PK - PreSol Notice Final.pdf

Pre-Solicitation Notice: RFP No. 75N91021R00007 Preclinical Pharmacokinetic and Pharmacology Evaluations of Agents Being Developed for Cancer Patients

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 March 23, 2020 under HHS-NIH-NCI-SBSS-TSB-30520-94.

Description

The central mission of the NCI Experimental Therapeutics (NExT) Program is the discovery and development of agents with clinical anticancer activity. Pharmacokinetic and metabolism evaluations are an integral part of the drug development process from discovery to clinical trials.

Characterization of the pharmacokinetics of new compounds provides critical information for the selection of optimal drug development candidates and design and interpretation of preclinical efficacy evaluations. NExT represents a significant expansion and reinvigoration of NCI drug discovery and developmental efforts. This acquisition will be to establish an Indefinite Delivery- Indefinite Quantity (IDIQ) pool as described below, for services outlined in greater detail in the Draft Statement of Work (SOW) attached to this notice.

NCI is seeking services for implementation of bioanalytical methods and conduct of pharmacokinetic evaluations in animals with compounds of interest to the NCI Experimental Therapeutics (NExT) program. Analysis of samples provided by the NCI from other sources, including human clinical trials, may be requested. Please reference the attached, draft SOW for specifics. The purpose of this acquisition is to obtain analytical, pharmacokinetic, metabolism, pharmacodynamic, and other pharmacologic data on new agents (including small molecules, peptides, oligonucleotides, and other biologicals) for the treatment of cancer. Awardees will implement and validate appropriate established analytical methodologies to quantify compounds in biological fluids and tissues from multiple species and rapid pharmacokinetic assessments to the NCI. Data generated will be used in all phases of the drug development process, from lead selection and development to the support of early clinical trials. For those agents that are selected for clinical trial, the reports generated under these contracts will comprise a portion of the Investigational New Drug (IND) submission to the Food and Drug Administration (FDA).

This is a recompetition of five (5) IDIQ contracts, including contract number HHSN261201600020I awarded to SRI International; contract number HHSN261201600021I awarded to Southern Research Institute; contract number HHSN261201600022I awarded to The University of Pittsburgh; contract number HHSN261201600023I awarded to IIT Research Institute (IITRI); and contract number HHSN261201600024I awarded to Mayo Clinic, each for a five-year period of performance.

The qualification criterion establishes conditions that must be met at the time of receipt of Technical Proposals 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:

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:

• Animal Welfare Regulations (9 CFR, 1985/1989) https://www.nal.usda.gov/awic/final-rules-animal-welfare-9-cfr-parts-1-2-and-3

• Guide for the Care and Use of Laboratory Animals 8th ed., National Research Council, http://www.ncbi.nlm.nih.gov/books/NBK54050/

• Public Health Service Policy on Humane Care and Use of Laboratory Animals, revised 2015.

https://grants.nih.gov/grants/olaw/references/phspol.htm.

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.

Each base IDIQ contract is anticipated to have a period of performance and ordering period of approximately seven years. Awards are anticipated on or about June 21, 2021 to Offerors capable of performing all aspects of the work described in the Draft SOW attached to this notice. Task orders placed within the ordering period of the resultant base IDIQ contracts may extend up to five years beyond the end date of the base IDIQ contracts’ period of performance/ordering period. We anticipate task orders issued against the IDIQ contracts will be cost reimbursement type and/or firm fixed price. While the base IDIQ contracts will not have options, options may be included at the individual task order level.

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).

The Request for Proposal (RFP) 75N91021R00007 is scheduled for electronic release on or about November 13, 2020 and receipt of proposals will be due at 4:00 PM ET on or about December 14, 2020. The RFP will only be available electronically and must be accessed through the SAM.beta 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.

https://www.nal.usda.gov/awic/final-rules-animal-welfare-9-cfr-parts-1-2-and-3 http://www.ncbi.nlm.nih.gov/books/NBK54050/ https://grants.nih.gov/grants/olaw/references/phspol.htm https://beta.sam.gov/

Primary Point of contact: Alexis Hudak, Contracting Officer via email at alexis.hudak@nih.gov Secondary Point of contact: Carrie Mills, Contracting Officer via email at carrie.mills@nih.gov mailto:alexis.hudak@nih.gov mailto:carrie.mills@nih.gov