Pharmacokinetic Analysis Resource Center

The National Institute on Drug Abuse (NIDA) intends to solicit proposals under full and open competition procedures from qualified businesses (NAICS Code 541715) for in-house capability to provide pharmacokinetic resources in support of the pharmacokinetic (PK) and pharmacodynamics (PD) aspects of the medication development. No actual clinical or laboratory studies will be carried out under this contract. The successful awardee shall:

1. Prepare study protocols;
2. Monitor clinical studies to assure that pertinent FDA regulations are met;
3. Perform data management for clinical and pharmacokinetic data;
4. Perform population pharmacokinetic (PK) and pharmacodynamic (PD) analysis for data obtained from clinical trials to investigate the relationships among dose, plasma concentration, and effect;
5. Perform statistical, PK and PK/PD analyses of experimental data obtained from clinical studies including clinical pharmacology and drug-drug interaction studies and;
6. Prepare study reports. The data/reports will be submitted to the FDA in support of INDs (Investigational New Drugs) and NDAs (New Drug Applications).

NIDA anticipates the award of a single, five-year, indefinite delivery, indefinite quantity (IDIQ), task order contract. This award is a recompetition of HHSN271201400009C, titled "Pharmacokinetic Analysis Resource Center." NIDA may award either cost reimbursement and/or fixed price task orders under this contract. NIDA anticipates that at least one task order will be awarded with the contract.

RFP No. NIHDA201800261 will be available electronically on or about October 19, 2018. 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 November 29, 2018. 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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