Air Quality Planning and 

Standards (C504–03), Environmental 

Protection Agency, Research Triangle 

Park, NC 27711; telephone number: 

(919) 541–3450; fax number: (919) 541–

5509; e-mail address: 

sutton.lisa@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does This Action Apply to Me? 

Entities affected by this rule include 

sources in all industry groups. The 

majority of sources potentially affected 

are expected to be in the following 

groups: 

Industry Group SIC a NAICSb

Electric Services ................................................................................ 491 221111, 221112, 221113, 221119, 221121, 221122. 

Petroleum Refining ............................................................................ 291 324110. 

Industrial Inorganic Chemicals .......................................................... 281 325181, 325120, 325131, 325182, 211112, 325998, 331311, 

325188. 

Industrial Organic Chemicals ............................................................ 286 325110, 325132, 325192, 325188, 325193, 325120, 325199. 

Miscellaneous Chemical Products .................................................... 289 325520, 325920, 325910, 325182, 325510. 

Natural Gas Liquids .......................................................................... 132 211112. 

Natural Gas Transport ...................................................................... 492 486210, 221210. 

Pulp and Paper Mills ......................................................................... 261 322110, 322121, 322122, 322130. 

Paper Mills ........................................................................................ 262 322121, 322122. 

Automobile Manufacturing ................................................................ 371 336111, 336112, 336211, 336992, 336322, 336312, 336330, 

336340, 336350, 336399, 336212, 336213. 

Pharmaceuticals ................................................................................ 283 325411, 325412, 325413, 325414. 

aStandard Industrial Classification. 

b North American Industry Classification System. 

Entities affected by the rule also 

include States, local permitting 

authorities, and Indian tribes whose 

lands contain new and modified major 

stationary sources. 

B. Where Can I Obtain Additional 

Information? 

In addition to being available in the 

docket, an electronic copy of this final 


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