FDA: Piracetam (aka Nootropil, Breinox, Dinagen, Lucetam, Nootropyl, Oikamid)

Cynthia Fernandez filed this request with the Food and Drug Administration of the United States of America.

It is a clone of this request.

Tracking #

2017-9362

Est. Completion None
Status
No Responsive Documents

Communications

From: Cynthia Fernandez

To Whom It May Concern:

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

+ Documents produced by the FDA from January 1st, 2003 through August 15th, 2017, that mention Piracetam (2-(2-oxopyrrolidin-1-yl)acetamide) either by the aforementioned chemical or structural name, or by the trade name Nootropil, Breinox, Dinagen, Lucetam, Nootropyl, or Oikamid.
+ This request should be construed to include:
- White papers
- Opinions
- Internal and external emails and memorandum
- New Dietary Ingredient Notifications
- Investigational New Drug information
- Applications
- Data
- Import alerts
- Seizure notices
- Studies
- Chemical analysis/testing.

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,

Cynthia Fernandez

From: Food and Drug Administration

An acknowledgement letter, stating the request is being processed.

From: Food and Drug Administration

Dear Cynthia Fernandez,

This is in response to your November 3, 2017 Freedom of Information Act (FOIA) request to the Center for Food Safety and Applied Nutrition (CFSAN) seeking copies of records related to:

* NOOTROPIL, BREINOX, DINAGEN, ETC - EMAILS, MEMOS, WHITE PAPERS, ETC 1/1/03 TO 8/15/17

Attached are documents 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)(4) of the FOIA 5 U.S.C. ยง 552, as amended and delineated below:

> Exemption (b)(4) permits the withholding of "trade secrets" (TS) and "commercial confidential information" (CCI). Disclosure of this information would impair the government's ability to obtain necessary information in the future and cause substantial harm to the competitive position of the person from whom the information was obtained. Under the balancing test of this exemption, we are withholding all proprietary information identified as TS and CCI.

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 your request closed.

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 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>.

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>.

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

Sincerely,

Samantha Wilde
for

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

Good day Cynthia Fernandez,

Please find the attached response from FDA's Division of Import Operations. If you have any questions or concerns, please see the response letter for contact information. Thank you!

S. Max Brewster, MBA | Division of Import Operations (OEIO) | Office of Regulatory Affairs | US Food and Drug Administration |301-796-8994| max.brewster@fda.hhs.gov<mailto:max.brewster@fda.hhs.gov>

From: Food and Drug Administration

Good day Cynthia Fernandez,

Please find the attached response from FDA's Division of Import Operations. If you have any questions or concerns, please see the response letter for contact information. Thank you!

S. Max Brewster, MBA | Division of Import Operations (OEIO) | Office of Regulatory Affairs | US Food and Drug Administration |301-796-8994| max.brewster@fda.hhs.gov<mailto:max.brewster@fda.hhs.gov>

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