FDA: Oxiracetam

Anthony Roberts filed this request with the Food and Drug Administration of the United States of America.

It is a clone of this request.

Tracking #


Est. Completion None
Partially Completed


From: anthony roberts

To Whom It May Concern:

This is a request under the Freedom of Information Act.

I am seeking all FDA documents dealing with Oxiracetam [(RS)-2-(4-hydroxy-2-oxopyrrolidin-1-yl)acetamide]. This should include Investigational New Drug Applications, compounding pharmacy requests, import alerts, import records and records of seizures, New Dietary Ingredient Notifications and resulting correspondence, plus internal and external documents not limited to email correspondences, white papers, and opinions.

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.


anthony roberts

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

Good Morning Mr. Roberts,

This email is in reference to your Freedom of Information Act request for records regarding OXIRACETAM - IND, COMPOUNDING PHARMACY REQUESTS, IMPORT ALERTS, ETC

We are unable to determine the date range for the records that you are requesting. Please contact me via email or by phone at the number listed below as soon as possible with the information identifying the dates for records.

Your requests will be placed on a 10 day hold and will not be processed further until we hear from you. If we do not hear from you within 10 days from the date of this notification, we will assume you are no longer interested in the processing of your requests and your requests will be considered close.

Thanks and I look forward to hearing from you soon.

Kimberly Jones
Administrative Support Specialist (CNI Technical Services Contractor)
Government Information Staff
Freedom of Information Act (FOIA)
Center for Food Safety & Applied Nutrition (CFSAN)
Office of Regulations and Policy (ORP)
PH (240) 402-1825


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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 Freedom of Information Act (FOIA) request to the Center for Food Safety and Applied Nutrition (CFSAN) seeking copies of records related to:


The attached is responsive to your request. Your request is granted in part. After a thorough review of the responsive records, we have determined that portions of the documents are exempt from disclosure under FOIA exemption (b)(6) and (b)(5) of the FOIA 5 U.S.C. ยง 552, as amended and delineated below:

Exemption (b)(6) permits the withholding of information which, if released, would constitute a clearly unwarranted invasion of personal privacy. In this case, it was determined that there is no countervailing public interest qualifying under the standard set forth, under exemption (b)(6), to release the personal identifying information of certain third parties.

Exemption (b)(5) permits the withholding of inter-agency or intra-agency communications records which are part of the deliberative process and pre-decisional. Disclosure of such material could inhibit the open and candid expression of opinions and diminish the quality of the decision-making process.

Please be advised that this response does not constitute a final agency action. Your request has been submitted to another component office within FDA. That office will reply to you directly. Therefore, the right to appeal this disclosure decision will be extended concurrent with the final response action by that office. CFSAN considers your request closed.

If you are not satisfied with any aspect of the processing and handling of this request, please contact samantha.wilde@fda.hhs.gov<mailto:samantha.wilde@fda.hhs.gov> or call 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>.

Please do not submit payment until you receive an invoice. The following charges for this request to date may be included in a monthly invoice:

Reproduction=$0.00 Search=$0.00 Review $0.00 Other $0.00 Total=$0.00


Samantha Wilde

Sheila Wright
Government Information Specialist
Center for Food Safety and Applied Nutrition (CFSAN)
Office of Regulations and Policy
U.S. Food and Drug Administration (FDA)

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