FDA: Corey Hilmas on Kratom

An acknowledgement letter, stating the request is being processed.

To: '48001-88698942@requests.mcukrock.com' <48001-88698942@requests.mcukrock.com>

Attn: Mr. Roberts:

This is in response to your January 25, 2018, Freedom of Information Act (FOIA) request to the Center for Food Safety and Applied Nutrition (CFSAN) requesting papers authored, presentations given and emails (date range 01/01/2011 thru 12/31/2014) sent and received by former FDA/CFSAN official Corey Hilmas that mention Kratom.

Attached are documents responsive to your request. They are being released in part. After a thorough review of the responsive records, we have determined that portions of the documents are exempt from disclosure under exemptions (b)(4)and (b)(5) of the FOIA 5 U.S.C. § 552, as delineated below.

Exemption (b)(4) permits the withholding of commercial or financial information that was obtained from a person outside the government and that is privileged or confidential. The withholding of such information is permitted if disclosure is likely to cause substantial competitive harm to the person who submitted the information.

Exemption (b)(5) permits the withholding of inter-agency or intra-agency communications records which are part of the deliberative process and pre-decisional. Disclosure of such material could inhibit the open and candid expression of opinions and diminish the quality of the decision-making process.

CFSAN consider 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 Michael Howard (michael.howard@fda.hhs.gov<mailto:michael.howard@fda.hhs.gov>) or at 240-402-2120. 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 $11.50 Other $0.00 Total=$11.50

I apologize for the delay. Your patience and consideration is appreciated throughout this process.

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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