Attachment_2_SOW_2016.docx

Attachment 2

STATEMENT OF WORK

March 24, 2016

INTRODUCTION

National Institute of Environmental Health Sciences (NIEHS) investigators utilize many rodent models (e.g. transgenic, knockout and mutant mice) as model systems to explore how human health and human disease are caused by the interaction of environment and individual susceptibility over time. The NIEHS maintains many genetically distinct laboratory animals utilized for this research. The validation and verification of the genotype of these animals is of critical importance to NIEHS investigators. Therefore, a genetic monitoring contract is needed to provide a rapid and accurate determination of the genotype of each animal. This will be accomplished by awarding a single contract to perform one or more DNA-based methods to determine the genotype of each animal sample and provide that information in a form acceptable to NIEHS investigators.

Work To Be Performed:

The contractor shall supply all necessary labor, materials, equipment, facilities and supplies under the terms of this contract, to perform the following tasks:

The contractor shall:

1. Determine the genotype of interest in animals with a DNA-based testing method that utilizes suitable high throughput DNA genotyping techniques including but not limited to PCR-based approaches (i.e. PCR, RT-PCR, Fragment Analysis).

2. Provide all necessary sample collection material for the shipment of samples including but not limited to: sample collection plate or vial, refrigerated sample storage method of samples prior to genotype analysis, appropriate pre-paid shipping containers, and a sample record tracking system/method.

3. Isolate DNA from tail clips, ear punch or other biological samples which may include but are not limited to specific organ tissue or blood. All available specimen information will be provided to the contractor prior to analysis. Samples will be furnished by the Government and sent at a rate ranging from 5,000 to 12,000 per month with an estimated average of approximately 8,000 samples per month. The contractor shall genotype the sample for the specific mutation or genetic alteration as directed by the Contracting Officer’s Representative (COR) or Principal Investigator from NIEHS.

4. Store all samples and leftover DNA from these tests for a minimum of six months and return them to the NIEHS COR or Principal Investigator when requested. Samples may be disposed of by the contractor only after obtaining written approval from the COR and NIEHS Investigator.

5. Report all testing results along with relevant data to both the COR and the individual NIEHS Investigator electronically as accumulated, using Excel spreadsheets, within a maximum turn-around time of 72 hours after the DNA sample has been shipped out from NIEHS. Results that deviate from those expected by the Project Officer COR shall be re-done. If the results are still other than those expected by the Project Officer COR, the contractor must immediately report the findings to the Project Officer COR and the individual NIEHS Investigator via telephone and/or e-mail.

6. Provide reproducible assay(s) for each genotype to determine the necessary information for its proper identification. Some sample genotypes may require more than one assay for identification of the correct genotype. Any and all assay developmental information including but not limited to reagent formulations, methodology, protocols, instrumentation type used and all settings and calibrations of instrument regarding each assay shall be reported to the COR and NIEHS Investigator within 24 hours of written request from NIEHS once the reproducible assay is made. NIEHS retains the right to use these assays for any future purposes.

7. In the case of a failure of a genotyping assay to accurately determine the necessary information for proper genotype identification, the contractor shall repeat the assay for that sample. The contractor shall include in all assays a quality control scheme for monitoring the success rate of the genotyping assays, such as but not limited to random replicates or spike-in control samples. The contractor shall provide back-up methods of testing to be available to be performed on problem samples, as requested by the COR to validate genotyping results. This may include but is not limited to DNA sequencing of the genotype in some samples.

8. Samples for genotyping and ancillary studies will focus on but not be limited to rodent tissue. The contractor will receive suitable specimens and all available sample information from NIEHS to perform their analysis. The contractor shall isolate DNA at the request and direction of NIEHS, using a method approved by the COR. Sample preparation and the specific type of analysis to be performed shall be decided on by NIEHS in discussion with the contractor consistent with the technology platforms in the contract.

9. As directed by the COR, validate experimental observations, such as but not limited to gene expression findings, based on additional replicates and targeted re-genotyping. Sample preparation and the specific type of analysis to be performed will be decided by the COR and the NIEHS Investigator in discussion with the contractor, consistent with the technology platforms in the Statement of Work (SOW).

10. Maintain the confidentiality of the genotyping data and provide secure backup of all data essential to the contract, including but not limited to all genotyping data generated, sample tracking and storage information, and QC information.

The contractor shall not publish or use the data and results for any purpose other than those expressly authorized by NIEHS. The contractor may publish technical or methods papers as approved by the COR and the NIEHS Investigator.