FDA: Duracap Labs

Dear Mr. Roberts,

We received status update requests from you last week for requests you say you submitted on July 29. We cannot check the status without control numbers. Please provide your control numbers.

Thank you,

Sarah B. Kotler, JD
Director, Division of Freedom of Information
U.S. Food & Drug Administration
5630 Fishers Lane, Room 1033
Rockville, MD 20857
(301)796-8976

Did you receive a control number?

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>

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An acknowledgement letter, stating the request is being processed.

Dear Mr. Roberts,

This is in response to your November 15, 2016 Freedom of Information Act (FOIA) request to the Center for Food Safety and Applied Nutrition (CFSAN) seeking copies of records related to:

* DURACAP LABS

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) and (b)(7)(a) 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.

Ø Exemption (b)(7) protects from disclosure "records or information compiled for law enforcement purposes, but only to the extent that the production of such law enforcement records or information (A) could reasonably be expected to interfere with enforcement proceedings.

Please be advised that your request may have been submitted to one or more component offices within FDA. These offices will reply to you directly. CFSAN considers your request closed.

If you have reason to believe that the information withheld should not be exempt from disclosure, 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 "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:

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

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,

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