FDA: Coluracetam
| Tracking # |
2017-9363 |
| Submitted | Aug. 18, 2017 |
| Est. Completion | April 6, 2018 |
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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, 2012 through August 15th, 2017, that mention Coluracetam (N-(2,3-dimethyl-5,6,7,8-tetrahydrofuro[2,3-b]quinolin-4-yl)-2-(2-oxopyrrolidin-1-yl)acetamide) by the aforementioned chemical or structural name. This request should be construed to include white papers, opinions, internal and external emails, New Dietary Ingredient Notifications, Investigational New Drug information, applications, and data, internal and external emails and memorandum, import alerts, seizure notices, studies, and 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: MuckRock.com
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information request, copied below, and originally submitted on Aug. 18, 2017. Please let me know when I can expect to receive a response, or if further clarification is needed.
Thanks for your help, and let me know if further clarification is needed.
From: MuckRock.com
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information request, copied below, and originally submitted on Aug. 18, 2017. Please let me know when I can expect to receive a response, or if further clarification is needed.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information request, copied below, and originally submitted on Aug. 18, 2017. Please let me know when I can expect to receive a response, or if further clarification is needed.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Dear Ms. Fernandez,
We just received several faxes regarding previously submitted FOIA requests. You stated that you submitted them by email, but FDA does not have an email box for FOIA submission (we use mail, fax, and an online submission portal), and therefore these were not received. We have a question about two of the requests - both seek the same records regarding Piracetam, but one has a longer timeframe that encompasses the shorter timeframe in the other request for records about Piracetam. Can we just log the one that incorporates both timeframes (1/1/03 to 8/15/17)?
Thank you,
Sarah B. Kotler, J.D.
Director
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8976
Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@fda.hhs.gov>
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>
[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Cynthia Fernandez
Hello Sarah,
Yes, that is fine. Do you have an estimate about when this will be completed?
Best,
Cynthia
From: Food and Drug Administration
Thank you. I don't have an estimate as it hasn't yet been logged. It will be logged and assigned to the Center for Drugs and the Center for Foods.
Sarah B. Kotler, J.D.
Director
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8976
Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@fda.hhs.gov>
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>
[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Food and Drug Administration
An interim response, stating the request is being processed.
From: Food and Drug Administration
Dear Ms. Fernandez,
This is in response to your November 3, 2017, Freedom of Information Act (FOIA) request for records pertaining to COLURACETAM - WHITE PAPERS, EMAILS, NEW DIETARY INGREDIENT NOTIFICATIONS, ETC 1/1/12 TO 8/15/17.
The Center Food Safety and Applied Nutrition (CFSAN) conducted a search and did not locate any records responsive to your request.
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 this request closed.
While we believe that an adequate search of appropriate files was conducted for the records you requested in CFSAN, 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 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>.
Kimberly Jones
for
Sheila Wright
FOIA Officer
Center for Food Safety & Applied Nutrition
Office of Regulations, Policy & Social Science
Tel: 240-402-2812
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>
[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information request, copied below, and originally submitted on Aug. 18, 2017. Please let me know when I can expect to receive a response, or if further clarification is needed. You had assigned it reference number #2017-9363.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Ms. Fernandez,
Your request was answered on November 8, the response letter is below. No further action is required and CFSAN considers your request closed.
Thank you
Samantha
Samantha Wilde
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)
Tel: 240-402-0003
samantha.wilde@fda.hhs.gov<mailto:samantha.wilde@fda.hhs.gov>
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>
[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Food and Drug Administration
Hi, Cynthia. We are getting a lot of faxed status requests from you, but none of them have your control number. Please match up your control numbers to your requests (the control number was provided in the acknowledgement letter sent to you after each request was logged) and then resend your status requests. It is difficult for us to provide a status update without a control number.
Thank you.
Sarah B. Kotler, J.D.
Director
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8976
Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@fda.hhs.gov>
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>
[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information request, copied below, and originally submitted on Aug. 18, 2017. Please let me know when I can expect to receive a response, or if further clarification is needed. You had assigned it reference number #2017-9363.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Good morning. Your request is pending with Office of Chief Counsel and the Center for Drugs. I will ask them to contact you re: status.
Thanks,
Sarah B. Kotler, J.D.
Director
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8976
Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@fda.hhs.gov>
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>
[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Aug. 18, 2017. Please let me know when I can expect to receive a response, or if further clarification is needed. You had assigned it reference number #2017-9363.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Dear Ms. Fernandez,
I understand that you have contacted FDA to seek a status update concerning this request. Currently your request is number 418 out of 565 in CDER's queue. FDA processes requests on a first-in, first-out basis, and consequently the response time frame to process your request is dependent on processing records responsive to the requests ahead of yours in the queue. I estimate that it will take approximately 18 to 24 months to process your case.
Regards,
Gary W. Jackson
Consumer Safety Officer
Division of Information Disclosure Policy
Center for Drug Evaluation and Research
From: Food and Drug Administration
To whom it may concern:
Please expect to receive correspondence from the Food and Drug Administration, Office of the Chief Counsel, regarding your August 18, 2017, Freedom of Information Act request by April 6, 2018.
Warm regards,
Lakita Ross
Government Information Specialist
Food and Drug Division
HHS, Office of the General Counsel
301.796.0661
From: Food and Drug Administration
A no responsive documents response.
From: Food and Drug Administration
In Response Refer to File: 2017-9363
Cynthia Fernandez
DEPT MR 42077
411A Highland Ave
Somerville, MA 02144
February 7, 2020
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 Coluracetam . Your request is currently pending.
If you're still interested in receiving this information, please notify me prior to March 07, 2020. 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
Division of Information Disclosure Policy
Office of Regulatory Policy
Center for Drug Evaluation and Research
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