Chemistry Center for Combating Antibiotic-Resistant Bacteria (CC4CARB)

Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The Centers for Disease Control and Prevention (CDC) has developed a list of organisms considered Antimicrobial Resistance (AR) threats. Many of the organisms are multidrug-resistant Gram-negative bacteria. The NIAID, Division of Microbiology and Infectious Diseases (DMID) has identified a significant lack of suitable chemical libraries accessible for screening as a major scientific bottleneck for the discovery and development of novel antimicrobial drugs due to multidrug-resistant (MDR) Gram-negative bacteria. There is a scarcity of novel chemical classes or natural compounds with properties appropriate for Gram-negative cell penetration and efflux avoidance. The NIAID, Division of Microbiology and Infectious Diseases (DMID) has a requirement to support a Chemistry Center for Combating Antibiotic-Resistant Bacteria (CC4CARB) for the design, synthesize and distribution of novel compound libraries to the scientific community for use in antibacterial drug discovery programs, particularly those targeting Gram-negative bacteria. The center will fit within the broader aims as stated in the National Action Plan for Combating Antibiotic Resistant Bacteria by synthesizing and delivering new compounds for antibacterial drug discovery, as well as chemical probes for establishing a better understanding of structure-activity relationships (SAR) for optimal activity against Gram-negative bacterial pathogens. Critical to the successful center will be strong capability for high-quality antibacterial medicinal chemistry design, timely synthesis of a diverse range of novel chemotypes, and in vitro screening for antibacterial activity, supported by a well-organized process for review and approval of design proposals from external scientists and a seamless mechanism for managing the storage and distribution of the resulting compound libraries to the scientific community. Purpose and Objectives The purpose of this contract is to continue the Chemistry Center for Combating Antibiotic-Resistant Bacteria (CC4CARB) responsible for coordinating and conducting the design, synthesis, in vitro testing, and distribution of chemical libraries of discrete natural products and small-molecules with diverse physicochemical properties, specifically designed to target Gram-negative bacterial pathogens and other antibiotic-resistant bacteria identified as Antimicrobial Resistance threats. Project requirements The CC4CARB will consist of requirements in four (4) key areas: 1) Library Design, 2) Compound Synthesis, 3) Compound Testing, and 4) Compound Management, and includes Project Management of all efforts across these requirements. CC4CARB's Library Design Requirement involves community outreach and engagement with the global antibacterial research community to solicit design ideas for new compound libraries and chemical series. The ideas are to be expanded, through collaboration between CC4CARB and the proposer, into libraries of novel compounds possessing attributes favorable for antibacterial activity, cell penetration, efflux avoidance, or other beneficial properties toward antibacterial activity. Ideas will be reviewed by a Scientific Advisory Board (SAB) and approved for synthesis by the COR. CC4CARB's Compound Synthesis Requirement involves synthesizing the libraries that are identified by the Library Design effort. This may include various methods of acquiring compounds including purchase and donation, in addition to traditional synthesis. The libraries resulting from the center's Compound Synthesis effort will be housed in the center's Compound Management unit. The Government anticipates producing 1,500 to 2,000 rationally designed and structurally diverse compounds per year over the 5-year chemical synthesis phase of the contract. CC4CARB's Compound Testing Requirement involves generating Minimum Inhibitory Concentration (MIC) and potentially other in vitro data on each compound included in the CC4CARB collection in an assay panel that is consistent across all compounds tested, allowing cross-comparison of all compounds in the collection. The Compound Testing effort should be coordinated with Library Design and Compound Synthesis to enable iterative design improvements in follow-on libraries. CC4CARB's Compound Management Requirement involves maintaining the synthesized libraries in appropriate storage conditions and managing the distribution of compounds to members of the external scientific community, including public disclosure of compound structures, associated data, synthetic routes, and handling specifications in a free, searchable database. Critical to success of this effort will be assignment of a single Principal Investigator (PI), ideally skilled in synthetic chemistry and medicinal chemistry, who will be accountable for coordinating all contract activities, along with comprehensive project management support, and for communicating progress and recommending approval decisions to the NIAID Contracting Officer's Representative (COR). Anticipated period of performance It is anticipated that one (1) cost-reimbursement, level-of-effort type contract will be awarded with a one-year base period beginning on or around Fiscal Year (FY) 2026. The award is anticipated to include four (4) one-year term option periods. In addition, there will be three (3) one (1) year term options for compound management and distribution support that may only be exercised after Term Options A1-A4 have been exhausted. There are four (4) quantity options per performance year that may be exercised at any time within their respective performance years for the first five (5) years of contract performance. The total period of performance, if all term and quantity options are exercised, shall be on or around FY 2026. The Government's level-of-effort requirement is estimated at 28,000 direct labor hours for the base year and each term option (A1-A4). The Government's level-of-effort requirement for each quantity option is estimated at 2,000 direct labor hours. The Government's level-of-effort requirement is estimated at 4,000 direct labor hours for each term option A5-A7. Other important considerations The Government anticipates producing 10,000 rationally designed and structurally diverse compounds over the period of the contract. Capability statement / information sought Capability Statements should clearly convey information regarding the respondent's capabilities including: (1) staff expertise, including their availability, experience, and formal and other training; (2) current in-house capability and capacity to perform the work; (3) prior completed projects of similar nature; and (4) institutional/corporate experience and management capability. Interested respondents must submit a capability statement describing their company's experience and ability to perform this effort that includes the following: A summary list of similar work previously performed; The professional qualifications and specific experience of staff who may be assigned to the requirement; Resumes for proposed key personnel, including the Principal Investigator, that reflect education, and previous work relevant to the proposed requirement; Documented adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity; Documented adequacy and appropriateness of proposed organization and staffing to ensure efficient planning, initiation, implementation, conduct, and completion of all activities, including plans for communication and sharing of research resources; Demonstrated ability to carry out the work; Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 5 pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. Required Business Information: Unique Entity ID. Company Name. Company Address. Company Point of Contact, Phone and Email address Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought. Do you have a Government approved accounting system? If so, please identify the agency that approved the system. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://www.sam.gov/index.html/#1. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern's name and address). Number of Copies: Please submit one (1) electric copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Aytaj Vily, Contracting Officer, at aytaj.vily@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify HHS-NIH-NIAID-SBSS-DMID-NIHAI75N93024R00022. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 5:00pm EST on 07/05/2024. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).