Federal Register - August 19, 2021
Versión en texto ¿Qué es?Dateas es un sitio independiente no afiliado a entidades gubernamentales. La fuente de los documentos PDF aquí publicados es la entidad gubernamental indicada en cada uno de ellos. Las versiones en texto son transcripciones no oficiales que realizamos para facilitar el acceso y la búsqueda de información, pero pueden contener errores o no estar completas.
Fuente: Federal Register
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 Commissions 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. 202117816 Filed 81821; 8:45 am BILLING CODE 702002P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Docket No. DEA887
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 registrants business activity is consistent with what is authorized under 21 U.S.C. 952a2.
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 441009P
Galephar has applied to be registered as an importer of basic classes of controlled substances.
Refer to SUPPLEMENTARY INFORMATION
listed below for further drug information.
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 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. 202117765 Filed 81821; 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 1301.34a, this is notice that on July 23, 2021, Galephar Pharmaceutical Research Inc., 100 Carr 198 Industrial Park, Juncos, Puerto Rico 007773873, applied to be registered as an importer of the following basic classes of controlled substances:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Docket No. DEA886
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 classes of controlled substances. 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 classes, 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 1301.34a, this is notice that on July 23, 2021, Chattem Chemicals, Inc., 3801 Saint Elmo Avenue, Chattanooga, Tennessee 374091237, applied to be registered as an importer of the following basic classes of controlled substances:
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 registrants business activity is consistent with what is authorized under 21 U.S.C. 952a2.
Authorization will not extend to the import of Food and Drug Administration-approved or non-
E:FRFM19AUN1.SGM
19AUN1