Pharmacology and Toxicology for Neurotherapeutics Program (PTNP), previously synopsized as "In-vivo ADMET Testing Services for Neurotherapeutics Development"

The National Institute of Mental Health (NIMH) proposes to issue a Request for Proposals (RFP) No. NIH-NIMH-2010-023 entitled "In-vivo ADMET Testing Services for Neurotherapeutics Development" under Full and Open Competition.

The objective of resultant contract is to provide a full range of in vitro and in vivo preclinical pharmacology and safety (ADMET) studies for the purposes of developing new drugs for nervous system disorders. The NIMH will require in vitro and in vivo ADMET services over the course of medicinal chemistry lead optimization and to prepare projects for IND applications. The NIMH anticipates requiring non-GLP ADMET services for up to 20 projects per year at the lead optimization stage and IND-directed GLP studies for 5-10 projects per year. The ADMET contractor must have the capacity to conduct multiple projects simultaneously. Medicinal chemistry, scale-up synthesis and GMP manufacture, and the preparation of the IND paperwork will be conducted under separate contracts. This contract will serve as part of the NIH Blueprint for Neurotherapeutics Network (http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm) and be utilized for individual drug development projects outside of the Blueprint Network.

Sources must meet the following criteria at the time of submission of original proposals:

(1). The laboratory facility must be in compliance with the Food and Drug Administration's (FDA) Good Laboratory Practice Regulations (GLP) as published in the December 22, 1978 Federal Register (Volume 43, No. 247, pp. 59986 60025). GLP Regulations are available on the World Wide Web (WWW) at www.fda.gov/ora/compliance_ref/bimo/glp/87finalrule.htm and GLP Regulations Questions and Answers are available at www.fda.gov/cder/guidance/old004fn.pdf. A copy of the most recent FDA GLP inspection report must be included in the proposal.

(2). The Contractor's animal facilities must be accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International as indicated by providing the latest accreditation report. Information about AAALAC accreditation is available on the WWW at www.aaalac.org. The Contractor must also provide an animal welfare assurance indicating compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, information for which is available on the WWW at http://ohrp.osophs.dhhs.gov/index.htm and http://grants.nih.gov/grants/olaw/olaw.htm.

A five (5) year contract is contemplated. Plans are to award a contract by June 30, 2011.

RFP No. NIH-NIMH-2010-023 will be available on or about November 5, 2010 and the receipt date of proposals on or about December 16, 2010. The RFP may be accessed through http://www.fedbizopps.gov. Please note that the RFP for this requirement will include the Statement of Work, Deliverables, and Reporting Requirements, the Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Following proposal submission and the initial review process, offerors comprising the competitive range will be requested to provide additional documentation to the Contracting Officer. All responsible sources are encouraged to submit a proposal that will be considered by the NIMH. This advertisement does not commit the Government to award a contract. Please contact Phil Hastings-Tickerhoff, Contracting Officer at 301-443-8402 or phastings@nida.nih.gov for further information.