NIMH Toxicological Evaluation of Novel Ligands Program

The purpose of this notice is to attach the solicitation document.

The purpose of this modification is to update the anticipated availability of this solicitation:

From:  on or about November 7, 2013 
To:      on or about December 23, 2013.

The National Institute of Mental Health (NIMH), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) intends to issue Request for Proposal (RFP) No. HHS-NIH-NIDA (MH)-14-272 to re-compete a requirement currently being performed under NIMH Contract
HHSN271200900018C entitled, "NIMH Toxicological Evaluation of Novel Ligands Program". This procurement is being competed under full and open competitive procedures under NAICS Code 541712. It is anticipated that a single Indefinite Delivery Indefinite Quantity (IDIQ) type contract, with both cost reimbursement and fixed price, severable and non-severable task orders will be awarded for a five (5) year period of performance beginning on or about May 26, 2014.

The purpose of this solicitation is to re-compete for contract services to support the NIMH Toxicological Evaluation of Novel Ligands Program. The contact services include the assessment of the toxicology and safety of promising, target-selective compounds for use in human studies. It is anticipated that NIMH-approved and coded samples will be submitted from a variety of sources including NIH-funded research programs, pharmaceutical companies, biotechnology companies, or other sources. Toxicology and safety data generated from this program will be used by investigators in support of an Investigational New Drug (IND) application or for Radioactive Drug Research Committee (RDRC) evaluation of the compound for human studies. In cases where the compound shows toxicity at doses within the range anticipated for human use, the data will provide investigators with valuable information upon which to base further development of structural analogs.

Toxicology studies that will be conducted under this contract may include the following major objectives:

-Determination of a maximum tolerated dose (MTD)
-Determination of dose-limiting toxicities (DLT)
-Determination of schedule-dependent toxicity
-Determination of the reversibility of adverse effects
-Determination of a safe clinical starting dose

In addition to these objectives, studies may also be designed to make the following determinations:

-Whether the efficacious drug levels can be attained in plasma in vivo
-Whether an agent crosses the blood-brain barrier

This is a pre-solicitation notice in advance of the Request for Proposal (RFP), and the Government is not committed to award a contract pursuant to this announcement. The RFP, detailing the specifics of the project as well as information pertinent to the development of an offeror's proposal will be available electronically on or about November 7, 2013 and may be accessed through the Internet at the Federal Business Opportunities website at: http://www.fedbizopps.gov. Any responsible offeror may submit a proposal which will be considered by the Agency. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.