83 FR 5274 - Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 25 (February 6, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 25 (February 6, 2018)
| Page Range | 5274-5274 | |
| FR Document | 2018-02345 |
[Federal Register Volume 83, Number 25 (Tuesday, February 6, 2018)] [Notices] [Page 5274] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02345] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, 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 April 9, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 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 December 11, 2017, Patheon Pharmaceuticals, Inc., 2110 E Galbraith Road, Cincinnati, OH 45237 applied for renewal of their registration as a bulk manufacturer of the Schedule I control substance Gamma Hydroxybutyric Acid (2010) the basic class of controlled substances. The Gama Hydroxybutyric Acid will be produced during the process of converting gamma-butyrolactone (GBL) into a new product for development. The company plans to manufacture the above listed controlled substance as Active Pharmaceutical Ingredient (API) that will be further synthesized into dosage forms of a new product. No other activities for this drug code are authorized for this registration. Dated: January 30, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018-02345 Filed 2-5-18; 8:45 am] BILLING CODE 4410-09-P
![5274 Federal Register / Vol. 83, No. 25 / Tuesday, February 6, 2018 / Notices
United States, or United States treated accordingly. All such requests ADDRESSES: Written comments should
consumers. should be directed to the Secretary to be sent to: Drug Enforcement
In particular, the Commission is the Commission and must include a full Administration, Attention: DEA Federal
interested in comments that: statement of the reasons why the Register Representative/DRW, 8701
(i) Explain how the articles Commission should grant such Morrissette Drive, Springfield, Virginia
potentially subject to the requested treatment. See 19 CFR 201.6. Documents 22152.
remedial orders are used in the United for which confidential treatment by the SUPPLEMENTARY INFORMATION: The
States; Commission is properly sought will be Attorney General has delegated his
(ii) Identify any public health, safety, treated accordingly. All information, authority under the Controlled
or welfare concerns in the United States including confidential business Substances Act to the Administrator of
relating to the requested remedial information and documents for which the Drug Enforcement Administration
orders; confidential treatment is properly (DEA), 28 CFR 0.100(b). Authority to
(iii) Identify like or directly sought, submitted to the Commission for exercise all necessary functions with
competitive articles that complainant, purposes of this Investigation may be respect to the promulgation and
its licensees, or third parties make in the disclosed to and used: (i) By the implementation of 21 CFR part 1301,
United States which could replace the Commission, its employees and Offices, incident to the registration of
subject articles if they were to be and contract personnel (a) for manufacturers, distributors, dispensers,
excluded; developing or maintaining the records importers, and exporters of controlled
(iv) Indicate whether complainant, of this or a related proceeding, or (b) in substances (other than final orders in
complainant’s licensees, and/or third internal investigations, audits, reviews, connection with suspension, denial, or
party suppliers have the capacity to and evaluations relating to the revocation of registration) has been
replace the volume of articles programs, personnel, and operations of redelegated to the Deputy Assistant
potentially subject to the requested the Commission including under 5 Administrator of the DEA Office of
exclusion order and/or a cease and U.S.C. Appendix 3; or (ii) by U.S. Diversion Control (‘‘Deputy Assistant
desist order within a commercially government employees and contract Administrator’’) pursuant to section 7 of
reasonable time; and personnel,2 solely for cybersecurity
(v) Explain how the requested 28 CFR part 0, appendix to subpart R.
purposes. All nonconfidential written In accordance with 21 CFR
remedial orders would impact United submissions will be available for public 1301.33(a), this is notice that on
States consumers. inspection at the Office of the Secretary December 11, 2017, Patheon
Written submissions must be filed no and on EDIS.3 Pharmaceuticals, Inc., 2110 E Galbraith
later than by close of business, eight This action is taken under the Road, Cincinnati, OH 45237 applied for
calendar days after the date of authority of section 337 of the Tariff Act renewal of their registration as a bulk
publication of this notice in the Federal of 1930, as amended (19 U.S.C. 1337), manufacturer of the Schedule I control
Register. There will be further and of §§ 201.10 and 210.8(c) of the substance Gamma Hydroxybutyric Acid
opportunities for comment on the Commission’s Rules of Practice and (2010) the basic class of controlled
public interest after the issuance of any Procedure (19 CFR 201.10, 210.8(c)). substances.
final initial determination in this The Gama Hydroxybutyric Acid will
By order of the Commission.
investigation. be produced during the process of
Persons filing written submissions Issued: February 1, 2018.
Lisa R. Barton, converting gamma-butyrolactone (GBL)
must file the original document
Secretary to the Commission.
into a new product for development.
electronically on or before the deadlines
The company plans to manufacture the
stated above and submit 8 true paper [FR Doc. 2018–02288 Filed 2–5–18; 8:45 am]
above listed controlled substance as
copies to the Office of the Secretary by BILLING CODE 7020–02–P
Active Pharmaceutical Ingredient (API)
noon the next day pursuant to § 210.4(f)
that will be further synthesized into
of the Commission’s Rules of Practice
dosage forms of a new product.
and Procedure (19 CFR 210.4(f)). No other activities for this drug code
Submissions should refer to the docket DEPARTMENT OF JUSTICE
are authorized for this registration.
number (‘‘Docket No. 3292) in a
Drug Enforcement Administration Dated: January 30, 2018.
prominent place on the cover page and/
or the first page. (See Handbook for Susan A. Gibson,
[Docket No. DEA–392]
Electonic Filing Procedures, Electronic Deputy Assistant Administrator.
Filing Procedures).1 Persons with Bulk Manufacturer of Controlled [FR Doc. 2018–02345 Filed 2–5–18; 8:45 am]
questions regarding filing should Substances Application: Patheon BILLING CODE 4410–09–P
contact the Secretary (202–205–2000). Pharmaceuticals, Inc.
Any person desiring to submit a
document to the Commission in ACTION: Notice of application. DEPARTMENT OF JUSTICE
confidence must request confidential
treatment. All such requests should be DATES: Registered bulk manufacturers of Drug Enforcement Administration
directed to the Secretary to the the affected basic classes, and [Docket No. DEA–392]
Commission and must include a full applicants therefore, may file written
statement of the reasons why the comments on or objections to the Bulk Manufacturer of Controlled
Commission should grant such issuance of the proposed registration in Substances Application: Chattem
daltland on DSKBBV9HB2PROD with NOTICES
treatment. See 19 CFR 201.6. Documents accordance with 21 CFR 1301.33(a) on Chemicals, Inc.
for which confidential treatment by the or before April 9, 2018.
Commission is properly sought will be ACTION: Notice of application.
2 All contract personnel will sign appropriate
1 Handbook for Electronic Filing Procedures: nondisclosure agreements. DATES: Registered bulk manufacturers of
https://www.usitc.gov/documents/handbook_on_ 3 Electronic Document Information System the affected basic classes, and
filing_procedures.pdf. (EDIS): https://edis.usitc.gov. applicants therefore, may file written
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Document Created: 2018-02-06 00:30:32
Document Modified: 2018-02-06 00:30:32
| 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 April 9, 2018. | |
| FR Citation | 83 FR 5274 |
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