Access to the Florence electronic Trial Master File (eTMF) Platform- 12 Months Annual Subscription

NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION

Title: Access to the Florence electronic Trial Master File (TMF) Platform

 (i)        This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

(ii)        The solicitation number is 75N95025Q00050 and the solicitation is issued as a request for quotation (RFQ).

This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures;  and FAR Part 12—Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold.

THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION 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 (OA), on behalf of the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Florence Healthcare  for Florence electronic Trial Master File (eTMF) Platform.

This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1).
 

The rationale for the brand-name justification is the Florence Healthcare eTMF software is necessary for secure data storage for the Rare Disease Clinical Research Network (RDCRN) program. After extensive evaluation of many tools, this is the only one that will meet the technical requirements of the data management coordinating center. This software is currently being used across the RDCRN. This platform has been adopted by the rest of the RDCRN so we cannot provide the Data Management Coordinating Center (DMCC) with a different environment as it would duplicate efforts. Additionally, we need continuity of what is currently being used as the eTMF platform.
 

(iii)       The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2025-01, with effective date 11/12/2024.

(iv)       The associated NAICS code is 513210 and the small business size standard is $47M.   This requirement is non-competitive and no set-aside restrictions are applicable.

(v)        This requirement is for the following services:

Florence electronic Trial Master File (eTMF) Platform-12 Months Annual Subscription

As further described in Attachment 1-Statement of Work

(vi)       The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated Period of Performance (PoP) is twelve (12) months. The estimated PoP is 01/01/2025 – 12/31/2025

(vii)      The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses:  https://www.acquisition.gov/browse/index/far   https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html   
 

(End of provision)

The following provisions apply to this acquisition and are incorporated by reference:

• FAR 52.204-7, System for Award Management (Oct 2018)
• FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020)
• FAR 52.204-29, Federal Acquisition Supply Chain Security Act Orders – Representation and Disclosures (Dec 2023)
• FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (Sep 2023)
• FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (May 2024)
• HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015)

The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:

https://www.acquisition.gov/browse/index/far     https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html  

(End of clause)

The following clauses apply to this acquisition and are incorporated by reference:

• FAR 52.204-13, System for Award Management Maintenance (Oct 2018)
• FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020)
• FAR 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services (Nov 2023). Addendum to this FAR clause applies to this acquisition and is attached.
• HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015)
• HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015)

The following provisions and clauses apply to this acquisition and are attached in full text.  Offerors MUST complete the provisions FAR 52.204-24, and FAR 52.204-26 below and submit completed copies as separate documents with their proposal.

• FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)
• FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020)
• FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Products and Commercial Services (Nov 2024)
• NIH Invoice and Payment Provisions

(viii)     The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes:

a. Technical capability of the item offered to meet the Government requirement;

b. Price; and

c. Past performance [see FAR 13.106-2(b)(3).

 

(ix)       Offerors must include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Feb 2024), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer.

(x)        The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices.

            Attachment 6 - IT Clauses

(xi)       The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

(xii)      Responses to this RFQ must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. Responses may exceed capability or performance characteristics of the solicitation's requirements. The Government reserves the right, but is not required, to award to a response that exceeds capability or performance characteristics of the solicitation's requirements if it provides a benefit to the Government.

The Unique Entity ID from SAM.gov, the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All quotations must be received by 01:00 p.m., Eastern Time,on December 24, 2024, and reference Solicitation Number 75N95025Q00050. Responses must be submitted electronically to Samson Shifaraw, Contracting Officer, at samson.shifaraw@nih.gov.

Fax responses will not be accepted.

(xiii)     Attachments:

The following are attached in full text:

1. Statement of Work
2. FAR 52.204-24
3. FAR 52.204-26
4. FAR 52.212-4
5. FAR 52.212-5
6. IT Clauses
7. Invoice Instructions