Importer of Controlled Substances; Notice of Application, 11148-11149 [E8-3858]

Download as PDF 11148 Federal Register / Vol. 73, No. 41 / Friday, February 29, 2008 / Notices appropriate nor necessary,’’ and that she ‘‘was told that this decision meant, in laymen’s terms, ‘that the arrest never happened.’ ’’ Id.2 Respondent further stated that she would submit the transcript from the proceeding to the Agency, Id., but did not do so. Discussion Section 303(f) of the Controlled Substances Act provides that an application for a practitioner’s registration may be denied upon a determination ‘‘that the issuance of such registration would be inconsistent with the public interest.’’ 21 U.S.C. 823(f). In making the public interest determination, the CSA requires the consideration of the following factors: (1) The recommendation of the appropriate State licensing board or professional disciplinary authority. (2) The applicant’s experience in dispensing * * * controlled substances. (3) The applicant’s conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances. (4) Compliance with applicable State, Federal, or local laws relating to controlled substances. (5) Such other conduct which may threaten the public health and safety. rwilkins on PROD1PC63 with NOTICES Id. • ‘‘These factors are considered in the disjunctive.’’ Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). I ‘‘may rely on any one or a combination of factors, and may give each factor the weight [I] deem[] appropriate in determining whether * * * an application for registration [should be] denied.’’ Id. Moreover, I am ‘‘not required to make findings as to all of the factors.’’ Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173–74 (D.C. Cir. 2005). Furthermore, under Section 304(a)(1), a registration may be revoked or suspended ‘‘upon a finding that the registrant * * * has materially falsified any application filed pursuant to or required by this subchapter.’’ 21 U.S.C. 824(a)(1). Under agency precedent, the various grounds for revocation or 2 Respondent also contended that while in June 1999, the Maryland Board ‘‘did indeed suspend her dental license for 12 months, [the suspension] was also stayed immediately.’’ Respondent’s Req. for Hearing at 1. The record contains, however, a copy of a June 2, 1999 consent order under which Respondent voluntarily agreed not to practice dentistry for a period of twelve months. This order contains no indication that it was stayed. The Show Cause Order did not, however, allege either that Respondent’s ‘‘no’’ answer to the liability question regarding whether her state license had been the subject of discipline or her statement that ‘‘[n]o state license was ever revoked and/or suspended’’ was materially false. I therefore do not consider whether either of these statements is grounds for the denial of her application. VerDate Aug<31>2005 19:22 Feb 28, 2008 Jkt 214001 suspension of an existing registration that Congress enumerated in section 304(a), 21 U.S.C. 824(a), are also properly considered in deciding whether to grant or deny an application under section 303. See Anthony D. Funches, 64 FR 14267, 14268 (1999); Alan R. Schankman, 63 FR 45260 (1998); Kuen H. Chen, 58 FR 65401, 65402 (1993). Thus, the allegation that Respondent materially falsified her application is properly considered in this proceeding, see Samuel S. Jackson, 72 FR 23848, 23852 (2007), and is, if proved, an adequate ground for denying her application. On the Show Cause Order, the Government made two allegations that Respondent engaged in material falsification. First, it alleged that in June 2004, Respondent failed to disclose her ‘‘post-1997 drug, abuse, arrest, and conviction’’ when she ‘‘appeared before the New York State Board of Dentistry * * * as an applicant for a license to practice dentistry.’’ Show Cause Order at 2. Respondent remains, however, licensed in good standing in the State of New York. Under these circumstances, the allegation that she failed to disclose to the New York Board of Dentistry the second arrest and conviction (and thus procured her dental license by fraudulent means) is a matter which should be resolved in the first instance by the State and not DEA. The allegation is therefore dismissed. Respondent’s statement on her DEA application is, however, properly before the Agency. Even accepting Respondent’s statement that she was advised by her legal counsel that she was not required to disclose her arrest and plea, DEA has long taken the view that even when a court withholds adjudication and ultimately dismisses the charge after the completion of probation, the proceeding is still a conviction within the meaning of the Controlled Substances Act. See Eric A. Baum, M.D., 53 FR 47272, 47274 (1988); see also David A. Hoxie, 69 FR 51477, 51478 (1994). Moreover, the failure to disclose such a conviction constitutes a material falsification because it is ‘‘capable of influencing’’ the decision as to whether to grant an application. See Kungys v. United States, 485 U.S. 759, 770 (1988) (int. quotation and other citation omitted). As DEA has frequently noted, an applicant’s answers to the various liability questions are material because the Agency ‘‘relies upon such answers to determine whether an investigation is needed prior to granting the application.’’ Martha Hernandez, M.D., 62 FR 61145, 61146 (1997). PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 Respondent’s failure to disclose the 2000 Maryland proceeding is material because the public interest inquiry under section 303(f) requires, inter alia, that the Agency examine her ‘‘experience in dispensing * * * controlled substances,’’ her ‘‘conviction record * * * relating to the * * * dispensing of controlled substances,’’ and her ‘‘[c]ompliance with applicable State, Federal, or local laws relating to controlled substances.’’ 21 U.S.C. 823(f). Respondent was therefore required to disclose the circumstances surrounding her subsequent arrest even if her conviction was expunged. Her failure to do so constitutes material falsification. Furthermore, even crediting Respondent’s statement that she was advised by counsel that she need not disclose the Maryland proceeding in the future, in her explanation she then proceeded to make an affirmative and material misrepresentation when she stated that ‘‘[n]o problems have occurred since’’ the 1997 federal proceeding. The statement was clearly false and Respondent had reason to know this to be so. I therefore conclude that Respondent knowingly made a material false statement in an attempt to obtain a favorable decision from the Agency on Respondent’s application and that granting Respondent a new registration ‘‘would be inconsistent with the public interest.’’ 21 U.S.C. 823(f); see also e.g., Dan E. Hale, 69 FR 69402 (2004). Order Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well as 28 CFR 0.100(b) & 0.104, I order that the application Pamela Monterosso, D.M.D., for a DEA Certificate of Registration as a practitioner, be, and it hereby is, denied. This order is effective March 31, 2008. Dated: February 15, 2008. Michele M. Leonhart, Deputy Administrator. [FR Doc. E8–3873 Filed 2–28–08; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a registration under this Section to a bulk manufacturer of a controlled substance in schedule I or II and prior to issuing a regulation under 21 U.S.C. 952(a)(2)(B) authorizing the importation E:\FR\FM\29FEN1.SGM 29FEN1 11149 Federal Register / Vol. 73, No. 41 / Friday, February 29, 2008 / Notices rwilkins on PROD1PC63 with NOTICES of such a substance, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing. Therefore, in accordance with Title 21 Code of Federal Regulations (CFR), 1301.34(a), this is notice that on January 28, 2008, Meridian Medical Technologies, 2555 Hermelin Drive, St. Louis, Missouri 63144, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Morphine (9300), a basic class of controlled substance listed in schedule II. The company plans to import products for research experimentation or clinical use and analytical testing. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic class of controlled substance may file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), Washington, DC 20537, or any being sent via express mail should be sent to Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than March 31, 2008. This procedure is to be conducted simultaneously with and independent of the procedures described in 21 CFR 1301.34(b), (c), (d), (e) and (f). As noted in a previous notice published in the Federal Register on September 23, 1975, (40 FR 43745–46), all applicants for registration to import a basic class of any controlled substance listed in schedule I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a), 21 U.S.C. 823(a), and 21 CFR 1301.34(b), (c), (d), (e) and (f) are satisfied. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E8–3858 Filed 2–28–08; 8:45 am] BILLING CODE 4410–09–P VerDate Aug<31>2005 19:22 Feb 28, 2008 Jkt 214001 DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a registration under this section to a bulk manufacturer of a controlled substance in schedule I or II, and prior to issuing a registration under 21 U.S.C. 952(a)(2) authorizing the importation of such a substance, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing. Therefore, in accordance with Title 21 Code of Federal Regulations (CFR), 1301.34(a), this is notice that on January 14, 2008, Supernus Pharmaceuticals, 1550 East Gude Drive, Rockville, Maryland 20850, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the basic classes of controlled substances listed in schedule II: Drug Schedule Oxycodone (9143) ........................ Morphine (9300) ........................... II II The company plans to import controlled substances for clinical trials and analytical testing. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances may file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), Washington, DC 20537, or any being sent via express mail should be sent to Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, VA. 22152; and must be filed no later than March 31, 2008. This procedure is to be conducted simultaneously with, and independent of, the procedures described in 21 CFR 1301.34(b), (c), (d), (e) and (f). As noted in a previous notice published in the Federal Register on September 23, 1975, (40 FR 43745–46), all applicants for registration to import a basic class of PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 any controlled substances in schedule I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied. Dated: February 20, 2008. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E8–3874 Filed 2–28–08; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on January 23, 2008, Stepan Company, Natural Products Dept., 100 W. Hunter Avenue, Maywood, New Jersey 07607, made application by renewal to the Drug Enforcement Administration (DEA) as a bulk manufacturer of the basic classes of controlled substances listed in schedule II: Drug Coca Leaves (9040) ..................... Cocaine (9041) ............................. Benzoylecgonine (9180) ............... Schedule II II II The company plans to manufacture the listed controlled substances in bulk for distribution to its customers. Any other such applicant and any person who is presently registered with DEA to manufacture such substances may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), Washington, DC 20537, or any being sent via express mail should be sent to Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152, and must be filed no later than April 29, 2008. E:\FR\FM\29FEN1.SGM 29FEN1

Agencies

[Federal Register Volume 73, Number 41 (Friday, February 29, 2008)]
[Notices]
[Pages 11148-11149]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3858]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Application

    Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to 
issuing a registration under this Section to a bulk manufacturer of a 
controlled substance in schedule I or II and prior to issuing a 
regulation under 21 U.S.C. 952(a)(2)(B) authorizing the importation

[[Page 11149]]

of such a substance, provide manufacturers holding registrations for 
the bulk manufacture of the substance an opportunity for a hearing.
    Therefore, in accordance with Title 21 Code of Federal Regulations 
(CFR), 1301.34(a), this is notice that on January 28, 2008, Meridian 
Medical Technologies, 2555 Hermelin Drive, St. Louis, Missouri 63144, 
made application by renewal to the Drug Enforcement Administration 
(DEA) to be registered as an importer of Morphine (9300), a basic class 
of controlled substance listed in schedule II.
    The company plans to import products for research experimentation 
or clinical use and analytical testing.
    Any bulk manufacturer who is presently, or is applying to be, 
registered with DEA to manufacture such basic class of controlled 
substance may file comments or objections to the issuance of the 
proposed registration and may, at the same time, file a written request 
for a hearing on such application pursuant to 21 CFR 1301.43 and in 
such form as prescribed by 21 CFR 1316.47.
    Any such written comments or objections being sent via regular mail 
should be addressed, in quintuplicate, to the Drug Enforcement 
Administration, Office of Diversion Control, Federal Register 
Representative (ODL), Washington, DC 20537, or any being sent via 
express mail should be sent to Drug Enforcement Administration, Office 
of Diversion Control, Federal Register Representative (ODL), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than March 31, 2008.
    This procedure is to be conducted simultaneously with and 
independent of the procedures described in 21 CFR 1301.34(b), (c), (d), 
(e) and (f). As noted in a previous notice published in the Federal 
Register on September 23, 1975, (40 FR 43745-46), all applicants for 
registration to import a basic class of any controlled substance listed 
in schedule I or II are, and will continue to be, required to 
demonstrate to the Deputy Assistant Administrator, Office of Diversion 
Control, Drug Enforcement Administration, that the requirements for 
such registration pursuant to 21 U.S.C. 958(a), 21 U.S.C. 823(a), and 
21 CFR 1301.34(b), (c), (d), (e) and (f) are satisfied.

Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
 [FR Doc. E8-3858 Filed 2-28-08; 8:45 am]
BILLING CODE 4410-09-P

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