Notice of Intent to Sole Source - Chemistry Center for Combating Antibiotic-Resistant Bacteria (CC4CARB)

Justification and Approval (J&A)

This document justifies the use of other than full and open competition for the "Chemistry Center for Combating Antibiotic Resistant Bacteria (CC4CARB)" project. The acquisition aims to continue work currently performed under contract 75N93021C00002, focusing on developing new chemical matter for penetrating and killing Gram-negative bacteria, a critical need identified in the Combatting Antibiotic Resistant Bacteria (CARB) National Action Plan.

• Continuation of active chemistry and compound management services.

• Synthesis and delivery of rationally designed compound libraries targeting Gram-negative pathogens.

• Testing of new compounds for in vitro potency.

• Making new compounds available to the public for drug discovery programs.

• Maintaining an integrated outreach function and network of collaborators.

• Proposed contract type: Cost Plus Fixed Fee Level of Effort.

• Estimated new cost: $25,000,000 for the first 5 years and $3,000,000 for the final three years, totaling $28,000,000.

• This is in addition to funds already obligated under the current CC4CARB contract.

• This is a sole-source justification, not a solicitation for proposals.

• The justification cites FAR 6.302-1(b)(1)(i) for unique supplies or services available from only one source.

• Market research included a Sources Sought Notice, which yielded six capability statements, none of which adequately met the SOW requirements.

• The Contracting Officer will review proposed prices with RTI International to ensure they are fair and reasonable.

• The acquisition is being conducted using other than full and open competition due to the unique capabilities of the incumbent contractor, RTI International.

• The incumbent contractor, RTI International, is identified as the sole source due to their established infrastructure, network of collaborators, and the significant costs and delays ($3.6M and 9-12 months) associated with transitioning the program to a new contractor.

Solicitation / RFP / RFQ

This solicitation is for the continuation of the Chemistry Center for Combating Antibiotic-Resistant Bacteria (CC4CARB) program. The objective is to coordinate and conduct the design, synthesis, in vitro testing, and distribution of chemical libraries of discrete small-molecules. These molecules are intended to target Gram-negative bacterial pathogens and other antibiotic-resistant bacteria identified as Antimicrobial Resistance threats.

• Design, synthesis, testing, and distribution of chemical libraries.

• Production of approximately 80 compounds per library design, with flexibility for low or high complexity.

• Development and submission of an Individual Library Production Plan (ILPP) for each library design.

• Submission of various reports, including:

  • Meeting Agenda and Minutes
  • Individual Library Production Plan Report (ILPP-R)
  • Singleton Synthesis Report (SSR)
  • Compound Testing Report (CTR)
  • Monthly Progress Report
  • Annual Progress Report
  • Final Report

• Adherence to NIH policies on reproducibility, public access to research, and dual-use research of concern.

• Compliance with regulations regarding select biological agents or toxins, and highly pathogenic agents.

• Proper handling and reporting of financial conflicts of interest.

• Compliance with Section 508 accessibility standards for electronic and information technology.

• The anticipated period of performance for the base period is February 1, 2027, through January 31, 2028.

• The contract includes option periods extending through January 31, 2035.

• The contract type is a negotiated fixed-price research and development contract.

• Proposals must be submitted electronically via the NIH eCPS website.

• Evaluation will be based on Technical Plan/Approach (50%), Technical Personnel (20%), Project Management (20%), and Facilities, Equipment, Resources (10%).

• Other evaluation factors include Price, Past Performance, and Subcontracting Program Evaluation Criteria.

• Proposals must demonstrate compliance with Section 508 accessibility standards.

• This requirement is not set-aside for small business.

• NAICS Code: 541714

• Small Business Size Standard: 1000 employees.

• The solicitation includes numerous FAR and HHSAR clauses that bidders must review.

• Specific instructions for proposal submission, including format and content, are detailed in Section L.

• The Statement of Work (SOW) is provided as Attachment 3.

Solicitation / RFP / RFQ

This solicitation is for the continuation of the Chemistry Center for Combating Antibiotic-Resistant Bacteria (CC4CARB) program. The objective is to coordinate and conduct the design, synthesis, in vitro testing, and distribution of chemical libraries of discrete small-molecules. These molecules are intended to target Gram-negative bacterial pathogens and other antibiotic-resistant bacteria identified as Antimicrobial Resistance threats.

• Design, synthesis, in vitro testing, and distribution of chemical libraries.

• Production of approximately 80 compounds per library, with flexibility for unanticipated chemistry.

• Development and submission of Individual Library Production Plans (ILPPs) for each library design.

• Submission of ILPP Reports (ILPP-R), Singleton Synthesis Reports (SSR), and Compound Testing Reports (CTR).

• Regular reporting, including Monthly Progress Reports, Annual Progress Reports, and a Final Report.

• Adherence to NIH policies on reproducibility, public access to research, and dual-use research of concern.

• Compliance with regulations regarding select biological agents or toxins, and highly pathogenic agents.

• The anticipated period of performance for the base period is February 1, 2027, through January 31, 2028.

• The contract includes option periods for performance, extending through January 31, 2035.

• Pricing will be based on agreed-upon provisions and excel pricing sheets.

• Proposals must be submitted electronically via the NIH electronic Contract Proposal Submission (eCPS) Website.

• Key deadlines and submission instructions are detailed in Section L.

• Evaluation factors include Technical Plan/Approach (50%), Technical Personnel (20%), Project Management (20%), and Facilities, Equipment, Resources (10%).

• Price, Past Performance, and Subcontracting Program Evaluation Criteria are also considered.

• Evaluation of options will be performed by adding the total price for all options to the total price for the basic requirement.

• This requirement is not set-aside for small business.

• The North American Industry Classification System (NAICS) code is 541714, with a small business size standard of 1000 employees.

• The solicitation includes numerous FAR and HHSAR clauses, covering areas such as contract administration, special contract requirements, and general clauses.

• Attachments include the Statement of Work (SOW), Reporting Requirements, Representations and Certifications, and various other forms and instructions.