NIDDK Genetics Repository

Added: June 26, 2007 Modified: October 25, 2007Track Changes The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) is soliciting proposals on a full and open competitive basis from qualified businesses, organizations, colleges, universities and institutions to award a contract to serve as the NIDDK Genetics Repository. Attached to this modification as Attachment 3 is the Proposal Intent Response Form, all parties intending to submit proposals in response to this RFP should either email (harrisd@mail.nih.gov) or fax (301) 480-4226 the form to the attention of Mr. Dana L. Harris no later than October 31, 2007. The deadline for submission of proposals in response to this RFP remains 3:00 pm local time on November 15, 2007.

Added: June 26, 2007 Modified: October 12, 2007Track Changes The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) is posting an amendment to the Request for Proposal (RFP) to make corrections to Section C - Article C.1. Statement of Work and Section M - Evaluation Factors. Please see Amendment One as attached.

Added: June 26, 2007 Modified: August 24, 2007Track Changes The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) is soliciting proposals on a full and open competitive basis from qualified businesses, organizations, colleges, universities and institutions to award a contract to serve as the NIDDK Genetics Repository. The Genetics Repository will provide for the continued storage, maintenance, quality control, and equitable, ethical distribution of DNA and other resources important to the study of diseases under the mandate of the NIDDK. The Genetics Repository facilitates the sharing of resources, thus encouraging work by a broad group of investigators and, perhaps, increasing the sample size and the resulting power of a study to identify the genetic determinants of a disease. The Genetics Repository helps ensure that research participants will be making a maximal contribution, and decreases duplicative sampling efforts.

The objective of this acquisition is to continue the NIDDK Genetics Repository in order to accomplish the following activities in a highly efficient, rapid, and cost-effective manner:



? Receive blood samples from NIDDK funded grants and contracts.

? Process these data and materials to create cell lines, cryopreserved lymphocytes, and/or DNA or RNA samples.

? Receive externally produced immortalized lymphocyte cell lines.

? Widely distribute all materials to qualified investigators in the scientific community in variety of customized formats.



Since 2003, Rutgers University has served as the contractor for the NIDDKGenetics Repository. Request for Proposal No. NIH-NIDDK-07-05 will be issued at the www.fedbizopps.gov website on or about September 8, 2007 with a receipt date for proposals on or about November 20, 2007. See Numbered Note 26.

Added: June 26, 2007 The National Institutes of Health, National Institutes of Diabetes and Digestive and Kidney Diseases is conducting a market survey to help determine the availability and technical capability of qualified small businesses, veteran-owned small businesses, service-disabled veteran-owned small businesses and/or HUBZone small businesses capable of serving the needs mentioned below.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) is seeking an organization or an institution to serve as the NIDDK Genetics Repository. The repository shall allow the continued storage, maintenance, and quality control, and equitable, ethical distribution of DNA and other resources important to the study of diseases under the mandate of the NIDDK. It facilitates sharing of resources, thus encouraging work by a broad group of investigators and, perhaps, increasing the sample size and the resulting power of a study to identify the genetic determinants of a disease. It helps to ensure that research participants will be making a maximal contribution, and decreases duplicative sampling efforts.



The objective of this acquisition will be to continue the NIDDK Genetics Repository, in order to accomplish the following in a highly efficient, rapid, and cost-effective manner:



? Receive blood samples from NIDK funded grants and contracts

? Process these data and materials to create cell lines, cryopreserved lymphocytes, and/or DNA or RNA samples

? Receive externally produced immortalized lymphocyte cell lines; and

? Widely distribute all materials to qualified investigators in the scientific community in variety of customized formats



The cell immortalization and other tasks outlined in this statement of work are highly technical, and require extensive experience and expertise. The success rate for cell immortalization is extremely variable. It depends, in large measure, on how well the established methods are implemented. As the entire value of many genetics studies rests on the ability to analyze the DNA of sib-pairs and other relatives, inability to recover DNA from any particular sample may negate the value of multiple samples. Therefore, it is essential that the success rate for establishing cell lines be as close to 100% as possible. Furthermore, the ability to track thousands of genetic samples, preventing sample mix-ups and cross-contamination while maintaining a high-throughput processing system, is crucial to the integrity of the studies being supported. The Contractor?s project director must have extensive experience in successfully providing these genetics and sample processing services, including blood cell immortalization and DNA extraction and distribution, to a large group of investigators. The Contractor?s staff must be highly trained to carry out exacting technical tasks accurately and reproducibly. As all the work is with samples from human subjects, all staff must be familiar with human subjects protections and be sensitive to the bioethical and safety issues involved in handling human biosamples. Finally, the Contractor must have a demonstrable long-term interest in providing these services, to ensure that there is continuity throughout the period of the contract.



Currently all of the required work is in the final year of a NIDDK 5-year funded contract with the Rutgers University Cell & DNA Repository.



All qualified small businesses, veteran-owned small businesses, service-disabled veteran-owned small businesses and/or HUBZone small businesses interested in submitting a corporate capability statement should demonstrate experience and knowledge for performing the following tasks:



1) Establish biospecimen preparation, shipping, receipt, and tracking systems for numerous individual multi-center clinical studies;



2) Maintain the confidentiality of subjects by removing all traditional personal identifiers from samples;



3) Establish one or more subcontracts for timely and cost-effective shipping of biosamples between multiple sites and the repository;



4) Create and store viable cell lines via Epstein-Barr virus transformation of lymphocytes from blood samples, with a success rate of 97% or greater and expanding the lymphoblastoid cell lines;



5) Receive and store lymphoblastoid cell lines prepared at other facilities and carry out quality control assessments;



6) Cryopreserve blood cells for eventual transformation and/or DNA extraction;



7) Extract and store DNA from cell lines or from isolated blood cells and, with designated samples, separating the white blood cells (buffy coat) from the plasma;



8) Receive externally produced DNA;



9) Carry out whole genome amplification, pedigree analyses and RNA extraction;



10) Distribute cell lines and biosamples to investigators granted access by the PO, including arraying in a variety of formats, packaging, handling, and coordinating sample shipments to domestic and international sites;



11) Withdraw and destroy samples from the repository as directed in writing by the Project Officer;



12) Establish and maintain Quality Assurance (QA) and Quality Control (QC) programs;



13) Provide security and back-up systems and a plan for disaster recovery;



14) Maintain high quality, secure information systems to allow detailed tracking and reporting of sample receipt, processing, storage and distribution, rapid retrieval of samples, storage of QA/QC information associated with the sample, seamless interaction with the Database Repository, and listing of investigators using the repository; and



15) Work in a cooperative fashion with the Project Officer, the External Advisory Committee, and the Steering Committee.



Special Instructions:



If you or your firm/business has an interest and possess the required expertise we invite you to submit a corporate capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502-2(b) whether or not this procurement will be set-aside for any of the programs described above. The intended procurement will be classified under North American Industrial Classification (NAICS) code 541710 with a size standard of 500 employees. All respondents are requested to identify their firm's size and type of business.



Interested firms responding to this sources sought should adhere to the following:



(a) Provide a capability statement demonstrating relevant experience, skills and ability to fulfill the Government's requirements for the above. The capability statement should contain sufficient detail for the Government to make an informed decision regarding your capabilities. The capability statement should not exceed 25 pages and five (5) copies should be submitted.



(b) The capability statement should include references, key personnel, and any teaming arrangements needed to fulfill the requirements.



(c) All capability statements must be submitted in writing to the address identified in this synopsis no later than July 10, 2007 no later than 3:00pm eastern standard time. Responses will not be accepted via email or fax.



This notice is for information and planning purposes only and is not to be construed as a commitment by the Government, nor will the Government pay for information solicited.