[Federal Register Volume 69, Number 24 (Thursday, February 5, 2004)]
[Notices]
[Page 5582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-2339]



[[Page 5582]]

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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); 
Nathanial-Aikens-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