[Federal Register: August 19, 2004 (Volume 69, Number 160)]
[Notices]
[Page 51481-51483]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19au04-75]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Proveedora Jiron, Inc. Edilberto Jiron, President; Denial of
Application
On October 30, 2003, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Proveedora Jiron, Incorporated, Edilberto Jiron,
President (Proveedora) proposing to deny its application, executed on
March 25, 2003, for DEA Certificate of Registration as a distributor of
list I chemicals. The Order to Show Cause alleged in relevant part that
granting the application of Proveedora would be inconsistent with the
public interest as that term is used in 21 U.S.C. 823(h) and 824(a).
The Order to Show Cause also notified Proveedora that should no request
for a hearing be filed within 30 days, its hearing right would be
deemed waived.
According to the DEA investigative file, the Order to Show Cause
was sent by certified mail to Edilberto Jiron (Mr. Jiron), President of
Proveedora at his firm's proposed registered location in Miami,
Florida. A return receipt, which was part of the investigative file,
indicates that the show cause order was received on November 12, 2003,
on behalf of Proveedora. DEA has not received a request for hearing or
any other reply from Proveedora or anyone purporting to represent the
company in this matter.
Therefore, the Deputy Administrator of DEA, finding that (1) thirty
days having passed since receipt of the Order to Show Cause, and (2) no
request for hearing having been received, concludes that Proveedora has
waived its hearing
[[Page 51482]]
right. See Aqui Enterprises, 67 FR 12576 (2002). After considering
relevant material from the investigative file in this matter, the
Deputy Administrator now enters her final order without a hearing
pursuant to 21 CFR 1309.53(c) and (d) and 1316.67 (2003). The Deputy
Administrator finds as follows:
List I chemicals are those that may be used in the manufacture of a
controlled substance in violation of the Controlled Substances Act. 21
U.S.C. 802(34); 21 CFR 1310.02(a). Pseudoephedrine and ephedrine are
list I chemicals commonly used to illegally manufacture
methamphetamine, a Schedule II controlled substance. As noted in
previous DEA final orders, Methamphetamine is an extremely potent
central nervous system stimulant, and its abuse is a persistent and
growing problem in the United States. Yemen Wholesale Tobacco and Candy
Supply, Inc., 67 FR 9997 (2002); Denver Wholesale, 67 FR 99986 (2002).
The Deputy Administrator's review of the investigative file reveals
that on March 25, 2003, Proveedora submitted an application for DEA
registration as a distributor of the list I chemicals ephedrine and
pseudoephedrine. The application was submitted on behalf of Proveedora
by Mr. Jiron. Upon receipt of the application, the DEA Miami Field
Division initiated a pre-registration investigation in or around April
or May of 2003.
According to a DEA investigative report contained in the
investigative file, on May 29, 2003, a DEA diversion investigator from
the Miami Field Division contacted Mr. Jiron by telephone to schedule
an appointment. Apparently, the investigator explained to Mr. Jiron
that ``information and documents'' were needed to process the firm's
application. There is no mention in the report of what specific
information or documents were requested of Mr. Jiron. Mr. Jiron is
quoted as replying to the investigator that he felt uncomfortable
``divulging this information'' although the investigator explained that
all documents and information will remain confidential.
Similarly, a review of a July 15, 2003, certified letter from the
DEA Miami Field Division to Mr. Jiron reveals a written reminder to the
applicant of a prior discussion he had with DEA personnel where it was
explained to that ``information and documents were needed to in order
to proceed with his application.'' Again, there is no reference in the
aforementioned letter of what information was requested of Mr. Jiron
for completion of his company's application for DEA registration.
According to the investigative file, the certified letter was returned
to DEA unclaimed.
The investigative file further reveals that on August 18, 2003, a
DEA diversion investigator telephoned an employee of Proveedora to
verify the firm's address, and left a message for Mr. Jiron to contact
the DEA apparently in regard to the firm's pending registration
application. However, Mr. Jiron never contacted DEA regarding the
matter.
Pursuant to 21 U.S.C. 823(h), the Deputy Administrator may deny an
application for Certificate of Registration if she determines that
granting the registration would be inconsistent with the public
interest as determined under that section. Section 823(h) requires the
following factors be considered in determining the public interest:
(1) Maintenance of effective controls against diversion of listed
chemicals into other than legitimate channels;
(2) Compliance with applicable Federal, State, and local law;
(3) Any prior conviction record under Federal or State laws
relating to controlled substances or to chemicals controlled under
Federal or State law;
(4) Any past experience in the manufacture and distribution of
chemicals; and
(5) Such other factors as are relevant to and consistent with the
public health and safety.
As with the public interest analysis for practitioners and
pharmacies pursuant to subsection (f) of section 823, these factors are
to be considered in the disjunctive; the Deputy Administrator may rely
on any one or combination of factors, and may give each factor the
weight she deems appropriate in determining whether a registration
should be revoked or an application for registration denied. See, e.g.,
Energy Outlet, 64 FR 14269 (1999). See also Henry J. Schwartz, Jr.,
M.D., 54 FR 16422 (1989).
In rendering a final agency decision in this matter, the Deputy
Administrator admittedly proceeds with great reluctance. Although a
finding has been made that the applicant has waived its right to a
hearing, nevertheless, the investigative file that has been provided
ostensibly to assist the Deputy Administrator in rendering a ruling in
this matter is at best, incomplete. The investigative file contains
scant information about DEA's investigation of the applicant, virtually
no information in any of the DEA investigative reports or
correspondences on what information the agency requested of the
applicant to complete its investigation, and no background information
which may have explained why the applicant declined DEA's repeated
requests for additional information.
Nevertheless, in balancing public interest concerns and in response
to the ongoing public health threat brought on by the diversion of list
I chemical products, the Deputy Administrator finds the balance of
interests weighs in favor of denying the application of Proveedora.
In its Order to Show Cause, the agency references the applicant's
failure to provide requested documents or statements within a
reasonable time, and how such inaction on the part of the applicant may
be deemed a waiver by the applicant to present such matters for
consideration by the Administrator pursuant to the ``Additional
information'' provision found at 21 CFR 1301.15. Notwithstanding the
above concerns surrounding the incomplete DEA investigative file, the
Deputy Administrator agrees that the record is silent with respect to
information that would support Proveedora's application. However, with
respect to the agency's request for additional information relevant to
an application for the registration of a list I chemical distributor,
the appropriate regulatory provision is found at 21 CFR 1309.35, which
is identical in scope to Sec. 1301.15 in that it provides:
The Administrator may require an applicant to submit such
documents or written statements of facts relevant to the application
as he deems necessary to determine whether the application should be
granted. The failure of the applicant to provide such documents or
statements within a reasonable time after being requested to do so
shall be deemed to be a waiver by the applicant of an opportunity to
present such documents or facts for consideration by the
Administrator in granting or denying the application.
It appears from the investigative file that the owners of
Proveedora were not compliant with repeated DEA request for information
necessary to the processing of its registration application. Such
information is a necessary part of the investigative function in
determining the fitness of an applicant to handle highly abused list I
chemical products. DEA has previously found that an applicant's failure
to provide information necessary to the completion of a pending
application was a relevant determination in a decision to deny the
application pursuant to 21 CFR 1309.35. Callahan's Foods, 68 FR 43750
(2003). See also, CHM Wholesale Co., 67 FR 9985 (2002).
[[Page 51483]]
In light of the above, and the absence of evidence to the contrary,
the Deputy Administrator is left to conclude that Proveedora cannot be
entrusted with the responsibilities of a DEA registration. As a result,
the Deputy Administrator further concludes that it would be
inconsistent with the public interest to grant the application of
Proveedora.
Accordingly, the Deputy Administrator of the Drug Enforcement
Administration, pursuant to the authority vested in her by 21 U.S.C.
823 and 28 CFR 0.100(b) and 0.104, hereby orders that the pending
application for DEA Certificate of Registration, previously submitted
by Proveedora Jiron, Incorporated, Edilberto Jiron, President, be, and
it hereby is, denied. This order is effective September 20, 2004.
Dated: July 27, 2004.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 04-18970 Filed 8-18-04; 8:45 am]
BILLING CODE 4410-09-M