FDA: Phenylpiracetam (aka Phenotropil or Carphedon)

An interim response, stating the request is being processed.

Good afternoon,

Please provide the request number if you want status updates. Also, please submit these by fax or through the FOIA request page, not through email.

Thank you,

Wilson M. Russ
Program Support Specialist
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8981
wilson.russ@fda.hhs.gov<mailto:wilson.russ@fda.hhs.gov>

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Dear Mr. Roberts,

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

· PHENOTROPIL, CARPHEDON - WHITE PAPERS, IMPORT ALERTS, TESTING, ETC 1/1/12 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) and (b)(5) 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.

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.

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.

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 and Policy
U.S. Food and Drug Administration (FDA)
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Dear Requestor,

After a diligent search of our files, the Division of Information Disclosure Policy of the Office of Regulatory Affairs (ORA) of the Food and Drug Administration was unable to locate any records responsive to your request 2018-1554 regarding:

PHENOTROPIL, CARPHEDON - WHITE PAPERS, IMPORT ALERTS, TESTING, ETC 1/1/12 TO 8/15/17

Please be advised that your request may have been submitted to one or more component offices within FDA, including the Center for Food Safety and Nutrition (CFSAN). These offices will reply to you directly.

If you have any questions about this response, you may contact Andrew Miller at 301-496-5313 or andrew.miller@fda.hhs.gov. All communications concerning this request should be identified with the reference number above.

If you are not satisfied with any aspect of the processing and handling of this request, please contact:

Division of Freedom of Information
U.S. Food & Drug Administration
5630 Fishers Lane, Room 1035
Rockville, MD 20857
PHONE: 301-796-3900
FAX: 301-827-9267

You may also contact the FDA Public Liaison for assistance at

Office of the Executive Secretariat
U.S. Food & Drug Administration
5630 Fishers Lane, Room 1050
Rockville, MD 20857
E-mail: 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: 202-741-5770
Toll-Free: 1-877-684-6448
E-mail: ogis@nara.gov<mailto:ogis@nara.gov>

Andrew R. Miller | Program Analyst | ORA Division of Information Disclosure Policy | U.S. Food and Drug Administration