Purchase Contracts, Orders, and Records Related to Tafenoquine (Arakoda)
| Tracking # |
FP-19-0010 |
| Submitted | Dec. 11, 2018 |
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Communications
From: Dr. Remington Nevin
Ms. Shallli Keller
Staff Action Control Officer
U.S. Army Medical Research and Materiel Command
Email: shalli.l.keller.civ@mail.mil
Tel: 301-619-7118
c/o
CDR USAMRMC
810 Schreider Street
Fort Detrick, MD 21702-5000
Re: FOIA Request
Dear Ms. Keller,
This is a request under the Freedom of Information Act. I hereby request the following records:
Copies of all purchase orders, contracts, records, and related correspondence between USAMMDA or other subordinate activity of USAMRMC, and 60 Degrees Pharmaceuticals or any intermediate wholesaler or distributor, for supplies of tafenoquine (Arakoda) intended for U.S. military use, from 2013 to the date of processing of this request.
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,
Dr. Remington Nevin
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following request, copied below. Please let me know when I can expect to receive a response.
Thanks for your help, and let me know if further clarification is needed.
From: U.S. Army Medical Research and Materiel Command
Dr. Nevin,
This Freedom of Information Act (FOIA) action is in response to your four (4) requests, dated 11 December 2018.
Your four (4) requests are being processed in accordance with Title 5 United States Code 552, The Freedom of Information Act. Your requests have been assigned the following case numbers:
FA-19-007708/FP-19-0007 - 125th Anniversary Celebration of the WRAIR Center for Military Psychiatry & Neuroscience, held 14 November 2018.
FA-19-007709/FP-19-0008 - Presentations made by USAMRMC and subordinate staff to the U.S. Food and Drug Administration Antimicrobial Drugs Advisory Committee Meetings, held 12 July 2018 and 26 July 2018.
FA-19-007710/FP-19-0009 - Proposed or planned policy for the use of tafenoquine (Arakoda) in the chemoprophylaxis of malaria.
FA-19-007713/FP-19-0010 - 60 Degrees Pharmaceuticals or any other intermediate wholesaler or distributor, for supplies of tafenoquine (Arakoda) intended for U.S. military use, from 2013 to date of process of this request.
Please see attached memorandums regarding these requests and the agencies assigned to each FOIA case.
Should you have any questions pertaining to this response, please contact me at the address and phone number below.
Thank you,
Shalli L. Keller
Staff Action Control Officer
Office of the SGS
U.S. Army Medical Research and Materiel Command
Fort Detrick, MD 21702
Phone: 301-619-7118
http://mrmc.amedd.army.mil/
From: U.S. Army Medical Research and Materiel Command
An acknowledgement letter, stating the request is being processed.
From: U.S. Army Medical Research and Materiel Command
Hi Dr. Nevin,
I wanted to update you on your FOIA Requests. I have received information for 3 of the requests, and I'm getting ready to mail those documents out to you this week. I should be receiving the documents for the 4th FOIA next week. Once those documents are received, and have been reviewed they'll be released to you. If you have any questions, please let me know.
Thank you,
Shalli L. Keller
Staff Action Control Officer
Office of the SGS
U.S. Army Medical Research and Materiel Command
Fort Detrick, MD 21702
Phone: 301-619-7118
http://mrmc.amedd.army.mil/
From: U.S. Army Medical Research and Materiel Command
Hi Dr. Nevin,
Your FOIA request #FA-19-0010 is attached. This request has also been sent in the mail. If you require any additional help, please let me know.
Thank you,
Shalli L. Keller
Staff Action Control Officer
Office of the SGS
U.S. Army Medical Research and Materiel Command
Fort Detrick, MD 21702
Phone: 301-619-7118
http://mrmc.amedd.army.mil/
-
[Non-DoD Source] Freedom of Information Act Request: Purchase Contracts, Orders, and Records Related to Tafenoquine (Arakoda)
From: Dr. Remington Nevin
CDR U.S. Army Medical Command
Attention: Freedom of Information/Privacy Acts Office (MCPA)
2748 Worth Road
JBSA, Fort Sam Houston, Texas 78234-6021
Re: Freedom of Information Act Appeal, #FA-19-0010
Dear Freedom of Information Office Staff,
This is an appeal under the Freedom of Information Act.
My original FOIA request, made December 11, 2018 to the US Army Medical Research and Materiel Command (USAMRMC), and assigned the above-referenced internal tracking number, was for “Copies of all purchase orders, contracts, records, and related correspondence between USAMMDA or other subordinate activity of USAMRMC, and 60 Degrees Pharmaceuticals or any intermediate wholesaler or distributor, for supplies of tafenoquine (Arakoda) intended for U.S. military use, from 2013 to the date of processing of this request”.
In response to this request, on March 5, 2019, I received a heavily redacted copy of a 3-page document titled “Arakoda (Tafenoquine) Transition Planning Meeting Agenda”. The document was redacted under FOIA exemptions b(4), b(5), and b(6). Both the acknowledgment letter and the redacted documented are attached to this appeal for your office’s review, together with USAMRMC’s explanation for the redactions.
In this appeal, I am requesting the release of an unredacted copy of this document, as USARMC’s claimed reasons for the redactions are without merit, and disclosure of the unredacted document is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government.
USAMRMC has claimed exception (b)(4), which it claims “[p]ermits the withholding of records related to trade secrets and other confidential business information”. Several of the document’s redactions under (b)(4) are clearly dates which are in the past; a trade name (likely “Arakoda”, a name that is not a trade secret), or refer to information that 60P has already publicly announced, including the product’s logistician. There is no convincing or compelling rationale to withhold this information under the (b)(4) exemption, given that this information does not meet the definition of a “secret”. Furthermore, given that 60P is the exclusive provider of this product to the U.S. Army, and as both USAMRMC and 60P have argued that tafenoquine is unique, the information withheld under (b)(4) cannot be considered “commercially valuable”, as it cannot give 60P a “competitive advantage… over competitors”, given that there are no competitors to this product.
USAMRMC has also claimed exception (b)(5), which it claims “[p]ermits the withholding of records under the deliberative process privilege”. An agency withholding information under this exemption must prove that this information is “predecisional and deliberative”. Several of the document’s redactions under the (b)(5) exemption include, by obvious context, such information as dates and meeting locations which clearly do not meet the burden of proof required of this exemption. This calls into question the reasonableness of the other redactions in this document under this claimed exemption.
USAMRMC has also claimed exception (b)(6), which it claims “[p]ermits the government to withhold information about individuals when the disclosure would constitute a clearly unwarranted invasion into the personal privacy of a third person”. Several of the document’s redactions under the (b)(6) exemption include the names of participants at the meeting in question. Courts have found that the FOIA statute “does not categorically exempt individuals’ identifies… because the ‘privacy interest at stake may vary depending on the context in which it is asserted’” (See: People for the Am. Way Found. v. Nat’l Park Serv., 503 F.Supp.2d 284, 304 (D.D.C. 2007) (quoting Judicial Watch, Inc. v. Food & Drug Admin., 449 F.3d 141, 153 (D.C. Cir. 2006))). In this particular context, the public has a compelling and overriding right to know the identifies of key military and industry figures involved in the agenda items which are the subject of the document.
Thank you for your consideration of this appeal.
Sincerely,
Dr. Remington Nevin
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 11, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FP-19-0010.
Thanks for your help, and let me know if further clarification is needed.
From: U.S. Army Medical Research and Materiel Command
CLASSIFICATION: UNCLASSIFIED
Dear Dr. Nevin,
This is to inform you that your Freedom of Information Act request, dated 11 December 2018, to the United States Army Medical Research and Materiel Command (USAMRMC) for documents pertaining to proposed or planned policy for the use of Tafenoquine (Arakoda) in the chemoprophylaxis of malaria, has been referred to the Headquarters, United States Army Medical Command (MEDCOM), Freedom of Information/Privacy Act Program Office for processing and response to you.
USAMRMC completed their search for documents responsive to your request, and the documents have been referred to U.S. Army Medical Command FOIA Office for final processing.
Should you have any questions pertaining to the status/processing of your request please contact the MEDCOM FOIA Office at the address below:
CDR USAMEDCOM
ATTN: MCFP / FOIA and Privacy Act Office
2748 Worth Road, STE 21
JBSA Fort Sam Houston, TX 78234-6021
210-221-4233
usarmy.jbsa.medcom.list.medcom-foia-users@mail.mil
Thank you,
Shalli L. Keller
Staff Action Control Officer
USAMRMC - Fort Detrick, MD
301-619-7118
CLASSIFICATION: UNCLASSIFIED
From: U.S. Army Medical Research and Materiel Command
CLASSIFICATION: UNCLASSIFIED
Good Afternoon,
This is an update on the following FOIA requests:
1. FA-19-0007, All presentations/materials presented at 125th WRAIR Celebration for Military Psychiatry & Neuroscience held on 14 Nov 18.
The DVD was mailed out but never received by your office. WRAIR is working on getting another DVD of this event. When I receive the DVD I will send out in the mail and email you the day it was sent.
2. FA-19-0009, Request all memoranda, reports, presentations and emails from MRMC & sub activities including USAMMA from and to any reps related to proposed or planned policy for Tafenoquine in the chemoprophylaxis of malaria. Request has been referred to MEDCOM FOIA Office.
3. FA-19-0010 Request copies purchase orders, contracts, records, and related correspondence between USAMMDA and sub activities of MRMC, 60 degrees pharmaceuticals or any wholesale or distributor for supplies of TQ intended for military use from 2013-present. You'll be contacted by the MEDCOM FOIA Office regarding your appeal.
If you have any further questions, please let me know.
Thank you,
Shalli L. Keller
Staff Action Control Officer
USAMRMC - Fort Detrick, MD
301-619-7118
CLASSIFICATION: UNCLASSIFIED
From: U.S. Army Medical Research and Materiel Command
Dear Dr. Nevin,
Your appeal, dated March 28, 2019, to the U.S. Army Medical Research and Materiel Command FOIA Office was referred to my office on 11 April 2019. (attached)
I have reviewed the redactions made to the 3-page document, the basis for your disagreement with the redactions, and your justification for the release of the redacted information.
Additionally, I received from the FOIA Office MRMC an additional 208 pages of documents responsive to your request.
I have reprocessed the 3 page document and processed the 208 page document.
Due to the size of the documents, 77 MB, they will be sent to you using the AMREDC Safe Access File Exchange (SAFE). You will receive a SAFE File Notification, Subject: AMREDC Safe Access File Exchange Delivery Notice. The SAFE Notification will provide you a password (copy the password ) and link (the files(s) will be available at:). Click on the link. When the link comes up, paste the password and click Submit. SAFE will further direct you as to how to download the file.
PLEASE NOTE: Once you receive the SAFE File Notification, the file will only be available to you for downloading from AMREDC for Two (2) days.
Please provide me with an email address that you wish the SAFE file to be delivered.
Once you have had the opportunity to review the documents, should you have any questions pertaining to the processing/redaction of the documents, I would be pleased to discuss the basis for my redactions with you.
Redactions to the documents were made pursuant to the following FOIA Exemptions:
FOIA Exemption 3 precludes the disclosure of information which is protected from release by provisions contained in other federal statutes. FOIA Exemption 3, specifically, 10 U.S.C § 130b. authorizes the withholding from disclosure to the public information pertaining to routinely deployable units.
FOIA Exemption 4 permits the withholding of records related to commercial or financial information in connection with bids, contracts and proposals or other proprietary data.
FOIA Exemption 5 permits the withholding of information under the deliberative process privilege. Deliberative information includes intra-agency or inter-agency communications that are antecedent to the adoption of the agency's action. Exemption 5 permits the open discussion of the widest range of possible positions and set of recommendations for consideration. The purpose of this privilege is to encourage open, frank discussions on matters of policy; to protect against the premature disclosure of proposed policies before they are actually adopted; and to protect against confusion that might result from the disclosure of reasons and rationales that may not, in fact, ultimately be the grounds for an agency's action.
FOIA Exemption 6 permits the government to withhold information about individuals when the disclosure would constitute a clearly unwarranted invasion of personal privacy if disclosed. When weighing the public interest in knowing how the government works against the privacy interests of individual persons we may conclude that no significant public interest will be served in the release of that information. The names of DoD personnel are also exempt from release pursuant to the DoD "Names" policy in force due to post-9/11 concerns on the security of our personnel.
Very Respectfully,
jpp
John P. Peterson
Chief, Freedom of Information/
Privacy Act Office
HQ, U.S. Army Medical Command
(W) 210-466-5933
john.p.peterson.civ@mail.mil
From: Dr. Remington Nevin
John P. Peterson
Chief, Freedom of Information/
Privacy Act Office
HQ, U.S. Army Medical Command
(W) 210-466-5933
john.p.peterson.civ@mail.mil
Dear Mr. Peterson,
Thank you very much for your assistance. Please send the AMREDC Safe Access File Exchange information to this email address, copying rnevin@quinism.org.
Sincerely,
Dr. Remington Nevin
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 11, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FP-19-0010.
Thanks for your help, and let me know if further clarification is needed.
From: U.S. Army Medical Research and Materiel Command
Good afternoon
Attached is a response to your FOIA request referenced below that was
submitted to Ms. Shalli Keller at the U.S. Army Medical Research and
Material Command. Your request was referred to our office for review and
direct response for the records under our purview.
If you have any questions, please contact me to discuss.
Thank you
Nancy Gaynor
FOIA Officer
USAMRAA
____________________________________________________________________________
____________________________________________________________________________
________________________________________________________
U.S. Army Medical Research and Materiel Command
FOIA Office
810 Schreider Street
Frederick, MD 21702-5000
December 11, 2018
Ms. Shallli Keller
Staff Action Control Officer
U.S. Army Medical Research and Materiel Command
Email: shalli.l.keller.civ@mail.mil <mailto:shalli.l.keller.civ@mail.mil>
Tel: 301-619-7118
c/o
CDR USAMRMC
810 Schreider Street
Fort Detrick, MD 21702-5000
Re: FOIA Request
Dear Ms. Keller,
This is a request under the Freedom of Information Act. I hereby request the
following records:
Copies of all purchase orders, contracts, records, and related
correspondence between USAMMDA or other subordinate activity of USAMRMC, and
60 Degrees Pharmaceuticals or any intermediate wholesaler or distributor,
for supplies of tafenoquine (Arakoda) intended for U.S. military use, from
2013 to the date of processing of this request.
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,
Dr. Remington Nevin
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03/05/2019
[Non-DoD Source] Freedom of Information Act Request: Purchase Contracts, Orders, and Records Related to Tafenoquine (Arakoda)