80 FR 78765 - Manufacturer of Controlled Substances Registration: Austin Pharma LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 242 (December 17, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 242 (December 17, 2015)
| Page Range | 78765-78765 | |
| FR Document | 2015-31667 |
[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)] [Notices] [Page 78765] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31667] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Manufacturer of Controlled Substances Registration: Austin Pharma LLC ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Austin Pharma LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Austin Pharma LLC registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated August 10, 2015, and published in the Federal Register on August 18, 2015, 80 FR 50043, Austin Pharma LLC, 811 Paloma Drive, Suite C, Round Rock, Texas 78665- 2402 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Austin Pharma LLC to manufacture the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration 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 these drug codes are authorized for this registration. Dated: December 9, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015-31667 Filed 12-16-15; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices 78765
requested, the Commission will provide easily converted to MSWord, and 1301.33, the above-named company is
its advice to USTR by May 24, 2016. should not include any confidential granted registration as a bulk
Written Submissions: No public business information. The summary will manufacturer of the following basic
hearing is planned. However, interested be published as provided if it meets classes of controlled substances:
parties are invited to file written these requirements and is germane to
submissions concerning this the subject matter of the investigation. Controlled substance Schedule
investigation. All written submissions In the appendix the Commission will
should be addressed to the Secretary, identify the name of the organization Marihuana (7360) ......................... I
and all such submissions should be furnishing the summary, and will Tetrahydrocannabinols (7370) ..... I
received not later than 5:15 p.m., include a link to the Commission’s
January 25, 2016. All written Electronic Document Information The company plans to manufacture
submissions must conform with the System (EDIS) where the full written bulk synthetic active pharmaceutical
provisions of section 201.8 of the submission can be found. ingredients (APIs) for product
Commission’s Rules of Practice and development and distribution to its
By order of the Commission. customers. No other activity for these
Procedure (19 CFR 201.8). Section 201.8
Dated: December 14, 2015. drug codes are authorized for this
and the Commission’s Handbook on
Lisa R. Barton, registration.
Filing Procedures require that interested
parties file documents electronically on Secretary to the Commission. Dated: December 9, 2015.
or before the filing deadline and submit [FR Doc. 2015–31734 Filed 12–16–15; 8:45 am] Louis J. Milione,
eight (8) true paper copies by 12:00 p.m. BILLING CODE 7020–02–P
Deputy Assistant Administrator.
eastern time on the next business day. [FR Doc. 2015–31667 Filed 12–16–15; 8:45 am]
In the event that confidential treatment
BILLING CODE 4410–09–P
of a document is requested, interested DEPARTMENT OF JUSTICE
parties must file, at the same time as the
eight paper copies, at least four (4) Drug Enforcement Administration
DEPARTMENT OF JUSTICE
additional true paper copies in which [Docket No. DEA–392]
the confidential information must be Drug Enforcement Administration
deleted (see the following paragraph for Manufacturer of Controlled
[Docket No. DEA–392]
further information regarding Substances Registration: Austin
confidential business information). Pharma LLC Bulk Manufacturer of Controlled
Persons with questions regarding Substances Application: Johnson
electronic filing should contact the ACTION: Notice of registration.
Matthey, Inc.
Secretary (202–205–2000). SUMMARY: Austin Pharma LLC applied
Any submissions that contain ACTION: Notice of application.
to be registered as a manufacturer of
confidential business information must
certain basic classes of controlled
also conform with the requirements of DATES: Registered bulk manufacturers of
substances. The Drug Enforcement
section 201.6 of the Commission’s Rules the affected basic classes, and
Administration (DEA) grants Austin
of Practice and Procedure (19 CFR applicants therefore, may file written
201.6). Section 201.6 of the rules Pharma LLC registration as a
manufacturer of those controlled comments on or objections to the
requires that the cover of the document issuance of the proposed registration in
and the individual pages be clearly substances.
accordance with 21 CFR 1301.33(a) on
marked as to whether they are the SUPPLEMENTARY INFORMATION: By notice
or before February 16, 2016.
‘‘confidential’’ or ‘‘non-confidential’’ dated August 10, 2015, and published in
ADDRESSES: Written comments should
version, and that the confidential the Federal Register on August 18,
2015, 80 FR 50043, Austin Pharma LLC, be sent to: Drug Enforcement
business information be clearly
identified by means of brackets. All 811 Paloma Drive, Suite C, Round Rock, Administration, Attention: DEA Federal
written submissions, except for Texas 78665–2402 applied to be Register Representative/ODW, 8701
confidential business information, will registered as a manufacturer of certain Morrissette Drive, Springfield, Virginia
be made available for inspection by basic classes of controlled substances. 22152. Request for hearings should be
interested parties. The Commission may No comments or objections were sent to: Drug Enforcement
include some or all of the confidential submitted for this notice. Administration, Attention: Hearing
business information submitted in the The DEA has considered the factors in Clerk/LJ, 8701 Morrissette Drive,
course of this investigation in the report 21 U.S.C. 823(a) and determined that Springfield, Virginia 22152.
it sends to the USTR and the President. the registration of Austin Pharma LLC to SUPPLEMENTARY INFORMATION: The
As requested, the Commission will issue manufacture the basic classes of Attorney General has delegated her
a public version of its report, with any controlled substances is consistent with authority under the Controlled
confidential business information the public interest and with United Substances Act to the Administrator of
deleted, shortly after it transmits its States obligations under international the Drug Enforcement Administration
report. treaties, conventions, or protocols in (DEA), 28 CFR 0.100(b). Authority to
Summaries of Written Submissions: effect on May 1, 1971. The DEA exercise all necessary functions with
The Commission intends to publish investigated the company’s maintenance respect to the promulgation and
asabaliauskas on DSK5VPTVN1PROD with NOTICES
summaries of the positions of interested of effective controls against diversion by implementation of 21 CFR part 1301,
persons in an appendix to its report. inspecting and testing the company’s incident to the registration of
Persons wishing to have a summary of physical security systems, verifying the manufacturers, distributors, dispensers,
their position included in the appendix company’s compliance with state and importers, and exporters of controlled
should include a summary with their local laws, and reviewing the company’s substances (other than final orders in
written submission. The summary may background and history. connection with suspension, denial, or
not exceed 500 words, should be in Therefore, pursuant to 21 U.S.C. revocation of registration) has been
MSWord format or a format that can be 823(a), and in accordance with 21 CFR redelegated to the Deputy Assistant
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Document Created: 2018-03-02 09:18:45
Document Modified: 2018-03-02 09:18:45
| 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 registration. | |
| FR Citation | 80 FR 78765 |
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