Importer of Controlled Substances Application: Galephar Pharmaceutical Research Inc., 46716 [2021-17765]

Download as PDF 46716 Federal Register / Vol. 86, No. 158 / Thursday, August 19, 2021 / Notices Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements. All nonconfidential written submissions will be available for public inspection on EDIS. This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and Part 210 of the Commission’s Rules of Practice and Procedure (19 CFR part 210). By order of the Commission. Issued: August 16, 2021. Lisa Barton, Secretary to the Commission. [FR Doc. 2021–17816 Filed 8–18–21; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–887] Importer of Controlled Substances Application: Galephar Pharmaceutical Research Inc. lotter on DSK11XQN23PROD with NOTICES1 17:28 Aug 18, 2021 Jkt 253001 Hydromorphone .............. Schedule I 9150 III The company plans to import the listed controlled substance in finished dosage form for analytical purpose 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 Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. Brian S. Besser, Acting Assistant Administrator. BILLING CODE 4410–09–P Galephar has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information. 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 September 20, 2021. Such persons may also file a written request for a hearing on the application on or before September 20, 2021. ADDRESSES: Written comments should be sent to: Drug Enforcement VerDate Sep<11>2014 Drug code Controlled substance [FR Doc. 2021–17765 Filed 8–18–21; 8:45 am] Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: SUMMARY: 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 July 23, 2021, Galephar Pharmaceutical Research Inc., 100 Carr 198 Industrial Park, Juncos, Puerto Rico 00777–3873, applied to be registered as an importer of the following basic class(es) of controlled substance(s): DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–886] Importer of Controlled Substances Application: Chattem Chemicals, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Chattem Chemicals, Inc., has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information. SUMMARY: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 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 September 20, 2021. Such persons may also file a written request for a hearing on the application on or before September 20, 2021. DATES: 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. ADDRESSES: In accordance with 21 CFR 1301.34(a), this is notice that on July 23, 2021, Chattem Chemicals, Inc., 3801 Saint Elmo Avenue, Chattanooga, Tennessee 37409–1237, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Methamphetamine ........... 4-Anilino-N-Phenethyl-4Piperidine (ANPP). Phenylacetone ................. Coca Leaves ................... Opium, Raw ..................... Poppy Straw Concentrate Tapentadol ...................... Drug code Schedule 1105 8333 II II 8501 9040 9600 9670 9780 II II II II II The company plans to import the listed controlled substances to manufacture bulk controlled substances for sale to its customers. The company plans to import an intermediate of Tapentadol (9780), to bulk manufacture Tapentadol for distribution to its customers. 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 Food and Drug Administration-approved or non- E:\FR\FM\19AUN1.SGM 19AUN1

Agencies

[Federal Register Volume 86, Number 158 (Thursday, August 19, 2021)]
[Notices]
[Page 46716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17765]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-887]


Importer of Controlled Substances Application: Galephar 
Pharmaceutical Research Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Galephar has applied to be registered as an importer of basic 
class(es) of controlled substance(s). Refer to SUPPLEMENTARY 
INFORMATION listed below for further drug information.

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 September 20, 
2021. Such persons may also file a written request for a hearing on the 
application on or before September 20, 2021.

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 July 23, 2021, Galephar Pharmaceutical Research Inc., 
100 Carr 198 Industrial Park, Juncos, Puerto Rico 00777-3873, applied 
to be registered as an importer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
                                          Drug
          Controlled substance            code           Schedule
------------------------------------------------------------------------
Hydromorphone..........................    9150  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substance in 
finished dosage form for analytical purpose 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 Food and Drug Administration-approved or non-approved finished 
dosage forms for commercial sale.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-17765 Filed 8-18-21; 8:45 am]
BILLING CODE 4410-09-P
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