REAGENT RESOURCES SUPPORT FOR AIDS VACCINE DEVELOPMENT - NIH-NIAID-DAIDS-03- 01 Release Date: March 18, 2002 NOTICE: NOT-AI-02-011 National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) Receipt Date: June 14, 2002 DESCRIPTION The Division of Acquired Immune Deficiency Syndrome (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is recompeting their current contract with Quality Biological, Inc., Contract Number N01-AI-65278. This solicitation will be a 100% Small Business Set-Aside, NAICS Code 54171, 500 employees. DAIDS is committed to the development of HIV/AIDS vaccines and other prevention strategies (e.g., topical microbicides) for worldwide use in stemming the AIDS epidemic. While industry, government, and academia have all targeted considerable resources to this end over the past 15 years, identification of an efficacious vaccine against HIV/AIDS has yet to be accomplished. Therefore, the highest priority of the DAIDS continues to be the discovery and evaluation of HIV/AIDS vaccines. In this effort DAIDS supports basic, preclinical, and clinical research to identify vaccine strategies against HIV/AIDS. To facilitate this research, the DAIDS has long provided the research community with standardized, quality-controlled reagents through the NIH AIDS Research and Reference Reagent Program. However, large-scale preclinical and clinical vaccine and prevention research studies, such as those carried out by DAIDS-sponsored Simian Vaccine Evaluation Units (SVEUs) and the expanded international HIV Vaccine/Prevention Trial Networks (HVTN and HPTN), require larger quantities of such reagents not typically available through the NIH AIDS Research and Reference Reagent Program. Therefore, to advance the vaccine development process, DAIDS is seeking ways to generate and acquire reagents and technologies, as needed, for sponsored AIDS vaccine/prevention research and development projects. Many such reagents are not commercially available and require customized production and quality control. Reagents required for this research include but are not limited to viral gene products and associated peptides, adjuvants, cytokines, virus stocks, expression vectors (including recombinant plasmid DNAs and RNAs), monoclonal and polyclonal antibodies, topical microbicides, and sometimes unforeseen but timely produced reagents. These reagents will be generated for evaluating vaccine safety, immunogenicity, and efficacy. The current Contractor supports a facility to produce or otherwise acquire these types of reagents for AIDS vaccine research and has the capability to store, maintain, assure quality control and distribute large quantities of reagents. This contract is utilized by nearly all facets of the vaccine development program funded by DAIDS. Grantees, contractors, and other investigators regularly make requests through this DAIDS contract to obtain essential reagents for their vaccine development studies. In addition, novel procedures are often developed for optimizing the production of these reagents (e.g., greater yields and higher purity). Offerors will be expected to: 1) produce (either through purchase or other means), purify, and test reagents for the DAIDS Vaccine and Prevention Research Program; these reagents include an array of viral proteins and peptides, virus stocks, monoclonal and polyclonal antibodies, topical microbicides, vaccine adjuvants and cytokines, and any additional reagents deemed necessary for the DAIDS vaccine program, 2) have capabilities for genetic cloning and sequencing, 3) be capable of producing and testing unique and customized reagents at the request of the program, including preparing and/or producing soluble proteins, expression vectors, and gene products (including experimental AIDS vaccines) under current Good Laboratory Practice (cGLP) or Good Manufacturing Practice (cGMP) as appropriate for their intended use, and preparing and/or producing these in large-scale production lots, 4) be able to analyze all acquired or generated reagents for purity and integrity, and to provide for their quality control and assurance, and 5) provide appropriate facilities for receipt and inventory tracking, storage, maintenance and distribution of all reagents. The Contractor will be monitored by regular communications between the NIAID Project Officer and the contract Principal Investigator and through site visits by DAIDS staff. NIAID will receive written reports (quarterly updates and annual reports) as well as reports of data from individual studies in progress. It is anticipated that a single cost reimbursement, completion type contract will be awarded for a period of seven (7) years, beginning approximately February 14, 2003. The total effort is estimated to be approximately 76,285 total labor hours or 37 FTEs. RFP NIH-NIAID-DAIDS-03-01 will be available electronically on or about March 14, 2002, and may be accessed through the NIAID Contract Management Branch (CMB) Home Page at http://www.niaid.nih.gov/cgi-shl/cmb/rfps.cfm -- and is also posted on FedBizOpps. Any responsible Offeror may submit a proposal that will be considered by the Government. Contracting Office Address National Institutes of Health National Institutes of Allergy and Infectious Diseases Contract Management Branch 6700-B Rockledge Drive Room 2230, MSC 7612 Bethesda, MD, 20892-7612 Point of Contact Lois Eaton, Contract Specialist, Phone 301-496-0611, Fax 301-480-5253, Email le52u@nih.gov Barbara Shadrick, Senior Contracting Officer, Phone 301-496-7288, Fax 301- 402-0972, Email bs92y@nih.gov This announcement does not commit the Government to award a contract. No collect calls will be accepted.
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