15DDHQ25Q00000010 Amendment 0001 03192025.pdf
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- Solicitation number
- 15DDHQ25Q00000010
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This is an Amendment to a federal solicitation (Amendment 0001) for a contract to evaluate the abuse potential of synthetic cannabinoids and phytocannabinoids using in vivo pharmacological studies. The amendment extends the closing date and time, extends question due dates, and adds critical documents including the Statement of Work (SOW), Evaluation Criteria, Contract Line Item Numbers (CLINs), clauses, and an updated pricing worksheet. The solicitation is issued by the Drug Enforcement Administration (DEA) with a base period from 05/01/2025 to 04/30/2026 and includes four additional one-year option periods through 05/01/2029. The contract requires conducting preclinical studies such as locomotor activity studies, cannabinoid tetrad studies, and drug discrimination studies on test substances, comparing them to appropriate controls and reference standard substances like THC. The vendor will be responsible for purchasing reference drugs and test substances, performing studies in rodents, and providing detailed investigational study reports to the DEA.
The solicitation includes multiple Contract Line Item Numbers (CLINs) for various assay types, such as Locomotor Activity Assay, Drug Discrimination Assays, Cannabinoid Tetrad Assay, and associated incidental costs. Each CLIN covers a specific one-year period from 05/01/2025 to 04/30/2029, with quantities ranging from 3 to 10 units per assay type. A separate CLIN for "Drug Cost Not to Exceed" is included, with quantities of 10 units per period. The vendor must have a Schedule I researcher registration with DEA, be capable of obtaining necessary test substances, and provide comprehensive documentation and reporting for each study. The solicitation indicates a best value trade-off approach for award, with non-price factors being significantly more important than price, and allows for evaluation of quotes from institutions classified under NAICS codes for Colleges, Universities, Medical Laboratories, Research and Development, and Testing Laboratories and Services.
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Other files
| File | Type | Posted |
|---|---|---|
| Pricing Sheet Templalte.xlsx | XLSX spreadsheet | |
| RFQ 15DDHQ25Q00000010.pdf | ||
| PRICING SHEET TEMPLATE - Attachment 1.xlsx | XLSX spreadsheet | |
| Sample BPA Call Order - Attachment 2.xlsx | XLSX spreadsheet |
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AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
1. CONTRACT ID CODE PAGE OF PAGES
1 77
2. AMENDMENT/MODIFICATION NUMBER
3. EFFECTIVE DATE
03/18/2025
4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)
15DDHQCODE
DEA
Attn: Office of Acquisition (FA) 8701 Morrissette Drive Springfield, VA 22152-1080
6. ISSUED BY CODE7. ADMINISTERED BY (If other than Item 6)
9A. AMENDMENT OF SOLICITATION NUMBER
15DDHQ25Q00000010
CODE FACILITY CODE
8. NAME AND ADDRESS OF CONTRACTOR (Number, street, country, state and ZIP Code) (X)
X 9B. DATED (SEE ITEM 11)
03/10/2025
10A. MODIFICATION OF CONTRACT/ORDER
NUMBER
10B. DATED (SEE ITEM 13)
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
X XThe above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.
Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing items 8 and 15, and returning ____copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.
12. ACCOUNTING AND APPROPRIATION DATA (If required)
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.
IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.
CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT
ORDER NUMBER IN ITEM 10A.
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
D. OTHER (Specify type of modification and authority)
E. IMPORTANT: Contractor is not, is required to sign this document and return _______ copies to the issuing office.
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.
15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)
Devine, Marie T.
(Signature of person authorized to sign)
15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED
By (Signature of Contracting Officer)
16B. UNITED STATES OF AMERICA 16C. DATE SIGNED
Previous edition unusable STANDARD FORM 30 (REV. 11/2016) Prescribed by GSA FAR (48 CFR) 53.243
15DDHQ25Q00000010/0001
X
The solicitation has been updated to extend the closing date and time, extend the question due dates, add the SOW, Evaluation Criteria, CLINS, Clauses and updated pricing worksheet.
Section 1 - Commodity or Services Schedule
SCHEDULE OF SUPPLIES/SERVICES
CONTINUATION SHEET
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0001 Locomotor Activity Assay Cost
PSC: Q301
Line Period of Performance: 05/01/2025 - 04/30/2026
Base Period
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0002 Locomotor Activity Assay Incidental Cost
PSC: Q301
Line Period of Performance: 05/01/2025 - 04/30/2026
Base Period
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0003 Drug Discrimination (monthly maintenance of training drug) Assay Cost
PSC: Q301
Line Period of Performance: 05/01/2025 - 04/30/2026
Base Period
Delivery Schedule:
Quantity: 3.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
3 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0004 Drug Discrimination (training drug) Incidental Cost
PSC: Q301
Line Period of Performance: 05/01/2025 - 04/30/2026
Base Period
Delivery Schedule:
3 EA $________ $_________________
15DDHQ25Q00000010/0001
Quantity: 3.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0005 Drug Discrimination of test drug Assay Cost
PSC: Q301
Line Period of Performance: 05/01/2025 - 04/30/2026
Base Period
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0006 Drug Discrimination of test drug Incidental Cost
PSC: Q301
Line Period of Performance: 05/01/2025 - 04/30/2026
Base Period
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0007 Cannabinoid Tetrad Assay
PSC: Q301
Line Period of Performance: 05/01/2025 - 04/30/2026
Base Period
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0008 Cannabinoid Tetrad Assay incidental cost
PSC: Q301
Line Period of Performance: 05/01/2025 - 04/30/2026
Base Period
Delivery Schedule:
10 EA $________ $_________________
Quantity: 10.000000 FOB:
Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0009 Drug Cost Not to Exceed
PSC: Q301
Line Period of Performance: 05/01/2025 - 04/30/2026
Base Period
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
1001 Locomotor Activity Assay Cost
PSC: Q301
Line Period of Performance: 05/01/2026 - 04/30/2027
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
1002 Locomotor Activity Assay Incidental Cost
PSC: Q301
Line Period of Performance: 05/01/2026 - 04/30/2027
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
1003 Drug Discrimination (monthly maintenance of training drug) Assay Cost
PSC: Q301
Line Period of Performance: 05/01/2026 - 04/30/2027
Unexercised Option
Delivery Schedule:
3 EA $________ $_________________
Quantity: 3.000000 FOB:
Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
1004 Drug Discrimination (training drug) Incidental Cost
PSC: Q301
Line Period of Performance: 05/01/2026 - 04/30/2027
Unexercised Option
Delivery Schedule:
Quantity: 3.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
3 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
1005 Drug Discrimination of test drug Assay Cost
PSC: Q301
Line Period of Performance: 05/01/2026 - 04/30/2027
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
1006 Drug Discrimination of test drug Incidental Cost
PSC: Q301
Line Period of Performance: 05/01/2026 - 04/30/2027
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
1007 Cannabinoid Tetrad Assay
PSC: Q301
Line Period of Performance: 05/01/2026 - 04/30/2027
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
10 EA $________ $_________________
Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
1008 Cannabinoid Tetrad Assay incidental cost
PSC: Q301
Line Period of Performance: 05/01/2026 - 04/30/2027
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
1009 Drug Cost Not to Exceed
PSC: Q301
Line Period of Performance: 05/01/2026 - 04/30/2027
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
2001 Locomotor Activity Assay Cost
PSC: Q301
Line Period of Performance: 05/01/2027 - 04/30/2028
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
2002 Locomotor Activity Assay Incidental Cost
PSC: Q301
Line Period of Performance: 05/01/2027 - 04/30/2028
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA
10 EA $________ $_________________
Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
2003 Drug Discrimination (monthly maintenance of training drug) Assay Cost
PSC: Q301
Line Period of Performance: 05/01/2027 - 04/30/2028
Unexercised Option
Delivery Schedule:
Quantity: 3.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
3 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
2004 Drug Discrimination (training drug) Incidental Cost
PSC: Q301
Line Period of Performance: 05/01/2027 - 04/30/2028
Unexercised Option
Delivery Schedule:
Quantity: 3.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
3 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
2005 Drug Discrimination of test drug Assay Cost
PSC: Q301
Line Period of Performance: 05/01/2027 - 04/30/2028
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
2006 Drug Discrimination of test drug Incidental Cost
PSC: Q301
Line Period of Performance: 05/01/2027 - 04/30/2028
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC)
10 EA $________ $_________________
8701 Morrissette Drive Springfield, VA 22152-1080
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
2007 Cannabinoid Tetrad Assay
PSC: Q301
Line Period of Performance: 05/01/2027 - 04/30/2028
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
2008 Cannabinoid Tetrad Assay incidental cost
PSC: Q301
Line Period of Performance: 05/01/2027 - 04/30/2028
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
2009 Drug Cost Not to Exceed
PSC: Q301
Line Period of Performance: 05/01/2027 - 04/30/2028
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
3001 Locomotor Activity Assay Cost
PSC: Q301
Line Period of Performance: 05/01/2028 - 04/30/2029
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
3002 Locomotor Activity Assay Incidental Cost
PSC: Q301
Line Period of Performance: 05/01/2028 - 04/30/2029
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
3003 Drug Discrimination (monthly maintenance of training drug) Assay Cost
PSC: Q301
Line Period of Performance: 05/01/2028 - 04/30/2029
Unexercised Option
Delivery Schedule:
Quantity: 3.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
3 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
3004 Drug Discrimination (training drug) Incidental Cost
PSC: Q301
Line Period of Performance: 05/01/2028 - 04/30/2029
Unexercised Option
Delivery Schedule:
Quantity: 3.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
3 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
3005 Drug Discrimination of test drug Assay Cost
PSC: Q301
Line Period of Performance: 05/01/2028 - 04/30/2029
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
3006 Drug Discrimination of test drug Incidental Cost
PSC: Q301
Line Period of Performance: 05/01/2028 - 04/30/2029
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
3007 Cannabinoid Tetrad Assay
PSC: Q301
Line Period of Performance: 05/01/2028 - 04/30/2029
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
3008 Cannabinoid Tetrad Assay incidental cost
PSC: Q301
Line Period of Performance: 05/01/2028 - 04/30/2029
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
3009 Drug Cost Not to Exceed
PSC: Q301
Line Period of Performance: 05/01/2028 - 04/30/2029
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
4001 Locomotor Activity Assay Cost
PSC: Q301
Line Period of Performance: 05/01/2029 - 04/30/2030
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
4002 Locomotor Activity Assay Incidental Cost
PSC: Q301
Line Period of Performance: 05/01/2029 - 04/30/2030
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
4003 Drug Discrimination (monthly maintenance of training drug) Assay Cost
PSC: Q301
Line Period of Performance: 05/01/2029 - 04/30/2030
Unexercised Option
Delivery Schedule:
Quantity: 3.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
3 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
4004 Drug Discrimination (training drug) Incidental Cost
PSC: Q301
Line Period of Performance: 05/01/2029 - 04/30/2030
Unexercised Option
Delivery Schedule:
Quantity: 3.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
3 EA $________ $_________________
4005 Drug Discrimination of test drug Assay Cost
PSC: Q301
Line Period of Performance: 05/01/2029 - 04/30/2030
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
4006 Drug Discrimination of test drug Incidental Cost
PSC: Q301
Line Period of Performance: 05/01/2029 - 04/30/2030
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
4007 Cannabinoid Tetrad Assay
PSC: Q301
Line Period of Performance: 05/01/2029 - 04/30/2030
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
4008 Cannabinoid Tetrad Assay incidental cost
PSC: Q301
Line Period of Performance: 05/01/2029 - 04/30/2030
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
4009 Drug Cost Not to Exceed
PSC: Q301
Line Period of Performance: 05/01/2029 - 04/30/2030
Unexercised Option
Delivery Schedule:
Quantity: 10.000000 FOB:
Delivery Address: DEA Attn: Diversion Control Division(DC) 8701 Morrissette Drive Springfield, VA 22152-1080
10 EA $________ $_________________
Section 1: Schedule of Services
Unit cost estimates for different pharmacological tests.
Advance payments for costs incurred to conduct assays as specified in the Tables are not authorized. Vendor will bill DEA on a monthly basis based on actual expenses (i.e., consumables, assay costs). Expense report will include total number of assays completed and the unit cost of each type of assay (e.g., 4 drug discrimination assays x specified unit cost = $). The unit cost for each assay is the assay cost plus the incidental cost. Drug costs will vary depending on amount needed. Any drug amount exceeding 1 g or a cost of $500 will need approval by DEA prior to ordering.
Section 2: Statement of Work Evaluation of Abuse Potential of Synthetic Cannabinoids and Phytocannabinoids Using In
Vivo Pharmacological Studies
1.0 Background
The Drug Enforcement Administration’s (DEA) Diversion Control Division (DC), Drug and Chemical Evaluation Section (DPE) is responsible for evaluating drugs and chemicals to determine whether these substances have abuse potential. These evaluations are used by DEA to support its domestic scheduling activities. In order for DEA to determine the abuse potential of drugs and chemicals, pharmacological, medical, epidemiological, and other scientific data for these drugs, when necessary, are needed to initiate the administrative procedure to place these substances under regulatory control according to the guidelines of the Controlled Substances Act
(CSA).
Recently, numerous novel psychoactive substances (NPS) to include synthetic cannabinoid and phytocannabinoid compounds have emerged within the United States and poses significant risk to the public safety. Numerous NPS have been identified in samples submitted to federal, state and local forensic laboratories. There have been reports of overdoses, including fatalities, associated with the abuse these substances. In response to the associated public health threat with the abuse of NPS, the Administrator of DEA has placed several NPS in Schedule I of the CSA under a temporary scheduling order to avoid an imminent hazard to the public safety.
Preliminary studies (in vitro) have shown that these substances share pharmacological similarities with other known drugs of abuse. Further, there are emerging NPS with paucity of pharmacology data. Detailed information on many NPS biological and pharmacological activities is limited.
2.0 Brief description of work
For this project, unless otherwise specified by the DEA representative, the vendor shall purchase the reference drugs and all test substances1 approved by the DEA for testing. The DEA will provide the test substances otherwise not commercially available to the potential vendor for the requested testing. Some of these substances are Schedule I substances. Therefore, the vendor should already have a Schedule I researcher registration with DEA. The vendor shall conduct appropriate preclinical studies such as locomotor activity study, cannabinoid tetrad study, and drug discrimination study on these substances in comparison to appropriate controls and reference standard substances. The type of study requested is dependent upon the class of substance. The reference training drugs shall include, but not be limited to THC (Δ9-tetrahydrocannabinol, and other drugs as directed by the DEA representative. Each substance shall be assessed for its abuse potential by using appropriate studies in rodents. The vendor will provide the DEA with investigational study results and a description of the methodology used to conduct the investigation in the form of a study report based on the timeline specified in this statement of work (SOW), if not earlier. If a report on all requested studies cannot be provided
1 The vendor shall provide adequate information on the purity of the test substance before conducting pharmacological testing. Also, should the drug cost exceed $500, the vendor shall contact DEA representative for approval.
by the specified timelines, a letter stating the anticipated date of completion of investigations and anticipated delivery of a study report will be required prior to that date. Final study conditions, including but not limited to the number of rodent, or the strain of rodent used, shall be subject to approval of the DEA representative. The vendor shall be able to conduct all studies though not all assays might be requested.
3.0 Specific requirements
Task 1. Drug source, storage and recordkeeping.
I. Drug Source: Unless otherwise specified by the DEA representative (if it is determined that the test substance is not commercially available), the vendor shall purchase the reference and test drugs2. The cost of the drug should not exceed $500. If there is a deviation, DEA representative should be notified immediately. Actual cost of drug can be billed as an invoice. The vendor shall conduct a preclinical evaluation of these test substances (as specified in tasks listed below) in comparison to appropriate controls and the appropriate reference standard. Pharmacological evaluation of each test substance shall be done using appropriate in vivo assays as approved by DEA.
II. Record Keeping: The vendor shall maintain electronic and paper copies of a chronological log of the test substance receipt and evaluation using Microsoft Excel spreadsheet software. When each substance is received, the following shall be recorded:
a) test substance's name;
b) source of the test substance (if it is a purchased or a standard substance);
c) purity of the test substance (all test and reference drug should be ≥ 98%);
d) date testing of the test substance was authorized;
e) date the test substance was received (If provided by the DEA);
f) amount of test substance received (if provided by the DEA);
g) pharmacological studies authorized by DEA for the test substance (e.g. locomotor activity and drug discrimination);
h) date when the study began for each authorized study;
i) amount of test substance used for each authorized study;
j) date when the study was completed for each authorized study;
k) date when the report was sent to the DEA.
This cumulative Receipt and Evaluation log shall be kept up to date and forwarded to the DEA representative upon request.
III. Drug Storage and Schedule I Researcher Registration Requirement: Some of the test substances maybe in Schedule I of the CSA. Under these circumstances, it is required that the test substances be stored under Schedule I requirements as specified by the CSA and that the vendor evaluating the test substances shall be registered with the DEA as a
2 The vendor shall provide adequate information on the purity of the test substance before conducting pharmacological testing.
Schedule I researcher. Some reference drugs are in Schedule II of the CSA. Therefore appropriate DEA license and storage requirement shall be maintained. In cases where test substances are not Schedule I, drug storage requirements shall be maintained under Good Laboratory Practices (GLP) or GLP-like conditions.
Task 2. Protocols of in vivo pharmacological studies (locomotor activity, cannabinoid tetrad studies, drug discrimination studies and other optional studies (e.g. head twitch response)) in laboratory rodent animals
General protocols that are used for in vivo locomotor activity and drug discrimination studies shall be provided by the vendor to the DEA. The protocols shall contain a description of the methodology used to conduct the investigation, a description of the apparatuses that will be used for conducting the studies, maintenance of the animals to be used in the tests, procedures for analysis of the data including proposed statistical methods, and proposed presentations of the data and study results. Specifically, the study protocol should conform to the following standards:
I. A study protocol shall be provided for each individual in vivo pharmacological study. For example, one protocol should be provided for locomotor activity and one protocol for drug discrimination study, etc.
II. The study protocols must be specifically written to meet the protocol preferences as listed in this SOW under Tasks 3, 4, 5 and 6.
III. The study protocol should closely follow the format of the materials and methods section that would be submitted for a peer-reviewed journal article. Details including the animal strain, number of animal, animal care, experimental design, data analysis including statistical methods and generation of results (e.g. ED50 and 95% confidence limit values, repeated measures ANOVA as appropriate) shall be included.
IV. The study protocol shall include examples of how data will be presented. For example, representative dose-response curves, tables, and statistical analyses should be included.
This information can be taken from previously published studies. However, this information should be included in a section as part of the study protocol and shall not be submitted as a separate file, but the data should be cited (i.e. submitting the example paper with the study protocol would not be considered acceptable).
V. Signature lines shall be included on each study protocol. Upon approval of the protocol by DEA and the vendor, the protocol will be signed by each representative. The original signed document will remain with DEA. A copy of the signed protocol will be provided to the vendor. The signed protocols will serve as an official record.
Following receipt of the standard protocols by the DEA representative, a phone conversation may be scheduled to discuss the study protocols and SOPs. Any significant deviations or modifications from the protocol by the vendor must be authorized by DEA. The vendor must provide a modified protocol (e.g., change in time points, change in vehicle used, modification needed based on a specific test substance, etc.), the amended or modified protocol must be submitted in writing to the DEA representative for review and approval. The DEA representative must approve work with each new assay modifications.
NOTE: The DEA representative must approve work with each new test method prior to its initiation. Only those test substance specified by the DEA shall be evaluated in the new study under development. For the most part, standard substances (known drugs of abuse such as THC and others) shall be used. Special reports and data summaries shall adhere to a format determined by the DEA.
Task 3. Evaluation of test substances in the in vivo locomotor activity study
I. Objective: Using the general protocol agreed to by the vendor and DEA in Task 2, the vendor shall, as specified by the DEA representative, evaluate standard (reference) and/or test substances using the in vivo locomotor activity assay. The goal of this in vivo pharmacological study (locomotor activity study) is to determine whether the test substance can elicit changes in locomotor activity of the rodent. Further, this study can be used to identify parameters to include but not limited to onset of action, time to peak effect, duration of action, and dose effect response before conducting other behavioral tests for the test substances.
II. Experimental Design: Locomotor activity assays shall be conducted in mice unless otherwise agreed upon by both the DEA and vendor. If alternative rodent animal species or alternate species are selected, the vendor will provide to the DEA a comprehensive rationale for selecting a different animal species. The DEA and the vendor shall agree on the strain of rodent to be used for each of the studies. Briefly, locomotor activity test will be conducted in an automated activity monitoring chamber located in a sound-attenuating device that provides dim illumination. Prior to testing, mice will be injected via appropriate route with either vehicle or reference substances or test substance and immediately placed in the chamber for locomotor activity monitoring. In all studies, horizontal activity (interruption of photocell beams) reported as horizontal activity count will be measured.
Testing shall be conducted with one mouse per activity chamber. Experimental groups for evaluating each test substance should consist of appropriate number of doses (three experimental doses at a minimum) using a pharmacologically- effective dose range to generate a dose response curve, and a statistically appropriate number of animals per group (at least 8 animals). Appropriate controls shall be used. For each test substance, ED50 (50% effective dose) and 95 % confidence limit values shall be calculated. Data on dose-response curves shall also be presented and reported.
III. Potential Experimental Issues and Reporting: In the event that any experimental issues arise (e.g., inability to dissolve test compound, unexpected results, animal lethality, deviation or departure from the agreed protocol, statistics issue due to experimental constrains), the vendor shall immediately notify the DEA representative, in writing (email) with the issue and if the issue was resolved. Based on the issue noted by the vendor, the DEA representative may schedule a phone conversation or respond by email. All experimental issues that arise and the resolutions shall be documented in writing even if the issue and resolutions are discussed in a phone conversation.
IV. Study Report: Following completion of the in vivo locomotor activity study for each test substance, the results in the form described in Task 8 (e.g. ED50 and 95% confidence limit values, dose response curves) shall be provided to the DEA representative for review and acceptance. The DEA representative may contact the vendor if there are any notable issues with the results.
Task 4. Evaluation of test substances in the in vivo cannabinoid tetrad testing battery.
I. Objective: The goal of this study is to evaluate the effects of test substances on antinociception, body temperature, spontaneous locomotor activity, and catalepsy. Using the general protocol with agreement of the vendor and DEA in Task 2, the investigators shall, as specified by the DEA representative, evaluate standard (reference e.g. THC) and/or test substances using the agreed upon in vivo tetrad testing battery.
II. Experimental Design: The in vivo tetrad testing battery shall be conducted in mice unless otherwise agreed upon by both the DEA and vendor. The vendor shall provide justification for the type of strain selected to conduct this study. Test substances selected for the tetrad test battery shall not be included as a test substance in Tasks 3 (in vivo locomotor activity test) unless otherwise specified by the DEA representative. Selection of the positive and/or negative control, if required, for each test substance selected for the tetrad testing battery shall be specified by DEA to vendor. Experimental groups for evaluating each test substance should consist of appropriate number of doses (three experimental doses at a minimum), using a pharmacologically-effective dose range to generate a dose response curve, and a statistically appropriate number of animals per group (at least 8 animals). Appropriate controls shall be used. For each active test substance, ED50 (50% effective dose) and 95% confidence limit values shall be calculated. Data on dose-response curves shall also be presented and reported.
III. Potential Experimental Issues and Reporting: In the event that any experimental issues arise (e.g. inability to dissolve test compound, unexpected results, animal lethality, deviation or departure from the agreed protocol, statistics issue due to experimental constrains), the vendor shall immediately notify the DEA representative, in writing (email) with the issue and if it was resolved. Based on the issue noted by the vendor, the DEA representative may schedule a phone conversation or respond by email. All experimental issues that arise and the resolutions shall be documented in writing even if the issue and resolutions are discussed in a phone conversation.
I. Study Report: Following completion of the in vivo tetrad assay for each test substance, the results in the form described in Task 8 (e.g. ED50 and 95% confidence limit values, dose response curves) shall be provided to the DEA representative for review and acceptance. The DEA representative may contact the vendor if there are any notable issues with the results.
Task 5. Evaluation of test substances in in vivo drug discrimination assay I. Objective: The goal of this in vivo pharmacological study is to understand whether the test substances can be substituted for the discriminative-stimulus effects produced by a known drug of abuse. Using the general protocol agreed to by the vendor and DEA in Task 2, the vendor shall, as specified by the DEA representative, evaluate standard (reference) and test substances using the in vivo drug discrimination assay.
II. Experimental Design: Drug discrimination studies shall be conducted in rats unless otherwise agreed upon by both the DEA and vendor. If alternative rodent animal species or alternate species are selected, the vendor will provide to the DEA a comprehensive rationale for selecting a different animal species. The DEA and the vendor shall agree on the strain of rodent to be used for each of the studies. The vendor shall maintain groups of animals (rats) trained to discriminate the stimulus effects of a given reference drug (from its vehicle during each year of the agreement. It is expected that drug discrimination training for the animals commence within a week after the protocol is approved. The reference training drugs shall include, but not be limited to THC and other drugs as directed by the DEA representative. The training and reference drugs should be tested periodically to establish a dose effect reference standard in the rats. The vendor shall have the equipment available for drug discrimination testing procedures such that the experiments can be conducted in a relatively expedient manner for this assay.
Additionally, it is encouraged to have multiple and/or automated apparatus for evaluating the discriminative stimulus effects in order to increase efficiency of completing the experiments.
III. Potential Experimental Issues and Reporting: In the event that any experimental issues arise (e.g. inability to dissolve test compound, unexpected results, animal lethality, deviation or departure from the agreed protocol, statistics issue due to experimental constrains ), the vendor shall immediately notify the DEA representative, in writing (email) with the issue and if the issue was resolved. Based on the issue noted by the vendor, the DEA representative may schedule a phone conversation or respond by email.
All experimental issues that arise and the resolutions shall be documented in writing even if the issue and resolutions are discussed in a phone conversation.
IV. Study Report: Following completion of the in vivo tetrad assay for each test substance, the results in the form described in Task 8 (e.g. ED50 and 95% confidence limit values, dose response curves) shall be provided to the DEA representative for review and acceptance. The DEA representative may contact the vendor if there are any notable issues with the results.
Task 6. Optional In Vivo Studies
The DEA is open to the inclusion of other behavioral studies (e.g., physical dependence, conditioned place preference, rotorod assays), pharmacokinetic studies, and route of administration (e.g., inhalation) that can provide further information on the pharmacological properties of this class of substances. Please note that inability to perform any of the suggested optional studies will not exclude a researcher for consideration. If the DEA representative and the vendor agree on all matters (i.e., feasibility, cost, etc.) regarding these optional in vivo studies then these study can be added to the contract.
Task 7. Data presentation
The data organized in tables shall be provided to the DEA representative. Information should include, but not be limited to: (1) name of substance; (2) in vivo assay tested; (3) date(s) of study;
(4) animal species used and source; (5) route(s) of administration, vehicle, and doses used; (6) number of animals per group; (7) observed effect at each selected dose level; and (8) calculated ED50 and 95 % confidence interval values. For instances where there is insufficient information to provide the specified information in the table, vendor will document the rationale in the table.
This recordkeeping of the data and results is separate from the recordkeeping of the test substance as listed in Task 1 and also is separate from the reporting of study results listed in Tasks 3 - 5. The summarized data ("cumulative data table") shall be forwarded monthly to the DEA representative. The vendor and DEA will ensure all electronic information is accessible to individuals with disabilities in accordance with Section 508 of the Rehabilitation Act (29 U .S.C.
794d), as amended in 1998.
Task 8. Final study report for each substance tested
Following completion of the experiments in Task 3, 4, and 5, a final study report containing the complete methodology, data analysis, and study results for each test substance shall be provided in electronic format to the DEA.
1) Study Report:
i) Study Reports: A final study report containing the complete methodology, data analysis, and study results for each compound/assay shall be provided to the DEA.
The DEA representative will provide an example of a Final Study Report for the vendor to use in preparation of the report. Where feasible, data shall be presented in tables and figures and the results shall be described in a textual format. Raw data should also be included in an appendix to the report. The vendor shall first submit a draft report in using Microsoft word to the DEA Representative. Upon review by the DEA Representative, revisions may need to be made. Once revisions are completed or the draft is cleared by the DEA Representative, final copies of the report shall be provided to the DEA Representative in electronic MS word version as well as a portable document file (PDF) format. Each report shall be due no later than thirty (30) calendar days after the study completion date specified in the Contractor's log of substance evaluation. The format shall be as follows:
ii) Front cover to contain: Date, title (to include compound name), researcher (name/address/phone number, email), contract number, DEA representative (name).
iii) Main body to contain: (1) A brief (one or two paragraph) summary of the findings (2) detailed methods, and (3) results organized as text, tables, and/or figures, as agreed upon with DEA representative.
Task 9. Reporting Requirements
All reports required herein shall be submitted in electronic format to the DEA representative as detailed in the following subsections. The preparation and submission of regularly recurring Technical Progress Reports will be required for this agreement. These reports shall require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined by the DEA Representative.
a) Monthly Reports: On or before the 5th working day of each month, the vendor shall submit one electronic copy in PDF format of a report on activities during the month. In the report, vendor shall include (1) all test substance evaluation reports completed during the month (2) a table, or set of tables, of all compounds tested in the contract, with the main results so far, and (3) entries for the compounds next in line for testing as specified above
b) Study Reports: See Task 7 for details on these reports.
c) Annual Progress Reports: On or before the 5th working day following the end of each period of performance year, the vendor shall submit a report on activities during the year.
Two copies, one paper copy and one electronic copy in Microsoft Word or PDF format, shall be sent to the DEA representative. In the report, vendor shall include: section 1 – a summary of the overall results generated on all substances during the past 12 months;
section 2 – a brief summary of any problems encountered while conducting the established experimental assays and, if applicable, a description of how those problems were resolved, as well as a brief summary of progress in any experimental assay development; section 3 – the log of test substance purchased, See Task 1; section 4 – any other information required. The summary of overall results (section 1) should not be an all-inclusive summary of data generated on standard substances but, rather a summary highlights.
Task 10. Level of Effort
The DEA Representatives reserve the right to visit the laboratory where testing is being conducted.
a) Meetings between DEA and vendor:
i. Monthly conference calls: The vendor and the DEA representative shall have a teleconference meeting once a month. Other DEA and contract staff may participate if necessary. These meetings may be waived at the discretion of the DEA representative. Specific items for discussion shall be subject to the approval of the DEA representative.
ii. In-person meetings: DEA representative reserves the right to visit the vendor’s facility for the purpose of site visitation. At approximately 12-month intervals, DEA representatives may set-up a meeting with the vendor for the purpose of reviewing past, current, and/or proposed work under this agreement. These meetings may be waived at the discretion of the DEA representative. Specific items for discussion shall be subject to the approval of the DEA representative.
iii. Pre-Meeting Materials: Three weeks before each meeting, the vendor shall prepare "pre-meeting packets" summarizing all data on test compounds to be presented and describing relevant assay methods. This packet shall also include summaries of: (1) Quotes for optimizing existing assays; (2) progress in ongoing assay development; (3) Quotes for new assay development; (4) problems encountered in implementing tasks required in the agreement; and (5) proposed solutions to problems encountered. The vendor shall deliver this information to the DEA representative at least 3 weeks in advance of the meeting for approval, and after approval has been obtained, to each consultant at least 2 weeks prior to the meeting.
iv. Post-Meeting Materials: After the meeting, the vendor shall prepare a post- Meeting report, summarizing the recommendations and comments of the attending consultants and DEA staff. The report shall include recommendations for optimizing specific assays and suggestions for incorporating new assays into the DEA testing program. The Post- Meeting Report shall be sent to the DEA representative within three (3) weeks of the meeting.
v. Meeting Location(s): The site of the meeting shall be either at the annual scientific meetings of professional associations such as the College on Problems of Drug Dependence and the Society for Neuroscience, the DEA headquarters or other locations as specified by the DEA. This agreement shall not be responsible for the payment of DEA consultants' expenses. Meetings via video teleconference to discuss status and other issues may be held, but could be cancelled at the DEA’s discretion.
4.0 Period of Performance
Period of Performance POP Start POP End Ordering Period 1 05/01/2025 04/30/2026 Ordering Period 2 05/01/2026 04/30/2027 Ordering Period 3 05/01/2027 04/30/2028 Ordering Period 4 05/01/2028 04/30/2029 Ordering Period 5 05/01/2029 04/30/2030
5.0 Deliverables
If a report on any of the requested studies cannot be provided by the specified timelines, the vendor must notify the DEA immediately upon obtaining this knowledge. This notification shall be followed up by a letter to the DEA stating the reason for the delay, the anticipated date of completion of investigations, and the anticipated delivery of the study.
ITEM DELIVERABLE DELIVERY SCHEDULE
1 Project kick-off meeting to discuss overall project expectations, timelines, and deliverables.
Agreed protocols of the in vivo locomotor activity, cannabinoid tetrad study and drug discrimination assays
Within 2 working days following receipt of protocol.
Initial protocols to be provided to DEA within 30 calendar days after start of the agreement period.
Modified or revised protocols to be provided to DEA for review within 7 calendar days of discussion/notification by either party that the protocol must be modified or revised.
2 Monthly Status Reports 30 days from contract award date and monthly thereafter.
3 Study Report To DEA no later than 30 calendar days after study completion date.
4 Annual Progress Reports To DEA on or before the 5th working day following each year.
5 Final Report To DEA on or before the expiration of the agreement period.
6 Laboratory Records and Test Substances To DEA on or before the expiration of the agreement period.
6.0 Use of Data
All documents, data, materials, records, and information sources provided to the vendor, developed or maintained by the vendor in the performance of this contract under this SOW are deemed to be the property of the DEA. All data collected, generated, manipulated or otherwise processed under this agreement are confidential information unless or until DEA authorizes its release. None of these data may be used at any time for any purpose except to generate reports or other requirements specified in the Statement of Work, without prior written approval of the DEA. The DEA and the vendor will mutually agree to discuss matters of Freedom of Information Act (FOIA) policy before each agency independently discloses requested information.
On or before the agreement year expiration, the vendor shall deliver (or otherwise dispose per the DEA) all data, including raw databases (electronic or hard copies), tapes, software programs used to interpret or manipulate data, weight calculation files, data collection forms, file definitions, and various edited databases generated under this contract to the DEA (except for data necessary only to comply with other Federal data retention requirements, such as requirements pertaining to clinical trials or the Food and Drug Administration's rules pertaining to drug applications).
During or after the agreement, no data may be released, presented or published except upon prior approval of the DEA.
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