PREVENT Cancer Preclinical Drug Development Program: Preclinical Efficacy and Intermediate Endpoint Biomarkers, Preclinical Services for Biopharmaceutical Product Development and Manufacturing, and Toxicology and Pharmacology Testing

Pre-Solicitation Notice: RFP No. 75N91023R00024 for PREVENT Cancer Preclinical Drug Development Program: Preclinical Efficacy and Intermediate Endpoint Biomarkers, Preclinical Services for Biopharmaceutical Product Development and Manufacturing, and Toxicology and Pharmacology Testing Contracting Office Address Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions (OA), Riverside Five, 8490 Progress Drive, Suite 400, Frederick, MD 21701-4998. Note: This synopsis follows Small Business Sources Sought (SBSS) notice that was released on February 18, 2022 under HHS-NIH-NCI-SBSS-TSB-75N91022R00012-18. This is a notice of proposed contract action. This is NOT a solicitation for proposals, proposal abstracts, capability statements, or quotations. The purpose of this notice is to notify potential offerors that the NIH/ NCI will post a solicitation for PREVENT Cancer Preclinical Drug Development Program: Preclinical Efficacy and Intermediate Endpoint Biomarkers, Preclinical Services for Biopharmaceutical Product Development and Manufacturing, and Toxicology and Pharmacology Testing under the 2022 North American Industry Classification System (NAICS) code 541714, with a Size standard of 1,000 employees. No proposal response is requested at this time and a formal acquisition solicitation/ Request for Proposal (RFP) will be issued in the Winter of 2022/2023. Potential interested parties are expected to review this notice and the Statements of Work (SOWs) to familiarize themselves with the requirement of these projects; failure to do so will be at your firm's own risk. The government intends to issue the RFP to obtain proposals to issue multiple-award Indefinite Delivery Indefinite Quantity (IDIQ) contract vehicles in response to RFP 75N91023R00024. No responses are requested at this time and no additional information will be provided for this synopsis issued in accordance with FAR 5.2. DESCRIPTION : The NCI PREVENT Cancer Preclinical Drug Development Program (PREVENT; http://prevention.cancer.gov/major-programs/prevent-cancer-preclinical) is a peer-reviewed research program managed by the Division of Cancer Prevention (DCP) with its primary mission to advance the preclinical development of cancer-preventive interventions and intermediate biomarkers toward clinical trials. The overall objective of the current acquisition is to provide a structured approach to drug and vaccine development, from discovery to the clinic. To achieve these goals, this acquisition is separated into three (3) separate Indefinite Delivery-Indefinite Quantity (IDIQ) Pools as described below, and as outlined in greater detail in the three (3) IDIQ Statements of Work (SOWs) attached to this SAM notice. The PREVENT program requires services under three (3) separate multiple-award IDIQ pools: 1) Preclinical Efficacy and Intermediate Endpoint Biomarkers, 2) Preclinical Services for Biopharmaceutical Product Development and Manufacturing, and 3) Toxicology and Pharmacology Testing. BACKGROUND STATEMENT The National Cancer Institute (NCI) Division of Cancer Prevention (DCP) is devoted to cancer prevention research with the overarching goal to prevent invasive cancer and associated deaths in human subjects, including the identification of safe and effective agents for the prevention of human cancers and the development of these agents for clinical trials. Toward the accomplishment of that mission, the PREVENT Cancer Preclinical Drug Development Program (PREVENT) was instituted in 2012 to Provide a structured approach to drug and vaccine development, from discovery to the clinic. The acquisition falls within the scope of NCI's Institute-Wide Acquisition Strategy which was approved by the Acquisition Strategy Review Board for NCI on 8/10/2017 and approved for renewal 10/04/2021 and received Board of Scientific Advisors (BSA) approval on 12/8/21. Pool 1: Preclinical Efficacy and Intermediate Endpoint Biomarkers The objective of the PREVENT Cancer Preclinical Drug Development Program: Preclinical Efficacy and Intermediate Endpoint Biomarkers Indefinite Delivery-Indefinite Quantity (IDIQ) contracts will be to continue evaluation of the efficacy of potential chemopreventive and immunopreventive regimens, as well as to identify pharmacodynamic and/or efficacy biomarkers which will enhance the development of these regimens for clinical trials. Resources from these contracts will be used to support development of several candidate cancer preventive agents. This pool encompasses three main technical task areas: (1) Preclinical Evaluation of Cancer Preventive Efficacy; (2) Evaluation and Validation of Intermediate Endpoints for Chemopreventive Agents; and (3) Evaluation and Validation of Intermediate Endpoints for Immunopreventive Agents as described in detail in the attached Statement of Work. The primary endpoint of the efficacy studies shall be to prevent the development of invasive cancers whereas the biomarker studies will identify and validate endpoints, which correlate with or represent the effectiveness of given chemopreventive agents, vaccines, or other immunopreventive agents. Resources from these contracts will be used to support development of several candidate cancer preventive agents. Pool 2: Preclinical Services for Biopharmaceutical Product Development and Manufacturing The - PREVENT Cancer Preclinical Drug Development Program: Preclinical Services for Biopharmaceutical Product Development and Manufacturing (also referred to as PREVENT Current Good Manufacturing Practices or PREVENT CGMP) IDIQ contracts will provide a broad and flexible range of timely, proactive preclinical product development and manufacturing support services for promising biopharmaceutical products and diagnostic reagents to help investigators in various scientific disciplines obtain critical data needed to advance their agents further through the PREVENT pipeline, acquire additional funding from elsewhere, gain prospective partnerships (either for further development or to support Phase I trials), fulfill regulatory requirements, and/or complete studies needed to apply for an Investigational New Drug (IND) and enter a Phase I trial. This pool encompasses four main technical task areas: (1) product development planning and evaluation; (2) analytical assay development and product characterization; (3) process development and related activities; and (4) CGMP manufacture related activities and documentation, as described in detail in the Statement of Work. The key objective of the PREVENT CGMP acquisition is to provide preclinical product development and CGMP manufacturing support for candidate cancer preventive vaccines for preclinical and clinical testing. Pool 3: Toxicology and Pharmacology Testing The objective of the PREVENT Cancer Preclinical Drug Development Program: Toxicology and Pharmacology Testing IDIQ contracts will be to continue evaluation of the pharmacological and toxicological effects of potential cancer preventative agents. Resources from these contracts will be used to support development of several candidate cancer preventive agents. This pool encompasses four main technical task areas: (1) genotoxicity testing; (2) general toxicity in experimental animals; (3) reproductive toxicology studies in rodents and rabbits; (4) specialized studies, as described in detail in the attached Statement of Work. Key objective of the PREVENT Toxicology/ Pharmacology Testing contract is to support the conduct of regulatory toxicological and pharmacological studies with potential cancer preventive agents to enable or advance human clinical trials. Purpose & Objectives: The purpose of this synopsis or notice of proposed contract action is to identify the anticipated release of solicitation for the requirement(s) described herein. The NCI does not intend to award a contract on the basis of responses received in response to this synopsis, nor otherwise pay for the preparation of any information received. This advertisement does not commit the United States Federal Government to award any contract. The NCI may issue a Request for Proposal (RFP) and a single RFP may be used to solicit for all three pools described above. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. Once an RFP is issued, the NCI anticipates that the following number of awards may result from the issuance of the RFP: Pool 1: Preclinical Efficacy and Intermediate Endpoint Biomarkers - estimates up to ten (10) IDIQ awards Pool 2: Preclinical Services for Biopharmaceutical Product Development and Manufacturing - estimates up to five (5) IDIQ awards Pool 3: Toxicology and Pharmacology Testing - estimates up to ten (10) IDIQ awards Anticipated Period of Performance: It is anticipated that any awards that may result from this solicitation will be Indefinite Delivery/Indefinite Quantity (IDIQ) contract(s). Task orders issued under the IDIQ contract(s) are anticipated to be either cost-plus-fixed-fee (CPFF), cost-reimbursement (CR) or Firm Fixed Price (FFP). The duration of the IDIQ contract(s) is anticipated to be for a five (5) year period with two (2) one (1)-year option periods (for a total length of seven (7) years if all option periods are exercised). The anticipated start date is on or about November 2023. The Request for Proposal (RFP) 75N91023R00024 is scheduled for electronic release on or about 01/04/2023 and receipt of proposals will be due at 3:00 pm ET on or about 2/20/2023. The RFP will only be available electronically and must be accessed through the Office of Acquisitions, NCI homepage by using the following address: (https://grants.nih.gov/grants/guide) or through SAM.gov https://www.sam.gov/. All information required for submission of a proposal will be contained in the electronic Request for Proposal (RFP) package. No collect calls will be accepted. No facsimile transmissions will be accepted. It is the offeror's responsibility to monitor the above-mentioned sites for release of the solicitation and any amendments. All responsible sources may submit a proposal, which shall be considered by the agency. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITIATION AND ANY AMENDMENTS THAT MAY BE ISSUED. FAILURE TO DO SO WILL BE AT THE FIRM'S OWN RISK. ALL INQUIRIES SHALL BE SUBMITTED ELECTRONICALLY TO THE CONTRACTING OFFICER LISTED AS THE POINT OF CONTACT HEREIN. NAICS Code and Size Standard: In event an RFP is issued, the 2022 NAICS code for this acquisition is 541714 Research and Development in Biotechnology (except Nanobiotechnology), which has a size standard of 1,000 employees. THIS ACQUISITION IS UNRESTRICTED (NOT A SET-ASIDE FOR SMALL BUSINESSES). Capability Statement/Information Sought: No information from potential offerors is requested in response to this synopsis. 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. 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. Responses to this notice will not be considered adequate responses to a solicitation. Point of contact: Rich Taylor, Contracting Officer at email rich.taylor@nih.gov. No phone calls will be accepted.