NIA Clinical Trails Operations Support Center

Status
Inactive
Published Date
November 16th, 2023
Response Deadline
December 1st, 2023
Notice Type
Special Notice
Solicitation No.
75N95024R00017

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NIDABethesda, MD, 20892, USA

PSC

SUPPORT- MANAGEMENT: OTHER (R799)

Summary

Special Notice HEALTH AND HUMAN SERVICES, DEPARTMENT OF NIA Clinical Trails Operations Support Center The National Institute on Drug Abuse (NIDA), Office of Acquisition, on behalf of the National Institute on Aging (NIA), intends to negotiate and award a modification to the NIA Clinical Trials Operations Support Center. The objective of this modification is to continue the operation of the CTOSC in order to provide support for the management, tracking, and oversight of clinical trials funded by the NIA. The contractor will provide technical and administrative assistance to investigators in the areas of quality assurance and safety. The contractor will also provide scientific resources and services necessary to support a broad range of activities required to effectively manage the NIA clinical trials. The period of performance for the contract ends on January 1, 2024, and this modification would extend the period of performance by three months with four one-month options, potentially through August 1, 2024. The intended procurement is classified under NAICS code 541990 – All other Professional, Scientific and Technical Services with a Size Standard of $17.0 million. This acquisition is conducted as non-competitive under the authority of 41 U.S.C. 3304(a) 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. The contractor shall provide all necessary services, qualified personnel, material, equipment, and facilities to serve as a Clinical Trials Operations Support Center. The contractor shall provide support in project management, clinical trials operations, quality assurance, safety-related operations, statistical and methodological consultation, training of NIA staff, maintenance of the NIA database, and transition plan and contract closeout. The contract type is Cost-Plus-Fixed-Fee. This modification is necessary to ensure continuing operations support for NIA-funded clinical trials while the NIA completes a new acquisition that will include the tasks of this contract along with other requirements. Interested parties may identify their interest and capability to respond to this notice. All responses must be received by Friday, December 1, 2023, at 11:00 AM Eastern Time and must reference number 75N95024R00017.

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 Institute on Drug Abuse (NIDA), Office of Acquisition, on behalf of the National Institute on Aging (NIA) intends to negotiate and award a modification to the NIA Clinical Trials Operations Support Center (HHSN271201800001C). The period of performance for the contract ends on January 1, 2024. This modification would extend the period of performance by three-months with four one-month options, potentially through August 1, 2024. There are no other changes to the contract. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541990 – All other Professional, Scientific and Technical Services with a Size Standard of $17.0 million. REGULATORY AUTHORITY The resultant modification will include all applicable provisions and clauses of the Federal Acquisition Requlation (FAR) in effect through the current Federal Acquisition Circular (FAC). STATUTORY AUTHORITY This acquisition is conducted as non-competitive under the authority of 41 U.S.C. 3304(a) 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 Project Description Project Title: NIA Clinical Trials Operations Support Center (CTOSC) General Requirements The objectives of this modification are to continue operation of the CTOSC in order to provide support for the management, tracking, and oversight of clinical trials funded by the NIA. This clinical trial support includes providing technical and administrative assistance to investigators in the areas of quality assurance and safety. The Contractor shall provide clinical trial support in the interpretation and implementation of quality assurance guidelines for specific clinical studies; maintain the NIA Clinical Research Study Investigator's Toolbox, a web based informational resource for researchers ensuring data quality and integrity; train clinical trial Principal Investigators (Pls) and staff on how to perform an internal audit or other study monitoring activities; maintain the NIA Safety Training Course; review awardees’ clinical trial materials and reports to ensure participant safety, and alert the NIA program staff about emerging safety concerns with studies, as well as recommend possible corrective actions to eliminate or decrease risks to study participants. The Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, in order to serve as a Clinical Trials Operations Support Center. The Contractor shall provide scientific resources and services necessary to support a broad range of activities required to effectively manage the NIA clinical trials, requiring advanced expertise in the design, conduct, and oversight of clinical trials. Seven distinct performance areas have been identified as follows: Work Area l - Project Management Work Area 2 - Clinical Trials Operations Support and Quality Assurance Work Area 3 - Safety-related Operations Support Work Area 4 - Statistical and Methodological Consultation Work Area 5 - Training of NIA Staff in Clinical Trials Procedures Work Area 6 - Maintenance of the NIA Database on Human Intervention Studies Work Area 7 - Transition Plan and Contract Closeout Period of Performance The current period of performance for contract HHSN271201800001C is: Base Year: January 2, 2018 – January 1, 2019 Option Year 1: January 2, 2019 – January 1, 2020 Option Year 2: January 2, 2020 – January 1, 2021 Option Year 3: January 2, 2021 – January 1, 2022 Option Year 4: January 2, 2022 – January 1, 2023 Option Year 5: January 2, 2023 – January 1, 2024 This proposed modification will add a three-month extension and four one-month options, with a potential period of performance of January 2, 2024 – August 1, 2024. Contract Type Cost-Plus-Fixed-Fee REASON FOR THE NON-COMPETITIVE ACTION This modification will ensure continuing operations support for NIA-funded clinical trials while the NIA completes a new acquisition that will include the tasks of this contract along with other requirements (Clinical Research Support Services, 75N95023R00013). Uninterrupted continuing operations support for NIA-funded clinial trials is vital to NIA fulfilling its mission to support and conduct genetic, biological, clinical, behavioral, social, and economic research on aging; foster the development of research and clinician scientists in aging; provide research resources; and disseminate information about aging and advances in research to the public, health care professionals, and the scientific community, among a variety of audiences. If contract HHSN271201800001C is not extended, there will be a gap in support. This could affect the implementation of NIA-funded clinical trials to a degree that would significantly impede NIA’s mission. Therefore, it is imperative that NIA extend the current contract for three-months and four one-month options, in order to ensure uninterrupted support to the NIA mission. CLOSING STATEMENT This notice of intent is not a request for competitive proposals.  However, interested parties may identify their interest and capability to respond to this notice.  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 (UEID), 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. 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. The information received will normally be considered solely for the purposes ofdetermining whether to proceed on a non-competitive basis or to conduct a competitiveprocurement for this requirement. The determination whether to proceed with the proposed contract modification is solely within the discretion of the Government. All responses must be received by Friday, December 1, 2023 at 11:00 AM Eastern Time and must reference number 75N95024R00017.  Responses must be submitted electronically to Hashim Dasti, Contract Specialist, at Hashim.Dasti@nih.gov and Karen Mahon, Contracting Officer, at Karen.Mahon@nih.gov, and must reference the solicitation number 75N95024R00017, on your response.  FAX requests are not accepted. All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.

Contact Information

PrimaryHashim Dasti
hashim.dasti@nih.gov
SecondaryKaren Mahon
Karen.Mahon@nih.gov

Opportunity Lifecycle

Title
Type
Special Notice

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