NCI OA Special Notice of Subcontract Opportunity at the Frederick National Laboratory for Cancer Research

This Special Notice is not a formal Invitation for Bid (IFB), Request for Proposal (RFP), Request for Quotation (RFQ) nor any type of Solicitation for offers. In accordance with FAR 15.201(d), this Special Notice is intended FOR INFORMATIONAL PURPOSES ONLY in order to publicize the requirements of the Frederick National Laboratory for Cancer Research (FNLCR). The FNLCR is a Government-Owned Contractor-Operated Federally Funded Research and Development Center (FFRDC) located at Fort Detrick, Maryland.

The FNLCR partners with university, Government, and corporate scientists to speed the translation of laboratory research into new diagnostic tests and treatments for cancer and AIDS. FNLCR is a multi-program laboratory currently operated by Leidos Biomedical Research, Inc. (Leidos Biomed) for the National Cancer Institute (NCI) under Prime Contract No. 75N91019D00024 & HHSN261201500003I, which provides Operations and Technical Support (OTS) for the FNLCR.

The Government assumes no liability for reimbursement for any effort or associated costs to respond, nor for any information provided as a result of this Special Notice as no information is being requested. Please be advised that any submissions provided, despite that no information is requested, become Government property and will not be returned, nor will there be any ensuing discussions or debriefings.

Responses submitted to this Special Notice are not offers and cannot be accepted by the U.S. Government to form a binding contract. It is the responsibility of the interested parties to monitor this site and any sites referenced herein for additional information pertaining to business opportunities with the FNLCR, if any.

The NIAID, DMID, rapidly deploys resources to facilitate the evaluation of high priority medical countermeasures critical to the mission of the NIAID and advancement of the NIH and Department of Health & Human Services (DHHS) Global Health Agendas. Fulfillment of this mission requires DMID to have the capacity to expeditiously support collaborative clinical research and conduct clinical trials both domestically and internationally.

In 2021, NIAID and partnering National Institutes of Health (NIH) Institutes and Centers initiated an intensive research program to prioritize and accelerate development of COVID-19 therapeutics. The Antiviral Program for Pandemics (APP) aims to develop safe and effective antivirals to combat SARS-CoV-2, the virus that causes COVID-19, as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential.

DMID is requesting the services of Leidos Biomedical Research, Inc. (Leidos Biomed) to develop a protocol for a Phase 1 study with a novel antiviral, followed by the implementation (management, oversight, execution, and closeout) of the Phase 1 trial, with an option for an additional trial.

The requested Phase 1 studies shall include but not be limited to single-ascending dose (SAD) and multiple-ascending dose (MAD) trials in healthy human volunteers, pharmacokinetic studies in specific populations such as volunteers with hepatic or renal impairment, studies investigating relative bioequivalence of drug preparations or formulations, studies investigating potential for drug-drug interactions, studies to assess risk of cardiac toxicity (“thorough QTc”), or studies to assess mass balance with 14C-labeled drug. Leidos Biomedical Research, Inc. Point of Contact for a copy of Solicitation/RFP No:

S24-003: Eileen Lake at Eileen.Lake@nih.gov Gary Krauss at Gary.Krauss@nih.gov For information concerning other opportunities with the FNLCR, please refer to:

https://frederick.cancer.gov/workwithus/solicitations