Pilot Project Program Under the Drug Supply Chain Security Act; Request for Comments

Résumé

The Food and Drug Administration (FDA or Agency) is announcing its intent to establish a pilot project program under the Drug Supply Chain Security Act (the DSCSA Pilot Project Program) to assist in development of the electronic, interoperable system that will identify and trace certain prescription drugs as these are distributed within the United States. Under this program, FDA will work with stakeholders to establish one or more pilot projects to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. Participation in the DSCSA Pilot Project Program will be voluntary and will be open to pharmaceutical distribution supply chain members. FDA will be particularly interested in participation reflecting the diversity of the supply chain, including large and small entities from all industry sectors. This notice describes the proposed DSCSA Pilot Project Program, including proposed instructions for submitting a request to participate. FDA is soliciting comments on the proposed collection of information associated with establishment of the DSCSA Pilot Project Program before submitting the proposed collection to the Office of Manage