Bulk Manufacturer of Controlled Substances Application: Alltech Associates, Inc., 50041-50042 [2015-20283]

Download as PDF 50041 Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices respondent in a particular case and the community of registrants. See Gaudio, 74 FR at 10095 (quoting Southwood, 71 FR at 36503). Cf. McCarthy v. SEC, 406 F.3d 179, 188–89 (2d Cir. 2005) (upholding SEC’s express adoption of ‘‘deterrence, both specific and general, as a component in analyzing the remedial efficacy of sanctions’’). Having reviewed Respondent’s Statement of Position, I conclude that he has failed to produce sufficient evidence to show why he should be entrusted with a new registration. His acceptance of responsibility is equivocal at best, as while he appears to acknowledge his wrongdoing with respect to his having provided the Schedule II order forms to Mr. Whitney, his explanation for why he materially falsified his DEA application is clearly disingenuous. So too, is his assertion that he ‘‘did not knowingly tell lies, nor . . . intentionally try to deceive anyone.’’ Because Respondent committed intentional misconduct when he materially falsified his application, I find his misconduct to be egregious.14 Accordingly, his failure to accept responsibility for this misconduct is reason alone to conclude that he cannot be entrusted with a new registration.15 Moreover, the Agency has a manifest interest in deterring misconduct on the part of others who may contemplate materially falsifying their applications for registration. Accordingly, I conclude that denial of his application is necessary to protect the public interest. Order Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well as 28 CFR 0.100(b), I order that the application of Arthur H. Bell, D.O., for a DEA Certificate of Registration as a practitioner be, and it hereby is, denied. This Order is effective immediately. Dated: August 10, 2015. Chuck Rosenberg, Acting Administrator. [FR Doc. 2015–20353 Filed 8–17–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Alltech Associates, Inc. ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before October 19, 2015. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on April 24, 2015, Alltech Associates, Inc., 2051 Waukegan Road, Deerfield, Illinois 60015 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ADDRESSES: asabaliauskas on DSK5VPTVN1PROD with NOTICES Controlled substance Schedule Methcathinone (1237) .................................................................................................................................................................................. N-Ethylamphetamine (1475) ........................................................................................................................................................................ N,N-Dimethylamphetamine (1480) .............................................................................................................................................................. 4-Methylaminorex (cis isomer) (1590) ......................................................................................................................................................... Gamma Hydroxybutyric Acid (2010) ........................................................................................................................................................... Alpha-ethyltryptamine (7249) ...................................................................................................................................................................... Lysergic acid diethylamide (7315) ............................................................................................................................................................... 2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C–T–7) (7348) ............................................................................................................... Tetrahydrocannabinols (7370) ..................................................................................................................................................................... Mescaline (7381) ......................................................................................................................................................................................... 4-Bromo-2,5-dimethoxyamphetamine (7391) .............................................................................................................................................. 4-Bromo-2,5-dimethoxyphenethylamine (7392) .......................................................................................................................................... 4-Methyl-2,5-dimethoxyamphetamine (7395) .............................................................................................................................................. 2,5-Dimethoxyamphetamine (7396) ............................................................................................................................................................ 2,5-Dimethoxy-4-ethylamphetamine (7399) ................................................................................................................................................ 3,4-Methylenedioxyamphetamine (7400) .................................................................................................................................................... N-Hydroxy-3,4-methylenedioxyamphetamine (7402) .................................................................................................................................. 3,4-Methylenedioxy-N-ethylamphetamine (7404) ........................................................................................................................................ 3,4-Methylenedioxymethamphetamine (7405) ............................................................................................................................................ 4-Methoxyamphetamine (7411) ................................................................................................................................................................... 5-Methoxy-N-N-dimethyltryptamine (7431) ................................................................................................................................................. Alpha-methyltryptamine (7432) ................................................................................................................................................................... Bufotenine (7433) ........................................................................................................................................................................................ Diethyltryptamine (7434) ............................................................................................................................................................................. Dimethyltryptamine (7435) .......................................................................................................................................................................... Psilocybin (7437) ......................................................................................................................................................................................... 14 Having found that Respondent’s material falsification of his application is egregious and that he has not accepted responsibility for the violation, I need not decide whether the other proven VerDate Sep<11>2014 17:02 Aug 17, 2015 Jkt 235001 violations are sufficiently egregious to support the denial of the application. 15 As to the violation in authorizing Whitney to order schedule II drugs, Respondent stated that this ´ was the result of ‘‘pure naivete and ignorance of the PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 I I I I I I I I I I I I I I I I I I I I I I I I I I law on my part.’’ However, Respondent has offered no evidence of remedial actions he has taken to demonstrate that he is now familiar with the laws and regulations applicable to the lawful dispensing of controlled substances. E:\FR\FM\18AUN1.SGM 18AUN1 50042 Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices Controlled substance Schedule Psilocyn (7438) ............................................................................................................................................................................................ 5-Methoxy-N,N-diisopropyltryptamine (7439) .............................................................................................................................................. N-Ethyl-1-phenylcyclohexylamine (7455) .................................................................................................................................................... 1-(1-Phenylcyclohexyl)pyrrolidine (7458) .................................................................................................................................................... 1-[1-(2-Thienyl)cyclohexyl]piperidine (7470) ............................................................................................................................................... 2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine (2C–E) (7509) ..................................................................................................................... 2-(2,5-Dimethoxyphenyl) ethanamine (2C–H) (7517) ................................................................................................................................. 2-(4-lodo-2,5-dimethoxyphenyl) ethanamine (2C–I) (7518) ........................................................................................................................ 2-(4-Isopropylthio)-2,5-dimethoxyphenyl) ethanamine (2C–T–4) (7532) .................................................................................................... Dihydromorphine (9145) .............................................................................................................................................................................. Heroin (9200) ............................................................................................................................................................................................... Normorphine (9313) .................................................................................................................................................................................... Methamphetamine (1105) ........................................................................................................................................................................... 1-Phenylcyclohexylamine (7460) ................................................................................................................................................................. Phencyclidine (7471) ................................................................................................................................................................................... Phenylacetone (8501) ................................................................................................................................................................................. 1-Piperidinocyclohexanecarbonitrile (8603) ................................................................................................................................................ Cocaine (9041) ............................................................................................................................................................................................ Codeine (9050) ............................................................................................................................................................................................ Dihydrocodeine (9120) ................................................................................................................................................................................ Ecgonine (9180) .......................................................................................................................................................................................... Meperidine intermediate-B (9233) ............................................................................................................................................................... Morphine (9300) .......................................................................................................................................................................................... Noroxymorphone (9668) .............................................................................................................................................................................. The company plans to manufacture high purity drug standards used for analytical applications only in clinical, toxicological, and forensic laboratories and for distribution to its customers. Dated: August 10, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–20283 Filed 8–17–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [Docket No. 13–29] Drug Enforcement Administration asabaliauskas on DSK5VPTVN1PROD with NOTICES Matthew Valentine/Liar Catchers; Order On April 5, 2013, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, issued an Order to Show Cause to Matthew Valentine (hereinafter, Applicant), of Lexington, Kentucky. The Show Cause Order proposed the denial of Applicant’s pending application for a DEA Certificate of Registration as a Researcher, which would authorize Applicant to possess and use controlled substances as a canine handler, on the ground that his registration would be inconsistent with the public interest. GX 1, at 1 (citing 21 U.S.C. 823(f)). On April 29, 2013, Applicant, acting pro se, filed a request for a hearing with the DEA Office of Administrative Law Judges. GX 2. After the matter was assigned to an Administrative Law Judge (ALJ), Applicant submitted a VerDate Sep<11>2014 17:02 Aug 17, 2015 Jkt 235001 letter in which he requested to withdraw his application. GX 3. Therein, Applicant stated that he was ‘‘not in a position to fight this legal battle at this time.’’ Id. A few weeks later, Applicant requested a stay until May 31, 2013, see GX 4, which was granted by the ALJ. See GX 5. Upon presentation of Applicant’s withdrawal request to the Office of Diversion Control (OD), the latter advised Government Counsel that it would accept the request only if Applicant agreed not to reapply for three years. Request for Final Agency Action, at 3. Applicant rejected OD’s offer. Id. Thereafter, OD made a subsequent offer that would have allowed Applicant to withdraw if he agreed not to reapply for two years. Id. Applicant also rejected this offer. Id. According to Government Counsel, on May 22, 2012, OD, ‘‘without providing a basis for its decision,’’ notified the former that it had rejected Applicant’s withdrawal request and ‘‘instructed Chief Counsel to take the matter to hearing.’’ Id. The next day, Government Counsel notified the ALJ of OD’s decision. The ALJ then vacated the stay and set the matter for hearing. GX 7, at 1–2. On May 29, 2013, Applicant submitted a request to waive his right to a hearing and submitted various documents in support of his application. GX 8. The ALJ then ordered that the proceeding be terminated. GX 9. Thereafter, on October 29, 2013, the Government submitted a Request for Final Agency Action. Req. for Final Agency Action, at 15. Therein, the PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 I I I I I I I I I I I I II II II II II II II II II II II II Government sought the denial of Applicant’s application. Id. at 1. Upon review, the then-Administrator denied the Government’s request. Order of the Administrator, at 3 (May 2, 2015) (hereinafter, Order). The thenAdministrator specifically explained that under a DEA regulation, ‘‘‘[a]n application may be amended or withdrawn with permission of the Administrator at any time where good cause is shown by the applicant or where the amendment or withdrawal is in the public interest.’’’ Id. at 2 (quoting 21 CFR 1301.16(a)). The thenAdministrator also relied on section 555(e) of the Administrative Procedure Act, which provides that: Prompt notice shall be given of the denial in whole or in part of a written application, petition, or other request of an interested person made in connection with any agency proceedings. Except in affirming a prior denial or when the denial is self-explanatory, the notice shall be accompanied by a brief statement of the grounds for denial. 5 U.S.C. 555(e) (quoted in Order, at 2). Based on the plain language of section 555(e), the then-Administrator held that Applicant’s withdrawal request clearly was a ‘‘request of an interested person made in connection with [an] agency proceeding.’’ Order, at 2. She further noted that the grounds for denying Applicant’s withdrawal request were not ‘‘self-explanatory,’’ and were, in fact, ‘‘totally unknown.’’ Id. Accordingly, the then-Administrator held that the Office of Diversion Control was required to provide Applicant with a ‘‘ ‘notice,’ ’’ which was ‘‘ ‘accompanied by a brief statement of the grounds for E:\FR\FM\18AUN1.SGM 18AUN1

Agencies

[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Notices]
[Pages 50041-50042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20283]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Alltech 
Associates, Inc.

ACTION: Notice of application.

-----------------------------------------------------------------------

DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration in accordance with 21 CFR 
1301.33(a) on or before October 19, 2015.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODXL, 
8701 Morrissette Drive, Springfield, Virginia 22152. Request for 
hearings should be sent to: Drug Enforcement Administration, Attention: 
Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Deputy Assistant Administrator of the DEA Office of Diversion 
Control (``Deputy Assistant Administrator'') pursuant to section 7 of 
28 CFR part 0, appendix to subpart R.
    In accordance with 21 CFR 1301.33(a), this is notice that on April 
24, 2015, Alltech Associates, Inc., 2051 Waukegan Road, Deerfield, 
Illinois 60015 applied to be registered as a bulk manufacturer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Methcathinone (1237)........................  I
N-Ethylamphetamine (1475)...................  I
N,N-Dimethylamphetamine (1480)..............  I
4-Methylaminorex (cis isomer) (1590)........  I
Gamma Hydroxybutyric Acid (2010)............  I
Alpha-ethyltryptamine (7249)................  I
Lysergic acid diethylamide (7315)...........  I
2,5-Dimethoxy-4-(n)-propylthiophenethylamine  I
 (2C-T-7) (7348).
Tetrahydrocannabinols (7370)................  I
Mescaline (7381)............................  I
4-Bromo-2,5-dimethoxyamphetamine (7391).....  I
4-Bromo-2,5-dimethoxyphenethylamine (7392)..  I
4-Methyl-2,5-dimethoxyamphetamine (7395)....  I
2,5-Dimethoxyamphetamine (7396).............  I
2,5-Dimethoxy-4-ethylamphetamine (7399).....  I
3,4-Methylenedioxyamphetamine (7400)........  I
N-Hydroxy-3,4-methylenedioxyamphetamine       I
 (7402).
3,4-Methylenedioxy-N-ethylamphetamine (7404)  I
3,4-Methylenedioxymethamphetamine (7405)....  I
4-Methoxyamphetamine (7411).................  I
5-Methoxy-N-N-dimethyltryptamine (7431).....  I
Alpha-methyltryptamine (7432)...............  I
Bufotenine (7433)...........................  I
Diethyltryptamine (7434)....................  I
Dimethyltryptamine (7435)...................  I
Psilocybin (7437)...........................  I

[[Page 50042]]

 
Psilocyn (7438).............................  I
5-Methoxy-N,N-diisopropyltryptamine (7439)..  I
N-Ethyl-1-phenylcyclohexylamine (7455)......  I
1-(1-Phenylcyclohexyl)pyrrolidine (7458)....  I
1-[1-(2-Thienyl)cyclohexyl]piperidine (7470)  I
2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine    I
 (2C-E) (7509).
2-(2,5-Dimethoxyphenyl) ethanamine (2C-H)     I
 (7517).
2-(4-lodo-2,5-dimethoxyphenyl) ethanamine     I
 (2C-I) (7518).
2-(4-Isopropylthio)-2,5-dimethoxyphenyl)      I
 ethanamine (2C-T-4) (7532).
Dihydromorphine (9145)......................  I
Heroin (9200)...............................  I
Normorphine (9313)..........................  I
Methamphetamine (1105)......................  II
1-Phenylcyclohexylamine (7460)..............  II
Phencyclidine (7471)........................  II
Phenylacetone (8501)........................  II
1-Piperidinocyclohexanecarbonitrile (8603)..  II
Cocaine (9041)..............................  II
Codeine (9050)..............................  II
Dihydrocodeine (9120).......................  II
Ecgonine (9180).............................  II
Meperidine intermediate-B (9233)............  II
Morphine (9300).............................  II
Noroxymorphone (9668).......................  II
------------------------------------------------------------------------

    The company plans to manufacture high purity drug standards used 
for analytical applications only in clinical, toxicological, and 
forensic laboratories and for distribution to its customers.

    Dated: August 10, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-20283 Filed 8-17-15; 8:45 am]
 BILLING CODE 4410-09-P