FDA: Trade Complaints on Selective Androgen Receptor Modulators
Tracking # |
2017-9370 |
Submitted | Oct. 31, 2017 |
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Communications
From: Anthony Roberts
To Whom It May Concern:
This is a request under the Freedom of Information Act.
I am seeking trade complaints on Selective Androgen Receptor Modulators (SARMs), i.e. complaints filed by (or at the behest of) dietary supplement or pharmaceutical companies against other companies (specifically dietary supplement or research chemical ones) for selling SARMs, between January 1st, 2015 and October 31st, 2017.
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,
anthony roberts
From: Food and Drug Administration
An acknowledgement letter, stating the request is being processed.
From: Food and Drug Administration
Dear Mr. Roberts,
This is in response to your November 3, 2017 Freedom of Information Act (FOIA) request to the Center for Food Safety and Applied Nutrition (CFSAN) seeking copies of records related to:
* CMPLNTS FILED BY DIETARY SUPPLEMENT OR PHARMACEUTICAL COMPANIES AGAINST OTHER COMPANIES FOR SELLING SELECTIVE ANDROGEN RECEPTOR MODULATORS 1/1/2015 - 10/31/2017
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)(6), (b)(4) and (b)(7)(A) of the FOIA 5 U.S.C. § 552, as amended and delineated below:
> Exemption (b)(6) permits the withholding of information which, if released, would constitute a clearly unwarranted invasion of personal privacy. In this case, it was determined that there is no countervailing public interest qualifying under the standard set forth, under exemption (b)(6), to release the personal identifying information of certain third parties.
> 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.
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, Policy and Social Sciences (ORPSS)
U.S. Food and Drug Administration (FDA)
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From: Food and Drug Administration
Dear Requestor,
The attached record(s) are being provided by the Office of Regulatory Affairs (ORA) Division of Information Disclosure Policy in response to your request 2017-9370 for record(s) from the Food and Drug Administration pursuant to the Freedom of Information Act regarding:
CMPLNTS FILED BY DIETARY SUPPLEMENT OR PHARMACEUTICAL COMPANIES AGAINST OTHER COMPANIES FOR SELLING SELECTIVE ANDROGEN RECEPTOR MODULATORS 1/1/31/15 TO 10/31/17
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 exemptions (b)(6) of the FOIA 5 U.S.C. § 552, as amended and delineated below:
Exemption (b)(6) permits the withholding of information which, if released, would constitute a clearly unwarranted invasion of personal privacy. In this case, it was determined that there is no countervailing public interest qualifying under the standard set forth, under exemption (b)(6), to release the personal identifying information of certain third parties.
ORA considers your request closed. If you have any questions about this response, you may contact Andrew Miller at 301-796-5313.
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.
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 person that worked on request. 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
From: Food and Drug Administration
Dear Requestor,
The attached record(s) are being provided by the Office of Regulatory Affairs (ORA) Division of Information Disclosure Policy in response to your request 2017-9370 for record(s) from the Food and Drug Administration pursuant to the Freedom of Information Act regarding:
CMPLNTS FILED BY DIETARY SUPPLEMENT OR PHARMACEUTICAL COMPANIES AGAINST OTHER COMPANIES FOR SELLING SELECTIVE ANDROGEN RECEPTOR MODULATORS 1/1/31/15 TO 10/31/17
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 exemptions (b)(6) of the FOIA 5 U.S.C. § 552, as amended and delineated below:
Exemption (b)(6) permits the withholding of information which, if released, would constitute a clearly unwarranted invasion of personal privacy. In this case, it was determined that there is no countervailing public interest qualifying under the standard set forth, under exemption (b)(6), to release the personal identifying information of certain third parties.
ORA considers your request closed. If you have any questions about this response, you may contact Andrew Miller at 301-796-5313.
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.
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 person that worked on request. 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
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