A -- Division of Microbiology and Infectious Diseases: Clinical Agent and Specimen Repository

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat and ultimately prevent the myriad of infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents other than Human Immunodeficiency Virus. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics, which is funded through a variety of research grants and contracts. Developing and testing new vaccines and therapies have historically been a major focus of the research supported by the DMID. Much of this research is devoted to addressing critical public health needs, such as those related to emerging and re-emerging infectious diseases (e.g., avian influenza and West Nile Virus), as well as those supporting the evaluation of the safety and efficacy of vaccine and therapeutic candidates against potential agents of bioterrorism, including NIAID priority biodefense pathogens (http://www3.niaid.nih.gov/Biodefense/bandc_priority.htm). In August 2000, NIAID awarded a contract to provide a wide variety of regulatory support services for DMID clinical research activities, including clinical site monitoring, management and preparation of regulatory files, and management and operation of a clinical agent and clinical specimen repository. This contract provides for the establishment and operation of a Clinical Agent and Specimen Repository (CASR) that adheres to current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) for the acquisition, receipt, storage and shipping of clinical agents and clinical specimens in support of DMID sponsored clinical trials and research programs in the U.S. and abroad. Regulatory support services are currently being recompeted through a separate contract solicitation. Clinical agents include study products (drugs, vaccines, and therapeutics), commercial products, placebos, syringes, and other protocol-mandated supplies to be used in DMID-sponsored clinical trials. For the purposes of this contract, other protocol-mandated supplies include electronic adherence measuring devices and associated devices for downloading data, thermometers, oral syringes, adaptors for transferring liquids from bottles to syringes, syringes for injection, and pregnancy test kits. Clinical specimens include sera or other protocol-mandated specimens obtained from DMID-funded clinical research sites, to be distributed to DMID approved testing laboratories for analysis. The current DMID Regulatory Affairs Support contractor will provide the Contractor with the existing DMID-owned Clinical Agent Repository Inventory Management (CARIM) Database System. The CARIM database is used in conjunction with the DMID owned regulatory affairs support Human Subjects Research Oversight and Accountability Database (HSROAD) which has an electronic ordering module. Currently both databases are being managed by the DMID Regulatory Affairs Support contractor. Potential sources must demonstrate and document the following in their capability statements: 1) Receipt, appropriate storage, monitoring, distribution and disposition of clinical agents from product suppliers in support of DMID-sponsored clinical research 2) Labeling, packaging and repacking of clinical agents for distribution to DMID-funded clinical research sites and DMID approved testing laboratories 3) Receipt of all required shipping documents 4) Validation of packaging and shipping procedures for the shipment of clinical agents under correct temperature conditions 5) Monitoring of product inventories and expiration dates 6) Acquisition of clinical agents and non-clinical testing 7) Receipt, short-term storage (two-years), monitoring, distribution, and disposition of clinical specimens in support of DMID sponsored clinical research 8) Aliquoting, labeling, of clinical specimens for distribution to DMID approved testing laboratories 9) Maintenance and operation of an electronic system for requesting services and tracking agents and specimens. There will be three options under this acquisition: Option 1: The Contractor shall increase clinical specimen capacity of the CASR in order to accommodate the following: -80oC (approximately 1600 cu. ft.) -20oC (approximately 1600 cu. ft.) Option 2: The Contractor shall increase the length of time for the storage of clinical specimens in the CASR to exceed the short-term storage requirement of two (2) years as specified in the base requirement, to provide for storage until the end of the contract period of performance. Option 3: The Government may extend the contract for up to an additional two (2) years beyond the contract base period of performance. Capability statements submitted by potential sources as a result of this announcement should demonstrate the offerors? qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to: Technical Approach: adequacy, appropriateness and feasibility of approaches to providing the proposed clinical agent and clinical specimen repository services. Personnel/Management: adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity. Facilities, Equipment, and Safety: adequacy, appropriateness, and availability of safe facilities of the offeror and all proposed subcontractors to carry out clinical agent and clinical specimen repository activities. Past Performance: Past performance is considered essential. In addition to demonstrating that they have met the above qualifications, interested parties must identify at least three other projects of similar size and complexity. All capable small business organizations are encouraged to submit capability statements based on this announcement. Interested organizations should submit two copies of their capability statement addressing each of the areas cited above. Any proprietary information should be so marked. Written capability statements should be received by the Contracting Officer by July 13, 2007. Please reference the solicitation number on all related correspondence. No collect calls will be accepted. Facsimile and e-mail transmissions will be accepted. Any proprietary information should be so marked (see Government-Wide Numbered Note 25). Contact: Brian Jamieson, Contract Specialist, Phone: 301-451-3678, Fax: 301-480-4675. Yvette R. Brown, Contracting Officer, Phone: 301-496-0612, Fax: 301-480-4675.