Importer of Controlled Substances Application: Caligor Pharma Services, 13927 [2020-04835]

Download as PDF 13927 Federal Register / Vol. 85, No. 47 / Tuesday, March 10, 2020 / Notices 4. Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Business or other for-profit. Other (if applicable): None. Abstract: A person engaged in the business of manufacturing explosives is required to have a license under the provisions of 18 U.S.C. 843. The Federal Water Pollution Control Act, 33 U.S.C. 1341, authorizes the execution of the Supplemental Information on Water Quality Considerations—ATF 5000.30, during the application process, in order to ensure compliance with the Act. 5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 680 respondents will utilize the form annually, and it will take each respondent approximately 30 minutes to complete their responses. 6. An estimate of the total public burden (in hours) associated with the collection: The estimated annual public burden associated with this collection is 340 hours, which is equal to 680 (# of respondents) *.5 (30 minutes). If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530. Dated: March 5, 2020. Melody Braswell, Department Clearance Officer for PRA,U.S. Department of Justice. [FR Doc. 2020–04889 Filed 3–9–20; 8:45 am] Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on September 6, 2019, Caligor Coghlan Pharma Services, 1500 Business Park Drive, Unit B, Bastrop, Texas 78602, applied to be registered as an importer of the following basic class(es) of controlled substance: Controlled substance Drug code Schedule Tapentadol ................ 9780 II The company plans to import the listed controlled substance in finished dosage form to be used in pediatric clinical trials. 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 be extended to the import of FDA approved or non-approved finished dosage forms for commercial use. Dated: February 11, 2020. William T. McDermott, Assistant Administrator. BILLING CODE 4410–18–P DEPARTMENT OF JUSTICE [FR Doc. 2020–04835 Filed 3–9–20; 8:45 am] BILLING CODE 4410–09–P Drug Enforcement Administration [Docket No. DEA 577] DEPARTMENT OF JUSTICE Importer of Controlled Substances Application: Caligor Pharma Services ACTION: khammond on DSKJM1Z7X2PROD with NOTICES [Docket No. DEA–599] Notice of application. Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before April 9, 2020. Such persons may also file a written request for a hearing on the application on or before April 9, 2020. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 DATES: VerDate Sep<11>2014 17:20 Mar 09, 2020 Jkt 250001 Drug Enforcement Administration Importer of Controlled Substances Application: SpecGx LLC ACTION: Notice of application. Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before April 9, 2020. Such persons may also file a written request for a hearing on the application on or before April 9, 2020. DATES: PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for a hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: In accordance with 21 CFR 1301.34(a), this is notice that on December 30, 2019, SpecGx LLC, 3600 North Second Street, Saint Louis, Missouri 63147 applied to be registered as an importer of the following basic class(es) of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Drug code Marihuana ......... Phenylacetone .. Coca Leaves .... Thebaine ........... Opium, raw ....... Poppy Straw Concentrate. Tapentadol ........ Schedule 7360 8501 9040 9333 9600 9670 I II II II II II 9780 II The company plans to import the listed controlled substances for bulk manufacture into Active Pharmaceutical Ingredients (API) for distribution to its customers. In reference to drug code 7360 (marihuana), the company plans to import synthetic cannabinol. No other activity for this drug is authorized for this registration. Placement of these codes onto the company’s registration does not translate into automatic approval of subsequent permit applications to import controlled substances. 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 the import of FDA approved or nonapproved finished forms for commercial sale. Dated: February 27, 2020. William T. McDermott, Assistant Administrator. [FR Doc. 2020–04834 Filed 3–9–20; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\10MRN1.SGM 10MRN1

Agencies

[Federal Register Volume 85, Number 47 (Tuesday, March 10, 2020)]
[Notices]
[Page 13927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04835]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA 577]


Importer of Controlled Substances Application: Caligor Pharma 
Services

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may file written comments on or objections to 
the issuance of the proposed registration on or before April 9, 2020. 
Such persons may also file a written request for a hearing on the 
application on or before April 9, 2020.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for a hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on September 6, 2019, Caligor Coghlan Pharma Services, 
1500 Business Park Drive, Unit B, Bastrop, Texas 78602, applied to be 
registered as an importer of the following basic class(es) of 
controlled substance:

------------------------------------------------------------------------
         Controlled substance           Drug code         Schedule
------------------------------------------------------------------------
Tapentadol...........................       9780   II
------------------------------------------------------------------------

    The company plans to import the listed controlled substance in 
finished dosage form to be used in pediatric clinical trials. 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 be extended to the import of FDA 
approved or non-approved finished dosage forms for commercial use.

    Dated: February 11, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-04835 Filed 3-9-20; 8:45 am]
 BILLING CODE 4410-09-P