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

An acknowledgement letter, stating the request is being processed.

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. § 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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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>

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>

Good morning Ms. Fernandez,

My name is Lakita Ross, and I am the Government Information Specialist for the Office of the Chief Counsel, Food and Drug Division.

I have a few topics I would like to discuss, concerning the attached FOIA request.

Please give me a call at your earliest convenience, 301-796-0661.

I look forward to speaking with you.

If I do not receive any communications from you within 30 days, I will consider your FOIA request withdrawn.

Thank you,

Lakita Ross
Government Information Specialist
Food and Drug Division
HHS, Office of the General Counsel
301.796.0661

Dear Requester,

A review of our files indicates that the Center for Drug Evaluation and Research (CDER) received a Freedom of Information (FOI) request that you submitted on November 03, 2017, in which you requested information related to Piracetam (2-(2-oxopyrrolidin-1-yl)acetamide). Your request is currently pending.

If you're still interested in receiving this information, please notify me prior to May 05, 2021. If we have not received a response by the given date, we will presume you are no longer interested, and close this request accordingly. We appreciate your assistance in clarifying the status of your FOI request.

Sincerely,

Gary W. Jackson

Consumer Safety Officer

US Food and Drug Administration

Center for Drug Evaluation and Research

Office of Regulatory Policy

Good morning,

We have received your request for status. Currently your request designated 2017-9362 is approximately number 94 out of 623 in CDER’s queue. The FDA CDER processes FOI requests in a two track system. That system operates on a first in first out basis. Your request has been assigned to the complex queue. Cases assigned to the complex queue generally experience a processing time frame of approximately 18 to 24 months however, in light of the many COVID-19 requests that CDER has received and which have been granted expedited processing – which moves them up the queue ahead of requests that came in before them – we cannot provide a definitive response timeframe.

Thank you for your understanding and patience.
Regards,
Gary Jackson
Consumer Safety Officer
CDER Division of Information Disclosure Policy

Good morning,
Regarding your request for the current processing status of FOIA submission 2017-9362, your request is approximately number 65 in the queue. The FDA CDER processes FOI requests in a two track system. That system operates on a first in first out basis. Your request has been assigned to the complex queue and will be processed in turn.
Regards,
Gary W. Jackson
Consumer Safety Officer
Division of Information Disclosure Policy
Center for Drug Evaluation and Research

Good morning,

Regarding your request for processing status please note that the FDA CDER processes FOI requests in a two track system. That system operates on a first in first out basis. Your request has been assigned to the complex queue. Cases assigned to the complex queue generally experience a processing time frame of approximately 18 to 24 months. however, in light of the many COVID-19 requests that CDER has received and which have been granted expedited processing – which moves them up the queue ahead of requests that came in before them – we cannot provide a definitive response timeframe. Your request is in the queue, and will be processed in turn.

Thank you for your understanding and patience.
Regards,
Gary Jackson
Consumer Safety Officer
Division of Information Disclosure Policy
Office of Regulatory Policy
Center for Drug Evaluation and Research
U.S. Food and Drug Administration