JPEO-CBRND-EB seeks to develop a disease-agnostic, integrated platform to identify the most potent antibodies against biological, toxin, and/or chemical threat agents in days.
Questions as of 17 Feb 23: Please clarify that the Project Objective "Provide rapid antigen production meeting government requirements (Minimum 500 micrograms of material in less than 3 months with go... Questions as of 17 Feb 23: Please clarify that the Project Objective "Provide rapid antigen production meeting government requirements (Minimum 500 micrograms of material in less than 3 months with goal for further timeline reduction is highly desirable).” is not a misstatement and that the performer must propose the ability to produce antigens to be used in the project within 3 months? Can the government provide details on the types of antigen production capability required (e.g. subunit protein, inactivated virus, toxin etc). Response: The production requirements are not a misstatement. The Government seeks proposals minimally producing r-protein. ************************************************************************************************************************************************** Questions as of 14 Feb 23: The pre-proprosal is listed as due on Monday Feb 20. That is a federal holiday. I assume this was known and it is truly due on Monday and not Tuesday? Response: The submission date has been moved to 21 Feb 23, 1600 hours. ***************************************************************************************************************************************************** Questions as of 10 Feb 23: Does JPEO have any templates we must use for the preproposal? a. For example, are there templates for the high-level WBS or ROM cost breakdown? Response: No templates are available. Offerors may use their own format. b. Does the title page need to have specific format? Response: No specific format. 2. Question on letters of intent. Response: Letters of intent, letter of support, or any other acknowledgement of subaward intended participation are not required 3. Other than providing the high-level budget document do we need to provide any justifications for costs? Response: A high level justification may be provided. 4. Do we need to address in detail any of the project management objectives stated in the RPP? It appears that these are requirements for any selected organization, but we do not provide a detailed description of our capabilities in each of these areas at this time. Response: A reasonable explanation may be provided to warrant an understanding of the objectives. 5. Is there a mandatory cost share requirement for the OTA. I did not see a referenced requirement. Response: The requirement for cost share is subject to the determination of a traditional defense contractor and no exceptions apply. Below is the statute: In accordance with statute, this authority may be used only when one of the following is met: The awardee is a non-traditional defense contractor OR a small business: “Non-traditional defense contractor” is defined by statute as “an entity that is not currently performing and has not performed, for at least the one-year period preceding the solicitation sources by the Department of Defense for the procurement or transaction, any contract or subcontract for the Department of Defense that is subject to the full coverage under the cost accounting standards prescribed pursuant to Section 1502 of title 41 and the regulations implementing such section.” “Small business” is defined under section 3 of the Small Business Act (15 U.S.C. 632). The awardee is a traditional defense contractor, but at least one of the following applies: At least one non-traditional contractor is participating to a “significant” extent All significant participants in the transaction other than the Federal Government are small businesses (including those participants in the Small Business Innovation Research (SBIRS) or Small Business Technology Transfer (STTR) program or nontraditional contractors. The awardee provides a financial or in-kind cost share – typically, a 1/3 cost share is required. However, the Government should not generally mandate cost-sharing requirements for defense unique items. The Service Acquisition Executive makes a written determination that exceptional circumstances justify the use of OTA for the purpose of executing innovative business models or structures that would not be feasible or appropriate with a FAR-based contract. 6. when do you anticipate posting Q&As? Response: All questions as of 10 Feb 23 are now posted. ***************************************************************************************************************************************************** Edgewood Contracting Division, Fort Detrick Request for Project Proposal W911SR-23-R-GUIDE Agency: Department of the Army Office: Army Contracting Command, Edgewood Contracting Division Location: Fort Detrick, MD, USA Program Office: JPEO CBRND Enabling Biotechnologies RPP Number: W911SR-23-R-GUIDE Date Issued: 3 Feb 2023 Proposals Due: 20 Feb 2023 NLT1600 EST 1. Through this Request for Project Proposal (RPP), the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense, Enabling Biotechnologies (JPEO-CBRND-EB) seeks to develop a disease-agnostic, integrated platform to rapidly identify the most potent antibodies against biological, toxin, and/or chemical threat agents as described in the attached Statement of Objectives (SOO). In accordance with Section III.F of announcement CBRND BAA 22-01, the Government is hereby requesting formal submission of preproposals to execute a formal agreement under 10 USC 4022, Other Transaction Authority (OTA) for the prototype project described below: • Upon receipt of a preproposal 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.) 2. This RPP is issued to request project proposals in compliance with USC 4022 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. 3. The JPEO-CBRND-EB was established to rapidly develop, manufacture, and deliver Medical Countermeasures (MCM) for emergency use. Recognizing the difficulty in coordinating a whole of government response to the SARS-CoV-2 pandemic, JPEO-CBRND-EB understands limitations in current MCM development is not rapid enough to effectively prevent infectious disease outbreaks, which impedes warfighter readiness. By leveraging the lessons learned and best practices from the response to the SARS-CoV-2 pandemic and the USG experience in developing an anti-SARS-CoV-2 therapeutic, the JPEO-CBRND-EB seeks to develop a disease-agnostic, integrated platform to identify the most potent antibodies against biological, toxin, and/or chemical threat agents in days. This effort intends to result in a platform that can feed other JPEO-CBRND-EB programs, e.g. Accelerated Antibodies and Generative Unconstrained Intelligent Drug Engineering (GUIDE), and substantially accelerate supply of the safe and efficacious MCM products against biological, toxin, and/or chemical threats for emergency use. Any resultant award may be issued as a prototype Agreement under the authority of 10 USC 4022, with the expectation that quantities necessary for fielding and testing new capabilities may be non-competitively awarded to the successful performer(s) of a prototype agreement in a follow-on production contract or other transaction. 4. The Government will review/evaluate the submitted preproposals and if there is Government interest, the Agreements Officer may issue a request for full proposal (RFFP) 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. 4022b 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. 5. Evaluation will be performed by JPEO-CBRND personnel, other Federal Agency Representatives or combinations thereof based on evaluation and selection of the best preproposal submission, and/or 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. 6. 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. 7. 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. 8. 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. 9. 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. 10. 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: a. 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]; b. 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. 11. Questions regarding this announcement may be submitted by email to Richard.w.totten2.civ@army.mil within 5 business days of the closing date. 12. In accordance with 10 U.S.C. § 4022(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. This requirement does not include follow-on production. 13. Proposals Brochures or other descriptions of general organizational or individual capabilities will not be accepted as a preproposal. 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 and determination. 14. 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 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. Late submissions will not be considered. 15. Requirements: See Attached Statement of Objectives (SOO). 16. Submissions: Preproposals should be limited to eleven pages (not including cover sheet) 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 must also include an anticipated rough order of magnitude (ROM) cost for the efforts described in the preproposal, including a high-level breakdown of the elements of cost for consideration (labor, hours, materials, ODC’s, other costs, indirects and fee). Preproposals shall be submitted to the following email address prior to the closing date noted above: usarmy.detrick.mcs.mbx.baa@mail.mil and Richard.w.totten2.civ@army.mil. EVALUATION FACTORS: The following factors will be considered during evaluation (in no particular order): Relevance. Projects must be directly relevant to the ultimate purpose of achieving the objective identified in the SOO. Funds Availability. The Government must have funds available to support the proposed work. Project Objectives. The stated objectives must be clear, valid and logical. Projects that demonstrate an innovative approach are desired. Facilities. Describe the proposed facilities and equipment, or unique combinations of these, in detail to demonstrate that the organization has, or may access, the necessary facilities required for the accomplishing the proposed objectives. Budget/Cost. The budget must reflect the actual needs of the proposed work and be fully justified so that the U.S. Government can evaluate and determine the cost to be fair and reasonable and commensurate with the complexity and nature of the work proposed. SELECTION FOR AWARD: Subject to availability of funds, if agreeable terms are reached after evaluation of the proposal and negotiations, an award will be made. ATTACHMENT 1 STATEMENT OF OBJECTIVES DESCRIPTION/OBJECTIVE OF THE PROJECT: The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense, Enabling Biotechnologies (JPEO-CBRND-EB), has been established to rapidly develop, manufacture and deliver Medical Countermeasures (MCM) for emergency use. Recognizing the difficulty in coordinating a whole of government response to the SARS-CoV-2 pandemic, JPEO-CBRND-EB understands limitations in current MCM development is not rapid enough to effectively prevent infectious disease outbreaks, which impedes warfighter readiness. By leveraging the lessons learned and best practices from the response to the SARS-CoV-2 pandemic and the USG experience in developing an anti-SARS-CoV-2 therapeutic, the JPEO-CBRND-EB seeks to develop a disease-agnostic, integrated platform to identify the most potent antibodies against biological, toxin, and/or chemical threat agents in days. This effort intends to result in a platform that can feed other JPEO-CBRND-EB programs, e.g. Accelerated Antibodies and Generative Unconstrained Intelligent Drug Engineering (GUIDE), and substantially accelerate supply of the safe and efficacious MCM products against biological, toxin, and/or chemical threats for emergency use. STATEMENT OF OBJECTIVES (SOO): Prototype Project Objective In response to a dynamically changing chemical and biological weapons threat landscape, and increasing potential for novel pathogens, the JPEO-CBRND-EB has been established to rapidly develop, manufacture and preposition MCMs for emergency use. JPEO-CBRND-EB is seeking a capability which provides: An integrated discovery platform capable of identifying antibodies with a high probability of efficacy and developability. The ability to begin a discovery campaign with or without the availability of convalescent serum from exposed human subjects. The ability to identify multiple non-interfering candidates, potentially including candidate specificities that are rare in the general population pool. The ability to internally or through subcontractors reliably and efficiently produce all required discovery and assay reagents and to develop all required assays needed for effective candidate selection and screening. An ability to screen and optimize candidates for known or predictable safety or developability liabilities. The ability to perform IND-enabling proof of concept animal efficacy studies. Government access to the above-described capabilities on a routine basis to address the specific needs of the Chem/Bio defense program. Negotiated mechanisms for immediate Government access to the above-described capabilities in the event of an emergency. Performance Objectives (required results) Project Objectives The primary objective of this effort is to rapidly and cost-efficiently develop and preposition MCM product prototypes for the national security preparedness. The objectives include: Exercise discovery platform at least 1 time per year at the Government’s direction for antigen of government choice to provide best candidate MCM. Continuously improve the efficiency of the platform to provide viable and highly effective candidates for further development to enhance platform’s ability to provide more robust and/or accelerated MCMs. Provide rapid antigen production meeting government requirements (Minimum 500 micrograms of material in less than 3 months with goal for further timeline reduction is highly desirable). Small-scale manufacturing appropriate to support Awardee proposed non-clinical testing (in vitro and in vivo). In vitro or in silico screening and optimization of identified candidate MCMs for potential safety or manufacturing issues. Small animal studies using the candidate MCM of the Government’s choosing in appropriate species to show proof-of-concept efficacy. Project Management Objectives It is anticipated that the offeror will be required to submit several documents to capture the progression of the project, post-award. Requirements may include, but are not limited to the following: A001 Quality Agreement Upon agreement award, the offeror will provide a draft Quality Agreement within 10 calendar days after award. The Government will respond with comments or acceptance 10 calendar days following receipt of the draft Quality Agreement. The final agreement with incorporated changes shall be submitted 5 calendar days after receipt of Government comments. The Government will provide written acceptance. The offeror will submit via e-mail in Microsoft Office format to the Government representatives listed in the RPP. A002 Meeting/Teleconference Minutes The offeror shall provide meeting minutes within 3 calendar days after all meetings/teleconferences conducted with JPEO-CBRND-EB. Frequency depends on number of meetings and teleconferences. A003 Monthly Progress Report The Monthly Progress Report shall contain regular status updates of all Intellectual Property (IP) license(s) related to the effort, in order to ensure that all license(s) are in good standing as the project progresses. In the event of any change in IP license(s) status or potentially imminent change in status, the offeror shall immediately contact the Agreements Officer (AO), Agreements Officer’s Representative (AOR) and, by telephone or e-mail communication. The Monthly Progress Report shall contain the technical progress made during the previous month and the updated resource-loaded master schedule (IMS) in Microsoft Project format. The schedule update shall include the explanation for any changes in the schedule, as well as drivers for the change, as applicable. The report will also address any concerns the Principal Investigator might have that would impact the performance, schedule, or cost planned for the effort. The offeror shall report using risk matrix format, to include risk mitigation strategies. Submission shall be 15 calendar days after the end of each month of performance. The Government will have 10 calendar days to respond to the report with any comments, and the offeror will have an additional 5 calendar days to revise the deliverable or respond to those comments. These reports will be used by the Government to assess both technical and schedule performance and will serve as milestones to allow invoicing for work executed to date. A004 Annual Report The annual report shall narrate a complete summary of the project execution and associated results obtained, to include project results and accomplishments, issues encountered and recommended solutions. The report shall also address tasks that were not completed, reasons for non-completion, and a plan to accomplish the tasks or alternative approach to accomplish project goals, and as needed, an updated Statement of Work (SOW). Submission shall occur within 15 calendar days of the anniversary date of award per annum. The Government will have 30 calendar days to respond to the report with any comments, and the offeror will have an additional 10 calendar days to revise the deliverable or respond to those comments. A005 Final Report A Final Report shall be prepared at the end of the effort. A final report shall be provided whether any or all of the project Stages are completed. This report takes the place of the last annual report due (a financial report is still required). The report shall narrate a complete summary of the project execution and associated results obtained. The narration will include outstanding problems and their potential solutions, and problems solved during the course of the year(s), along with the solution to the solved problems. The report shall demonstrate how the prototype was advanced. The offeror shall submit a Draft Final Report by the 30th calendar day following the end of the project period of performance. The Government shall provide comments to the offeror by the 30th calendar day following receipt of the offeror’s Draft Final Report. The offeror shall submit the Final Report on the 30th calendar day after receipt of Government comments. A006 Master Government Property – Physical Inventory During performance of the agreement, the offeror may purchase material or equipment using Government funds [Contractor Acquired Property (CAP)] if approved by the AO and/or AOR. The offeror shall perform, record, and disclose physical inventory results of all CAP in the offeror's possession. A007 Patents – Reporting of Subject Inventions In accordance with the terms and conditions of the agreement. A008 Expenditure Forecast The offeror shall submit the first expenditure forecast within 30 calendar days after award. An updated forecast shall be submitted within 15 calendar days of any agreement modifications that change the period of performance or the cost of the agreement. The monthly expenditure forecast submission shall include analysis of the cost drivers for Estimate to Complete changes, if any, from the previous month’s projection. All submissions must be provided in Excel format, including all formulas. The expenditure forecast shall be submitted 15 calendar days from the start of each month, and shall include both the monthly planned accrual and the cumulative total. A009 Miscellaneous Data Submissions Required submissions include but are not limited to, Point Papers, Briefings, Target Product Profile (TPP), Product Development Plan (PDP), Regulatory Strategy, Technology Transfer Report and Gap Analysis, Formulation Development, Feasibility and Optimization Reports, Animal Care and Use Review Office (ACURO) Approvals, and Technical Presentations and Publications. In addition, the offeror shall provide any formal technical reports that have been prepared for eventual submission to FDA or other regulatory agencies. This is to include reports on Pharmaceutical Development, Manufacturing Development, Manufacturing Validation, Analytical Development and Validation, Drug Substance and Product Stability, and the like. The offeror shall also submit completed batch records, certificates of analysis, and the like. A010 Work Breakdown Structure (WBS) The offeror shall provide a four-level WBS with costs and schedule (top level is program, level 2 is Stage, level 3 are major tasks, level 4 are subordinate tasks). For the lowest task level, the offeror shall provide a breakdown for labor, material, and other indirect costs. The WBS shall be updated annually or 30 calendar days after a SOW modification. Government review/approval is 15 calendar days after receipt of first submittal. The offeror shall provide changes to the draft within 10 calendar days of such request. The offeror shall provide the final document within 10 calendar days after approval of changes is received from the Government. A011 Integrated Master Schedule (IMS) The offeror shall provide within 15 calendar days after agreement award, an IMS in Microsoft Project format. Any updates to the IMS shall be included in the monthly progress reports. Any event that impacts the critical path by more than 30 days shall result in an off-cycle IMS update. Submission shall be 15 calendar days after the end of each month of performance. The Government will have 10 calendar days to respond to the report with any comments, and the offeror will have an additional 5 calendar days to revise the deliverable or respond to those comments. Operational Constraints/Limitations/Restrictions: Not Applicable PERIOD AND PLACE OF PERFORMANCE: The anticipated Period of Performance for this effort is up to 5 years from date of award. Specific dates to be negotiated. It is anticipated that the primary place of performance will be the contractors’ facilities, however this aspect can be negotiated as part of each Offerors’ submission. DELIVERABLES: The contractor will be required to provide a number of deliverables throughout the course of this project, categorized as either Data or Prototype. DATA DELIVERABLES: Data deliverables include meeting minutes, financial reports, technical progress reports, annual reports, property inventory, patents and invention reports, regulatory documentation and technical data packages, forecasts, WBS, IMS, copies of FDA submissions, FDA correspondence, Office of Research Protections (ORP) correspondence, Regulatory Strategy, TPP, and any other data necessary to document the product development. In addition, there will be collection, curation, and storage of the data in the Government-issued data format for future transfer to the Government. The Government is seeking unlimited rights to the data generated through the performance of any resultant agreement. SPECIAL REQUIREMENTS: Export Control: In accordance with applicable laws and regulations. Security and Classified Data: The security classification level for this effort will be Unclassified. In the event that Controlled Unclassified Information is provided or must be generated under this agreement, it is subject to the safeguarding and reporting requirements of the terms of the agreement. Travel: No specified Government travel. GOVERNMENT FURNISHED PROPERTY: Not Applicable FUNDING CONFIDENCE LEVEL: CL-2: Moderately confident funds will be available.
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