Thursday, August 6, 2015

FDA Looking For Consulting Org To Run DSCSA Pilots - RxTrace.com

Dirk Rodgers of RxTrace.com writes about an RFP the FDA issued last month that is due August 13th... Check it out, in full, on RxTrace.com...
Last week the FDA quietly posted a Request For Proposal (RFP) on the FedBizOpps.gov government bidding site for a consulting organization to design and implement a program of pilot projects that explore and evaluate methods to enhance the safety and security of the pharma supply chain.  The scope of work is:
“Development and implementation of a program for the pilot projects will include, but is not limited to: development of the program structure, determination of the scope of the pilot projects and what issues should be covered, ensuring the pilot project design fulfills the requirement of the DSCSA, development of an enrollment process for potential participants, development of timing and schedule, development of monitoring and reporting schedule, development of pilot project metrics and evaluation plan; and development of a communication plan. The pilot project(s) developed under the DSCSA need to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain, through
  1. utilization of the product identifier for tracing of a product throughout the supply chain and may include verification of product identifier, including the use of aggregation and inference;
  2. improvement of the technical capabilities of each sector and subsector to comply with systems and processes needed to utilize the product identifiers to enhance tracing of a product; and
  3. identification of system attributes that are necessary to implement the requirements established under the DSCSA.”
The RFP was posted on July 31, 2015 and responses must be submitted by midnight on August 13, 2015.  As part of developing the program, the contractor will also help the FDA run a public workshop and docket to collect ideas and comments that will help guide the design of the pilots.  The “period of performance” is eight months from date of the award.
Check out the full article at RxTrace.com...