AN41-- NCPTSD DHMC CPSR Core

discretion of the Contracting Officer. Item description: Clinical pharmacology services for research. This contract is to create a blanket purchasing agreement to fully utilize the Clinical Pharmacology Shared Resource (CPSR) core at Dartmouth, the academic affiliate of the White River Junction VA Healthcare System. Creating this agreement will facilitate the utilization of an established core to perform services for funded investigators, which will improve output for existing research laboratories and further improve research productivity at the White River Junction VA. This agreement will allow investigators to purchase services as needed throughout the year. It is not feasible to use a purchase card to pay for services for each individual project, due to VA restrictions on service limits. Implementing a larger purchasing range with this agreement will support the capacity of current and anticipated work. This option will also eliminate the need to create multiple contracts utilizing the same services, thus eliminating redundancies, unnecessary paperwork, and excessive use of staff time. This mechanism will save time, improve productivity, and reduce unnecessary government spending. Pharmacokinetic and pharmacodynamic methodology and analysis of study samples will be performed on de-identified pre-clinical and clinical samples. Expected purchases may include: Biospecimen processing storage and distribution. Bioanalytical analyses, including method development, validation, and implementation of LC�MS/MS and LC-UV based analytical methods for quantitative determination of drugs, drug metabolites, and endogenous metabolites in biosamples. Pharmacokinetic (PK) and/or pharmacodynamic (PD) studies in clinical and pre-clinical studies, including consultation, method development, and experimental design. PK and PK-PD data analysis and modeling: providing state of the art compartmental and non-compartmental PK analysis, direct and indirect modeling of PD data, and evaluation of dose-exposure-response relationships to provide data-guided optimization of drug dosing regimens. In vitro pharmacology: providing drug-drug combination-effect (e.g., cytotoxicity) data generation and analysis based on the Chou-Talalay median-effect model using CalcuSyn software. Salient characteristics: Dedicated, highly trained staff with scientific oversight. Expertise in pharmacokinetic and pharmacodynamic methodology to support basic, translational, and clinical research. State-of-the-art bioanalytical instrumentation and software. Ability to process a wide range of tissues, including clinical and pre-clinical samples. Ability to balance the need for quality, efficiency, flexibility, and cost effectiveness to maximize research output and productivity. Expertise in providing tech-enabled workflows to provide accelerated and reproducible data. Strict quality control ensuring the delivery of relevant, consistent, and reproducible data. Estimated yearly costs: This multi-year agreement anticipates up to $75,000 in service utilization costs per year (maximum of $300,000 over a four-year period; base plus three option years). Services will be paid as utilized throughout each fiscal year. Records Management Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.