Preclinical Pharmacology and Toxicology Studies

N01CN25000-26 NOTICE INFORMATION Agency/Office: National Institutes of Health Location, National Cancer Institute, Office of Acquisitions Title: Preclinical Pharmacology and Toxicology Studies Description(s): This Small Business Sources Sought Notice (SBSS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI). THERE IS NOT A SOLICITATION AVAILABLE. THIS IS STRICTLY MARKET RESEARCH. The purpose of this SBSS is to IDENTIFY QUALIFIED SMALL BUSINESS CONCERNS including Small Disadvantaged Businesses (SDB), Women-owned Small Business (WOSB), Historically Underutilized Business Zone (HUBZone) Small Business, Veteran-Owned Small Business (VOSB), 8(a) Small Business, and Service-Disabled Veteran-owned Small Business (SDVOSB) that are interested in and capable of performing the work described herein. Small Businesses whose size classification relative to the North American Industry Classification System (NAICS) code #541711 may consider responding to this notice. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The NCI does not intend to award a contract on the basis of responses nor otherwise pay for preparation of any information submitted. Preclinical In Vitro and In Vivo Agent Development Assays, a project within the Chemopreventive Agent Development Research Group, Division of Cancer Prevention (DCP), National Cancer Institute (NCI) is seeking capability statements from all eligible Small Businesses as stated above, under NAICS Code #541711 (Research and Development in Biotechnology) with a size standard of 500 employees. The NCI, CADRG/DCP is seeking contractors who demonstrate the ability to develop assays. Summary of Project: The purpose of the anticipated requirement is to support the conduct of toxicological and pharmacological evaluations of potential cancer preventive agents for Investigational New Drug (IND) applications to the Food and Drug Administration (FDA) for phase 0, 1-3 clinical studies, New Drug Applications (NDA) to the FDA, and to select appropriate first-in-human (FIH) doses. The Contractor shall be able to complete tasks in the following areas: 1. TASK AREA 1 - GENOTOXICITY TESTING. The Contractor shall determine the homogeneity, concentration, and stability of the test substance/test substance mixture under the conditions of use, as appropriate. A. Bacterial Reverse Mutation Test B. An In Vitro Test with Cytogenetic Evaluation of Chromosomal Damage with Mammalian Cells C. An In Vivo Test for Chromosomal Damage Using Mouse or Rat Hematopoietic Cells 2. TASK AREA 2 - GENERAL TOXICOLOGY IN EXPERIMENTAL ANIMALS. A. Acute Oral Toxicity in Rodents B. Twenty-Eight Day Study in Rodents and Dogs C. Ninety Day, Oral Toxicity Study in Rodents and Dogs D. Six Month Rodent and Nine Month Dog Chronic Toxicity Studies E. Carcinogenicity Studies in Rodents 3. TASK AREA 3 - REPRODUCTIVE TOXICITY STUDIES IN RODENTS AND RABBITS. A. Segment II Teratogenicity Studies B. Two Generation Reproduction Studies in Rodents 4. TASK AREA 4 - SPECIALIZED STUDIES. A. Bioanalytical Methodology Studies B. Pharmacokinetic and Pharmacokinetic-Pharmacodynamic Studies C. Bioavailability and Bioequivalence Studies D. Drug Metabolism/Drug Interaction Studies E. Specific Safety Studies F. Genomics/Proteomics/Metabolomics G. Computational (Predictive) Pharmacology/Toxicology 5. GENERAL PROCEDURES A. Animal Facility The Contractor shall be required to conduct studies under the Food and Drug Administration Good Laboratory Practice Regulations as published in the Federal Register CFR Title 21, Part 58). Laboratories shall be accredited by or registered with the following: i. Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC or equivalent) ii. Office of Laboratory Animal Welfare (OLAW) iii. United States Department of Agriculture (USDA), and iv. Institutional Animal Care and Use Committee (IACUC) All animals for toxicological studies shall be furnished by the Contractor from established, reputable, known commercial breeders. The Contractor shall quarantine the animals for an appropriate period prior to placing them on test for toxicological studies and their release shall be documented by the attending American College of Laboratory Animal Medicine (ACLAM) veterinarian. B. Pathology The Contractor shall ensure that proper examination and reporting of pathologic alterations in organs and tissues in each toxicological study are of conducted to demonstrate histopathological evaluations correlated to clinical, hematologic, or clinical chemistry evidence of toxicity to an organ system with direct injury to that system. The Contractor shall ensure that precision and accuracy in reporting the type and severity of lesions in animals is provided in order to increase the efficiency of prediction for toxic manifestations of agents administered to patients in subsequent clinical trials. The Contractor shall ensure that: i. All lesions are categorized as either drug-related or non drug-related; ii. Each lesion is listed and coded by the most specific topographical and morphological diagnoses, severity, and distribution using Systemized Nomenclature of Medicine (SNOMED) codes. C. Assay of Test Material and Formulations DURATON: It is anticipated that the ordering period for this ID/IQ contract will be 24 months. Task Orders my extend beyond the 24 month contract period. CAPABILITY CRITERIA: Capabilities will be judged based on the following criteria: Interested qualified small business organizations should submit a capability statement, not to exceed 15 total single-spaced pages using a 12 point font size at a minimum, that clearly details the ability to perform and that addresses the specific requirements described above. All proprietary information should be marked as such. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. 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. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. 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. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your responses. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). All capability statements sent in response to this SMALL BUSINESS SOURCES SOUGHT notice must be submitted electronically (via email) to Kathleen Sears, Contract Specialist at searsky@mail.nih.gov either in MS Word, Wordperfect or Adobe Portable Document Format (PDF) not later than FRIDAY, SEPTEMBER 9, 2011, 3:00PM EST. All responses must be received by the specified due date and time in order to be considered. ANY RESPONSES RECEIVED AFTER THAT DATE AND TIME WILL NOT BE CONSIDERED.