[Federal Register: February 5, 2004 (Volume 69, Number 24)]
[Notices]
[Page 5582]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05fe04-132]
[[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