SOLICITATION NOTICE
B -- Islet Cell Distribution coordination Center
- Notice Date
- 11/24/2008
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Library of Medicine, 8600 Rockville Pike, Bethesda, Maryland, 20894
- ZIP Code
- 20894
- Solicitation Number
- NIH-NIDDK-08-99SB
- Archive Date
- 2/12/2009
- Point of Contact
- Sally Boakye, Phone: 301-496-6546, Ed Kostolansky,, Phone: 301-594-4758
- E-Mail Address
-
boakyes@mail.nih.gov, Edward.Kostolansky@nih.gov
- Small Business Set-Aside
- N/A
- Description
- The Department of Health and Human Services, National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) will solicit proposals for a coordinating center for the distribution of human cadaveric islets for laboratory research. This procurement will support a single coordinating center that subcontracts to qualified islet isolation facilities to prepare and distribute human islets for investigational research. The coordinating center will maintain a roster of investigators approved to receive islets and will assume responsibility to notify investigators and distribute islets when they are available. Contract funds will provide partial cost recovery to islet isolation facilities for islets distributed and investigators that receive them will have cost sharing charges for the islets received. The resultant contract will be a Cost- Reimbursement Contract under Full and Open Competitive Procedures. Currently, the National Institutes of Health and NIDDK support a multi-facetted research program to further the development of islet transplantation as a viable therapy including clinical trials, preclinical studies in animal models, fundamental research, and provision of resources to supplement these efforts. This support includes investigator initiated research projects and consortia funded through cooperative agreements and contracts. Of relevance to this notice, the Islet Cell Resource (ICR) program is currently comprised of an interactive consortium of academic clinical islet isolation facilities and a coordinating center (for more information, visit http://icr.coh.org ). These islet isolation facilities have responsibilities for the procurement of human pancreata, purification and quality control of islet cell preparations, and distribution of viable islets for approved research or clinical protocols. They also perform research and development to improve isolation techniques, cellular viability and function, and shipping conditions. To receive research islets from the ICR, investigators must apply to the Administrative and Bioinformatics Coordinating Center (ABCC). Eligibility requires that investigators either have ongoing, peer reviewed grant funding or have obtained protocol approval by an ICR scientific subcommittee. The ABCC maintains a web-based data collection system that archives detailed information about all phases of islet procurement and a sophisticated algorithm that electronically selects prioritized investigator users to receive islets. In the past five years the ICR has distributed more than 100 million islet equivalents for research studies, and growing needs from the research community are projected. The information gained from fundamental islet research should greatly enhance the current understanding of human islet function and enable transplantation and other therapies for treating diabetes. The objective of this forthcoming procurement is to establish a successor coordinating center to the ICR in order to continue providing human islet availability following the conclusion of the ICR project period on July 31, 2009. The NIDDK plans to support a contract for islet distribution for laboratory research to accomplish the following objectives in an efficient and cost effective manner: 1. Receive requests for islet applications, qualify investigator recipients, and process these data to maintain a complete and continuously updated electronic roster of approved investigator users and their projected needs. For purposes of this solicitation, the 2008 roster lists 147 investigators who estimate their annual research needs to exceed 30 million IEQ per year. 2. Solicit and qualify potential islet production centers with respect to cGMP certification, assure quality performance standards of prepared islets, provide training for standardized distribution protocols, subcontract to appropriate facilities to provide islets for laboratory research, and adjust these subcontracts as warranted. Solicitation and Qualification of Islet Production Centers: Islets will be sourced from islet production facilities in two ways. The first method of sourcing will utilize NIH-sponsored clinical islet transplantation trials in North America that include the University of Miami, University of Minnesota, University of Edmonton, University of Pennsylvania, Emory University, University of California at San Francisco, University of Illinois at Chicago, and Northwestern University. These institutions comprise the NIH-funded Clinical Islet Transplantation Consortium (CITR) and are in the midst of initiating a series of clinical islet transplantation protocols. Due to the complexities of the islet production process, it is anticipated that only 50% of the isolations attempted will have suitable yield and quality required for clinical use. Islets purified with the intent of clinical use but not used for clinical transplantation, if sufficiently viable, will be salvaged and shipped for research. The second source will be from one or more subcontract site. Because the timing and quantity of clinical islet transplantation activity is unpredictable, NIDDK anticipates that islet production will also be solicited from one or more specific site to assure an availability continuum. The process by which subcontracted facilities are selected will be open, subject to independent peer review, and will follow a general announcement. The Contractor, in conjunction with the approval of the NIDDK Project Officer and an External Evaluation Committee, shall design and distribute the announcement and organize the review of candidate facilities. 3. Develop and maintain an electronic communication system that will monitor and match islet availability from production sites with user requirements and will notify production sites of need for islets and users of availability. 4. Develop and maintain financial records of reimbursements to the islet production facilities and receivables, and house the consolidated database of approved islet production facilities and investigators. 5. Maintain accurate records of islet shipments from production sites to islet recipients including quantities and batch release characteristics of islets shipped as assessed by production sites and recipients. Establish subcontracts with commercial carriers for overnight shipping of islets between multiple sites, domestic or international, in accordance with Standard Industry Practice, FDA Requirements, approved Standard Operating Procedures, city, state, and/or Federal regulations, and any special instructions given. Analyze trends in demand for islets and project future requirements for islets. 6. Collect information on performance site islet quality and investigator user satisfaction and analyze these respective data so that processes and quality can be improved. 7. Compile evidence of scientific progress attributable to human islet distribution as shown by publications and other tangible results. 8. Maintain an External Evaluation Committee (EEC) of advisors to guide development and improvement of the resource and support the technical and administrative functions including subcontracts as determined by the Project Officer and External Evaluation Committee. It is anticipated that the EEC will have membership of four to six non-Federal members and will conduct direct meetings at least annually. The proposed acquisition will be procured under FAR Part 15- Contract by Negotiation. Full text of clauses and provisions are available at Federal Acquisition Regulations (FAR) http://www.arnet.gov/far/index.html The expected release date of the Request for Proposal (RFP) will be on or about December 17, 2008 with proposals due January 28, 2009. Organizations interested in responding to the RFP may find the complete RFP posted on the FedBizOpps website. RFP responses must be in writing and must be received by 12:00 EST on February 1, 2009. Email or faxed proposals will not be accepted. Inquiries regarding this procurement may be made to Sally Boakye, Contract Specialist, NLM on 301-496-6546 or Ed Kostolansky, Branch Chief, NLM on 301-594-4758.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=30a9d0cd8bda8effb0592365c4c34cd9&tab=core&_cview=1)
- Place of Performance
- Address: N/A, United States
- Record
- SN01709626-W 20081126/081124215042-30a9d0cd8bda8effb0592365c4c34cd9 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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