MODIFICATION
A -- RECOVERY-PD Tests in Phase 0 Clinical Trials
- Notice Date
- 8/9/2010
- Notice Type
- Modification/Amendment
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 427, Room 12, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- RECOVERY-ST10-1096
- Archive Date
- 10/1/2010
- Point of Contact
- Howard R. Souder, Jr., Phone: 3018465096
- E-Mail Address
-
souderhr@mail.nih.gov
(souderhr@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- PLEASE REFER TO THE ATTACHED DOCUMENT FOR ACCESS TO THE LINKS OUTLINED IN THIS NOTICE. ARRA PD Assays Program: Development of Circulating Tumor Cell Pharmacodynamic Assays for Determining Effects of Targeted Therapies I. INTRODUCTION A. SAIC-Frederick, in support of NCI, requests that qualified U.S. businesses submit proposals to develop pharmacodynamic assays for measuring drug response of a number of high-priority molecular targets. Real-time assays to rapidly assess molecular response to treatment, with the capability of performing multiple assessments of patient response at multiple time points in the treatment protocol, are highly desirable as a means to rapidly develop single agent and combination targeted regimens. The capture and quantification of circulating tumor cells (CTCs) in patients with metastatic carcinoma may be a useful technique to provide an immediate assessment of prognosis and response to therapy. Enumeration of CTCs has been established as a useful prognostic indicator of patient survival after therapy for breast, colon, and prostate cancer and the CellSearch platform (JNJ Veridex) has received FDA clearance as a clinical diagnostic test. Some significant advantages of CTCs are that they can be monitored in "real-time", they can collected by minimally invasive procedures, and a patient can be tested repeatedly, potentially allowing construction of a true dynamic plot of drug action on molecular targets in tumors Circulating tumor cells can be captured and quantified either by immuno-magnetic separation, or by physical characteristics (e.g. density gradient separation, electrical, or filtration). The CellSearch System is an example of a technology which captures CTCs using antibody coated magnetic beads that recognize an epithelial cell surface antigen. The cells are then labeled with a second epithelial marker and quantified by a semiautomated fluorescent-based microscopy system. A weakness of this particular approach is that it does not provide an immediate distinction between cells derived from tumors and coincidental epithelial cells. It is envisioned that the NCI will assist the selected Offerors in the development of robust pharmacodynamic assays for immediate clinical application via collaboration and partnership. An example of this collaboration is provision of blood from relevant drug-treated engrafted (xenograft) mouse models for the target of interest and in certain circumstances the contribution of bulk critical reagents, calibrators, and positive and negative controls generated in NCI's laboratories and in GMP-grade contracting and manufacturing facilities. The provision of high quality assay kit components is essential for ensuring successful analytical validation of the assay. Furthermore, these assays will undergo "clinical fit-for-purpose" studies in NCI Phase 0/I clinical drug trials, which in turn may lead to the generation of FDA-quality data for 510k or PMA filings by the Offeror clearance. The clinical demonstration of assay performance is often critical to capture market share through widespread clinical adoption, as well as obtaining coverage by healthcare insurers. Although the type of partnership/collaboration will be unique for each assay, the NCI will be able to significantly accelerate the timeline for generating data required for CLIA laboratory adoption and/or FDA approval by leveraging the NCI's resources. B. The goal of the ARRA-funded NCI PD Assay program is to fund eligible U.S. businesses to develop commercially viable products that advance the research and development needs of the Institute. It is expected that companies will extend this work into developing research kits or diagnostic reagents to stratify patients for clinical trial selection and/or to evaluate dosing and target modulation to new therapeutic agents. The NCI Strategic Plan identifies validating molecular targets for cancer prognosis, metastasis, treatment response, and cancer progression as a strategic priority (Strategy 4.2). Part of this strategy includes creating a library of validated molecular target assays in order to advance broad development of targeted anti-tumor agents. Grant mechanisms thus far have not been an effective method of developing these assays, as they have little publication value. Market analysis indicates that CLIA-quality pharmacodynamic assay development, qualified critical reagents, fit-for-purpose target modulation are valuable steps for eventual commercialization of cancer diagnostics and laboratory assays, in addition to serving the needs of cancer therapeutic development. C. The goal of this project is to develop and deliver a method for detection, purification, enumeration and characterization of CTCs that has the following characteristics: 1. The method is suitable for use on small animals. Implicit in this requirement is the ability to analyze sample volumes ranging from 0.1-1.0 mL for CTC determination a. Methods for CTC analysis should be performed on the same aliquot of blood as is used for CTC enumeration. b. Methods for collection, handling, and storage of CTC should be optimized to provide at least a 72 hour window for analysis after sample collection. 2. A method that does not rely on CTC collection by use of a single cell surface marker, while yielding efficient recovery of all intact CTC present. 3. A method that yields CTC of sufficient purity and quality to allow RT-qPCR analysis of gene expression without significant interference from contaminating MNCs and normal epithelial cells 4. The instrument platform should be suitable for investigational use (currently or within 3 years of award of this contract. in a clinical laboratory setting. The required instrument design is open architecture: i.e. amenable to development of research assays by qualified clinical staff. At the conclusion of the project, the Offeror(s) is expected to contribute to advancing the use of circulating tumor cells in patient care by the development of more efficient platforms, especially using lower blood volumes, and the development of ‘pharmacodynamic' assays to interrogate the captured cells. The method, with full development, should allow quantification of the modulation of molecular targets upon treatment with investigational anticancer therapeutics and support pharmacodynamic studies in animal models and in human cancer patients. Ultimately, these studies may find a correspondence between quantitative pharmacodynamic response and degree of tumor growth modulation in animal efficacy models via the same target. Company deliverables are Standard Operating Procedures (SOPs) for these assays, all supporting data, and critical reagents for independent validation, and necessary instrumentation. II. BACKGROUND A. NCI Developmental Therapeutics Clinic for Phase 0, I and II Clinical Trials To support discoveries made in the NCI NExT Program, the NCI's scientific expertise and state-of-the-art drug development resources are being directed towards more rational selection and clinical evaluation of new molecularly targeted agents to identify safer, more effective treatments for cancer. One of the avenues available for evaluating new anticancer agents is through the conduct of Phase 0 clinical trials. The NCI established the Developmental Therapeutics Clinic (DTC) within the NIH Clinical Center so that DCTD could use Phase 0 clinical trial designs as permitted by the FDA's Exploratory IND Guidance to evaluate agents early in the clinical development process. Phase 0 studies are first-in-human studies of molecularly targeted agents that can evaluate a pharmacodynamic response to drug therapy -as measured by target modulation in tumor-and the agent's PK properties before the more traditional Phase I safety and tolerability evaluation. By administering pharmacologically active but sub-therapeutic, non-toxic doses, Phase 0 trials can support imaging and biodistribution studies, evaluate clinically relevant biomarkers, evaluate the kinetics and/or dynamics of multiple analogs, or assess an agent's MOA. Conducting such a Phase 0 trial can require extensive preclinical effort to develop and validate the PD assay or the imaging agent that will serve as the primary clinical trial endpoint, but the data obtained will inform subsequent Phase I/II single agent or combination studies with suitable agents. These efforts will also focus resources on only the most promising new anticancer drugs by eliminating investigational agents that are unlikely to have activity in large Phase II/III clinical trials. B. DCTD also designs and conducts extramural Phase I and II trials of novel agents, supporting the expedited bench-to-bedside goal of the NCI. The potential for rapid patient accrual combined with world-class resources in basic, clinical, and translational sciences allow the optimum evaluation of promising new anticancer agents. DCTD's Protocol and Information Office (PIO) and Cancer Therapy Evaluation Program (CTEP) shepherds new trials through the review and approval process-many of the trials are multicenter collaborations with other specialist cancer centers and oncology groups and consortia. C. Key Role of Validated, Fit-for-Purpose PD Assays in Phase 0 and Other Early Stage Clinical Studies Evaluation of targeted agents in Phase 1 clinical trials is complicated by difficulty of achieving any clinical effect by RECIST criteria, since drugs are administered as single agents despite most tumors having multiple molecular defects. This conventional approach applied to targeted therapies establishes tolerated dose levels but does not provide evidence of drug efficacy or lack of efficacy. Phase 0 clinical trials are specifically designed to test drug activity on a molecular target in the tumor, and measurement of that drug effect is a clinical trial endpoint. A report of a successful Phase 0 trial using a pharmacodynamic endpoint can be found at: Journal of Clinical Oncology 27:2705, 2009. Meeting these challenges requires rigorously developed and validated, quantitative assays, that have direct pre-clinical evidence, either in animal models or in ex vivo studies with human tissues, of utility in detecting drug effect on target (pharmacodynamics, PD). An example of one such assay specifically developed for use on Circulating Tumor Cells can be found in Clinical Cancer Research 16:1073, 2010. D. Current Status of Therapeutics Discovery by the NCI The primary strength of the NCI's Experimental Therapeutics (NExT) Program is transitioning agents from early development to first-in-human studies. The NCI is highly effective in taking late-stage preclinical drug candidates through the final steps of development that lead to a successful IND filing with the US Food and Drug Administration (FDA); these efforts have resulted in the approval of more than 40 anticancer agents. The core elements for late-stage drug development are the conduct of toxicology studies and production of clinical-grade material-activities that are the most expensive and least available in the academic sector. In addition, the NCI's efforts to move agents from late preclinical studies to first-in-human clinical trials have been significantly enhanced over the past 3 years through initiatives designed to increase the flow of molecules from intramural and extramural investigators into the clinic. The culmination of the DCTD and the CCR combined efforts was recently exemplified in the NCI's completion of first Phase 0 trial of a therapeutic agent in oncology. A critical component of this success has been the connection of the molecular pharmacology and early clinical testing resources of the CCR with the extramural resources of the DCTD in the areas of screening, imaging, preclinical pharmacology (PK and PD), toxicology, and formulation, to produce an NCI-led oncologic therapeutics development effort capable of expediting the evaluation of novel anticancer molecules towards the clinic. The NCI has also assembled a team of highly talented clinical investigators who can launch the initial clinical evaluation of a new agent at the conclusion of pre-clinical development, an invaluable resource for NMEs without prior human experience. E. The DCTD Pharmacodynamics Program This program is supported preclinically by the Laboratory of Human Toxicology & Pharmacology (LHTP) and clinically by the National Clinical Target Validation Laboratory (NCTVL). LHTP integrates PD, toxicodynamics, and biopharmaceutics to identify preclinical modeling conditions in the mouse that will closely replicate the clinical situation. The resulting "humanized," nonclinical model of cancer is expected to better predict therapeutic outcome and biomarker changes than more traditional preclinical studies. Using humanized treatment and assessment conditions in mouse models of human disease is important in validating the analytical performance of PD assays prior to their use as primary endpoints of Phase 0 trials. Validated PD assays and the companion Standard Operating Procedures (SOPs) for specimen handling, processing, and storage required to obtain valid assay results, are formally transferred from PADIS to the NCTVL; the NCTVL uses these validated PD assays to measure molecular drug effects in clinical specimens from Phase 0 and I trials aiming to confirm preclinical activity of new agents against intended molecular targets in human disease. Close collaboration between CCR investigators, NCTVL and the Pharmacodynamics Assay Development & Implementation Section (PADIS) in LHTP ensures the "clinical readiness" of valid laboratory assays for clinical confirmation of molecular activity of CBC agents in these first-in-human studies. Confirmation of drug action on intended molecular target in a Phase 0/I trial is a Stage Gate for a compound to advance into Phase I/II clinical trials under NCI sponsorship, with possible continued NCTVL support of PD studies. PD-based Phase 0/I trials that confirm drug action on intended molecular targets can provide data to accelerate the incorporation of targeted agents into existing clinical treatment regimens and develop new combination regimens from these agents. F. NCI-Frederick, the Federally Funded Research and Development Center at the NCI The NCI-Frederick is the advanced technology development facility for the NCI. For agents that require specific genetically engineered mouse models, it is anticipated that the CCR's Mouse Cancer Genetics Program (MCGP) through the newly established Center for Advanced Preclinical Research will conduct efficacy studies in those models or supply animals for DCTD's Biological Testing Branch to do so. The MCGP uses molecular mouse genetics as a primary tool to better understand the fundamental processes underlying mammalian development and disease III. MINIMAL TECHNICAL REQUIREMENTS FOR PROPOSED PLATFORMS The proposal must demonstrate that the proposed platform(s) meets these minimum technical requirements; if not, the proposal will not qualify for further review. A. The required instrument design is open architecture, i.e., amenable to development of research assays by qualified clinical laboratory staff. B. The instrument platform should be suitable for investigational use in a clinical laboratory setting within 3 years from date of award. C. The instrument should minimally be manufactured in an ISO-9xxx-certified facility within the US. D. The instrument manufacturer should minimally have a strategic plan for obtaining CE Mark, or FDA Clearance or CLIA Compliance. A current manufacturer's Filing at FDA is acceptable. E. Provide a reference material or standard to be used in gauging accuracy of CTC determination in specimens within 3 years from date of award. F. Methods for CTC molecular analysis should be performed on the same aliquot of blood as is used for CTC enumeration and preferably on the same cells. IV. DELIVERABLES A. Platform: For each platform, the subcontractor shall provide a validation package, a standard operating procedure (SOP), characterized cell lines, and sufficient reagents for SAIC-F quality control (IQC) testing and verification of performance and successful replication of the capture method using the platform placed at the PADIS laboratory at NCI-Frederick by the company /institution for at least a 3 month time period (beta-site testing of SOP-based assay performance using qualified reagents ). 1. Establish separation technology using cell lines with differences in physical characteristics and/or expression of molecular target analytes. The molecular targets in these cell lines are to be verified with molecular measurements such as Western blotting, etc. 2. Establish CTC recovery and analytical performance within the sample volume range 0.1 - 1.0 ml blood, and optimal blood handling criteria, including CTC permeabilization and fixation, by using samples spiked with the appropriate cell line. 3. Demonstrate reproducibility of capture, cell quality (viability or assay ability), and cell purity (%Tumor cell vs. %MNCs, %tumor cell vs.% normal epithelial cells). 4. Optimize reagents and protocol. - Methods for collection, handling, and storage of CTCs should be optimized to provide at least a 72 hour window for analysis after sample collection. 5. Provide fully detailed SOPs for instrument operation, calibration and specimen handling. B. Assay For each assay, the Subcontractor will provide a validation package, an assay-specific data analysis algorithm, and report template (Excel macro or other universal format), a standard operating procedure (SOP), and sufficient reagents for SAIC-F quality control (IQC) testing and verification of performance and successful replication of the assay. NCI will assist in providing appropriate cell lines and testing drugs/compounds. 1. Establish reagent specificity verified with independent molecular measurements, for example a. Western blot or ELISA validation of capture and target reagents. b. Flow cytometry to show the physical characteristics and antigen expression of the selected control cell lines. 2. Provide a reference material or standard to be used in gauging accuracy of CTC determination in specimens. 3. Establish reagent specificity with a cell line set including known expressors and non-expressors of the molecular target for capture and detection. The cell lines are to be verified with specific molecular measurements. a. Establish that modulation of a molecular target (such as pY1235 -MET) can be detected in the responsive cell line by treatment with a target-specific agent. b. Establish that the target is not detectably modulated in the responsive cell line by a compound known to not affect the assay target. c. Demonstrate that the study agent does not interfere with optical readouts in the CTC measuring instrument. d. Optimize specimen handling criteria to preserve target analytes to include CTC permeabilization and fixation (preferably performed on-line in the instrument to be used on exactly the same cells being enumerated). e. Procure one lot of conjugated reporter (e.g. fluor-tagged antibody to PSA, PSMA, Her2, etc.) and demonstrate that it meets performance criteria of step one. C. System Validation: 1. Finalize specimen handling criteria to preserve target analytes to include CTC permeabilization and fixation. a. Methods for collection, handling, and storage of CTC should be optimized to provide at least a 72 hour window for analysis after sample collection (storage temperature as recommended by Offeror). b. Validate that the range of blood volumes (0,1 - 1.0 mL) the optimal blood handling criteria, including CTC permeabilization and fixation, by using samples spike with the appropriate cell line(s) in the specimen collection tube. 2. Demonstrate Assay Analytical Performance a. Demonstrate reproducibility of capture, cell quality (viability or assay-ability), and cell purity (%tumor cell vs. %MNCs, and % tumor cell vs. % normal epithelial cell). b. Optimize reagents and protocol. 3. Demonstrate Assay Analytical Performance for each molecular target a. Spike Recovery: Using the appropriately processed cancer cell lines, spiked into whole blood in the clinical collection tube, establish the recovery and specificity of the assay reagents to be used for CTC molecular characterization. i. Recovery target is 100+/- 20% of spiked tumor cells. ii. The range of linearity of recovery (by CTC number and blood volume) will be determined. iii. Specify the range of CTC enumeration for which recovery is 80 to 120 %, testing spikes ranging from a minimum of 10 up to a maximum of 500 spiked cells per blood aliquot. iv. Perform the identical study on three different days. 4. Development and validation test runs will be performed with instrument runs of calibrators and controls simultaneously, and results are considered valid only if the calibrators and controls perform within manufacturer's specification. V. MATERIALS TO BE FURNISHED TO THE SUB-CONTRACTOR BY NCI-FREDERICK. A. Blood specimens (coded) for Fit for Purpose studies. B. Control specimens for assay validation and transfer, including recovery, dilution linearity, etc. C. NCI-generated data on reagent qualification and prototype assay performance. VI. MILESTONES AND PERFORMANCE A. Milestone I Activities and Expected Deliverables: Objective: Assemble all key assay reagents and demonstrate a working prototype assay on the instrument platform to be used. 1. Identify and procure or produce specific reagents for the CTC platform, including calibrators that allow verifiable quantitation of CTC numbers in specimens to be assayed. 2. Provide samples of the reagents selected for the research grade assay to NCI in sufficient quantities for QA analysis. 3. Develop a research grade method capable of labeling carcinoma cells (epithelial derived cancers) with a recognized tumor marker, e.g., PSA. 4. Characterize assay reproducibility, variability and accuracy. 5. Write a plan for pharmacodynamic assay development in Milestone II. The plan should consider measurement of a recognized cancer biomarker analyzed on a PCR platform, as an example of a molecular analysis application. The completion of a working CTC assay method for use in small blood volumes that establishes feasibility for the target range (0.1 - 1.0 mL) plus the written plan will allow progression to Milestone II and payment while other Milestone I activities continue. (Note each milestone is a separate task). B. Milestone II Activities and Expected Deliverables Objectives: Develop a research grade, analytically validated, pharmacodynamic assay using qualified critical reagents for a suitable molecular target, e.g. Topoisomerase I. 1. Deliver to NCI the SOP(s) of the pharmacodynamic assay for the molecular target described and all supporting data. 2. Transfer the assay and reagents to NCI. 3. Deliver to the NCI the SOP of a CLIA-quality assay method for Circulating Tumor Cells in patient blood specimens. 4. Demonstrate that the analysis of the proposed cancer biomarker can be restricted to the circulating tumor cells. Completion of objectives 1, 2, and 3 will allow progression to Milestone III and pro-rated payment. Full completion of Milestone II must include objective 4. C. Milestone III: Activities and Expected Deliverables. Objective: Transfer of the Assays to NCI for Fit for Purpose testing. 1. Transfer the SOP-based assay to the PADIS lab at NCI-Frederick. 2. Both the subcontractor laboratory and PADIS conduct an evaluation of Fit for Purpose test specimens. 3. Make available to NCI sufficient critical reagents (100 assays) and instrumentation (if applicable) for independent test evaluation of pharmacodynamic responses. 4. Perform studies as directed by SAIC-Frederick to characterize pharmacodynamic response of CTCs in blood specimens from pre-clinical studies (approximately 1000 specimens provided by NCI). 5. Determine next steps for generation of kits and reagents suitable for sale to the research community. 6. Prepare a written commercialization plan for generation of kits and reagents suitable for sale to the research community, the Operations and Technical support contractor to the NCI-Frederick, (currently SAIC-Frederick), and the US government. VII. Abandoned Project If the assays developed under this contract are not commercialized and available for sale within 24 months of completing Milestone III, SAIC-Frederick and/or the NCI may produce and distribute the assay test kits and/or reagents to the non-commercial research community VIII. Responsibilities A. SAIC-F Contracting Officer's Technical Representative (COTR) The Contracting Officer's Technical Representative is responsible for: (1) Monitoring the subcontract technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) Interpreting the Statement of Work and any other technical performance requirements; (3) Performing technical evaluation as required; (4) Performing technical inspections and acceptances required by the subcontract; and (5) Assisting in the resolution of technical problems encountered during performance. The SAIC-F Project Management Office will assist the COTR in managing these duties. The COTR will be identified by the time of the award. Neither the COTR nor the Project Management Office nor any person or entity other than the Contracting Officer possess any authority, implied or apparent, to provide direction that may cause or influence the Subcontractor to incur additional costs for which reimbursement may be sought. Any costs incurred by the Subcontractor not delineated herein or without the prior written approval of the Contracting Officer are incurred at the Subcontractor's significant risk of non-payment. B. Project Management The COTR will coordinate and track the progress of projects to ensure activity is focused on achieving specific milestones and deliverables. The DCTD Project Management Office (PMO) will integrate the progress of projects to ensure activity is focused on achieving Stage Gate milestones. The PMO will provide scientific writing, document management, and training support to the ARRA-PD Program. The PMO will also prepare reports for Project Leader/Team interactions with the Pharmacodynamics Assay Management Team and/or the Next Committees. Project Managers or COTR in each Project Team will have the following tasks: Working with the Project Leader and other Project Team members to prepare the operational plan for each new Project based on Next Committee recommendations. Developing work breakdown structures, timelines, critical paths and high risk areas, and templates to tract project status and deliverables. Documenting milestones and project progression. Preparing quarterly reports for the SAIC-Frederick Development Team, and Senior Management Committees. Supporting tools and infrastructure for the ARRA PD Program will consist of Enterprise-wide software systems to manage data, documents, projects, and project portfolios. The data will be available to Project Team members and the PAMT to support resource management and decision making. To accomplish this effectively, Participants will manage all of the resources generated under this agreement, including IP, in a manner which promotes the sharing of research resources, candidates, and data among the ARRA Participants. It is understood by the Participants that the primary goal is the development of novel pharmacodynamics assay. On a quarterly basis, Project teams will report on project status including immediate plans and fiscal expenditures to the appropriate Discovery or Development Committee. IX. ADDITIONAL SUBCONTRACTOR REQUIREMENTS A. Project Team The Offeror(s) shall appoint a Project Team Leader who will represent their project team, consisting of scientists with expertise in relevant disciplines according to the context of their proposal (e.g. apoptosis Multiplex Panel, DNA repair global assessment panel). The On-site Project Leader and other project team members will participate in scientific/technical and project-specific discussions with SAIC-F COTR, NCI Project Sponsor, and SAIC-Frederick, or NCI scientists with pertinent expertise, as warranted by the nature of tasks or requested by either party. These discussions will take place at a minimum every two weeks until each party is satisfied that lines of communication are firm or when requested by either party. B. Reporting Requirements 1. Progress Reports The Offeror's Project Manager will deliver quarterly formal reports to the SAIC-F COTR detailing progress on the project compared t timelines and milestones, as well as anticipated activities over the coming quarter. There will be bi-weekly project review meetings conducted by the SAIC-F COTR. A representative of the company will present a written budget summary for the current quarter along with forward-looking expenses for the coming quarter. The SAIC-F COTR will submit a quarterly report for each project, which is to be established for the purpose of reviewing the progress of all the projects initiated under the current SOW. If the project is determined to be unsatisfactory or failing due to lack of progress or deficient deliverables, SAIC-F will issue a Stop-Work order (project termination) in accordance with Section 19 - Termination of the Subcontract Agreement. The Offeror(s) will be required to submit a final project report up to the last achieved milestone or completion of the project. 2. Final Reports The Offeror shall submit a report at the conclusion of the project, detailing work completed, to include: a. Final SOP b. Assay Compositions 1) Instrument Performance Specifications 2) Assay Performance Specifications 3) Assay Validation Package a) Analytical Validation b) Assay Transfer Validation c) Fit for Purpose data as appropriate, in conjunction with NCI-Frederick. The SAIC-F Contracting Officer's Technical Representative (COTR), in conjunction with the SAIC-F Contracting Officer, will review the submitted reports and determine whether the progress of each specified task is on track as evidenced by on-time delivery of deliverables and/or achievement of milestones. 3. Operating Constraints This effort is to be solely funded by the American Recovery and Reinvestment Act (ARRA) Funds. The Offeror(s) with the ARRA-funded projects will be subjected to all the ARRA-mandated activities and reporting requirements as applicable.
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- Address: Subcontractor's location - TBD, United States
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