SOLICITATION NOTICE
A -- Microbicide Design and Development Teams
- Notice Date
- 2/11/2004
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Branch 6700 B Rockledge Room 2230 MSC7612, Bethesda, MD, 20892-7605
- ZIP Code
- 20892-7605
- Solicitation Number
- RFP-NIH-NIAID-DAIDS-04-04
- Response Due
- 7/27/2004
- Archive Date
- 8/11/2004
- Point of Contact
- Donald Collie, Contract Specialist, Phone 301-496-0992, Fax 301-402-0972, - Thomas Hastings, Contracting Officer, Phone 301-496-0194, Fax 301-402-0972,
- E-Mail Address
-
dc128b@nih.gov, ph23k@nih.gov
- Description
- The discovery, development, and evaluation of promising HIV microbicides is a high priority for the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH). To augment the microbicide product pipeline, we are seeking opportunities to advance microbicide concepts toward the product stage via a focused, product development-based approach. Specifically, the long-range goal of this solicitation is the development of new safe and effective microbicide candidates that merit further evaluation in large human trials. The HIV Microbicide Design and Development Teams (HMDDT) solicitation seeks to fund consortia of scientists with product development experience from industry and/or academia that have 1) identified a promising microbicide concept, and 2) devised a plan for its targeted development into a product testable in humans. A microbicide product is defined here to be a material and its manner of administration that could reasonably provide protection against the sexual transmission of HIV safely, even when used repeatedly. The expectation is that the Teams advance their microbicide concepts along a well-defined development path in a timely manner to a microbicide product and into clinical testing within the five-year period of the award. Offerors are encouraged, but not required to conduct phase I/II trials in collaboration with the NIH/NIAID/DAIDS-supported HIV Prevention Trials Network (the HPTN; http://www.hptn.org). Support for Phase III studies will not be funded under this solicitation. Because the goal of this effort is the development of microbicide products, each Team will be required to demonstrate proven scientific and development expertise, and provide a comprehensive plan that lays out clearly defined objectives and milestones for the project?s duration. Because the design and development path for any microbicide product cannot be entirely anticipated, the Team must articulate its vision of how new scientific findings will be integrated into the proposed goals and milestones. Offerors will be required to articulate and implement a strategic research plan that includes: (a) key development objectives and a detailed work plan describing proposed time schedules for achieving contract objectives and milestones, and maintaining quality control over the implementation and operation of the contract, (b) how decisions to proceed or not proceed will be made (i.e. specific qualitative and quantitative criteria for product advancement through each stage of pre-clinical, including IND-enabling, development and Phase I/II safety evaluations), (c) plans for GMP microbicide lot production and packaging, and (d) obtaining the necessary regulatory and human subjects approvals to proceed. This strategic plan shall articulate how the Team will efficiently allocate and utilize the resources, and redirect the focus (including reallocation of funds) depending upon the project?s changing needs and emerging new knowledge. It shall, also, articulate how patent coverage and licensing of the resulting HIV microbicide will be obtained and the procedures to be followed for the resolution of potential legal issues that may arise. It is anticipated that up to two (2) cost-reimbursement, completion type contracts will be awarded for a period of five (5) years, beginning approximately February 15, 2005. RFP-NIH-NIAID-DAIDS-04-04 will be available electronically on or about February 25, 2004, and may be accessed through the NIAID Contract Management Program (CMP) Home Page by using the following electronic address and instructions: NIAID/CMP Home Page (via the WWW): Use http://www.niaid.nih.gov/contract to access the NIAID/CMP Home Page. Once at the NIAID/CMP Home Page, click on the "RFPs" link and then click on "RFP NIH-NIAID-DAIDS-04-04." Please note that the RFP has been revised to include only the Work Statement, Deliverable and Reporting Requirements, Special Requirements, Technical Evaluation Criteria, and the Specific RFP Instructions and Provisions. All information required for the submission of an offer will be contained in the electronic RFP package. Responses to this RFP will be due on July 27, 2004. Any responsible offeror may submit a proposal for consideration by the Government. This advertisement does not commit the Government to award a contract. No collect calls will be accepted. Point of Contact Donald E. Collie, Contract Specialist, Phone 301-496-0612, Fax 301-402-0972, mailto:dc128b@nih.gov or Thomas P. Hastings, Contracting Officer, Phone 301-496-0194, Fax 301-402-0972, mailto:lb13t@nih.gov
- Record
- SN00520406-W 20040213/040211212051 (fbodaily.com)
- Source
-
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