Lacosamide scheduling documents (Department of Health and Human Services)
| Tracking # |
2020-00777-FOIA-OS, 2020-00777-FOIA-PHS, 2020-2670 2020-00777-FOIA-OS, 2020-00777-FOIA-PHS 2020-00777-FOIA-OS |
| Multi Request | Lacosamide scheduling documents |
| Submitted | March 18, 2020 |
| Est. Completion | None |
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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: Department of Health and Human Services
Dear Shawn Musgrave,
A temporary password has been issued and sent to the email address provided. Please check your email for this temporary password and return to https://requests.publiclink.hhs.gov/palMain.aspx to login. If you have any previously submitted requests to U.S. Department of Health & Human Services you will be able to view them by logging into your user account
Kindly change the password provided by us.
Regards,
U.S. Department of Health & Human Services
From: Department of Health and Human Services
Dear Shawn Musgrave,
Once you login, please change your password to protect your account details.
Password: 60R2qp%%
Regards,
U.S. Department of Health & Human Services
From: Department of Health and Human Services
Dear Shawn Musgrave,
Case Number 2020-00777-FOIA-OS has been assigned to the request you submitted. In all future correspondence regarding this request please reference case number 2020-00777-FOIA-OS.
Regards,
U.S. Department of Health & Human Services
From: Department of Health and Human Services
Dear Shawn Musgrave,
The status of your FOIA request #2020-00777-FOIA-OS has been updated to the following status 'Received'. To log into the HHS FOIA Submission Site click on the Application URL below.
https://requests.publiclink.hhs.gov/palMain.aspx
Sincerely,
U.S. Department of Health & Human Services
From: Department of Health and Human Services
Dear Musgrave: This is in response to your Freedom of Information Act (FOIA) request, dated: March 25, 2020. We've received and have begun processing your request. Please review the attached documents for more details and next steps. Thank you, Mary Jones
From: Department of Health and Human Services
RE: 2020-00777-FOIA-OS Shawn Musgrave
411A Highland Ave MR90858
Somerville, MA 02144 Dear Mr. Musgrave: We received your request on March 25, 2020 and are referring it to the Food and Drug Administration (FDA) for direct response to you. You may check on the status of your request with FDA at (301) 796-3900. S incerely,
Kaira Wells
GIS (Contractor)
Main Office Line: 202-690-7453
From: Department of Health and Human Services
Dear Shawn Musgrave,
The status of your FOIA request #2020-00777-FOIA-OS has been updated to the following status 'In Process'. To log into the HHS FOIA Submission Site click on the Application URL below.
https://requests.publiclink.hhs.gov/palMain.aspx
Sincerely,
U.S. Department of Health & Human Services
From: Department of Health and Human Services
Dear Shawn Musgrave,
Your case Number was changed from 2020-00777-FOIA-OS to 2020-00777-FOIA-PHS, by the agency. Please note the new case number to quote in your future correspondence about the request.
Regards,
U.S. Department of Health & Human Services
From: Department of Health and Human Services
Sarah B. Kotler, J.D.
Director, Division of Freedom of Information
US FDA
301-796-8976
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on March 25, 2020. Please let me know when I can expect to receive a response. You had assigned it reference number #2020-00777-FOIA-OS, 2020-00777-FOIA-PHS, 2020-2670.
Thanks for your help, and let me know if further clarification is needed.
From: Department of Health and Human Services
This request was closed as a duplicate request.
Sarah B. Kotler, J.D.
Director, Division of Freedom of Information
US FDA
301-796-8976
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