NIA Clinical Trails Operations Support Center

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 August 1, 2024. This modification would extend the period of performance by three-months, through November 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 Regulation (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 during the transition period 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 NIA staff and investigators in all areas of the SOW, as required. The Contractor shall provide all services under the SOW as requested by the NIA, and continue to do so until the services are completely and satisfactorily  transitioned over to the successor contract, as appropriate.

The Contractor shall continue to 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 the NIA’s clinical trials enterprise.

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
Option Period 6: January 2, 2024 – April 1, 2024
Option Period 7: April 2, 2024 – May 1, 2024
Option Period 8: May 2, 2024 – June 1, 2024
Option Period 9: June 2, 2024 – July 1, 2024
Option Period 10: July 2, 2024 – August 1, 2024     

This proposed modification will add a three-month extension, with a period of performance of August 2, 2024 – November 1, 2024.

Contract Type
Cost-Plus-Fixed-Fee

REASON FOR THE NON-COMPETITIVE ACTION
This modification will ensure there is enough time for a smooth transition to the next contract. Uninterrupted continuing operations support for NIA-funded clinical 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 may not be sufficient time for a complete transition. 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, in order to ensure the NIA mission can be met effectively.

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 of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement 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 Thursday, July 18, 2024 at 10:00 AM Eastern Time and must reference number 75N95024R00105. 

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 75N95024R00105, 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.