5582 Federal Register / Vol. 69, No. 24 / Thursday, February 5, 2004 / Notices 

DEPARTMENT OF JUSTICE

Drug Enforcement Administration 

Timothy J. Irby/M.C.B.D. Pro 

International, TM Pure Dope 

Productions; Publishing Music Agency 

and Lab Research: Denial of 

Registration 

On June 6, 2003, the Deputy Assistant 

Administrator, Office of Diversion 

Control, Drug Enforcement 

Administration (DEA), issued an Order 

to Show Cause to Mr. Timothy J. Irby 

and his business, which he identified as 

‘‘M.C.B.D. Pro International; TM Pure 

Dope Productions; Publishing Music 

Agency and Lab Research‘‘(MCBD) 

notifying Mr. Irby/MCBD of an 

opportunity to show cause as to why, 

pursuant to 21 U.S.C. 823(f) and 824(a), 

DEA should not deny the pending 

application for a DEA Certificate of 

Registration as a Researcher in Schedule 

I and II controlled substances. The 

Order to Show Cause alleged in relevant 

part that Mr. Irby and MCBD did not 

possess a State license to conduct 

research in controlled substances in 

Nevada, the State in which the 

applicant intended to conduct research 

and that registration would be 

inconsistent with the public interest. 

The Order to Show Cause was sent by 

certified mail to Mr. Irby/MCBD at the 

registered location and last known 

address, identified in the application as 

5450 Black Rock Way, Las Vegas, 

Nevada 89111–3705. This was Mr. Irby’s 

residence. The Order to Show Cause 

was returned to DEA and the envelope 

marked by the United States Postal 

Service as ‘‘Moved. Left no address.’’

NEA has no further information 

regarding the whereabouts of Mr. Irby/

MCBD, nor any information from 

anyone purporting to represent them in 

this matter. 

Therefore, the Acting Deputy 

Administrator of DEA, finding that: (1) 

30 days having passed since the 

attempted delivery of the Order to Show 

Cause at Mr. Irby/MCBD’s last known 

address, and (2) no requests for hearing 

having been received, concludes that 

Mr. Irby/MCBD are deemed to have 

waived their hearing rights. See Kenneth 

S. Nave, M.D., 68 FR 24761 (2003); 

Samuel S. Jackson, D.D.S., 67 FR 65145 

(2002); David W. Linder, 67 FR 12579 

(2002); Lawrence C. Agee, M.D., 66 FR 

52934 (2001). After considering material 

from the investigative file in this matter, 

the Acting Deputy Administrator now 

enters her final order without a hearing 

pursuant to 21 CFR 1301.43(d) and (e) 

and 1301.46. 

The Acting Deputy Administrator’s 

review of the investigative file reveals 

that on behalf of MCBD, Mr. Irby 

requested a DEA Certificate of 

Registration as a Researcher in schedule 

I and II controlled substances. The 

controlled substances identified in the 

application were cocaine, 

methamphetamine and marijuana. A 

DEA diversion investigator conducting a 

pre-registration investigation 

established that the intended place of 

registration was Mr. Irby’s personal 

residence and that he does not possess 

a medical degree, any State licenses and 

was not affiliated with any medical 

facility, laboratory, clinic or staff. 

Mr. Irby advised the DEA investigator 

he intended to conduct human research 

with the specified controlled 

substances. However, he has not 

obtained the required permissions to 

conduct human research from either the 

Food and Drug Administration or the 

State of Nevada, Health Division, 

Department of Licensure and 

Certification. Neither is Mr. Irby 

licensed with the Nevada State Board of 

Pharmacy or the Nevada Department of 

Health and Human Services nor does he 

possess a valid State business license. 

In sum, the investigative file contains 

no evidence Mr. Irby/MCBD have 

personal licenses or affiliations with any 

legitimate medical or research facilities 

and have not taken even minimal steps 

to obtain requisite consents to conduct 

drug or human research in Nevada. 

Therefore, the Acting Deputy 

Administrator finds Mr. Irby/MCBD are 

not currently authorized to conduct 

research with controlled substances in 

the State of Nevada and it is reasonable 

to infer they are also without 

authorization to handle controlled 

substances in that State. 

DEA does not have statutory authority 

under the Controlled Substances Act to 

issue a registration if the applicant is 

without State authority to handle 

controlled substances in the State in 

which he conducts business. See 21 

U.S.C. 802(21), 823(f) and 824(a)(3). The 

Acting Deputy Administrator and her 

predecessors have consistently so held. 

See Douglas L. Geiger, M.D., 67 FR 

64418 (2002); Theodore T. Ambadgis, 

M.D., 58 FR 5759 (1993); Ihsan A. 

Karqaagac, M.D., 51 FR 34695 (1986). 

Considering the foregoing, the Acting 

Deputy Administrator concludes, 

pursuant to 21 U.S.C. 823(f), that Mr. 

Irby/MCBD lack authority under the 

laws of Nevada, the State of applied-for 

registration, to dispense or conduct 

research with respect to controlled 

substances and the application should 

be denied on that ground. 

Because Mr. Irby/MCBD lack State 

authorization to handle controlled 

substances, the Acting Deputy 

Administrator concludes it is 

unnecessary to address whether or not 

his application for DEA registration 

should be denied based upon the public 

interest grounds asserted in the Order to 

Show Cause. See Samuel Silas Jackson, 

D.D.S., 67 FR 65145 (2002); NathanialAikens-Afful, M.D., 62 FR 16871 (1997); 

Sam F. Moore, D.V.M., 58 FR 14428 

(1993). 

Accordingly, the Acting Deputy 

Administrator of the Drug Enforcement 

Administration, pursuant to the 

authority vested in her by 21 U.S.C. 823 

and 824 and 28 CFR 0.100(b) and 0.104, 

hereby orders that the pending 

application for DEA Certificate of 

Registration, submitted by Timothy J. 

Irby on behalf of M.C.B.D. Pro 

International, TM Pure Dope 

Productions, Publishing Music Agency 

and Lab Research, be, and it hereby is, 

denied. This order is effective March 8, 

2004.

Dated: January 7, 2004. 

Michele M. Leonhart, 

Acting Deputy Administrator.

[FR Doc. 04–2339 Filed 2–4–04; 8:45 am] 

BILLING CODE 4410–09–M

DEPARTMENT OF JUSTICE

Drug Enforcement Administration 

Importer of Controlled Substances 

Notice of Registration 

By notice dated October 7, 2003, and 

published in the Federal Register on 

October 29, 2003 (68 FR 61700), ISP 

Freetown Fine Chemicals, 238 Main 

South Street, Assonet, Massachusetts 

02702, made application by renewal to 

the Drug Enforcement Administration 

(DEA) to be registered as an importer of 

Phenylacetone (8501), a basic class of 

controlled substance listed in Schedule 

II. 

The firm plans to import 

Phenylacetone to manufacture 

amphetamine. 

No comments or objections have been 

received. DEA has considered the 

factors in title 21, United States Code, 

section 823(a) and determined that the 

registration of ISP Freetown Fine 

Chemicals to import the listed 

controlled substances is consistent with 

the public interest and with United 

States obligations under international 

treaties, conventions, or protocols in 

effect on May 1, 1971, at this time. DEA 

has investigated ISP Freetown Fine 

Chemicals on a regular basis to ensure 

that the company’s continued