Early Bactericidal Activity (EBA) of Anti-TB Drugs in India

Department of Health and Human Services, Centers for Disease Control and Prevention, Office of Financial Resources, Office of Acquisition Services, Room 3000, 2920 Brandywine Road, Atlanta, GA 30341-3724 The Centers for Disease Control and Prevention (CDC), Center for Global Health (CGH) Division of Global HIV & Tuberculosis (DGHT), Global TB Prevention and Control Branch, intends to negotiate a sole source contract with National Institute for Research in Tuberculosis (NIRT), India for technical support services for the implementation of a small early bacterial activity (EBA) study in Chennai, India. The implementation of EBA of anti-TB drugs study will generate the evidence needed to fill a specific gap in CDC's knowledge about treatment of drug-resistant TB to inform practice recommendations for the control and prevention of drug-resistant TB. The National Institute for Research in Tuberculosis (NIRT) in Chennai, India, is the only governmental institution in India with the experience and trained staff to conduct clinical trials in tuberculosis patients, including drug-resistant tuberculosis. NIRT is also the only governmental organization that has established working relationship with clinical centers or facilities in Chennai, India, that can consent, enroll, diagnose, treat, and monitor patients, collect and store sputum specimens for research purposes, and maintain meticulous records. NIRT also has established and validated laboratory procedures for the proposed EBA study, in addition to reference-laboratory level routine microbiological and molecular procedures: overnight sputum collection and logistics, quantitative cultures on Middlebrook 7H11S agar plates per SOP, quantitative cultures in MGIT 960 per SOP, phenotypic drug susceptibility testing, and genotypic drug susceptibility testing with line probe assay (LPA) for isoniazid, rifampicin, fluroquinolones, and aminoglycosides. NIRT also has an established institutional ethics committee to review and approve the research protocol specified, and to obtain all the necessary government of India approvals. The justification for this non-competitive action is in accordance with 13.106-1(b)(1), only one source is reasonably available which states that, "For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available. This notice of intent is not a request for competitive proposals. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. Interested parties who believe they possess the capabilities to satisfy this requirement should submit a Capability Statement demonstrating their abilities to meet this requirement. All responses will be considered. All Capability Statements shall be received by the closing date of this synopsis and shall be submitted in writing. Responses may be sent via email to luw9@cdc.gov. No solicitation will be issued. No telephone inquiries will be accepted.