Notice of Intent to Award a Contract Modification to Physical Pharmaceutica

Notice of Intent to Award a Contract Modification to Physical Pharmaceutica The Food and Drug Administration intends to modify contract HHSF223201610105C, "Investigation of release rates and factors affecting release rate tests of cyclosporine from ophthalmic emulsions formulations using pulsatile microdialysis (PMD)" in the amount of $45,000 . The contract modification will be awarded to: Physical Pharmaceutica, LLC 67 Davenport Road Yonkers, New York 10710 In accordance with FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. Physical Pharmaceutica is conducting the initial study only they can make the needed changes as they have already developed many of the formulations required. FDA subject matter experts identified additional tasks that will provide supportive data for the contractor's evaluation of the drug release mechanism, and guidance needed as to what manufacturing parameters are the most impactful on drug release. The contractor will then be able use this guidance in Phase 4 of the contract (where additional formulations are manufactured for PMD testing) to better ensure that the subsequent in vitro release tests yield more informative data that are not simply a repeat of the release data obtained in the previous contract phases. The FDA requires additional testing and research to develop an in vitro release test for cyclosporine ophthalmic emulsions using pulsatile microdialysis (PMD). Evaluation is needed to determine whether these in vitro tests can discriminate between cyclosporine ophthalmic emulsions manufactured using different processes. Uutilization of the in vitro release data with a physicochemical evaluation of the formulations is needed to better understand the drug release mechanism and critical parameters that can affect the drug release profiles from emulsion formulations. The NAICS code for this action is 541712. This procurement is made under the authority of FAR 6.302- Only one responsible source and no other supplies or services will satisfy agency requirements. This is a notice of intent to issue an award on a sole source basis. This notice of intent is not a solicitation for competitive proposals. Any other firms desiring consideration must fully identify their interest and capability to provide this item to: Lisa Yaw Contracts Specialist Lisa.Yaw@fda.hhs.gov 240-402-4018 A determination by the government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. The projected award date is on or about June 23, 2017.