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

Introduction: This is a R&D Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources, including small and small disadvantaged businesses, to perform a potential R&D requirement. Background: 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. 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 performancefrom 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. Purpose and Objectives: The purpose of this Research and Development (R&D) Sources Sought Notice is to discern whether or not there are other contractors, including small or small disadvantaged businesses, capable of and interested in performing the work described herein. The NIAID does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. As a result of this R&D Sources Sought Notice, the NIAID may issue a Request for Proposals (RFP), if it deemed necessary and appropriate. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against the NIAID shall arise as a result of a response to this Sources Sought Notice or the NIAID's use of such information, as either part of our evaluation process or in developing specifications of any subsequent requirement. 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, Letters of Amendments, 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. Project requirements: 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, technical and project management services to support NIAID COVID-19 clinical research. 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) Anticipated period of performance: The period of performance of the contract will not change. The increase in FTEs is anticipated to occur during the period of April 15, 2021 through April 14, 2024. Other important considerations: Work under this contract will be performed in the U.S. Expedited protocol registration and IND support services are performed in the NIAID Clinical Research Management System (N-CRMS). Any alternate vendor would need extensive demonstrated experience utilizing N-CRMS components, including: Master Contact, Protocol Management, Protocol Registration, Protocol Development Tracking, and Investigational New Drug Application Management. Capability statement / information sought: Capability statements submitted as a result of this announcement should demonstrate the offeror's qualification, expertise and experience, specifically providing evidence as to the capability to perform this requirement. Capability statements should clearly convey information regarding the respondent's capabilities, including: (1) staff expertise, including their availability, experience and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of a similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. Interested Contractors must submit a capability statement (five page limitation, excluding resumes) describing their company's experience and ability to perform this effort, which includes the following: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator/co-PI, which reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work. Each response should include the following Business Information: DUNS number Company Name Company Address Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses Current GSA Schedule appropriate to this Sources Sought Do you have a Government-approved accounting system? If so, please identify the agency that approved the system. Type of Company (i.e., large business, non-profit, educational institute, small business, 8(a), woman owned, veteran owned, etc.), as validated via the System for Award Management (SAM). All offerors must be registered in the SAM, located at http://www.sam.gov/ Responses must be submitted no later than 3:00 PM (EST), on January 19, 2021. Capability statements will not be returned and will not be accepted after the due date. These statements should be submitted electronically (via e-mail) to Robert Corno, Contracting Officer, at cornorj@niaid.nih.gov. These statements should be submitted in Adobe Portable Document Format (PDF); however, capability statements in Microsoft Word will also be accepted. The e-mail subject line must specify RDSS-75N93021R00007. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted, tailored capability statements are due not later than 3:00 PM (EST), on January 19, 2021. CAPABILITY STATEMENTS WILL NOT BE RETURNED AND WILL NOT BE ACCEPTED AFTER THE DUE DATE. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following addresses: Contracting Officer: Robert Corno Email Address: cornorj@niaid.nih.gov Contracting Officer: John Manouelian Email Address: manouelj@mail.nih.gov Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.