Inactive

Amendment to this notice is hereby issued to advise the solicitation will now be released on or around April 20, 2020. Amendment to this notice to advise that the associated solicitation will now be r... Amendment to this notice is hereby issued to advise the solicitation will now be released on or around April 20, 2020. Amendment to this notice to advise that the associated solicitation will now be released on or around March 18, 2020. Amendment to this notice to correct closing date to 04/23/2020 and advise that solicitation will now be release on or around 04/20/2020. Amendment to this notice to correct closing date to 03/14/2020 and change NAICS to 541715 as appropriate. Pre-solicitation Notice for Tuberculosis Trials Consortium Services This presolicitation notice is to advise of pending release of a solicitation for provision of clinical research activities for TBTC studies in the treatment, diagnosis and prevention of tuberculosis (TB) over the course of a 10-year period of performance inclusive of a 1-year base and 9 one-year option periods to be exercised or not at the government’s discretion. The service code associated with the requirement will be AN12. A description of the types of services anticipated under the pending solicitation are as follows: The purpose of this procurement is to support clinical trials and clinical research on the treatment, diagnosis and prevention of tuberculosis (TB). Emphasis will be given to studies of latent TB infection in the United States, and studies of active TB disease both domestically and internationally. All phases of clinical trials in patients with TB disease or latent TB infection will be required, including (as needed) screening, diagnosis, enrollment, treatment, observation, clinical testing, data collection, and follow-up after treatment. Studies of candidate TB vaccines may be undertaken at future times if judged of sufficiently high priority and recommended by CSG, approved by the TBTC Steering Committee, and supported by DTBE. Specific contract requirements will include participation in clinical research studies, completion and adherence to start-up requirements within 60 days of contract award (with specific addenda for every protocol) as applicable and whenever site changes occur that impact requirements, and participation (as a member) of the TB Trials consortium. The scope of activities may range from small laboratory-based and/or single site studies to large Phase 2 and long-term Phase 3 clinical trials to evaluate new TB drugs and drug regimens, diagnostics, and preventive interventions. Each vendor research site shall, as an independent organization and not as an agent of the Government, furnish all the necessary services, qualified personnel, material, equipment, and facilities to concurrently perform multiple clinical trials and/or studies for the treatment of active and/or latent tuberculosis (TB), for the evaluation of new tests or approaches for the diagnosis of TB infection and disease, and for the prevention of TB, using procedures outlined in each trial or study’s applicable protocol. Detailed Description of the 10 annual phases are as follows: Base YEAR – Phase I: The vendor shall perform start-up/preparation activities in accordance with the procedures and guidelines outlined in detail in the enclosed examples of a Phase 2 clinical trial, a Phase 3 clinical trial, and/or a pharmacokinetic protocol. Examples of protocols for TBTC Studies are provide as Attachments in Section J. Enrollment into a study may not begin until the relevant ethical committees or Institutional Review Boards (IRBs) have granted approval. The vendor shall participate fully as a member of the TB Trials Consortium as described above. This will include, during this and all subsequent phases, attendance at TBTC group meetings. The purpose of these meetings has been to review progress and implementation of current trials, to learn from outside experts, and to discuss possible new studies. These meetings will be held once or twice a year (generally in Atlanta, GA). In the future, some meetings may be focused on issues related to trial implementation, regulatory compliance and quality assurance. OPTION YEAR 1 – Phase II: The vendor shall start or continue the enrollment, treatment, testing, follow-up, observation, data collection, specimen collection, and compliance activities for the studies chosen to be implemented. The government estimates that 0-2 new studies may be initiated during this phase. OPTION YEAR 2 – Phase III: The vendor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and specimen collection, and compliance activities for the studies chosen to be implemented. The government estimates that 0-2 new studies may be initiated during this phase. OPTION YEAR 3 – Phase IV: The vendor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and specimen collection, and compliance activities for the studies chosen to be implemented. The government estimates that 0-2 new studies may be initiated during this phase. OPTION YEAR 4 Phase V: The vendor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and specimen collection, and compliance activities for the studies chosen to be implemented. The government estimates that 0-4 new studies may be initiated during this phase. OPTION YEAR 5 – Phase VI: The vendor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and specimen collection, and compliance activities for the studies chosen to be implemented. The government estimates that 0-2 new studies may be initiated during this phase. OPTION YEAR 6 – Phase VII: The vendor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and specimen collection, and compliance activities for the studies chosen to be implemented. The government estimates that 0-2 new studies may be initiated during this phase. OPTION YEAR 7 - Phase VIII: The vendor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and specimen collection, and compliance activities for the studies chosen to be implemented. The government estimates that 0-2 new studies may be initiated during this phase. OPTION YEAR 8 – Phase VIIII: The vendor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and specimen collection, and compliance activities for the studies chosen to be implemented. The government estimates that 0-2 new studies may be initiated during this phase. OPTION YEAR 9 – Phase X: The vendor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and specimen collection, and compliance activities for the studies chosen to be implemented. The government estimates that 0-2 new studies may be initiated during this phase. While a solicitation number is still to be determined, it is estimated that a solicitation will be issued to secure these services on or around February 28, 2020. The anticipated award date associated with this anticipated solicitation is estimated to be July 2020. Additional detail or items to be determined are as follows: Proposed Solicitation Number – TBD Closing Response Date – January 29, 2020 Contract Award and Solicitation Number – TBD Contract Award Dollar Amount -TBD Line Item Number – TBD Contractor(s) – TBD Place of Contract Performance – TBD Set-aside Status: None National Stock Number (NSN) if assigned – N/A Specification and whether an offeror, its product, or service must meet a qualification requirement in order to be eligible for award, and identification of the office from which additional information about the qualification requirement may be obtained (see subpart 9.2) - TBD Manufacturer, including part number, drawing number, etc. – N/A Size, dimensions, or other form fit or functional description. – N/A Predominant material of manufacture – N/A Quantity, including any options for additional quantities. – N/A Unit of issue – 1 Job Destination information – TBD Delivery schedule – TBD Sustainable acquisition requirements (or a description of high-performance sustainable building practices required, if for design, construction, renovation, repair, or deconstruction) (see parts 23 or 36). – TBD Point of Contact: Contracting Officer: Candice L. Simmons at iie3@cdc.gov or (770) 488-1432 Centers for Disease Control and Prevention (CDC) 2939 Brandywine Rd (MS-K15), Atlanta, GA 30341. All inquiries regarding this Pre-Solicitation notice must be received electronically at iie3@cdc.gov with subject line titled “Tuberculosis Trials Consortium Services “ no later than 02/10/2020. Telephonic and US mail inquiries will not be accepted. **Please note the government’s requirement as stated herein is subject to change before release of pending solicitation. If and at such time a solicitation is released it may or may not reflect the same verbiage/information herein. The primary purpose of this notice is to advise of potential pending release of a solicitation for Tuberculosis Trials Consortium Services.** ** This is not an offical Request for Proposal**