AN91--Intent to sole source - -CrownBioScience (VA-20-00031926)
The Department of Veterans Affairs, South Texas VA Health Care System, intends to negotiate on a sole source basis, pursuant to FAR 6.302-5, with the Crown Biosciences to test the efficacy of palmatine alone and in combination with standard of care agent in preventing pancreatic tumor growth using a molecular/biochemical marker of efficacy in biospecimens. Biosciences will provide support services for E4244-U2001 CBSD Organoid Study on 4 PDXO models. Crown BioScience is the only company that has generated more than 100 models including genomic sequencing on each of these models. This information nis critical for appropriate selection of models for pre-clinical testing. No other companies were identified with the number of validated models. This is a notice of intent is not a request for competitive proposals; however, any responsible source who believes it is capable of meeting the requirement may submit a capability statement to the contracting office no later than Wednesday, March 25th, 5:00 PM, EST. Interest/capability statements may be sent to Lynn Portman at lynn.portman@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.
36C24E20Q0090 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 4
Special Notice 1/1
3/20/20, 10:30 AM Animal Influenza Virus Characterization and Analyses
The Centers for Disease Control and Prevention intends to award a sole source firm fixed price purchase order to Cornell University Animal Health Diagnostic Center & New York State Veterinary Diagnostic Laboratory (AHDC) for yearly influenza virus testing, subtyping by whole genome sequencing, and prompt reporting of result analyses on canine and feline samples. As the primary institution leading the Canine Influenza Virus (CIV) Network, AHDC is the sole institute that receives PCR results and specimens from all over the United States for CIV H3N2 and CIV H3N8 diagnostics and confirmatory purposes. Additionally, AHDC is the originator of a comprehensive CIV whole genome sequencing pipeline which allows for further virus characterization to evaluate mutation impact on virus transmissions. AHDC is a U.S. Department of Agriculture, Animal and Plant Health Inspection Service, National Animal Health Laboratory Network Level 1, USG designated laboratory testing of agricultural species for influenza. Lastly, they perform laboratory testing under ISO 17025 Biological Scope of accreditation.. This contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b) (SAP) and 41 U.S.C. 3304(a)(1).. Interested persons may identify their interest and capability to respond to the requirement or submit proposals.
This notice of intent is not a request for competitive quotations; however, all quotations/responses received within fifteen (15) days of the issuance of this notice will be considered by the government. A determination by the government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any quotation/response should be emailed to William Brannen at VWL0@cdc.gov by 3:30 P.M., EST., May 27, 2020.
45927 Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services
Pre-Solicitation 1/1
5/12/20, 3:07 PM AN91--36C24E-20-AP-0077 | 508-20-1-1030-0055 | T3 Laboratories
Page 2 of 2
The Veterans Health Administration (VHA), Office of Research and Development (R&D), Regional Procurement Office (RPO) East in Pittsburgh, PA intends to negotiate on a sole source basis with Translational Testing And Training Laboratories, Inc (T3).
The requirement is for the procurement of 12 months of services for endovascular cardiovascular operations and magnetic resonance imaging for large animal studies.
T3 possesses the combination of expertise, equipment, and imaging necessary for the safe and successful completion of Dr. Brewster s SPiRE Award, which involves the use of pigs and endovascular occlusion of the right leg artery and magnetic resonance imaging and then necropsy of these animals.
This procurement is being conducted IAW FAR 13.106-1(b), Soliciting from a single source for purchases not exceeding the simplified acquisition threshold; and VHAPM 813.106-1(b), Soliciting from a Single Source for Single Source Awards using Simplified Acquisition Procedures (SAP) under Simplified Acquisition Threshold (SAT). This is because the Government asserts that T3 is the only contractor that can provide these specific services needed by the R&D Laboratory at the Atlanta VA Medical Center in Decatur, Georgia.
T3 is a pre-clinical institute operating a GLP compliant and AAALAC accredited facility which is a requirement for the Atlanta VAMC R&D Department. Additionally, T3 is in close proximity to the Atlanta VAMC (within 30 minutes); this is crucial to enable travel without compromising the protocol and scientific rigor.
This notice of intent is not a request for competitive proposals. However, any responsible source who believes it is capable of meeting the requirement may submit a capability statement and supporting documentation to the Contracting Officer no later than Friday, May 15, 2020, (6:00 PM, EST). Interest/capability statements may be sent by email to Mr. Robin Simmons at robin.simmons@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.
36C24E20Q0144 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 4
Special Notice 1/1
5/12/20, 5:29 PM FSS Paraguay
The Naval Medical Research Unit No. 6 (NAMRU-6) is looking for a public or private institution in the country of Paraguay with a large trajectory of research in infectious and tropical diseases, mainly in viruses, for a collaborative research effort to execute in Paraguay the study entitled: “Characterization of the infectious causes of acute febrile and exanthematous illness in Latin America”. This study is aimed at determining the etiology of febrile disease syndromes in a number of countries throughout Latin America including Paraguay. This acquisition requires carrying out coordination and obtainment of study authorization from local health facilities to perform the study in one Paraguayan site: Mariscal Estigarribia in El Chaco region; obtainment of local IRB approval; recruitment and training of local health personnel for performing the study; screening at least 300 potential study participants per performance period; performing the informed consent process as described in the protocol; collecting all the study approved information and biological samples; labeling and keeping of samples in adequate cold-chain conditions to preserve viruses; maintenance of all forms with identifiers in a locked office inside the site; preparation of biological samples for shipments to NAMRU-6 in adequate cold-chain conditions; shipment of samples in proper cold-chain conditions to NAMRU-6; delivery to NAMRU-6 of all samples collected as part of the study, consent/assent documents, and all epidemiological forms; reporting laboratory results provided by NAMRU-6 to local health authorities. All activities must be carried out with the utmost adherence to all ethical and quality standards, in order to minimize risk of performance errors and maintain compliance with appropriation of funds and expectations of the sponsor. The period of performance is 4 months with an optional two 1-month extensions, effective from the date of contract approval.
VEID200260 Department of the Navy Naval Supply Systems Command
Solicitation 1/1
3/3/20, 9:55 AM AN91-- RESEARCH SERVICE - MEG ANALYSIS
BACKGROUND: Mild traumatic brain injury (mTBI) is a leading cause of sustained physical, cognitive, emotional, and behavioral deficits in OEF/OIF/OND Veterans and the general public. However, the underlying pathophysiology is not completely understood, and there are few effective treatments for post-concussive symptoms (PCS). In addition, there are substantial overlaps between PCS and post-traumatic stress disorder (PTSD) symptoms in mTBI. IASIS is among a class of passive neurofeedback treatments that combine low-intensity pulses for transcranial electrical stimulation (LIP-tES) with electroencephalography (EEG) monitoring. LIP-tES techniques have shown promising results in alleviating PCS individuals with TBI. However, the neural mechanisms underlying the effects of LIP-tES treatment in TBI are unknown, owing to the dearth of neuroimaging investigations of this therapeutic intervention. Conventional neuroimaging techniques such as MRI and CT have limited sensitivity in detecting physiological abnormalities caused by mTBI, or in assessing the efficacy of mTBI treatments. In acute and chronic phases, CT and MRI are typically negative even in mTBI patients with persistent PCS. In contrast, evidence is mounting in support of resting-state magnetoencephalography (rs-MEG) slow-wave source imaging (delta-band, 1-4 Hz) as a marker for neuronal abnormalities in mTBI. The primary goal of the present application is to use rs-MEG to identify the neural underpinnings of behavioral changes associated with IASIS treatment in Veterans with mTBI. Using a double-blind placebo controlled design, we will study changes in abnormal MEG slow-waves before and after IASIS treatment (relative to a sham treatment group) in Veterans with mTBI. In addition, we will examine treatment-related changes in PCS, PTSD symptoms, neuropsychological test performances, and their association with changes in MEG slow-waves. We for the first time will address a fundamental question about the mechanism of slow-waves in brain injury, namely whether slow-wave generation in wakefulness is merely a negative consequence of neuronal injury or if it is a signature of ongoing neuronal rearrangement and healing that occurs at the site of the injury. Specific Aim 1 will detect the loci of injury in Veterans with mTBI and assess the mechanisms underlying functional neuroimaging changes related to IASIS treatment using rs-MEG slow-wave source imaging. We hypothesize that MEG slow-wave source imaging will show significantly higher sensitivity than conventional MRI in identifying the loci of injury on a single-subject basis. We also hypothesize that in wakefulness, slow-wave generation is a signature of ongoing neural rearrangement / healing, rather than a negative consequence of neuronal injury. Furthermore, we hypothesize IASIS will ultimately reduce abnormal MEG slow-wave generation in mTBI by the end of the treatment course, owing to the accomplishment of neural rearrangement / healing. Specific Aim 2 will examine treatment-related changes in PCS and PTSD symptoms in Veterans with mTBI. We hypothesize that compared with the sham group, mTBI Veterans in the IASIS treatment group will show significantly greater decreases in PCS and PTSD symptoms between baseline and post-treatment assessments. Specific Aim 3 will study the relationship among IASIS treatment-related changes in rs-MEG slow-wave imaging, PCS, and neuropsychological measures in Veterans with mTBI. We hypothesize that Reduced MEG slow-wave generation will correlate with reduced total PCS score, individual PCS scores (e.g., sleep disturbance, post-traumatic headache, photophobia, and memory problem symptoms), and improved neuropsychological exam scores between post-IASIS and baseline exams. The success of the proposed research will for the first time confirm that facilitation of slow-wave generation in wakefulness leads to significant therapeutic benefits in mTBI, including an ultimate reduction of abnormal slow-waves accompanied by an improvement in PCS and cognitive functioning.
The Contractor shall provide services in support of Dr. Huang s VA Research Study, H170033, Passive Electrical Neurofeedback Treatment of MTBI: MEG and Behavioral outcomes MEG Level 2 Analysis Hours will be used for advanced MEG data analysis including but not limited to Utilization of Matlab Software and Dr. Huang s Patented Software fast-vestal, programming of the software applications pertinent to the subject populations and higher order statistical analysis, and assistance with new study design and provide service in support of Dr. Huang s VA IRB Study, H170033, Passive Electrical Neurofeedback Treatment of MTBI: MEG and behavioral outcomes may Level 1 analysis hours will be used for the management of data quality activities, provide basic level of data pre-processing including utilization of MEG data analysis software including Neuromag Software and Freesurfer, and Basic Statistical Analysis of MEG data.
SPECIFIC TASKS:
MEG Level 1 Analysis Hours
- Management of data quality activities
- Provide basic level of data pre-processing including utilization of MEG data analysis software including Neuromag software and Freesurfer
- Basic statistical analysis of MEG data
MEG Level 2 Analysis Hours
- Advanced MEG data anaylsis including but not limited to utilization of Matlab software and Dr. Mingxiong Huang s patented software Fast-VESTAL
- Programming of software applications pertinent to the subject populations and higher order statistical analysis
- Assistance with new study design
PERFORMANCE MONITORING:
The PI, Dr. Mingxiong Huang, will be checking the quality of performance when MEG analysis hours are used for both Level 1 and Level 2 MEG Analysis.
PLACE OF PERFORMANCE: UCSD RIL: 3510 Dunhill Street, San Diego, CA 92121
36C26220C0174 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 22
Special Notice 1/1
7/7/20, 4:34 PM