Inactive

The Contraceptive Development Program (CDP) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is issuing this Request for Proposals (RFP) for the recompeti... The Contraceptive Development Program (CDP) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is issuing this Request for Proposals (RFP) for the recompetition of the Chemical Synthesis Facility (CSF) contract. The RFP is a full and open competitive procurement under the North American Industry Classification Systems Code 541715. The CDP supports research and research training programs in contraceptive discovery and development. Major research areas include (1) studies of mechanisms of action and effects of approved contraceptive methods and reproductive hormones, (2) evaluation of novel methods under development (drugs, devices, and procedures), and (3) development and evaluation of optimal formulations and dosages of contraceptive agents and devices. The main goal of the CSF is the cGMP manufacture of drug substances for clinical trials conducted by the Contraceptive Clinical Trials Network (CCTN). The mission of the CDP is to provide new and/or improved safe and effective contraceptive methods necessitates making scientific progress. Many of the compounds evaluated by the CDP are new chemical entities (NCEs) and are not available commercially off the shelf (COTS). Such NCEs must be custom synthesized. The use of a CSF with the ability to make products under cGMP is required and critical for carrying out the mission.

Inactive

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) plans to issue a Request for Proposal from interested and qualified offerors ial sources for a Chemical Synt... The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) plans to issue a Request for Proposal from interested and qualified offerors ial sources for a Chemical Synthesis Facility (CSF)capable of synthesizing potential anti-fertility agents on a laboratory milligram scale to a relatively larger kilogram scale. The kilogram scale chemical agents are manufactured under current Good Manufacturing Practices (cGMP) for comprehensive contraceptive evaluation, including toxicology studies and preclinical safety studies before entering human clinical studies. THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION ANNOUNCEMENT ONLY.

Inactive

AMENDMENT NO. 01 - The purpose of this Amendment is to add the title to this Sources Sought announcement: Chemical Synthesis Facility. The Eunice Kennedy Shriver National Institute of Child Health and... AMENDMENT NO. 01 - The purpose of this Amendment is to add the title to this Sources Sought announcement: Chemical Synthesis Facility. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) seeks capability statements from interested and qualified potential sources for a Chemical Synthesis Facility (CSF) capable of synthesizing potential anti-fertility agents on a laboratory milligram scale to a relatively larger kilogram scale. The kilogram scale chemical agents are manufactured under current Good Manufacturing Practices (cGMP) for comprehensive contraceptive evaluation, including toxicology studies and preclinical safety studies before entering human clinical studies.