Request for MIRENA IUS death follow-up info

Claire Tighe filed this request with the Food and Drug Administration of the United States of America.

It is a clone of this request.

Tracking #

FDA1848631

Status
Rejected

Communications

From: Claire Tighe


To Whom It May Concern:

Pursuant to the Freedom of Information Act, I hereby request the following records:

A copy of all available information on the FDA's follow-ups, including records from analysis and subsequent investigations, for the following CASE IDs from the FDA FAERS database, for deaths caused by Mirena IUS drug. Case IDs as follows:

12443150
9789824
10141869
10191951
10189095

I am available to be contacted by phone at 847-471-9257 or by email at claireAtighe@gmail.com.

Claire Tighe
10 Sutton Street #3R
Brooklyn, NY 11222

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,

Claire Tighe

From: Food and Drug Administration

*** This is an automated message. Please do not reply to this email. ***

Reference: FDA1848631

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

Note: Do NOT reply directly to this E-mail
Claire Tighe Claire Tighe
Re: Confirmation # FDA1848631
In Reply refer to: 2018-9498
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
12443150 9789824 10141869 ETC
Original Subject: To Whom It May Concern: Pursuant to the Freedom of Information Act, I hereby request the following records: A copy of all available information on the FDA's follow-ups, including records from analysis and subsequent investigations, for the following CASE IDs from the FDA FAERS database, for deaths caused by Mirena IUS drug. Case IDs as follows: 12443150 9789824 10141869 10191951 10189095 I am available to be contacted by phone at 847-471-9257 or by email at claireAtighe@gmail.com. Claire Ti...
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 Rochelle A. Coleman, Information Technician at (301) 796-8982 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: Muckrock Staff

To Whom It May Concern:
I wanted to follow up on the following request, copied below. Please let me know when I can expect to receive a response.
Thanks for your help, and let me know if further clarification is needed.

From: Food and Drug Administration

This is a duplicate of 2018-9494 and is closed.

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