Amendment 4 is posted. The date specified for receipt of offerors is changed to July 13, 2010. The receipt time remains unchanged at 2:00 p.m., Eastern Prevailing Time. Amendment 3 is posted with attachments. Amendment 2 Posted without links. Proceed to Amendment 3. PRECLINICAL TOXICOLOGY & PHARMACOLOGY OF DRUGS DEVELOPED FOR CANCER AND OTHER DISEASES The Developmental Therapeutics Program (DTP) of the Division of Cancer Treatment, Diagnosis and Centers (DCTDC) of the National Cancer Institute (NCI) intends to re-compete a requirement currently being performed under contracts N01CM42200, N01CM42201, N01CM42202, N01CM42203, and N01CM42204. This procurement is being competed under full and open competitive procedures under NAICS 541712. DTP is seeking organizations to carry out pharmacology and toxicology studies, the data from which must be suitable for filing with the Food and Drug Administration as part of Investigational New Drug Applications. The organizations should have the facilities and staff to carry out such studies and the management expertise to analyze and evaluate the data. Multiple contracts will be awarded and each will be administered on a work assignment-managed basis. Work assignments will be issued under the "funded cost-reimbursement, multiyear" contracts resulting from this solicitation. Assignments are estimated to involve two to three chemical agents annually, per contract The objectives of the work assignments in relative order of importance are: 1) assessment of acute and subacute toxicity in rodents and dogs including determination of a maximum tolerated dose (MTD), of dose limiting toxicities (DLT), schedule-dependent toxicity, of the reversibility of adverse effects and of a safe clinical starting dose; 2) validation of analytical methodology to quantitate plasma drug levels in preclinical animal models and to measure plasma drug levels in rodents, dogs and/or non-human primates treated with the agent under study; 3) determination of bioavailability of drug after parenteral and/or oral administration, if efficacious drug levels can be attained in plasma in vivo and if the drug crosses the blood-brain barrier; 4) the use of pharmacokinetic information to permit extrapolation of toxic effects across species by relating plasma drug levels to the time of appearance and severity of toxicity; and to establish the safety of potentially efficacious doses. The Principal Investigator should have a doctoral degree in pharmacology/ toxicology plus at least five years experience in directing, implementing and evaluating drug toxicity studies in experimental animals. The Pathologist, Pharmacokineticist and Analytical Chemist should likewise have credentials that illustrate their competence and accomplishments in serving as critical team members in the conduct of such studies. The government anticipates multiple awards of multiyear contracts with increments of funding. Mandatory Qualification/Mandatory Exclusion Criteria: The GLP qualification must be met at the time of submission of the initial proposal. Since the toxicology studies will be used by the National Cancer Institute to satisfy the safety testing requirement of the Food and Drug Administration in the submission of an Investigational New Drug Application, the studies must be conducted and the data must be stored in accordance with the Good Laboratory Practice Regulations as outlined in the Federal Register Friday, December 22, 1978. The NCI also signs legally binding agreements with certain suppliers (often pharmaceutical or chemical companies) which state that all information on the compounds submitted by the supplier must be held confidential. The Contractor will be expected to evaluate the toxicity of such commercially confidential (discreet) materials. Therefore, the Contractor must be willing to sign a Confidentiality of Information Agreement at the time of award. Mandatory Exclusion Criterion The Offeror may not be a pharmaceutical, chemical, or biotechnology firm. For purposes of this RFP, a pharmaceutical, chemical or Biotechnology Company is defined as an organization which sells drugs and/or chemicals to the general public for profit or is engaged in research leading to such products. The National Institutes of Health (NIH) requires that prior to awarding of funds for contracts involving the use or intended use of animals in research; an acceptable assurance statement must be on file with the Office for Protection from Research Risks (OPRR). REPORTS AND DELIVERABLES: The following reports will be required: Draft Study Report, Final Study Report, Monthly Technical Progress Report, Annual Technical Progress Report, and Final Report. ANTICIPATED PERIOD OF PERFORMANCE: The anticipated period of performance is five years (4/1/2011 through 3/31/2016). CONFIDENTIALITY. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). DISCLAIMER AND IMPORTANT NOTES. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. This solicitation is scheduled for release on or about April 30, 2010. The RFP may be accessed through the NCI Office of acquisitions home page located at http://rcb.cancer.gov/rcb-internet/index.jsp. It is the offerors responsibility to monitor the above internet site for release of this solicitation as well as any amendments. ALL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. IN ADDITION ALL QUESTIONS MUST BE SUBMITTED ELECTRONICALLY. NO COLLECT CALLS WILL BE ACCEPTED.
