Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Rules and Regulations 53959

October 3, 1996, and will remove the

exemption from regulation for

pseudoephedrine and

phenylpropanolamine drug products

effective October 3, 1997, making

persons who distribute the respective

products subject to the registration

requirement on those dates.

Determination of the appropriate

procedures and amendment of the

regulations to set the new fees will

extend well beyond those deadlines for

registration. Therefore, DEA is waiving

a portion of the application fee for new

registration. It would be inconsistent

with the principles of OMB Circular A–

25 to charge a fee for a specific service,

e.g., completing the processing of the

application and the pre-registration

investigation, knowing that the costs

and resources to be expended in

providing that service will change.

Persons who have already applied for

registration to distribute regulated drug

products and paid the existing fee will

be refunded the amount of fee that is

being waived.

The Acting Deputy Administrator of

DEA is, therefore, waiving that portion

of the fee for registration as a non-retail

distributor of regulated drug products

associated with the 12 hours of

investigator time allocated for the onsite visit and travel time, which, at

$39.92 per hour, amounts to $479.00

(See 59 FR 51892). The remaining

administrative costs and time allotted

for background checks and reports will

continue. Thus the fee for an initial

application for registration as a nonretail distributor of regulated drug

products is $116.00. That fee will

remain in effect until the review of the

registration procedures has been

completed and a determination has been

made regarding how the processing of

such applications and the preregistration investigation will be carried

out. At that time, a notice will be

published in the Federal Register

regarding the procedures to be followed

and fee that will be required for future

applications.

This waiver applies only to applicants

for registration as non-retail distributors

of regulated drug products. All other

applicants remain subject to the full

fees, as set forth in Title 21, Code of

Federal Regulations, Section 1309.11.

As noted earlier, persons who have

already submitted an application for

registration as a non-retail distributor of

regulated drug products and paid the

full fee will be provided with a $479.00

refund.

Dated: October 8, 1997.

James S. Milford,

Acting Deputy Administrator.

[FR Doc. 97–27452 Filed 10–16–97; 8:45 am]

BILLING CODE 4410–09–M

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1309 and 1310

[DEA Number 168I]

RIN 1117–AA46

Temporary Exemption From Chemical

Registration for Distributors of

Pseudoephedrine and

Phenylpropanolamine Products

AGENCY: Drug Enforcement

Administration (DEA), Justice.

ACTION: Interim Rule with request for

comments.

SUMMARY: DEA is amending its

regulations to provide a temporary

exemption from registration for persons

who distribute pseudoephedrine and

phenylpropanolamine drug products.

The Comprehensive Methamphetamine

Control Act of 1996 (MCA) amends the

Controlled Substances Act of 1970

(CSA) to require that, effective October

3, 1997, persons who distribute these

drug products shall be subject to the

chemical registration requirement. To

avoid interruption in the legitimate

distribution of the drug products

pending promulgation of final

regulations and issuance of

registrations, DEA is amending its

regulations to provide certain temporary

exemptions from the registration

requirement.

DATES: October 17, 1997. Persons

required to register to handle

pseudoephedrine or

phenylpropanolamine must submit an

application on or before December 3,

1997, in order to continue their

activities pending final action by DEA

on their application. Written comments

or objections must be submitted on or

before December 16, 1997.

ADDRESSES: Comments and objections

should be submitted in quintuplicate to

the Deputy Administrator, Drug

Enforcement Administration,

Washington, DC 20537, Attention: DEA

Federal Register Representative/CCR.

FOR FURTHER INFORMATION CONTACT: G.

Thomas Gitchel, Chief, Liaison and

Policy Section, Office of Diversion

Control, Drug Enforcement

Administration, Washington, DC 20537,

Telephone (202) 307–7297.

SUPPLEMENTARY INFORMATION: The

Comprehensive Methamphetamine

Control Act of 1996 (MCA) requires that,

effective October 3, 1997,

pseudoephedrine and

phenylpropanolamine drug products

(regulated drug products) will become

subject to regulation as List I chemicals.

Under this new requirement, any person

who wishes to distribute, import, or

export these products must first obtain

a DEA chemical registration. Because

full implementation of this provision

and issuance of the registrations will not

be possible prior to the October 3, 1997

deadline, DEA is establishing temporary

exemptions from the registration

requirement for persons handling

regulated drug products to allow for

continuation of legitimate commerce in

the products. In addition, the existing

exemptions from chemical registration

for persons registered with DEA to

handle controlled substances, which is

contained in 21 CFR 1309.25, and for

distributors of prescription drug

products, which is contained in 21 CFR

1309.28, will also apply to the regulated

drug products.

The first exemption applies to retail

distributors of regulated drug products.

A single transaction limit of 24 grams

has been established by the MCA for

retail distributions of regulated drug

products. Consistent with previous

proposals regarding the regulation of

retail distributions of drug products that

contain List I chemicals, DEA is

temporarily exempting retail

distributors from the registration

requirement. Under this exemption,

retail distributors will not be required to

obtain a registration if they engage

exclusively in distributions of regulated

drug products below the 24-gram limit

in a single transaction for legitimate

medical use, either directly to walk-in

customers or in face-to-face transactions

by direct sales. This exemption is set

out in 21 CFR 1309.29(b).

The second exemption applies to

those persons who are required to

obtain a registration. Any such person

who submits an application for

registration for activities involving

regulated drug products on or before

December 3, 1997 will be exempt from

the registration requirement for their

lawful activities with regulated drug

products until the Administration has

taken final action with respect to that

application. This exemption is set out in

21 CFR 1310.09.

DEA recognizes that, unlike the

second exemption, which provides a

general benefit to all affected persons,

the first exemption is limited in its

application. Therefore, while the

regulatory changes in this notice take
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