Release Date: November 4, 2020
Proposal submission date: on or about December 16, 2020
Estimated award date: on or about July 1, 2020
National Cancer Institute (NCI)
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.
Note: This notice follows a Small Business Sources Sought (SBSS) notice that was released in beta.SAM.gov on April 6, 2020 under HHS-NIH-NCI-SBSS-TSB-00401-55.
NCI expects to release a Request for Proposals (RFP 75N91020R00004) for conducting toxicology studies.
The Toxicology and Pharmacology Branch (TPB) of the Developmental Therapeutics Program (DTP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is the focus for obtaining and evaluating preclinical toxicology and pharmacology data on anti-cancer drugs and biologicals that have been approved for NCI discovery and development. The objective of the “Preclinical Toxicology of Large Molecule Drugs Developed for Cancer and Other Indications” contract will be to conduct toxicology studies that will be used in the preclinical development of large molecule drugs for patients with cancer and other diseases. The use of preclinical models is necessary to determine the potential toxicity of drugs and the reversibility of such toxicities in humans. Preclinical toxicology studies are a regulatory requirement by the Food and Drug Administration for drugs developed for clinical use. The primary goal of the DTP is to develop anti-cancer drugs and advance them to the clinic. Under certain conditions, drugs for other indications, i.e., from other NCI divisions or other NIH institutes, may be evaluated under these contracts. These toxicology studies are an integral part of the information supplied to the FDA for an Investigational New Drug (IND) application. One award is anticipated to result from this solicitation. This acquisition will be to establish a Cost-Reimbursement-Fixed-Fee Term contract as described below, and as outlined in greater detail in the Draft Statement of Work (SOW) available through the pre-solicitation notice posted here: https://beta.sam.gov/opp/1469f0e2b7ba40ac92d87976334eb5e0/view?index=opp&sort=-modifiedDate&page=1&keywords=&date_filter_index=0&inactive_filter_values=false¬ice_type=p&naics=541715.
The qualification criteria establish conditions that must be met at the time of receipt of the Final Proposal Revision by the Contracting Officer in order for a proposal to be considered any further for award. The following Mandatory Qualification Criteria for this RFP is as follows:
GLP Compliance: The laboratory facility must be in compliance with the Food and Drug Administration's (FDA) Good Laboratory Practice Regulations (GLP) as published in CFR Title 21, Part 58, and as updated. Some, but not all, toxicology studies submitted in support of an Investigational New Drug application to the FDA must be GLP-compliant. As such, the contractor must be able to conduct GLP-compliant studies since DTP/NCI anticipates needing several of these studies each year. Documentation shall be in the form the most recent FDA Establishment Inspection Report demonstrating that the facility is currently in compliance with FDA GLP regulations, i.e. not currently disqualified.
Animal Care and Use: The Offeror shall establish and provide resources for an animal care and use program that is managed in compliance with applicable federal, state, and local laws and regulations, such as:
To demonstrate compliance with the above policies and guidance, Offerors shall submit with their Technical Proposal: 1) a copy of your organization’s most recent letter from NIH’s Office of Laboratory Animal Welfare (OLAW) documenting approval of a valid Animal Welfare Assurance,and 2) a copy of your organization’s most recent USDA Animal Welfare Act registration certificate.
This is a recompetition of five (5) IDIQ contracts, including contract numbers: HHSN261201600015I awarded to IIT Research Institute (IITRI); contract number HHSN261201600016I awarded to Battelle; contract number HHSN261201600017I awarded to SRI International; contract number HHSN261201600018I awarded to Southern Research Institute; and contract number HHSN261201600019I awarded to University of Illinois at Chicago, each for a five-year period of performance.
The solicitation is anticipated to result in one Cost-Plus-Fixed-Fee contract. The duration of the contract will be a one-year base period, with six subsequent one-year option periods, for a total period of performance of seven years. Award is anticipated on or about July 1, 2021.
This advertisement does not commit the United States Federal Government to award any contract. The NAICS code for this acquisition is 541715, Research & Development (R&D) in the Physical, Engineering, and Life Sciences, which has a size standard of 1,000 employees. THIS ACQUISTION IS UNRESTRICTED (NOT A SET-ASIDE FOR SMALL BUSINESSES).
Place of Performance:
The place of performance will be the Contractor’s work site.
Set Aside Status:
The Request for Proposal (RFP) 75N91021R00004 is scheduled for electronic release on or about November 16, 2020 and receipt of proposals will be due at 3:00 PM ET on or about December 16, 2020. The RFP will only be available electronically and must be accessed through the Beta SAM website at https://beta.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.
This advertisement does not commit the Government to award a contract.