83 FR 8107 - Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 37 (February 23, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 37 (February 23, 2018)
| Page Range | 8107-8107 | |
| FR Document | 2018-03723 |
[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)] [Notices] [Page 8107] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03723] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Mylan 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 on or before March 26, 2018. Such persons may also file a written request for a hearing on the application March 26, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: 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 Assistant Administrator of the DEA Diversion Control Division (``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on December 7, 2017, Mylan Pharmaceuticals Inc., 2898 Manufacturers Road, Greensboro, NC 27406 applied to be registered as an importer of Nabilone (7379), a basic class of controlled substance listed in Schedule II. The company plans to import the listed controlled substance in finished dosage form for commercial distribution purposes only. No other activity for this drug code is authorized for this registration. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale. Dated: February 14, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018-03723 Filed 2-22-18; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Notices 8107
stated above and submit 8 true paper Issued: February 20, 2018. Pharmaceuticals Inc., 2898
copies to the Office of the Secretary by Katherine M. Hiner, Manufacturers Road, Greensboro, NC
noon the next day pursuant to § 210.4(f) Supervisory Attorney. 27406 applied to be registered as an
of the Commission’s Rules of Practice [FR Doc. 2018–03774 Filed 2–22–18; 8:45 am] importer of Nabilone (7379), a basic
and Procedure (19 CFR 210.4(f)). BILLING CODE 7020–02–P class of controlled substance listed in
Submissions should refer to the docket Schedule II.
number (‘‘Docket No. 3297) in a The company plans to import the
prominent place on the cover page and/ DEPARTMENT OF JUSTICE listed controlled substance in finished
or the first page. (See Handbook for dosage form for commercial distribution
Electonic Filing Procedures, Electronic Drug Enforcement Administration purposes only. No other activity for this
Filing Procedures.1) Persons with drug code is authorized for this
[Docket No. DEA–392]
questions regarding filing should registration. Approval of permit
contact the Secretary (202–205–2000). Importer of Controlled Substances applications will occur only when the
Any person desiring to submit a Application: Mylan Pharmaceuticals registrant’s business activity is
document to the Commission in Inc. consistent with what is authorized
confidence must request confidential under 21 U.S.C. 952(a)(2). Authorization
treatment. All such requests should be ACTION: Notice of application. will not extend to the import of FDA
directed to the Secretary to the approved or non-approved finished
Commission and must include a full DATES: Registered bulk manufacturers of dosage forms for commercial sale.
statement of the reasons why the the affected basic classes, and
Dated: February 14, 2018.
Commission should grant such applicants therefore, may file written
Susan A. Gibson,
treatment. See 19 CFR 201.6. Documents comments on or objections to the
issuance of the proposed registration on Deputy Assistant Administrator.
for which confidential treatment by the
or before March 26, 2018. Such persons [FR Doc. 2018–03723 Filed 2–22–18; 8:45 am]
Commission is properly sought will be
treated accordingly. All such requests may also file a written request for a BILLING CODE 4410–09–P
should be directed to the Secretary to hearing on the application March 26,
the Commission and must include a full 2018.
DEPARTMENT OF JUSTICE
statement of the reasons why the ADDRESSES: Written comments should
Commission should grant such be sent to: Drug Enforcement [OMB Number 1105—New]
treatment. See 19 CFR 201.6. Documents Administration, Attention: DEA Federal
for which confidential treatment by the Register Representative/DRW, 8701 Agency Information Collection
Commission is properly sought will be Morrissette Drive, Springfield, Virginia Activities; Proposed eCollection
treated accordingly. All information, 22152. All requests for hearing must be eComments Requested; New
including confidential business sent to: Drug Enforcement
information and documents for which AGENCY: Civil Division, Department of
Administration, Attn: Administrator,
confidential treatment is properly Justice.
8701 Morrissette Drive, Springfield,
sought, submitted to the Commission for Virginia 22152. All requests for hearing ACTION: 60-Day notice.
purposes of this Investigation may be should also be sent to: (1) Drug
disclosed to and used: (i) By the SUMMARY: The Department of Justice,
Enforcement Administration, Attn: Civil Division, is submitting the
Commission, its employees and Offices, Hearing Clerk/LJ, 8701 Morrissette
and contract personnel (a) for following information collection request
Drive, Springfield, Virginia 22152; and to the Office of Management and Budget
developing or maintaining the records (2) Drug Enforcement Administration,
of this or a related proceeding, or (b) in (OMB) for review and approval in
Attn: DEA Federal Register accordance with the Paperwork
internal investigations, audits, reviews, Representative/DRW, 8701 Morrissette
and evaluations relating to the Reduction Act of 1995.
Drive, Springfield, Virginia 22152.
programs, personnel, and operations of DATES: The Department of Justice
SUPPLEMENTARY INFORMATION: The
the Commission including under 5 encourages public comment and will
Attorney General has delegated his
U.S.C. Appendix 3; or (ii) by U.S. accept input until April 24, 2018.
authority under the Controlled
government employees and contract Substances Act to the Administrator of FOR FURTHER INFORMATION CONTACT: If
personnel,2 solely for cybersecurity the Drug Enforcement Administration you have additional comments
purposes. All nonconfidential written (DEA), 28 CFR 0.100(b). Authority to especially on the estimated public
submissions will be available for public exercise all necessary functions with burden or associated response time,
inspection at the Office of the Secretary respect to the promulgation and suggestions, or need a copy of the
and on EDIS.3 implementation of 21 CFR part 1301, proposed information collection
This action is taken under the incident to the registration of instrument with instructions or
authority of section 337 of the Tariff Act manufacturers, distributors, dispensers, additional information, please contact
of 1930, as amended (19 U.S.C. 1337), importers, and exporters of controlled Talitha Guinn-Shaver, 950 Pennsylvania
and of §§ 201.10 and 210.8(c) of the substances (other than final orders in Ave. NW, Washington, DC 20005, Attn:
Commission’s Rules of Practice and connection with suspension, denial, or Civil Communications Office (Attn:
Procedure (19 CFR 201.10, 210.8(c)). revocation of registration) has been Elder Justice Initiative) (Phone: 202–
By order of the Commission. redelegated to the Assistant 598–0292).
daltland on DSKBBV9HB2PROD with NOTICES
Administrator of the DEA Diversion SUPPLEMENTARY INFORMATION: Written
1 Handbook for Electronic Filing Procedures:
Control Division (‘‘Assistant comments and suggestions from the
https://www.usitc.gov/documents/handbook_on_ Administrator’’) pursuant to section 7 of public and affected agencies concerning
filing_procedures.pdf.
2 All contract personnel will sign appropriate
28 CFR part 0, appendix to subpart R. the proposed collection of information
nondisclosure agreements. In accordance with 21 CFR are encouraged. Your comments should
3 Electronic Document Information System 1301.34(a), this is notice that on address one or more of the following
(EDIS): https://edis.usitc.gov. December 7, 2017, Mylan four points:
VerDate Sep<11>2014 18:52 Feb 22, 2018 Jkt 244001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\23FEN1.SGM 23FEN1](https://thefederalregister.org/doc/83_FR_8144/page/1.svg)
Document Created: 2018-02-23 01:32:38
Document Modified: 2018-02-23 01:32:38
| 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 on or before March 26, 2018. Such persons may also file a written request for a hearing on the application March 26, 2018. | |
| FR Citation | 83 FR 8107 |
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