A -- Regulatory Affairs Support

Sources Sought Notice Information Division of Microbiology and Infectious Diseases: Regulatory Affairs Support RFP-NIH-NIAID-DMID-08-05 Introduction THIS NOTICE IS FOR INFORMATION AND PLANNING PURPOSES ONLY. THIS IS NOT A REQUEST FOR PROPOSAL AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON CAPABILITY STATEMENTS RECEIVED IN RESPONSE TO THIS SOURCES SOUGHT ANNOUNCEMENT THIS ACQUISITION MAY BE SOLICITED AS A 100% SMALL BUSINESS SET-ASIDE. ALL SMALL BUSINESS ORGANIZATIONS (SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB) ARE ENCOURAGED TO RESPOND TO THIS NOTICE. SMALL BUSINESS ORGANIZATIONS MUST HAVE THEIR SIZE STATUS CERTIFIED BY THE SMALL BUSINESS ADMINISTRATION. ALL SMALL BUSINESSES ARE ENCOURAGED TO RESPOND. THE NAICS CODE IS 541990 WITH A SIZE STANDARD OF ___500______. Description Currently DMID has a contract that provides regulatory support services including data and document collection and compilation for regulatory filing (pre-IND, IND) with the U.S. Food and Drug Administration (FDA), among other services. The intent of this initiative is to continue such services. Research supported and conducted by 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 order to ensure that the development, testing and manufacture of products evaluated under DMID-supported clinical research are executed with a rigor that will support licensure by the Food and Drug Administration (FDA), DMID supports an infrastructure to provide regulatory assistance in the development and testing of these products. Currently, DMID sponsors approximately 100 Investigational New Drug Applications (INDs) or Master Files (MFs) which span more than 200 clinical trials. This includes both multicenter trials and single center studies, and encompasses Phase 1, 2, and 3 clinical trials performed at both domestic and foreign sites. DMID files approximately 10-20 new INDs each year, and in this capacity, serves as the official IND sponsor and liaisons with the FDA with respect to all regulatory requirements. Currently, the DMID IND portfolio is comprised of approximately 75% vaccine and other biologic INDs (monoclonal), 20% drug INDs, and 5% MFs. In addition, it is anticipated that Investigational Device Exemptions (IDEs) will be required during the contract period of performance. Potential sources must demonstrate and document the following in their capability statements: Capability statements submitted 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 the following: 1) Relevant experience in the review, preparation and submission of regulatory documents, such as Investigational New Drug (IND) applications. 2) Ability to conduct regulatory and training activities. 3) Ability to provide specialized regulatory expertise, e.g., assay development and validation, and to provide and/or oversee regulatory audits. 4) Ability to provide, maintain and operate regulatory database information systems. 5) Ability to coordinate regulatory support functions with other clinical research support contractors. 6) Capacity and facilities to perform regulatory tasks. 7) Ability to provide personnel who have the training, expertise, and experience necessary to accomplish the full scope of regulatory requirements. 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. 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 March 19, 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: Gehmelle L. Johnson, Contract Specialist, Phone: 301-451-3689, Fax: 301-480-4675. Yvette R. Brown, Contracting Officer, Phone: 301-496-0612, Fax: 301-480-4675.