FDA: Dymethazine
| Tracking # |
2017-4968 |
| Submitted | June 2, 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 FDA documents that mention 17b-hydroxy 2a,17b-dimethyl 5a-androstan 3-one azine (Dymethazine). I would like adverse reaction reports, both consumer complaints and industry complaints, that mention this compound in a dietary supplement or otherwise . I would also like lab tests (whether conducted by the FDA, at the FDA's behest, or simply forwarded to the FDA) that have revealed or sought to reveal the presence of this compound in dietary supplements. I am also seeking any enforcement actions that have resulted from any of the aforementioned complaints, lab tests, or adverse reaction reports. Should there be an import alert on Dymethazine, I would like a copy of that plus documentation of the decision making process that preceded it. In addition I am seeking internal and external emails that mention this compound.
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: MuckRock.com
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information request, copied below, and originally submitted on June 2, 2017. Please let me know when I can expect to receive a response, or if further clarification is needed. You had assigned it reference number #2017-4968.
Thanks for your help, and let me know if further clarification is needed.
From: McIntosh-Ball, Melissa
Good afternoon Mr. Roberts - Our office has received the request for status. It is our goal to respond to your request in a timely manner. We are required to respond to request in a first in-first out basis. We have reviewed your request letter and the program offices has provided responsive records. We are coordinating the response for both request because the responses are similar. It is our plan to send the responses for both request together.
I hope this information was helpful. We appreciate your patience.
Melissa McIntosh-Ball
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
Tel: 240-402-9215
Melissa.McIntosh-Ball@fda.hhs.gov<mailto:Melissa.McIntosh-Ball@fda.hhs.gov>
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>
[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Wright, Sheila
Dear Mr. Roberts,
This is in response to two of your June 5, 2017 Freedom of Information Act (FOIA) requests to the Center for Food Safety and Applied Nutrition (CFSAN) seeking copies of records related to:
* 2017-4968 - DYMETHAZINE (17B-HYDROXY 2A, 17B-DIMETHYL 5A-ANDROSTAN 3-ONE AZINE) - CMPLNTS, ENFORCEMENT ACTIONS, CAERS, ETC) and
· 2017-4969 - METHYLSTENBOLONE - CAERS, LAB TESTS, CMPLNTS, ETC
The attached documents are responsive to both requests. Your requests are 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), (b)(5) and (b)(6) 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)(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.
Ø 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.
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 "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:
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
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>
[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Food and Drug Administration
An interim response, stating the request is being processed.
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