Lacosamide scheduling documents (Food and Drug Administration)
| Tracking # |
FDA2063588 |
| Multi Request | Lacosamide scheduling documents |
| Submitted | March 18, 2020 |
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Communications
From: Shawn Musgrave
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.
Sincerely,
Shawn Musgrave
From: Food and Drug Administration
*** This is an automated message. Please do not reply to this email. ***
Reference: FDA2063588
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administration
pursuant to the Freedom of Information Act.
FOIA staff will review your request to determine whether it has sufficient information to be processed;
if so, you will receive another email as a formal acknowledgement of your request, with a control number for your request.
If your request is not sufficiently described,
or if there are any other deficiencies with your submission, FOIA staff will contact you via telephone or email.
From: Food and Drug Administration
Shawn Musgrave Shawn Musgrave
Re: Confirmation # FDA2063588
Requester Ctrl #:
In Reply refer to: 2020-2446
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
scheduling of Lacosamide (sold under the brand "Vimpat") as Schedule V
We will respond as soon as possible and may charge you a fee for processing your request. If your informational needs change, and you no longer need the requested records, please contact us to cancel your request, as charges may be incurred once processing of your request has begun. For more information on processing fees, please see http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm.
Due to an increase in the number of incoming requests, we may be unable to comply with the twenty-working-day time limit in this case, as well as the ten additional days provided by the FOIA. The actual processing time will depend on the complexity of your request and whether sensitive records, voluminous records, extensive search, and/or consultation with other HHS components or other executive branch agencies are involved. Please note that requests for medical device approval records (e.g. 510K, PMA, DEN) may take up to 18 to 24 months to process.
If you have any questions about your request, please call Rochelle A. Coleman, Information Technician at 301-796-8982 or write to us at:
Division of Freedom of Information,
U.S. Food and Drug Administration
5630 Fishers Lane, Room 1050
Rockville, MD 20857
Fax: 301-827-9267
You also have the right to seek dispute resolution services from:
FDA FOIA Public Liaison
and/or:
Office of the Executive Secretariat
5630 Fishers Lane, Room 1050
Rockville, MD 20857
E-Mail: FDAFOIA@fda.hhs.gov
Office of Government
Information Services
National Archives and Administration
8601 Adelphi Road - OGIS
College Park, MD 20740-6001
Telephone: 202-741-5770
Toll-Free: 1-877-684-6448
E-Mail: ogis@nara.gov
Fax: 202-741-5769 Note: Do NOT reply directly to this E-mail
From: Food and Drug Administration
A copy of documents responsive to the request.
From: Food and Drug Administration
A letter stating the requester must agree to or prepay assessed or estimated fees in order for the agency to continue processing the request.
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