Professional, Scientific, and Technical Support Services for the Division of Intramural Research (DIR) and the Vaccine Research Center (VRC)

The National Institute of Allergy and Infectious Diseases (NIAID), Division of Intramural Research (DIR) and Vaccine Research Center (VRC) require qualified and experienced personnel to support a full-range of activities, including new and in-progress research projects, program deployment and implementation, ongoing management and operations, and other activities necessary to conduct the business of the NIAID's research program. NIAID conducts and supports basic, translational and clinical research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. Infectious diseases include global killers such as human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), tuberculosis (TB), and malaria; emerging and re-emerging threats such as influenza, novel pathogenic coronaviruses (e.g., Middle East respiratory syndrome), Ebola, Zika, chikungunya, multidrug-resistant bacteria (e.g., multidrug-resistant Staphylococcus aureus), and extensively drug-resistant TB (XDR TB); and "deliberately emerging" threats from potential agents of bioterrorism. Immune-mediated disorders include autoimmune diseases such as lupus and type 1 diabetes; asthma; allergies; and graft rejection and other problems associated with tissue and organ transplantation. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests and other technologies that have improved the health of millions of people in the US and around the world. The scope of NIAID research portfolio has expanded considerably in recent years in response to new challenges such as bioterrorism, emerging and re-emerging infectious diseases, and the increase of asthma prevalence among children in this country. The Government intends to increase the current ceiling of contract HHSN272201500015I by an amount up to $45,078,989 from $179,023,570 to $224,102,559 for services in support of the NIAID DIR and VRC. It is estimated that a follow-on contract for the services described below will be solicited and awarded no later than September of 2020. This is a non-personal services contract to provide Professional, Scientific, and Technical Support Services for the DIR and the VRC. The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, other items and non-personal services necessary to provide technical support in the areas as defined in the Performance Work Statement except for those items specified as Government-furnished property and services; 1) Scientific research and analysis support; 2) Bioinformatics and computational biology; 3) Scientific and technical writing; 4) Scientific and medical domain expertise; 5) Scientific and research data management; 6) Laboratory management and support; 7) Scientific project management; 8) Information systems support; and 9) Clinical support services. The contractor shall perform to the standards in this contract. The requested ceiling increase will be utilized for ongoing tasks and projects that do not fit under other requirements, these projects include but are not limited to: - Produce influenza challenge viruses, bpl inactivation mix, and final formulation testing; qualify other vaccine components; prepare and qualify cell lines for use in the production of such viruses; or perform routine qualification testing (such as bacterial sterility) on stored vaccine preparations - Produce a variety of vectors for use in clinical trials conducted under a Phase I IND; includes Lentivirus, IL15/IL21, and KK-LC-1 - On-going support and enhancement to the customer myRTB software, in use through-out DIR Labs - Provide assistance in auditing NIH facilities and outside vendors to ensure they are qualified and operating in accordance with regulations to manufacture sterile specialized pharmaceutical and cell therapy products used in NIH intramural research protocols - Support for a centralized international database for dengue vaccine - Assessment of existing business operations and systems to identify ways to increase efficiency and accuracy in budgeting for, tracking, and reporting of the scientific research portfolio; evaluate opportunities to re-engineer existing business processes and implement a unified suite of tools to unify scientific administration and cost accounting information systems, giving researchers and administrative staff a resource to get a real-time overview of their programs, studies, and projects - Institutional Review Board (IRB) Consolidation support services - Intramural Research Program (IRP) compliance assessment and oversight of clinical protocol activities, focusing on expedited event reporting, patient consent and inclusion/exclusion criteria - Biovitrum and Rilonacept - Natural History clinical study support - Contamination control - high level aseptic cleaning/microbial decontamination of hospital areas used for patient procedures - Research support for influenza RNA samples - Services and support for the enterprise-wide human biospecimen electronic data system - Customized software services for the NIH iRIS-software system - Provide subject matter expertise for developing and revising SOPs and batch records for a new GMP facility for viral vector and cell production The NIAID intends to negotiate, under the authority of FAR 6.302-1 and HHSAR 306.302-1, on a sole source basis, with Medical Science and Computing, Inc., an increase the current ceiling of contract HHSN272201500015I by an amount up to $45,078,989 from $179,023,570 to $224,102,559. No other source is able to provide these critical/essential services beginning in February 2019 without causing unacceptable delays to the Government in fulfilling the agency's requirements. This Source Sought notice is not a request for competitive proposals. However, responsible sources may express their interest by submitting a capability statement. All capability statements received within fourteen (14) days from the date of the publication of this notice will be considered by the Government. A determination by the Government not to compete this proposed contract action based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Any concerned parties may address questions to the Contract Specialist, Patrick Wilson, at wilsonpm@mail.nih.gov. This notice does not commit the Government to award a contract. 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