80 FR 50041 - Bulk Manufacturer of Controlled Substances Application: Alltech Associates, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 159 (August 18, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 159 (August 18, 2015)
| Page Range | 50041-50042 | |
| FR Document | 2015-20283 |
[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)] [Notices] [Pages 50041-50042] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-20283] ----------------------------------------------------------------------- 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
![Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices 50041
respondent in a particular case and the that denial of his application is ADDRESSES: Written comments should
community of registrants. See Gaudio, necessary to protect the public interest. be sent to: Drug Enforcement
74 FR at 10095 (quoting Southwood, 71 Administration, Attention: DEA Federal
Order
FR at 36503). Cf. McCarthy v. SEC, 406 Register Representative/ODXL, 8701
F.3d 179, 188–89 (2d Cir. 2005) Pursuant to the authority vested in me Morrissette Drive, Springfield, Virginia
(upholding SEC’s express adoption of by 21 U.S.C. 823(f), as well as 28 CFR 22152. Request for hearings should be
‘‘deterrence, both specific and general, 0.100(b), I order that the application of sent to: Drug Enforcement
as a component in analyzing the Arthur H. Bell, D.O., for a DEA Administration, Attention: Hearing
remedial efficacy of sanctions’’). Certificate of Registration as a Clerk/LJ, 8701 Morrissette Drive,
Having reviewed Respondent’s practitioner be, and it hereby is, denied. Springfield, Virginia 22152.
Statement of Position, I conclude that he This Order is effective immediately. SUPPLEMENTARY INFORMATION: The
has failed to produce sufficient evidence Dated: August 10, 2015. Attorney General has delegated his
to show why he should be entrusted Chuck Rosenberg, authority under the Controlled
with a new registration. His acceptance Acting Administrator. Substances Act to the Administrator of
of responsibility is equivocal at best, as [FR Doc. 2015–20353 Filed 8–17–15; 8:45 am]
the Drug Enforcement Administration
while he appears to acknowledge his (DEA), 28 CFR 0.100(b). Authority to
BILLING CODE 4410–09–P
wrongdoing with respect to his having exercise all necessary functions with
provided the Schedule II order forms to respect to the promulgation and
Mr. Whitney, his explanation for why DEPARTMENT OF JUSTICE implementation of 21 CFR part 1301,
he materially falsified his DEA incident to the registration of
application is clearly disingenuous. So Drug Enforcement Administration manufacturers, distributors, dispensers,
too, is his assertion that he ‘‘did not importers, and exporters of controlled
knowingly tell lies, nor . . . [Docket No. DEA–392] substances (other than final orders in
intentionally try to deceive anyone.’’ connection with suspension, denial, or
Because Respondent committed Bulk Manufacturer of Controlled revocation of registration) has been
intentional misconduct when he Substances Application: Alltech redelegated to the Deputy Assistant
materially falsified his application, I Associates, Inc. Administrator of the DEA Office of
find his misconduct to be egregious.14 Diversion Control (‘‘Deputy Assistant
Accordingly, his failure to accept ACTION: Notice of application. Administrator’’) pursuant to section 7 of
responsibility for this misconduct is 28 CFR part 0, appendix to subpart R.
reason alone to conclude that he cannot DATES: Registered bulk manufacturers of In accordance with 21 CFR
be entrusted with a new registration.15 the affected basic classes, and 1301.33(a), this is notice that on April
Moreover, the Agency has a manifest applicants therefore, may file written 24, 2015, Alltech Associates, Inc., 2051
interest in deterring misconduct on the comments on or objections to the Waukegan Road, Deerfield, Illinois
part of others who may contemplate issuance of the proposed registration in 60015 applied to be registered as a bulk
materially falsifying their applications accordance with 21 CFR 1301.33(a) on manufacturer of the following basic
for registration. Accordingly, I conclude or before October 19, 2015. 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 (2C–T–7) (7348) ............................................................................................................... I
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 (7402) .................................................................................................................................. I
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
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Bufotenine (7433) ........................................................................................................................................................................................ I
Diethyltryptamine (7434) ............................................................................................................................................................................. I
Dimethyltryptamine (7435) .......................................................................................................................................................................... I
Psilocybin (7437) ......................................................................................................................................................................................... I
14 Having found that Respondent’s material violations are sufficiently egregious to support the law on my part.’’ However, Respondent has offered
falsification of his application is egregious and that denial of the application. no evidence of remedial actions he has taken to
he has not accepted responsibility for the violation, 15 As to the violation in authorizing Whitney to demonstrate that he is now familiar with the laws
I need not decide whether the other proven order schedule II drugs, Respondent stated that this and regulations applicable to the lawful dispensing
was the result of ‘‘pure naiveté and ignorance of the of controlled substances.
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![50042 Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices
Controlled substance Schedule
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 (2C–E) (7509) ..................................................................................................................... I
2-(2,5-Dimethoxyphenyl) ethanamine (2C–H) (7517) ................................................................................................................................. I
2-(4-lodo-2,5-dimethoxyphenyl) ethanamine (2C–I) (7518) ........................................................................................................................ I
2-(4-Isopropylthio)-2,5-dimethoxyphenyl) ethanamine (2C–T–4) (7532) .................................................................................................... I
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 letter in which he requested to Government sought the denial of
high purity drug standards used for withdraw his application. GX 3. Applicant’s application. Id. at 1.
analytical applications only in clinical, Therein, Applicant stated that he was Upon review, the then-Administrator
toxicological, and forensic laboratories ‘‘not in a position to fight this legal denied the Government’s request. Order
and for distribution to its customers. battle at this time.’’ Id. A few weeks of the Administrator, at 3 (May 2, 2015)
Dated: August 10, 2015. later, Applicant requested a stay until (hereinafter, Order). The then-
Joseph T. Rannazzisi, May 31, 2013, see GX 4, which was Administrator specifically explained
Deputy Assistant Administrator.
granted by the ALJ. See GX 5. that under a DEA regulation, ‘‘‘[a]n
Upon presentation of Applicant’s application may be amended or
[FR Doc. 2015–20283 Filed 8–17–15; 8:45 am]
withdrawal request to the Office of withdrawn with permission of the
BILLING CODE 4410–09–P
Diversion Control (OD), the latter Administrator at any time where good
advised Government Counsel that it cause is shown by the applicant or
DEPARTMENT OF JUSTICE would accept the request only if where the amendment or withdrawal is
Applicant agreed not to reapply for in the public interest.’’’ Id. at 2 (quoting
[Docket No. 13–29] three years. Request for Final Agency 21 CFR 1301.16(a)). The then-
Action, at 3. Applicant rejected OD’s Administrator also relied on section
Drug Enforcement Administration offer. Id. Thereafter, OD made a 555(e) of the Administrative Procedure
subsequent offer that would have Act, which provides that:
Matthew Valentine/Liar Catchers;
allowed Applicant to withdraw if he Prompt notice shall be given of the denial
Order
agreed not to reapply for two years. Id. in whole or in part of a written application,
On April 5, 2013, the Deputy Applicant also rejected this offer. Id. petition, or other request of an interested
Assistant Administrator, Office of According to Government Counsel, on person made in connection with any agency
Diversion Control, Drug Enforcement May 22, 2012, OD, ‘‘without providing proceedings. Except in affirming a prior
a basis for its decision,’’ notified the denial or when the denial is self-explanatory,
Administration, issued an Order to the notice shall be accompanied by a brief
Show Cause to Matthew Valentine former that it had rejected Applicant’s
statement of the grounds for denial.
(hereinafter, Applicant), of Lexington, withdrawal request and ‘‘instructed
Chief Counsel to take the matter to 5 U.S.C. 555(e) (quoted in Order, at 2).
Kentucky. The Show Cause Order
proposed the denial of Applicant’s hearing.’’ Id. The next day, Government Based on the plain language of section
pending application for a DEA Counsel notified the ALJ of OD’s 555(e), the then-Administrator held that
Certificate of Registration as a decision. The ALJ then vacated the stay Applicant’s withdrawal request clearly
Researcher, which would authorize and set the matter for hearing. GX 7, at was a ‘‘request of an interested person
Applicant to possess and use controlled 1–2. made in connection with [an] agency
substances as a canine handler, on the On May 29, 2013, Applicant proceeding.’’ Order, at 2. She further
ground that his registration would be submitted a request to waive his right to noted that the grounds for denying
asabaliauskas on DSK5VPTVN1PROD with NOTICES
inconsistent with the public interest. GX a hearing and submitted various Applicant’s withdrawal request were
1, at 1 (citing 21 U.S.C. 823(f)). documents in support of his not ‘‘self-explanatory,’’ and were, in
On April 29, 2013, Applicant, acting application. GX 8. The ALJ then ordered fact, ‘‘totally unknown.’’ Id.
pro se, filed a request for a hearing with that the proceeding be terminated. GX 9. Accordingly, the then-Administrator
the DEA Office of Administrative Law Thereafter, on October 29, 2013, the held that the Office of Diversion Control
Judges. GX 2. After the matter was Government submitted a Request for was required to provide Applicant with
assigned to an Administrative Law Final Agency Action. Req. for Final a ‘‘ ‘notice,’ ’’ which was ‘‘ ‘accompanied
Judge (ALJ), Applicant submitted a Agency Action, at 15. Therein, the by a brief statement of the grounds for
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Document Created: 2015-12-15 12:04:54
Document Modified: 2015-12-15 12:04:54
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| 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. | |
| FR Citation | 80 FR 50041 |
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