SOLICITATION NOTICE
B -- ACTIV-1 Time-limited Biospecimen Storage and Related Services (COVID-19)
- Notice Date
- 5/16/2022 6:54:32 AM
- Notice Type
- Presolicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95022R00057
- Response Due
- 5/29/2022 10:00:00 AM
- Point of Contact
- Mark McNally, Phone: 301-827-5869
- E-Mail Address
-
mark.mcnally@nih.gov
(mark.mcnally@nih.gov)
- Description
- INTRODUCTION PURSUANT TO FAR Subpart 5.2�Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT ACTION. �� THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).� The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) intends to award a contract to Technical Resources International, Inc. (TRI), 6500 Rock Spring Drive, Bethesda, MD 20817-1197, titled: Long-term Storage, Distribution and Analysis of Biospecimens from the ACTIV-1 Master Protocol and Related Services (COVID-19). The rationale for this sole source is as follows: To meet the unprecedented public health crisis created by the COVID-19 pandemic, the National Institutes of Health (NIH) announced on April 17, 2020, the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines. Coordinated by the Foundation for the National Institutes of Health (FNIH), ACTIV brought NIH together with its sibling agencies in the Department of Health and Human Services, including the Biomedical Advanced Research and Development Authority (BARDA), Centers for Disease Control and Prevention (CDC), and the U.S. Food and Drug Administration (FDA); other government agencies including the Department of Defense (DoD) and Department of Veterans Affairs (VA);� United States Government COVID-19 Response; the European Medicines Agency (EMA); and representatives from academia, philanthropic organizations, and numerous biopharmaceutical companies. One of the programs established within the ACTIV framework was the Therapeutics Development Working Group that was charged with rapidly organizing and implementing clinical trials using adaptive platform trial designs that could test multiple agents and use shared control groups to accelerate testing and obtain much needed answers quickly to help guide clinical care of COVID-19 patients. NIH�s National Center for Advancing Translational Sciences (NCATS) and BARDA are leading one of the ACTIV trials, ACTIV-1. NCATS coordinated and oversaw the ACTIV-1 trial in partnership with and with funding from BARDA. BARDA engaged Technical Resources International, Inc (TRI), part of BARDA�s medical countermeasures clinical studies network, to support the management of ACTIV-1 Master Protocol via a Task Order (TO) Number 75A50120F33002 under the Contract Number HHSO100201400002I. The period of performance for the BARDA TO is from 08/17/2020 to 09/30/2022. The ACTIV-1 Master Protocol is a randomized, double-blind, placebo-controlled adaptive trial that enrolled 1,971 hospitalized adults with moderate to severe COVID-19 at medical facilities in the U.S. and Latin America. The trial evaluated infliximab (REMICADE�), developed by Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson; abatacept (ORENCIA�), developed by Bristol Myers Squibb; and Cenicriviroc (CVC), an investigational late-stage agent developed by AbbVie. Each agent was evaluated as add-on therapy to the current standard of care for hospitalized COVID-19 patients, which included remdesivir for most participants (supplied by the study). The research objectives were to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization. TRI supported BARDA and NCATS in the management of the ACTIV-1 Master Protocol by overseeing the trial operations under the direction of the Government, including contracting, management of necessary subcontractors, data management, data monitoring, site monitoring, international site selection and management, statistical support, investigational product and biospecimen repository, international regulatory assistance, and contracting of a commercial central Institutional Review Board (IRB). During the trial, research samples of whole blood, serum and plasma were collected from the consented study participants at approximately 46 medical facilities in the U.S. These biospecimens are currently stored in a commercial repository under the supervision of TRI. A portion of these biospecimens have been used for cytokine, inflammatory markers and SARS-CoV-2 serology assays as part of the exploratory assessments stated in the ACTIV-1 Master Protocol and the remaining biospecimens will be available for investigators or entities interested in conducting secondary research. In addition, data collected from the consented participants is stored and managed by a data coordinating center (DCC) under the supervision of TRI. The DCC will provide selected anonymized data matched with the biospecimens for the exploratory assessments and secondary research. NCATS is seeking assistance to continue the support of selected existing activities under the BARDA TO and to establish new activities including time-limited storage, distribution, destruction (if needed) of biospecimens and clinical data, data management support to match clinical data subsets with biospecimens, additional statistical analyses for ACTIV-1 study, collection and management of Material Transfer Agreements and IRB review after conclusion of the BARDA TO on September 30, 2022. TRI is in a unique position to provide the continuity of the existing activities under the BARDA TO and to establish the new activities under the NCATS contract as the resources required for these activities are already in place. Additionally, TRI has been an integral part of the ACTIV-1 Master Protocol implementation since the trial was launched. They have the familiarity and deep knowledge of complex platform trial data to perform additional analyses necessary to better understand the relationships of baseline SARS-CoV-2 serology status, inflammatory biomarkers and cytokines to the overall clinical course of patients with COVID-19 and their responses to immune modulators treatment. The Government will benefit from the time and cost saving of a seamless transition between the BARDA TO and NCATS PO and avoid possible inaccurate data analyses, the potential risk of damage to the biospecimens or breach of ACTIV-1 data during the transition between TRI and a new vendor. � NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541380 with a small business size tandard of $16.5 million. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses of the Federal acquisition Requlation (FAR) in effect through the Federal Acquisition Circular (FAC) at the time of award. � STATUTORY AUTHORITY This acquisition is conducted as non-competitive under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. � DESCRIPTION OF REQUIREMENT Background To meet the unprecedented public health crisis created by the COVID-19 pandemic, the National Institutes of Health (NIH) announced on April 17, 2020, the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines. Coordinated by the Foundation for the National Institutes of Health (FNIH), ACTIV brings NIH together with its sibling agencies in the Department of Health and Human Services, including the Biomedical Advanced Research and Development Authority (BARDA), Centers for Disease Control and Prevention (CDC), and the U.S. Food and Drug Administration (FDA); other government agencies including the Department of Defense (DoD) and Department of Veterans Affairs (VA);� United States Government COVID-19 Response; the European Medicines Agency (EMA); and representatives from academia, philanthropic organizations, and numerous biopharmaceutical companies. One of the programs established within the ACTIV framework was the Therapeutics Development Working Group that was charged with rapidly organizing and implementing clinical trials using adaptive platform trial designs that could test multiple agents and use shared control groups to accelerate testing and obtain much needed answers quickly to help guide clinical care of COVID-19 patients. NCATS and BARDA were asked to lead one of the ACTIV trials, ACTIV-1 Immune Modulators (IM), and implement the trial using the 60 US academic centers comprising the NCATS Clinical and Translational Science Award (CTSA) Program, plus additional non-CTSA US sites and sites outside the United States. This procurement will provide assistance to maintain and provide additional services for ACTIV-1 as described below. Purpose and Objectives The National Center for Advancing Translational Sciences (NCATS) is procuring assistance for the long-term storage, distribution and selected analysis of samples collected from participants enrolled in the ACTIV-1 Immune Modulators (IM) Master Protocol. Research samples of whole blood, serum and plasma were collected during the trial from approximately 60 US academic centers comprising the NCATS Clinical and Translational Science Award (CTSA) Program and non-CTSA US sites.� These specimens were collected as part of the Biomedical Advanced Research and Development Authority (BARDA) task order number 75A50120F33002, contract number HHSO100201400002I, but the BARDA task order does not provide for long-term biospecimen storage, distribution of biospecimens and matched clinical data subsets from the trial, collection and management of needed Material Transfer Agreements (MTAs) or analysis of any biospecimens after the conclusion of the ACTIV-1 IM trial.� These biospecimens were collected for future use from consented participants and can provide critical data about the COVID-19 pandemic. Project Description The Contractor shall provide all the necessary services, qualified personnel, tools, materials, equipment, and facilities, not otherwise provided by the Government to perform the following tasks: Project Management: Describe the project management systems that will be used to track activities and to keep multiple activities on time and budget. It must include a description of the quality control methods that will be used to ensure the effective and efficient initiation, implementation, management, and oversight of contract requirements. Provide for the safe and efficient assumption of activities from the ACTIV-1 Contractor to ensure a seamless transition without loss of time and loss of specimens and clinical data. Execute any necessary Material Transfer Agreement (MTA) with the long-term biorepository, with timing to have such MTA in place based upon the expected project duration. Develop and implement communication Standard Operating Procedures (SOPs) for management of biospecimen inventory and clinical data with the NIH or designated party within 30 business days of the contract award. a)������ Establish and maintain Quality Assurance (QA) and Quality Control (QC) Programs that includes valid SOPs in accordance with best practices and covers all activities critical to the successful operation of the biorepository and clinical data management. The QA/QC Program shall include, but is not limited to: validating procedures for long-term storage of each material type of biospecimen and clinical data management; verifying accuracy of data entry, inventory database, and shipping and receipt records; and monitoring the mechanical functioning of freezers and other storage equipment including alarm and back-up systems. � Biospecimen Management: Each biospecimen is unique and cannot be replaced if lost, damaged or contaminated. Therefore, it is essential that the biospecimens be stored under optimal conditions to maintain their integrity and biological properties, which vary from biospecimen type to biospecimen type. Storage facilities with the College of American Pathologist�s (CAP) Biorepository Accreditation is preferred. The Contractor shall comply with all Federal, State, and local requirements and current best practices for the collection, handling, preservation, storage, retrieval, and distribution of biological material for scientific research. � Data Management: Receive data files (manifests) containing biospecimen identifiers from the ACTIV-1 Contractor, and employ a laboratory information management system to provide detailed tracking of receipt, storage, retrieval, distribution, and destruction of biospecimens. Receive via secure file transfer and verify clinical data files (source Medidata�s Rave Electronic Data Capture) containing clinical data from the ACTIV-1 Contractor. Data formats include raw datasets in XPT/SAS files, Study Data Tabulation Model (SDTM) datasets and Analysis Data Model (ADaM) datasets with approximately total size of 30 GB. Provide data management including correlation of clinical data files with specimen data files and retrieval of the data elements in format (e.g., csv files) as requested by the NIH or designated party. Data management of any biospecimen analysis data generated by the designated third party is the responsibility of the third party. � Statistical Support: Provide statistical support to correlate clinical data with the specimen data for accurate transfer of the dataset matching the biospecimens. Period of Performance The anticipated period of performance for these non-severable activities is three years. � CLOSING STATEMENT This synopsis is not a request for competitive proposals; however, All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. Responses to this solicitation must include clear and convincing evidence of the offeror�s technical capability of fulfilling the requirement. Responses that fail to include relevant technical capability information and all terms and conditions may be assessed as not capable of meeting the requirement. The respondent must also provide their Unique Entity Identifier (UEI), organization name, address, point-of-contact, and size and type of business (e.g., 8(a), HubZone, etc.), pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.� The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.�� All responses must be received by 01:00 PM Eastern Daylight Time, May 29, 2022, and reference number 75N95022R00057. All responses must be emailed to Mark McNally, Contracting Officer, at mark.mcnally@nih.gov.� All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.
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- Record
- SN06327898-F 20220518/220516230059 (samdaily.us)
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