SOURCES SOUGHT
B -- Platelet Study
- Notice Date
- 6/13/2014
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1133255
- Archive Date
- 7/9/2014
- Point of Contact
- Crystal G. McCoskey, Phone: 8705437267
- E-Mail Address
-
crystal.mccoskey@fda.hhs.gov
(crystal.mccoskey@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a sources sought to determine the availability and capability of small businesses to provide services for a clinical platelet study. The associated North American Industry Classification System (NAICS) Code is‐ 541712, Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology); Small Business Size Standard is 500 employees. Section I: Requirements Part I: General Information (Introduction/Background/Scope) The U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER) has a requirement for an exploratory study of in vivo recovery and survival of autologous, leukocyte reduced, apheresis platelets stored at room temperature or at cold Temperature-Cycled (TC) conditions for seven (7) days. The objective of this study is to demonstrate if platelets stored under TC conditions will remain in circulation when transfused into healthy human volunteers in a manner comparable to platelets stored in conventional, Room-Temperature (RT) conditions. Storing platelets in the cold is proven to be beneficial because cold temperatures can reduce proliferation of bacteria, if the platelets were contaminated during collection. Currently bacterial contamination in platelets occurs in ~1/5000 platelet units collected. Platelet units can be stored at RT for up to five (5) days and bacteria, if present, can proliferate during the course of storage to levels high enough to have clinical impact. Upon transfusion to patients the bacteria in the platelet units can cause significant morbidity and even mortality. Storage in cold temperatures could reduce the morbidity and mortality; however, exposure of platelets to the cold produces biochemical and morphological changes in the platelets which causes them to be rapidly cleared from circulation. Historically, the rapid clearance of cold stored platelets from circulation has prevented their use for transfusion in prophylactic treatment of thrombocytopenic patients who are at risk for bleeding. Fortunately, if the cold exposures are brief (<18 hours), the changes in platelets can be reversed with warming. Preliminary experiments have shown that TC can prevent the changes in platelets associated with continuous cold storage. TC storage can produce an improvement of platelet in vitro studies, and also improve in vivo recovery in animal models of transfusion when compared to platelets stored continuously in the cold. The effects of cold on platelets can be reversed if the platelets are re-warmed before eighteen (18) hours in the cold (Kattlove, Alexander et al. 1972; McGill 1978a; McGill 1978b; White and Rao 1998). Rewarming cold stored platelets to 37o C can lead to restoration of disassembled microtubules, return of the platelet discoid shape and normalization of in vitro physiologic responses, such as increased response to agonists and loss of hypotonic shock recovery, which were altered by continuous cold exposure (McGill 1978). This temperature cycle can be repeated periodically during cold platelet storage to prevent the permanent effects of the cold. In the mid 1970's McGill proposed that TC could be used to extend platelet storage in the cold to five (5) and to seven (7) days (McGill 1978a; McGill 1978b). He reached this conclusion after extensive studies on platelet morphology and in vitro testing which showed that repeated cycles with 30 minutes warm up to 37o C after twelve (12) hours in 4o C was sufficient for platelet storage of up to five (5) days and for efficient blood bank logistics. The study participants will be subject to occupational radiation exposure. Risks associated with exposure to low dose ionizing radiation are described in the Nuclear Regulatory Research Regulatory Guide 8 "Instructions Concerning Risks from Occupational Radiation Exposure" (See Appendix A).The Radiation Safety Officer (RSO) maintains records and conducts inspections of the laboratory to assure compliance. The Radiation Safety Committee oversees the radiation safety program and the RSO. Part II: Work Requirements The Contractor shall have approval from the US Nuclear Regulatory Commission to use radioisotopes, obtain IRB (Institutional Review Board) approval to perform this clinical trial, and conduct studies under Good Laboratory Practice. All laboratory staff shall be trained by the RSO in radiation safety. Seven (7) healthy volunteers shall be selected by the Contractor using Appendix B, Checklist for Donor Inclusion in the Study. Any "yes" answers in the "Checklist for Donor Exclusion from the Study" section of Appendix B shall render the volunteer ineligible for participation in the study. The Contractor shall administer the informed consent documentation on the selected volunteers and follow the clinical trial protocol approved under Investigational New Drug (IND) (See Appendix A). The Contractor is responsible for recruiting and compensating the volunteers. Due to CBER's facility move expected to the address below around mid-August 2014, a Notice to Proceed (NTP) shall be issued by the Contracting Officer prior to commencement of recruitment of volunteers to ensure the remaining stored samples can be processed by the FDA researchers concurrently with the human study. The move date is subject to change but will be completed and NTP issued by no later than 31 December 2014. The study shall be a prospective, open label, paired, active control design using two (2) units of autologous apheresis platelets, with one unit stored at RT for seven (7) days (control), and the identical other autologous platelet unit collected from the same donor stored for one (1) day at room temperature then six (6) days in TC conditions. The platelet collection shall be performed using a TRIMA apheresis instrument manufactured by Terumo Corporation. The cycling schedule shall consist of eleven (11) hours in 5o C and one (1) hour warming to 37o C, with agitation during the warm up period. On day five (5) of platelet storage a sample (8-10 mL) of each unit will be taken and tested for bacteria in a BacT Alert bacterial detection device (BioMeriuex Corp). If bacteria is present in any sample, only a 1/2000-5000 per unit chance, the volunteer shall be dismissed from the study and the process to replace that volunteer via the same steps above shall begin. Additionally, the Contracting Officer shall be notified immediately if any volunteer is dismissed from the study. On day seven (7) post-collection, another small sample (10-15mL), from each apheresis unit shall be incubated for approximately 20 minutes with a radioactive tracer. Each platelet sample from each apheresis unit shall be randomly assigned a distinguishing tracer, either approximately 60 uCi of Indium 111 (In111 ) or 100 uCi of Chromium 51 (Cr51). The radiolabelling of the cells shall be performed according to a standard protocol published by the Biomedical Excellence for Safer Transfusion (BEST) Collaborative (Dumont, LJ et al. Transfusion 2006) (see Appendix A). Independently, the platelets shall then be extensively washed, with only approximately 20 uCi of each isotope remaining, re-suspended in Phosphate-Buffered Saline (PBS), and simultaneously infused intravenously into the volunteer. After infusion of the radiolabelled platelets, serial blood samples shall be collected over a period of ten (10) days (one sample per day) to monitor and determine the amount of each cell-associated radioactivity remaining in circulation. The recovery and clearance of the RT and TC platelets shall be calculated from the data points, analyzed and reported in a final summary document. The remaining stored platelets shall be received in the FDA laboratory in Bethesda, MD within two (2) hours of termination of storage on day seven (7) post-collection. These remaining platelets shall be in plasma in platelet storage bags and at room temperature (20-24 C) for the duration of the transport. This time requirement is a critical factor for the viability of the cells and second stage of the experiment, which takes place at the FDA CBER internal animal facility, US Food and Drug Administration, 9000 Rockville Pike, Bethesda, MD, 20892. Deliverables • obtain and provide IRB approval to conduct this clinical trial (30 calendar days from date of award) • recruit healthy human volunteers provide inclusion checklist (45 calendar days from date of NTP) • administer the Informed Consent, collect sample data from each volunteer and follow the clinical trial protocol approved under IND (within 60 calendar days from NTP) • Provide/deliver apheresis platelet samples for each volunteer to be delivered to CBER, FDA on the day of infusion to the volunteer, for the animal study (200-300 ml) within 2 hours of completion of 7 day RT and TC condition storage process (within 67 calendar days from NTP) • analyze data and provide a summary of the data collected over the ten (10) day period for all 7 volunteers (within 100 calendar days from NTP) Part III: Supporting Information A. Return Address for Samples: US Food and Drug Administration Attn: COR (to be provided with award) 9000 Rockville Pike Bethesda, MD, 20892 B. Period of Performance Final summary report shall be provided within 100 days of NTP. Ultimate completion shall be no later than April 10, 2015. Section II: Instructions to Prospective Respondents Responses to this sources sought shall unequivocally demonstrate that respondent has the required equipment and personnel to perform the services. Though the target audience is small businesses capable of performing the sequencing, any interested party 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, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; • Information on the equipment, personnel and methods to be used to conduct the study. If interested offer is located outside a two (2) hour driving radius of the FDA Laboratory in Bethesda, MD, provide rational or approach to achieve the required two (2) hour delivery time; • Three (3) years of past performance information for the service of same or substantially similar items, to include date of services, description (should also include technical literature and specifications), dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, and client point of contact email address; • Descriptive literature, brochures, specifications, marketing material, etc. detailing the nature of the services the responding firm is regularly engaged in providing; • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement; • If a large business, identify the subcontracting opportunities that would exist for small business concerns; • Although this is not a request for quote, informational pricing is encouraged; • The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. The Government is not responsible for locating or securing any information, not identified in the response. Interested Parties 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 June 24, 2014 by 1:00 PM (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Crystal G. McCoskey, 3900 NCTR Road, Bldg 50/Room 426, HFT‐320, Jefferson, AR 72079‐9502 or email crystal.mccoskey@fda.hhs.gov. Reference 1133255 in all correspondence with the point of contact listed above. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether this requirement should be set aside for small business, made available to full and open competition or procured through other than full and open acquisition procedures. 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 combined synopsis/solicitation (No. 1133255) may be published via 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1133255/listing.html)
- Place of Performance
- Address: FDA CBER internal animal facility, US Food and Drug Administration, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03395154-W 20140615/140613234937-38b7ee83b2d43cfda8dd227edf4d3055 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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