53960 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Rules and Regulations

effect upon publication, the notice is

open for public comment or objection

until December 16, 1997. Further, the

exemptions are temporary and may be

subject to change, based on the

comments or objections received.

The Deputy Assistant Administrator

for the Office of Diversion Control

hereby certifies that this interim

rulemaking will not have a significant

economic impact upon a substantial

number of entities whose interests must

be considered under the Regulatory

Flexibility Act, 5 U.S.C. 601 et seq. This

interim rulemaking is an administrative

action to make the regulations

consistent with the law and to avoid

interruption of legitimate commerce by

granting temporary exemptions from

registration pending promulgation,

through notice and comment, of the

regulations necessary to implement the

provisions of the MCA pertaining to

regulated drug products. Further, since

this is a temporary action which

provides affected persons with a means

to comply with the law pending

promulgation of regulations

implementing the MCA, this action is

not a significant regulatory action and

therefore has not been reviewed by the

Office of Management and Budget

pursuant to Executive Order 12866.

This action has been analyzed in

accordance with the principles and

criteria in Executive Order 12612, and it

has been determined that this interim

rule does not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

List of Subjects

21 CFR Part 1309

Administrative practice and

procedure, Drug traffic control, List I

and List II chemicals, Security

measures.

21 CFR Part 1310

Drug traffic control, List I and List II

chemicals, Reporting and recordkeeping

requirements.

For the reasons set out above, 21 CFR

parts 1309 and 1310 are amended to

read as follows:

PART 1309—[AMENDED]

1. The authority citation for part 1309

continues to read as follows:

Authority: 21 U.S.C. 821, 822, 823, 824,

830, 871(b), 875, 877, 958.

2. Section 1309.29 is revised to read

as follows:

§ 1309.29 Exemption of retail distributors

of regulated drug products.

The requirement of registration is

waived for any retail distributor whose

activities with respect to List I

chemicals are restricted to the

distribution of below-threshold

quantities of a drug product that

contains a List I chemical that is

regulated pursuant to

§ 1300.02(b)(28)(1)(D) of this chapter to

an individual for legitimate medical use.

PART 1310—[AMENDED]

1. The authority citation for part 1310

continues to read as follows:

Authority: 21 U.S.C. 802, 830, 871(b).

2. Section 1310.09 is amended by

redesignating the existing text as

paragraph (a) and adding a new

paragraph (b) to read as follows:

§ 1310.09 Temporary exemption from

registration.

* * * * *

(b) Each person required by section

302 of the Act (21 U.S.C. 822) to obtain

a registration to distribute, import, or

export a drug product that contains

pseudoephedrine or

phenylpropanolamine that is regulated

pursuant to § 1300.02(b)(28)(1)(D) of this

chapter is temporarily exempted from

the registration requirement, provided

that the person submits a proper

application for registration on or before

December 3, 1997. The exemption will

remain in effect for each person who has

made such application until the

Administration has approved or denied

that application. This exemption applies

only to registration; all other chemical

control requirements set forth in parts

1309, 1310, and 1313 of this chapter

remain in full force and effect.

Dated: October 8, 1997.

James S. Milford,

Acting Deputy Administrator.

[FR Doc. 97–27453 Filed 10–16–97; 8:45 am]

BILLING CODE 4410–09–M

DEPARTMENT OF VETERANS

AFFAIRS

38 CFR Part 17

RIN 2900–AH72

Informed Consent for Patient Care

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

SUMMARY: This document amends VA

medical regulations concerning

informed consent for patient care. It

describes the requirements for obtaining

and documenting informed consent. It

also describes the types of treatments or

procedures for which the patient’s or

surrogate’s signature on a VAauthorized form is required and

establishes a list and priority of

surrogates authorized to act on behalf of

patients who lack decision-making

capacity. Further, it establishes an

internal decision-making process for

patients who lack decision-making

capacity and who have no authorized

surrogate. This is intended to protect

patient rights and ensure that the

patient (or the patient’s surrogate or

representative) receives sufficient

information to make an informed

health-care decision.

DATES: Effective Date: November 17,

1997.

FOR FURTHER INFORMATION CONTACT:

Ruth-Ann Phelps, Ph.D., Veterans

Health Administration, Patient Care

Services (11B), 810 Vermont Avenue,

NW, Washington, DC 20420, (202) 273–

8473.

SUPPLEMENTARY INFORMATION: In a

document published in the Federal

Register on August 7, 1996 (61 FR

41108), we proposed to amend our

regulations concerning informed

consent for patient care. Interested

parties were invited to submit written

comments on or before October 7, 1996.

We received comments from one

commenter, the American Psychiatric

Association.

Comments

The commenter suggested that

whenever the word ‘‘patient’’ appears in

the document, the phrase ‘‘or patient

surrogate’’ should be added. In

response, we have added the words ‘‘or

surrogate’’ wherever appropriate. This is

intended to clarify, consistent with the

intent of the proposal, that a surrogate

may give informed consent on behalf of

a patient who lacks decision-making

capacity.

With respect to requirements

regarding the administration of

psychotropic medication to an

involuntarily committed patient, the

commenter asserted that the prescribing

of such medications should be limited

to psychiatrists, and further asserted

that the multi-disciplinary review

committee constituted for purposes of

review of the decision to administer or

continue the administration of such

medications should be required to

include a psychiatrist. We do not

believe that psychotropic medication

should be prescribed only by

psychiatrists. We believe that patients

are adequately served as long as the

prescribing physician is privileged to

prescribe such medication. Also, we

have added the requirement that the

committee must include a psychiatrist

or a physician who has
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Rules and Regulations 53961

psychopharmacology privileges. We

believe this is adequate for the types of

determinations that need to be made.

With respect to the revocation of

consent (including the revocation of

HIV testing consent), the commenter

suggested that the regulations should

require that documentation immediately

be added at the place in the medical

records that contained the earlier record

of consent. No changes are made based

on this comment. We note that the

regulations provide that the informed

consent process must be appropriately

documented in the medical record. This

requires documentation for revocations

of consent, and we do not believe

further instructions in the regulations

are necessary (see § 17.32(d)).

The commenter suggested that

consents regarding HIV testing (required

to be on VA form 10–012) be filed in the

patient record. No changes are made

based on this comment. This already is

required by these regulations (see

§ 17.32(g)(4)).

The proposal provided that HIV

antibody testing must be accomplished

by pre-test and post-test counseling. The

commenter suggested that the

counseling be at least equivalent to

guidelines for testing from the Centers

for Disease Control and Prevention and

other Federal or State agencies which

set HIV serologic testing policies. The

commenter further suggested that the

form and language of such counseling

should be appropriate to the patient’s or

surrogate’s educational level as well as

cognitive and emotional state. No

changes are made based on these

comments. VA health-care professionals

are provided with guidance

commensurate with the guidelines

suggested by the commenter. Further,

there does not appear to be a need to

specifically address the educational

level and cognitive and emotional state

of the patient or surrogate. This already

is covered since the final rule requires

that health-care professionals explain

consent matters in language

understandable to the patient or

surrogate (see § 17.32(c)).

Paperwork Reduction Act

The collection of information

contained in the notice of the proposed

rulemaking was submitted to the Office

of Management and Budget (OMB) for

review in accordance with the

Paperwork Reduction Act (44 U.S.C.

3504(h)). The information collection

subject to this rulemaking concerns the

disclosure requirements that non-VA

physicians contracting to perform

services for VA must follow in

conducting informed consent

procedures. The information provided is

designed to ensure that the patients (or

in some cases, others) have sufficient

information to provide informed

consent. Interested parties were invited

to submit comments on the collection of

information. However, no comments

were received. OMB has approved this

information collection under control

number 2900–0583.

VA is not authorized to impose a

penalty on persons for failure to comply

with information collection

requirements which do not display a

current OMB control number, if

required.

Executive Order 12866

This final rule has been reviewed by

OMB under Executive Order 12866.

Regulatory Flexibility Act

The Secretary hereby certifies that the

adoption of this final rule would 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

adoption of the final rule would affect

VA beneficiaries but would not affect

small businesses. Therefore, pursuant to

5 U.S.C. 605(b), this rulemaking is

exempt from the initial and final

regulatory flexibility analyses

requirements of §§ 603 and 604.

The Catalog of Federal Domestic

Assistance Program numbers are 64.009,

64.010, 64.011.

Lists 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 home, Philippines, Reporting

and recordkeeping requirements,

scholarships and fellowships, Travel

and transportation expenses, and

Veterans.

Approved: September 5, 1997.

Hershel W. Gober,

Acting Secretary of Veterans Affairs.

In consideration of the foregoing, 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, unless

otherwise noted.

2. Section 17.32 is revised to read as

follows:

Protection of Patient Rights

§ 17.32 Informed consent.

(a) Definitions:

Close Friend. Any person eighteen

years or older who has shown care and

concern for the patient’s welfare, who is

familiar with the patient’s activities,

health, religious beliefs and values, and

who has presented a signed written

statement for the record that describes

that person’s relationship to and

familiarity with the patient.

Decision-making capacity. The ability

to understand and appreciate the nature

and consequences of health-care

treatment decisions.

Health-Care Agent. An individual

named by the patient in a Durable

Power of Attorney for Health Care.

Legal Guardian. A person appointed

by a court of appropriate jurisdiction to

make decisions for an individual who

has been judicially determined to be

incompetent.

Practitioner. Any physician, dentist,

or health-care professional who has

been granted specific clinical privileges

to perform the treatment or procedure

involved. For the purpose of obtaining

informed consent for medical treatment,

the term practitioner includes medical

and dental residents regardless of

whether they have been granted clinical

privileges.

Signature consent. The patient’s or

surrogate’s signature on a VAauthorized consent form, e.g., a

published numbered VA form (OF 522)

or comparable form approved by the

local VA facility.

Special Guardian. A person

appointed by a court of appropriate

jurisdiction for the specific purpose of

making health-care decisions.

Surrogate. An individual,

organization or other body authorized

under this section to give informed

consent on behalf of a patient who lacks

decision-making capacity.

(b) Policy. Except as otherwise

provided in this section, all patient care

furnished under title 38 U.S.C. shall be

carried out only with the full and

informed consent of the patient or, in

appropriate cases, a representative

thereof. In order to give informed

consent, the patient must have decisionmaking capacity and be able to

communicate decisions concerning

health care. If the patient lacks decisionmaking capacity or has been declared

incompetent, consent must be obtained

from the patient’s surrogate.

Practitioners may provide necessary

medical care in emergency situations
53962 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Rules and Regulations

without the patient’s or surrogate’s

express consent when immediate

medical care is necessary to preserve

life or prevent serious impairment of the

health of the patient or others and the

patient is unable to consent and the

practitioner determines that the patient

has no surrogate or that waiting to

obtain consent from the patient’s

surrogate would increase the hazard to

the life or health of the patient or others.

In such circumstances consent is

implied.

(c) General requirements for informed

consent. Informed consent is the freely

given consent that follows a careful

explanation by the practitioner to the

patient or the patient’s surrogate of the

proposed diagnostic or therapeutic

procedure or course of treatment. The

practitioner, who has primary

responsibility for the patient or who

will perform the particular procedure or

provide the treatment, must explain 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. The patient or

surrogate must be given the opportunity

to ask questions, to indicate

comprehension of the information

provided, and to grant permission freely

without coercion. The practitioner must

advise the patient or surrogate if the

proposed treatment is novel or

unorthodox. The patient or surrogate

may withhold or revoke his or her

consent at any time.

(d) Documentation of informed

consent. (1) The informed consent

process must be appropriately

documented in the medical record. In

addition, signature consent is required

for all diagnostic and therapeutic

treatments or procedures that:

(i) Require the use of sedation;

(ii) Require anesthesia or narcotic

analgesia;

(iii) Are considered to produce

significant discomfort to the patient;

(iv) Have a significant risk of

complication or morbidity;

(v) Require injections of any

substance into a joint space or body

cavity; or

(vi) Involve testing for Human

Immunodeficiency Virus (HIV).

(2) The patient’s or surrogate’s

signature on a VA-authorized consent

form must be witnessed. The witness’

signature only attests to the fact that he

or she saw the patient or surrogate and

the practitioner sign the form. When the

patient’s or surrogate’s signature is

indicated by an ‘‘X’’, two adults must

witness the act of signing. The signed

form must be filed in the patient’s

medical record. A properly executed OF

522 or other VA-authorized consent

form is valid for a period of 30 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 30-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.

(3) If it is impractical to consult with

the surrogate in person, informed

consent may be obtained by mail,

facsimile, or telephone. A facsimile

copy of a signed consent form is

adequate to proceed with treatment.

However, the surrogate must agree to

submit a signed consent form to the

practitioner. If consent is obtained by

telephone, the conversation must be

audiotaped or witnessed by a second

VA employee. The name of the person

giving consent and his or her authority

to act as surrogate must be adequately

identified for the record.

(e) Surrogate consent. If the

practitioner who has primary

responsibility for the patient determines

that the patient lacks decision-making

capacity and is unlikely to regain it

within a reasonable period of time,

informed consent must be obtained from

the patient’s surrogate. Patients who are

incapable of giving consent as a matter

of law, i.e., persons judicially

determined to be incompetent and

minors not otherwise able to provide

informed consent, will be deemed to

lack decision-making capacity for the

purposes of this section. If the patient is

considered a minor in the state where

the VA facility is located and cannot

consent to medical treatment, consent

must be obtained from the patient’s

parent or legal guardian. The surrogate

generally assumes the same rights and

responsibilities as the patient in the

informed consent process. The

surrogate’s decision must be based on

his or her knowledge of what the patient

would have wanted, i.e., substituted

judgment. If the patient’s wishes are

unknown, the decision must be based

on the patient’s best interest. The

following persons are authorized to

consent on behalf of patients who lack

decision-making capacity in the

following order of priority:

(1) Health-care agent;

(2) Legal guardian or special guardian;

(3) Next-of-kin: a close relative of the

patient eighteen years of age or older, in

the following priority: spouse, child,

parent, sibling, grandparent, or

grandchild; or

(4) Close friend.

(f) Consent for patients without

surrogates. (1) If none of the surrogates

listed in paragraph (e) of this section are

available, the practitioner may request

Regional Counsel assistance to obtain a

special guardian for health care or

follow the procedures outlined in this

paragraph (f).

(2) Facilities may use the following

process to make treatment decisions for

patients who lack decision-making

capacity and have no surrogate. For

treatments or procedures that involve

minimal risk, the practitioner must

verify that no authorized surrogate can

be located. The practitioner must

attempt to explain the nature and

purpose of the proposed treatment to

the patient and enter this information in

the medical record. For procedures that

require signature consent, the

practitioner must certify that the patient

has no surrogate. The attending

physician and the Chief of Service (or

his or her designee) must indicate their

approval of the treatment decision in

writing. Any decision to withhold or

withdraw life-sustaining treatment for

such patients must be reviewed by a

multi-disciplinary committee appointed

by the facility Director. The committee

functions as the patient’s advocate and

may not include members of the

treatment team. The committee must

submit its findings and

recommendations in a written report to

the Chief of Staff who must note his or

her approval of the report in writing.

After reviewing the record, the facility

Director may concur with the decision

to withhold or withdraw life support or

request further review by Regional

Counsel.

(g) Special consent situations. In

addition to the other requirements of

this section, additional protections are

required in the following situations.

(1) No patient will undergo any

unusual or extremely hazardous

treatment or procedure, e.g., that which

might result in irreversible brain

damage or sterilization, except as

provided in this paragraph (g). Before

treatment is initiated, the patient or

surrogate must be given adequate

opportunity to consult with

independent specialists, legal counsel or

other interested parties of his or her

choosing. The patient’s or surrogate’s

signature on a VA authorized consent

form must be witnessed by someone

who is not affiliated with the VA healthcare facility, e.g., spouse, legal guardian,

or patient advocate. If a surrogate makes

the treatment decision, a multi-
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Rules and Regulations 53963

disciplinary committee, appointed by

the facility Director, must review that

decision to ensure it is consistent with

the patient’s wishes or in his or her best

interest. The committee functions as the

patient’s advocate and may not include

members of the treatment team. The

committee must submit its findings and

recommendations in a written report to

the facility Director. The Director may

authorize treatment consistent with the

surrogate’s decision or request that a

special guardian for health care be

appointed to make the treatment

decision.

(2) Administration of psychotropic

medication to an involuntarily

committed patient against his or her

will must meet the following

requirements. The patient or surrogate

must be allowed to consult with

independent specialists, legal counsel or

other interested parties concerning the

treatment with psychotropic

medication. Any recommendation to

administer or continue medication

against the patient’s or surrogate’s will

must be reviewed by a multidisciplinary committee appointed by

the facility Director for this purpose.

This committee must include a

psychiatrist or a physician who has

psychopharmacology privileges. The

facility Director must concur with the

committee’s recommendation to

administer psychotropic medications

contrary to the patient’s or surrogate’s

wishes. Continued therapy with

psychotropic medication must be

reviewed every 30 days. The patient (or

a representative on the patient’s behalf)

may appeal the treatment decision to a

court of appropriate jurisdiction.

(3) If a proposed course of treatment

or procedure involves approved medical

research in whole or in part, the patient

or representative shall be advised of

this. Informed consent shall be obtained

specifically for the administration or

performance of that aspect of the

treatment or procedure that involves

research. Such consent shall be in

addition to that obtained for the

administration or performance of the

nonresearch aspect of the treatment or

procedure and must meet the

requirements for informed consent set

forth in 38 CFR Part 16, Protection of

Human Subjects.

(4) Testing for Human

Immunodeficiency Virus (HIV) must be

voluntary and must be conducted only

with the prior informed and (written)

signature consent of the patient or

surrogate. Patients who consent to

testing for HIV must sign VA form 10–

012, ‘‘Consent for HIV Antibody

Testing.’’ This form must be filed in the

patient’s medical record. Testing must

be accompanied by pre-test and posttest counseling.

(The information collection requirements in

this section have been approved by the Office

of Management and Budget under control

number 2900–0583)

(Authority: 38 U.S.C. 7331, 7332, 7333)

[FR Doc. 97–27565 Filed 10–16–97; 8:45 am]

BILLING CODE 8320–01–P

DEPARTMENT OF VETERANS

AFFAIRS

38 CFR Part 36

RIN 2900–AI16

Loan Guaranty: Credit Standards

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

SUMMARY: This document amends the

Department of Veterans Affairs (VA)

loan guaranty regulations regarding

credit standards used by lenders to

evaluate the creditworthiness of

veteran-borrowers for home loans. VA is

committed to regular review and

revision of the standards used to

determine the creditworthiness of

veteran-applicants as issues arise and as

the mortgage industry changes. These

changes are designed to keep VA in step

with the rest of the home mortgage

industry, at least to an extent

appropriate for a Government benefitrelated mortgage program.

DATES: Effective Date: November 17,

1997.

FOR FURTHER INFORMATION CONTACT: Ms.

Judith Caden, Assistant Director for

Loan Policy (264), Loan Guaranty

Service, Veterans Benefits

Administration, Department of Veterans

Affairs, 810 Vermont Avenue, NW,

Washington, DC 20420, (202) 273–7368.

SUPPLEMENTARY INFORMATION: In a

document published in the Federal

Register on May 7, 1997 (62 FR 24874),

VA proposed to amend its loan guaranty

credit standards, set forth at 38 CFR

36.4337, used by lenders to evaluate the

creditworthiness of veteran-borrowers

for home loans. Based on the rationale

set forth in the proposed rule and this

document the proposed changes are

adopted, with differences explained

below.

Please refer to the May 7, 1997,

Federal Register for a complete

discussion of the proposed

amendments. Interested persons were

given 60 days to submit comments. The

comment period ended July 7, 1997. VA

received three comments regarding the

proposed changes.

The first commenter, an association

which represents mortgage lenders,

supported adoption of the proposed

rule.

The second commenter, an

association representing home builders,

suggested that the language of proposed

paragraph 36.4337(c)(5)(xii) be changed

to accept other forms of tax credits in

addition to those for child care as

compensating factors. This was

intended to cover child care tax credits

of a continuing nature. VA agrees that

there is no basis for distinguishing child

care tax credits from other forms of tax

credits of a continuing nature. The final

rule at paragraph 36.4337(c)(5)(xii) is

changed accordingly.

The third commenter, a lender who

actively participates in the VA

Guaranteed Home Loan Program,

expressed general support for the

proposed rule, but raised several

concerns. The first concern related to

proposed paragraphs 36.4337 (d) and (f),

which would allow lenders to ‘‘gross

up’’ income to account for the impact of

tax-free income on the debt-to-incomeratio when underwriting a loan. The

commenter observed that the ‘‘grossingup’’ calculations should be kept simple

and suggested that it would be helpful

if VA could provide an example or

formula of how ‘‘grossing up’’

calculations are performed. We agree

that the ‘‘grossing up’’ calculation needs

to be simple and understandable and

believe that the revised regulations on

this point are simple and

understandable. Also, we note that the

term ‘‘grossing up’’ is well understood

by the mortgage industry. The mortgage

industry has been ‘‘grossing up’’ income

on conventional loans for many years.

Under paragraph 36.4337(f)(4), the

adjustment may be made by using

current income tax tables. The lender

need only determine what amount of

income, when taxed at the proper

combination of State and Federal rates,

would yield an after-tax income

equivalent to the tax-free income the

veteran actually receives. The purpose

of allowing lenders to ‘‘gross up’’

income is to enable the lender to

calculate the debt-to-income ratio as if

the veteran’s tax-free income were

‘‘after-tax’’ income. The arithmetic will

vary by State, depending on various

State and local tax rates. The lender

would then use this amount to calculate

the veteran’s debt-to-income ratio, while

using the actual tax-free income to

calculate the residual income.

For example, in a State with no

income tax, the lender could simply

show that, for a veteran in the 15

percent Federal income tax bracket,

$1,000 of tax-free income is equivalent