[Federal Register Volume 69, Number 160 (Thursday, August 19, 2004)]
[Notices]
[Pages 51481-51483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18970]


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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