80 FR 50043 - Bulk Manufacturer of Controlled Substances Application: Austin Pharma LLC
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 | 50043-50043 | |
| FR Document | 2015-20284 |
[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)] [Notices] [Page 50043] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-20284] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Austin Pharma LLC 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 23, 2015, Austin Pharma LLC, 811 Paloma Drive, Suite C, Round Rock, Texas 78665-2402 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Marihuana (7360)........................... I Tetrahydrocannabinols (7370)............... I ------------------------------------------------------------------------ The company plans to manufacture bulk synthetic active pharmaceutical ingredients (APIs) for product development and distribution to its customers. No other activity for this drug code is authorized for this registration. Dated: August 10, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015-20284 Filed 8-17-15; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices 50043
denial’ ’’ of his withdrawal request. Id. ADDRESSES: Written comments should ACTION: 30-Day notice.
at 3 (quoting 5 U.S.C. 555(e)). be sent to: Drug Enforcement
Because the Office of Diversion Administration, Attention: DEA Federal SUMMARY: The Department of Justice,
Control had not complied with section Register Representative/ODXL, 8701 Office of Justice Programs, Bureau of
555(e), the then-Administrator denied Morrissette Drive, Springfield, Virginia Justice Assistance, will submit the
the Government’s Request for Final 22152. Request for hearings should be following information collection request
Agency Action. Id. The then- sent to: Drug Enforcement for review and clearance in accordance
Administrator returned the record to the Administration, Attention: Hearing with the Paperwork Reduction Act of
Government’s Counsel, with the Clerk/LJ, 8701 Morrissette Drive, 1995. The proposed information
instruction that its Request should not Springfield, Virginia 22152. collection was previously published in
be re-submitted until such time as the SUPPLEMENTARY INFORMATION: The 80 FR 32180, on June 5, 2015, allowing
Office of Diversion Control complied Attorney General has delegated his for a 60-day comment period.
with 5 U.S.C. 555(e) and explained why authority under the Controlled
Applicant has not demonstrated good DATES: Comments are encouraged and
Substances Act to the Administrator of will be accepted for an additional 30
cause to withdraw his application, as the Drug Enforcement Administration
well as why the withdrawal is not in the days until September 17, 2015.
(DEA), 28 CFR 0.100(b). Authority to
public interest. Id. exercise all necessary functions with FOR FURTHER INFORMATION CONTACT: If
On August 7, 2015, Government respect to the promulgation and you have additional comments,
Counsel filed a Request for Dismissal of implementation of 21 CFR part 1301, suggestions, or need a copy of the
Order to Show Cause. Therein, incident to the registration of proposed information collection
Government Counsel represents that on manufacturers, distributors, dispensers, instrument with instructions or
July 30, 3015, the Office of Diversion importers, and exporters of controlled additional information, please contact
Control had decided to allow substances (other than final orders in C. Casto at 1–202–353–7193, Bureau of
Respondent to withdraw his connection with suspension, denial, or Justice Assistance, Office of Justice
application. The Government therefore revocation of registration) has been Programs, U. S. Department of Justice,
requests an Order dismissing the Show redelegated to the Deputy Assistant 810 7th Street NW., Washington, DC,
Cause Order. Administrator of the DEA Office of 20531 or by email at Chris.Casto@
Because the Office of Diversion Diversion Control (‘‘Deputy Assistant usdoj.gov. You may also contact the
Control has granted Respondent’s Administrator’’) pursuant to section 7 of Office of Management and Budget,
withdrawal request, there is no longer 28 CFR part 0, appendix to subpart R. Office of Information and Regulatory
an application to act upon and the case In accordance with 21 CFR Affairs, Attention Department of Justice
is now moot. See Thomas E. Mitchell, 1301.33(a), this is notice that on April Desk Officer, Washington, DC 20503.
76 FR 20032, 20033 (2011). 23, 2015, Austin Pharma LLC, 811 Additionally, comments may be
Accordingly, I grant the Government’s Paloma Drive, Suite C, Round Rock, submitted via email to OIRA_
Request and dismiss the Order to Show Texas 78665–2402 applied to be submissions@omb.eop.gov.
Cause. registered as a bulk manufacturer of the
SUPPLEMENTARY INFORMATION: Written
Order following basic classes of controlled
comments and suggestions from the
substances:
Pursuant to the authority vested in me public and affected agencies concerning
by 21 U.S.C. 823(f), as well as 28 CFR Controlled substance Schedule the proposed collection of information
0.100(b), I order that the Order to Show are encouraged. Your comments should
Cause issued to Matthew Valentine/Liar Marihuana (7360) ......................... I address one or more of the following
Catchers be, and it hereby is, dismissed. Tetrahydrocannabinols (7370) ..... I four points:
This Order is effective immediately. —Evaluate whether the proposed
The company plans to manufacture
Dated: August 10, 2015. collection of information is necessary
bulk synthetic active pharmaceutical
Chuck Rosenberg,
ingredients (APIs) for product for the proper performance of the
Acting-Administrator. development and distribution to its functions of the National Motor
[FR Doc. 2015–20344 Filed 8–17–15; 8:45 am] customers. No other activity for this Vehicle Title Information System
BILLING CODE 4410–09–P drug code is authorized for this (NMVTIS), including whether the
registration. information will have practical utility;
—Evaluate the accuracy of the agency’s
DEPARTMENT OF JUSTICE Dated: August 10, 2015.
estimate of the burden of the
Joseph T. Rannazzisi,
proposed collection of information,
Drug Enforcement Administration Deputy Assistant Administrator. including the validity of the
[Docket No. DEA–392] [FR Doc. 2015–20284 Filed 8–17–15; 8:45 am] methodology and assumptions used;
BILLING CODE 4410–09–P
—Evaluate whether and if so how the
Bulk Manufacturer of Controlled quality, utility, and clarity of the
Substances Application: Austin information to be collected can be
Pharma LLC DEPARTMENT OF JUSTICE
enhanced; and
[OMB Number 1121–0335] —Minimize the burden of the collection
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ACTION: Notice of application.
Agency Information Collection of information on those who are to
DATES: Registered bulk manufacturers of Activities; Proposed eCollection respond, including through the use of
the affected basic classes, and eComments Requested; National appropriate automated, electronic,
applicants therefore, may file written Motor Vehicle Title Information System mechanical, or other technological
comments on or objections to the (NMVTIS) collection techniques or other forms
issuance of the proposed registration in of information technology, e.g.,
accordance with 21 CFR 1301.33(a) on AGENCY:Bureau of Justice Assistance, permitting electronic submission of
or before October 19, 2015. Department of Justice. responses.
VerDate Sep<11>2014 17:02 Aug 17, 2015 Jkt 235001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\18AUN1.SGM 18AUN1](https://thefederalregister.org/doc/80_FR_50202/page/1.svg)
Document Created: 2015-12-15 12:04:42
Document Modified: 2015-12-15 12:04:42
| 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 50043 |
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