SPECIAL NOTICE
A -- Ventilator Challenge Call for Proposals
- Notice Date
- 5/7/2020 3:05:44 PM
- Notice Type
- Special Notice
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- W6QK ACC-APG NATICK NATICK MA 01760-5011 USA
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-20-S-0010
- Response Due
- 5/12/2020 9:00:00 AM
- Archive Date
- 05/27/2020
- Point of Contact
- Richard Totten, Phone: 3016192446
- E-Mail Address
-
richard.w.totten2.civ@mail.mil
(richard.w.totten2.civ@mail.mil)
- Description
- Ventilator Challenge Call for Proposals Contracting Agency: Department of the Army Contracting Office: Army Contracting Command, Natick Contracting Division (NCD) Contracting Office Location: Fort Detrick, MD, USA Program Office: JPEO CBRND Medical PBA CALL Number: W911QY-20-S-0011 CALL Issuance Date: 7 May 2020 Proposals Due: 5 days from posting date A prize competition was held under U.S.C 2374(a) for COVID-19 Ventilators executed by the US Army. This Request for Project Proposals (RPP) is being issued as a follow-on to the prize competition. The Government is hereby requesting formal submission of proposals to execute a formal agreement under 10 USC 2371(b), Other Transaction Authority for the prototyping. Upon receipt of a proposal submitted in response to this RPP, the next steps are as follows:�� The Government will evaluate the proposal. Discussions among the parties, whether verbally or in writing, will occur as appropriate. The Government will send an agreement to the offeror. Additional discussions will occur as necessary. Awards will be made after evaluation and selection of a successful proposal.� (Note: Awards are dependent upon the availability of funds.) Objective. Under the Initial Challenge Solicitation, technology pitches were submitted/selected based on the requirements of the posted solicitation. As such, the subsequent award document requiring any such development and demonstration of the concept prototype shall be an agreement authorized by 10 USC 2374a. In this regard, the senior procurement executive for the agency determined use of 10 USC 2374a authority meets the condition specified at 10 USC 2374a (d)(1)(D). This Request for Project Proposal (RPP) is issued to request project proposals in compliance with USC 2371(b), and is being issued for planning purposes only.� It is not to be construed as a commitment by the Government to award an agreement, nor will the Government pay for the information solicited. Due date: The date and time set for submission of Proposals is shown above. Proposals received after the set time will not be considered unless the Government, at any time, elects to allot further time for Proposal submissions. Proposals shall be sent by email to: richard.w.totten2.civ@mail.mil The Government will review/evaluate the submitted proposals and if there is Government interest, the Agreements Officer may issue one or several OTAs for the development of prototype(s). The Government may award an agreement based on the proposal submission, or may require submission of additional details. The award of Prototype OTAs shall be for the development of prototypes in accordance with 10 U.S.C. 2371b for projects that are directly relevant to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the Department of Defense, or to improvement of platforms, systems, components, or materials in use by the Armed Forces. A prototype project can generally be described as a preliminary pilot, test, evaluation, demonstration, or agile development activity used to evaluate the technical or manufacturing feasibility or military utility of a particular technology, process, concept, end item, effect, or other discrete feature. Only a warranted Agreements Officer may obligate the U.S. Government to the expenditure of funds for awards under this Announcement.� Evaluation will be performed by JPM Medical scientists, other Federal Agency Representatives, outside scientists with diverse expertise, clinicians, consumers, or combinations thereof based on Appendix 1 to this announcement. After the JPM Medical evaluation and selection, an award will be made to the successful proposal. Subsequent awards depend upon the availability of funds and fulfillment of requirements and priorities determined to exist at the time of award. In some cases, funding priorities may change as certain scientific tasks are addressed and new mission assignments arise. Award may also be dependent upon demonstration by the offeror that they have adequately addressed the requirements. The U.S. Government does not fund preparation of proposals or support work efforts or tasks that are inferred from discussions with technical project officers. The Offeror will not be reimbursed for any costs incurred prior to the effective date of the agreement. There are certain post-employment restrictions on former Federal officers and employees as defined in 18 USC 207 and FAR 3.104-4(c).� If an offeror believes a post-employment restriction or conflict of interest exists, notification should be sent to the Agreements Officer prior to initiating efforts on a full proposal. The FOIA (5 USC 552) provides a statutory basis for public access to official U.S. Government records.� �Records� are defined to include documentation received by the U.S. Government in connection with the transaction of public business. Certain types of information submitted to the Government in a process having the potential for award of an OT are exempt from disclosure requirements of 5 U.S.C. 552 (the Freedom of Information Act-FOIA) for a period of five (5) years from the date the Government receives the information.� The types of information listed above may continue to be exempted, in whole or in part, from disclosure after the expiration of the five (5) year period if it falls within an exemption to the FOIA such as trade secrets and commercial or financial information obtained from a person and privileged or confidential. Offerors should mark business plans and technical information that are to be protected for five years from FOIA disclosure with a legend identifying the documents as being submitted on a confidential basis. The Government is prohibited from soliciting and awarding actions to contractors that have engaged or are suspected to have engaged in criminal, fraudulent, or seriously improper conduct. Prospective contractors shall complete electronic annual representations and certifications at https://beta.sam.gov/.� By submission of an offer, the Offeror acknowledges the requirement that prospective awardees MUST be registered in the System for Award Management (SAM) database prior to submitting an invoice and through final payment of any contract resulting from this RPP.� Offerors that are not registered should consider applying for registration immediately upon receipt of this solicitation.� To remain registered in the SAM database after the initial registration, the Offeror is required to review and update on an annual basis from the date of initial registration (or subsequent updates) its information in the SAM database to ensure it is current, accurate and complete. Data submitted that cannot be disclosed to the public for any purpose, or used by the Government except for evaluation purposes, shall be marked on the title page with the below legend and mark each data sheet as follows: TITLE PAGE LEGEND: This Proposal includes data that shall not be disclosed outside the Government and shall not be duplicated, used, or disclosed--in whole or in part--for any purpose other than to evaluate this Proposal. If, however, an agreement is awarded as a result of--or in connection with-- the submission of this data, the Government shall have the right to duplicate, use, or disclose the data to the extent provided in the resulting award. This restriction does not limit the Government's right to use information contained in this data if it is obtained from another source without restriction. The data subject to this restriction are contained in sheets [insert numbers or other identification of sheets]; DATA SHEET MARKING: Mark each sheet of data it wishes to restrict with the following legend: Use or disclosure of data contained on this sheet is subject to the restriction on the title page of this proposal. �Questions regarding this announcement may be submitted by email to richard.w.totten2.civ@mail.mil within 2 days of the closing date. Pursuant to 10 USC 2371b, the Government may pursue production of any Prototype successfully developed under an Agreement, pursuant to the terms of a subsequent follow-on contract or agreement with the participants entered into the Agreement. Any subsequent follow-on contract or agreement may be for a quantity equating up to 10,000 each. Proposals Brochures or other descriptions of general organizational or individual capabilities will not be accepted as a proposal.� All proposals will be assigned an identification number and an email will acknowledge receipt of a proposal. Generally, the Project Manager of the submitting organization should receive a decision letter or email upon completion of the evaluation. Administration: The Government will retain comments and information received in response to this RPP. Do not use Government security classification markings. All written responses must be received by midnight of the due date. Submission should be identified with a Subject Line of Responding Organization and RPP Title. Material that is advertisement only in nature is not desired. Objectives: This Statement of Objectives (SOO) relates to an xTech COVID-19 Ventilator Challenge Special Notice as follows: The Army seeks a low-cost, readily manufacturable emergency ventilator to quickly augment ventilator capacity in the exigent COVID-19 pandemic. The technology solution must provide a rapid response breathing apparatus capable of short-term, rugged field operation. In addition, the ventilator must be low cost, require minimal components, with a small footprint, and designed for mass production. Ideally, the technology would support field hospitals that are still acquiring critical infrastructure such as generators, power distribution and pressurized oxygen. The Army is seeking to support Food and Drug Administration (FDA) emergency approval and scale-up manufacturing and production capacity for ventilators. The scope of this effort is focused on Food and Drug Administration (FDA) regulatory approval and developing manufacturing capacity ventilators to support potential follow-on production. STUDY OBJECTIVES. Key Performance Parameters Food and Drug Administration Approval: The device must have or be capable of receiving Food and Drug Administration (FDA) approval or emergency use approval. �Key system attributes Cost per unit: T=$1000/unit; O=$2500/unit Respiratory rate of 0 to 60 bpm Tidal volume of 50 to 1000 mL Ability to measure and control peak inspiratory pressure Provides Positive End Expiratory Pressure (PEEP) Able to use ambient air, or low pressure oxygen Operational capabilities are provide to help understand the basic operational intent, in order to help derive requirements.� System Design: Technical Viability - Provide information on foundational and proven technologies that you rely on to manufacture and deliver your solution.� Clinical Requirements � The ventilator solution should meet the following: Respiratory rate of 0 to 60 bpm; Tidal volume of 50 to 1000 mL; Ability to measure and control peak inspiratory pressure; Adjustable inspiratory to expiratory time ratio; Ability to support triggered breaths; Provides Positive End Expiratory Pressure (PEEP); Able to use ambient air, or low pressure oxygen. Mechanical Requirements - Rugged enough for a field hospital; Small footprint; Accommodate standard hoses and fittings; Able to use ambient air, or low pressure oxygen. Electrical and Electronic Requirements Able to operate off generator power sources; Able to trigger alarms for key critical parameters, such as disconnect from patients, apnea, pressure, power failures. Usability and Training - The controls and displays in the design should be easily used and read for personnel in full protective gear. The� ventilator will require 30-min. or less training for critical care health professionals who are not respiratory therapists Testing and Validation Adult Test Lung � Provide information on device validation including Adult Test Lung measurement system. Briefly describe the performed testing modalities and results, e.g. Volume Controlled Ventilation Test Compliance, Volume Controlled Ventilation Test Resistance, etc. Materials � The ventilator should use appropriate materials for all components that are consistent with regulations and best practices for medical devices. Reliability � The design will easily operation for 14 days continuously without failure at 100 % duty cycle Software � The software development process controls should prevent ventilator failures Clinical Data � Provide information on preclinical and/or clinical data collected on the device to support regulatory approval. Note: DoD-funded work involving human subjects requires approval from the Human Research Protections Office (HARPO) prior to initiation. Regulatory FDA approval status � Provide information on the current FDA approval status of your device. FDA Regulatory Strategy � If not FDA-approved, provide information on the proposed strategy for rapid FDA approval for emergency use during the COVID-19 crisis. This may include historical FDA communication documents relevant to the product submission. Manufacturability Component Sourcing - Provide your maximum rate of production and lead time of most-difficult to source parts. Design for Manufacturing � Provide information on manufacturing process at scale and current Manufacturing Readiness Level (MRL). Time to 10,000 units � Provide information on time source for 10,000 units. Quality Management System (QMS) � Provide information on current Quality Management System and current Good Manufacturing Practice (cGMP) compliance and/or proposed Contract Manufacturing Operation (CMO) and their QMS. Cost Unit Cost - Provide cost/unit; assume an order quantity of 10,000 units. Evidence � Provide evidence for cost estimate Operational Costs � provide anticipated cost of material required to operate the system. Programmatic Provide a schedule including design testing, FDA regulatory strategy, and scale-up manufacturing phases or events.�� Data Deliverable: Biweekly program updates at a minimum to discuss progress. Proposal submissions should be clear, limited to 15 pages, and provide a technical description of the proposed solution, in addition to substantive cost and schedule information. The proposal should include a cover page (not counted) providing name, type of business, POC�s, CAGE and DUNS. The proposal should also include your ability to meet or exceed the stated objectives. �
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/98ebbf6aae51473691f5c968094dfde6/view)
- Record
- SN05649688-F 20200509/200507230202 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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