77328 Federal Register / Vol. 65, No. 238 / Monday, December 11, 2000 / Proposed Rules

1This order shall not become effective unless and

until the requirements of § 900.14 of the rules of

practice and procedure governing proceedings to

formulate marketing agreements and marketing

orders have been met.

List of Subjects in 7 CFR Part 930

Marketing agreements, Tart cherries,

Reporting and recordkeeping

requirements.

Dated: December 5, 2000.

Kenneth C. Clayton,

Associate Administrator, Agricultural

Marketing Service.

Order Amending the Order Regulating

the Handling of Tart Cherries Grown in

the States of Michigan, New York,

Pennsylvania, Oregon, Utah,

Washington, and Wisconsin 1

Findings and Determinations

Thefindings and determinations

hereinafter set forth are supplementary

and in addition to the findings and

determinations previously made in

connection with the issuance of the

order; and all of said previous findings

and determinations are hereby ratified

and affirmed, except insofar as such

findings and determinations may be in

conflict with the findings and

determinations set forth herein.

(a) Findings and Determinations Upon

the Basis of the Hearing Record.

Pursuant to the provisions of the

Agricultural Marketing Agreement Act

of 1937, as amended (7 U.S.C. 601 et

seq.), and the applicable rules of

practice and procedure effective

thereunder (7 CFR part 900), a public

hearing was held upon the proposed

amendments to the Marketing

Agreement and Order No. 930 (7 CFR

part 930), regulating the handling of tart

cherries Grown in the States of

Michigan, New York, Pennsylvania,

Oregon, Utah, Washington, and

Wisconsin.

Upon the basis of the evidence

introduced at such hearing and the

record thereof, it is found that:

(1) The marketing agreement and

order, as hereby proposed to be

amended, and all of the terms and

conditions thereof, will tend to

effectuate the declared policy of the Act;

(2) The marketing agreement and

order, as hereby proposed to be

amended, regulate the handling of tart

cherries grown in the production area in

the same manner as, and is applicable

only to persons in the respective classes

of commercial and industrial activity

specified in the marketing order upon

which hearings have been held;

(3) The marketing agreement and

order, as hereby proposed to be

amended, are limited in application to

the smallest regional production area

which is practicable, consistent with

carrying out the declared policy of the

Act, and the issuance of several orders

applicable to subdivisions of the

production area would not effectively

carry out the declared policy of the Act;

and

(4) The marketing agreement and

order, as hereby proposed to be

amended, prescribe, insofar as

practicable, such different terms

applicable to different parts of the

production area as are necessary to give

due recognition to the differences in the

production and marketing of tart

cherries grown in the production area;

and

(5) All handling of tart cherries grown

in the production area is in the current

of interstate or foreign commerce or

directly burdens, obstructs, or affects

such commerce.

Order Relative to Handling

It is therefore ordered, That on and

after the effective date hereof, all

handling of tart cherries grown in the

States of Michigan, New York,

Pennsylvania, Oregon, Utah,

Washington and Wisconsin, shall be in

conformity to, and in compliance with,

the terms and conditions of the said

order as hereby proposed to be amended

as follows:

The provisions of the proposed

marketing agreement and the order

amending the order contained in the

Recommended Decision issued by the

Administrator on December 29, 1999,

and published in the Federal Register

on January 5, 2000, shall be and are the

terms and provisions of this order

amending the order and are set forth in

full herein.

PART 930—TART CHERRIES GROWN

IN THE STATES OF MICHIGAN, NEW

YORK, PENNSYLVANIA, OREGON,

UTAH, WASHINGTON, AND

WISCONSIN

1. The authority citation for 7 CFR

part 930 continues to read as follows:

Authority: 7 U.S.C. 601–674.

2. In part 930, § 930.16 is revised to

read as follows:

§ 930.16 Sales constituency.

Sales constituency means a common

marketing organization or brokerage

firm or individual representing a group

of handlers and growers. An

organization which receives

consignments of cherries and does not

direct where the consigned cherries are

sold is not a sales constituency.

3. In § 930.50, paragraph (a) is revised

to read as follows:

§ 930.50 Marketing policy.

(a) Optimum supply. On or about July

1 of each crop year, the Board shall hold

a meeting to review sales data,

inventory data, current crop forecasts

and market conditions in order to

establish an optimum supply level for

the crop year. The optimum supply

volume shall be calculated as 100

percent of the average sales of the prior

three years, reduced by the average sales

that represent dispositions of restricted

percentage cherries qualifying for

diversion credit for the same three

years, unless the Board determines that

it is necessary to recommend otherwise

with respect to sales of restricted

percentage cherries, to which shall be

added a desirable carryout inventory not

to exceed 20 million pounds or such

other amount as the Board, with the

approval of the Secretary, may establish.

This optimum supply volume shall be

announced by the Board in accordance

with paragraph (h) of this section.

* * * * *

[FR Doc. 00–31455 Filed 12–8–00; 8:45 am]

BILLING CODE 3410–02–P

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA–209P]

RIN 1117–AA59

Schedule of Controlled Substances:

Placement of Dichloralphenazone Into

Schedule IV

AGENCY: Drug Enforcement

Administration (DEA), Department of

Justice.

ACTION: Notice of proposed rulemaking.

SUMMARY: This proposed rule is issued

by the Deputy Administrator of the Drug

Enforcement Administration (DEA) to

expressly list dichloralphenazone as a

Schedule IV controlled substance under

the Controlled Substances Act (CSA).

This proposed action is based on the

DEA’s interpretation that

dichloralphenazone is a compound

containing chloral hydrate, a Schedule

IV controlled substance under 21 CFR

part 1308; by definition,

dichloralphenazone is also a Schedule

IV substance. If finalized, this action

will impose the regulatory controls and

criminal sanctions of Schedule IV on

those persons who handle

dichloralphenazone or products

containing dichloralphenazone.

DATES: Comments must be received by

February 9, 2001.

Federal Register / Vol. 65, No. 238 / Monday, December 11, 2000 / Proposed Rules 77329

ADDRESSES: Comments should be

submitted in triplicate to the Deputy

Administrator, Drug Enforcement

Administration, Washington, D.C.

20537; Attention: DEA Federal Register

Representative/CCR.

FOR FURTHER INFORMATION CONTACT:

Frank Sapienza, Chief, Drug and

Chemical Evaluation Section, Drug

Enforcement Administration,

Washington, D.C. 20537, (202) 307–

7183.

SUPPLEMENTARY INFORMATION:

What Is Dichloralphenazone?

Dichloralphenazone (also known as

dichloralantipyrine) is a compound

containing two molecules of chloral

hydrate (2,2,2-trichloro-1,1-ethanediol)

and one molecule of phenazone (1,2-

dihydro-1,5-dimethyl-2-phenyl3Hpyrazol-3-one); CAS No. 480–30–8.

Dichloralphenazone is a sedative

typically used in combination with

isometheptene mucate and

acetaminophen in formulating

prescription pharmaceuticals for the

relief of tension and vascular headaches.

When dichloralphenazone is

administered or placed in an aqueous

solution (a liquid preparation of any

substance dissolved in water) it

dissociates to form chloral hydrate and

phenazone.

Why Is DEA Issuing This Notice?

Schedule IV controlled substances are

listed in 21 CFR 1308.14. Section

1308.14(c) lists 49 depressants,

including chloral hydrate, that are

Schedule IV controlled substances. The

first sentence of 21 CFR 1308.14(c)

states that the category of Schedule IV

depressants includes ‘‘any material,

compound, mixture, or preparation

which contains any quantity of’’ the

substances listed in the section. Since

dichloralphenazone is a compound

containing chloral hydrate, it is likewise

a Schedule IV depressant.

It has come to the attention of the

DEA that a large portion of the

pharmaceutical industry that handles

dichloralphenazone or products

containing dichloralphenazone has

failed to recognize that this is a

compound containing chloral hydrate.

To clarify this situation, the Deputy

Administrator is publishing this notice

proposing that dichloralphenazone be

expressly listed as a Schedule IV

depressant and assigned a specific DEA

control number.

What Is the Effect of This Notice?

This notice clarifies the DEA’s

position regarding the control status for

dichloralphenazone. This proposed

rule, if finalized, would specifically list

dichloralphenazone as a Schedule IV

depressant. In addition, this notice

provides an opportunity for interested

persons to comment, in writing, with

regard to any information they feel may

have a bearing on this matter.

What Regulatory Requirements Will Be

Applied to Handlers of

Dichloralphenazone?

Persons currently involved with the

manufacture or handling of this

substance are not expected to comply

with DEA regulations applicable to a

Schedule IV substance until such time

as a final rule is published in the

Federal Register. If/When a final rule is

published in the Federal Register,

persons who manufacture, distribute,

dispense, import, export, store or engage

in research with dichloralphenazone

will be provided with delayed dates for

compliance with Federal regulations in

order to avoid imposing any special

hardship. Upon publication of a final

rule, the applicable regulations and

amount of time for compliance will be

as follows:

1. Registration

Any person who manufactures,

distributes, dispenses, imports or

exports dichloralphenazone or who

engages in research or conducts

instructional activities or chemical

analysis with respect to this

preparation, or who proposes to engage

in such activities, must be registered to

conduct such activities in accordance

with 21 CFR part 1301 on and after 30

days from date of the publication of the

final rule in the Federal Register. Any

person who is currently engaged in any

of the above activities must submit an

application for registration by 30 days

from date of publication of the final rule

in the Federal Register. Any such

person may then continue their

activities until the DEA has approved or

denied that application.

2. Disposal of Stocks

Any person who elects not to obtain

a Schedule IV registration or is not

entitled to such registration must

surrender all quantities of currently

held dichloralphenazone in accordance

with procedures outlined in 21 CFR

1307.21 on or before 30 days from date

of publication of the final rule in the

Federal Register, or may transfer all

quantities of currently held

dichloralphenazone to a person

registered under the CSA and

authorized to possess Schedule IV

control substances on or before 30 days

from date of publication of the final rule

in the Federal Register.

Dichloralphenazone to be surrendered

to DEA must be listed on a DEA Form

41, ‘‘Inventory of Controlled Substances

Surrendered for Destruction.’’ DEA

Form 41 and instructions can be

obtained from the nearest DEA office.

3. Security

Dichloralphenazone must be

manufactured, distributed and stored in

accordance with 21 CFR 1301.71,

1301.72(b), (c), and (d), 1301.73,

1301.74, 1301.75(b) and (c) and 1301.76

after date of publication of the final rule

in the Federal Register.

4. Labeling and Packaging

All commercial containers of

dichloralphenazone that are packaged

on or after 180 days from date of

publication of the final rule in the

Federal Register must have the

appropriate Schedule IV labeling and

packaging as required by 21 CFR

1302.03–1302.07. Commercial

containers of dichloralphenazone

packaged before 180 days from date of

publication of the final rule in the

Federal Register and not meeting the

requirements specified in 21 CFR

1302.03–1302.07 may be distributed

until 270 days from date of publication

of the final rule in the Federal Register.

On and after 270 days from date of

publication of the final rule in the

Federal Register all commercial

containers of dichloralphenazone must

bear the CIV labels as specified in 21

CFR 1302.03–1302.07.

5. Inventory

Registrants possessing

dichloralphenazone are required to take

inventories pursuant to 21 CFR 1304.03,

1304.04 and 1304.11 after publication of

the final rule in the Federal Register.

6. Records

All registrants must keep records

pursuant to 21 CFR 1304.03, 1304.04

and 1304.21–1304.23 after publication

of the final rule in the Federal Register.

7. Prescriptions

All prescriptions for

dichloralphenazone or prescriptions for

products containing dichloralphenazone

are to be issued pursuant to 21 CFR

1306.03–1306.06 and 1306.21–1306.26.

All prescriptions for

dichloralphenazone or products

containing dichloralphenazone issued

on or before 60 days from date of

publication of the final rule in the

Federal Register, if authorized for

refilling, shall, as of that date, be limited

to five refills and shall not be refilled

after 180 days from date of publication

of the final rule in the Federal Register.

77330 Federal Register / Vol. 65, No. 238 / Monday, December 11, 2000 / Proposed Rules

8. Importation and Exportation

All importation and exportation of

dichloralphenazone shall be in

compliance with 21 CFR part 1312 after

publication of the final rule in the

Federal Register.

9. Criminal Liability

Any activity with dichloralphenazone

not authorized by, or in violation of, the

CSA or the Controlled Substances

Import and Export Act shall be unlawful

on or after 30 days from date of

publication of the final rule in the

Federal Register, except as authorized

in that rule.

Regulatory Certifications

Regulatory Flexibility Act

The Deputy Administrator hereby

certifies that this rulemaking has been

drafted in a manner consistent with the

principles of the Regulatory Flexibility

Act (5 U.S.C. 601 et seq.). It will not

have a significant economic impact on

a substantial number of small business

entities. Most handlers of

dichloralphenazone or prescription

products containing this substance are

already registered to handle controlled

substances and are subject to the

regulatory requirements of the CSA.

Executive Order 12866

The Deputy Administrator further

certifies that this rulemaking has been

drafted in accordance with the

principles in Executive Order 12866

Section 1(b). DEA has determined that

this is not a significant rulemaking

action. Therefore, this action has not

been reviewed by the Office of

Management and Budget.

Executive Order 12988

This regulation meets the applicable

standards set forth in Sections 3(a) and

3(b)(2) of Executive Order 12988 Civil

Justice Reform.

Executive Order 13132

This rulemaking does not preempt or

modify any provision of state law; nor

does it impose enforcement

responsibilities on any state; nor does it

diminish the power of any state to

enforce its own laws. Accordingly, this

rulemaking does not have federalism

implications warranting the application

of Executive order 13132. Unfunded

Mandates Reform Act of 1995

This rule will not result in the

expenditure by State, local, and tribal

governments, in the aggregate, or by the

private sector, of $100,000,000 or more

in any one year, and will not

significantly or uniquely affect small

governments. Therefore, no actions were

deemed necessary under the provisions

of the Unfunded Mandates Reform Act

of 1995.

Small Business Regulatory Enforcement

Fairness Act of 1996

This rule is not a major rule as

defined by Section 804 of the Small

Business Regulatory Enforcement

Fairness Act of 1996. This rule will not

result in an annual effect on the

economy of $100,000,000 or more; a

major increase in costs or prices; or

significant adverse effects on

competition, employment, investment,

productivity, innovation, or on the

ability of United States-based

companies to compete with foreignbased companies in domestic and

export markets.

Plain Language Instructions

The Drug Enforcement

Administration makes every effort to

write clearly. If you have suggestions as

to how to improve the clarity of this

regulation, call or write Patricia M.

Good, Chief, Liaison and Policy Section,

Office of Diversion Control, Drug

Enforcement Administration,

Washington, D.C. 20537, telephone

(202) 307–7297.

List of Subjects in 21 CFR Part 1308

Administrative practice and

procedure, Drug traffic control,

Narcotics, prescription drugs.

Under the authority vested in the

Attorney General by Section 201(a) of

the CSA [21 U.S.C. 811(a)], and

delegated to the Administrator of the

DEA by the Department of Justice

regulations (21 CFR 0.100), and

redelegated to the Deputy Administrator

of the DEA pursuant to 28 CFR 0.104,

the Deputy Administrator hereby

proposes that 21 CFR part 1308 be

amended as follows:

PART 1308—[AMENDED]

1. The authority citation for 21 CFR

part 1308 continues to read as follows:

Authority: 21 U.S.C. 811, 812, 871(b)

unless otherwise noted.

2. Section 1308.14 is proposed to be

amended by redesignating the existing

paragraphs (c)(15) through (c)(49) as

(c)(16) through (c)(50) and by adding a

new paragraph (c)(15) to read as follows:

§ 1308.14 Schedule IV.

* * * * *

(c) * * *

(15) Dichloralphenazone ................................ 2467

* * * * *

Dated: November 30, 2000.

Julio F. Mercado,

Deputy Administrator.

[FR Doc. 00–31356 Filed 12–8–00; 8:45 am]

BILLING CODE 4410–09–M

LIBRARY OF CONGRESS

Copyright Office

37 CFR Part 201

[Docket No. RM 2000–4B]

Public Performance of Sound

Recordings: Definition of a Service

AGENCY: Copyright Office, Library of

Congress.

ACTION: Petition for rulemaking, denial.

SUMMARY: On April 17, 2000, the Digital

Media Association (‘‘DiMA’’) filed a

petition with the Copyright Office,

requesting that the Office initiate a

rulemaking proceeding to amend the

rule that defines the term ‘‘Service’’ for

purposes of the statutory license

governing the public performance of

sound recordings by means of digital

audio transmissions. DiMA sought an

amendment that, if adopted, would

expand the current definition of the

term ‘‘Service’’ to state that a service is

not interactive simply because it offers

the consumer some degree of influence

over the programming offered by the

webcaster. For the reasons set forth in

this notice, the Copyright Office is

denying the DiMA petition.

DATE: December 11, 2000.

FOR FURTHER INFORMATION CONTACT:

David O. Carson, General Counsel, or

Tanya M. Sandros, Senior Attorney,

Copyright Arbitration Royalty Panel,

P.O. Box 70977, Southwest Station,

Washington, DC 20024. Telephone:

(202) 707–8380. Telefax: (202) 252–

3423.

SUPPLEMENTARY INFORMATION:

Background

Since the enactment of the Digital

Performance Right in Sound Recordings

Act of 1995 (‘‘DPRA’’), Public Law 104–

39, copyright owners of sound

recordings have enjoyed an exclusive

right to perform their copyrighted works

publicly by means of a digital audio

transmission, subject to certain

limitations and exemptions. Among the

limitations on the newly created digital

performance right was the creation of a

statutory license for nonexempt,

noninteractive, digital subscription

transmissions. 17 U.S.C. 114(d)(2), (3)

and (f) (1995).