FDA: Scientific and Medical Evaluation of Kratom
| Tracking # |
2017-9718 |
| Submitted | Nov. 14, 2017 |
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Communications
From: Anthony Roberts
To Whom It May Concern:
This is a request under the Freedom of Information Act. I hereby request the scientific and medical evaluation conducted by the FDA on kratom, in response to a DEA request, as described in this press release:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584970.htm
"In response to a request from the Drug Enforcement Administration (DEA), the FDA has conducted a comprehensive scientific and medical evaluation of two compounds found in kratom."
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,
anthony roberts
From: Food and Drug Administration
An interim response, stating the request is being processed.
From: Food and Drug Administration
Dear Mr. Roberts,
This is in response to your November 16, 2017, Freedom of Information Act (FOIA) request for records pertaining to "KRATOM- EVALUATION."
The Center Food Safety and Applied Nutrition (CFSAN) conducted a search and did not locate any records responsive to your request.
Please be advised that your request has been submitted to one or more component offices within FDA. These offices will reply to you directly. CFSAN considers this request closed.
While we believe that an adequate search of appropriate files was conducted for the records you requested in CFSAN, you have the right to appeal this determination. By filing an appeal, you preserve your rights under FOIA and give the agency a chance to review and reconsider your request and the agency's decision. Your appeal must be mailed within 90 days from the date of this response, to: Agency Chief FOIA Officer, U.S. Department of Health and Human Services, Office of the Assistant Secretary for Public Affairs, Room 729H, 200 Independence Avenue, S.W., Washington, DC 20201; e-mail FOIARequest@PSC.hhs.gov<mailto:FOIARequest@PSC.hhs.gov>. Please clearly mark both the envelope and your letter or e-mail "FDA Freedom of Information Act Appeal."
If you would like to discuss our response before filing an appeal to attempt to resolve your dispute without going through the appeals process, please contact Samantha.Wilde@fda.hhs.gov<mailto:Samantha.Wilde@fda.hhs.gov> or 240-402-0003. You may also contact the FDA FOIA Public Liaison for assistance at: Office of the Executive Secretariat, US Food & Drug Administration, 5630 Fishers Lane, Room 1050, Rockville, MD 20857, E-mail: FDAFOIA@fda.hhs.gov<mailto:FDAFOIA@fda.hhs.gov>.
If you are unable to resolve your FOIA dispute through our FOIA Public Liaison, the Office of Government Information Services (OGIS), the Federal FOIA Ombudsman's office, offers mediation services to help resolve disputes between FOIA requesters and Federal agencies. The contact information for OGIS is as follows: Office of Government Information Services, National Archives and Records Administration, 8601 Adelphi Road-OGIS, College Park, MD 20740-6001; telephone at 202-741-5770; toll free at 1-877-684-6448; or facsimile at 202-741-5769; e-mail at ogis@nara.gov<mailto:ogis@nara.gov>.
Kimberly Jones
for
Sheila Wright
FOIA Officer
Center for Food Safety & Applied Nutrition
Office of Regulations, Policy & Social Science
Tel: 240-402-2812
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From: Food and Drug Administration
The request has been rejected by the agency.
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