1. Prototype development of an FDA approved electroporation device

Request for Project 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 Enabling Biotechnologies RPP Number: W911QY-20-S-0012 Date Issued: 19 May 2020 Proposals Due: May 25, 2020 by 11:59 PM EST Prototype development of an FDA approved electroporation device compatible with delivery of an intradermal DNA vaccine. This Prototype project is a combination of an agile development activity, design, and demonstration of the technical and operational utility of a product to move forward to FDA licensure. In accordance with Section III.F of announcement MCS BAA-17-01, the Government is hereby requesting formal submission of preproposals to execute a formal agreement under 10 USC 2371(b), Other Transaction Authority (OTA) for the prototype project described above: Upon receipt of a proposal submitted in response to this RPP, the next steps are as follows: The Government will evaluate the preproposal. Discussions among the parties, whether verbally or in writing, will occur as appropriate. The Government may request a full proposal from the offeror. Additional discussions will occur as necessary. Award may be made after evaluation and selection of a successful proposal. (Note: Awards are dependent upon the availability of funds.) This Request for Project Proposal (RPP) is issued to request project preproposals 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. Preproposals 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: contact@example.gov The Government will review/evaluate the submitted preproposals and if there is Government interest, the Agreements Officer may issue a request for full proposal in response to this RPP. The Government may award an agreement based on the proposal submission, or may require submission of additional details. The award of Prototype agreements 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 JPEO-CBRND Enabling Biotechnologies (EB) personnel, other Federal Agency Representatives, outside scientists with diverse expertise, clinicians, consumers, or combinations thereof based on evaluation and selection of the best preproposal submission, and subsequent full proposal submission. After evaluation and selection, an award will be made to the successful offeror(s). 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 Freedom of Information Act (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 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 awardees that have engaged or are suspected to have engaged in criminal, fraudulent, or seriously improper conduct. Prospective awardees 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 contact@example.gov within 2 days of the closing date. In accordance with 10 U.S.C. - 2371b(f), the Government may award a follow-on production contract or Other Transaction (OT) for any OT awarded under this BAA if: (1) that participant in the OT, or a recognized successor in interest to the OT, successfully completed the entire prototype project provided for in the OT, as modified; and (2) the OT provides for the award of a follow-on production contract or OT to the participant, or a recognized successor in interest to the OT. Follow-on production is anticipated to 3 million arrays and 100 devices. Proposals Brochures or other descriptions of general organizational or individual capabilities will not be accepted as a preproposal. All preproposals 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. Requirements: JPEO-EB is requesting proposals with the following objectives:Offeror shall provide for the development of device compatible with electroporation of intradermal delivered DNA plasmid Offeror shall provide documentation for any FDA regulatory interactions for this device or similar device Regulatory strategy to secure necessary FDA clearance of the device within 6-9 months. Offeror shall provide information on scaling the device and associated consumables for use in a pandemic response. (for example supporting 10M vaccinations in the next 12 months) Offeror shall provide a description of location of production and associated supply chain for the device and consumables associated Offeror shall provide a device that is logistically supportable for wide spread use Offeror shall provide options for procurement of devices and consumables for use by the DoD in clinical settings and beyond 17. Submissions: Preproposals should be limited to three to five pages, and include a description of the relevant technology including supporting data, the scope of the proposed effort including a high-level Work Breakdown Structure (WBS), and a description of the proposer's research, development, manufacturing, past performance, or other special qualifications. The preproposal should indicate the Technology Readiness Level (TRL) level of the proposed design per the TRL level definitions found in Attachment 0001 of the MCS BAA 17-01, publically available at beta.sam.org, keywords MCS BAA 17-01. The preproposal must also include an anticipated cost for the efforts described in the preproposal. Preproposals shall be submitted to the following email address: contact@example.gov.