Request for Proposals No.: | BAA-HB-03-06 |
Amendment No.: | 01 (One) |
Issue Date: | January 27, 2003 |
Issued By: | Joanna Magginas, Contracting Officer NIH/NHLBI Contracts Operations Branch 6701 ROCKLEDGE DR MSC 7902 BETHESDA MD 20892-7902 |
Telephone Number: | (301) 435-0360 |
FAX Number: | (301) 480-3432 |
E-Mail: | magginaj@nhlbi.nih.gov |
Purchase Authority: | 42USC201, Public Health Service Act of 1944, as amended |
Just In Time: | Yes; See Part IV Section L |
Small Business Set-Aside: | No; NAICS 541710 |
Proposal Intent Due Date: | February 03, 2003 |
Proposal Due Date: | March 03, 2003 4:00 PM (Eastern Time) |
RFP BAA-HB-03-06 is amended as follows:
"The study schedule is anticipated to be as follows:
Phase I6 months (September 30, 2003March 31, 2004): planning phase
Phase II54 months (April 1, 2004September 29, 2008): development of somatic cellular therapies"
"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."
"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.]