A -- Collaborative Network for Clinical Research on Immune Tolerance

1. The due date for proposals has been extended to Thursday, June 8, 2006 at 3:00pm EST. 2. The primary point of contact for RFP-NIH-NIAID-DAIT-07-33 is changed to: Phil Hastings-Tickerhoff phastings@niaid.nih.gov tel. 301-496-0194 3. The following questions were submitted regarding RFP-NIH-NIAID-DAIT-07-33; the responses are listed below each question. 1. OVERALL STRUCTURE a. Does the 300 page limit include appendices? RESPONSE: The page limit refers only to the technical proposal (see cover sheet and Attachment 5, page 1 of Appendix A - Additional Proposal Instructions). b. Should SOPs be placed in appendices? Linked to a website? RESPONSE: SOPs are part of the 300 page limit (see references to RFP in 1a, above). Attachment 5, Appendix A, paragraph E.1.e refers to providing examples of SOPs for laboratory capabilities; other references to SOPs in the Statement of Work (SOW, Attachment 3) refer to work to be performed by the awardee, e.g., develop and disseminate SOPs for specific work items. 2. BUDGET a. How should ongoing trial commitments be incorporated into the budget: the detailed budgets for each site in an Appendix, or just a lump sum for each trial listed in the RFP? RESPONSE: The RFP refers to these issues in the sections on Transition Plans. Attachment 5 (H.1.d of Appendix A) refers to - a plan to establish subcontracts, consulting agreements, . The SOW (Attachment 3, IX.A) states that an Initial Transition Plan, including a plan to establish subcontracts shall be submitted with 6 weeks of the contract award. Attachment 6, Appendix B, Additional Business Proposal Instructions, Section 3.2.a states that - offerors should assume - clinical trials - in progress - will be transitioned . Section 5 Budget Instructions describes a one page budget summary as well as individual budget breakdowns by research category. 3. TRIAL IMPLEMENTATION RESPONSIBILITIES a. Please confirm that the RFP requires that the ITN be responsible for Trial implementation. Does the ITN gain oversight of CRO activities or does that remain the responsibility of the NIAID? This question is based on the following statements in RFP: i. "assign Protocol Managers to oversee the implementation and conduct of each clinical trial and to serve as the primary contact to the NIAID medical monitors, NIAID project managers, and NIAID regulatory affairs officers." ii. - Provide protocol managers to facilitate study implementation, monitor patient accrual and retention, assess compliance with protocol requirements and adherence to study timelines, and report progress to designated NIAID Project Manager. iii. - The primary role of NIAID staff will be to facilitate, but not to direct, protocol selection, development and implementation activities. NIAID staff and ongoing NIAID clinical research support contracts will provide a broad range for services to the Contractor for the design, development, implementation and analysis of Network studies. RESPONSE: The Network will not be responsible for oversight o current NIAID CRO contractors. Attachment 34, Appendix E NIAID-Funded Clinical Research Support Services Contracts describes contracts that the NIAID/DAIT holds to support the effort of the Network. As noted, the successful Offeror is expected to interact in order to perform functions specified within the SOW . No oversight role of these contracts by the Network is requested in the RFP. 4. STUDY PRODUCT DISTRIBUTION a. There is an inconsistency in the RFP related to Drug distribution - which is correct and does the ITN oversee the contractor (Eminent) i. FROM SOW: Ensure that all clinical sites receive the required supply of study products for clinical trial initiation and conduct, and monitor supply throughout the duration of the clinical trial. Report to the designated NIAID Project Manager any changes in requirements for study products. ii. FROM TOC: Study Product Distribution: NIAID will: Manage all activities related to study product distribution, tracking and retrieval and ensure that such activities are in compliance with cGCP and consistent with relevant Clinical Trial Agreements, where applicable. RESPONSE: The Network will not oversee the drug distribution contractor; this remains an NIAID responsibility. It is expected that the Network will assist NIAID to ensure drug availability through and exchange of information concerning on-site drug supplies and needs. Attachment 34, Appendix E NIAID-Funded Clinical Research Support Services Contracts describes the role of the NIAID/DAIT Drug Distribution Center, which provides pharmaceutical services to support the Network. The SOW section referenced above (IV.D.8) provides instruction that the Network is monitoring study product at the site level and reports to NIAID any necessary changes. The NIAID would then instruct the drug distribution contractor to address these changes