|Multi Request||Lacosamide scheduling documents|
|Submitted||March 18, 2020|
|Due||April 15, 2020|
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To Whom It May Concern:
Pursuant to the Freedom of Information Act, I hereby request the following records regarding the scheduling of Lacosamide (sold under the brand "Vimpat") as Schedule V :
- The letter and all accompanying materials sent on Dec. 2, 2008 from the Assistant Secretary for Health of the DHHS to the Administrator of the DEA regarding the scheduling of lacosamide. As described in the Federal Register (21 CFR Part 1308, also available online at https://www.deadiversion.usdoj.gov/fed_regs/rules/2009/fr0521.htm): "On December 2, 2008, the Assistant Secretary for Health of the DHHS sent the Administrator of the DEA a scientific and medical evaluation and a letter recommending that lacosamide be placed into Schedule V of the CSA."
- The document prepared by the FDA and enclosed with the Dec. 2008 letter, which was entitled, “Basis for the Recommendation for Control of Lacosamide in Schedule V of the Controlled Substances Act (CSA).” As described in the Federal Register: "Enclosed with the December 2, 2008 letter was a document prepared by the FDA entitled, 'Basis for the Recommendation for Control of Lacosamide in Schedule V of the Controlled Substances Act (CSA).'"
The requested documents will be made available to the general public, and this request is not being made for commercial purposes.
In the event that there are fees, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.
Thank you in advance for your anticipated cooperation in this matter.
I look forward to receiving your response to this request within 20 business days, as the statute requires.
Good Afternoon Mr. Musgrave,
Attached, please find the acknowledgement letter for your recently submitted Freedom of Information/Privacy Act request. If you have any questions regarding your request, please contact our Customer Service Hotline on 202-307-7596. Thank you.
Government Information Specialist
Freedom of Information & Privacy Act Unit (FSRF)
HQ Drug Enforcement Administration (DEA)