Pharmacokinetic and Pharmacodynamic Studies for Medications Development

Added: Apr 01, 2017 2:53 pm The National Institute on Drug Abuse (NIDA) plans to solicit proposals under full and open competition procedures from offerors having the capability 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 but not limited to 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 Investigational New Drug (IND) applications and New Drug Applications (NDAs). 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 successful contractor shall follow pertinent FDA guidelines/guidance.

In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that the successful offeror shall demonstrate possession of a Drug Enforcement Administration (DEA) Research Registration for Schedules II to V, and shall demonstrate either possession of or ability to obtain a DEA Research Registration for Schedule I controlled substances. The successful offeror must have a Federal Wide Assurance (FWA) currently accepted and approved by the Department of Health and Human Services' (HHS) Office for Human Research Protections (OHRP) or demonstrate that it has submitted to OHRP for issuance of an Assurance. The successful offeror must comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR 46 and must have a board-certified physician on the project.

NIDA anticipates the award of a single, five-year, indefinite delivery indefinite quantity (IDIQ)-type contract. NIDA anticipates awarding fixed price and/or cost reimbursement task orders as needed throughout the period of performance to maintain flexibility in issuing work. This award is a competitive renewal of Contract No. HHSN271201200018C, titled "Pharmacokinetic and Pharmacodynamic Studies for Medications Development."

RFP No. N01DA-17-8935 will be available electronically on or about 15 days from the date of this posting. You can access the RFP through the FedBizOpps (URL: http://fedbizopps.gov) or through the NIDA website (URL: http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps). All information required for the submission of a proposal will be contained in or accessible through the RFP package. Responses to the RFP will be due 45 days from the release date. NIDA anticipates a September 2017 award date. NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract.

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 or organizations 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.