PREVENT Cancer Preclinical Drug Development Program

Pre-Solicitation Notice of Intent to Sole SourcePREVENT Cancer Preclinical Drug Development Program:This is a sole source synopsis for the Indefinite Delivery Indefinite Quantity (IDIQ) contracts within the PREVENT Cancer Preclinical Drug Development Program, herein referred to as the PREVENT 2019 IDIQ Contracts. The current IDIQ consists of three pools, Preclinical Efficacy and Intermediate Endpoint Biomarker Pool (herein referred to as the Efficacy Pool), Toxicology and Pharmacology Testing Pool (herein referred to as the Tox/Pharm Pool), and Biopharmaceutical Product Development and Manufacturing Pool (herein referred to as the CGMP Pool). This announcement constitutes a synopsis for this requirement, is issued for notification purposes only and is not a request for competitive proposals.The National Cancer Institute (NCI) plans to issue modifications to increase the shared programmatic ceilings on each of the PREVENT 2019 IDIQ Contracts to continue to advance the preclinical

development of cancer-preventative interventions and intermediate biomarkers and to support/enable their clinical translation. This continued Efficacy work is accomplished by conducting preclinical animal studies for cancer preventive efficacy evaluation, employing detailed pharmacological and/or immunological studies, determining pharmacodynamic (PD) and/or immunodynamic (ID) effects of test agents, and correlating pharmacokinetic and/or immunologic biomarker profile(s) with the effectiveness of test agents. This continued Tox/Pharm work is accomplished through studies in genotoxicity testing, general toxicology in experimental animals, reproductive toxicology studies in rodents and rabbits and other  specialized studies. This continued cGMP work is accomplished through product development planning and evaluation, analytical assay development and product characterization, process development and related activities and cGMP manufacture, related activities and documentation. The modifications for this requirement are anticipated to take place on or about December 30, 2022.The fourteen contractors that are currently part of the PREVENT 2019 IDIQ Contracts are as follows:Efficacy Pool:IIT Research Institute, 75N91019D00012, 10 West 35th Street, Chicago, IL 60616 SRI International, 75N91019D00014, 333 Ravenswood Avenue, Menlo Park, CA 94025 Toxicology Research Laboratory, University of Illinois at Chicago, 75N91019D00016, 1901 South First Street, Suite A, Champaign, IL 61820University of Alabama at Birmingham, 75N91019D00019, 1720 2nd Avenue South, 801 Financial Services Building, Box 16, Birmingham, AL 35233University of Oklahoma Health Sciences Center, 75N91019D00020, PO Box 26901, URP865, Suite 490, Oklahoma City, OK 73126University of Texas MD Anderson Cancer Center, 75N91019D00021, 1515 Holcombe Boulevard, Box 1676, Houston, TX 77030 The Research Institute of Fox Chase Cancer Center, 75N91019D00022, 333 Cottman Avenue, Philadelphia, PA 19111 Tox/Pharm Pool:IIT Research Institute, 75N91019D00013, 10 West 35th Street, Chicago, IL 60616 SRI International, 75N91019D00015, 333 Ravenswood Avenue, Menlo Park, CA 94025 Toxicology Research Laboratory, University of Illinois at Chicago, 75N91019D00017, 1901 South First Street, Suite A, Champaign, IL 61820Southern Research Institute, 75N91019D00018, P.O. Box 55305, Birmingham, AL 35255 CGMP Pool:Advanced Biocience Laboratories, 75N91019D00025, 9800 Medical Center Drive, Building D, Rockville, MD 20850 International Aids Vaccine Initiative, 75N91019D00026, 125 Broad Street, 9th Floor, New York, NY 10004 Kindred Biosciences, 75N91019D00027, 1555 Bayshore Highway, Suite 200, Burlingame, CA 94010The modifications will increase the maximum shared ceiling value across all PREVENT IDIQ contracts issued from $49,995,000 by $25 million to $74,995,000. In order to ensure operation and continuity of essential research and development services during the next three cycles of the PREVENT Program, NCI needs to increase the ceiling, which will allow for the funding of complex task orders to include highly complex genetically engineered mouse models, among other studies, to advance through the program pipeline as a result of the adoption of more advanced, cutting-edge tools and technologies. The NCI intends to issue these modifications on a non-competitive basis to each of the fourteen contractors that are part of the PREVENT 2019 IDIQ Contracts. This decision is based on current market research and is in accordance with 10 U.S.C 2304(c)(1), as implemented by FAR 6.302-1(a)(2), "Only one responsible source and no other supplies or services will satisfy agency requirements."This notice is not a request for competitive proposals; however, if any interested and responsible source, especially small businesses, believes it can meet the requirements as outlined in the attached Statements of Work (SOWs), submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Interested organizations may submit their capabilities and qualifications to perform the effort in writing to the identified point of contact not later than 4:00 p.m., Eastern Standard Time, on October 28, 2022. Such capabilities/qualifications will be evaluated solely for the purpose of determining whether or not to conduct this procurement on a competitive basis. 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. Oral and facsimile communications shall not be accepted in response to this notice.In accordance with FAR 16.505(b)(8), the following individual has been designated as the NIH Ombudsman for these task order contracts:Sheryl K. Brining, Ph.D.Director, Office of Research Information Systems (ORIS)NIH Competition Advocate6705 Rockledge Dr.Bethesda, MD 20892Phone: (301) 451-1763Email: sheryl.brining@nih.govDISCLAIMER: THIS NOTICE IS FOR INFORMATIONAL AND PLANNING PURPOSES ONLY. THIS IS NOT A REQUEST FOR QUOTE AND IS NOT A COMMITMENT BY THE US GOVERNMENT TO PROCURE SUBJECT PRODUCTS. NO SOLICITATION SHALL RESULT FROM THIS NOTICE. NO FUNDS ARE AVAILABLE TO ACCOUNT FOR PREPARATION OF RESPONSES TO THIS NOTIFICATION. THE GOVERNMENT WILL USE THE INFORMATION RECEIVED TO DETERMINE WHETHER OTHER SOURCES ARE AVAILABLE THAT ARE CAPABLE TO SATISFY THIS REQUIREMENT.