PRE-SOLICITATION NOTICE OF INTENT
NON-COMPETITIVE
INTRODUCTION
Pursuant to FAR Subpart 5.2—Synopses of Proposed Contract Actions, this is a Pre-Solicitation Notice of a proposed contract to action.
THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).
The National Institute on Drug Abuse (NIDA) Office of Acquisition (OA) on behalf of the National Institute of Mental Health (NIMH) intends to negotiate and award a modification to the following single award type contract that was awarded under Solicitation Number 75N95022R00044:
It is estimated that the modification would increase the contract value of services effective at time of exercise of Option Period One (1) from August 7, 2024 to August 6, 2025 to include an increased expansion of the coordination of the distribution of data and specimens stored at other national and international clinical sites that the Government will acquire by $16,000,000 from $16,483,737 to $32,483,737. The contract has a base period of performance from August 7, 2023 to August 6, 2024 and four option periods to extend the term of the contract through August 6, 2028 if all options are exercised. There are no other changes to the contract.
This contract was awarded to establish a Data Coordinating Center (DCC) to work collaboratively with the National NeuroHIV Tissue Consortium (NNTC) Clinical Sites in which NIMH, National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Drug Abuse (NIDA), and National Institute on Aging (NIA) continue to seek to support the collection and distribution of central nervous system (CNS) and peripheral nervous system (PNS) biospecimens and antemortem clinical data for research on NeuroHIV.
REGULATORY AND STATUTORY AUTHORITY
The resultant modification will include all applicable provisions and clauses of the Federal Acquisition Regulation (FAR) in effect through the current Federal Acquisition Circular (FAC).
This acquisition is conducted as non-competitive under the authority of 41 U.S.C. 3304(a)(1) 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
Background: The NNTC DCC contract shall function as part of the NNTC, a national resource that provides clinical data and biological specimens to NeuroHIV investigators interested in conducting research on Human Immunodeficiency Virus (HIV) associated CNS comorbidities in the context of anti-retroviral therapy (ART), as well as investigators who are advancing efforts towards a cure for HIV. The NNTC DCC shall work cooperatively with the NNTC-affiliated clinical sites.
The clinical sites affiliated with the NNTC shall have all patient contact which shall include all clinical assessments antemortem. The clinical sites shall also be responsible for the collection and housing of postmortem clinical specimens. The DCC shall serve as a NeuroHIV data repository which shall include the clinical assessment data and data obtained postmortem including brain pathology reports, laboratory tests conducted on the collected specimens/fluids, a comprehensive inventory of those specimens housed at each clinical site, and research data, such as bioinformatics. The DCC shall help remove a significant barrier to information exchange in the field and shall provide an innovative means to examine and analyze a rich source of data as well as specimens for research.
Goals and Objectives: NIMH including the following National Institutes of Health (NIH) Institutes and Centers (ICs) – NINDS, NIDA, and NIA seek to continue to support the collection and distribution of CNS and PNS biospecimens and antemortem clinical data for research on NeuroHIV.
The key objective for this contract is to enable continued operations of the DCC. The DCC works with the NNTC Clinical Sites to provide the following:
In this consortium, the clinical sites affiliated with the NNTC will have contact with patients and study volunteers, which will include all antemortem clinical assessments. The clinical sites will also be responsible for the collection and housing of postmortem clinical specimens. The DCC will serve as a data repository for all NNTC-affiliated clinical site activities including the clinical assessment data and data obtained postmortem including brain pathology reports, laboratory tests conducted on the collected specimens/fluids, a comprehensive inventory of those specimens housed at each clinical site, and research data including bioinformatics data sets and/or other data provided by NeuroHIV investigators who have used NNTC resources.
The DCC works collaboratively with the clinical sites to define recruitment strategies to selectively enhance the recruitment of subjects with and without HIV into the clinical site cohort. Recruitment strategies should be responsive to the evolving research needs of NeuroHIV investigators who require CNS and PNS tissue, fluids and data sets. The needs of NeuroHIV investigators for NNTC resources may be identified and informed by the scope of prior requests,
There are four (4) NNTC clinical cites the NNTC DCC works collaboratively with as follows:
REASON FOR THE NON-COMPETITIVE ACTION
The NNTC DCC contract awarded to The Emmes Company was originally competed and awarded based on full and open competition. FAR Part 15 source selection procedures were followed during the pre-award process, including: NIH concept clearance for Research and Development (R&D) procurements, an independent peer review, an internal review by NIMH of both the technical and cost proposals submitted, and discussions with the offeror regarding the proposal. The contract was awarded on August 4, 2023 and included one 12-month base period, four 12-month option periods and optional items.
In fiscal year 2023, the NNTC DCC Contract was awarded with the intention of fulfilling NIMH study needs with only the inclusion of four (4) NNTC clinical sites over a five-year period if all term options are exercised. To continue the services under this contract, it is now necessary to increase the contract value to include an increased expansion of the coordination of the distribution of data and specimens stored at other national and international clinical sites, which NIMH anticipates awarding up to 1-2 contracts for additional NNTC clinical sites by August 7, 2024.
Since 2023, NIMH requirements for these services have surpassed original estimates due to NIMH, NINDS, NIDA and NIA essential need for expanding the clinical sites to continue to support the collection and distribution of CNS and PNS biospecimens and antemortem clinical data for research on NeuroHIV. As a result the NIDA OA on behalf of NIMH issued RFP Number 75N95024R00013 titled The NIH National NeuroHIV Tissue Consortium - New Clinical Site on February 26, 2024.
This expansion shall be a critical resource for catalyzing high priority research in NeuroHIV (CNS complications in people with HIV), including studies to understand the mechanisms of HIV neuropathogenesis, aging with long-term HIV and ART, and research towards an HIV cure. The new NNTC clinical sites shall collect, store, and provide clinical data and well characterized biological specimens, including antemortem/ postmortem tissue from study volunteers and/or organ donors with HIV as well as HIV-negative controls. Furthermore, the establishment of a new NNTC clinical site is necessary to ensure geographic diversity particularly in the southern and midwestern United States.
The Emmes Company has unique qualifications to provide the services for this requirement and is the only organization that can complete the specific work at this time. The Contractor has the necessary resources and infrastructure currently in place to meet the NIMH requirements and adhere to NIH and federal policies, laws and regulations.
The Emmes Company provides a Principal Investigator (PI) who is primarily responsible and accountable for the overall implementation of the awarded contract, serves as the central contact for scientific and technical aspects of the contract, and has significant experience in the development of informational platforms and data management systems to support the research efforts of the Consortium and greater neuroHIV scientific community.
The Emmes Company has also assembled resources with all the necessary core expertise, including, but not limited to, biostatisticians, biomedical data science and bioinformatics personnel, a project management support team, data management and information technology support teams. These highly specialized teams are assembled to provide the services of the NNTC DCC. The contract-holder provides the majority of the services at their own institutions and have established storage and facilities and clinical research infrastructure, with the appropriate number and mix of resources and support personnel to conduct the services, which can meet NIMH’s expanded needs of up to 1-2 new clinical sites.
The Emmes Company maintains a Project Management Plan to ensure effective management of the contract infrastructure including its clinical site and support services, progress tracking, communication and preparation of deliverables, and archival activities. Their systems are also compliant with HHS information access security standards, including: applying approved security configurations to information technology (IT) that is used to process information on behalf of HHS, adhering to all NIH configuration standards and policies, configuring computers that contain HHS data with the latest applicable United States Government Configuration Baseline (USGCB), encrypting equipment and sensitive information stored and/or processed by such equipment in accordance with HHS and FIPS 140-2 encryption standards, and configuring systems to allow for periodic HHS vulnerability and security configuration assessment scanning.
Modifying the incumbent contract to increase the contract value is the only efficient and effective way to ensure continuation of these scientific services. Conducting a new acquisition for these R&D services would require a minimum lead time of 12 to 18 months. The latter alternative would also entail a duplication of direct labor costs for new contractor staff (scientific, information technology, and administrative) to develop necessary documentation, reports, and internal processes. This approach would also require Government staff to spend a significant amount of time and effort on pre-award activities and program initialization. This would result in an unacceptable delay in fulfilling the agency's needs as a central goal of the NIMH programs for the collection and distribution of central nervous system (CNS) and peripheral nervous system (PNS) biospecimens and antemortem clinical data for research on NeuroHIV as efficiently and safely as possible. Modifying the current contract to increase the contract ceiling is the only effective way to support this goal without duplication of time and effort.
PERIOD OF PERFORMANCE
The contract proposed for modification includes one 12-month base period and four 12-month option periods as follows:
Base Period: August 7, 2023 to August 6, 2024
Option Period One (1): August 7, 2024 to August 6, 2025
Option Period Two (2): August 7, 2025 to August 6, 2026
Option Period Three (2): August 7, 2026 to August 6, 2027
Option Period Four (3): August 7, 2027 to August 6, 2028
CONTRACT TYPE
Cost reimbursement, term (level or effort) type contract with one 12-month base period and four (4) 12-month option periods, and optional quantities in accordance with the contract terms and conditions for 75N95023C00013.
NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE
The proposed action is classified under NAICS code 541715 with a small business size standard of 1,000 employees.
INTENDED SOURCE
The Emmes Company, LLC
401 N Washington Street, Suite 700
Rockville, MD 20850-1785
CLOSING STATEMENT
This notice of intent to increase the maximum value of the existing contract is NOT a request for competitive proposals; however, interested parties may identify their interest and capability to respond to this notice.
A determination by the Government not to compete this proposed work based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The Government will consider any such information solely for the purpose of determining whether to proceed on a non-competitive basis or to conduct a competitive acquisition. The determination whether to proceed with the proposed contract modification is solely within the discretion of the Government.
Responses to this notice must contain sufficient information to establish the interested parties’ bona-fide capability of fulfilling the requirements described herein. The statement must also include the contractor’s Unique Entity ID (UEI), Taxpayer Identification Number (TIN), and its certification of business size. All offerors must have an active registration in the System for Award Management (SAM), which can be accessed at www.sam.gov.
All responses must be received by 9:00 A.M., Eastern Time on Tuesday, July 9, 2024. and reference notice number 75N95024R00099. Responses must be submitted via email to Rieka Plugge, Contracting Officer, at rieka.plugge@nih.gov with a copy to Joe Kennedy, Contract Specialist, at joseph.kennedy@nih.gov. Fax responses will not be accepted.
Google
Office
LinkedIn
Slack