Fecal Transplant Adverse Events
| Tracking # |
2019-6320 |
| Submitted | July 17, 2019 |
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Communications
From: Ed Cara
To Whom It May Concern:
Pursuant to the Freedom of Information Act, I hereby request the following records:
- The adverse event report, or similar documentation, of a patient death associated with investigational fecal microbiota for transplantation, or FMT, as detailed here: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/important-safety-alert-regarding-use-fecal-microbiota-transplantation-and-risk-serious-adverse
- Any adverse event reports of patient infections by a multi-drug resistant organism associated with investigational FMT.
- Any correspondence with medical clinics, institutions, or researchers that are linked to these adverse events, such as where the trial(s) was conducted.
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.
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,
Ed Cara
From: Food and Drug Administration
*** This is an automated message. Please do not reply to this email. ***
Reference: FDA1955627
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administrationpursuant 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
Note: Do NOT reply directly to this E-mail
Ed Cara Ed Cara
Re: Confirmation # FDA1955627
In Reply refer to: 2019-6320
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
The adverse event report, or similar documentation, of a patient death associated with investigational fecal microbiota for transplantation, or FMT
Original Subject: To Whom It May Concern: Pursuant to the Freedom of Information Act, I hereby request the following records: - The adverse event report, or similar documentation, of a patient death associated with investigational fecal microbiota for transplantation, or FMT, as detailed here: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/important-safety-alert-regarding-use-fecal-microbiota-transplantation-and-risk-serious-adverse - Any adverse event reports of patient infections ...
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. If you have any questions about your request, please call Claire B. Stansbury, Information Technician at (301) 796-8979 or write to us at: (http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm)
Division of Freedom of Information, U.S. Food and Drug Administration
5630 Fishers Lane, Room 1035
Rockville, MD 20857
Fax:(301)827-9267
You also have the right to seek dispute resolution services from:
FDA FOIA Public Liaison
Office of the Executive Secretariat
5630 Fishers Lane, Room 1050
Rockville, MD 20857
E-Mail: FDAFOIA@fda.hhs.gov and/or:
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
From: Food and Drug Administration
Good morning Mr. Cara,
Please find attached the response to your Freedom of Information Act Request f19-6320. Please note that your response is being sent in 2 emails. Please let me know if you are unable to open the attachments.
Best regards,
Cathy Wilusz
Consumer Safety Officer
Access Litigation and Freedom of Information Branch
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
240-402-8184
From: Food and Drug Administration
Good morning,
Please find attached the rest of the response to your Freedom of Information Act Request F19-6320. Please let me know if you are unable to open the attachments.
Best regards,
Cathy Wilusz
Consumer Safety Officer
Access Litigation and Freedom of Information Branch
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
240-402-8184
From: Food and Drug Administration
Attached is FDA's response to your request.
Regards,
Katherine Uhl
Denials and Appeals Officer
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8975
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