Axona/FDA correspondence

Ed Cara filed this request with the Food and Drug Administration of the United States of America.
Tracking # 2017-5230
Est. Completion None
Status
No Responsive Documents

Communications

From: Ed Cara

To Whom It May Concern:

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

I'd like any available correspondence between the FDA and biomedical company Accera Inc concerning their medical food product, Axona.

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,

Ed Cara

From: Food and Drug Administration

An acknowledgement letter, stating the request is being processed.

From: Wright, Sheila

This is in response to your June 14, 2017, Freedom of Information Act (FOIA) request for records pertaining to "any correspondence between FDA and biomedical company Accera Inc. concerning their medical food product, Axona."

The Center Food Safety and Applied Nutrition (CFSAN) conducted a search and did not locate any records responsive to your request. Therefore, we are closing our file on this case

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:

Ms. Catherine Teti
Deputy 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

Please clearly mark both the envelope and your letter "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 me directly. 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

Office of Government Information Services
National Archives and Records Administration
8601 Adelphi Road-OGIS
College Park, MD 20740-6001

r/v
Sheila Wright
FOIA Officer
Center for Food Safety & Applied Nutrition
Office of Regulations, Policy & Social Science
Tel: 240-402-2812
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