Toxicological Evaluations of Potential Medications to Treat Drug Abuse

The National Institute on Drug Abuse (NIDA) intends to solicit proposals from offerors having the capability to perform the following: Offerors must conduct systematic preclinical toxicology and safety pharmacology studies, and preclinical cardiovascular safety studies that support the development of pharmacotherapies as medications to reduce substance abuse. The preclinical studies shall adhere to Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) guidelines, as set forth by relevant Food and Drug Administration (FDA) guidances and regulations (Code of Federal Regulations Title 21, Chapter 1, Subchapter A, Part 58). Offerors must have on-site in vivo toxicology (rodent, rabbit, guinea pig, canine and nonhuman primate) and in vivo cardiovascular safety testing facilities with telemetric recording (rat, dog and nonhuman primate), access to state-of-the-art equipment for performing in vitro tests on cardiac muscle (hERG channel assays and action potential duration tests), access to state-of-the-art equipment for performing mutagenicity and genotoxicity tests and access to state-of-the-art equipment for performing analytical testing of dosing solutions and verification of identity of the bulk substance (HPLC, GC/LC-MS, IR and NMR). Offerors must possess experience conducting rodent, dog and non-human primate GLP studies designed to evaluate the safety of test compounds in the presence of common drugs of abuse, including ethanol, cocaine, methamphetamine and opiates and must possess experience in preparing reports acceptable in format for both paper and electronic submission to the FDA. After the Request for Proposals (RFP) is issued, and prior to award, each offeror must: - Be accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). - Demonstrate its understanding and compliance with the NIH guidelines on the care and use of laboratory animals. - Show that it has an Animal Welfare Assurance on file with the Office of Extramural Research, Office of Laboratory Affairs (OLAW; see http://grants.nih.gov/grants/olaw/olaw.htm). To handle test substances under the Controlled Substances Act of 1970, and prior to award, each offeror must possess a U.S. Drug Enforcement Administration (DEA) Registration for Schedules II to V. In addition, each offeror must either possess, or demonstrate the ability to obtain prior to award, DEA Registration for Schedule I controlled substances. NIDA anticipates the award of a single, five-year, indefinite delivery, indefinite quantity (IDIQ), task order contract. NIDA may award either cost reimbursement and/or fixed price task orders under this contract. NIDA anticipates that at least one task order will be awarded with the contract. RFP No. N01DA-13-8911 will be available electronically on or about December 3, 2012. You will be able to access the RFP through the FedBizOpps (URL: http://www.fedbizopps.gov or through the NIDA website at the following address: (URL: http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps). All information required for the submission of an offer will be contained in or accessible through the RFP package. Responses to the RFP will be due on or about 45 days after we release the RFP. NIDA will consider proposals submitted by any responsible offeror. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice. This advertisement does not commit the Government to award a contract.