FDA/Response Letters

Tom Zeller Jr. filed this request with the Food and Drug Administration of the United States of America.
Tracking # 2016-8555
Status
Completed

Communications

From: Russ, Wilson

Good morning,

We received a faxed FOIA request on 9/6/16 asking for complete response letter from FDA to Boehringer-Ingelheim but, the fax was cut off in certain spots. Because of this we could not log your request. Please refax your request to 301-827-9267. Thanks.

Thank you,

Wilson M. Russ
Program Support Specialist
Division of Freedom of Information/Privacy
Office the Executive Secretariat, OC
U.S. Food & Drug Administration
5630 Fishers Lane., Room 1028
Rockville, Maryland 20857
301-796-8981 (direct)
301-796-3900 (main)
301-827-9267 (fax)

From: Tom Zeller Jr.

To Whom It May Concern:

This is a request under the Freedom of Information Act. I hereby request the following records:

To Whom It May Concern:

This is a request under the Freedom of Information Act. I hereby request the following records:

This is a request under the Freedom of Information Act.

I request copies of the following documents.

-- The Complete Response Letter from FDA to Boehringer-Ingelheim regarding NDA 022526, including any attachments, which was transmitted on or around August 27, 2010.

-- The Complete Response Letter from FDA to Sprout Pharmaceuticals regarding NDA 022526, including any attachments, which was transmitted on or around September 27, 2013.

In case any of these requests are denied, I request that a reason for the denial is given in writing, and the non-exempt portions of those records be released with the omissions clearly explained.

If possible, I would like to receive the documents in electronic format -- PDFs, DOCs, TXTs, RTFs, TIFFs, JPGs, GIFs, or other commonly-used formats would be fine.

This particular FOI request is intended to provide information for a journalistic work in progress which is intended for publication in a major media outlet. As a member of the media, I am entitled to be placed in the "news media, educational, or scientific requesters" category. As such, I should only be charged for duplication fees beyond the first 100 pages.

Further, I assert that this request is in the public interest, because it is likely to contribute significantly to public understanding of the operations and activities of the government, and I therefore request a waiver of fees.

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,

Tom Zeller
Editor in chief, Undark
Knight Science Journalism Program
Massachusetts Institute of Technology
E19-623, Cambridge, MA 012133
917-385-2754

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,

Tom Zeller Jr.

From: Food and Drug Administration

An acknowledgement letter, stating the request is being processed.

From: Food and Drug Administration

A cover letter granting the request and outlining any exempted materials, if any.

From: Food and Drug Administration

A cover letter granting the request and outlining any exempted materials, if any.

Files

pages

Close