Comprehensive Resources for HIV Microbicides and Biomedical Prevention

The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) is seeking a contractor to provide a resource of preclinical and non-clinical services to advance the development of Topical microbicides (TM) and biomedical prevention (BP). There is a critical need to promote discovery and transition of new strategies into clinical trials. This NIAID-sponsored contract focuses on promoting the development of strategies containing TM/BP as a means to address the NIAID and Division of AIDS (DAIDS) priority of controlling and preventing the HIV/AIDS epidemic worldwide. This contract will provide pre-clinical and non-clinical development services of TM/BP products essential for advancement to clinical testing and for supporting activities required for IND and NDE applications to the FDA. TM/BP products for development services will be provided by or through the Project Officer and will be identified through NIAID-funded grants and contracts, the private sector, or other sources. The specific services required will depend on the status of the individual candidate(s), the need to prioritize potential candidates, and an overall product development plan and/or regulatory submission plan to the FDA. The scope of pre-clinical and non-clinical services to be provided include: (1) Individual gap-filling services on a case-by-case basis, to advance TM/BP products in the development pathway toward clinical assessment; (2) Comprehensive services for selected TM/BP products through a Go/No-Go milestone-driven pathway to accelerate a product toward clinical testing in the most efficient manner; and (3) Support for Best Practices Working Groups (BPWGs) composed of non-contract investigators to assess the critical processes and assays used to compare and advance products to clinical studies. This activity will ultimately lead to identification and validation of surrogate biomarkers for safety and efficacy testing in clinical trials. NIAID proposes to seek a deviation from FAR clauses 52.227-11 to restrict the Contractor's rights to subject inventions arising under any resultant contract. Furthermore, the timing of data publication would need to be restricted to allow adequate time for patent applications to be filed on inventions arising from the proposed contract. The NIAID intends to accomplish this restriction by a deviation from FAR clause 52.227-14, Rights in Data-General. The Government anticipates the potential need to exercise options for additional BPWGs during the life of the contract. It is estimated that up to four options for a total of 4 BPWGs will be exercised at the discretion of the Government during the period of the contract. These options may be exercised during contract years 2-7. The NIAID reserves the right to exercise more than one option per year, however, the total number of options will not exceed four during the 7-year period of the contract. The NAICS code is 541 & 541712 with a size standard of 500 employees. All responsible sources may submit a proposal which will be considered by the agency. This RFP will be available electronically on/about October 17, 2008, and may be accessed through the Federal Business Opportunities at https://www.fbo.gov and the NIAID Office of Acquisition (OA) Home Page at http://www.niaid.nih.gov/contract. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. This notice does not commit the Government to award a contract now or in the future.