25894 Federal Register / Vol. 65, No. 87 / Thursday, May 4, 2000 / Proposed Rules

LIBRARY OF CONGRESS

Copyright Office

37 CFR Part 201

[Docket No. RM 99–7C]

Exemption to Prohibition on

Circumvention of Copyright Protection

Systems for Access Control

Technologies

AGENCY: Copyright Office, Library of

Congress.

ACTION: Announcement of change in

time a hearing will begin.

SUMMARY: The Copyright Office of the

Library of Congress announces a change

in the time of a public hearing on the

possible exemptions to the prohibition

against circumvention of technological

measures that control access to

copyrighted works to be held in

Stanford, California on May 18, 2000.

The date and location of the hearing

remain unchanged

DATES: May 4, 2000.

FOR FURTHER INFORMATION CONTACT:

Robert Kasunic, Senior Attorney, Office

of the General Counsel, Copyright GC/

I&R, P.O. Box 70400, Southwest Station,

Washington, D.C. 20024. Telephone:

(202) 707–8380. Telefax: (202) 707–

8366.

SUPPLEMENTARY INFORMATION: The

Copyright Office is conducting a

rulemaking pursuant to 17 U.S.C.

1201(a)(1), which provides that the

Librarian of Congress may exempt

certain classes of works from the

prohibition against circumventing a

technological measure that controls

access to a copyrighted work. On March

17, 2000 (65 FR 14505), the Office

published a notice which announced

that public hearings relative to the

rulemaking would be held in

Washington, DC on May 2–4, 2000, and

in Stanford, California on May 18 and

19, 2000. A schedule for all of the

hearings can be found on the office’s

website at www.loc.gov/copyright/

1201/hearing.html. The Stanford

hearings were scheduled to be held from

9:30 a.m. to 6:00 p.m. The hearing on

May 18, 2000, is now scheduled to

begin at 2:00 p.m. rather than 9:30 a.m.

Dated: May 1, 2000.

Marilyn J. Kretsinger,

Assistant General Counsel.

[FR Doc. 00–11151 Filed 5–3–00; 8:45 am]

BILLING CODE 1410–30–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 141 and 142

[FRL–6587–8]

RIN 2040–AA97

Ground Water Rule Public Meeting

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of public meeting.

SUMMARY: Notice is hereby given that

the Environmental Protection Agency

(EPA) is holding a public meeting on

May 18, 2000 in the EPA auditorium in

Washington, DC. The meeting will

provide a description and summary of

the proposed Ground Water Rule (GWR)

to be published in the Federal Register

on May 10, 2000.

EPA is inviting all interested members

of the public to attend the meeting. EPA

is instituting an open door policy to

allow any member of the public to

attend the meeting for any length of

time. Approximately 150 seats will be

available for the public. Seats will be

available on a first-come, first served

basis.

DATES: The meeting will start at 2 PM

on May 18, 2000 and will adjourn at

4:00 PM.

ADDRESSES: The meeting will be held in

the EPA auditorium located at 401 M

Street SW, Washington, DC 20460.

For information about the meeting,

contact the Office of Ground Water and

Drinking Water (MC 4607), U.S.

Environmental Protection Agency, 1200

Pennsylvania Ave. NW, Washington, DC

20460; telephone (202) 260–3309. The

GWR proposal, GWR fact sheet, and

GWR draft implementation guidance

may be obtained from www.epa.gov/

safewater or by calling the Safe Drinking

Water Hotline, telephone (800) 426–

4791.

FOR FURTHER INFORMATION CONTACT: For

general information, contact the Safe

Drinking Water Hotline, telephone (800)

426–4791. The Safe Drinking Water

Hotline is open Monday through Friday,

excluding Federal holidays, from 9 a.m.

to 5:30 p.m. Eastern Time.

Dated: April 28, 2000.

Cynthia C. Dougherty,

Director, Office of Ground Water and Drinking

Water.

[FR Doc. 00–11136 Filed 5–3–00; 8:45 am]

BILLING CODE 6560–50–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

42 CFR Part 9

Opioid Drugs in Maintenance and

Detoxification Treatment of Opiate

Addiction; Conditions for the Use of

Partial Agonists Treatment

Medications in the Office-Based

Treatment of Opiate Addiction

AGENCY: Substance Abuse and Mental

Health Services Administration, HHS.

ACTION: Notice of intent to issue

regulations.

SUMMARY: The Secretary, Department of

Health and Human Services, is

announcing its intent to develop and

issue regulations to address the use of

approved partial agonist treatment

medications in the ‘‘office-based’’

treatment of opiate addiction.

FOR FURTHER INFORMATION CONTACT:

Nicholas Reuter, Center for Substance

Abuse Treatment (CSAT), SAMHSA,

5600 Fishers Lane, Rockville, MD

20857, 301–443–0457.

SUPPLEMENTARY INFORMATION:

I. Background

Section 4 of the Comprehensive Drug

Abuse Prevention and Control Act of

1970 (Pub. L. 91–513) requires the

Secretary of Health and Human Services

(the Secretary) to determine the

appropriate methods of professional

practice for the medical treatment of

narcotic addiction. In addition, the

Narcotic Addict Treatment Act of 1974

(Pub. L. 93–281) amended the

Controlled Substances Act (21 U.S.C.

823) to require that practitioners who

wish to dispense narcotic drugs to

individuals for the maintenance

treatment or detoxification treatment of

narcotic addiction must be registered

annually with the Department of Justice,

Drug Enforcement Administration

(DEA). Registration depends, in part,

upon a determination by the Secretary

that the applicant is qualified, under

treatment standards established by the

Secretary, to provide such treatment. In

addition, the applicant must comply

with standards established by the

Secretary (after consultation with DEA)

respecting the quantities of narcotic

drugs that may be provided for

unsupervised use by individuals in such

treatment. Finally, the applicant must

comply with standards established by

DEA respecting security of stocks of

narcotic drugs used

Federal Register / Vol. 65, No. 87 / Thursday, May 4, 2000 / Proposed Rules 25895

for such treatment and maintenance of

records on such drugs.

These statutory mandates have been

reflected in treatment regulations that

have been enforced by the Food and

Drug Administration (FDA) since 1972.

EDA has approved over 900 ‘‘narcotic

treatment programs’’ under these

regulations. Up until 1993, methadone

was the only narcotic treatment

medication approved for use under

these regulations. In 1993, the

regulations were revised to add

regulatory standards for the use of levoalpha-acetyl-methadol (LAAM),

following review and approval of a New

Drug Application (NDA) for this use by

FDA.

FDA has received and is reviewing

NDAs for two new narcotic treatment

medications, buprenorphine and

buprenorphine/naloxone

(buprenorphine/nx). If approved, both

products must be the subject of

treatment standards.

The Secretary recognizes that partial

or mixed agonist medications, are

different than full agonists, such as

methadone and LAAM. The Secretary

has, therefore, determined that these

differences warrant a different treatment

standard model:

The Secretary notes that there are new

medications under development for the

treatment of opioid addiction. While still

under investigation and review, it is

conceivable that these new medications will

present safety and effectiveness profiles that

differ from the existing approved treatment

medications, methadone and LAAM. A new

medication, for example, could rely on weak

or partial agonist properties or on mixed

agonist-antagonist properties, with

pharmacokinetic and pharmacodynamic

properties that would minimize the risk of

deliberate abuse through injection and, in

turn, would minimize the overall risk of

diversion. As such, it may be appropriate to

tailor the Federal opioid treatment standards

to the specific characteristics of these future

medications. (See Federal Register, July 22,

1999, 64 FR 39810.)

Because of their special

characteristics, partial agonist

medications should be the subject of

specific treatment standards. Indeed,

partial agonist medications’

pharmacological properties and safety

profiles warrant a new paradigm in

narcotic addiction treatment, officebased treatment. Therefore, the

Department of Health and Human

Services is announcing its intent to

develop and issue a proposed rule that

will address the use of partial agonist

treatment medications in the officebased treatment of narcotic addiction.

II. Office-Based Treatment of Narcotic

Addiction

The Department is preparing a

proposed rule for publication in the

near future that will address the use of

approved narcotic partial agonist

treatment drugs controlled in Schedules

III–V, in office-based settings. The

proposed rule will include standards

and procedures for determining the

training and experience necessary to

safely and effectively treat opiate

addicts with partial agonist treatment

medications in an office-based setting.

This may include limits on the number

of patients that may be treated by any

one office-based physician. In addition,

the proposal will include standards that

relate to medical and psychosocial

services, including counseling, that

should be available to patients that are

determined to need them. The proposed

rule will include standards respecting

the quantities of medications that may

be prescribed, dispensed or

administered to patients for

unsupervised use.

In anticipation of the availability of

partial agonist treatment medications, a

Subcommittee on Buprenorphine was

formed as part of SAMHSA’s Center for

Substance Abuse Treatment (CSAT)

National Advisory Council. The

Subcommittee considered the available

research base on buprenorphine, officebased settings, and Federal oversight

during two public meetings. The full

CSAT National Advisory Council, after

deliberation, adopted the

Subcommittee’s findings and

recommendations which were

subsequently conveyed to CSAT by the

Council on June 11, 1999, in the form

of a comprehensive report. The report

may be obtained by notifying the CSAT

contact listed above. The report is also

available at the SAMHSA website

(www.samhsa.gov).

SAMHSA believes that a key feature

of office-based treatment will be the

ability of the office-based physician to

prescribe partial agonist treatment

medications to patients in treatment.

Without the ability to prescribe, officebased physicians would have to store

and dispense medications directly to

patients. These practices could be

expensive and impractical for the

patient and office-based physician.

Current regulations enforced by the

Drug Enforcement Administration (21

CFR 1306.07(a)) prohibit prescriptions

for narcotics drugs used in the treatment

of narcotic addiction. However, DEA is

preparing a separate proposed rule to

rescind this prohibition as it pertains to

narcotic treatment drugs controlled in

Schedules III–V.

III. References

1. Using Buprenorphine for OfficeBased Treatment of Opiate Addiction,

Recommendations to the Center for

Substance Abuse Treatment.

Dated: December 29, 1999.

Nelba Chavez,

Administrator, Substance Abuse and Mental

Health Services Administration.

Dated: March 30, 1999.

Donna E. Shalala,

Secretary, Health and Human Services.

[FR Doc. 00–10969 Filed 5–3–00; 8:45 am]

BILLING CODE 4162–20–M

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 73

[MM Docket No. 00–44; FCC 00–93]

Extension of the Filing Requirement

for Children’s Television Programming

Reports (FCC Form 398)

AGENCY: Federal Communications

Commission.

ACTION: Proposed rule.

SUMMARY: The document proposes to

amend the FCC’s rules to continue

indefinitely the requirement that

commercial broadcast television

licensees file with the Commission, on

an annual basis, their quarterly

Children’s Television Programming

Reports (FCC Form 398). The

Commission’s rules currently state that

such reports shall be filed on an annual

basis for an experimental period of three

years, from January 1998 through

January 2000. Continuation of the

annual filing requirement will permit

the Commission to continue to enforce

the Children’s Television Act of 1990

(‘‘CTA’’), and its rules implementing the

CTA, by monitoring the amount and

quality of educational television

programming for children and industry

compliance with the FCC’s children’s

educational programming requirements.

DATES: Comments are due on or before

June 12, 2000; reply comments are due

on or before July 12, 2000.

ADDRESSES: Federal Communications

Commission, 445 12th Street, SW, Room

TW–A306, Washington, DC 20554.

FOR FURTHER INFORMATION CONTACT: Kim

Matthews, Policy and Rules Division,

Mass Media Bureau, (202) 418–2154.

SUPPLEMENTARY INFORMATION: This is a

summary of the Commission’s Notice of

Proposed Rulemaking (‘‘NPRM’’), MM

00–44; FCC 00–93, adopted March 9,

2000; released April 6, 2000. The full