SOW.pdf

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Preparation of Radiolabeled Materials
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N02-CM-87025-39
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RFP/N02-CM-87025-39

October 1, 2008

STATEMENT OF WORK

STATEMENT OF WORK

A. Independently and not as an agent of the Government, the Contractor shall furnish services, qualified personnel, equipment, and facilities, not otherwise provided by the Government, to operate a preparative laboratory for the synthesis of radiolabeled materials in 1 to 50 millicurie (mCi) quantities as assigned by the Project Officer.

Priorities for preparation will originate with the Project Officer. The Project Officer will transmit with each request the name and structure of the compound assigned; quantities desired and method of preparation, when available; specifications, when available; and other pertinent information. Specific analytical tests to be performed by the Contractor will also be specified by the Project Officer.

Synthetic schemes and procedures will be supplied by the Project Officer, and contractor is not expected to conduct basic research involving radiolabel synthesis.

Overall Objective

To synthesize, store, and distribute radiolabeled compounds for the NCI to be used by recipients of RAID, DDG, OC and JDC initiatives. Syntheses will cover a wide variety of chemical classes including heterocyclics, alkaloids, nucleosides, peptides and natural products. Major emphasis will be placed on 14C- and 3H- labeled materials but other isotopes such as 35S, 131I 32P and stable isotopes such as 13C may be included.

Specific Tasks

(1) Operate a synthetic laboratory for the preparation of radiolabeled materials in quantities ranging from 1 to 50 mCi. The desired quantity, specific activity, label and site of label will be specified by the Project Officer who will supply method(s) of synthesis when available, as well as intermediates, if available. The NCI expects that two (2) to five (5) radiolabeled compounds, both synthetics and natural products, will be synthesized each year during the base period of five (5) years as well as each of the two (2) option years. In addition, an option quantity of up to two (2) additional compounds may be exercised each year.

(2) Assay synthesized compounds to insure their chemical and radio chemical purity and shelf life.

(3) Provide synthetic routes and analytical data sheets on all compounds synthesized.

(4) Provide itemized costs for each of the compounds prepared.

(5) Have in place a minimum of 36 cubic feet of low temperature storage, i.e. -70 degrees C, for approximately 150 labeled compounds. Such stored materials shall be assayed and /or re-purified, as needed.

(6) Analyze, weigh, label and ship requested compounds of radiolabeled compounds to qualified researchers upon authorization by the Project Officer. Two to six shipments per month are anticipated.

(7) Treat the assigned radiolabeled materials as proprietary in nature. No information related to the radiolabeled materials shall be made available without written approval of the Project Officer.

(8) Ensure that all activities related to radiolabeled synthesis, waste management, storage and shipping of target compounds comply with all Federal, State and Local Government regulations.

(9) Report to the Project Officer and Contracting Officer without delay, unexpected events, such as accidents resulting in loss of working time greater than one day, rashes, changes in personnel and the like.

Transition from Existing Contract

The Contractor, Project Officers, and key NCI staff will establish a schedule with appropriate priority assigned to each project during the entire phase-in period.

Completion of the transition period should take place within the first three months of the contract period.

Transition to Successor Contract

60 days prior to the completion date of this contract, the Contractor, in conjunction with the Project Officer, shall establish a detailed transition plan for transfer of contractual activities to a successor contract. During the transition period, if required, the Contractor shall turn over contract materials, files, documents, and any other holding to any organization or group selected by NCI as well as provide continuity of service to NCI during the transition period if a transfer is necessary. The Contractor shall provide any other assistance deemed reasonable by NCI that may be required for the smooth transfer of contract responsibility. The Contractor shall transfer working papers and all information gathered during this contract to any group or organization selected in the event of recompetition of this project.

Please see Section L., Additional Technical Proposal Instructions Specific to this Solicitation, for further guidance on transition activities.

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