NIAID/Division of AIDS: Regulatory Support Center (RSC)

Anticipated Period of Performance The anticipated period of performance is April 15, 2021 through April 14, 2022 with 2 term options to extend services for an additional 12 month period per option, starting on April 15, 2022, through April 14, 2024 (if all term options are exercised) Anticipated award date: April 15, 2021 Introduction The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), conducts and supports research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. The mission of Division of AIDS (DAIDS), NIAID, is to bring an end to the HIV/AIDS epidemic by increasing the basic knowledge of the pathogenesis and transmission of HIV, to support the advancement of therapies for HIV infection and its complications, and to support the development of HIV/AIDS vaccines and other prevention measures. NIAID/DAIDS, henceforth referred to as DAIDS, supports extramural Clinical Trials Networks, investigator-initiated clinical trials, and partners with other Government and private organizations, in order to accomplish DAIDS's scientific objectives. Through grants and contracts, DAIDS sponsors Phase I, II, III and IV clinical trials to evaluate the safety and efficacy of therapeutics, vaccines, and other preventive modalities. The DAIDS global clinical trial portfolio includes approximately 440 active protocols, 73 active INDs, 300+ network study sites in 22 countries, and collaborations with 60 pharmaceutical companies. As the Investigational New Drug (IND) Application Sponsor for a large number of DAIDS-funded clinical trials, DAIDS is required to ensure compliance with applicable regulations, including Title 21 Code of Federal Regulations (CFR) Part 312, Human Subjects Protection Title 45 CFR Part 46, and ICH E6(R2) International Conference on Harmonisation-Good Clinical Practices (ICH-GCP). This contract provides comprehensive clinical regulatory support services for all DAIDS-supported network and non-network clinical trials. Description In order to provide regulatory support services for the aforementioned DAIDS clinical trials portfolio, a restricted competition (small business set-aside) was held, which resulted in the award of a contract to Technical Resources International, Inc., 6500 Rock Spring Drive, Suite 650, Bethesda, MD 20817. A cost-plus-award fee, term form contract was awarded on April 15, 2017, to deliver 48.45 full time equivalents (FTEs) per year, with term options to extend the period of performance, for a total period of seven years, through April 14, 2024, and quantity options for increased level of effort for unanticipated increases in demand. The total value of the contract is $79,104,240 including the Base Period and all Options. This contract provides regulatory expertise and support to operate and manage the NIAID/ DAIDS Regulatory Support Center (RSC), to provide a wide range of clinical research activities and programs for DAIDS, including the delivery of regulatory support services for unanticipated DAIDS clinical research projects that may be required in response to emerging needs or public health emergencies. The DAIDS RSC provides comprehensive regulatory support to: 1) perform DAIDS-funded and DAIDS-sponsored domestic and international clinical trial research? 2) provide training in key functions of clinical trial research to DAIDS staff, investigators, and collaborators? and 3) maintain all contract-associated data and records in the DAIDS Enterprise System (DAIDS-ES) and NIAID-Clinical Research Management System (N-CRMS), including the electronic submission of required regulatory information. On October 15, 2019, in response to addressing unanticipated increases in contract activity, the contract was modified to incorporate 146,640 direct labor hours. This resulted in increases to term Options 2-6 and were incorporated into the contract via Modification #6. As a result of Modification #6, the total contract value was increased by $17,518,057, from $79,104,240 to $96,622,297. On August 12, 2020, in response to the COVID-19 pandemic, the contract was modified to procure regulatory support services for a sponsored DAIDS COVID-19 clinical trial, entitled, - A5401: Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID), also known as ACTIV- 2. This clinical trial is one of the studies identified by Operation Warp Speed for the identification of a therapeutic for COVID-19 as quickly as possible. The support services provided, to date, (these activities are within the existing scope of the contract) includes project management, negotiation and development of clinical trial agreements, preparation and submission of regulatory filings, such as IND submissions, Letters of Amendment (LOAs), protocol amendments and appendicies to the Food and Drug Administration (FDA), and expedited protocol registration to verify that clinical sites have received the necessary applicable Regulatory Entity (RE)/Approving Entity (AE) approvals and documentation required by regulatory authorities. A total of 24,369 direct labor hours were added to the contract to address this COVID-19 requirement. The total estimated cost-plus award fee of the contract was increased by $2,363,306, to cover performance from August 15, 2020 through August 14, 2021. The additional work was added to the contract on a sole source basis as a result of the HHS Class J&A for unusual and compelling urgency for the COVID-19 Response. This Sources Sought Notice (SS) is for information and planning purposes only, and shall not be construed as a solicitation or as an obligation on the part of the NIAID. At this time, both the complexity as well as quantity of requirements for full clinical trial support services for ACTIV- 2 have significantly increased based on - real time clinical trial implementation data, as well as evolving scientific requirements. Specifically, the following significant increases of ACTIV-2 key clinical trial activity drivers have transpired since August 15, 2020: Increase in number of protocol documents including additional IND submissions, LOAs, protocol amendments for protocol updates and new appendices to the FDA. The RSC has assumed responsibility for additional (27% increase) study arms than originally scoped, resulting in a 55% increase in the number of protocol versions/amendments to the FDA. Increased number of clinical sites. The RSC has assumed responsibility for significantly more clinical research sites (172% increase) than originally scoped, resulting in significantly more expedited protocol registration activities. 238% increase in period of performance of study than originally scoped. 10% increase in number of study products than originally scoped. As a result of these increases in clinical trial support activities, the Government will require additional support to address these needs. The objective of this acquisition is to procure 94.07 FTEs to be delivered to the Government during the period April 15, 2021 through April 14, 2024. These additional resources are needed to provide the support, as listed above. Specifically, the Contractor will be responsible for continuing to provide clinical research support activities needed for the completion of the ACTIV-2 study, which includes the following activities: Expedited clinical trial protocol registration of research sites; Preparation and submission of regulatory filings, such as IND submissions, LOAs, protocol amendments, and appendicies to the FDA; Negotiation and development of clinical trial agreements; and Technical and project management services to support NIAID COVID-19 clinical research. The NIAID intends to negotiate, under the authority of FAR Part 6.302-1, full and open competition need not be provided for when there is only one responsible source and no other supplies or services will satisfy agency requirements. The NIAID intends to modify the existing contract with Technical Resources International, Inc., to provide an increase to the required Level of Effort under the base requirement (Options 4-6), as follows: An increase of 28.69 FTEs (from 68.58 FTEs to 97.27 FTEs) during Option 4/Contract Year 5 (04/15/2021 - 04/14/2022) An increase of 32.82 FTEs (from 64.45 FTEs to 97.27 FTEs) during Option 5/Contract Year 6 (04/15/2022 - 04/14/2023) An increase of 32.56 FTEs (from 63.45 FTEs to 96.01FTEs) during Option 6/Contract Year 7 (04/15/2023 - 04/14/2024) _______________________________________________________ A Total Increase of 94.07 FTEs (Options 4-6/Contract Years 5-7) The COVID-19 pandemic continues to grow at an alarming rate and has catastrophically affected the health and economic stability of the world. To combat this global threat and to prevent the further spread of the coronavirus, NIAID must continue to execute a rapid, efficient and scalable response. The work related to this JOFOC is critical to continue the Phase 2 and 3 testing of lifesaving COVID-19 therapeutics. Due to the complex nature of the NIAID/DAIDS ACTIV-2 trial, the full integration of RSC staff, processes and data systems with DAIDS processes as well as the urgent public health need for a COVID-19 therapeutic, this work can only be completed using the current contractor. Attempting to bring in a new contractor would result in a significant disruption to critical services and could jeopardize participant safety and data integrity. Further, it would result in a catastrophic disruption of the NIAID/DAIDS ACTIV-2 trial, which in turn would likely result in further loss of life by depriving the nation of a therapeutic during an unprecedented pandemic. Any disruption to the NIAID/DAIDS ACTIV-2 trial would be disastrous. If a new contractor, with no institutional history, no established relationships, no established processes, and no experience/operational knowledge base was required to integrate its activities, de novo, into this existing, highly complicated, regulatory support network, there would be an immediate fracturing of these already established systems/processes/communication pathways. Additionally, due to the tight integration of current system requirements, the introduction of a new contractor would impose a significant disruption to even existing operations. Any impedance/disruption would, in turn, jeopardize the continuation of the NIAID/DAIDS ACTIV 2 trial; impact the rights, safety and well-being of the clinical trial subjects; and diminish the quality and integrity of the clinical trial data. This notice of intent is not a request for competitive proposals. However, responsible sources may express their interest by submitting a capability statement. All capability statements received within fifteen 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. This proposed acquisition was previously published under a Research and Development Sources Sought Notice that was posted on the beta.SAM.gov website on December 31, 2020 as notice number RDSS-75N93021R00007.