Request for Proposals Under BAA-HB-03-06
Somatic Cell Therapy Processing Facilities

RFP BAA-HB-03-06 is amended as follows:

1. The Statement of Work is revised to add the following:

   "The study schedule is anticipated to be as follows:
   Phase I—6 months (September 30, 2003—March 31, 2004): planning phase
   Phase II—54 months (April 1, 2004—September 29, 2008): development of somatic cellular therapies"

2. Statement of Work, paragraph a., first sentence, currently reads "The project is designed to develop novel somatic cellular therapies that will aid investigators by providing support in areas ranging from basic science through animal studies to proof-of-principle and eventually human trials." The term "investigators" is hereby interpreted to mean any investigator requesting support. Both investigators within or outside the facility contract institution are eligible to receive support. The project is not solely to support investigators at the institution awarded a facility contract.

3. Technical Objective 1. is revised to read as follows:

   "To provide for rapid, safe, and equable transition of basic research ideas in clinical practice. This may include pre-clinical development work, scale-up, validation, and stability type studies required prior to developing a clinical grade therapeutic product. For proposal purposes, the offeror shall give examples of products manufactured in the offeror's facility. Describe the development of these products and how they have transitioned into clinical studies, including quality assurance and quality control plans. If no products have been manufactured, propose a sample plan for the production and development of a clinical grade therapeutic product."

4. Additional Somatic Cell Processing Facility Project Requirements, item 1., is clarified as follows: The cost information associated with the examples of previous clinical grade biological products shall be included in the cost proposal; however, costs shall not be included as a line item in the total 5-year project cost. These costs are for informational purposes only and should be shown in a separate section of the cost proposal.

5. Additional Somatic Cell Processing Facility Project Requirements, item 3, is revised to read as follows:

   "In conjunction with the SCAC and the other cell processing facilities, the cell processing facility shall participate in developing a manual of procedures (MOP) during the first six months of the contract. The MOP shall describe the operation of the SCAC and the cell processing facilities and shall include procedures for the evaluation, prioritization and processing of requests for service from investigators. The facility shall be responsible for adhering to procedures that are outlined in the MOP and shall transmit accurate data to the SCAC as required. The MOP shall be completed and approved before any requests for service can be accepted by the facility. [NOTE: During Phase I, possible implementation of user fees will be discussed.]