The medications development program of the National Institute on Drug Abuse intends to solicit proposals to carry out clinical studies to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of new medications for the treatment of substance use disorders. As medications are often taken with other treatment drugs or drugs of abuse (such as cocaine, methamphetamine, etc), information on the extent and nature of the interaction between the medications and other treatment drugs/drugs of abuse will also be a focus of this contract. Such studies require the intravenous administration of drugs to human subjects.

The data obtained will be submitted to the Food and Drug Administration (FDA) in support of INDs (Investigational New Drugs) and NDAs (New Drug Applications). All studies must be carried out under pertinent FDA regulations, such as current Good Clinical Practice (cGCP) and current Good Laboratory Practice (cGLP) regulations. The pertinent FDA's guidelines/guidance shall be followed.

In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that the successful contractor possess a DEA Research Registration for Schedules II to V and demonstrate the capability to obtain a DEA registration for Schedule I controlled substances. The successful contractor must also have an OHRP-approved assurance of compliance with the HHS regulations (45 CFR 46.103) for the protection of human subjects and must have a board certified physician on the project.

NIDA anticipates the award of a single cost-reimbursement indefinite delivery, indefinite quantity type contract. NIDA anticipates that one task order shall be awarded with the contract. RFP No. N01DA-12-8905 will be available electronically on or about February 27, 2012. You can access the RFP through the FedBizOpps (URL: http://www.fedbizopps.gov or through the NIDA website at the following address: (URL: http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps). All information required for the submission of an offer will be contained in or accessible through the RFP package. Responses to the RFP will be due on or about April 12, 2012. NIDA will consider proposals submitted by any responsible offeror. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the contracting officer their interest and capability to satisfy the Government’s requirement with a commercial item within 15 days of this notice. This advertisement does not commit the Government to award a contract.

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