FDA Investigational New Drug Exemption for Hubbard Detoxification Program (Scientology GWIRP Study)
| Tracking # |
2015-7639 |
| Submitted | Sept. 19, 2015 |
| Est. Completion | None |
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Communications
From: R. M. Seibert
To Whom It May Concern:
This is a request under the Freedom of Information Act (FOIA). I hereby request the following records:
Copies of any September 2011 correspondence and related documentation submitted to the FDA’s Office of Drug Evaluation that was received from, sent to and/or regarding a treatment protocol for a clinical trial conducted by David O. Carpenter, M.D., New York State University of Albany. Dr. Carpenter is the Principal Investigator of a pilot study on the application of the "Hubbard Detoxification Program" conducted on veterans With Gulf War Illness. This study was funded by a grant from the Department of Defense under the direction of the U.S. Army Medical Research and Materiel Command (USAMRMC), Congressionally Directed Medical Research Programs (CDMRP).
The documentation I am seeking pertains to the FDA's "New Investigational Drug" exemption that was rendered for Dr. Carpenter's clinical trial, which is classified as follows.
Brief title: Gulf War Illness: Evaluation of an Innovative Detoxification Program
CDMRP Program: Gulf War Illness Research Program (GWIRP)
USAMRMC Proposal Number: GW093066
USAMRMC Award Number: W81XWH-10-1-1004 ( http://1.usa.gov/1V2sS9H )
NIH Clinical Trial Identifier: NCT01672710 ( http://1.usa.gov/1Waotif )
The existence of the documentation I am seeking was publicly disclosed by the USAMRMC in a September 10, 2015 response I received on a related FOIA Request where the annual progress report from Dr. Carpenter for the fiscal year 2011 made the following statement:
"USAMRMC staff then raised the concern the Food and Drug Administration approval might have to be obtained for the treatment protocol. Therefore on 27 September 2011 a request was submitted to the FDA that our protocol be determined to be exempt from the requirement for review as a 'investigational new drug', and on 29 September 2011 that request was granted in an Email from [name redacted], Deputy Director, Office of Drug Evaluation IV, FDA."
For verification of the related FOIA disclosure that is quoted above, please see:
http://bit.ly/1QOLyEf
http://bit.ly/1FmS4kb
I also request that, if appropriate, fees be waived as I believe this request is in the public interest due to recent media coverage and public outcry over Dr. Carpenter being awarded government funding for this controversial Scientology detoxification program. For a sampling of this media and public response, please see:
http://thebea.st/1f7Qsy8
http://bit.ly/1Jci2So
http://bit.ly/1JhKWlu
http://bit.ly/1Jhj5AJ
Additionally, 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 fees cannot be waived, 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,
Ms. R. M. Seibert
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 Sept. 19, 2015. Please let me know when I can expect to receive a response, or if further clarification is needed. You had assigned it reference number #2015-7639.
Thanks for your help, and let me know if further clarification is needed.
From: Sullivan, Nicholle (NIH/NHLBI) [E]
Ms. Siebert,
I issued a final response in this FOIA Request to the NIH on September 23rd. The Office of Grants Management searched its files and no records responsive to your request were located. I have forwarded the message I sent to you that day (See below) and have copied and pasted your message from today in the body of this email, to connect the two. I hate that you did not receive the final response sent at that time. The final response was sent to the preferred email address listed on the original FOIA Request, attached.
Please let me know that you have received this message and that this satisfies your inquiry regarding FOIA Case Number: 15-FOI-00420-NCCIH
NIH Case Number: 44194.
Thank you,
Nicholle
Nicholle Sullivan, J.D.
Lead Government Information Specialist
Freedom of Information and Privacy Act Branch OM/OD/NHLBI
6705 Rockledge Dr., Suite 6054
Bethesda, MD 20892-7957
301-496-9737 (office)
240-507-9935 (direct line)
301-402-3604 (fax)
sullivann@mail.nih.gov
--------------------------------------------------------------------------------------------
October 28, 2015
Food and Drug Administration
Food and Drug Administration
Division of Freedom of Information
Office of the Executive Secretariat, OC
12420 Parklawn Drive
ELEM-1029
Rockville, MD 20857
This is a follow up to request number 2015-7639:
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information request, copied below, and originally submitted on Sept. 19, 2015. Please let me know when I can expect to receive a response, or if further clarification is needed. You had assigned it reference number #2015-7639.
Thanks for your help, and let me know if further clarification is needed.
---
On Sept. 28, 2015:
An acknowledgement letter, stating the request is being processed.
---
On Sept. 19, 2015:
To Whom It May Concern:
This is a request under the Freedom of Information Act (FOIA). I hereby request the following records:
Copies of any September 2011 correspondence and related documentation submitted to the FDA's Office of Drug Evaluation that was received from, sent to and/or regarding a treatment protocol for a clinical trial conducted by David O. Carpenter, M.D., New York State University of Albany. Dr. Carpenter is the Principal Investigator of a pilot study on the application of the "Hubbard Detoxification Program" conducted on veterans With Gulf War Illness. This study was funded by a grant from the Department of Defense under the direction of the U.S. Army Medical Research and Materiel Command (USAMRMC), Congressionally Directed Medical Research Programs (CDMRP).
The documentation I am seeking pertains to the FDA's "New Investigational Drug" exemption that was rendered for Dr. Carpenter's clinical trial, which is classified as follows.
Brief title: Gulf War Illness: Evaluation of an Innovative Detoxification Program
CDMRP Program: Gulf War Illness Research Program (GWIRP)
USAMRMC Proposal Number: GW093066
USAMRMC Award Number: W81XWH-10-1-1004 ( http://1.usa.gov/1V2sS9H )
NIH Clinical Trial Identifier: NCT01672710 ( http://1.usa.gov/1Waotif )
The existence of the documentation I am seeking was publicly disclosed by the USAMRMC in a September 10, 2015 response I received on a related FOIA Request where the annual progress report from Dr. Carpenter for the fiscal year 2011 made the following statement:
"USAMRMC staff then raised the concern the Food and Drug Administration approval might have to be obtained for the treatment protocol. Therefore on 27 September 2011 a request was submitted to the FDA that our protocol be determined to be exempt from the requirement for review as a 'investigational new drug', and on 29 September 2011 that request was granted in an Email from [name redacted], Deputy Director, Office of Drug Evaluation IV, FDA."
For verification of the related FOIA disclosure that is quoted above, please see:
http://bit.ly/1QOLyEf
http://bit.ly/1FmS4kb
I also request that, if appropriate, fees be waived as I believe this request is in the public interest due to recent media coverage and public outcry over Dr. Carpenter being awarded government funding for this controversial Scientology detoxification program. For a sampling of this media and public response, please see:
http://thebea.st/1f7Qsy8
http://bit.ly/1Jci2So
http://bit.ly/1JhKWlu
http://bit.ly/1Jhj5AJ
Additionally, 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 fees cannot be waived, 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,
Ms. R. M. Seibert
Filed via MuckRock.com
E-mail (Preferred): requests@muckrock.com
For mailed responses, please address (see note):
MuckRock
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PLEASE NOTE: This request is not filed by a MuckRock staff member, but is being sent through MuckRock by the above in order to better track, share, and manage public records requests. Also note that improperly addressed (i.e., with the requester's name rather than "MuckRock News" and the department number) requests might be returned as undeliverable.
Nicholle Sullivan, J.D.
Lead Government Information Specialist
Freedom of Information and Privacy Act Branch OM/OD/NHLBI
6705 Rockledge Dr., Suite 6054
Bethesda, MD 20892-7957
301-496-9737 (office)
240-507-9935 (direct line)
301-402-3604 (fax)
sullivann@mail.nih.gov
From: R. M. Seibert
Dear Ms. Sullivann,
Thank you for re-sending the final response to my FOIA request, reference number #2015-7639. I am now in receipt of your finding and please accept my apologies the original sending didn't get recorded correctly.
With gratitude,
Ms. R. M. Seibert
From: Sullivan, Nicholle (NIH/NHLBI) [E]
No problem, I am glad you checked back. Thank you and have a great day.
Nicholle
Nicholle Sullivan, J.D.
Lead Government Information Specialist
Freedom of Information and Privacy Act Branch OM/OD/NHLBI
6705 Rockledge Dr., Suite 6054
Bethesda, MD 20892-7957
301-496-9737 (office)
240-507-9935 (direct line)
301-402-3604 (fax)
sullivann@mail.nih.gov
From: Food and Drug Administration
A no responsive documents response.
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