QA RFP 15DDHQ24R00000025 - Amendment 0001.pdf

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Evaluation of Abuse Potential of Synthetic Opioids and Other Depressants Using In Vivo Pharmacological Studies
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15DDHQ24R00000025
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This document appears to be a set of Questions and Answers related to a Request for Proposal (RFP) issued by the Drug Enforcement Administration (DEA) Diversion Control Division for the Evaluation of Abuse Potential of Synthetic Opioids and Other Depressants Using In Vivo Pharmacological Studies.

The key details are: The RFP calls for the contractor to provide investigational study results and methodology for evaluating the abuse potential of synthetic opioids and other depressant drugs. The contractor is not required to subcontract with synthetic chemists, as the DEA will provide the test substances if the vendor cannot procure them commercially. The pricing template includes a set amount for the test drugs, with any costs above $500 requiring DEA approval. The RFP does not require antagonism studies in the drug discrimination task, only in the analgesia task. The pricing spreadsheet and sample BPA call order should be submitted as separate Excel files, not included within the PDF business proposal.

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The RFP example, as well as the Pricing sheet template and Sample BPA call order, refers to locomotor activity studies; is it OK to substitute “analgesia” for locomotor activity?

In the RFP example, CLIN 0003, 1003, 2003, 3003, 4003 titled Antagonist studies are the Analgesia studies (that includes antagonist, see

3.3. Task 3). Locomotor studies are a separate

CLIN and therefore, should not be substituted. No change to RFP

The RFP calls for the vendor to acquire all reference and test drugs but does not provide specific information on the test drugs of interest. Are the drugs commercially available, or will the vendor bear the responsibility of subcontracting with synthetic chemists?

The vendor is not required to subcontract with synthetic chemists. DEA will provide the test substances in the event the vendor cannot procure the test substances commercially. The CLIN for the drugs are a set amount in the pricing sheet template and does not need to be adjusted. Any pricing above the $500 can be invoiced separately but will need DEA's approval. No change to RFP

13-14 Antagonism studies are called for only in Task 3 (analgesia). Is there any interest in antagonism studies in Task 4 (drug discrimination)?

If so, would they require additional CLIN in the pricing spreadsheets?

No, we are not interested in antagonism studies in Task 4. No change to RFP

25 For the Business Proposal (Volume II), should the Pricing Spreadsheet and Sample BPA Call Order be included as attachments within the PDF file, or should they be submitted as separate excel files? Submit as separate Excel files. No change to RFP

Questions CommentsGovernment Technical ResponseItem

RFP 15DDHQ24R00000021 - Q&A RESPONSE -Evaluation of Abuse Potential of Synthetic Opioids and Other Depressants

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