67172 Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Notices 

years into the federal laws and 

regulations governing drugs of abuse 

and are reflected in published federal 

court decisions and DEA final 

administrative orders. A more detailed 

recitation of these principles, as they 

relate to the dispensing of controlled 

substances for the treatment of pain, 

will be provided in a future Federal 

Register document to be published by 

the agency. 

Nature of This Document and the 

August 2004 FAQ Under the 

Administrative Procedure Act 

This document is a statement of 

policy within the meaning of the 

Administrative Procedure Act (APA). It 

is termed an ‘‘interim’’ statement to 

indicate that a more complete statement 

on the subject will subsequently be 

issued by the agency. (Given the 

misstatements in the August 2004 FAQ, 

and the significant questions DEA has 

received following the withdrawal of 

that document, an immediate 

preliminary explanation is warranted.) 

The APA expressly requires agencies to 

make available to the public and 

publish in the Federal Register

statements of general policy and 

interpretations formulated and adopted 

by the agency. 5 U.S.C. 552(a)(1)(D). 

Further, the APA contemplates that 

agencies shall issue policy statements 

without engaging in the notice-andcomment proceedings that are required 

for legislative rules. 5 U.S.C. 553(b)(A). 

This is because policy statements, 

unlike legislative rules, are not binding. 

Consistent with these APA principles, 

this document does not create any new 

substantive requirements or change the 

rights and duties of any member of the 

public; nor is DEA applying the CSA or 

DEA regulations in a new manner as a 

result of this document. Rather, this 

document provides the public with 

DEA’s policy for ensuring that the law 

administered by the agency relating to 

the subject matter of this document is 

faithfully executed. 

It also bears emphasis that the August 

2004 FAQ was not an official statement 

of the agency. As indicated above, the 

APA requires publication in the Federal 

Register of agency policy statements or 

interpretations of the law administered 

by the agency. The August 2004 FAQ 

was not published by the agency in the 

Federal Register and did not constitute 

an authoritative or official statement of 

the agency.

Dated: November 12, 2004. 

Michele M. Leonhart, 

Deputy Administrator.

[FR Doc. 04–25469 Filed 11–12–04; 10:57 

am] 

BILLING CODE 4410–09–U

DEPARTMENT OF JUSTICE

Drug Enforcement Administration 

[Docket No. DEA–249F] 

Controlled Substances: Final Revised 

Aggregate Production Quotas for 2004

AGENCY: Drug Enforcement 

Administration (DEA), Justice.

ACTION: Notice of final aggregate 

production quotas for 2004. 

SUMMARY: This notice establishes final 

2004 aggregate production quotas for 

controlled substances in Schedules I 

and II of the Controlled Substances Act 

(CSA). The DEA has taken into 

consideration comments received in 

response to a notice of the proposed 

revised aggregate production quotas for 

2004 published September 9, 2004 (69 

FR 54703).

EFFECTIVE DATE: November 16, 2004.

FOR FURTHER INFORMATION CONTACT:

Christine A. Sannerud, Ph.D., Chief, 

Drug and Chemical Evaluation Section, 

Drug Enforcement Administration, 

Washington, DC 20537, Telephone: 

(202) 307–7183.

SUPPLEMENTARY INFORMATION: Section 

306 of the CSA (21 U.S.C. 826) requires 

that the Attorney General establish 

aggregate production quotas for each 

basic class of controlled substance listed 

in Schedules I and II. This 

responsibility has been delegated to the 

Administrator of the DEA by Section 

0.100 of Title 28 of the Code of Federal 

Regulations. The Administrator, in turn, 

has redelegated this function to the 

Deputy Administrator, pursuant to 

Section 0.104 of Title 28 of the Code of 

Federal Regulations. 

The 2004 aggregate production quotas 

represent those quantities of controlled 

substances in Schedules I and II that 

may be produced in the United States in 

2004 to provide adequate supplies of 

each substance for: the estimated 

medical, scientific, research and 

industrial needs of the United States; 

lawful export requirements; and the 

establishment and maintenance of 

reserve stocks (21 U.S.C. 826(a) and 21 

CFR 1303.11). These quotas do not 

include imports of controlled 

substances. 

On September 9, 2004 a notice of the 

proposed revised 2004 aggregate 

production quotas for certain controlled 

substances in Schedules I and II was 

published in the Federal Register (69 

FR 54703). All interested persons were 

invited to comment on or object to these 

proposed aggregate production quotas 

on or before September 30, 2004. 

Eight companies commented on a 

total of 15 Schedules I and II controlled 

substances within the published 

comment period. The companies 

commented that the proposed aggregate 

production quotas for amphetamine, 

codeine (for conversion), fentanyl, 

hydrocodone, hydromorphone, 

marihuana, methamphetamine (for 

conversion), methamphetamine (for 

sale), methylphenidate, morphine (for 

conversion), morphine (for sale), opium, 

tetrahydrocannabinols, and thebaine 

were insufficient to provide for the 

estimated medical, scientific, research, 

and industrial needs of the United 

States, for export requirements and for 

the establishment and maintenance of 

reserve stocks. 

DEA has taken into consideration the 

above comments along with the relevant 

2003 year-end inventories, initial 2004 

manufacturing quotas, 2004 export 

requirements, actual and projected 2004 

sales and use, and research and product 

development requirements. Based on 

this information, the DEA has adjusted 

the final 2004 aggregate production 

quotas for codeine (for conversion), 

fentanyl, hydromorphone, 

methamphetamine (for conversion), 

methamphetamine (for sale), 

methylphenidate, morphine (for sale), 

tetrahydrocannabinols, and thebaine to 

meet the legitimate needs of the United 

States.

Regarding amphetamine, 

hydrocodone, marihuana, morphine (for 

conversion), and opium the DEA has 

determined that the proposed revised 

2004 aggregate production quotas are 

sufficient to meet the current 2004 

estimated medical, scientific, research, 

and industrial needs of the United 

States and to provide for adequate 

inventories. 

Therefore, under the authority vested 

in the Attorney General by Section 306 

of the Controlled Substances Act of 

1970 (21 U.S.C. 826), and delegated to 

the Administrator of the DEA by Section 

0.100 of Title 28 of the Code of Federal 

Regulations, and redelegated to the 

Deputy Administrator, pursuant to 

Section 0.104 of Title 28 of the Code of 

Federal Regulations, the Deputy 

Administrator hereby orders that the 

2004 final aggregate production quotas 

for the following controlled substances, 

expressed in grams of anhydrous acid or 

base, be established as follows:

Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Notices 67173

Basic class Established final 

2004 quotas 

Schedule I

2,5–Dimethoxyamphetamine ......................................................................................................................................................... 3,501,000 

2,5–Dimethoxy-4-ethylamphetamine (DOET) ................................................................................................................................ 2 

2,5–Dimethoxy-4-n-proplythiophenetyhlamine (2C-T–7) ............................................................................................................... 10 

3–Methylfentanyl ............................................................................................................................................................................ 2 

3–Methylthiofentanyl ...................................................................................................................................................................... 2 

3,4–Methylenedioxyamphetamine(MDA) ....................................................................................................................................... 11 

3,4–Methylenedioxy-N-ethylamphetamine (MDEA) ....................................................................................................................... 5 

3,4–Methylenedioxymethamphetamine (MDMA) ........................................................................................................................... 16 

3,4,5–Trimethoxyamphetamine ..................................................................................................................................................... 2 

4–Bromo-2,5–Dimethoxyamphetamine (DOB) .............................................................................................................................. 2 

4–Bromo-2,5–Dimethoxyphenethylamine (2–CB) ......................................................................................................................... 2 

4–Methoxyamphetamine ................................................................................................................................................................ 2 

4–Methylaminorex .......................................................................................................................................................................... 2 

4–Methyl-2,5–Dimethoxyamphetamine (DOM) ............................................................................................................................. 2 

5–Methoxy-3,4–Methylenedioxyamphetamine .............................................................................................................................. 2 

5–Methoxy-N,N-diisopropyltryptamine (5–MeO-DIPT) .................................................................................................................. 10 

Acetyl-alpha-methylfentanyl ........................................................................................................................................................... 2 

Acetyldihydrocodeine ..................................................................................................................................................................... 2 

Acetylmethadol .............................................................................................................................................................................. 2 

Allylprodine .................................................................................................................................................................................... 4 

Alphacetylmethadol ........................................................................................................................................................................ 2 

Alpha-ethyltryptamine .................................................................................................................................................................... 2 

Alphameprodine ............................................................................................................................................................................. 2 

Alphamethadol ............................................................................................................................................................................... 3 

Alpha-methyltryptamine (AMT) ...................................................................................................................................................... 10 

Alpha-methylfentanyl ..................................................................................................................................................................... 2 

Alpha-methylthiofentanyl ................................................................................................................................................................ 2 

Aminorex ........................................................................................................................................................................................ 2 

Benzylmorphine ............................................................................................................................................................................. 2 

Betacetylmethadol ......................................................................................................................................................................... 2 

Beta-hydroxy-3-methylfentanyl ...................................................................................................................................................... 2 

Beta-hydroxyfentanyl ..................................................................................................................................................................... 2 

Betameprodine ............................................................................................................................................................................... 2 

Betamethadol ................................................................................................................................................................................. 2 

Betaprodine .................................................................................................................................................................................... 2 

Bufotenine ...................................................................................................................................................................................... 2 

Cathinone ....................................................................................................................................................................................... 2 

Codeine-N-oxide ............................................................................................................................................................................ 502 

Diethyltryptamine ........................................................................................................................................................................... 2 

Difenoxin ........................................................................................................................................................................................ 8,000 

Dihydromorphine ............................................................................................................................................................................ 1,101,000 

Dimethyltryptamine ........................................................................................................................................................................ 3 

Gamma-hydroxybutyric acid .......................................................................................................................................................... 8,000,000 

Heroin ............................................................................................................................................................................................ 5 

Hydromorphinol .............................................................................................................................................................................. 2 

Hydroxypethidine ........................................................................................................................................................................... 2 

Lysergic acid diethylamide (LSD) .................................................................................................................................................. 61 

Marihuana ...................................................................................................................................................................................... 840,020 

Mescaline ....................................................................................................................................................................................... 2 

Methaqualone ................................................................................................................................................................................ 5 

Methcathinone ............................................................................................................................................................................... 4 

Methyldihydromorphine .................................................................................................................................................................. 2 

Morphine-N-oxide .......................................................................................................................................................................... 502 

N,N-Dimethylamphetamine ............................................................................................................................................................ 2 

N-Ethyl-1–Phenylcyclohexylamine (PCE) ...................................................................................................................................... 5 

N-Ethylamphetamine ..................................................................................................................................................................... 7 

N-Hydroxy-3,4–Methylenedioxyamphetamine ............................................................................................................................... 2 

Noracymethadol ............................................................................................................................................................................. 2 

Norlevorphanol ............................................................................................................................................................................... 52 

Normethadone ............................................................................................................................................................................... 2 

Normorphine .................................................................................................................................................................................. 12 

Para-fluorofentanyl ......................................................................................................................................................................... 2 

Phenomorphan .............................................................................................................................................................................. 2 

Pholcodine ..................................................................................................................................................................................... 2 

Propiram ........................................................................................................................................................................................ 210,000 

Psilocybin ....................................................................................................................................................................................... 2 

Psilocyn .......................................................................................................................................................................................... 2 

Tetrahydrocannabinols .................................................................................................................................................................. 180,000 

Thiofentanyl ................................................................................................................................................................................... 2 

Trimeperidine ................................................................................................................................................................................. 2 

67174 Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Notices 

Basic class Established final 

2004 quotas 

Schedule II

1–Phenylcyclohexylamine .............................................................................................................................................................. 2 

1–Piperidinocyclohexanecarbonitrile (PCC) .................................................................................................................................. 10 

Alfentanil ........................................................................................................................................................................................ 2,000 

Alphaprodine .................................................................................................................................................................................. 2 

Amobarbital .................................................................................................................................................................................... 3 

Amphetamine ................................................................................................................................................................................. 12,700,000 

Cocaine .......................................................................................................................................................................................... 200,000 

Codeine (for sale) .......................................................................................................................................................................... 41,341,000 

Codeine (for conversion) ............................................................................................................................................................... 48,252,000 

Dextropropoxyphene ...................................................................................................................................................................... 167,365,000 

Dihydrocodeine .............................................................................................................................................................................. 776,000 

Diphenoxylate ................................................................................................................................................................................ 836,000 

Ecgonine ........................................................................................................................................................................................ 38,000 

Ethylmorphine ................................................................................................................................................................................ 2 

Fentanyl ......................................................................................................................................................................................... 1,428,000 

Glutethimide ................................................................................................................................................................................... 2 

Hydrocodone (for sale) .................................................................................................................................................................. 34,000,000 

Hydrocodone (for conversion) ....................................................................................................................................................... 1,500,000 

Hydromorphone ............................................................................................................................................................................. 1,724,000 

Isomethadone ................................................................................................................................................................................ 2 

Levo-alphacetylmethadol (LAAM) .................................................................................................................................................. 2 

Levomethorphan ............................................................................................................................................................................ 2 

Levorphanol ................................................................................................................................................................................... 15,000 

Meperidine ..................................................................................................................................................................................... 9,753,000 

Metazocine ..................................................................................................................................................................................... 1 

Methadone (for sale) ..................................................................................................................................................................... 14,720,000 

Methadone Intermediate ................................................................................................................................................................ 18,296,000 

Methamphetamine [675,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 1,525,000 

grams for methamphetamine mostly for conversion to a Schedule III product; and 50,000 grams for methamphetamine 

(for sale)] .................................................................................................................................................................................... 2,250,000 

Methylphenidate ............................................................................................................................................................................. 28,693,000 

Morphine (for sale) ........................................................................................................................................................................ 35,021,000 

Morphine (for conversion) .............................................................................................................................................................. 110,774,000 

Nabilone ......................................................................................................................................................................................... 2 

Noroxymorphone (for sale) ............................................................................................................................................................ 99,000 

Noroxymorphone (for conversion) ................................................................................................................................................. 3,800,000 

Opium ............................................................................................................................................................................................ 1,300,000 

Oxycodone (for sale) ..................................................................................................................................................................... 49,200,000 

Oxycodone (for conversion) .......................................................................................................................................................... 920,000 

Oxymorphone ................................................................................................................................................................................ 534,000 

Pentobarbital .................................................................................................................................................................................. 18,251,000 

Phencyclidine ................................................................................................................................................................................. 2,060 

Phenmetrazine ............................................................................................................................................................................... 2 

Phenylacetone ............................................................................................................................................................................... 11,000,000 

Racemethorphan ........................................................................................................................................................................... 2 

Secobarbital ................................................................................................................................................................................... 2 

Sufentanil ....................................................................................................................................................................................... 4,000 

Thebaine ........................................................................................................................................................................................ 72,453,000 

The Deputy Administrator further 

orders that aggregate production quotas 

for all other Schedules I and II 

controlled substances included in 

Sections 1308.11 and 1308.12 of Title 21 

of the Code of Federal Regulations 

remain at zero. 

The Office of Management and Budget 

has determined that notices of aggregate 

production quotas are not subject to 

centralized review under Executive 

Order 12866. 

This action 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 

action does not have federalism 

implications warranting the application 

of Executive Order 13132. 

The Deputy Administrator hereby 

certifies that this action will have no 

significant impact upon small entities 

whose interests must be considered 

under the Regulatory Flexibility Act, 5 

U.S.C. 601 et seq. The establishment of 

aggregate production quotas for 

Schedules I and II controlled substances 

is mandated by law and by international 

treaty obligations. The quotas are 

necessary to provide for the estimated 

medical, scientific, research and 

industrial needs of the United States, for 

export requirements and the 

establishment and maintenance of 

reserve stocks. While aggregate 

production quotas are of primary 

importance to large manufacturers, their 

impact upon small entities is neither 

negative nor beneficial. Accordingly, the 

Deputy Administrator has determined 

that this action does not require a 

regulatory flexibility analysis. 

This action meets the applicable 

standards set forth in Sections 3(a) and 

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

Justice Reform. 

This action will not result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $113,000,000 or more 

in any one year, and will not 

significantly or uniquely affect small 

Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Notices 67175

governments. Therefore, no actions were 

deemed necessary under the provisions 

of the Unfunded Mandates Reform Act 

of 1995. 

This action is not a major rule as 

defined by Section 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996. This action 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.

Dated: November 5, 2004. 

Michele M. Leonhart, 

Deputy Administrator.

[FR Doc. 04–25340 Filed 11–15–04; 8:45 am] 

BILLING CODE 4410–09–P

DEPARTMENT OF JUSTICE

Office of Justice Programs 

[OJP (OJJDP) Docket No. 1412] 

Meeting of the Juvenile Justice 

Advisory Committee

AGENCY: Office of Juvenile Justice and 

Delinquency Prevention (OJJDP), Office 

of Justice Programs, Justice.

ACTION: Notice of meeting.

SUMMARY: The Office of Juvenile Justice 

and Delinquency Prevention is 

announcing the meeting of the Juvenile 

Justice Advisory Committee (JJAC) in 

Washington, DC, on December 9, 2004, 

at the meeting times and location noted 

below. The meeting will discuss and 

approve two annual reports for 2004. 

The first report contains 

recommendations to the President and 

Congress on Federal legislation 

pertaining to juvenile justice and 

delinquency prevention. The second 

report contains recommendations to the 

Administrator regarding the work of 

OJJDP. The meeting will also reorganize 

the JJAC subcommittees and begin 

discussing recommendations for the 

2005 reports.

DATES: The meeting will take place on 

Thursday, December 9, 2004, from 9 

a.m. to 3 p.m., E.D.T.

ADDRESSES: The meeting will take place 

at the Capital Hilton, 1001 16th Street, 

NW., Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT:

Timothy Wight, Designated Federal 

Official, OJJDP, at 

Timothy.Wight@usdoj.gov, or by 

telephone at (202) 514–2190. [Note: this 

is not a toll-free number.]

SUPPLEMENTARY INFORMATION: The 

Juvenile Justice Advisory Committee, 

established pursuant to sec. 3(2)A of the 

Federal Advisory Committee Act (5 

U.S.C. App. 2), will meet to carry out its 

advisory functions under sec. 

223(f)(2)(C–E) of the Juvenile Justice and 

Delinquency Prevention Act of 2002. 

JJAC is composed of one representative 

from each state and territory and the 

District of Columbia. Their duties are to 

review Federal policies regarding 

juvenile justice and delinquency 

prevention; advise the OJJDP 

Administrator with respect to particular 

functions and aspects of the work of 

OJJDP; and advise the President and 

Congress with regard to state 

perspectives on the operation of OJJDP 

and federal legislation pertaining to 

juvenile justice and delinquency 

prevention. More information on JJAC, 

including a list of members, may be 

found at http://www.ojjdp.ncjrs.org/

jjac/.

Schedule: The schedule of events is as 

follows: 

9 a.m.–9:15 a.m.—Call to Order by 

JJAC Chairman (Open Session) 

9:15 a.m.–9:45 a.m.—Opening 

Remarks by OJJDP Administrator J. 

Robert Flores, followed by 

questions and answers 

9:45 a.m.–10 a.m.—Annual Report 

Committee: Recommendations to 

approve the 2004 Annual Report to 

the President and Congress and the 

2004 Annual Recommendations 

Report to the Administrator of 

OJJDP 

10 a.m.–10:40 a.m.—Reorganization of 

JJAC Subcommittees (if necessary) 

in preparation for calendar year 

2005 activities 

10:45 a.m.–1 p.m.—Working Lunch 

for JJAC Annual Report, Grants, 

Legal Affairs, and Planning 

Subcommittees (Closed Session) 

1 p.m.–3 p.m.—Subcommittee 

Reports (Open Meeting) 

3 p.m.—Meeting will be adjourned

Access: Members of the public who 

wish to attend the open sessions of the 

meeting should register by sending an email containing their name, affiliation, 

address, phone number, and a statement 

concerning the sessions they would like 

to attend, to JJAC@jjrc.org. If e-mail is 

not available, please call (301) 519–6473 

(Daryel Dunston). Because space is 

limited, notification should be sent by 

November 24, 2004. 

Written Comments: Interested parties 

may submit written comments by 

November 24, 2004, to Timothy Wight, 

Designated Federal Official for the 

Juvenile Justice Advisory Committee, 

OJJDP, at Timothy.Wight@usdoj.gov, or 

by telephone at (202) 514–2190. [Note:

this is not a toll-free number.] No oral 

presentations will be permitted at this 

meeting.

Dated: November 10, 2004. 

J. Robert Flores, 

Administrator, Office of Juvenile Justice and 

Delinquency Prevention.

[FR Doc. 04–25408 Filed 11–15–04; 8:45 am] 

BILLING CODE 4410–18–P

DEPARTMENT OF LABOR

Office of the Secretary 

Submission for OMB Review: 

Comment Request 

November 1, 2004. 

The Department of Labor (DOL) has 

submitted the following public 

information collection request (ICR) to 

the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995 (Pub. L. 104–13, 

44 U.S.C. chapter 35). A copy of this 

ICR, with applicable supporting 

documentation, may be obtained by 

contacting Darrin King on 202–693–

4129 (this is not a toll-free number) or 

e-mail: king.darrin@dol.gov.

Comments should be sent to Office of 

Information and Regulatory Affairs, 

Attn: OMB Desk Officer for the Mine 

Safety and Health Administration 

(MSHA), Office of Management and 

Budget, Room 10235, Washington, DC 

20503, 202–395–7316 (this is not a tollfree number), within 30 days from the 

date of this publication in the Federal 

Register. 

The OMB is particularly interested in 

comments which: 

• Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

• Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

• Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

• Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology,