RESOURCES > Federal Register Notices > Importers Notice of Application - 2016 > Fresenius Kabi USA, LLC
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[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Notices]
[Pages 54601-54602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19434]
[Notices]
[Pages 54601-54602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19434]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Fresenius Kabi USA, LLC
ACTION: Notice of application.
SUMMARY: Registered bulk manufacturers of the affected basic class, and applicants therefor, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before September 15, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 15, 2016.
ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 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/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 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 1301.34(a), this is notice that on June 13, 2016, Fresenius Kabi USA, LLC, 3159 Staley Road, Grand Island, New York 14072 applied to be registered as an importer of remifentanil (9739), a basic class of controlled substance listed in schedule II.
The company plans to import the listed controlled substance for product
[[Page 54602]]
development and preparation of stability batches.
Louis J. Milione,
Deputy Assistant Administrator.
Deputy Assistant Administrator.
[FR Doc. 2016-19434 Filed 8-15-16; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).
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News
COVID-19: An Open Letter
The Fresenius Kabi Team sends this message with our deepest gratitude to every health care professional on the front lines of COVID-19. Schwartz 1 7 – template based graphics code generator. Now more than ever, it is vital we stand together in caring for life.
CAREERS
As a part of Fresenius Kabi, you can enjoy an exciting career, a company culture based on a clear purpose and values, and the knowledge that your work makes a real difference. If you would like to learn more about us, we would love to hear from you.
COVID-19: An Open Letter
Fresenius Parts Manual
The Fresenius Kabi Team sends this message with our deepest gratitude to every health care professional on the front lines of COVID-19. Now more than ever, it is vital we stand together in caring for life.
CAREERS
As a part of Fresenius Kabi, you can enjoy an exciting career, a company culture based on a clear purpose and values, and the knowledge that your work makes a real difference. If you would like to learn more about us, we would love to hear from you.
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