67170 Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Notices 

1The report is available on the SAMHSA Web 

site at http://oas.samhsa.gov/NHSDA/2k3NSDUH/

2k3results.htm.

(NAGPRA), 25 U.S.C. 3005, of the intent 

to repatriate a cultural item in the 

possession of the Heard Museum, 

Phoenix, AZ, that meets the definition 

of ‘‘cultural patrimony’’ under 25 U.S.C. 

3001.

This notice is published as part of the 

National Park Service’s administrative 

responsibilities under NAGPRA, 25 

U.S.C. 3003 (d)(3). The determinations 

in this notice are the sole responsibility 

of the museum that has control of the 

cultural item. The National Park Service 

is not responsible for the determinations 

in this notice.

The one cultural item is a Dilzini 

Gaan headdress made of painted wood 

and cloth.

It is not known exactly when, where, 

or by whom the headdress was 

collected, or under what circumstances 

the Heard Museum acquired the 

headdress. The museum probably 

acquired the headdress before 1952, 

since the museum’s collections were 

re-cataloged after 1951, and the 

headdress appears to match a catalog 

description that was probably written 

between 1931 and 1947.

Representatives of the Mescalero 

Apache Tribe of the Mescalero 

Reservation, New Mexico; San Carlos 

Apache Tribe of the San Carlos 

Reservation, Arizona; Tonto Apache 

Tribe of Arizona; White Mountain 

Apache Tribe of the Fort Apache 

Reservation, Arizona; and 

Yavapai-Apache Nation of the Camp 

Verde Indian Reservation, Arizona 

examined the museum’s collections, 

consulted with museum staff, and 

identified the headdress as an object of 

cultural patrimony eligible for 

repatriation under NAGPRA. The White 

Mountain Apache Tribe demonstrated 

that the cultural item has ongoing 

traditional and cultural importance to 

the tribe and could not have been 

conveyed by any individual tribal 

member.

Officials of the Heard Museum have 

determined that, pursuant to 25 U.S.C. 

3001 (3)(D), the cultural item has 

ongoing historical, traditional, or 

cultural importance central to the White 

Mountain Apache Tribe of the Fort 

Apache Reservation, Arizona, rather 

than property owned by an individual. 

Officials of the Heard Museum also have 

determined that, pursuant to 25 U.S.C. 

3001 (2), there is a relationship of 

shared group identity that can be 

reasonably traced between the object of 

cultural patrimony and the White 

Mountain Apache Tribe of the Fort 

Apache Reservation, Arizona.

Representatives of any other Indian 

tribe that believes itself to be culturally 

affiliated with the object of cultural 

patrimony should contact Frank 

Goodyear, Director, Heard Museum, 

2301 N. Central Avenue, Phoenix, AZ 

85004, telephone (602) 252-8840, before 

December 16, 2004. Repatriation of the 

object of cultural patrimony to the 

White Mountain Apache Tribe of the 

Fort Apache Reservation, Arizona may 

proceed after that date if no additional 

claimants come forward.

The Heard Museum is responsible for 

notifying the Apache Tribe of 

Oklahoma; Fort Sill Apache Tribe of 

Oklahoma; Jicarilla Apache Nation, New 

Mexico; Mescalero Apache Tribe of the 

Mescalero Reservation, New Mexico; 

San Carlos Apache Tribe of the San 

Carlos Reservation, Arizona; Tonto 

Apache Tribe of Arizona; White 

Mountain Apache Tribe of the Fort 

Apache Reservation, Arizona; and the 

Yavapai-Apache Nation of the Camp 

Verde Indian Reservation, Arizona that 

this notice has been published.

Mary Downs,

Acting Manager, National NAGPRA Program

[FR Doc. 04–25353 Filed 11–15–04; 8:45 am]

BILLING CODE 4312–50–S

DEPARTMENT OF JUSTICE

Drug Enforcement Administration 

[Docket No. DEA–258S] 

Dispensing of Controlled Substances 

for the Treatment of Pain

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice.

ACTION: Interim policy statement.

SUMMARY: In August 2004, DEA 

published on its Office of Diversion 

Control Web site a document entitled: 

‘‘Prescription Pain Medications: 

Frequently Asked Questions and 

Answers for Health Care Professionals 

and Law Enforcement Personnel’’

(August 2004 FAQ). The August 2004 

FAQ was not published in the Federal 

Register and was not an official 

statement of the agency. DEA 

subsequently withdrew the document 

because it contained misstatements. 

This interim policy statement explains 

how some of the statements in the 

August 2004 FAQ were erroneous. In 

addition, this interim statement 

explains how DEA plans to address in 

a future Federal Register document the 

issue of dispensing controlled 

substances for the treatment of pain.

FOR FURTHER INFORMATION CONTACT:

William J. Walker, Deputy Assistant 

Administrator, Office of Diversion 

Control, Drug Enforcement 

Administration, Washington, DC 20537; 

Telephone: (202) 307–7165.

SUPPLEMENTARY INFORMATION: In August 

2004, DEA published on its Office of 

Diversion Control Web site a document 

entitled: ‘‘Prescription Pain 

Medications: Frequently Asked 

Questions and Answers for Health Care 

Professionals and Law Enforcement 

Personnel’’ (August 2004 FAQ). For the 

reasons provided below, the August 

2004 FAQ was not an official statement 

of the agency and DEA subsequently 

withdrew the document because it 

contained misstatements. Nonetheless, 

the subject matter—dispensing 

controlled substances for the treatment 

of pain—is extremely important to the 

public health and welfare. As the 

agency primarily responsible for 

enforcement and administration of the 

federal laws and regulations governing 

controlled substances, DEA believes that 

further discussion of the subject is 

warranted for two fundamental reasons. 

First, the abuse of pharmaceutical 

narcotics and other prescription 

controlled substances is increasing in 

the United States. According to the 

latest National Survey on Drug Use and 

Health, which is published by the 

Department of Health and Human 

Services, Substance Abuse and Mental 

Health Services Administration 

(SAMHSA), the number of Americans 

aged 12 or older who have engaged in 

illicit (nonmedical) use of pain relievers 

during their lifetime has risen to more 

than 31 million.1 A portion of this type 

of drug abuse is directly facilitated by a 

small number of physicians who 

dispense controlled substances for other 

than legitimate medical purposes and 

then fraudulently claim that the drugs 

were dispensed for the treatment of 

pain.

Second, chronic pain is a serious 

problem for many Americans. It is 

crucial that physicians who are engaged 

in legitimate pain treatment not be 

discouraged from providing proper 

medication to patients as medically 

justified. DEA recognizes that the 

overwhelming majority of physicians 

dispense controlled substances lawfully 

for legitimate medical reasons, 

including the treatment of pain. 

Accordingly, DEA plans to address the 

subject of dispensing controlled 

substances for the treatment of pain in 

a future Federal Register document, 

taking into consideration the views of 

the medical community. The document 

will be aimed at providing guidance and 

reassurance to physicians who engage in 

Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Notices 67171

legitimate pain treatment while 

deterring the unlawful conduct of a 

small number of physicians and other 

DEA registrants who exploit the term 

‘‘pain treatment’’ as a pretext to engage 

in prescription drug trafficking. In the 

meantime, the agency wishes to correct 

here a few of the significant 

misstatements contained in the August 

2004 FAQ. 

Misstatements in the August 2004 FAQ 

Although not an exhaustive 

discussion, the following is an 

explanation of some of the 

misstatements that were contained in 

the August 2004 FAQ. 

Commencement of investigations—

The August 2004 FAQ erroneously 

stated: ‘‘The number of patients in a 

practice who receive opioids, the 

number of tablets prescribed for each 

patient, and the duration of therapy 

with these drugs do not, by themselves, 

indicate a problem, and they should not 

be used as the sole basis for an 

investigation by regulators or law 

enforcement.’’ In fact, each of the 

foregoing factors—though not 

necessarily determinative—may indeed 

be indicative of diversion. As one 

federal appeals court has correctly 

stated, one can glean from the reported 

cases in which physicians have been 

convicted of dispensing controlled 

substances for other than a legitimate 

medical purpose ‘‘certain recurring 

concomitance of condemned behavior,’’

such as the following:

(1) An inordinately large quantity of 

controlled substances was prescribed. 

(2) Large numbers of prescriptions were 

issued. 

(3) No physical examination was given. 

(4) The physician warned the patient to fill 

prescriptions at different drug stores. 

(5) The physician issued prescriptions to a 

patient known to be delivering the drugs to 

others. 

(6) The physician prescribed controlled 

drugs at intervals inconsistent with 

legitimate medical treatment. 

(7) The physician involved used street 

slang rather than medical terminology for the 

drugs prescribed. 

(8) There was no logical relationship 

between the drugs prescribed and treatment 

of the condition allegedly existing.

(9) The physician wrote more than one 

prescription on occasions in order to spread 

them out.

United States v. Rosen, 582 F.2d 

1032, 1035–1036 (5th Cir. 1978) 

(citations omitted). 

Moreover, it is a longstanding legal 

principle that the Government ‘‘can 

investigate merely on suspicion that the 

law is being violated, or even just 

because it wants assurances that it is 

not.’’ United States v. Morton Salt Co.,

338 U.S. 632, 642–643 (1950). It would 

be incorrect to suggest that DEA must 

meet some arbitrary standard or 

threshold evidentiary requirement to 

commence an investigation of a possible 

violation of the Controlled Substances 

Act (CSA). 

Refills of schedule II prescriptions—

The August 2004 FAQ stated: ‘‘Schedule 

II prescriptions may not be refilled; 

however, a physician may prepare 

multiple prescriptions on the same day 

with instructions to fill on different 

dates.’’ (Italics added.) The first part of 

this sentence is correct, as the CSA 

expressly states: ‘‘No prescription for a 

controlled substance in schedule II may 

be refilled.’’ 21 U.S.C. 829(a). However, 

the second part of the sentence 

(italicized above) is incorrect. For a 

physician to prepare multiple 

prescriptions on the same day with 

instructions to fill on different dates is 

tantamount to writing a prescription 

authorizing refills of a schedule II 

controlled substance. To do so conflicts 

with one of the fundamental purposes of 

section 829(a). Indeed, as the factors 

quoted above from the Rosen case 

indicate, writing multiple prescriptions 

on the same day with instructions to fill 

on different dates is a recurring tactic 

among physicians who seek to avoid 

detection when dispensing controlled 

substances for unlawful (nonmedical) 

purposes. It is worth noting here that 

the DEA regulations setting forth the 

requirements for the issuance of a 

controlled substance prescription are set 

forth in 21 CFR 1306.01–1306.27. 

Reselling of controlled substances—

The August 2004 FAQ listed a number 

of behaviors, or ‘‘red flags,’’ that are 

‘‘probable indicators of abuse, 

addiction, or diversion.’’ These 

behaviors include ‘‘selling 

medications.’’ The document suggested 

that certain steps be taken to deal with 

such indicators, including ‘‘appropriate 

management’’ and possible referral to an 

addiction specialist. The document 

went on to state that these behaviors 

(including reselling medications) 

‘‘should not be taken to mean that a 

patient does not have pain, or that 

opioid therapy is contraindicated.’’ The 

document also stated: ‘‘Management 

may or may not include continuation of 

therapy, depending on the 

circumstances.’’ Finally, the document 

stated that ‘‘if continued opioid therapy 

makes medical sense, then the therapy 

may be continued, even if drug abuse 

has occurred. Additional monitoring 

and oversight of patients who have 

experienced such an episode is 

recommended.’’ (Italics added.) 

The behaviors listed in the August 

2004 FAQ as ‘‘red flags’’ are indeed 

indicators of possible diversion. 

However, the August 2004 FAQ 

understated the degree of caution that a 

physician must exercise to minimize the 

likelihood of diversion when dispensing 

controlled substances to known or 

suspected addicts. If a physician is 

aware that a patient is a drug addict 

and/or has resold prescription narcotics, 

it is not merely ‘‘recommended’’ that the 

physician engage in additional 

monitoring of the patient’s use of 

narcotics. Rather, as a DEA registrant, 

the physician has a responsibility to 

exercise a much greater degree of 

oversight to prevent diversion in the 

case of a known or suspected addict 

than in the case of a patient for whom 

there are no indicators of drug abuse. 

Under no circumstances may a 

physician dispense controlled 

substances with the knowledge that they 

will be used for a nonmedical purpose 

or that they will be resold by the 

patient. 

In a similar vein, the August 2004 

FAQ incorrectly minimized the 

potential significance of a family 

member or friend expressing concern to 

the physician that the patient may be 

abusing the pain medication. The 

document stated:

Family and friends, or health care providers 

who are not directly involved in the therapy, 

may express concerns about the use of 

opioids. These concerns may result from a 

poor understanding of the role of this therapy 

in pain management or from an unfounded 

fear of addiction; they may be exacerbated by 

widespread, sometimes inaccurate media 

coverage about abuse of opioid pain 

medications.

While it is true that concerns of 

family members are not always 

determinative of whether the patient is 

engaged in drug abuse, the above-quoted 

statement is incorrect to the extent it 

implies that physicians may simply 

disregard such concerns expressed to 

them by family members or friends. 

Indeed, a family member or friend might 

be aware of information that the 

physician does not possess regarding a 

patient’s drug abuse. Given the 

addictive and sometimes deadly nature 

of prescription narcotic abuse, the 

tremendous volume of such drug abuse 

in the United States, and the propensity 

of many drug addicts to attempt to 

deceive physicians in order to obtain 

controlled substances for the purpose of 

abuse, a physician should seriously 

consider any sincerely expressed 

concerns about drug abuse conveyed by 

family members and friends. 

It bears emphasis that none of the 

principles summarized above is new. 

Rather, these are concepts that have 

been incorporated for more than 80 

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: