Research Study Services for Electron Paramagnetic Resonance

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE. The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) has issued this sources sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER) in order to determine if there are existing small business sources capable of providing Research Study Services for Electron Paramagnetic Resonance (EPR) facility to quantify tissue pO2 following acute blood loss in rats and resuscitation with stored rat blood cells (RBCS). If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 541380 - Testing Laboratories; with a Small Business Size Standard of $15 Million, and believe that your firm would be able to provide the FDA with the services described below, please submit an email to Yolanda.peer@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements. Background: The Food and Drug Administration (FDA)/CBER intends to acquire Research Study Services for Electron Paramagnetic Resonance (EPR) facility to quantify tissue pO2 following acute blood loss in rats and resuscitation with stored RBCS. The Statement of Work is as follows: STATEMENT OF WORK FOR THE USE OF AN ELECTRON PARAMAGNETIC RESONANCE FACILITY TO QUANTIFY TISSUE pO2 FOLLOWING ACUTE BLOOD LOSS IN RATS AND RESUSCITATION WITH STORED RAT RBCS. A. Background Red blood cell (RBC) transfusion is a common medical procedure used to restore tissue oxygenation. Currently, RBC storage is allowed for up to 42 days in most storage solutions. However, animal and human studies suggest that older storage units (35 days or older) of RBCs may be of a lesser quality than fresh units. Approximately 20% of RBC units remain in storage until 35 - 41 days prior to use. Given this information it is important to understand the ability of stored RBCs to deliver oxygen to tissues when RBCs are stored for a 35-41 day equivalent. Pre-clinical studies have evaluated the efficacy associated with RBC age by using HIF-1? expression and pimonidazole adduct formation. However, these are indirect methods of accessing tissue oxygenation of fresh and older storage units. This project will focus on potentially more reliable direct measurements of tissue oxygen concentration using Electron Paramagnetic Resonance Spectroscopy also known as EPR Oximetry. It is based on the hypothesis that when compared to indirect methods (HIF-1? expression and pimonidazole adduct formation), EPR oximetry could provide a more robust and non-invasive approach to evaluating tissue oxygenation post-transfusion. The results of the study will provide important information on the ability of EPR oximetry to evaluate tissue oxygen concentrations post transfusion. The goal is to eventually use this method to establish an oxygen delivery based quality assessment of RBC products prior to FDA approval. B. Scope The effects of acute blood loss will be studied in inbred Lewis rats (LEW/Crl) 300-400 g. Rats represent a species of rodent that are amenable to transfusion studies and acute blood loss. Lewis rats represent a strain used in transplant studies and their RBCs can be readily collected, pooled, stored and transfused into recipient rats. The study design should follow a specific protocol including: (Part 1) Blood collection and storage - Using aseptic technique, blood (10-15 ml) will be collected from anesthetized donor Lewis rats (n=40) via a left carotid artery catheter attached to anti-coagulant filled syringes. Blood will be centrifuged at 2000 rpm for 10 minutes followed by collection and freezing of plasma. RBC collections will be pooled and leukocyte reduced using a neonatal high efficiency leukocyte reduction filter and storage bag. RBCs will be supplemented with an additive/preservative solution (AS 1, 3 or 5). The final preservative concentration will be 14% of the RBC volume per storage bag, and storage bags will be maintained at 4'C over a 14- day period. Four bags will be required as follows; Bag 1 -RBCs from 10 rats stored for 1 day, Bag 2 - RBCs from 10 rats stored for 7 days, Bag 3 - RBCs from 10 rats stored for 14 days, and Bag 4 (surplus bag) - RBCs from 10 rats stored for not longer than 14 days and used if extra RBCs are required at any of the storage times. (Part 2) Acute blood loss and replacement - Rats will be bled through an implanted carotid catheter at 1 ml/min over period of 12-15 minutes, such that a total of 65% of the blood volume is removed (12-15 ml in 300-400 g rats). A 30 minute period of time will be allowed to establish an oxygen (O2) deficit. Blood pressure will be monitored by tail cuff starting at baseline and throughout the hemorrhage period. (3) pO2 will be monitored in muscle and kidney at baseline (0-15 minutes), period of O2 deficit/blood withdrawal (16-60 minutes) and during/post resuscitation (61-120 minutes). Transfusion will be performed with Fresh RBCs used within 1 day of collection, intermediate age RBCs will be used at 7 days of storage and maximal age RBCs will be used at 14 days of storage. 5% human serum albumin will be used to replace volume, but not replace O2. The Group requirements for study parts 1 and 2 are listed below. Donor/Treatment animals required: (Part 1) Blood collection and storage: (1) 1 day storage (n=10 donor rats) (2) 7 day storage (n=10 donor rats) (3) 14 day storage (n=10 donor rats) (4) Surplus (n=10 donor rats) Donor rats: n = 40 (Part 2) Treatment groups: (1) Acute blood loss/fresh blood transfusion (1 day storage) - n = 8 (2) Acute blood loss/intermediate storage time blood (7 day storage) - n = 8 (3) Acute blood loss/maximal storage time blood (14 day storage) - n = 8 (4) Acute blood loss/albumin 5% - (non-oxygen carrying control) - n = 8 Treatment rats: n = 32 Total animals required = 72 A. Technical requirements - Shall provide an Animal Welfare Assurance (Assurance) which commits the organization to comply with the provisions of the PHS Policy, the Animal Welfare Act, and the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC). In accordance with the PHS Policy, offerors must establish an Institutional Animal Care and Use Committee (IACUC) protocol, within 30 days of notice of selection for award. - Shall have an Electron Paramagnetic Resonance Spectroscopy (EPR) facility that is capable of measuring oxygen at two tissue sites simultaneously in the rat. - Shall have a minimum of two EPR instruments capable of making the measurements in rats in order to meet the timeliness requirements for the measurements in cohorts the vendor. - EPR facility shall have the oximetry probes and a high degree of experience in making repeated measurements of oxygen in the tissues of interest including both continuous measurements for several hours and repeated measurements at the same sites on different days without read ministering the oximetry probe. - Shall be capable of providing terminal plasma, muscle, liver, kidney, heart, and brain tissue as both frozen samples and in paraffin embedded blocks. B. Deliverables - Shall provide data tables in Microsoft Excel of tissue oxygenation from two sites (muscle and kidney) collected at 5 minute intervals over the two hour study period for each treatment group rat (n = 32). - Shall provide terminal plasma, muscle, liver, kidney heart and brain tissue both frozen and in paraffin embedded blocks for each rat. - All data and tissues shall be made available within one year of the award. PERIOD OF PERFORMANCE: The entire study, data, plasma and tissue samples will be completed within one year of the time of award. Place of Performance: Contractor's Facility Service Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA COR and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed. FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. FOB Point of Delivery for Services and Supplies will be the FDA located at Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Bldg 52, Silver Spring, MD 20993. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: - Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a product and service offered by another firm. - Past Performance information for the same or substantially similar services to include description of service, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address. - Shall provide facility experience conducting in vivo EPR oximetry studies. An established history of publication of EPR oximetry studies shall be provided with references to publications in PubMed - Descriptive literature, brochures, marketing material, etc. detailing the nature of the product and service the responding firm is regularly engaged in. - Though this is not a request for quote, informational pricing is required. - If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. If a large business, provide if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response. Interested Contractors must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before May 26, 2017 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Yolanda Peer, 3900 NCTR Road, HFT?320, Bldg. 50, Rm 420 Jefferson, AR 72079?9502 or email yolanda.peer@fda.hhs.gov. Reference: FDA_17-223-SOL-1184160. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre?solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non?proprietary technical information in any resultant solicitation(s). Additional Notes: If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.