Division of Microbiology & Infectious Diseases: Regulatory Affairs Support
Added: Mar 19, 2014 2:16 pm Type of Requirement: Re-competition (HHSN272200800069C) Current Contractor:SAIC5202 Presidents CourtSuite 110Frederick, MD 21703 Contracting Office Address:Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 6700-B Rockledge Drive, Room 3223, MSC 7612, Bethesda, MD, 20892-7612Duration of contract: 1 Year Base Period plus 6 Additional Option YearsIf Options will be included, describe Options: - Option Periods 6 one-year Option Periods.- Option Quantities 4 Option Quantities for each contract period, to increase the level of effort.Total Small Business Set-AsideThis solicitation is reserved exclusively for small business concerns, pursuant to FAR 19.502-2 Total Small Business Set-Asides. The NAICS Code is 541711 with a size standard of 500 employees.Anticipated award date: 07/01/15Presolicitation Notice InformationIntroductionThe National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of Microbiology and Infectious Diseases, has a requirement for regulatory assistance for a broad spectrum of DMID research activities poised for regulatory approval or licensure.Description 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 teaten 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 tough 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 (monoclonal) INDs, 20% drug INDs, and 5% MFs. DMID is also the sponsor of an open Investigational Device Exemption application (IDE) and supports interaction with the FDA for studies that support 501(k) filings.The purpose of this solicitation is to provide scientific, regulatory, technical, project management, and administrative assistance for a broad spectrum of DMID research activities poised for regulatory approval or licensure.It is anticipated that a single cost-reimbursement, Level of Effort type contract will be awarded with a one-year base period of performance beginning on or about 07/01/2015 and the inclusion of 6 one-year option periods. The Government estimates that the Level of Effort will be 28,252 labor hours, inclusive of subcontractors and consultants, for the base period and for each one-year option period. Additionally, each contract period will contain 4 option quantities totaling another potential 28,252 labor hours.Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about 04/03/2014, and may be accessed tough FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.
NIAID-DMID-NIHAI2014004 Department of Health and Human Services National Institutes of Health
3/19/14, 2:16 PM