Notice_of_Intent_SS_HHSN273201600002I - Clinical Research Suppt Svcs.pdf

Title: Notice of Intent to Sole Source – Extension of Ordering Period for IDIQ Contract HHSN273201600002I, Social & Scientific Systems, Inc. (SSS), DLH, LLC.

Reference Number: HHSN273201600002I

Description

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT MODIFICATION

WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION. THIS IS NOT A SOLICITATION

OR A REQUEST FOR COMPETITIVE PROPOSALS.

The purpose of this announcement is for the Clinical Research Support Services for NIEHS, within the National Institute of Environmental Health Services (NIEHS), National Institutes of Health, to issue a modification to the existing Indefinite Delivery, Indefinite Quantity (IDIQ) contract number HHSN273201600002I on a sole source basis, under the authority of 41 U.S.C. §3304(a)(1) as implemented by FAR 6.302-1: Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements and FAR 6.301-1(a)(2)(ii) to extend the ordering period of the existing IDIQ contract with Social & Scientific Systems, Inc. (SSS), DLH, LLC (shall be used throughout this document)), entitled “Clinical Research Support Services for NIEHS.”

The objective of this modification is to extend the ordering period to ensure continuity of mission-critical research while the NIH procurement team continues acquisition planning for the re-competition of these services. Due to the contractor’s extensive institutional knowledge, specialized expertise, and demonstrated ability to perform the required work, the Government has determined that award to this contractor is necessary to meet mission requirements without unacceptable delays or duplication of effort.

The proposed twenty-four (24) month extension of the ordering period is necessary to prevent a lapse in continuity of critical services essential to the NIEHS Clinical Research Support Services IDIQ contract, which supports the NIEHS Clinical Research Program (CRP) within the Division of Intramural Research (DIR). The CRP conducts and oversees clinical research studies, including interventional clinical trials, at the NIEHS Clinical Research Unit and other medical facilities. The program translates basic laboratory findings into clinical applications; investigates the interaction between genetic susceptibility and environmental exposures as they relate to complex traits and diseases in human populations; develops preventive, therapeutic, and other intervention strategies;

and conducts research on the health effects of natural and man-made disasters, including the collection of time-critical exposure and health data to address emerging public health concerns. Continuity of these services is essential to ensure uninterrupted support of ongoing clinical studies, coordination of study activities, regulatory compliance, subject enrollment and management, data collection and management, and associated research activities essential to the NIEHS mission.

This action is necessary to ensure the continued success of the Clinical Research Support Services IDIQ contract so that the incumbent contractor, DLH, can continue providing the specialized clinical research support capabilities, infrastructure, and expertise required to meet the needs of the Division of Intramural Research (DIR), NIEHS. DLH, LLC provides comprehensive support for the NIEHS Clinical Research Program (CRP), including clinical, scientific, technical, regulatory, data management, and programmatic support services necessary to conduct and oversee clinical research studies and interventional clinical trials at the NIEHS Clinical Research Unit and other medical facilities. These services support the translation of laboratory discoveries into clinical applications; the investigation of interactions between genetic susceptibility and environmental exposures in human disease; the development and implementation of preventive and therapeutic interventions;

and research addressing the health effects of natural and man-made disasters.

Based on DLH’s existing experience, operational infrastructure, and institutional knowledge of the NIEHS Clinical Research Program, the contractor can mobilize quickly to support new and ongoing Task Orders without disruption. As DLH currently manages all active Task Orders under this IDIQ, transitioning these services to another contractor at this time would result in substantial duplication of costs and unacceptable delays in the performance of critical clinical research activities. DLH provides specialized clinical, scientific, technical, regulatory, and operational support necessary to conduct and oversee clinical research studies and interventional clinical trials at the NIEHS Clinical Research Unit and other collaborating medical facilities. Continuity of contractor support is essential to ensure uninterrupted operations, regulatory compliance, subject safety, and the successful execution of ongoing clinical studies.

The ordering period will be extended by twenty-four (24) months, from May 23, 2026 to May 23, 2028. This extension is required to complete critical activities in support of the NIEHS Clinical Research Program (CRP) within the Division of Intramural Research (DIR) and to ensure continuity of clinical research support services without disruption while the NIEHS procurement team continues to pursue the re-competition of these services under a new full and open cost-reimbursement contract.

DLH’s responsibilities include, but are not limited to, the following activities:

• Study Planning and Support o Provide administrative, scientific, clinical, and technical expertise to support observational clinical research studies and interventional clinical trials o Assist in protocol development, study design, feasibility assessments, and operational planning o Prepare manuals of operations, training materials, and study documentation

• Study Initiation and Regulatory Support o Coordinate communications and meetings among investigators, collaborators, advisory committees, and oversight bodies o Support regulatory submissions, IRB documentation, informed consent development, and compliance with applicable Federal regulations o Maintain required reporting and documentation in accordance with NIH and HHS requirements

• Subject Identification, Recruitment, and Retention o Develop and implement recruitment strategies o Identify, screen, enroll, and track study participants o Maintain participant tracking systems and promote retention to minimize loss to follow-up

• Clinical Trial Operations and Data Collection o Support the implementation and conduct of interventional clinical trials o Coordinate clinical procedures, intervention administration, and participant follow-up o Collect, manage, and monitor clinical and research data in compliance with regulatory and quality standards

• Specimen Collection, Processing, and Laboratory Support o Collect, process, store, and ship biological and environmental specimens o Maintain chain-of-custody documentation and laboratory quality control procedures

• • Data Management, Statistical Analysis, and Reporting o Develop and maintain study databases and tracking systems o Perform data preparation, validation, quality assurance/quality control

(QA/QC), and statistical analyses o Prepare progress reports, technical reports, and other required deliverables

Transitioning these services to a new contractor would result in significant disruption to ongoing clinical research studies and interventional trials supported under this IDIQ. DLH currently executes the operational, regulatory, clinical, and data management infrastructure for active Task Orders and provides direct support to Principal Investigators within the Division of Intramural Research (DIR). A transition would interrupt subject enrollment and retention activities, delay clinical interventions and follow-up procedures, disrupt specimen management and laboratory coordination, and impact regulatory compliance and data integrity. Such delays would pose unacceptable risk to ongoing clinical research activities and could adversely affect participant safety and the integrity of study outcomes. The loss of institutional knowledge and established operational systems would result in substantial duplication of costs to the Government and unacceptable delays in the execution of critical clinical research activities supporting the NIEHS mission.

There will not be a solicitation or Request for Proposals (RFP) issued as a result of this announcement. Any responses to this notice must demonstrate clear and convincing evidence that competition would be advantageous to the Government. All information received will be used for planning and market research purposes only.

The statutory authority for this sole source action is 41 U.S.C. § 3304(a)(1), as implemented by FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. The award is subject to approval of the Justification and Approval (J&A) for Other Than Full and Open Competition.

Once the Justification and Approval (J&A) is approved, this action will modify the IDIQ contract to extend the ordering period. Notwithstanding the Government’s stated intent, if any responsible source believes it can fully meet the Government’s requirement, it must submit a written capability statement. The capability statement must contain sufficient documentation to establish a bona fide capability to fulfill the requirement and must be received by the response date indicated in this notice. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.

NIEHS will not be responsible for any costs incurred by interested parties in responding to this notice. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the evaluation results. This notice is not a Request for Proposals and does not commit the Government to award a contract.

Interested parties may submit capability statements via email to Sarah Bank, Contracting Officer, at sarah.bank@nih.gov and Lisa Schaupp, Contracting Officer, at lisa.schaupp@nih.gov, no later than 4:00 p.m. Eastern Daylight Time (EDT), March 19, 2026. Emails must reference the announcement number in the subject line. This is not an RFP, and this announcement does not commit the Government to award a contract. The reference number to be used is HHSN273201600002I.

mailto:sarah.bank@nih.gov mailto:lisa.schaupp@nih.gov